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FDA Attacks Claims for Reflexology Device (1976)

In the mid-1970s, I received a brochure for the Rowe Reflex-O-Sage Hand & Foot Roller, which was developed and marketed by Lowell V. Rowe (1920-1997), a chiropractor who practiced in  Hot Springs, Arkansas. The brochure claimed that rolling the device on the hand or foot would relieve many ailments: Reflexology, upon which the device was …

In the mid-1970s, I received a brochure for the Rowe Reflex-O-Sage Hand & Foot Roller, which was developed and marketed by Lowell V. Rowe (1920-1997), a chiropractor who practiced in  Hot Springs, Arkansas. The brochure claimed that rolling the device on the hand or foot would relieve many ailments:

Reflexology, upon which the device was based, is a pseudoscience whose proponents claim that each body part is “represented” on the hands and feet and that pressing on specific areas on the hands or feet can have therapeutic effects in other parts of the body.

The brochure was accompanied by an article in which Rowe outlined a plan to donate money to chiropractic colleges. The device retailed for $11.95. If 5,000 or 6,000 chiropractors averaged 5 sales per month, he would donate $3 per sale which total about  a million dollars annually. The article also contained this disclaimer:

I am not suggesting that doctors or the colleges endorse this product. As the brochure points out, Rowe Reflex-O-Sage was designed for massage therapy or sub-clinical conditions. We make no clinical claims that would take away from your professional image. Nor is it contrary to F. D. A. regulations. Rowe Reflex-O- Sage is responsible for all contents of the Brochure.

It turned out, however, that the FDA saw things differently. On May 20, 1976, Rowe’s company issued this notice:

URGENT: DEVICE LABELING RECALL

The U. S. Food & Drug Administration has alleged that the labeling and literature accompanying the Rowe Reflex-O-Sage Device is false and misleading as to health claims, and fails to bear adequate directions for the use of the device. Consequently, pursuant to the request of the FDA, we are recalling all Reflex-O-Sage literature and labeling.

Please fill out the enclosed card if you are a purchaser or distributor of the Reflex-O-Sage device, and return it by· means of the enclosed return envelope. If you have in your possession any Reflex-O-Sage labeling or literature, please return it immediately by means of the enclosed envelope so that it might be destroyed.

This recall is being made with the knowledge of the U. S. Food & Drug Administration and the Arkansas Department of Health. We appreciate your assistance.

Melinda Bacon
Director of Sales

 

I received no further mail about this device and can find no information about it by searching with Google. So it looks like its marketing was short-lived.



Quackery-Related Depositions

This page provides convenient access to depositions in quackery-related lawsuits and regulatory actions. Some include admissions that severely dimish the credibility of the deponents. Alvin Arzt, DDS (dental malpractice suit, 10/19/95) Robert C. Atkins, MD (false advertising case, 6/25/80) Kenneth Bock, MD (chelation case, 2/27/04) Tim Bolen (Cavitat case, 4/12/06) Jerry E. Bouquot, DDS Disciplinary …

This page provides convenient access to depositions in quackery-related lawsuits and regulatory actions. Some include admissions that severely dimish the credibility of the deponents.



A Skeptical Look at Deborah E. Banker, M.D.

Deborah Ellen Banker, M.D. (1952-2007), was an ophthalmologist who died of breast cancer [1] during a period when the Medical Board of California was questioning her fitness to practice. The DrBanker.com Web site, which has been maintained by one of her long-time associates, describes her this way: In The Field of Ophthalmology and Regenerative Nutrition …

Deborah Ellen Banker, M.D. (1952-2007), was an ophthalmologist who died of breast cancer [1] during a period when the Medical Board of California was questioning her fitness to practice. The DrBanker.com Web site, which has been maintained by one of her long-time associates, describes her this way:

In The Field of Ophthalmology and Regenerative Nutrition For The Eyes, Dr. Banker recognized that the health of the entire body, as well as nutrition and attitude, has a great deal to do with vision, energy of the body and the aging process. Dr. Banker’s non-invasive approach to vision improvement combines techniques of Western, Oriental and Holistic medicine. Dr. Banker’s approach to Non Surgical, Alternative Eye Care integrates modern medicinal understanding of optics, refraction and anatomy along with ancient techniques such as Yoga, Chinese Acupressure, Tai Chi, Ayurveda, Tibetan eye exercises, Japanese Shiatsu, Chinese Medicinal Herbal Eye Care Supplements, and more—along with classic Western Orthoptics and Holistic Ophthalmology. Dr. Banker’s associates work with people both on an individual basis and in group sessions and classes offered several times per year. Dr. Banker’s personally trained associates will guide you through Self Help Vision Improvement exercises for your body and eyes originating from all over the world, such as Bates, Ballet, Kinesiology, Polarity Therapy, Reflexology, Auricular Therapy, Energy Healing, Anti-Aging Techniques, Manual Energy Transfer, Massage and more. Called a “Modern Galileo” by the National Health Federation, Dr. Banker lectured throughout the country crusading for Electromagnetic Medicine and Natural Vision Improvement [2].

The Web site describes Banker’s “electromedicine” this way:

For more than 100 years, electromagnetic medicine has been used to treat various diseases of the body with great success, especially those for which there have been no cures. But little is known to the general public. Electromagnetic medicine dates back as far as 1882 to the work done with batteries by Dr. S.E. Morrill M.D.

Dr. Banker has incorporated twenty years of scientific research on the human electromagnetic field into her specialty of regenerative medicine for the eyes. This knowledge led to the creation of her patented SEEDS machine. Dr. Banker employs electromagnetic medicine or microcurrent stimulation as an integral part of her unique treatment program along with other traditional healing methods and alternative modalities. She uses a microcurrent stimulating device she invented, SEEDS (subtle electromagnetic energy device system), to stimulate energy and life force into damaged or traumatized nerve cells and tissue. In many cases, the nonfunctioning nerve is swollen, not dead, and can be reactivated.

We see tremendous results using the SEEDS system on degenerative eye diseases such as Macular Degeneration, Diabetic Retinopathy, Vascular Retinal Disease, Retinitis Pigmentosa, Glaucoma and Blindness. Besides improving many forms of progressive blindness, the SEEDS machine helps to reset the autonomic nervous system, boosts the immune system, has brought people out of comas and helps reverse many types of degenerative eye diseases. Dr. Banker has thousands of case studies showing miraculous improvements with diseases formerly considered incurable. Some of the “Transcutaneous Electrical Nerve Stimulation” (TENS) devices currently used in the medical treatment of neurological eye diseases are the SEEDS System, the Electro-Acuscope 80, the Micro Stim 100 and other microcurrent systems [3].

Although she claimed to have done research, I was unable to locate any research reports published under her name in a scientific journal or elsewhere. Nor could I locate any details about the SEEDS device.

Her 286-page book Self-Help Vision Care [4] contains hundreds of recommendations for exercises, dietary systems, dietary supplements, Bach flower remedies, and herbal products, not just for eye problems but for dozens of other ailments. Most of the recommendations were useless but physically harmless, but her recommended dosage of vitamin A (25,000 to 50,000 IU per day) was high enough to cause liver toxicity and some of her dietary suggestions could led to dietary inadequacy.

Her acupressure recommendations illustrate her extreme departure from rational medical care. The chart below from page 6-5 of the book is followed by a 3-page table that says which points should be pressed or “shaken” to treat astigmatism, blurry vision, cataract, colds, color blindness, conjunctivitis, diabetes, dizziness, dry eyes, excessive tearing, facial paralysis, facial paralysis, farsightedness, glaucoma, headache, infantile convulsions, insomnia, jaw spasm – grinding teeth, macular degeneration, nearsightedness, night blindness, optic atrophy, pain/swelling, retinitis pigmentosa, sinusitis, tooth problems, twitching eyelids, and several other conditions.

To use the book, she recommends that you try what seems to suit your needs and personality and “check your vision before and after your exercises or methods, to see which ones improve your eyes the fastest and stick with these the most, but do all of them periodically.” A more appropriate title for the book would be Delusional Medicine: A Handbook for People Who Are Clueless.

People who wanted more guidance could order Banker’s Self Help Vision Care Kit—which included a workbook, five tapes, a vision game, and laminated charts—or could purchase phone consultations, self-improvement classes, or a week of treatment (approximately 30 hours) at the Malibu Life Center, which cost $4,000 in 2002 [5].

Medical Board Actions

Dr. Banker received her premedical training at the University of Colorado and obtained her medical degree in 1978 from the University of North Dakota. She completed a residency program in ophthalmology at the University of California, Irvine, but did not become board-certified. She had additional training in acupuncture and Oriental medicine. She became licensed in Colorado in 1988 and practiced there, but failed to renew her license in 1997. In 1998, the Colorado State Board of Medical Examiners charged her with unprofessional conduct and summarily suspended her license. The board was concerned that she was (a) practicing after her medical license had lapsed, (b) treating macular degeneration patients with electrotherapy, massage, and other nonstandard modalities, and (c) prescribing controlled substances after her narcotics license had expired. A few months later, the matter was settled with an agreement under which she was not found to have engaged in unprofessional conduct but would never apply for reinstatement of her Colorado license.

After leaving Colorado, she began practicing in California, which had licensed her since 1989. However, based on what had happened in Colorado, the California Medical Board wanted her competence evaluated. In 2000, she signed a stipulation under which she was reprimanded, was assessed $2,000, and agreed to complete the Physician Assessment and Clinical Education (PACE) Program at the University of California, San Diego, School of Medicine. However, she did not complete the program and told the board:

  • She could not afford the cost of the program because her income was low and the Internal Revenue Services, to which she owed $100,000, had seized money that she was saving to pay for the program.
  • She could not study adequately for the assessment because her vision was impaired.
  • She was concerned that she would not pass the tests given to PACE participants because they were based on Western medicine while most of her medical practice is grounded in alternative medicine.
  • She did not want to undergo a physical and mental examination at PACE because her physical and mental states were never at issue in either the Colorado or California disciplinary action.

In 2006, after additional proceedings, the board placed her on probation for a minimum of two years and indicated that failure to complete the PACE program within a year would be considered a violation of her probation. She was also ordered to pay $$6,706.75 for prosecution costs and was banned from practicing medicine from home [6]. It would be interesting to know whether or not PACE’s examiners would have judged her mentally competent to return to practice, but she appears to have died before they could do so.

Current Promotion

Banker’s methods and products are now promoted by John Monroe, of Boulder, Colorado, who describes himself as a “Natural Vision Educator.” In a recent podcast, he said:

I met Dr. Banker back in the early ’90s like ’91, and I started working with her full time in 1993, so I’ve been doing this over 20 years now. She developed the Self-Help Vision Care Kit. It’s basically used for improving nearsightedness, farsightedness, presbyopia, which is trouble reading small print. We also use it for amblyopia, lazy eye. It’s also used to help get more energy and blood circulation to the eye which can help with eye diseases like macular degeneration, diabetic retinopathy, retinitis pigmentosa. We also work with glaucoma and cataracts.

We’ve had people who are children, adults, seniors. People in their 80s and 90s work with this. We also use attitude changes, lifestyle changes, environmental changes. We also go into diet, nutrition, supplements, herbs, vitamins, Chinese herbal medicines that we’ve been using for years. We’ve helped reverse eye problems and halt the progression of them. If we catch these problems in early stages, the eye diseases and things, it’s a lot easier to reverse them. And then, depending on how strong your prescription is on your glasses and contacts and bifocals and readers, that determines how long it will take to eliminate your need for the glasses.

Among other things, Monroe claimed that exercise can strengthen and improve circulation in the muscles that control the eye, which can help improve such problems as macular degeneration, retinitis pigmentosa, and diabetic retinopathy [7]. DrBanker.com still markets Banker’s book, herbal products, supplements, and “Natural Vision Improvement Workshops.”

Potential Danger

The idea that exercise can improve vision was popularized in the early 1900s by William Horatio Bates and thoroughly debunked by the scientific community [8]. Banker wrote that Bates was correct but said that other techniques she had added improved on what he advised [4]. I believe that for most people, following her advice would be a waste of time, money, or both. But for those with age-related macular degeneration (AMD), it could prove dangerous. In the most serious form (called wet AMD), blood vessels behind the retina grow and leak fluid, which distorts the retina, causes scarring, and interferes with central vision. If detected early, the growth and leakage can usually be controlled by periodic injections into the eye of a drug that stops the abnormal blood growth [9]. If not treated, most of the person’s vision will be lost. The earlier that treatment is started, the better the outcome will be, which means that delaying treatment by pursuing ineffective methods—in some cases, even for a few days—can have serious consequences.

Dr. Banker was only 55 when she died of breast cancer. It would be interesting to know whether her negative feelings about standard medical care influenced her survival time.

References
  1. Obituary: Deborah Banker. The Malibu Times, May 30, 2007.
  2. Deborah E. Banker, M.D.: ophthalmologist / general practitioner, internationally known lecturer in health and vision improvement. DrBanker.com Home page, accessed November 30, 2019.
  3. Research. DrBanker.com, accessed June 26, 2020.
  4. Banker DE. Self Help Vision Care: The Best Preventive Eye Care of Western, Oriental and Wholistic Medicine. Printed by Malibu Life Center Foundation, Malibu, California, March 1994.
  5. Products. DrBanker.com, archived Dec 9, 2002.
  6. Decision after nonadoption. In the matter of the accusation against Deborah Ellen Banker, M.D. before the Medical Board of California, Case No. 16-1999-95260, Dec 14, 2005. (Includes all the previous regulatory documents to which the article refers.)
  7. Monroe J. Healthy eyes and ears. Aging Info Radio podcast, Jan 17, 2016.
  8. Pollack P. The Bates system. In Pollack P. The Truth about Eye Exercises, Chiulton Co., Philadelphia, 1956.
  9. Barak Y and others. The past, present, and future of exudative age-related macular degeneration treatment. Middle East African Journal of Ophthalmology 19:43-51, 2012.


Sparks Fly at Denenberg Hearing on Chiropractic (1972)

During the 1970s, chiropractors campaigned relentlessly for a law that would force Pennsylvania Blue Shield to pay for chiropractic x-rays. In  1972, while one such bill (H.B. 816) was being considered, Insurance Commissioner Herbert S. Denenberg scheduled a hearing to consider a Blue Shield request to increase its premiums. When I asked him to include …

During the 1970s, chiropractors campaigned relentlessly for a law that would force Pennsylvania Blue Shield to pay for chiropractic x-rays. In  1972, while one such bill (H.B. 816) was being considered, Insurance Commissioner Herbert S. Denenberg scheduled a hearing to consider a Blue Shield request to increase its premiums. When I asked him to include discussion of chiropractic’s role in health care, he agreed to do so and invited me to testify.

Denenberg, who was sometimes referred to as “the Ralph Nader of Insurance,” had spoken out repeatedly about excessive medical costs and the overuse of x-rays by medical doctors and dentists. About a year before the hearings were held, I suggested that he also look at chiropractic use of x-rays. He invited me to meet with a member of his staff and to send relevant documents, which I did. He also received reports from the Pennsylvania Medical Society.

My concern about chiropractors was largely provoked by chiropractic ads that greatly exaggerated what they could do. About six months before the hearing, syndicated columnist Jack Anderson became interested in this topic and asked me to keep him informed. At that time, a practice-building organization called Share International marketed collection of newspaper ads that it said had been used effectively in many parts of the country. The instructions for the ads said: ““Re-type each ad on your own stationery for presentation to your editor. This would indicate that they are your own creations, and that the cases mentioned, conditions discussed, etc., are from your own files.” [1]

One of the chiropractors lobbying for passage of the insurance bill was Monroe Schneier, D.C., president of the Pennsylvania Chiropractic Association. Schneier was newsworthy because he had treated Pennsylvania Governor Milton J. Shapp and had contracted with the state to evaluate chiropractic invoices to the Medical Assistance program. Nine days before the hearing, after learning from me that Schneier was using the Parker advertising system, Anderson reported this [2] and Philadelphia’s press outlets amplified the story. During the evening before the Denenberg hearing, I notified the network TV newsrooms that I would be testifying at the hearing and would display the ads.

The hearing was fascinating. Denenberg had done his homework. During the morning  he displayed studies which concluded that chiropractic had no scientific validity and was dangerous. He also asked chiropractors whether they had “anything to really refute these studies” and they said no. During this time and in the early afternoon, no TV crews were present and I began to worry that they would not show up. But five minutes before I was scheduled to testify, two camera crews rolled in. As I approached the podium their floodlights went on, which made it clear to everyone that they had come to film me!

I spoke about the shortcomings of chiropractic education, deceptive advertising, and the probable costs of H.B. 816. In addition to displaying ads in which Schneier had advertised case histories of patients whom he had never seen, I showed ads from other Pennsylvania chiropractors who claimed they could treat gall-bladder disease, heart disease; flu, ulcers, high blood pressure, and hundreds of other conditions. Then I played part of a speech by a prominent chiropractor who says that everyone should see a chiropractor at least once a week for what he called “preventative maintenance.”  I also suggested  that “if chiropractors and their patients want insurance, they should start their own company.” [3]

After I finished, Denenberg invited Schneier and two other chiropractors to join me for a “roundtable discussion.” However, instead of responding to the content of what I had said, Schneier asserted that my testimony was invalid, that I knew nothing about chiropractic, had not studied it, had not practiced it, had not researched it, and had merely presented my own “biases.” After droning on for several minutes about supposed chiropractic benefits and medical shortcomings, he said again that “no one but chiropractors are capable of talking about chiropractic coherently.” At that point, Denenberg referred to the critical studies he had reviewed, which Schneier (incorrectly) claimed were outdated, and they argued back and forth for about half an hour more. The TV crews stopped filming about a minute after Schneier began to speak.

On the day of the hearing, Denenberg issued a news release that cited the H.E.W. Report in Chiropractic and two other reports that were very critical of chiropractic [4]. Newspapers also notred that he handed out a statement that called chiropractic a “cult” and said that Pennsylvania should reconsider its policy of licensing them [5,6]. After the hearing, I told my local legislators that voting for H.B. 816 at the same time the Insurance Commissioner might make headlines opposing it would not be politically smart—and I asked them to point this out when they caucused with other legislators to discuss the bill.

The chiropractors apparently panicked. Instead of waiting until the heat died down, their lobbyists pressured the bill’s sponsors for an immediate vote. This backfired, however, and the bill was defeated by a vote of 107 to 70.

One week later, Schneier ran an ad which characterized the critical studies presented the hearing as the “historical equivalent” of a “scientific study” that the Nazis used in 1952 to “prove” that “Jews were an “inferior and dangerous people who should be exterminated.” [7]

A law was eventually passed to force Pennsylvania Blue Shield to pay for chiropractic x-rays. But the publicity generated by Jack Anderson’s column and the Denenberg hearing helped to delay its passage for several years.

References
  1. Barrett S. Share International’s fraudulent ad system. Chirobase, Nov 14, 2014
  2. Anderson J. Shapp’s chiropractor.  Sept 18, 1972.
  3. Transcript. Public Hearing on Premium Request of Blue Shield of Pennsylvania and the Health Care Delivery System in Pennsylvania. Philadelphia, Sept 27, 1972.
  4. Denenberg questions value of chiropractic treatment. News release, Pennsylvania Insurance Department, Sept 27, 1972.
  5. Sprague B. Denenberg urges ending Pa. chiropractor licensing. Bethlehem Globe -Times, Sept 28, 1972.
  6. Coverage denied: Chiropractic bill defeated in House. Allentown Morning Call, Sept 28, 1972.
  7. Schneier M. Denenberg’s dilemma. Middletown Press-Journal, October 4, 1972.


James Gary Davidson and the Monterey Wellness Center

The Monterrey Wellness Center—previously called the Davidson Cancer Clinic—was an outpatient facility operated by James Gary Davidson in Monterrey, Mexico, that was falsely claimed to have a very high cure rate for cancers. According to its Web site: The therapy has proven effective in a wide variety of cancers, including breast cancer, brain cancer, lung …

The Monterrey Wellness Center—previously called the Davidson Cancer Clinic—was an outpatient facility operated by James Gary Davidson in Monterrey, Mexico, that was falsely claimed to have a very high cure rate for cancers. According to its Web site:

The therapy has proven effective in a wide variety of cancers, including breast cancer, brain cancer, lung cancer, bone cancer, skin cancer, prostate cancer, cancers of the stomach, liver cancer, colon cancer, pancreatic cancer, leukemia, all of P-53 gene category cancer. The patient is asked to undergo two treatments a day for an amount of time to be determined after doctor’s diagnosis. The treatments consist of lying on a table similar to getting an MRI or X-ray. . . .

A world renowned scientist has developed a scanning method of locating the cancers in a person’s body by focusing on a specific protein found in cancer. Then, by directing a specific electromagnetic frequency [similar to a radio wave] at the cancer cells, the cancer cells implode in the body. Once the cancer cells are killed, the dead cells and matter are absorbed and excreted through normal body processes. These proteins can be detected and measured in the patient’s urine, although the clinic does not conduct measurements. There are no chemicals introduced to the body, and this cancer treatment is absolutely non-invasive with no side effects [1].

To receive the treatment, the patient lay on a table inside a “treatment ring” that created a magnetic field for up to a hour, twice a day. The cost was US$17,500 plus Mexican taxes of US$2,625. These figures did not include travel costs, hotel, food, and other incidental expenses.

The site also claimed that “people have come to this Clinic with inoperable cancer and have left with the cancer completely cured.” Although the Web site did not directly advise whether to give up standard treatment, it encouraged women diagnosed with breast cancer to “consider coming before having any surgery, because CT scans done before and after the Clinic’s treatment have shown clearance of the cancer.” [2]

There is no reason to believe that any of the above claims of effectiveness were true. There is no scientific evidence exposure to magnetic fields is effective against cancer, that cancer cells respond differently than normal cells to a magnetic field, or that the magnetic field produced by the clinic’s device can cause any cell to implode.

The magnetic resonance imaging (MRI) devices used for medical diagnosis use radiofrequency waves, a very strong magnetic field, and a computer to produce cross-sectional images of the body. The patient is placed inside a large magnetic coil. When the magnetic field is turned on, it causes hydrogen nuclei (protons) within the body to line up in one direction. Then selected radiofrequency waves flip these particles in another direction. When the waves are turned off, the particles realign, releasing an electromagnetic signal that the computer translates into an image. The procedure produces no known permanent effect on cell structure or function. It may show the presence of a cancer by producing shadows that represent tumor masses. But it cannot detect any difference between normal and cancer cells at the cellular level.

If magnetic fields were capable of killing cells, MRI devices might seriously damage the patient’s body. Furthermore, even if powerful magnetic fields could kill cancer cells, there is no reason to believe that the clinic’s device—which had a much weaker magnetic field—could have had the same ability.

Because cancers frequently recur, cancer survival statistics are usually expressed in terms of 5-year follow-up. Thus, even if a procedure can cure, it would not be possible to know the outcome without following the patient’s status for many years. Thus the clinic’s claim that people were completely cured before they left was not credible. In addition, there was good reason to conclude that clinic owner, James Gary Davidson, was not trustworthy.

Background History

In 1980, when Davidson lived in Michigan, he made local headlines with claims that he had invested a way to change water into “hydroziene,” a fuel that allegedly delivered nine times the mileage of propane used in trucks. The Grand Rapids Press reported that Davidson had claimed to have a doctorate in nuclear physics from Ohio State University, a master’s degree in microbiology from Ohio University, and a bachelor’s degree in mechanical engineering from Southern Illinois University. However, officials at Ohio State and Ohio University told the reporter that they were unable to find any record that he had attended these schools, and a Southern Illinois official reported that a James Davidson had attended for two semesters at age 17. Although Davidson’s patent attorney said that Davidson had said he had worked for the Atomic Energy Commission, a personnel official at the Department of Energy said that Davidson had never worked for the Commission. The newspaper report indicated that investors had sunk $625,000 into a Davidson-run company that supposedly was studying the fuel, but they had received no test results [3].

In 1992, Davidson was named as a defendant in a civil suit that charged  that he and others conspired to defraud investors in a company called Adtech [4]. Davidson settled with the plaintiffs in 2005, but the court records do not contain the settlement details.

In 1994, Davidson was charged with four counts of securities fraud by selling shares in a plan to develop a synthetic fuel called Chasoline. The criminal information accused him of falsely claiming that (a) he had a Ph.D. degree, (b) “Chasoline”—supposedly made from corn, coal, and water—was better than gasoline, (c) he would build a plant in Illinois to manufacture the product, (d) the licensing for “Chasoline” had been  sold to the Tennessee Valley Authority [5]. Press reports indicate that he  had allegedly bilked about 25 investors out of $45,000 and promised to employ 1,200 people at the manufacturing facility [6]. After pleading guilty to one count of fraud, he received an 18-month conditional discharge and ordered to pay restitution of $19,425 plus fines and court costs [7].

In 1994, Davidson and the company that was supposedly developing Chasoline were accused in a civil suit of borrowing a new tractor, claiming ownership, and trading it in to purchase a different one [8}. The bill of sale was attached to the complaint. I do not know the outcome of the suit.

In 1996, the state accused him of violating the terms of his plea agreement by practicing medicine without a license in Tennessee—using a device claimed to alleviate pain in cancer patients. He then negotiated an agreement in which his conditional discharge was extended by six months and he was fined $6,000 plus $784 for costs [9].

Second Fraud Conviction Leads to Prison Sentence

In June 2000, Davidson, five others, and Macrotech (a corporation he founded) were charged with criminally defrauding clinic patients and investors in the corporation [10]. The 63-count indictment stated:

  • Macrotech was incorporated in Illinois in 1989 and conducts business from its principal office in Paris, Tennessee.
  • As Macrotech’s president and director, Davidson directed its promotion and sale of “investments” in various medical and other ventures, based on false claims that its methods were effective against cancer and various other serious diseases.
  • The others charged in the scheme were:
    • Davidson’s wife Marilyn, was secretary and a director of Macrotech.
    • Thomas S. Sawyer, a vice president or director who promoted the sale of “investments.”
    • Edward Griswold, Jr., a consultant who promoted the sale of “investments.”
    • Graydon Hoover, company accountant who later became a director.
    • William Hardy, assistant manager of the company.
  • The conspirators falsely represented that Macrotech was a scientifically advanced company capable of investigating and offering effective treatments for cancer, multiple sclerosis, arthritis, coronary heart disease, AIDS, emphysema, Alzheimer’s disease, and muscular dystrophy.
  • Through Macrotech, Davison offered treatment for cancer and multiple sclerosis which consisted of passing the victim through a ring-type device that allegedly produced a magnetic field that would allegedly cure the specific disease.
  • Davidson falsely claimed that:
    • He had obtained a doctorate in physics from Karl Marx University in Germany.
    • He was a “Nuclear Physics Doctor.”
    • He was involved in the teaching of “pre-med” students.
    • He was a retired or former agent of the Central Intelligence Agency (CIA)
    • He was born in Germany as a result of human breeding experiments.
  • Davidson discouraged victims from receiving legitimate medical treatment by falsely representing that to severely ill cancer victims that conventional chemotherapy treatments interfered with his treatment.
  • Davidson falsely represented that the cancer treatment offered by Macrotech was capable of exploding or imploding cancer cells which were then purported to have been discharged through the urine of the patient in the form of protein.
  • The defendants used false and fraudulent statements to obtain money as investments or payments to purchase the rights to the falsely represented medical technology and medical treatments. Two investors signed agreements to pay a total of $2.9 million (not all of which was subsequently paid).
  • The defendants omitted and/or fraudulently misrepresented material facts concerning the true nature of Macrotech and the defendants’ qualifications, criminal history, and medical results, namely that:
    • The defendants had no education, training, viable experience or medical credentials related to diagnosing, treating, researching, or administering of medical disease treatments.
    • The defendants falsely claimed to have cured large numbers of cancer patients with Macrotech’s treatments.
    • Potential investors in Macrotech were not told that Davidson had been convicted of a felony securities fraud violation in Illinois.
  • In 1995 and 1996, Davidson falsely represented to several patients and/or their family that the patients were cured or cancer-free after receiving treatment at his clinic. [Assistant U.S. Attorney R. Leigh Grinalds, who prosecuted the case, told the Commercial Appeal reporter that all of the patients were dead.]
  • The various schemes resulted in payments totaling $675,000 to Macrotech [11].

In March 2002, Davidson pleaded guilty to one count of money laundering and one count of mail fraud. The other five defendants had their charges dismissed as part of Davidson’s plea agreement. Davidson faced a minimum sentence of nearly six years in prison, a $500,000 fine, and an order to pay $675,000 in restitution [12]. On September 13, he paid the restitution and was sentenced to 88 months in federal prison plus 2 years of supervised release. He was released on March 17, 2009.

Additional Information
References
  1. Non-invasive, non-chemical based cancer treatment. Monterrey Alternative Wellness Center Web site, accessed June 23, 2000.
  2. FAQs. Monterrey Alternative Wellness Center Web site, accessed June 23, 2000.
  3. Gryzan M. Local inventor, hydroziene remain mystery. The Grand Rapids Free Press, Oct 26, 1980.
  4. Complaint. Philip E. Boynton and others v. Headwaters, Inc., f/k/a Covol Technologies, James G. Davidson, and others. U.S. District Court for the Western District of Tennessee, Case No.1:02-cv-01111, filed May 6, 2002.
  5. Information. People of the State of Illinois v. James Gary Davidson. In the Circuit Court of the Second Judicial Circuit, filed July 18, 1994.
  6. Rash J. J.G. Davidson charged with fraud in Chasoline plan. Hardin County Independent, July 14, 1994.
  7. James G. Davidson convicted of fraud in Chasoline scam. Hardin County Independent, Dec 13, 1994.
  8. Complaint. Bill Nolen v. James Gary Davidson and Panopic Energy Research Corp., Circuit Court of the Second Judicial Circuit Case No 94-LM-19, filed Sept 28, 1994.
  9. Order revoking and modifying conditional discharge. People of the State of Illinois v. James Gary Davidson. Circuit Court of the Second Judicial Circuit, Case No. 94-CF-20, filed April 8, 1997.
  10. Sullivan B. Macrotech Corp. accused of cancer-fighting quackery. Commercial Appeal, June 20, 2000..
  11. Indictment. United States of America, plaintiff, v. James Gary Davidson, Marilyn Davidson, Thomas A. Sawyer, Edgar Griswold, Jr., Albert Graydon Hoover, a/k/a/Graydon Hoover, William Hardy, and Macrotech Corporation, defendants. In the United States District Court for the Western District of Tennessee, Eastern Division. Filed June 19, 2000.
  12. Paris man pleads guilty. USDOJ press release, March 4, 2002


Laetrile in Historical Perspective

Laetrile’s history has been complex, tortuous, kaleidoscopic. Beginning inauspiciously like hundreds of other small-time anti-cancer schemes, Laetrile soared to a notorious pinnacle as the unorthodox brand-name health promotion generating the largest amount of public furor in the nation’s history. Numerous actors played roles in this perfervid drama. Laetrile’s history, first, may be placed within three …

Laetrile’s history has been complex, tortuous, kaleidoscopic. Beginning inauspiciously like hundreds of other small-time anti-cancer schemes, Laetrile soared to a notorious pinnacle as the unorthodox brand-name health promotion generating the largest amount of public furor in the nation’s history. Numerous actors played roles in this perfervid drama. Laetrile’s history, first, may be placed within three successive periods which may be designated: the creation by the Krebs, the McNaughton ascendancy, the appeal to freedom. Then the Laetrile pattern may be compared with the pattern of earlier cancer unorthodoxies.

The Creation by the Krebs

Two men, each named Ernst T. Krebs, father and son, bring Laetrile to market and dominate its early years. Their backgrounds may prove instructive.

Ernst Krebs, Sr., born in 1876, son of a California pharmacist, himself worked as a pharmacist before attending the San Francisco College of Physicians and Surgeons [1,2]. He received his medical degree in 1903. Practicing in Nevada during the influenza pandemic of 1918, Dr. Krebs became persuaded that an old Indian remedy possessed great efficacy in combatting the flu. A rare species of parsley, Leptotoemia dissecta, Krebs wrote in a Nevada State Board of Health bulletin, had permitted the Washoe Indians to survive the epidemic without loss of life, whereas members of other tribes died in great numbers [3,4].

Krebs promptly commercialized his discovery. In San Francisco he set up the Balsamea Company to market a proprietary named Syrup Leptinol, recommended for use in epidemic influenza, bronchial asthma, whooping cough, pneumonia, and pulmonary tuberculosis [5]. A later version called Syrup Bal-Sa-Me-A, with rhubarb added, bore labeling which recounted how Leptotoemia had protected the Washoes and which promised users “miraculous results” [6]. “It strikes at the cause,” the circular read, “quickly checking germ action.” Such claims so disturbed Krebs’ fellow physicians that he resigned from medical societies and never rejoined [1]. Such claims also disturbed the Bureau of Chemistry of the Department of Agriculture, in charge of enforcing the Pure Food and Drugs Act of 1906. The Bureau had shipments of Krebs’ proprietary seized in Missouri, Illinois, and Oregon, terming its labeling false and fraudulent [5,6]. When no claimants appeared, courts condemned the medicines and ordered them destroyed. Dr. Krebs did not give up on his product. At the end of the 1950s a Syrup of Balsamea was still being sold, and Krebs’ promotion contained the suggestion that he had discovered the first antibiotic [7,8]. No longer an over-the-counter proprietary, Krebs now distributed Balsamea under the guise of an investigational prescription drug.

In the intervening years Dr. Krebs had continued to seek new therapeutic entities. Before 1951, when Laetrile surfaced surely in the public record, he had been involved with both cancer treatments and apricot kernels. Krebs had promoted an enzyme, chymotrypsin, as a cancer remedy, explaining its action by the same trophoblastic theory, borrowed from John Beard, a turn-of-the-century Edinburgh embryologist, that was to undergird later Laetrile promotion [9]. And in 1945 Krebs submitted a New Drug Application (NDA) for a drug called Allergenase, manufactured from the kernels of shelled apricot seeds, and claimed to be ”a systemic detoxicant” for treating all allergies, including arthritis, asthma, and “shingles.” [10,11] He had begun work on this drug, he said, in 1924. In due course Allergenase evolved into pangamic acid, otherwise known as Vitamin B-15.

Dr. Krebs told two tales about Laetrile’s origin. The earlier account ascribed a recent discovery date. The later account, furnished in a court affidavit signed by Dr. Krebs in 1965, provided a more remote origin. As of 1965, having a long history for Laetrile had become legally important, because of so-called “grandfather” clauses relating to drugs in both the 1938 Food, Drug, and Cosmetic Act and the 1962 Kefauver-Harris Amendments to that law. Drugs in use before critical dates escaped some aspects of regulation.

Some versions of the Laetrile legend traced the drug’s origin to Dr. Krebs’ researches in the 1920s aimed at making bootleg liquor palatable [12]. In his 1965 affidavit Krebs stated that he had first made an extract from apricot kernels in 1926, calling it Sarcarcinase, containing amygdalin, a chemical known for a century [13]. A later critic has denied that Sarcarcinase could have been Laetrile’s amygdalin-containing ancestor, because Sarcarcinase was a chloroform extract of apricot kernels, and the amygdalin would have gone down the drain with the discarded aqueous portion [14]. In any case, Dr. Krebs stated in his affidavit that sarcarcinase proved too toxic a drug when injected into rats. Steadily improving his extraction process, Krebs asserted, he achieved an ever higher level of amygdalin purity. In 1949 Krebs’ son slightly modified his father’s process and named the result Laetrile. This version of Laetrile’s origin became the standard canon among its promoters.

The earlier tale that Dr. Krebs had told about Laetrile’s beginning dated its birth to 1951. In an interview with Food and Drug Administration officials during December 1952, Dr. Krebs said that ten months before he had begun experimenting with a cyanogenetic glucoside which he had extracted from a mixture containing apricot pits [15]. He had tested it successfully on patients, he asserted, but had kept no records. Injected near the site of a cancerous lesion, Laetrile worked by liquefying the malignant growth through the release of cyanide.

Soon Dr. Krebs and his son presented a more elaborate explanation for Laetrile’s mode of action. The theory proved to be the same one which they had recently used to justify the presumed anti-cancer activity of an enzyme with which they had been experimenting.

Ernst Krebs, Jr., who coined the name Laetrile, had come home to California after peripatetic schooling. He did not have a Ph.D. from the University of Illinois, as he sometimes asserted, nor had he yet received his only claim to the doctorate, an honorary Doctor of Science degree from the American Christian College in Tulsa, Oklahoma [16]. According to California state investigators, Krebs had attended colleges in Mississippi, Tennessee, and California before receiving a bachelor of arts degree in 1942 from the University of Illinois. Also before going to Illinois, Krebs had spent three years as a medical student at Hahnemann Medical College in Philadelphia, the second of which was a repetition of the first year’s work. Krebs devoted two years, from 1943 to 1945, to graduate study of anatomy at the University of California, but was dismissed because of his pursuit of what was deemed unorthodoxy [17].

Krebs, Jr., continued his researches in collaboration with Dr. Charles Gurchot, a pharmacologist who also had left the university (18). The two had published a letter in Science, “Growth of Trophoblast in the Anterior Chamber of the Eye of the Rabbit” ([19] and now set up a foundation bearing Beard’s name to seek a cancer cure fitting his principles [18].

In 1950 Krebs-père and -fils published their own version of Beard’s trophoblastic or unitarian thesis [9]. All cancer, they asserted, is one, brought on when the normal trophoblast cell goes wrong. This cell, which in both sexes emerges from a very primitive cell, is best known for its role in securing the embryo to the uterine wall. This function, the Krebs stated, demands erosion, infiltration, and metastasizing. In becoming cancerous, trophoblasts do the same things, dangerously. Beard had said that some pancreatic enzymes attack trophoblasts. The Krebs and Gurchot had found an enzyme they believed to be specifically antithetical to malignant cells.

The 1950 article, seeing great promise in the enzyme chymotrypsin, did not mention Laetrile. At about the very same time, however—at least, according to Dr. Krebs’ 1952 account—Laetrile was born. And soon the Krebs presented a Beardian explanation for Laetrile’s mode of action. The Laetrile molecule, the theory held, when it reached the site of the cancer, was hydrolyzed by an enzyme, beta-glucosidase, releasing cancer-killing hydrogen cyanide [20,21]. This enzyme accumulated in cancerous areas in much greater quantity than it did in healthy cells, so the cyanide was released where it was needed. Moreover, normal cells were protected by another enzyme, rhodanese, which detoxified any cyanide that might be liberated in or stray to them. Cancerous cells lacked rhodanese. Thus Laetrile, according to its promoters’ theory, fulfilled a prime objective of the nascent field of cancer chemotherapy, specificity of action: it targeted damage to cancerous cells without injuring normal cells unduly.

Right from the start Laetrile became related to a number of separate but intertwining organizations, legally distinct but linked, at least so FDA officials came to believe, through Ernst Krebs, Jr., their “guiding light.” [8,22] The John Beard Memorial Foundation, the research unit, became Krebs, Sr.’s province. Krebs, Jr., personally supervised production in the Krebs’ Research Laboratories. The finished product then went to the Spicer-Gerhart Company in Pasadena which distributed Laetrile as an investigational drug. Some California general practitioners began to use it in treating patients with cancer, and requests for it came in from other states and from overseas. A New Jersey group of doctors, for example, used Laetrile. Their business manager, Glenn Kittler, upon hearing a tape recording of Krebs’ explanation of the trophoblastic theory, responded by opining that Krebs was “well on his way toward the Nobel Prize.” [22]

California cancer specialists were not so quickly persuaded. The Cancer Commission of the California Medical Association sought to secure some Laetrile from Krebs to permit a clinical trial under the direction of the Research Committee and the Tumor Board of the Los Angeles Hospital. While “anxious” to have clinical work commenced, Krebs, Jr., replied, he foresaw difficulties [23]. Especially he objected to tests made by physicians ignorant of trophoblastic theory. “Conducting work under these conditions,” he wrote, “is almost tantamount to attempting to conduct an orderly practical industrial implementation of nuclear fission with the cooperation of physicists who failed to accept the E=mc2 formula and were gravely in doubt about the atomic constitution of matter.” Unless a doctor of his own choosing could direct the experiment, Krebs would send no Laetrile. Such a stance recurred not infrequently in Laetrile’s future: an expressed desire, sometimes a demand, for trials, but heel-dragging about complying with the established parameters of scientific research, a denial that mainstream scientists could test Laetrile fairly. In Krebs’ metaphor from physics, be it noted, he baldly transposed orthodoxy and unorthodoxy.

With a supply of Laetrile secured from the Food and Drug Administration [24], the Cancer Commission of the California Medical Association sponsored at three cancer research centers controlled trials of Laetrile as a treatment for various cancers in mice [25]. None of the tests revealed that Laetrile had any effect on the course of the disease. The Commission also assembled as much information as it could about patients who had been treated with Laetrile—forty-four cases in all—and found no objective evidence that Laetrile alone exercised any control over cancer. The conclusion was based on examination of seventeen cancer sufferers still alive and on autopsies of nine of the nineteen patients who had died. Furthermore, the Commission disputed the explanation by the Krebs as to how Laetrile purportedly functioned. The molecule-cleaving enzyme which supposedly released hydrogen cyanide at the site of the cancer, held by the Krebs to be more abundant in cancerous than in normal cells, in fact, said the Commission, was not; normal cells contained more of the enzyme than did neoplastic tissue. In time scientists were to presume that, because of the extremely small concentrations of beta-glucosidase in human tissues, Laetrile administered parenterally would undergo scarcely any metabolic breakdown and would leave the body in the urine virtually intact [26].

Krebs, Jr., and the small coterie of Laetrile physicians dismissed the California Cancer Commission’s report. A newer improved version of Laetrile and new dosage levels, they said, invalidated the Commission’s distorted findings [22,27]. In any case, asserted one Laetrile doctor, no curative claims had ever been held out, only the promise of stopping the cancer’s growth and prolonging the patient’s life with diminished pain and greater comfort. Despite the denial, Dr. Krebs, Sr., had in fact been quoted in the press as saying that Laetrile wrought cures in forty percent of cancer patients and brought improvement to the remaining sixty percent [28].

Laetrile’s proponents no doubt welcomed controversy as a way of making their product better known. They had courted publicity. The Cancer Commission first heard about Laetrile through a barrage of inquiries from national magazines, news services, and the California press [25]. A Laetrile physician had given a list of his patients to a newspaper, inviting reporters to interview and photograph them. Krebs, Jr., worked hard at expanding the market for his investigational drug. Some insight into his zeal may be derived from what he wrote, some years later, to an entrepreneur hoping to market Laetrile under his own trade name in foreign areas:

… [T)he field of cancer chemotherapy is a law to itself. This jungle offers the greatest opportunity anywhere in commerce at this moment, but there are snakes in every bush. I believe . . .  it’s best to push hard, sell, don’t be backward about disaffecting a few, and establish . . . [Laetrile] right from the start as something precious that not even hospitals get for nothing.” [29]

In the same letter Krebs noted: “. . .  [O]ne can usually buy even the top medical investigators as one does sirloin steak—and at about the same price.”

In fact, reports suggesting Laetrile’s utility in cancer came not from the top but from a few clinicians overseas and several American general practitioners (26] American cancer experts dismissed the pro-Laetrile studies as purely anecdotal or so poorly designed as to lack validity. If the market grew for Laetrile during the 1950s, it was at a modest rate. Krebs, Jr., secured a British patent for the product, but it did not mention cancer [30].  He joined with Fred J. Hart, a promoter of therapeutic devices, in testifying against a California bill aimed at curbing cancer quackery, but the law passed anyway [31]. Another signal ominous for the Krebs appeared at the start of the new decade. In 1960 the Food and Drug Administration made its first seizure of an interstate shipment of Laetrile. That same year a decade of litigation had finally driven Harry Hoxsey from the field of cancer quackery [32]. His successor at the Dallas clinic, barred from using Hoxsey’s mix of botanicals, had ordered the lot of Laetrile which the FDA had seized [33].

The Food and Drug Administration had watched the Laetrile venture from its early days. The California Cancer Commission critique of 1953 raised the question of taking regulatory steps. After weighing the matter at the highest level, FDA opted for continuing close scrutiny of operations, not immediate action. Other projects held higher priority, and manpower was short. Laetrile was both small in size and difficult to combat. “. . . [T)his type of promotion, namely an article distributed as a new drug for investigational purposes but indirectly promoted for use in cancer, is hard to handle” (34] So concluded a headquarters memorandum. If Laetrile were directly offered as a cancer treatment in printed labeling, chances for controlling it through regulation would be “brighter.” Thus the Krebs’ cautious approach, depending mainly on word-of-mouth promotion instead of bold labeling claims, postponed trouble, probably at the expense of growth. The 1960 seizure signaled a change.

The first period of Laetrile’s history, during which the Krebs’ brand of amygdalin, shrewdly but cautiously promoted, made modest gains without encountering serious regulatory troubles, ended about 1963. By then both state and federal governments, the latter with powerful new weapons given it by the Kefauver-Harris law, had attacked in force. Public worry about drugs, cued by Senator Estes Kefauver’s hearings and the frightening thalidomide episode, which lay behind the Tennessee Senator’s law, had soared to new heights. Besieged by regulatory actions, the Krebs yielded real control over their enterprise to a Canadian citizen possessing capital, audacity, and a broader vision of Laetrile’s destiny.

The McNaughton Ascendancy

Andrew Robert Leslie McNaughton first met Ernst Krebs, Jr., so McNaughton testified, in a Miami drugstore in 1956 or 1957 [12]. Shortly before this, McNaughton had informally set up a foundation in Montreal, incorporated in 1958, to support researchers possessing unorthodox but possibly useful ideas who found it difficult to secure funds elsewhere. In 1960, after spending several weeks in the Krebs’ San Francisco laboratory, McNaughton Look some Laetrile back with him to Canada, persuaded several tobacco companies to contribute research funds, and, through his McNaughton Foundation, distributed Laetrile to a number of Quebec physicians as an investigational drug. In 1961 McNaughton founded Biozymes International Ltd., a manufacturing concern, which the next year began to produce Laetrile [36].

McNaughton came from a notable family and had enjoyed a glamorous if at times checkered career [36-38]. His father had headed Canada’s armed forces during World War II. The son had served as chief test pilot for the Royal Canadian Air Force. He had sold arms to Israel and had let Fidel Castro capture weapons which McNaughton had been commissioned to sell to Batista, the Cuban president, for use in suppressing Castro’s insurgency. In time McNaughton and his foundation became targets of a suit brought by the U.S. Securities and Exchange Commission, charging promotion and sale of unregulated securities, stock in Biozymes International-al. In 1973 a district court in California, not having received an answer to the complaint, rendered a default judgment of permanent injunction (39]

Besides launching his Laetrile enterprises in Canada, McNaughton undertook an initiative in the United States. Taking Krebs, Jr., and a pro-Laetrile. physician along, McNaughton went to Washington. Through the good offices of a New Jersey Congressman, he secured conferences with Health, Education and Welfare and Food and Drug Administration officials [40,41]. What would it take, the Laetrile party asked, to have a New Drug Application favorably considered? Krebs explained the rationale behind Laetrile’s purported action, indicating that dosage levels now were higher than those first used. No claims for cure of cancer would be made, only for palliation. While safety data seemed complete, evidence of effectiveness admittedly rested on clinical research outside the nation’s borders, although three United States clinical investigations were under way. In the granting of an NDA was only safety considered? Not, FDA officials replied, with drugs prescribed for life-threatening diseases. In such cases safety and efficacy could not be separated. An innocuous product which failed to help the patient would constitute a hazard when used in lieu of treatment that offered some promise of success. Without sound clinical evidence from recognized experts, the government men told Krebs and McNaughton, a New Drug Application could not be deemed complete.

In November 1961 the FDA charged Krebs and the John Beard Memorial Foundation with violating the law [42]. The case involved not Laetrile, but Krebs’ other major product, pangamic acid or Vitamin B-15. Krebs had shipped capsules of this new drug into Oregon and Florida without having an effective NDA, in the same way in which he was distributing Laetrile. Both the Foundation and its sole officer pleaded guilty to the charge, Krebs being fined $3,750 and sentenced to prison. Imprisonment was suspended when Krebs agreed to the terms of a three-year probation. One of those terms barred Krebs and his Foundation from manufacturing and distributing Laetrile until there should be an approved NDA.

The court shortly agreed to a modification of the probation order permitting Krebs to exhaust the supply of Laetrile on hand by shipping it without payment to the McNaughton Foundation in Montreal and to a few physicians in the United States so that experiments might continue [43,44]. Laetrile patients and their families had written pleading letters to the judge.

When the small reserve supply of Laetrile came to an end, interstate distribution supposedly would cease. NDAs submitted by both Krebs, Jr., and Krebs, Sr., fell short of meeting FDA’s standards for acceptance [45]. Krebs, Jr., and the John Beard Memorial Foundation obeyed the court’s ruling and stopped making Laetrile. But production and distribution did not stop. Krebs, Sr., and Krebs Laboratories, according to FDA records, picked up the task. And McNaughton’s Canadian venture quickened. He got some of his raw material for making Laetrile from England, Krebs, Jr., thought, and for one stage in the production process sent the drug into New Jersey [46].

Indeed, McNaughton increasingly made his powerful presence felt on the entire Laetrile scene. He strove, without success, to get the Damon Runyon Cancer Fund to evaluate Laetrile, reaping some headlines from the effort [47]. However, a vastly more successful publicity coup soon followed. The American Weekly, a Hearst publication, during March 1963 ran two articles presenting Laetrile in a most favorable light [48]. They were followed shortly by a paperback book from which they had been taken, Laetrile, Control for Cancer[2]. “The most important medical news of our time, “the cover promised, “First major breakthrough in the cancer mystery. The day is near when no one need die from cancer. LAETRILE, the revolutionary new anti-cancer drug . . . WILL BE TO CANCER WHAT INSULIN IS TO DIABETES.” Written by Glenn D. Kittler, who earlier had acclaimed Krebs, Jr., as Nobel Prize material, the book presented a highly dramatic version of Laetrile’s discovery and a most optimistic rendering of Krebs-sponsored clinical experience with the drug. To use the term “cures” for cancer Kittler considered “inaccurate. but he added: “The idea of a cancer control, on the other hand, is perfectly plausible. In the minds of an increasing number of leading scientists, the best control now available is Laetrile.” The book concluded by quoting Andrew McNaughton to the same effect. McNaughton contributed also the book’s foreword, to which he appended his Foundation’s Montreal address. Letters of inquiry sent to the Foundation received replies saying Laetrile might soon be available

from Canada and asking cancer sufferers to have their doctors write the Foundation [49]. Some United States citizens crossed the border to Montreal to get Laetrile injections [50].

While thus deeply involved in a publicity venture tremendously expanding Laetrile’s national visibility, McNaughton also worked away on other fronts. He sent Laetrile made in Canada to a foreign trade zone in San Francisco for trans-shipment to markets in the Far and Middle East [51]. And he continued to deal with the Krebs. Relations were sometimes tense, but McNaughton — at least in the judgment of observing food and drug officials — came to assume the upper hand [52]. In speaking of Laetrile, he often used the proprietary “we,” and he acted as if he were making the important decisions. When the probation stock of Laetrile ran out, it was McNaughton who went to Washington, this time alone, to see if he could pressure the FDA into letting him have more, arguing that he should not be penalized for the misdeeds of Ernst Krebs, Jr. [53]. FDA officials pointed out that Laetrile still did not have a completed NDA and that the new Kefauver law had stiffened standards for admitting new drugs to the market.

Legal difficulties, indeed, soon cast shadows across the publicity coup resulting from Kittler’s book. California, after holding hearings under its new law aimed at specious cancer treatments, banned Laetrile as a quack remedy [54,55]. The Canadian Food and Drug Directorate barred further distribution of Laetrile by the McNaughton Foundation on the grounds that its safety and efficacy had not been proved [56]. McNaughton, calling unconstitutional the law under which the Directorate had moved, sought in 1964 to enjoin the Directorate from enforcing it. But McNaughton lost in court. The next year the Food and Drug Administration strove to curb Dr. Krebs, Sr.’s small-scale but persistent shipment of Laetrile in interstate commerce. After protracted court action, he was enjoined, later cited for criminal contempt, and finally fined for violating his probation [57]. Dr. Krebs probably prescribed Laetrile for his patients through the remainder of his life, although he gave up manufacturing and distributing it, while maintaining the production of pangamic acid [58]. He died in 1970 from a fall on the stairs at the age of 94 [59,60].

In the meantime, Andrew McNaughton had moved to California. Both the Krebs, father and son, had been enjoined from dealing in Laetrile, and in Canada so had McNaughton himself. Using several corporate names, McNaughton continued the manufacture of Laetrile in San Francisco, then in Sausalito [38,61], and from his transplanted McNaughton Foundation he tried once more in 1970 to get FDA approval for experimental use of Laetrile on human subjects [62-64]. McNaughton’s submission of an IND, an Investigational New Drug application, a document required by the Kefauver-Harris Act before human trials could proceed, became a cause celebre. Upon receipt of the IND, the FDA routinely approved it, in accordance with then prevailing practice. A quick appraisal did not reveal in the application the kind of promising evidence from animal experimentation that would provide a reasonable basis for expecting anti-tumor activity in man. Eight days later the FDA wrote McNaughton that the IND could not be continued without more satisfactory data, and when no new information arrived before the deadline set in regulations, the FDA cancelled the application. Further information later submitted by McNaughton did not persuade Food and Drug officials to change their minds. Manufacturing controls and preclinical and clinical data all remained unsatisfactory.

Laetrile supporters reinterpreted these events into a tale of FDA’s perfidy. According to this version, FDA’s initial automatic acceptance of an IND until the evidence could be examined became instead a bona fide acceptance which the agency then reversed under pressure from the political moguls of the cancer research establishment [65,66]. A pro-Laetrile reporter predicted “a showdown” between the hidden forces of repressive orthodoxy and champions of alternate modalities [65].

A showdown did indeed occur. A varied constellation of circumstances had moved the Laetrile cause upward on the path of political power. Not only had Hoxsey’s star set through governmental action and exposure, so too had Krebiozen’s virtual demise arrived by 1966, thus creating a vacuum at the apex of cancer unorthodoxy ready for filling by a new contender. The publicity generated by Kittler’s book gave Laetrile a good boost toward the top. Moreover, McNaughton gained a recruit to his cause from the inner citadel of the cancer research establishment who was destined to play for Laetrile something like the role Andrew Ivy had played for Krebiozen. Dean Burk, who had received his Ph.D. in biochemistry from the University of California, had devoted a more than forty-year career to cancer investigation, with many honors along the way, and now was chief of the Cytochemistry Section of the National Cancer Institute [65,67]. In 1968 McNaughton had persuaded Burk to undertake research on Laetrile, and by the time two years later of FDA’s rejection of the McNaughton Foundation’s IND, Burk had become a fervent Laetrile champion, calling many of his contrary-minded governmental associates “scientifically immoral.” [65] Stepped-up Laetrile publicity focused the spotlight on Burk.

The scope of Laetrile publicity had also broadened because a new organization had sprung up to wave its banner and because an established league of unorthodox health promoters had taken up Laetrile’s cause. The new group, the International Association of Cancer Victims and Friends, was founded in 1963 by a San Diego schoolteacher, Cecile Pollack Hoffman [50,68]. She herself had turned to Laetrile with despair and hope. In 1959 she had sustained a radical mastectomy because of breast cancer, and three years later the spread of cancer led to further surgery. She learned of Laetrile when her husband saw a copy of Kittler’s book in an airport lobby. Cued by McNaughton’s foreword, Mrs. Hoffman journeyed to Montreal for Laetrile injections. She continued receiving them closer to home, by crossing the border to Tijuana, becoming the first Laetrile patient of a Mexican physician, Ernesto Contreras Rodriguez. Persuaded that Laetrile had saved her life, angry that this treatment was not legally available in the United States, Mrs. Hoffman established her International Association. Through print, meetings, and personal evangelism, the association castigated “out-of-date, outmoded, so-called ‘orthodox’ treatment” and vigorously espoused what Mrs. Hoffman termed “non-toxic, beneficial therapies,” especially Laetrile. Krebs, Jr., Contreras, and in time Dean Burk addressed IACVF assemblies [69-71]. The organization provided cancer sufferers with information on how to get to Tijuana. When Canada joined the United States in making Laetrile illegal, Dr. Contreras’ business boomed. Mrs. Hoffman died in 1969 of metastatic cancer, but her organization continued on [72].

Mrs. Hoffman’s emphasis upon “Freedom of Choice” in cancer treatment echoed the constantly reiterated dominant theme of another organization which had been established eight years before she founded the IACVF. The National Health Federation was founded in 1955 [73,74]. The moving spirit in its creation was Fred J. Hart, a California promoter of health devices who had just been enjoined by Food and Drug Administration initiative from distributing them in interstate commerce. Other NHF founding fathers also had encountered legal restraints, some spending time in jail, for false claims about devices, dietary wares, and so-called cancer treatments. One of Harry Hoxsey’s lawyers became the Federation’s first legal representative in Washington. The Federation developed into a powerful league linking the various segments of health unorthodoxy. They held up each other’s spirits and sought new converts at frequent meetings, developed skillful propaganda playing on public anxieties and frustrations, grew adept at pressure politics, mobilizing the faithful for letter-writing campaigns and confrontation lobbying. Hart and Krebs both testified against the California cancer law, and the Federation welcomed Laetrile supporters to its ranks and gave their cause strong support. Condemning overweening and bumbling bureaucracy for administering health laws to favor the medical establishment, the NHF pleaded for patient freedom of choice so that each ailing person might treat himself from amongst unorthodoxy’s abundant catalog of wares. The Federation journal pictured Washington and Lincoln on its cover over the caption, “They Too Fought for Liberty Against Great Odds.” These criticisms of governmental actions in the health field mounted amidst the growing broader disillusion with governmental policy resulting from the war in Vietnam.

The distorted Laetrile version of the FDA’s rejection of McNaughton’s IND received widespread coverage in the publications of unorthodoxy and in the sensationalist press [75]. A barrage of angry mail bombarded Washington. FDA’s police state tactics, charged one protester, “reduce[d] Hitler and Stalin to the status of small time hoodlums.” [76]

Mail deluged the Congress as well as the FDA [77]. The National Health Federation Bulletinhad explicitly urged this action [78]. Representative Lawrence H. Fountain, after committee hearings, brought pressure on Elliot Richardson, Secretary of Health, Education, and Welfare, to sponsor further evaluation of Laetrile’s efficacy [79]. The FDA checked its own internal judgment by soliciting external expert opinion. A panel of independent cancer specialists was assembled, which reviewed the data submitted in McNaughton’s application, heard face-to-face what McNaughton and Burk had to say, sought whatever new information Laetrile physicians like Contreras might have to offer, then concluded that the sum total of evidence did not warrant testing Laetrile on humans. Further rodent tests in recognized independent laboratories, the committee held, might be desirable. The Secretary considered the conclusions of FDA’s ad hoc committee valid [63,80]. National Cancer Institute tests on mice had offered no promise of Laetrile’s effectiveness, and no new NCI tests seemed worth undertaking. That Institute, however, the Secretary said, would recognize grant applications for further testing from qualified independent investigators. Secretary Richardson reported his judgments to Congressman Fountain who did not continue to press the issue. A bill introduced into the House by another member, to authorize research on and testing of non-toxic substances for the diagnosis, treatment, and prevention of cancer, made no headway [81].

Regulatory pressure on Laetrile promoters did not subside. In 1971 the state of California began a criminal case against Ernst Krebs, Jr., charging him with practicing medicine without a license and, aided by his brother Byron, an osteopathic physician, with distributing a prohibited drug [82-84] Two years later the brothers pleaded nolo contendereto violating the state cancer act’s taboo on Laetrile. The judge fined them and placed them on probation. The terms required them to obey all city, state, and federal laws, especially the cancer treatment provisions of the California code, and forbade Krebs, Jr., to practice medicine without a license. California took further legal steps as well. A case against Mary Whelchel sought to impede the turning wheels of an accelerating “underground railroad” which assembled cancer victims from all over the nation in a boarding house on the United States side of the border, then ran them across to Tijuana for Laetrile treatment in Dr. Contreras’ flourishing operation [84,85]. In 1971, Mrs. Whelchel was convicted of delivering an illegal compound for treating cancer, fined, and, as a term of her probation, was forbidden to transport anyone to Mexico. (It should be noted, however, that this conviction was set aside two years later.)

The Appeal to Freedom

Such relentless regulation coupled with scant success from the epistolary campaign in Washington sped changes already launched that remade Laetrile’s self-image, the explanation for its therapeutic action, indications for its use, the strategy and tactics of its promotion, even its very name. Andrew McNaughton remained commanding general but became an officer in exile. In 1974 his reputation in his Canadian homeland suffered a blow when a judge convicted him of conspiring fraudulently to affect the market price of a mining stock [86]. The United States, with Laetrile under attack on both state and federal levels, must have seemed increasingly hostile. McNaughton took up residence in Tijuana. The press credited his foundation with sponsoring both manufacturing and clinical facilities for Laetrile in the Mexican city [36], stations at the underground railroad’s terminus. The railroad began to run the other way, carrying smuggled Mexican Laetrile into the U.S.A. [87].

McNaughton thus continued, as a reporter put it, “more than any other man … the driving force behind the Laetrile movement.” [88] In this third period, however, McNaughton in exile gained powerful allies of great leader-ship potential in the United States. This chain of events began in 1972 when a California general practitioner, Dr. John A. Richardson, was arrested at his Albany clinic, charged with prescribing Laetrile in violation of the state’s anti-quackery law [89]. The dramatic arrest, filmed on television cameras, involved policemen with drawn guns and a thorough search of the premises. The physician spent a brief time in jail. A trial before a judge, finding Richardson guilty, was quashed on appeal. Two jury trials followed, both ending with jurors split [36,90] Eventually the California Board of Medical Quality Assurance revoked Dr. Richardson’s license to practice medicine on grounds of “Gross negligence and incompetence.” [91,92]

Richardson’s initial arrest upset some of his fellow members of the John Birch Society. Such dedicated disciples of freedom-from-government doctrine saw in Richardson’s plight a prime example of bureaucratic oppression. Led by Robert W. Bradford of Los Altos, a small group of ultraconservatives founded yet another organization to help Laetrile’s besieged prescribers [93]. Bradford was a nuclear technician on the Stanford University staff, working on the building of a linear accelerator for research in subatomic physics. Poised, articulate, skilled at organization, Bradford, aided by equally dedicated associates, quickly made a success of the new Committee for Freedom of Choice in Cancer Therapy [36,94,95]. In 1975 he gave up his Stanford job to devote full time to the Committee and to Laetrile. Ties with the nation’s already existing conservative network surely helped immensely in the speed with which the Committee established local branches. By 1977 Bradford claimed five hundred chapters with some 35,000 members.

The Committee and its allies focused upon freedom, making any governmental interference with a cancer sufferer’s right to take any remedy available seem a violation of the Constitution and the fundamental rights of man. Thus an atmosphere of high principle infused the zealous campaigning in Laetrile’s behalf. Laetrile’s opponents, in the Committee’s propaganda, constituted a selfish conspiracy of those involved in orthodox cancer research and therapy, futilely cutting, burning, and poisoning their victims, and rejecting hopeful treatments like Laetrile for fear of doing themselves out of their jobs. The Committee showed great ingenuity at making their message widely known. They employed meetings, films, pamphlets, paperback books, quickly triggered letter-writing campaigns, and the assembling of the faithful for legislative hearings. Full-time crusaders sought out cancer victims and urged Laetrile upon them and upon members of their families [96]. Counsel could be given as to how to get to Contreras’ clinic in Mexico or how to acquire Laetrile in the United States. Indeed, some Committee leaders, including President Bradford himself, allegedly at great personal profit, engaged in a conspiracy to smuggle Laetrile in from Mexico and, with much surreptitious ingenuity, distribute it within the United States. After a three-month trial in 1977, Bradford, Dr. Richardson, and others were convicted of this conspiracy; the Court of Appeals for the Ninth Circuit confirmed the convictions [97]. McNaughton, also indicted, pleaded guilty [87].

Laetrile in the 1970s assumed a different character from the chemotherapeutic Laetrile with which the Krebs began. In 1963, in a letter to the Food and Drug Administration, Dr. Krebs had asserted: “The cyanogenetic glucosides belong to the nutritional vitamins and should not be classified as drugs.” [98] Here appears the earliest reference encountered in the file to Laetrile’s future destiny. Already, Krebs, Jr., had committed himself, as part of his probation, not to distribute Laetrile as a drug. Perhaps both father and son had begun to wonder if legal restrictions might not be less stringent under the food sections of the law. Such a shift in Laetrile’s status would require a modification of the prevailing chemotherapeutic explanations of Laetrile’s mode of action. Shortly Krebs, Jr., published a pamphlet, not really retreating, but adding the suggestion that Laetrile could be characterized as a pro-vitamin for B-12. The pamphlet bore the title, “Cancer Is a Deficiency Disease.” [21]

As regulatory actions mounted, Krebs, Jr., in 1970 brought his pamphlet title to full flower. In an article in the Journal of Applied Nutrition he asserted that Laetrile and other “nitrolosides” made up a true vitamin which he denominated B-17 [99]. Vitamin B-17, he wrote, amounted to a cancer-protective factor. Moreover, Krebs asserted, in this “new vitamin . . . all of us are severely deficient.” Cancer could be cured by massive injections of the vitamin. Cancer could also be prevented by smaller quantities, made from de-fatted apricot kernels, regularly taken by mouth. Four years before the appearance of this article Dr. Krebs had begun to distribute an oral dosage form of Laetrile (100]. Now that form became popular, widely publicized by McNaughton, as co-therapy with injections of Laetrile in cancer treatment and, among perfectly healthy people, as a presumed preventive. Chewing unprocessed apricot kernels bought at health food stores also came into vogue.

If one were interested in Laetrile as a commercial venture, one might anticipate several advantages from this combination of new directions. Vitamin status for a product, one could argue and hope, might bring some immunity from actions under the drug provisions of both state and federal law. Moreover, the concept of cancer prevention would certainly elicit broad public interest, for of all threats, including war, Americans feared cancer most. Potential sales of a preventive could be enormous. And, if to the popular mind the word “cancer” bore ominous overtones, the word “vitamin” evoked glamorous reverberations of buoyant health (101]. Americans had mounted to a new plateau of concern about their health, accompanied by a wide variety of approaches toward do-it-yourself safeguarding, by no means all of them sound. Health food marketers, including National Health Federation members, both agitated the public’s concern about health and oversold the need for vitamin supplementation [102].

Nutritional scientists repeatedly denied that Laetrile fulfilled any of the criteria for a true vitamin [103-105]. “In short,” summed up a veteran vitamin researcher, Dr. Thomas H. Jukes, “nothing could be less like a vitamin than laetrile.” (106] Despite such criticism, Laetrile’s vendors continued to assert this claim. In testifying in 1977 before Senator Edward Kennedy’s Subcommittee on Health, Ernst Krebs, Jr., termed Laetrile “a scientific revolution as profound as the germ theory of disease . . . and the Copernican theory.” [107] What Vitamin C is to scurvy, niacin to pellagra, and Vitamin D to rickets, he suggested, Vitamin B-17 is to cancer. If every American took Laetrile regularly, Dr. Richardson told the subcommittee, “in 20 years cancer would be relegated to the dusty pages of history.”

To make amygdalin accessible for regular self-dosage by the American public, Laetrile’s sponsors displayed much marketing skill. In 1972 there appeared in California a consumer product bearing the trade name Seventeen. Just in front of the name on the carton came a picture of a bee. A McNaughton Foundation representative offered a reporter from a San Jose newspaper a chance to interview the noted cancer specialist, Dean Burk, who happened to be visiting the Bay area [108,109]. By this route Burk’s praise for the new food supplement found its way into the press. Bee-Seventeen, Burk said, contained three percent Laetrile, thirty percent protein, fifty percent unsaturated fats, with the remainder minerals. The powder was to be taken daily with juices or milk. Laetrile, Burk told the reporter, could both prevent and cure cancer, but no medical claims were being made on behalf of Bee-Seventeen. It was offered for sale solely as a food.

Such a ruse did not protect the product from action by the Food and Drug Administration. The manufacturers of Bee-Seventeen were enjoined from distributing what the court termed both an unapproved food additive and a misbranded drug [110]. Other amygdalin-containing products, like Aprikern, though devoid of therapeutic claims in their labeling, were also barred from the marketplace [111].

Laetrile’s champions not only propagated their vitamin gospel with aggressive vigor; they also took the offensive against their critics in other ways. Oppressed by federal food and drug law and by the California anti-quackery statute, the Laetrile coalition turned its attention to legislative chambers. Several efforts to repeal the efficacy provision in the California law failed [112]. In the national Congress, Laetrile supporters favored a bill introduced by Representative Steven D. Symms of Idaho which would have repealed the provision of the Kefauver-Harris Act requiring that new drugs be proved effective before being permitted on the market [113,114]. This bill gained some 140 co-sponsors in the House but made no progress toward enactment.

Laetrile’s major legislative push aimed at persuading state legislatures to pass laws legalizing the extract made from apricot kernels. Bills differed in substance from state to state, although most would at least permit physicians to prescribe Laetrile for patients certified as terminally ill of cancer [115]. Cancer specialists pointed to the great difficulty in achieving any satisfactory definition of the word “terminal.” [116] Alaska enacted the first such law in September 1976, and within two years sixteen other states had followed suit. Other legislatures pondered Laetrile bills and defeated them. The deliberative bodies in Indiana, Illinois, and Rhode Island enacted their measures over vetoes by the governors [117,118]. In New York, two years in succession the governor’s veto held.

The scenarios in the several states had much in common [119]. A cooperative assemblyman introduced a bill at the request of a constituent. In due course the health committee held hearings. The hearings, replete with drama, became newsworthy happenings, recorded by television cameras, widely reported in the press. In some states, orthodoxy and unorthodoxy got equal time in number of testifying witnesses. In other states, pro-Laetrile sentiment was dominant. In news coverage, unorthodoxy—the underdog, the challenger—received the greater play. Members of The Committee for Freedom of Choice in Cancer Therapy turned out in force. Wearing campaign buttons, they packed the galleries, intense, completely absorbed. Depending on the strictness of the rules imposed, Laetrile’s friends either shouted or murmured praise for pro-Laetrile testimony, and heaped imprecations, either loudly or sotto voce, upon spokesmen from the state medical society, nearby universities, the American Cancer Society, the Food and Drug Administration, who explicated Laetrile’s unproven status. The Laetrile lobby produced living testimonials claiming to demonstrate the contrary. After my operation—so the pattern went—my doctors gave me only a year to live, but I took Laetrile and here I am three years later, speaking before you legislators. The main thrust, however, of Laetrile spokesmen, often the national leaders of the movement, fell upon freedom of choice. State legislators had their own problems with the powerful federal presence, and might listen with sympathy to constituents blasting segments of the Washington bureaucracy. In any case, pleaded Laetrile witnesses in many states, only a little freedom was being sought, freedom for the dying, under a doctor’s direction, to try Laetrile as a last resort.

After the hearings came continued pressure upon legislators, through conversations and a massive deluge of mail. Occasionally, if the terms of initial bills seemed too broad for acceptance, successive versions would follow with ever weaker provisions, until skeptical assemblymen would consider the measure too innocuous to matter and could thus satisfy both their consciences and the demands of those who had sent in the preponderance of mail.

No matter how weak the laws enacted, each one, announced to the nation through growing media coverage, contributed to bandwagon psychology, giving the imprimatur of another state’s approval to Laetrile. To the ordinary citizen, sanction might equate with efficacy. Thus each new law enhancing Laetrile’s prestige made it seem like legitimate therapy to victims of cancer and their families, including those victims whose cancer had just been diagnosed. And each law, making a specific exemption of Laetrile, dealt a new blow to the theory behind the federal law, which many states had imitated, that promoters of new drugs must prove them efficacious and safe before they could be marketed. The Kefauver law, moreover, demanded a high standard for proving efficacy, the results of adequate and well-controlled studies, not random cases proclaiming benefit, whether presented in paperback book or in testimony at committee hearing.

The state laws, however, did not negate the national law, and Laetrile remained illegal in interstate commerce. It was reported that McNaughton, allied with Bradford in a new John Beard Research Institute in Palo Alto, hoped to set up plants to manufacture Laetrile and clinics to dispense it within states enacting favorable laws [120], although these projects did not move rapidly forward. And in Illinois at least, where legal use of Laetrile was hedged in with many restrictions, the pattern set by the law has not been much employed [121]. Rather, black market Laetrile has continued to be vended in the most dangerously careless way. A Chicago reporter told of buying Laetrile surreptitiously from a foot doctor downstate who asked no medical questions [122].

A second legal route for Laetrile prescribing, this one breaching the ban on interstate commerce, developed from action in the federal courts. As the Laetrile forces undertook a counter-offensive against regulation on the legislative front, so also did they on the judicial front. The key case in the campaign centered on Glen L. Rutherford, a manufacturer’s representative who lived in Conway Springs, Kansas [123]. Upon receiving a medical diagnosis that he suffered from a cancerous polyp, Rutherford refused radical surgery of the larger bowel. Instead he went to Dr. Contreras’ clinic in Tijuana. The physician in charge of Rutherford’s case later wrote a federal judge that Rutherford was treated with Laetrile and proteolytic enzymes, and then the remaining polyp was “cauterized.” [123] Cancer specialists indicate that the excision of a polyp of this type solves the problem in a high proportion of cancer cases [124].

Upon returning home, Rutherford sought to ensure himself of a continuing supply of Laetrile. He joined a law suit already begun, became the sole surviving plaintiff, and in 1975 won from the United States District Court in Oklahoma an injunction against federal regulators which permitted him and other terminally ill cancer patients to import from Mexico a limited amount of the drug for their personal use [123]. Judge Luther Bohanon insisted that each patient present a physician’s affidavit certifying to the stage of illness and specifying the quantity of Laetrile needed to be imported.

Upon appeal of the Rutherford case, the United States Court of Appeals for the Tenth Circuit upheld the injunction [125]. The court also instructed Judge Bohanon to require the Food and Drug Administration to develop an administrative record on two points contested in the case: whether or not Laetrile was a “new drug” as defined by law, and whether or not it was exempt from premarketing approval requirements by reason of being “grandfathered.” FDA complied. In its proceeding, the agency received four hundred written statements from friends and foes of Laetrile and held in May 1977 two days of public hearings in Kansas City [126]. Jammed with Laetrile supporters, these hearings had the emotional flavor of hearings in the states [105]. Cheers greeted pro-Laetrile speakers, boos and hisses their opponents. To one distinguished scientist present, “the affair appeared to be a confrontation between two cultures. One side was characterized by the voice of science—skeptical, analytical, orderly, but sometimes bluntly critical and uncompromising. The other side faced the situation with fervor, passion, conviction, revolt against logic, all emotionally expressed. They seemed to willfully reject distasteful facts.” [105]

Food and Drug Commissioner Donald Kennedy and his staff turned their court-appointed responsibility into a comprehensive review of Laetrile, as thorough, broad-gauged, and insightful an analysis of a highly promoted but unorthodox drug as could be found in the American literature [21]. Besides answering the court-posed issues—Laetrile had not been “grandfathered” under either the 1938 or 1962 law; experts did not consider it either safe or effective for its prescribed uses—the report discussed other significant matters relating to Laetrile. Laetrile’s composition and identity would be difficult to define, the report stated, because so many different chemical entities had appeared under that name in both the literature printed about and the products distributed as Laetrile. The Commissioner countered the various claims made for Laetrile’s effectiveness in cancer, disputing the shifting theories, remarking the inadequate anecdotal character of pro-Laetrile case reporting, and citing the lack of promise in  numerous well controlled animal studies that had been made by the National Cancer Institute and private cancer research centers. The few animal tests interpreted as favorable to Laetrile by Dean Burk and others, the report criticized directly, concluding that Laetrile had failed “to show any effect in the animal system.” The document found the nature of Laetrile’s appeal in the psychology of patients and their loved ones caught in the crushing cancer crisis. The “disparagement of conventional therapy,” the Commissioner stated, “a bulwark of the campaigns of Laetrile proponents, is perhaps the most morally reprehensible aspect of the pattern of the drug’s promotion.” This disparagement led sufferers away from proven remedies, that might offer some chance, to almost certain disaster. Even short delays could mean the difference between life and death.

Commissioner Kennedy met the “freedom of choice” argument head on. Congress had decided, he noted, “that the absolute freedom to choose an ineffective drug was properly surrendered in exchange for the freedom from the danger to each person’s health and well-being from the sale and use of worthless drugs.” In any case, the choice to use Laetrile, made in an atmosphere of double stress, compounded from fear of disease and from the zeal of Laetrile advocates, with seldom any “rational laying out of competing arguments,” can seldom be properly described as free.

The Commissioner’s conclusions and all their buttressing evidence did not persuade the Oklahoma judge. He ruled that Laetrile was exempt from the need for pre-market approval and forbade the Food and Drug Administration from interfering with its importation and transport in interstate commerce or with its use by licensed medical practitioners in treating cancer patients [127]. Again the FDA appealed.

When the Tenth Circuit considered FDA’s appeal of this new Rutherford decision, the judges cut back markedly on the District Court’s liberality toward Laetrile, but still authorized its use for a restricted segment of the population [128]. Ruling in July 1978, the appellate judges concluded that the law’s taboo against unsafe and ineffective drugs did not apply to people who were dying. Therefore, patients whose physicians would certify that they were terminally ill with cancer could legally import Laetrile—but only for intravenous injections, not in its oral form.

This last proviso revealed that the Court of Appeals was taking into account, as the District Court had not, evidence of amygdalin’s toxicity when taken by mouth. Evidence submitted to the Commissioner’s review, testimony given before Senator Kennedy’s subcommittee, and stories in the press cited severe poisonings and even deaths from the ingestion of Laetrile tablets and apricot kernels [21,129-132]. Enzymes in the gastrointestinal tract split the amygdalin molecule and released its cyanide.

The Tenth Circuit did not heed other evidence submitted to it with the FDA’s appeal, that the long-vaunted claims made in behalf of injectable Laetrile’s non-toxicity might not be completely true. Little research had been undertaken on Laetrile’s action when injected into the body. Some physicians began to report unfortunate consequences, surmising that many such adverse effects had earlier occurred but had been blamed not upon the treatment but upon the disease [133].

That the dying should be barred from the law’s protective mantle, Commissioner Kennedy deemed a “remarkable finding” indeed, and he urged an appeal of the Tenth Circuit’s opinion to the Supreme Court [134]. In August 1978 the Commissioner thought his hand strengthened when the Court of Appeals for the Seventh Circuit rendered an anti-Laetrile decision. In 1977 FDA had seized apricot kernels, partially processed kernels, and empty capsules intended for filling with Laetrile at perhaps the largest processing plant in the United States, a former dairy in Manitowoc, Wisconsin. Later the company, which had sold two million dollars worth of its illegal product, was enjoined from continuing its business [135]. On appeal, the Seventh Circuit ruled that Laetrile could properly be excluded from interstate commerce until it should be proven safe and effective [136]. In due course the Supreme Court could be expected to decide between the contrary opinions of the Tenth and Seventh Circuits [137].

Other con and pro decisions marked Laetrile’s increasingly litigious history. In California, the state’s effort to restrain Laetrile practitioners ran into a snag. A state appeals court called the California cancer law unconstitutional, ruling that the state had no power to deny doctors the right to use non-toxic unorthodox cancer treatments [138]. The state Supreme Court in 1978 granted a petition for review of this decision [139]. In Georgia, a jury exonerated one of the most notable personages in the ranks of Laetrile proponents. Larry P. McDonald, physician and member of the John Birch Society and of the United States Congress, had prescribed only Laetrile for a patient’s cancer [140]. When the man died, his family sued for malpractice. The jury decided not so, yet feeling sympathy for the widow decided that she should be reimbursed for the expense of her dead husband’s treatment.

The Food and Drug Administration continued seizing imports of Laetrile from Mexico and from Germany not protected by court-ordered physician affidavits swearing that the drug was intended for a particular patient who was terminally ill. Moreover, some samples offered for import turned out to be not amygdalin at all, but a dangerous fever reducer; other samples were contaminated with fungus [141,142]. Indeed, even the affidavit system itself, the FDA soon charged, had become a cloak for fraud (143]. Reporters visiting Tijuana observed stacks of presigned affidavits available for the asking to Laetrile purchasers [122]. Hitherto Laetrile smuggling, as revealed in the trial at which Dr. Richardson and Bradford had been convicted, had been an underground operation. Now, the government alleged in a seizure action, the druggist at a Baltimore pharmacy had manipulated the affidavit system for his own profit [144,145]. He had obtained affidavits from a physician and had filled them in for the maximum importable amount of Laetrile, using the names of cancer patients who had in fact ordered smaller quantities or none at all. The druggist had then sold the surplus to other patients, sometimes getting the authorized release and sometimes not. A judge upheld the validity of the seizure, but, pending a Supreme Court decision, would not order the seized Laetrile destroyed.

The extensive litigation and the legislative battles in the states made Laetrile an issue of national interest and debate. News magazines carried cover stories [37]. Television—including the program “60 Minutes” [146]—looked at Laetrile. The press kept tabulated track of contests in the states. Conservative columnists, most notably James J. Kilpatrick, attracted to the freedom-of-choice theme, repeatedly gave Laetrile users a prestigious boost [147]. The promoters intensified their own publicity. Paperback successors followed Kittler’s original success: G. Edward Griffin’s World Without Cancerin 1974 [148]; Mike Culbert’s Freedom from Cancer in 1976 [149]; John Richardson’s Laetrile Case Histories [90] and Robert Bradford’s Now That You Have Cancer in 1977 [150]. A majority of American citizens, according to a Louis Harris poll, thought decriminalization of Laetrile would be a good idea [151]. Some Laetrile leaders sounded smug at their success.

“Rest assured, gentlemen,” Bradford told Senator Kennedy’s subcommittee, “that the people demand Laetrile. And they are going to get it whether Big Brother wants it or not . . . . [W]e cannot expect that thousands of American cancer sufferers are going to wait for more long years, while the Federal Government fiddle-faddles through animal tests and more red tape.  Do we really want another American civil war?” [152]

So disturbed became the state of the mass mind that a segment of sober opinion, unbelievers in Laetrile’s efficacy, concluded that the speediest way to quiet public clamor would be to let Laetrile’s worthlessness be proved either by widespread use or in a series of well controlled clinical trials in humans conducted by investigators of unimpeachable integrity and skill. Some scientists, indeed, believe that any drug should be tested for which suggestive evidence exists, even hearsay, that the drug might be of benefit. To test Laetrile in humans would breach the prevailing system, which puts the burden of proof upon a new drug’s sponsor. Such a step, further, would fly in the face of the weight of animal evidence. The major pro-Laetrile animal experiments, announced in 1977 at a National Health Federation meeting by Harold W. Manner, a zoologist at Loyola University in Chicago [153,154], have received severe criticism on the grounds of inadequate methodology [155]. Human trials with Laetrile, therefore, posed grave ethical questions respecting patient rights and the value of expending limited resources available for testing in such a way [156]. But so dangerous seemed the consequences of the spirit behind the new Laetrile state laws that some commentators, both laymen and physicians, resorted to the forbidden fruit argument. The way to dampen “Laetrilomania,” suggested F. J. Ingelfinger, distinguished editor of the New England Journal of Medicine, might be to reduce the glamor derived from its illicit status by making it freely available, and then keeping accurate records of patient experience [157]. The editors of the New York Timestook a similar tolerant approach toward Laetrile distribution [158]. Charles G. Moertel of the Mayo Clinic favored a less extreme course: if Laetrile’s sponsors would not assume their legal obligations, then reputable scientists must undertake the task. “The only established means of proving a drug effective or ineffective, safe or unsafe, is by a properly designed, tightly controlled clinical trial.” [159]

Officials at the National Cancer Institute reluctantly reached the same conclusion. If such action had to come, FDA Commissioner Kennedy argued at Senator Kennedy’s hearing, at least all parties must agree on the specific chemical formula, among the many that had been posited and marketed, of the “Laetrile” to be tested [160]. Senator Kennedy labored diligently throughout the hearing and believed he had achieved a consensus on this point which included Laetrile’s promoters. Tests would weigh the merit of amygdalin [161].

After careful review of the situation, National Cancer Institute officials decided not to launch human trials immediately, but to undertake a retrospective study of patients who, according to their .physicians, might have benefited objectively from the use of Laetrile [162]. From the purportedly 70,000 patients in the United States who had been treated with Laetrile, the NCI hoped to get full enough records to permit analysis of two or three hundred cases. In quest of such records a much publicized appeal went forth to the more than 400,000 physicians and other health professionals in the nation. The director of the project sought to persuade the Laetrile inner ring of leadership to urge physicians active in Laetrile prescribing to submit case records [163].

In the end, however, only ninety-three cancer cases were submitted for evaluation, only twenty-two of them concerning patients who had been treated with Laetrile alone for whom the records were adequate for appraisal [164]. A panel of twelve cancer experts stated that under Laetrile treatment apparently seven of the patients had worsened, nine had remained the same, and six had responded favorably, two with complete and four with partial remissions. These conclusions, the reviewers granted, had to be taken with a grain of salt because of the possible “submission of incorrect clinical interpretations, falsified data and intentional or unintentional omission of data.” Nor had the review been designed to discover patients who had not responded to Laetrile. Nonetheless, more than two hundred physicians had volunteered evidence about more than a thousand patients who had shown no beneficial response.

After further review, the National Cancer Institute revived its earlier decision to undertake a clinical trial of amygdalin in some 150 to 300 terminal cancer patients. Dr. Arthur Upton, NCI director, announced the plan in September 1978, expressing hope that the outcome would resolve the debate over Laetrile “once and for all.” [165]

Such optimism seemed scarcely warranted. Laetrile proponents, while publicly appealing for testing, had been customarily reluctant or unable to provide complete data on patients for evaluation. The FDA’s request for clinical records to Dr. Contreras and to a German experimenter, Dr. Hans Nieper, had not brought in usable material. Nieper submitted no data at all, and Contreras’ case records, when evaluated by NCI scientists, showed no patient benefits ascribable to Laetrile [166]. Contreras, in fact, insisted to a reporter that employing his clinic for purposes of research would be unethical [167]. Nor had a whole succession of animal experiments, which to established cancer researchers offered no hint of Laetrile’s efficacy, satisfied Laetrile’s proponents, who sought to reinterpret a few such trials in a way favorable to their product [168].

From the beginning, indeed, as a basic premise, Laetrile’s supporters questioned the validity of experiments conducted by experimenters who did not share faith in the theories supporting Laetrile’s value. Pro-Laetrile physicians must direct the clinical trials, Krebs, Jr., had told the California Cancer Commission in 1952, or he would not provide Laetrile for experimentation [23]. In 1977 Krebs made essentially the same point: those inside and outside the Laetrile movement “do not necessarily speak the same language.” [107] Each dwells “in a different universe.” [60] Unless, a pro-Laetrile physician told the Kennedy subcommittee, the NCI study should be conducted “in the way that the proponents of Laetrile . . . are urging that it be done,” then “it will be an absolute sham.” [107] Robert Bradford echoed these sentiments: “the protocols that exist for orthodox therapy are not applicable, for the most part, to metabolic therapy and Laetrile.” [95] Traditional oncologists, for example, held that the removal or reduction in the size of a neoplasm measured the success of therapy, whereas espousers of Vitamin B-17, believing cancer to be a deficiency disease, considered the size of the lump irrelevant. “You do not and cannot expect to get results from laetrile treatment,” Bradford said at the Kansas City hearing, “unless you are a trained metabolic physician.” [169]

Commissioner Donald Kennedy wondered if some maneuvers by Laetrile’s promoters might not be intended for the purpose of disparaging test results adverse to the drug [160]. “[I)n sifting the strange mixture of nomenclature, alleged chemical identity, and proposed mechanism of action that comprises Laetrile’s record of the past twenty-five years,” Dr. Kennedy said, “one becomes gradually convinced that these uncertainties are not accidental. They provide an effective cover for the promoters, since failure to achieve a result can always be attributed to having used the wrong material and arguments against one hypothesis of action can always be met by embracing another.”

During the Vitamin B-17 period, the increasing stress upon “total metabolic therapy” marked another change in approach to the promotion of Laetrile. In treating cancer, according to the new doctrine, Laetrile alone could not be relied upon. While Vitamin B-17 held the indispensable place, it needed to be administered as part of a complex program involving a multitude of variables [150]. The other parts consisted of diet, exercise, rest, detoxification, minerals, enzymes, vitamins A, C, and E, and that other major Krebs’ promotion, Vitamin B-15 or pangamic acid. A patient might require “several dozen tablets every day.”

In Bradford’s book, Now That You Have Cancer, he likened the metabolic program to a crown containing nine jewels, with Laetrile “the crown jewel within that diadem.” [150] Such a “total approach,” combining an attack on the cancer, a bolstering of the body, and a positive mental attitude, metabolic physicians held, provided “the best chance to control cancer.” If the metabolic doctrine bolstered Laetrile with a host of attendant therapies, the system also expanded Laetrile’s prowess beyond cancer. In a book titled How You Can Beat the Killer Diseases, Harold W. Harper accorded Laetrile a role in preventing and treating a broad range of other ailments, including diabetes, emphysema, arthritis, and cardiovascular disease [170].

The diversified regimen of metabolic therapy certainly complicated the problem of evaluating in human trials Laetrile’s role as a possible therapeutic agent for cancer, and made second-guessing of results inevitable. Nonetheless, the National Cancer Institute’s Dr. Upton stated that, in devising the Institute’s experiments, he would “not rule out the possibility of looking at combinations” of Laetrile and high-potency vitamins [165]. Laetrile’s advocates greeted the NCI’ s retrospective review as ”Laetrile’ s biggest breakthrough,” because “from now on the myth as to the ‘officially’ observed lack of validity in Laetrile has been destroyed.” [171] Yet Bradford had told the Kansas City hearing that no “effective agreed upon protocol” for a study of cancer under metabolic therapy could be set up [169]. Whatever a NCI trial might show, disputations between advocates of orthodoxy and champions of unorthodoxy seemed certain to continue.

The Pattern of Cancer Unorthodoxies

Health quackery has flourished since that ancient day when, as Voltaire put it, the first knave met the first fool. Through most of American history, nourished by the Enlightenment concepts of the Revolutionary generation, the presence of quackery has been acknowledged but its status has been considered transitory. When medical science had expanded its horizons a little further, when the populace had received a little more schooling, when the Congress had enacted another protective law, then would quackery vanish, consigned to the museum of outmoded delusions. Certainly through the Progressive period at the beginning of our own century, such optimism sustained itself [172]. When the Pure Food and Drugs Act became law in 1906, the New York Times editorialized: “the purity and honesty of the . . . medicines of the people are guaranteed.” [173]

As the twentieth century has proceeded, despite enhanced medical science, more universal schooling, and a great increase in social legislation, observers have grown less confident about predicting quackery’s imminent demise. The course of events and the pathways of philosophy both have chilled such naive optimism. The doctrine of inevitable progress fell under the impact of a series of terrible wars. Faith in the inherent goodness of human nature, battered by new philosophical perspectives, crumbled under the revelations from the Nazi concentration camps. Belief in education as a panacea withered. Science-technology inventiveness did continue to produce wondrous products for mankind’s benefit but also devised nuclear weapons and polluted the environment. Modern industrial civilization struck many people as part of the cause for burgeoning unhappiness, Ernst Krebs, Jr., among them. At the Kansas City hearing, Krebs expressed abhorrence for “the horrible onslaught of technology blindly impinging upon the fragile flesh that contains our flame of life.” [60] Some disturbed souls sought to return to nature. Pressing upon this long developing crisis of confidence came Vietnam, an unpopular and unsuccessful war that put generations at each other’s throats, and Watergate, seeming proof of what some voices had long been crying, that blame for the discontents of civilization could be laid upon leadership.

Such an atmosphere induces irrational approaches to fundamental problems. The disillusioned, questing for new faith, are terribly vulnerable to false prophets. Distrust of established authorities encompasses all those who have traditionally sought to protect the public from charlatanry. The medical profession suffers suspicion, including the specialists within it concerned with cancer. In a behavioral survey sponsored by the Food and Drug Administration and other federal agencies, it was revealed that forty-two per-cent of American adults would not be persuaded by almost unanimous expert opinion that an unorthodox “cancer cure” held out false hope [101].

Cancer quackery in America goes back to the earliest days. In colonial times one purported cure consisted of alleged “Chinese Stones” vended by a self-styled Frenchman who hawked his wares from town to town [174]. At the beginning of this century, the first major case lost by the government under the 1906 law had aimed at suppressing Dr. Johnson’s Mild Combination Treatment for Cancer [175]. By mid-century unorthodox cancer promotions loomed largest among the illegal operations which regulatory agencies sought to control.

Basic to this circumstance were both the impact and the image of cancer in our society. With the decline of infectious diseases as a cause of death, due to sanitation, vaccines, and chemotherapy, cancer had risen to second place in the mortality lists. The 1900 death rate for malignant neoplasms was 64 per 100,000 deaths, the 1977 estimated rate 177 [176]. On the disease and death front, cancer had moved to the center of public attention. A sense of urgency led to an all-out attack, with billions of dollars appropriated by the Congress in imitation of the nation’s venture into outer space, in an effort to conquer cancer once and for all. But the enemy proved to be too complex for such a battle plan. Despite many advances, failure to fulfill the central promise brought new disillusionment [177].

Yet the image of cancer may be an even more important force for quackery than its factual circumstances. Heart deaths exceed cancer deaths, but no wave of cardiovascular cures has surfaced similar to those in the cancer field. That centuries ago cancer began to acquire a hostile and terrifying image may be deduced from the word “cancer” itself, derived from the Greek work for crab. The crawling spread of cancer, gradual but mainly relentless, whether external and observable or internal and secretive, through the centuries appeared to be, and indeed generally did amount to, a sentence of death. This image hangs on, a powerful force in men’s minds, a force not adequately revised by the victories orthodoxy increasingly has won. In our mythology, Susan Sontag has written, cancer has become a “cosmic disease: the emblem of all the destructive, alien powers to which the organism is host . . . [C]ancer is thought of as a disease of the contamination of the whole world.” [178] “As long as a particular disease is treated as an evil, invincible predator, not just a disease,” she states, “most people with cancer will indeed be demoralized by learning what disease they have.” And Sontag cites Karl Menninger to the effect that “the very word ‘cancer’ is said to kill some patients.” This deeply imbedded fear is constantly revivified in the lurid tracts and the camp meeting oratory of orthodoxy’s opponents.

Four major unorthodoxies have emerged in the United States during the last half century. First, a Detroit physician, William F. Koch, proclaimed his newly discovered Glyoxilide an anti-toxin for cancer. Each ampule, costing $25, Koch said, contained one part Glyoxilide to one trillion parts of water. Three thousand American health practitioners bought and administered the purported chemical, charging up to $300 per injection [179].

Second, a former coal miner, Harry Hoxsey, after treating external cancers with caustics here and there in Illinois, made his way to Dallas, Texas, where he set up a clinic for treating internal cancer. At its peak, the clinic had ten thousand patients on its books, charging each one a fixed four hundred dollar fee, prescribing a “pink medicine” and a “black medicine.” The former contained lactated pepsin and potassium iodide, the latter a botanical laxative in an extract of prickly ash bark, buckthorn bark, barberry root, licorice root, pokeweed, alfalfa, and red clover blossoms [32,179].

Third, two Yugoslavian brothers named Durovic brought from Argentina to the United States a whitish powder called Krebiozen, said to have come from the blood of horses which had been injected with a micro-organism responsible for “lumpy jaw” in cattle [179,180]. Their assertion that Krebiozen could cure cancer won the dogged allegiance of one of the nation’s leading cancer experts, Dr. Andrew Ivy of the University of Illinois. Thousands of physicians secured vials of this so-called investigational drug for eager patients, making a nine dollar “donation” for each ampule. In 1963 a team of FDA chemists, analyzing the only sample of Krebiozen ever secured from its sponsor, discovered it to be the common amino acid, creatin monohydrate. Simultaneous analyses of the Krebiozen distributed to physicians revealed it to be nothing but mineral oil.

The fourth major promotion has been that of Laetrile.

Laetrile possesses a more complex chronicle and a more varied cast of characters than those of Glyoxilide, Hoxsey’s botanicals, and Krebiozen, and has created greater public impact and gained more political power than did its three predecessors. Nonetheless, Laetrile impresses the historian as conforming to a ten-point profile of health quackery de-rived from a study of past quackish ventures [181].

Exploitation of Fear

Quacks have traditionally scared their victims with disturbing language, frightening pictures, and grim statistics, stressing pain and threat of death. A turn-of-the-century pamphlet described gruesomely how cancer ate away the sufferer’s nose, face, palate, and throat [182].

The modern promotional mode employs greater subtlety in playing on the morbid fear of cancer in our society. Laetrile agents try to reach patients when cancer has just been diagnosed and panic is high, and, like others before them, interpret orthodox therapies as essentially useless and more painful than the disease itself. One physician testifying in Kansas City told of a patient who, within a day of having lung cancer diagnosed, received Laetrile advertising in the mail [183]. “Cutting, burning, and poisoning” to characterize surgery, radiation, and chemotherapy have become a litany in Laetrile literature [184]. “Voodoo witchcraft” would do more good.

Promise of Painless Treatment and Good Results

“No knife or pain,” advertised a Chicago cancer quack in 1912, promising to cure breast cancer [185]. The history of cancer quackery reveals constant assurances of easy treatment and good results. In earlier days, sure cures were promised. More recently, prudence has dictated greater caution. By treating cancer with nothing more painful than injections of a non-toxic drug, according to a Laetrile tract, fifteen percent of patients with advanced metastasized cancer and eighty percent of those with early diagnosed cancer “will be saved.” [186] And Dr. Richardson evoked the vision of a cancerless nation in a mere two-score years, achieved by nothing more arduous than regular oral doses of Laetrile [107].

Claims of a Miraculous Scientific Breakthrough

Marvelous new discoveries are a dime a dozen in the literature of quack promotions. In earlier times the secret might be an herb brought back by a missionary from some primitive overseas tribe or pried loose by an explorer from an Indian medicine man [187]. Hoxsey attributed his botanical formula to the perception of his great-grandfather who noted the healing of the cancer on the leg of his horse which grazed in a pasture where the plants grew [32]. Recent “discoveries” have generally been said to derive from inspired research. The Durovics’ horse experiments in the Argentine furnish an example.

Laetrile’s heroic tale centers on the humble physician, Ernst Krebs, Sr., busy with his practice yet always seeking out drugs and vitamins to benefit mankind, and on his son, Krebs, Jr., inveterate researcher, who modified the cyanide-containing chemical his father had found in apricot kernels so that it could kill cancer cells but leave healthy cells unharmed [2]. To the audiences at the legion of Laetrile meetings before which Krebs, Jr., appears, he has become a figure of awe and veneration, acclaimed as a Pasteur and linked with the signers of the Declaration of Independence [188], a myth in his own time.

One Cause / One Therapeutic System

Quacks often win allegiance to their doctrines by promising to end confusion and doubt and to make complexity simple and comprehensible to the untutored mind. Disease, the quack says, has but one cause. Therefore, one treatment is all that is needed to fight it. In the nineteenth century Benjamin Brandreth blamed all illness on vitiation of the blood caused by constipation [189]. For a perfect panacea, therefore, try Brandreth’s cathartic pills. Later Samuel Hartman’s high-alcoholic Peruna promised only to cure catarrh, but Hartman defined catarrh to cover almost every symptom in the book [190].

A similar sweeping boldness has operated in the cancer realm. Reputable authorities now assert that there are as many different cancers as there are different common colds, over a hundred, with a broad range of causes. But for Koch all cancer came from a single toxin. For Hoxsey all cancer resulted from a disturbance in body chemistry. At the start, Laetrile’s sponsors rooted their explanation in the unitarian or trophoblastic theory, and more lately have denominated all cancer dietary deficiency disease. Initially Laetrile alone played the role of virtual specific. “Laetrile does not palliate,” Dr. Krebs wrote in an early pamphlet, “it acts chemically to kill the cancer cell selectively without injury to the normal tissues of the body.” [191] Recently Laetrile in its new guise of Vitamin B-17 has assumed central place in a therapeutic system, complex, but according to its proponents, integrated. Robert Bradford envisioned metabolic health centers as “the wave of the medical future,” replacing orthodoxy’s rugged and allegedly futile methods, and heralding the day “when the killer degenerative [disease) . . . of the civilized world would come to an end.” [150] In the same year Dr. John Richardson could posit use of Laetrile alone as a universal cancer preventive [107].

The implication of these futuristic claims is bold enough, in contrast with the restraint about Laetrile’s current effectiveness in public utterances. At the hearings held by the FDA in Kansas City and by Senator Kennedy’s subcommittee in Washington, Laetrile’s sponsors made the most modest of claims. The public record, however, and private conversations sometimes take on a different tone. Ernst Krebs, Jr. , could say in Kansas City, “We disclaim saving anyone’s life.” [60] But during a trial at which the state of California had charged Krebs with violating his probation, evidence indicated that his promises were not so circumscribed [192]. A widow testified that her husband, learning that he had lung cancer, had rejected the operation which his doctor had told him had a ninety percent chance of success. Instead, having heard Krebs on television, the man looked his name up in the telephone directory and asked his advice. Krebs told the inquirer that, if he relied on Laetrile, his chance of recovery would be one hundred percent. Krebs sent the man to Dr. Richardson. Nine months later the man was dead.

The Galileo Ploy

In response to criticism from the community of scientists, quackery has often brought into play the Galileo ploy. The unorthodox say the orthodox are wrong, just as earlier critics condemned pioneering explorers, inventors, and scientists. We are, the unorthodox assert, like Columbus, Jenner, and Pasteur—the list is long. We are today misunderstood by blind men but are destined to be heroes to future generations.

In 1951 at the trial of a woman who sold a so-called Radio Therapeutic Instrument, claiming it could cure cancer of the breast with rays beamed over great distances, her attorney trotted out Columbus, Harvey, and Semmelweiss in her defense [193]. Laetrile promoters have offered the same gambit. The text of a film strip, World Without Cancer, likened Krebs, Jr., to these three worthies, as well as to Galileo and the Wright brothers (184]. In praising Krebs before Senator Kennedy’s subcommittee, Robert Bradford admitted that Krebs had “only an honorary doctorate,” then added: “Are you aware, gentlemen, that Christopher Columbus never went to nautical school? Can we recall the shoddy credentials of Thomas Edison? Was Albert Einstein all that bright a student in school?” [95]

The Conspiracy Theory

Another time-tested response to criticism is the shouting of conspiracy. The scientific establishment doesn’t dare recognize the validity of my great discovery, the quack claims, for it will undermine their power and prestige and eliminate their jobs. So the establishment scientists conspire to suppress the wonderful new remedy.

Koch, Hoxsey, and the Krebiozen forces all resorted to the conspiracy theory, and so do the Laetrile supporters. Dr. Richardson sees the Rockefeller family at the center of the web, controlling pharmaceutical manufacturers and preventing them from developing drugs not made from oil [194]. The Rockefellers also control the American Cancer Society, a staunch foe of Laetrile. In this nightmare, the National Cancer Institute, the Food and Drug Administration, and organized medicine are likewise deemed members of the selfish conspiracy to suppress Laetrile.

Shifts to Adjust to Circumstances

Quackery has never felt obliged to retain a given posture if some change might offer greater prosperity or safety. In the nineteenth century a cold cure that wasn’t selling became a stomach remedy and reaped huge profits.

Laetrile’s history has been marked by many changes. When the Krebs’ version of amygdalin emerged, chemotherapy as a mode of treating cancer was new, public excitement about it high. The first pro-Laetrile paperback, Kittler’s Control for Cancer, grafted the apricot pit drug onto that interest, stressed Laetrile’s chemical nature, did not mention the word “vitamin.” [2] By the 1970s nature’s way toward health enjoyed great public favor, chemicals in cancer therapy had slipped some in popular prestige, and chemicals in the environment had come under grave suspicion. John Richardson’s Laetrile Case Histories blasted chemotherapy in cancer, denied explicitly that Laetrile was a “drug,” and concluded that control of cancer had been found “in nature.” [195] From drug to vitamin, from cure to palliative and preventive, from low dosage to high dosage level, the pattern of Laetrile’s postures has been kaleidoscopic. “The mere fact that there is a constantly changing set of theories as to why laetrile should be used or how it does work,” asserted the American Medical Association to the Kennedy subcommittee, “is sufficient to lead objective persons to question the validity of any of the theories put forth.” [196]

Reliance on Testimonials

Through history the testimonial has been a major weapon in the arsenal of quackery. When someone just like you and me says, with urgent sincerity, “I was cured,” the persuasive power ranks high. “Our experience of more than thirty years in the enforcement of the Food and Drug Act,” a former Commissioner once wrote, “has demonstrated that testimonials may be obtained for practically any article labeled as a treatment for practically any disease.” [197] But testimonials given in the first flush of hope prove sadly premature. Old newspapers contain instances of testimonials appearing in the same issues with the obituaries of the testators [198]. Modern science holds that drug efficacy can not be determined by individual instances, nor even by a series of such cases. Much more sophisticated scientific methods are required. As a matter of law, the Supreme Court has so ruled [199].

All major cancer unorthodoxies have relied heavily on testimonials. The despairing cancer victim hears or reads such success stories as part of an enthusiastic promotional presentation, one that resounds with a sense of conviction and with every evidence of sincere concern for the victim’s welfare. He is offered hope, told things he himself may do to take his own treatment into his own hands. His new painless therapy, his new diet, his sense of support from new acquaintances, his more cheerful expectations, do indeed enhance the way he feels. The placebo effect is powerful, if temporary, medicine. An injection of confidence may indeed give the patient a better appetite, let him gain weight, enhance the way he looks, improve the way he feels. If he has been suffering from the side effects of effective treatment, perhaps nausea and the loss of hair, a switch to unorthodoxy may end these unpleasant consequences. Under these circumstances both the patient and the doctor who is administering the unorthodox treatment may pen testimonials. If, as a result of previous or concomitant orthodox therapy, the patient’s health may indeed be improved, the testimonial may nonetheless give all the credit to unorthodoxy.

In preparing for legal action against Hoxsey’s enterprise, the Food and Drug Administration investigated the writers of all the testimonials which Hoxsey had printed in behalf of his internal cancer treatment [32]. Hoxsey’s claimed cures, the FDA was able to demonstrate in court, fell into three classes. Either the patients had never had cancer — and some cancers are extremely difficult to diagnose—although treated for it at Hoxsey’s Dallas clinic. Or they had been cured of cancer by proper orthodox treatment before or while consulting Hoxsey. Or they had had cancer and either still were afflicted despite Hoxsey’s treatment or else had died. This evidence substantiated the scientific inadequacy of anecdotal evidence, no matter how sincere the testimony. The same findings resulted from the National Cancer Institute’s evaluation of Dr. Contreras’ cases [166].

Further, one of the odd paradoxes relating to quackery is that failure seldom diminishes patient loyalty. The duped seem unable to realize deception has occurred. The quack has done such a good job of exuding sincerity and concern that the victim believes the false explanation that the specious remedy or routine would have healed had treatment only begun a little sooner. And the misery of the decline toward death had seemed, under the unorthodox regimen, less arduous than would otherwise have been the case [200].

Laetrile promotion has relied heavily on testimonial evidence, given by patients before legislative committees, compiled by Laetrile advocates between the covers of books. The scientific weakness of such an approach, as exemplified by Dr. John Richardson’s Laetrile Case Histories, receives stark underlining in the analysis of this volume presented in Commissioner Kennedy’s report to the Oklahoma court [21].

Distortion of the Idea of “Freedom”

Before food and drug laws were enacted, quacks waved the banner of “freedom” to smear criticism aimed at them by physicians and pharmacists. When drug laws came, quacks formed protest groups with high-sounding names, like the National League for Medical Freedom and the American Medical Liberty League [201]. “Freedom” is certainly one of the most treasured words in the American lexicon. As has been seen above, the manipulation of this word by unorthodox health promoters has constituted their major symbolic campaign during the last quarter century. Thus Laetrile’s loud appeal for “freedom of choice” in cancer therapy is nothing new. Pushed with vigor, however, by those with ultraconservative convictions about the governmental role in society, in a climate of opinion worried about over-regulation, Laetrile’s “freedom” pitch has persuaded more numerous converts to its cause than any previous unorthodoxy has succeeded in winning. The prevailing mythology of cancer, Susan Sontag has written, conjoins with “a simplistic view of the world that can turn paranoid.” “Perhaps,” she adds, “right-wing groups are the main organized support for quack cures like Laetrile because they also share a paranoid view of the world.” [178]

Such a direction for “freedom” leads toward the license of those ancient days, when “the toadstool millionaires,” operating without restraint, fleeced and often killed their victims. That is a fate from which seven decades of constructive legislation, beginning with the Pure Food and Drugs Act of 1906, has somewhat rescued the nation. Complex, modern, industrial, urbanized society, with standards of medical judgment far more precise than in the nineteenth century, can not afford to let the nation’s health concerns be governed by a distorted definition of that great symbol “freedom” which would return piratical anarchy to the realm of health.

Large Sums of Money Are Involved

It was Oliver Wendell Holmes who termed nineteenth century nostrum vendors “toadstool millionaires.” [202] They might not make a million, but money was their goal.

Laetrile is big business. Investigations by California authorities revealed what huge sums some of the Laetrile leaders had been putting in the bank [36,92]. Robert Bradford, according to an agent of the Food and Drug Bureau cited in the New York Times, had been taking in an estimated $150,000 to $200,000 a month in Laetrile sales. In slightly over two years, Dr. John Richardson had deposited some $2,800,000 in a single checking account [203].  The quantity of Laetrile that Judge Bohanon determined to be a six-month supply would have cost the user about $2,250 [204]. Estimating Laetrile users at 75,000, the mathematics mounts to millions.

Laetrile Within the Perspective of the Past

Fear of cancer, suspicion of government, a primitivistic retreat from complex civilization to “natural” ways, skillful organization, adept lobbying, and a shrewdness at borrowing time-tested techniques from quackery’s well-stocked past, such factors undergird the Laetrile movement. In the face of scientific evidence and informed advice, frightened people place vain hope in it.

What guide might the past provide as to Laetrile’s future? The other major cancer unorthodoxies of the twentieth century, Glyoxilide, Hoxsey’s botanicals, Krebiozen, have virtually disappeared within the United States, although they linger outside the nation’s borders, available to the desperate traveler. What brought Koch, Hoxsey, the Durovics and Ivy down from their peaks of prominence was a combination of vigorous regulatory action, sustained critique, and faddist fascination with still newer unorthodoxies.

Dr. William Koch underwent two very long trials in 1943 and 1946, charged with promoting misbranded and ineffective drugs [179]. The first ended with a hung jury, the second when a juror became ill. Koch gave up business and retired to Brazil. Against Harry Hoxsey, the Food and Drug Administration initiated numerous actions. Injunction proceedings begun in 1950 before a judge disposed in Hoxsey’s favor were finally won only after the case had twice reached the Supreme Court [32]. In 1957 an injunction closed Hoxsey’s satellite operation in Pennsylvania. Krebiozen came to a halt in interstate commerce when its sponsors withdrew a plan for the investigational use of the drug which they had submitted to the FDA [179,180]. This ban held, even though the government failed to convict the Durovics and Dr. Ivy in a nine-month criminal case decided in 1966 by a Chicago jury. Later, an investigation of jury tampering led to the conviction and jailing of one of the jurors. Thus regulatory action almost completely removed the unorthodox cancer treatments from interstate commerce, permitting their sponsors almost no elbow room for continuing promotion.

Not that unorthodoxy did not fight back. Hoxsey, for example, strove strenuously for political support, gaining favorable recognition from several United States Senators [32]. And he sought to establish and ally with organized support for his cancer clinic. In 1959 Hoxsey spoke at a naturopathic convention in Chicago, which also hearkened to the National Health Federation’s president, Fred J. Hart. At NHF membership rallies, Hart solicited funds to help Hoxsey carry on his contest with the FDA, and Hoxsey in turn gave royalties from his autobiography to help finance the NHF. Despite his efforts, Hoxsey did not develop an institutional base broad and strong enough to permit his unorthodox clinics to survive. Nor did the promoters of Glyoxilide or Krebiozen succeed with similar attempts.

Prior to Laetrile’s series of victories in the legislatures of seventeen states, the major political triumph achieved by the forces of unorthodoxy came in the national Congress with the enactment of the Vitamin Amendments of 1976 [102]. Led by the National Health Federation, promoters of nutritional products skillfully mobilized their followers into a powerful lobbying force. By securing the new law, the health food industry not only succeeded in thwarting the Food and Drug Administration’s attempt to tighten the stringency of regulation in this field, they won from Congress a curtailment of FDA’s authority below that which had been given the agency by Congress in the 1938 law.

This episode reveals that health unorthodoxy has the capability of mounting sufficient political power to win important victories. The obviously growing strength of nutritional unorthodoxy may well have played a role in Laetrile’s transmogrification into a “vitamin.” The National Health Federation has accepted and promoted Laetrile’s vitamin status. In 1977 the NHF made legalizing Laetrile its “No. 1 priority.” [205] It remains to be seen whether the millions of Americans who flirt with nutritional unorthodoxy will welcome an anti-cancer Vitamin B-17. Not all citizens who believe in extra vitamins as a sure road to extra pep may so readily accept vitamins in the treatment of cancer.

No previous cancer unorthodoxy ever approximated the institutional base which Laetrile achieved, resting on the International Association of Cancer Victims and Friends; the Cancer Control Society, formed by dissident members of the IACVF [206)] and particularly the Committee for Freedom of Choice in Cancer Therapy, whose motivation is as much political as therapeutic. The big question is whether this political base is firm enough to establish Laetrile in an institutionalized sense in our society, whatever else may happen. Indeed, it may be surmised that Laetrile’s boom has peaked and now is in decline. Reports about toxicity doubtless dampened public ardor. Laetrile bills before state legislatures did not fare so well during 1978 as in 1977 [115]. Future consideration and reconsideration may find state assemblymen looking more probingly past the freedom of choice argument at the scientific facts, following the example of Massachusetts [207]. Inquiries about Laetrile to the Food and Drug Administration have fallen off [208]. Media coverage has declined, despite such newsworthy events as the announcement of the National Cancer Institute’s proposed trials and the Tenth Circuit’s decision in the Rutherford case. Even should that decision stand, the legal use of Laetrile would be drastically curtailed from the level defined in Judge Bohanon’s decision, with oral dosage forms eliminated. The Supreme Court, in adjudicating between the Tenth and Seventh Circuits, may confirm the FDA’s authority to ban Laetrile completely from interstate commerce [209].

Even if Laetrile should follow Krebiozen and the others off center stage, this does not mean unorthodoxy’s demise. As long as cancers remain a grave problem and wear a fearful image, quackery threatens. Much disenchantment exists with scientific medicine. Cancer patients have felt rejected by some orthodox physicians who have seemed to lose interest in their cases when nothing more medically could be done. The unorthodox offer considerable psychological support. The quixotic state of public feelings about health conduces to strange enthusiasms and open sesame for charlatans. Despite such a hopeful development as the hospice movement [210], offering skilled and considerate support to the dying and their families, a gloomy prognosis is hard to avoid. The broader and more diffuse approach of metabolic therapy, in which Laetrile is now enveloped, may prove a more difficult regulatory problem to confront than combatting a single unproven entity.

A shrewd and seasoned observer, looking ahead, recently took a somber tone:

During the past decade, a change has taken place in public attitudes toward medical science. There has been an increasing acceptance of misinformation, as shown for example by the success of the laetrile and ‘health food’ movements. This acceptance has been aided by the media, especially television, which publicize sensational and erroneous statements. These are seldom rebutted. There is distrust of the ‘establishment,’ and a feeling that doctors are exploiting patients. I believe this trend is so well established, and so little challenged, that its impact will produce a decline of scientific medicine, and its replacement by quackery [211].


This article was originally presented at the symposium on politics, science, and cancer held at the 1979 annual meeting of the American Association for the Advancement of Science in Houston, Texas. Dr. Young was professor of history at Emory University.


References and Notes
  1. Report by Jack Forbragd and Kenneth B. Ewing of interview with Ernst T. Krebs, Sr., Dec. 11, 1962, San Francisco District File CF: 10 183, Krebs Laboratories, vol. 1, Food and Drug Administration Records (San Francisco).
  2. G.D. Kittler, Control for Cancer (Paperback Library, New York, 1963).
  3. Bull. Nev. State Bd. of Health, Jan. 1920, clipping, FDA report, Dec. 9, 1957, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 4, FDA Recorqs (San Francisco).
  4. Nevada Appeal, Carson City, Nov. 14, 1957, clipping, ibid.
  5. Bureau of Chemistry, Department of Agriculture, Notices of Judgment 11193 (1923) and 12047 (1924).
  6. FDA D.N.J. 17066 (1930).
  7. S.B. Gilmore and J.B. Corson to San Francisco District, Apr. 1, 1958, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 6, FDA Records (San Francisco).
  8. San Francisco District Summary and Recommendation for Prosecution, Oct. 20, 1960, ibid.
  9. E. Krebs, Jr., E. Krebs, Sr., and H. H. Beard, The Unitarian or Trophoblastic Thesis of Cancer (McNaughton Foundation, Montreal, 1950).
  10. Walter Van Winkle, Jr., to Ernst T. Krebs, May 7, 1945, [re NDA 5703), AF 26-731, vol. 1, FDA Records (Rockville).
  11. Edward V. O’Gara to San Francisco District, July 14, 1945, ibid.
  12. D. Rorvik, New West, Apr. 25, 1977, p. 51.
  13. Affidavit of Ernst T. Krebs, Sr., Apr. 28, 1965, FDA File on Labeling and Composition of Laetrile, FDA Records (Rockville).
  14. Statement of Eric E. Conn on Patent Specifications 13228, vol. M, item 424, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  15. Russell C. White and Donald L. Taylor to San Francisco District, Dec. 15, 1952, FDA File on Labeling and Composition of Laetrile, FDA Records (Rockville).
  16. Statement of Carol M. Hehmeyer, Banning of the Drug Laetrile from Interstate Commerce by FDA (95th Cong., 1st sess, Hearing before the Subcommittee on Health and Scientific Research of the Committee on Human Resources, U.S. Senate, July 12, 1977 [hereafter, Hearing before Kennedy subcommittee]), pp. 239-40.
  17. Ralph Weilerstein to San Francisco District, series of 1945 memoranda, AF 26-731, vol. 1, FDA Records (Rockville).
  18. Eugene Eno to San Francisco District, Sep. 13, 1950, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 1, FDA Records (San Francisco.
  19. Science, 103, 25, (1946).
  20. E.T. Krebs, M.D., Laetrile (San Francisco, n.d.), in Laetrile file of exhibits, AF 26-731, Accession 88-73-6, box 50, FDA Records, Record Group 88, Washington National Records Center (Suitland, MD) (hereafter, WNRC).
  21. FDA, Laetrile, Commissioner’s Decision on Status, Fed.Reg. 42, 39773 (1977).
  22. Richard M. Stalvey to San Francisco District, Sep. 10, 1953, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 1, FDA Records (San Francisco).
  23. Krebs, Jr., to Ian McDonald, Dec. 8, 1952, ibid.
  24. Memorandum of interview between Ralph Weilerstein and L. Henry Garland, Dec. 9, 1952, ibid.
  25. Cancer Commission of the California Medical Association, Calif. Med. 78, 320 (1953).
  26. R. T. Dorr and J. Paxinos, Ann. Internal Med. 89, 389 (1978).
  27. Memorandum of interview between Ralph Weilerstein and E.W. DeLong, Aug. 24, 1953, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 1, FDA Records (San Francisco).
  28. San Francisco News, Mar. 24, 1953.
  29. Krebs, Jr., to Richard E. Sponholz, Mar. 28, 1961, in Laetrile file of exhibits, AF 26-731, Acc. 88-73-6, box 50, FDA Records, RG 88, WNRC.
  30. Patent Specification 788,855 (1958).
  31. San Francisco District Report, Dec. 9, 1957, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 4, FDA Records (San Francisco).
  32. J. H. Young, The Medical Messiahs (Princeton University Press, Princeton, 1967), pp. 360-89.
  33. FDA D.D.N.J. 6543 (1960).
  34. M. L. Yakowitz to J. R. Cain, July 6, 1953, AF 26-731, vol. 1. FDA Records (Rockville).
  35. Deposition of Andrew R. L. McNaughton, June 2, 1964, The Canadian Laetrile (Anti-Cancer Drug) Case (Montreal, 1964), in Laetrile file of exhibits, AF 26-731, Acc. 88-73-6, box 50, FDA Records, RG 88, WNRC.
  36. New York Times, June 26, 1977.
  37. Newsweek June 27, 1977, pp. 48-56.
  38. The Financial Post, Toronto, Mar. 10, 1973.
  39. SEC v. Biozymes International Ltd., et al. U.S. District Court, Northern District of California, Civil Action No. C72-2217-SW, Apr. 27, 1973.
  40. Memorandum of interview at HEW by W. B. Rankin, Oct. 18, 1961, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 4, FDA Records (San Francisco) .
  41. Memorandum of interview at FDA by Ralph G. Smith, Oct. 18, 1961, ibid.
  42. FDA D.D.N.J. 7062 (1962).
  43. Many documents dealing with the circumstances of Krebs’ probation are filed in San Francisco District File l- 412P, vols. 3 and 4, FDA Records (San Francisco).
  44. Krebs argued that his violation of the law had been technical, cued by his haste to beat the Russians in pangamic acid research, which, because oxygen utilization was involved, might help the United States triumph over the Soviet Union in the space race. Krebs to Robert M. Ensign, Sep. 18, 1963, ibid., vol. 4.
  45. Maurice P. Kerr to Chief Inspector, Dec. 9, 1963, San Francisco District File, CF: 10 183, Krebs Laboratories, vol. 1, FDA Records (San Francisco).
  46. Krebs to John A. Sprague, May 1, 1963, San Francisco District File l-412P, vol. 3, FDA Records (San Francisco).
  47. Gregory S. Stout to California State Board of Health, June 27, 1963, ibid., vol. 4.
  48. G. D. Kittler, “The Struggle,” American Weekly, Mar. 3 and 10, 1963.
  49. James Nakada to District Directors, May 1, 1963, San Francisco District File l-412P, vol. 3, FDA Records, (San Francisco).
  50. Interview with Cecile Pollack Hoffman by William P. Leckwold, Feb. 12, 1965, San Francisco District File, CF: 10 183, Krebs Laboratories, vol. 1, FDA Records (San Francisco).
  51. McKay McKinnon to Wallace Janssen, June 12, 1964, San Francisco District File l-412P, vol. 4, FDA Records, (San Francisco).
  52. Arthur Dickerman to William Goodrich, Jan. 25, 1963, ibid., vol. 3.
  53. Memorandum of interview with McNaughton by G. S. Goldhammer, Feb. 1, 1963, ibid.
  54. California Cancer Advisory Council, Report on the Treatment of Cancer with Beta-Cyanogenetic Gluosides (“Laetriles”) (1963), exhibit to affidavit of w. Sherwood Lawrence, Vol. F, item 183, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  55. San Francisco Examiner, June 6, 1963.
  56. FDA Report on Enforcement and Compliance, Aug. 1964, pp. 8-9.
  57. William C. Hill to K. F. Ernst, May 25, 1967, Krebs Injunction 508 File, vol. 2, FDA Records (San Francisco).
  58. San Francisco District Report, Sep. 22, 1969, San Francisco District File, CF: 10 183, Krebs Laboratories, vol. for 1969-71, FDA Records (San Francisco).
  59. San Francisco Chronicle, Jan. 27, 1970.
  60. Testimony of Ernst Krebs, Jr., vol. 0-1, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  61. Numerous documents during 19~9 and 1970 in San Francisco District File, CF: 10 183, Krebs Laboratories, FDA Records (San Francisco).
  62. FDA news release about NDA 6734, Sep. 1, 1971.
  63. HEW Secretary Elliot Richardson to Congressman Lawrence H. Fountain, Aug. 26, 1971, AF 26-731, vol. 12, FDA Records (Rockville).
  64. FDA letters to McNaughton Foundation, Apr. 20 and 28, 1970, ibid.
  65. Don C. Matchan in Alameda (CA) Times-Star, July 14, 1970.
  66. Dean Burk to Secretary Richardson, Mar. 23, 1971, AF 26- 731, vol. 12, FDA Records (Rockville).
  67. Dean Burk, in Who’s Who in America, 40th Edition, 1978-1979 (Marquis Who’s Who, Chicago, 1978), vol. 1, p. 470.
  68. C. P. Hoffman and E. N. Blaauw, If It Is True Cancer Can Be Controlled Why Isn’t It?, 1964 pamphlet, in San Francisco District File, CF: 10 183, Krebs Laboratories, vol. 1, FDA Records (San Francisco).
  69. James A. Crandall to Los Angeles District, July 12, 1965, ibid., vol. for 1965-68.
  70. John w. Holten to Los Angeles District, Aug. 23, 1965, ibid.
  71. Memorandum of telephone conversation between Gordon R.Wood and T. M. Rice, June 23, 1969, ibid., vol. for 1969-71.
  72. S. Barrett and G. Knight, eds., The Health Robbers (George F. Stickley, Philadelphia, 1976), p. 9.
  73. Ibid., pp. 189-201.
  74. Young, The Medical Messiahs, pp. 383-84, 400-401.
  75. Clippings from the National Health Federation Bulletin, Prevention, and National Enquirer, AF 26-731, vol. 11, FDA Records (Rockville).
  76. Walter Ermer to M. J. Ryan, Oct. 16, 1970, ibid.
  77. Numerous letters, ibid., vols. 11 and 12.
  78. NHF Bulletin, Sep. 1970, clipping, ibid., vol. 11.
  79. Fountain to Richardson, Mar. 16, 1971, ibid., vol. 12.
  80. FDA news release, Sep. 1, 1971, with attached Report of the Ad Hoc Committee of Oncology Consultants.
  81. H. R. 12092, introduced by John G. Schmitz, Dec. 7, 1971, Cong. Rec., 92nd Cong., 1st ses., p. 45120.
  82. People v. Ernst T. Krebs, Jr., Malvina Cassese, and Byron Krebs, San Francisco Municipal Court, Dept. 6, Docket No. G-14656 et al.
  83. Testimony of Carol M. Hehmeyer, Hearing before Kennedy subcommittee, pp. 226, 237.
  84. Resume of Laetrile cases, State of California, Health and Welfare Agency, Department of Health Services, various dates.
  85. People v. Mary Whelchel, San Diego Superior Court, Dept. 18, Docket CR 23718, Jan. 14 and 17, 1972; Feb. 13, 1974.
  86. Her Majesty the Queen v. Andrew R. L. McNaughton, Province of Quebec, District of Montreal, Court of Sessions of the Peace, No. 499-72, Judgment, Apr. 22, 1974.
  87. McNaughton pleaded guilty to a charge of conspiracy to facilitate the transportation of smuggled Laetrile. United States v. Andrew R. L. McNaughton, U.S. District Court, Southern District of California, No. 76-0448- Criminal, Judgment, Dec. 12, 1977.
  88. Newsday, Apr. 23, 1977.
  89. Unsigned memorandum for file, Mar. 10, 1972, AF 26-731, vol. 19, FDA Records (Rockville).
  90. J. A. Richardson and P. Griffin, Laetrile Case Histories (Bantam Books, New York, 1977), pp. 13-17, 71-73.
  91. California Board of Medical Quality Action Report, 10/1/ 76-12/30/76, John A. Richardson, M.D., Albany, Nov. 29, 1976.
  92. Testimony of Herbert B. Hoffman, Joseph Consentino, and Louis Castro, Hearing before Kennedy subcommittee, pp. 189-98.
  93. Robert W. Bradford to Dear Friend, The Committee for Freedom of Choice in Cancer Therapy brochure, [early 1973), in AF 26-731, vol. 22, FDA Records (Rockville).
  94. San Francisco Chronicle, Aug. 11, 1976.
  95. Statement of Robert W. Bradford, Hearing before Kennedy subcommittee, pp. 280-311.
  96. Affidavit of O.E. Kelly, vol. K, item 389, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  97. U.S. v. Bradford and U.S. v. Richardson, U.S. District Court, Southern District, California, 76-0448 Criminal, Judgment and Probation filed Dec. 12, 1977; U.S. v. Richardson, Bowman, Salaman, and Bradford, U.S. Court of Appeals, 9th Circuit, Nos. 77-2203, 77-204, 22-2262, and 77-2288, opinion filed Oct. 20, 1978.
  98. Ernst Krehs, Sr., to FDA, Apr. 18, 1963, San Francisco District File, CF: 10 183, John Beard Memorial Foundation, vol. 6, FDA Records (San Francisco).
  99. E.T. Krebs, Jr., Jnl. Applied Nutrition 22, 75 (1970).
  100. Frank D. Corum memorandum, Mar. 24, 1966, San Francisco District File 131-699B, FDA Records (San Francisco).
  101. National Analysts, Inc., A Study of Health Practices and Opinions (National Technical Information Service, Springfield, VA, 1972).
  102. H. Young, “The Agile Role of Food,” in Nutrition and Drug Interrelations, J.N. Hathcock and J. Coon, eds. (Academic Press, New York, 1978), pp. 1-18.
  103. M. Greenberg, West. J. Med., 122, 345 (1975).
  104. National Nutrition Consortium, Inc., Statement on Laetrile-Vitamin B 7, Dec. 21, 1976.
  105. H. Jukes, Nutrition Today 12, 12 (Sep.-Oct. 1977).
  106. Testimony of Thomas H. Jukes, vol. 0-1, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  107. Testimony of John A. Richardson, Robert Bradford, Ernst T. Krebs, Jr., and Bruce Halstead, Hearing before Kennedy subcommittee, pp. 272-74.
  108. Mercury, San Jose, Sep. 7, 1972.
  109. Merlyn Wurscher to San Francisco District, Oct. 19, 1972, San Francisco District File, CF: 10 183, Krebs Laboratories, vol. for 1972, FDA Records (San Francisco)
  110. FDA N.J.s 29 (Oct. 1975) and 31 (Nov. 1975).
  111. FDA N.J.s 32 and Inj. 660 (Apr. 1978).
  112. Sacramento Bee, June 24, 1978. On the California cancer quackery law, first enacted in 1959 and made permanent in 1969, see L. F. Saylor, Calif. Med. 112, 94 (1970).
  113. R. 12573, introduced by Steven D. Symms, Mar. 16, 1976, 94th Cong. 2nd ses., p. H2002.
  114. Symms interview, U.S.News and World Report, June 13, 1977, pp. 51-52.
  115. L. Nightingale and F. D. Arnold, Legal Aspects of Medicine 6, 31 (1978).
  116. Affidavit of Peter H. Wiernik, vol. H. item 200, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  117. New York Times, May 2, Aug. 16 and 25, 1977; June 7, 1978.
  118. Atlanta Journal and Constitution, Nov. 20, 1977.
  119. Based on author’s observations in one state and conversations with several observers in other states.
  120. Arizona Republic, Phoenix, June 20, 1977.
  121. Chicago Tribune, Aug. 27, 1978.
  122. Chicago Sun-Times, Mar. 5, 1978.
  123. Rutherford v. United States, 399 F. Supp. 1208 (W.D. Okla., 1975).
  124. Medical World News, June 28, 1976, pp. 17-20. Medical World News quotes Rutherford as saying that in Mexico surgeons “cauterized” the growth, and also quotes a Chicago pathologist as stating: “It is exceptionally rare for this type of tumor to metastasize. Local excision of the polyp virtually always cures the patient.”
  125. Rutherford v. United States, 542 F. 2d 1137 (10th Cir. 1976).
  126. FDA Administrative Record, Laetrile, Docket No. 77N- 0048.
  127. Rutherford v. United States, 438 F. Supp. 1287 (W. D., Okla. 1977).
  128. Rutherford v. United States, 10th Circuit opinion, text cited in United States v. Rutherford, Petition for a Writ of Certiorari, filed with the Supreme Court, Oct. 10, 1978.
  129. Statement of Joseph F. Ross, with exhibits, Hearing before Kennedy subcommittee, pp. 62-188.
  130. Medical World News, Jan. 9, 1978, pp. 16, 21.
  131. Charlotte (NC) Observer, Sep. 12, 1976.
  132. P. Lehmann, FDA Consumer 11, 10 (Oct. 1977).
  133. F. P. Smith et al., JAMA 238, 1361 (1977).
  134. FDA Talk Paper, July 12, 1978.
  135. United States v. Mosinee Corp., Inj. 789, FDA news release, May 16, 1977.
  136. FDA news release, Aug. 18, 1978.
  137. On June 18, 1979, a unanimous Supreme Court reversed the Tenth Circuit, holding that the safety and effectiveness standards in the law do apply to terminal patients. The high court did not address some issues which the district court had raised but the circuit court had not. United States v. Rutherford, No. 78-605.
  138. People v. Privitera, Court of Appeals, Fourth Appellate District, Division One, 4 Cr. No. 8323 (1977).
  139. The Supreme Court reversed the appellate course in this case. People v. Privitera, Supreme Court of the State of California, No. Crim. 20340 (1979), Sup., 153 Cal. Rptr. 431.
  140. Atlanta Constitution, Feb. 1-23, 1978, passim.
  141. FDA news release, Mar. 26, 1978.
  142. FDA Drug Bulletin, Nov.-Dec. 1977.
  143. United States v. Articles of Drug . . . Amigdalina Cyto Pharma De Mexico, S.A., Docket No. K77-1283, U.S. District Court for Maryland, filed Aug. 4, 1977, cited in Brief Amicus Curiae of the American Cancer Society, by Grace Powers Monaco, Mar. 8, 1979, in United States v. Rutherford, No. 78-605, in the Supreme Court of the United States, October Term, 1978.
  144. Medical World News, Sep. 5, 1977, p. 22.
  145. Interview with Eu9ene Pfeifer, Oct. 25, 1978.
  146. On Mar. 31, 1974.
  147. Atlanta Constitution, Aug. 21, 1975; Feb. 10, Apr. 1, May 13, 1976; Apr. 19, Dec. 8, 1977; Feb. 9, 1978.
  148. American Media, Westlake Village, CA,1974.
  149. ’76 Press, Seal Beach, CA, 1976.
  150. Choice Publications, Los Altos, CA, 1977.
  151. Cited in statement of Robert W. Bradford, Hearing before Kennedy subcommittee, p. 285.
  152. Ibid., pp. 272, 310.
  153. Los Angeles Times, Sep. 8, 1977.
  154. H.W. Manner, The Remission of Tumors with Laetrile Therapy (text of presentation to annual meeting, NHF, 1977) .
  155. Robert S.K. Young, Review of “The Remission of Tumors with Laetrile Therapy” (text of critique, 1977).
  156. M.B. Lipsett and J.C. Fletcher, N. Engl. J.  Med. 297, 1183 ( 1977) .
  157. J. Ingelfinger, N. Engl. J.  Med.. 296, 1167 (1977). After toxicity evidence concerning Laetrile had begun to mount, Ingelfinger told a reporter that he might not write the kind of editorial again that he had earlier written. Chicago Sun-Times, Mar. 8, 1978.
  158. New York Times, Feb. 11, 1977.
  159. G. Moertel, N. Engl. J.  Med.. 298, 218 (1978).
  160. Statement of Donald Kennedy, Hearing before Kennedy subcommittee, pp. 26-38.
  161. Hearing before Kennedy subcommittee, pp. 248-50, 295.
  162. Statement by Guy R. Newell, M.D., Deputy Director, National Cancer Institute, on Retrospective Evaluation of Laetrile Anticancer Activity in Man, Jan. 26, 1978.
  163. Neil M. Ellison, Report on a Doctors’ Workshop on Metabolic Therapy, Amygdalin, and Cancer–Newark, New Jersey, Feb. 4-5, 1978.
  164. M. Ellison, D. P. Byar and G. R. Newell, N. Engl. J. Med. 299, 549 (1978).
  165. Atlanta Constitution, Sep. 28, 1978. In December 1978 the NCI ‘ormally applied to the FDA for an IND to permit the clinical trials.
  166. Robert C. Wetherell, Jr., Status of Laetrile, Feb. 6, 1975, AF 26-731, vol. 31, FDA Records (Rockville).
  167. Newsday, Apr. 25, 1977.
  168. Dean Burk to Edward Kennedy, Nov. 16, 1977, and exhibits, Hearing before Kennedy subcommittee, pp. 384- 419.
  169. Testimony of Robert W. Bradford, vol. 0-2, FDA Administrative Record, Laetrile, Docket No. 77N-0048.
  170. D. Leff, Medical World News, May 1, 1978, pp. 43-51.
  171. Editorial, The Choice (Oct. 1978).
  172. J H. Young Cimarron Rev., No. 8, 31 (1969).
  173. New York Times, July 1, 1906.
  174. Pennsylvania Gaazette, Philadelphia, Oct. 17 and 31, 1745.
  175. Young, The Medical Messiahs, pp. 48-49.
  176. American Cancer Society, 1977 Cancer Fact & Figures (New York, 1976).
  177. Donald Kennedy, text of speech on “Cancer Politics,” Nov. 3, 1977.
  178. Susan Sontag, New York Review, Jan. 26, pp. 10-16; Feb. 9, pp. 27-29; and Feb. 23, 1978, pp. 29-33. These articles have been combined into a book, Illness as Metaphor (Farrar, Straus and Giroux, New York, 1978).
  179. W.F. Janssen, Analytical Chem., 50, 197A (1978).
  180. Young, The Medical Messiahs, pp. 401-402, 420.
  181. This pattern the author first explored in Newsday, May 1, 1978.
  182. American Medical Association, Nostrums and Quackery, 2nd ed. (AMA Press, Chicago, 1912), p. 56.
  183. Testimony of David T. Carr, vol. 0-1, FDA Administa¬tive Record, Laetrile, Docket No. 77N-0048.
  184. Edmund Griffin, World Without Cancer, transcript of sound track of documentary film, supplied by Food and Drug Administration.
  185. American Medical Association, Nostrums and Quackery, p. 39.
  186. Edmund Griffin, in Richardson, Laetrile Case Histories, p. 64.
  187. H. Young, The Toadstool Millionaires (Princeton University Press, Princeton, 1961), pp. 165-89.
  188. San Francisco Chronicle, Aug. 11, 1976.
  189. Young, Toadstool Millionaires, pp. 75-89.
  190. Ibid., pp. 220-21.
  191. Affidavit of W. Sherwood Lawrence, vol. F, item 183, FDA Administrative Record, Laetrile, Docket No. 77N- 0048.
  192. California v. Krebs and Cassese, San Francisco Municipal Court, No. G 14673 and G 14670, 1977.
  193. Young, The Medical Messiahs, pp. 239-57.
  194. Richardson, Laetrile Case Histories, pp. 97-102.
  195. Ibid., pp. xv, 4, 55-65.
  196. Statement of the American Medical Association, Hearing before Kennedy subcommittee, pp. 327-32.
  197. G. Campbell to Leland M. Ford, Mar. 4, 1941, Inter-state Office Seizure No. 16224-E File, FDA Records, RG 88, National Archives Bz an ch , WNRC.
  198. Arthur J. Cramp, Nostrums and Quackery and Pseudo-Medicine (AMA, Chicago, 1936), pp. 198-208.
  199. Weinburger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609.
  200. An apparent example of this circumstance is revealed in a letter headed “Cancer and Oncologists versus Laetrile,” July 25, 1975, AF 26-731, vol. 30, FDA Records (Rockville).
  201. Cramp, Nostrums and Quackery and Pseudo-Medicine, pp. 218-21.
  202. W. Holmes, Medical Essays (Houghton Mifflin, Boston, 1891), p. 186.
  203. Richardson comments on these circumstances in Laetrile Case Histories, pp. 76-77.
  204. Order and Affidavit and Extension, filed May 10, 1977, by Judge Luther Bohanon, Rutherford v. United States. I have multiplied the quantity of tablets and injectable liquid authorized by the then current cost, one dollar a tablet and ten dollars for a 3g. ampule.
  205. Form letter from National Health Federation, [Dec. 1977), promoting “Fund to Stop Government Ban on Laetrile,” Decimal File 539,ILX, vol. 33, FDA Records (Rockville).
  206. A most useful sociological study of persons who attended a “Cancer Control Symposium” sponsored by a Michigan chapter of the Cancer Control Society appears in G. E. Markle, J.C. Petersen, and M.O. Wagenfeld, Soc. Sci. & Med., 12, 31 (1978).
  207. Boston Herald-American, May 19, 1978.
  208. Interview with Stuart L. Nightingale, Oct. 24, 1978.
  209. It has been suggested, however, that the right of privacy doctrine established by the Supreme Court in Griswold v. Connecticut, 381 u. S. 479 (1965), might provide grounds for a challenge of federal law restrictions on the consumer’s free choice of drugs. D. G. Rushing, UCLA Law Rev., 25, 577 (1978).
  210. Death Education devoted its double Spring/Summer 1978 issue to the Hospice movement.
  211. Thomas H. Jukes to author, Aug. 11, 1978.


Karima Hirani, M.D., Accused of Unprofessional Conduct

In March 2020, the Medical Board of California accused Karima Hirani., M.D. of gross negligence; repeated negligent acts; and excessive prescribing or treatment in her management of a nine-year-old girl with a chief complaint of intermittent stomach pain. The Accusation, shown below, states that Hirani: Recommended and/or prescribed a gluten-free, dairy-free, sugar-free diet, several six …

In March 2020, the Medical Board of California accused Karima Hirani., M.D. of gross negligence; repeated negligent acts; and excessive prescribing or treatment in her management of a nine-year-old girl with a chief complaint of intermittent stomach pain. The Accusation, shown below, states that Hirani:

  • Recommended and/or prescribed a gluten-free, dairy-free, sugar-free diet, several six nutritional supplements.
  • Ordered approximately 30 laboratory test panels, many of which were redundant or lacked medical justification.
  • Diagnosed the child with active Lyme disease, active varicella (chickenpox), and mycoplasma (walking pneumonia) infections, diagnoses that were not properly supported by the laboratory results.
  • Ordered a homeopathic product for the alleged Lyme disease without disclosing that no peer-reviewed studies supported its use.

Hirani operates the Hirani Medical Wellness Center in Culver City, California where she practices what she calls “holistic and preventative medicine.”


XAVIER BECERRA
Attorney General of California
JUDITH T. ALVARADO
Supervising Deputy Attorney General
PEGGIE BRADFORD TARWATER
Deputy Attorney General
State Bar No. 169127
California Department of Justice
300 South Spring Street, Suite I 702
Los Angeles, California 90013
Telephone: (213) 269-6448
Facsimile: (213) 897-9395
E-mail: Peggie.Tarwater@doj.ca.gov

Attorneys for Complainant

BEFORE THE
MEDICAL BOARD OF CALIFORNIA
DEPARTMENT OF CONSUMER AFFAIRS
STATE OF CALIFORNIA

In the Matter of the Accusation Against:

KARIMA HIRANI, M.D.
9736 Venice Boulevard
Culver City, California 90232

Physician’s and Surgeon’s Certificate
No. G 79715

Respondent.


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Case No. 800-2017-038476

FIRST AMENDED ACCUSATION

 

FILED March 7, 2018

Complainant alleges:

PARTIES

  1. Christine J. Lally (Complainant) brings this First Amended Accusation solely in her official capacity as the Interim Executive Director of the Medical Board of California, Department of Consumer Affairs (Board).
  2. On August 24, 1994, the Medical Board issued Physician’s and Surgeon’s Certificate Number G 79715 to Karima Hirani, M.D. (Respondent). The Physician’s and Surgeon’s Certificate was in full force and effect at all times relevant to the charges brought herein and will expire on April 30, 2020, unless renewed.

JURISDICTION

  1. This First Amended Accusation is brought before the Board under the authority of the following laws. All statutory references are to the Business and Professions Code (Code) unless otherwise indicated.
  2. Section 2227 of the Code provides that a licensee who is found guilty under the Medical Practice Act may have his or her license revoked, suspended for a period not to exceed one year, placed on probation and required to pay the costs of probation monitoring, or such other action taken in relation to discipline as the Board deems proper.

STATUTORY PROVISIONS

  1. Code section 2234 states, in pertinent part:

The board shall take action against any licensee who is charged with unprofessional conduct. In addition to other provisions of this article, unprofessional conduct includes, but is not limited to, the following:

(a) Violating or attempting to violate, directly or indirectly, assisting in or abetting the violation of, or conspiring to violate any provision of this chapter.

(b) Gross .negligence.

(c) Repeated negligent acts. To be repeated, there must be two or more negligent acts or omissions. An initial negligent act or omission followed by a separate and distinct departure from the applicable standard of care shall constitute repeated negligent acts.

(1) An initial negligent diagnosis followed by an act or omission medically appropriate for that negligent diagnosis of the patient shall constitute a single negligent act.

(2) When the standard of care requires a change in the diagnosis, act, or omission that constitutes the negligent act described in paragraph (1), including, but not limited to, a reevaluation of the diagnosis or a change in treatment, and the licensee’s conduct departs from the applicable standard of care, each departure constitutes a separate and distinct breach of the standard of care.

¶….¶

  1. Code section 725 states:

(a) Repeated acts of clearly excessive prescribing, furnishing, dispensing, or administering of drugs or treatment, repeated acts of clearly excessive use of diagnostic procedures, or repeated acts of clearly excessive use of diagnostic or treatment facilities as determined by the standard of the community of licensees is unprofessional conduct for a physician and surgeon, dentist, podiatrist, psychologist, physical therapist, chiropractor, optometrist, speech-language pathologist, or audiologist.

(b) Any person who engages in repeated acts of clearly excessive prescribing or administering of drugs or treatment is guilty of a misdemeanor and shall be punished by a fine of not less than one hundred dollars ($ I 00) nor more than six hundred dollars ($600), or by imprisonment for a term of not less than 60 days nor more than 180 days, or by both that fine and imprisonment.

(c) A practitioner who has a medical basis for prescribing, furnishing, dispensing, or administering dangerous drugs or prescription controlled substances shall not be subject to disciplinary action or prosecution under this section.

(d) No physician and surgeon shall .be subject to disciplinary action pursuant to this section for treating intractable pain in compliance with Section 2241.5.

FIRST CAUSE FOR DISCIPLINE

(Gross Negligence)

  1. Respondent is subject to disciplinary action for gross negligence under Code section 2234, subdivision (b). The circumstances are as follows:
  2. Respondent practices functional medicine and complementary alternative medicine in an integrative practice.
  3. On September 17, 2017, Patient I, a nine-year-old female, presented to Respondent with a chief complaint of intermittent stomach pain. Her health history also included recurrent ear infections, fear of kidnapping, and a history of an autoimmune illness called Henoch Schonlein Purpura, a disease causing swelling of small blood vessels commonly found in children. Overall, Patient I had seen her pediatrician in May 2015 for an insect bite that had resulted in a fever. Patient 1 ‘smother explained that she wished to be proactive in minimizing stomach sensitivities that may disrupt schooling.
  4. On the first visit, Respondent recommended a gluten-free, dairy-free, sugar-free diet. She recommended six nutritional supplements. She ordered approximately 30 laboratory panels, which included redundancies, such as two celiac panels from two different laboratories and herpes simplex virus antibody and human herpes virus 6 antibody tests from two different laboratories. Many of the labs were not relevant to Patient l’s chief complaint of intermittent stomachache.
  5. Respondent proceeded with extensive testing while also acknowledging that blood tests are often not useful in looking for food sensitivities and that positive outcomes for Patient 1 ‘s complaints could occur with a simple anti-inflammatory dietary intervention.
  6. Patient I returned for a follow-up visit on October 18, 2017. Patient 1’s mother reported that the stomachaches had subsided with the dietary changes, a probiotic, a digestive enzyme, and L-glutamine amino acid.
  7. The standard of care requires a physician practicing complementary medicine to ordr tests appropriate for the nature and severity of the chief complaint.
  8. Respondent was grossly negligent in the care and treatment of Patient 1 in that she engaged in excessive and unnecessary testing without medical justification.

SECOND CAUSE FOR DISCIPLINE

(Repeated Negligent Acts)

  1. Respondent is subject to disciplinary action under section 2234, subdivision (c), in that she committed repeated negligent acts in her care and treatment of Patient I. The circumstances are as follows.
  2. The allegations in the First Cause for Discipline are incorporated by reference.
  3. Respondent diagnosed Patient 1 with active Lyme disease, active varicella (chicken pox), and mycoplasma (walking pneumonia) infections, diagnoses which are not properly supported by Patient l’s laboratory results. During an interview related to Patient l’s care conducted on behalf of the Board, Respondent admitted that Patient 1 did not have active infections to these agents, but rather an autoimmune process or reaction to the agents that could have been better explained.
  4. Respondent told the mother of Patient I that Lyme disease could be transmitted through spider bites and mosquito bites without explaining that this view contradicted the opinionof the Centers for Disease Control that the disease is transmitted through tick bites or the rare process of in utero transmission.
  5. Respondent recommended a homeopathic treatment for the Lyme disease, consisting of low dose immunotherapy (LDI).1 LDI, while safe, is not the conventional treatment for Lyme disease. Respondent did not explain to the mother of Patient 1 that LOI is an alternative and complementary medicine treatment for Lyme disease nor did she explain that there are no peer­reviewed studies supporting its use. She did not explain or offer the conventional Lyme disease treatment for Patient 1.

1 LDI involves obtaining liquid antigens from a compounding pharmacy and diluting the liquid hundreds of times such that it contains little of the original substances. Homeopathic doctors believe that if properly diluted, a substance that causes disease symptoms in a healthy person can improve the symptoms in a sick person.

  1. Respondent told Patient l’s mother that Patient 1 was not very symptomatic despite the three infections, allergies, and “the mold thing going on.” Respondent said nobody else would find “it” and that, “You’re dodging a big bullet if you follow my recommendations.”
  2. The standard of care is to interpret laboratory tests accurately, explain the results to patients in an understandable way, and to explain the risks and benefits of treatments offered.
  3. Respondent departed from the standard of care in diagnosing active Lyme, Varicella, and Mycoplasma infections instead of taking adequate time to fully explain the autoimmune phenomena.
  4. Respondent departed from the standard of care by stating that Lyme disease can be transmitted by spiders and mosquitoes without explaining that this opinion contradicts that of the Centers for Disease control.
  5. Respondent departed from the standard of care in offering LOI treatment without explaining the homeopathic nature of the treatment and that there are no peer-reviewed studies supporting its use.

THIRD CAUSE FOR DISCIPLINE

(Excessive Prescribing or Treatment)

  1. By reason of the facts alleged in the First Cause for Discipline, Respondent is subject to disciplinary action under section 725, in that she engaged in excessive testing and treatment in her care and treatment of Patient 1.

WHEREFORE, Complainant requests that a hearing be held on the matters herein alleged, and that following the hearing, the Medical Board of California issue a decision:

  1. Revoking or suspending Physician’s and Surgeon’s Certificate Number G 79715, issued to Respondent Karima Hirani, M.D.;
  2. Revoking, suspending or denying approval of Respondent’s authority to supervise physician assistants and advanced practice nurses;
  3. If placed on probation, ordering Respondent to pay the Board the costs of probation monitoring; and
  4. Taking such other and further action as deemed necessary and proper.

DATED: Mar 23, 2020

_______________________
CHRISTINE J. LALLY
Interim Executive Director
Medical Board of California
Department of Coinsumer Affairs
State of California
Complainant



FCC Proposes Record $225 Million Fine for Massive Spoofed Robocall Campaign

On June 9, 2020, the Federal Communications Commission (FCC) proposed a $225 million fine against Texas-based health insurance telemarketers for apparently making more than one billion illegally spoofed robocalls. The FCC news release said the action was the largest proposed fine in the FCC’s 86-year history and reflected the seriousness of the apparent violations by …

On June 9, 2020, the Federal Communications Commission (FCC) proposed a $225 million fine against Texas-based health insurance telemarketers for apparently making more than one billion illegally spoofed robocalls. The FCC news release said the action was the largest proposed fine in the FCC’s 86-year history and reflected the seriousness of the apparent violations by John C. Spiller and Jakob A. Mears, who used business names including Rising Eagle and JSquared Telecom.

Rising Eagle made approximately one billion spoofed robocalls across the country during the first 4½ months of 2019 on behalf of clients that sell short-term, limited-duration health insurance plans. Mr. Spiller admitted to the USTelecom Industry Traceback Group that he knowingly called consumers on the Do Not Call list as he believed that it was more profitable to target these consumers. The FCC’s Enforcement Bureau determined that at one point Rising Eagle used at east 60 spoofed caller IDs and made at least 86,864,456 robocalls to wireless phones as well as 56,635,935 robocalls to numbers listed on the National Do Not Call Registry. 

The robocalls falsely claimed to offer health insurance plans from well-known health insurance companies such as Aetna, Blue Cross Blue Shield, Cigna, and UnitedHealth Group. For example, one call stated:

Are you looking for affordable health insurance with benefits from a company you know? Policies have all been reduced nationwide such as Cigna, Blue Cross, Aetna, and United just a quick phone call away. Press 3 to get connected to a licensed agent or press 7 to be added to the Do Not Call list.

If they did press 3, consumers were transferred to a call center with no affiliation to the named companies, where call center representatives then would attempt to convince the consumer to purchase an insurance product sold by one of Rising Eagle’s clients. Rising Eagle’s largest client, Health Advisors of America, was sued by the Missouri Attorney General for telemarketing violations in February 2019.

Beginning in 2018, there was an increase in consumer complaints and robocall traffic related to health insurance and other health care products. The Traceback Group determined that approximately 23.6 million health insurance robocalls were crossing the networks of the four largest wireless carriers each day. The FCC Enforcement Bureau’s investigation found that a large portion of this unwelcome robocall traffic was driven by Rising Eagle.

The Truth in Caller ID Act prohibits manipulating caller ID information with the intent to defraud, cause harm, or wrongfully obtain anything of value. The FCC’s investigation found that the robocalls made by Rising Eagle were spoofed in order to deceive consumers, targeted millions of Do Not Call list participants, and were received on many wireless phones without prior consumer consent. The scam also caused the companies whose caller IDs were spoofed to become overwhelmed with angry call-backs from aggrieved consumers. At least one company was hit with several lawsuits because its number was spoofed, and another was so overwhelmed with calls that its telephone network became unusable.

Illegal robocalls are the FCC’s top complaint. In recent years, the agency has issued a number of very large fines and proposed fines for spoofing violations. In addition, it has permitted phone companies to block suspected malicious robocalls before they get to consumers; led the push for caller ID authentication using STIR/SHAKEN standards; worked to reduce unwanted calls to reassigned numbers; took steps to prevent scam robotexts; and provided many alerts, tips, and other education tools to help consumers protect themselves from scammers. Unfortunately, as two of the five FCC Commissioners pointed out in the Notice, the Department of Justice has lessened the agency’s effectiveness by failing to help collect fines imposed in previous cases.

The proposed action, formally called a Notice of Apparent Liability for Forfeiture, or NAL, contains only allegations that advise a party on how it has apparently violated the law and may set forth a proposed monetary penalty. The Commission may not impose a greater monetary penalty in this case than the amount proposed in the NAL. Neither the allegations nor the proposed sanctions in the NAL are final Commission actions. The party will be given an opportunity to respond and the Commission will consider the party’s submission of evidence and legal arguments before acting further to resolve the matter. More information about robocall regulation is available at: https://www.fcc.gov/spoofed-robocalls.

The FCC’s action against this scheme provides some hope that robocalls can be controlled. But it also spotlights why laws are needed to make illegal robocalling a crime that can be punished by imprisonment.



Disciplinary Actions against Terry J. Lee, D.D.S.

Terry J. Lee, D.S., of Phoenix, Arizona, has been disciplined by the Arizona Dental Board seven times. In 1990, he was censured and placed on 12 months probation for routinely advising patients to have their amalgam fillings replaced. In 1999, the board censured Lee and ordered him to serve 5 years’ probation, take 48 hours …

Terry J. Lee, D.S., of Phoenix, Arizona, has been disciplined by the Arizona Dental Board seven times.

  • In 1990, he was censured and placed on 12 months probation for routinely advising patients to have their amalgam fillings replaced.
  • In 1999, the board censured Lee and ordered him to serve 5 years’ probation, take 48 hours of continuing education, and undergo  5 years of quarterly audits of diagnosis, treatment, planning skills, and recordkeeping. The order was preceded by 16 days of hearings, after which an administrative law judge had recommended that Lee’s dental license be revoked. The judge’s findings, which are described in the order below, reveal the extent to which Lee engaged in highly dubious practices. During the proceedings, I testified as an expert for the board. Knowledgeable observers believe that the relatively light penalty resulted from threats by state legislators to abolish the board if it revoked Lee’s license. A subsequent investigation by the Arizona Auditor General concluded that the board’s sanction was based on the quality of his dental work and not his “holistic” philosophy.
  • In October 2002, the board censured Lee, ordered him to take additional continuing education courses, and restricted certain practices until the courses were completed.
  • In December 2002, the board issued a consent agreement under which Lee was fined $2,000, ordered to take additional courses, and banned from doing cavitational surgery or using applied kinesiology or a Computron device as a sole basis for for extracting root-canal-treated teeth.
  • In, 2004, the board charged Lee with unprofessional conduct by failing to maintain adequate records. The complaint was filed after an audit of his charts found that (a) he did not record evaluations for many patients for whom he provided periodontal (gum) treatment; (b) he administered intravenous vitamin C infusions without documenting any diagnosis or health history justifying their use; and (c) he made notions of “detox” without sufficiently identifying what it is or wny he believed it was necessary. In February 2005, the board upheld the complaint, assessed a $4,000 penalty, and suspended his dental license for 45 days. Lee appealed but the Arizona Court of Appeals upheld the board.
  • In February 2008, the board fined Lee $1,000 for failing to complete previously ordered continuing education.
  • In June 2008, the board issued a consent agreement and order under which Lee agreed to a remedial dental education course and to have his practice monitored.

BEFORE THE BOARD OF DENTAL EXAMINERS OF THE STATE OF ARIZONA
In the Matter of

Terry J. Lee, DDS
Holder of License Number D 1555
For the Practice of Dentistry
In the State of Arizona


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Case Numbers:
95083, 95084, 95135,
5178, 95312, 96024, 96054,
96175 and 97341

On February 19, 1999, this matter came before the Board of Dental Examiners of the State of Arizona for oral argument and consideration of the Recommended Decision and Order presented by the Administrative Law Judge/Arizona State Office of Administrative Hearings. Terry J. Lee, DDS appeared in person and was represented by Charles G. Brown, Attorney at Law; the State of Arizona was represented by Assistant Attorney General Victoria M. Mangiapane; the Board was advised by Assistant Attorney General Thomas J. Dennis, of the Civil Appeals Section of the Office of the Attorney General. The Board, having considered the entire Administrative Record in this matter, hereby issues the following Findings of Fact, Conclusions of Law and Order:

FINDINGS OF FACT

1. The Respondent herein, Terry J. Lee, D.D.S., is and at all times material hereto was, a dentist licensed in the State of Arizona by the Board of Dental Examiners, holding License Number 1555. He is a general practitioner, and an adherent to what he calls “holistic, biological type of dentistry.” According to him tenets of that practice include the use of “nontoxic or least toxic dental materials that effect [sic] the teeth, gums, oral cavities which general dentist [sic] usually use or practice.” He does not “do root canal fillings.” (Transcript of Evidence, Volume 20, pages 4 and 5; hereinafter abbreviated thusly: 20:4,5). Respondent also employs other techniques in his practice which he testified sets him and other socalled “holistic” dentists apart from all other dentists, including the use of “electrodermal screening” and “applied kinesiology.” (20:6) He counsels all his patients regarding his “holistic” approach. (22:44, 45). Which of those that are relevant to these cases will be described and discussed below where appropriate. The number of dentists who refer to themselves as “holistic” or “biological” amount to a small minority of dentists in the profession. (Record as a whole.)

2. Essentially there is but one path to the career of a dentist in Arizona, and nowhere along the way is a distinction drawn as between “holistic” dentists and any other kind. Aspirants to a career as a dentist must first earn an undergraduate degree (or nearly do so), then graduate from an accredited dental school, pass a character and fitness background check, pass a jurisprudence test, take and pass the National Boards, take and pass the Western Regional Examination Board, and then apply for and receive an Arizona license. (32:3436).

3. This contested matter includes nine consolidated cases, each involving a separate patient of the Respondent’s. The patients, for the purpose of preserving their confidentiality, are referred to by their initials in all cases save one, where the patient preferred to be identified by her name.

4. The first case is Complaint Number 95083, involving patient S.T. According to Respondent’s patient records, S.T. presented to Respondent on or about January 3rd, 1995. S.T. had no dental problems when first she went to Respondent. (7:122). She had an existing crown on tooth #19. She was suffering with hyperthyroidism and hoped to obtain some treatment from Respondent that would improve that condition. She had been told by medical doctors that her thyroid should be ablated, and she went to Respondent seeking a less invasive treatment of her thyroid condition. (1:35; 7:116; 20:45, 46). S.T. was counseled by Respondent that he could perhaps help her hyperthyroidism with his dental treatment. (7:40; 20:45, 46).

5. Respondent failed to perform a comprehensive examination of S.T. on her initial visit. (20:53). Respondent’s diagnosis of S.T. consisted of testing her with an amalgameter. (20:43). An amalgameter is a “microamp meter”” which is supposed to check for “microamperage,” or electrical current on crowns, amalgams, and bridges, (20:30, 31; 22:122). An amalgameter is not a generally accepted diagnostic tool in the dental community (9:29; 31:54;

State’s Exhibit 28 (hereinafter abbreviated as SE_)). There is no substantial evidence of record to show that the amalgameter has any diagnostic value in dentistry. According to Respondent, the amalgameter indicated that S.T.’s tooth #19 had a “high negative.” “[S]he had, “according to Respondent, “electrical current that was being generated in that area which was blocking the (acupuncture) meridians.” (20:48). This reading formulated Respondent’s diagnosis and prompted him to remove the crown from #19. The only patient record documentation of the diagnosis of tooth #19 Respondent recorded was: “35.”

6. Respondent placed a provisional crown on S.T.’s #19, but never seated a permanent crown for her. While it is true that S.T. ceased treating with Respondent after he placed the provisional crown, it is also true that Respondent never advised her after the termination of his treatment that she should return to him or see another dentist for placement of a permanent crown. (20:92, 9799).

7. Respondent also performed cavitational surgery on S.T.’s tooth #17. A cavitation is a residual area of necrotic bone in the upper or lower jawbone around the former site of a tooth. Cavitational surgery involves cutting into the soft tissue to reach the bone, and curetting, or cleaning out, the bone surrounding the necrotic area. (1:49; 20:148). The procedure is no longer encouraged in modern dentistry. (SE 23). Respondent based his diagnosis of the cavitation on the results of the amalgameter, the computron and applied kinesiology. (20:34, 40, 41;22:121123). The amalgameter already has been discussed.

8. The computron is claimed to be a legitimate electrodiagnostic device. In Respondent’s words the computron is “just simply a resistance meter that measures the resistance, the skin resistance. Basically, what it is an ohm meter. That’s what it is, just an ohm meter, resistance meter.” (27:18). It is used, he testified, to “(m)easure the electromagnetic system of the body. And it will tell us whether there’s a field of disturbance or not.” (27:135). the State’s expert witness, Dr. Stephen Barrett, testified that these devices are “complete nonsense,” “just silly,” and that the computron is a “delusional test.” (31:34). When using the computron that patient grasps a cylinder usually having moistened gauze around it, and the device sometimes is filed with purported remedies. The user then applies some probes to the skin of the patient’s mouth at where are understood to be acupuncture meridians, and the device yields a reading of some measurement. What actually determines the reading given by the machine is the amount of pressure the user applies with the probes to the patient’s skin. (27:24026; 331:2935). These devices have no dental treatment value, and no legitimate diagnostic use in dentistry. These devices actually are nothing more than fancy galvanometers. (SE38). In the testimony of Dr. Barrett, the best they can hope to measure objectively is “the amount of sweat on you skin.” (31:35, 39.) Respondent even admitted that his computron has not been approved by the federal Food and Drug Administration; that it is an “experimental instrument” which he is allowed to use for “study purposes.” (27:17. Respondent uses his computron as an aid in diagnosing cavitations. (27:19).

9. Applied Kinesiology (AK) is, according to Respondent, “muscle testing,” and is used to see if the patient “has normal body regulation, if she has normal polarity.” (20:34,35). He uses AK routinely in his office. (27:21) . AK is performed by “[p]lacing your finger in the area where it may cause a problem, which stimulates that area. Resistance then is applied to a patient’s muscle, often the arm. If there’s a problem, you will have a weakness in the muscle.” (27:20). AK also incorporates acupuncture meridians as a factor in its diagnosis. (SE 39). When a patient suppers from arthritis or other afflictions which reduce the musculatory function of a patient, the Respondent then employs his assistant as a “surrogate” in the test. In such cases, the patient places a finger inside her or his mouth, touching the subject area, while the “surrogate” touches the patient. Then, through a process described by the Respondent as a “transference,” the “reading” is sent from the patient to the “surrogate,” whose performance is merely that of a “conduit.” Even according to the Respondent, the use of AK as a diagnostic tool is “hard to explain in a lot of ways. Unless you’ve gone through it, unless you’re the tester, it’s a matter of feel.” (27:21, 8183). Two published researches have tried without success to demonstrate the effectiveness and usefulness of AK. (SE39,40). Dr. Barrett considers AK simply as “quackery,” and the claim of “transference” as “completely looney [sic].” (31:40). AK has no demonstrated value as a diagnostic tool in dentistry.

10. S.T.’s bone at tooth area #17 was not pathologically involved. There was no reason for Respondent to have performed cavitational surgery at that site. (5/6:102, 103; 32:79, 80).

11. Respondent’s dental records kept for S.T. are lacking almost to the point of nonexistence. his charts and file on S.t. do not contain any written , legible diagnosis, no written treatment plan, no dental charting and no periodontal charting. Respondent’s recordkeeping of S.T. was “abysmal,” and “terrible.” (1:36,37;5/6:103,104). The administrative record contains no justification for these deficiencies. (see, e.g.: 1:50). S.T.’s records were below the standard of care acceptable for a dentist (9:33,34). For example, Respondent’s “record” for S.T.’s tooth #19 was an horizontal blue line over the depiction of that particular tooth in the file chart. According to the Respondent that blue line meant to him that “the crown was taken off and it was temperized [sic]. basically that amalgam that was underneath it was taken out, a buildup material was placed and the provisional crown placed.” (20:41). It would have required very little of Respondent’s time indeed for him to have written those very words on S.T.’s record, but he did not.He did not because, as he testified, “all those marks[such as the blue line] mean something to me and my staff.” (20:41,42). For another example, Respondent utilizes red and blue carets which, to him, indicate a cavitation and cavitational surgery performed, respectively. According to Respondent, once the cavitational surgery is performed the red caret is erased and a blue caret drawn over its former place. (20:39,40). Respondent conceded his own doubt that his colored lines and carets would mean something to another dentist such as the Board of Dental Examiners’ Chief Investigator, Dr. Larry Pozil. (20:42;1:23). According to Respondent this method of his is quite subjective, being :just something that I developed on my own.” Nor does Respondent have any written legend or key to which another dentist could reference for explanation. (20:52). He had his staff carry the legend around in their head (22:37). The importance of a dentist’s thorough and legible patient records is obviously vital. What has been done to a patient, when and why, as well as what treatment of that patient lies ahead, all are essential information. While patient records need not be kept to the degree of writing out every procedural step with excruciating minutiae, if standard of care can be found to mean anything, surely the standard demands such records to be more than any individual dentist’s scanty, personalized hieroglyphics.

12. Respondent never promised S.T. that his dental treatment would cure her hyperthyroidism. However, he did instill in her the empty hope that his treatment could possibly help that condition of her. (See: Finding of Fact #4, supra). There is no credible evidence of record to support a finding that the dental procedures Respondent performed on S.T. had the slightest chance of affecting a positive changed in S.T.’s hyperthyroidism to any degree. Therefore, it is found that Respondent was not treating a medical condition (hyperthyroidism). Finding the opposite would be tantamount to finding that Respondent actually was treating hyperthyroidism by his dental procedures, and would lend credence or dignify Respondent’s claim of the possibility that his dental practice on S.T. could have caused an improvement of her hyperthyroidism, which is found not to be credible. What he did simply was practice dentistry, but make a false claim to what health benefit might derive as a result of his dental treatment.

13. S.T.’s husband testified that he did observe his wife “felt better after [the crown on #19] was removed for I believe it was about 24 hours.” (7:126). However, based on the other evidence of record it is found that this was not evidence of the crown removal helping her condition, but a manifestation of her own predisposition to believe in the treatment. Following Respondent’s last procedure on S.T., the cavitational surgery on #17, she and the Respondent’s relationship deteriorated, and she did not return to him for further treatment. Her thyroid condition extremely worsened, and she was taken to a hospital. Doctors there performed the thyroid ablation surgery on S.T. Now, “[s]he’s doing fine.” (7:128,129,162165).

14. S.T. signed Respondent’s standard consent form before he began treatment. However, this does not relieve Respondent as a dentist from his duty to provide adequate care to a patient. A dentist’s first duty is to do no harm, and a patient cannot consent to be harmed. (25:143).

15. S.T.’s Complaint to the Board was filed not by her, but by her husband, D.T. (1:35). S.T. did not appear and testify at the hearing; however, the facts found in her case are amply supported by the testimony of her husband, the Respondent’s own records and testimony, and the testimonies of other witnesses. Moreover, D.T. did not “speak for her,” an inaccurate characteristic of his testimony imputed by Respondent in posthearing memorandum. He spoke of the circumstances of her treatment with Respondent, testimony he gave from his own personal knowledge.

16. The second case is Complaint Number 95084, involving patient D.T., who is S.T.’s husband. D.T. first presented to Respondent’s office on January 4th, 1995. (27:13). He was not experiencing any pain at the time, but was seeking relief from his migraine headaches. (7:117, 130132). Respondent’s treatment records reveal that he performed cavitational surgery at the area of D.T.’s tooth #16, on January 25th, 1995. (7:132;27:16). D.T. signed a consent form to have all surgeries recommended by Respondent performed.

17. The Respondent performed the cavitational surgery on D.T. based on his diagnostic findings with panographic radiographs, the computron and applied kinesiology. (27:16,19; D.T. patient records). None of this information provides a justifiable diagnosis for performing the cavitational surgery. (5/6:98, 99;32:81, 83). Findings as to the computron and AK already have been made. The panographic radiographs showed no evidence of need for a cavitational surgery. (Id., and 32:81, 83).

18. Respondent’s treatment records of D.T. were below the standard of care. They contain no clinical examination notes, written diagnosis or treatment plan for D.T. (9:31; and D.T. patient records). D.T.’s treatment records contain no record of existing restorations. (27;30,31). Respondent’s treatment records of D.T. contain no periodontal charting, even though Respondent testified to the importance of that information. (D.T. patient records and 22:34). Respondent testified that he does perform a periodontal examination for each patient, but that his practice is not to make a record of the results of the examination for pocketing in the gums unless a pocket is four millimeters deep or deeper. Respondent’s position is that periodontal pockets less than four millimeters deep are within the normal range, so he does not write those scores into the record. (21:46; 20:155, 157). * Respondent at least should make a written record that all pockets were less than four millimeters, but he did not even do that much. Not recording the periodontal scores of healthy patients leaves a record devoid of any evidence that the exam was ever performed, and not only should there be such a record, there also should be a record that the periodontal scores were healthy. (4:22, 23; 10:6669). This is found as fact notwithstanding the testimony of Dr. Richard Carl, State’s consultative witness, that the State requires its consultative dentists to record on the consultation form only pockets deeper than three millimeters. (4:23). The State’s consultation form and a dentist’s patient record are two forms of documentation having materially different purposes in this regard. (10:69,70). For all the above deficiencies, Respondent’s treatment records for D.T. were below the standard of care. (See also: 9:11,12,15,16 32,91). Respondent testified that D.T. was a pushy and demanding patient. (27:14)> Assuming that to be so, such does not justify Respondent’s dispensing with the standard of care for D.T.’s treatment, including record keeping. Respondent also defended his lack of adequate patient record by offer of his symbolic markings already discussed supra. (*The Board amended this finding from that proposed by the Administrative Law Judge by deleting a sentence because it sets forth an incorrect standard of care.)

19. Respondent diagnosed D.T. (and other of the nine patients considered herein, including S.T.) with a condition known as neuralgia inducing cavitational osteonecrosis, popularly referred to by the acronym NICO. (S.T.) at 1:58, 59, 12:140; M.R. at 32:72ff; L.B. at 12:141, and N.F. at 12:147; 12:139, 140; SE3;

Respondent Exhibits U and V; hereinafter abbreviated thusly: RE__). Whether NICO even exists as a pathology in its own right is a question which has provided the source of not an inconsiderable amount of debate within the dental community. (Record as a whole). This nation’s leading proponent of NICO is Respondent’s witness Dr. Jerry Bouquot, presently the Director of Research at the Maxillofacial Center for Diagnostics & Research in Morgantown, West Virginia. He has been a licensed dentist since 1971, and is Board Certified in Oral Pathology. He specializes in oral and maxillofacial pathology. He has had a long and distinguished career. (12:74; RE120). He is widely and extensively published on the subject of NICO. (SE 25,45;RE 128, 129, 150). According to Dr. Bouquot, “NICO is just the-the jawbone version of a disease that occurs and has been reported in virtually every bone in the human body, as well several animals”.” (12:82). However, again according to Dr. Bouquot, NICO is a lesion histologically unique from other forms of osteomyelitis. (SE45). Therein lies the claim by Dr. Bouquot which has generated widespread opposition to, or at least withholding of, acceptance of NICO by the majority of the dental community as a whole. Put in Dr. Bouquot’s words, “The real question is whether NICO differs from classic forms of acute or chronic osteomyelitis[?]” Dr. Bouquot wrote in a 1992 article published in Oral Surgery, Oral Medicine, and Oral Pathology, of four conditions he claims supports his contention that the correct answer to that question is “it does.” (SE45). First, Dr. Bouquot writes that in “acute osteomyelitis, pain intensity is directly related to the presence of significant suppuration and considerable relief is immediately noted on cortical perforation and free egress of pus from the medullary spaces. Such does not appear to be the case with NICO lesions.” Second, “the character of local pain differs between these two diseases. Acute osteomyelitis produces much more intense bone pain on palpitation (tenderness) and is often very painful even without palpitation[.] NICO cavities, while known to trigger lancinating, paroxysmal attacks on palpitation, may be only mildly tender themselves and seldom demonstrate sharp local pain without palpitation.” Third, is “the virtual absence of new bone formation or healing . . . . contrary to chronic osteomyelitis. . .[and]. . . a surprising lack of active resorption of nonviable or necrotic bony flakes and spicules.” Fourth, “Chronic osteomyelitis typically contains foci of isolated suppuration (acute inflammation) and presents a course of acute exacerbations admixed with periods of quiescence.” “True chronic osteomyelitis encompasses a group of diseases usually categorized under the term chronic nonsuppurative osteomyelitis. . . .Each differs substantially from NICO[.] (SE45; all emphases added but the last). It appears that in most instances Dr. Bouquot qualifies the differences between chronic osteomyelitis and NICO which he listed in this exhibit. Additionally, Dr. Bouquot concedes in this article that it is purposed as a “preliminary microscopic evaluation and characterization of a large number [224] of NICO lesions and to differentiate them from other forms of osteomyelitis.” As Dr. Bouquot seems to recognize, 224 tissue samples is not a large enough sampling to provide conclusive evidence. He also wrote of his hope that “enough interest will be generated to lead to controlled prospective studies of the relationship between jawbone infections and facial neuralgias.” Evidently there had been none by 1992. Dr. Bouquot, quite forthrightly, includes as a part of his conclusion to the article his statement: “The present analysis, of course, has several flaws that stem from its uncontrolled, retrospective nature.:” Also bearing mention is the fact that this article was published under the journal’s heading “Controversies in Oral pathology,” itself indicating a large measure of rejection of NICO by members of the profession. The journal invited commentary on the article, and received and published such in the form of a critique written by William C. Donlan, DMD, MA, at the University of the Pacific. He opined as to Dr. Bouquot’s paper,”The content of this paper and its theories are . . . . nonscientific.” Dr. Donlan concludes “This paper does not define a new pathologic lesion, explain the pain caused by said lesions, or lend any additional credence to this hypotheses.”

20. Dr. Bouquot copublished a review of NICO in 1997. (RE 128, 129). It was based on experience with more than 2,000 patients. Dr. Bouquot’s premise in this paper included proposing NICO “as a common basis for many of today’s facial pain syndromes. . . .” He emphasized that even by then, 1997, “no indepth casecontrolled prospective investigations are yet available.” And, he continued, his and his coauthor’s presentation was of “hypotheses.” Dr. Bouquot wrote under the subtopic of Microscopic Appearance that many NICO tissue samples had fragments “coated by a film of fibrin and may show aggregates of this material, or of platelets, within areas of damaged fatty marrow.” but then he wrote “While such features are occasionally seen in routine intraosseous inflammation, they are much more common in NICO.” (emphases added.) He wrote in Part II of this same paper (RE 129) “We wish to emphasize, however, that the “NeuralgiaInducing” term in NICO was intended from the start only to emphasize this most unique feature of the disease, neuralgic pain is not a requirement of diagnosis.” (Emphases original.) So, not only in 1992, but by 1997, Dr. Bouquot still seems to have been hedging quite a bit in the subject of just what sets NICO apart from other garden variety osteomyelitis. As see, in one fell swoop, Dr. Bouquot emphasizes that the very name neuralgiainducing cavitational osteonecrosis is misleading; that “the most unique feature” (his words) of NICO is not so unique after all. It is no wonder that NICO has been the recipient of such widespread criticism.

21. The State produced the testimony by Dr. Francis V. Howell, to rebut Respondent’s proNICO evidence. Dr. Howell has been a dentist since 1950, and an Oral Pathologist almost since then. He has been a Diplomate of the American Board of Oral Pathology since 1956. He, as Dr. Bouquot, has enjoyed a long and distinguished career in his chosen professional field. (32:48, 49; SE 44). Dr. Howell was critical of NICO. He testified that even defining NICO presents difficulty because there is not “very much to it.” (32:51). He denies the existence of any verifiable symptomatology involved in NICO (32:54), which seems to corroborate the earlier findings herein that Dr. Bouquot seems to hedge at times when he writes of NICO’s distinguishing characteristics. Dr. Howell in his profession as a pathologist, a diagnostician, has himself viewed many specimens sent to him by others suspecting a NICO. He has “yet to see anything that I would call a significant pathological entity.” (32:55). Dr. Howell concurs 100% with the opinion of Dr. Donlan, as the latter wrote in the critique of Dr. Bouquot’s 1992 article, and described hereinabove. (32:61). Finally, Dr. Howell states that NICO is “absolutely not” widely accepted in oral pathology and oral surgery circles. (32:55). Such is the finding made, based on all the evidence of record. This is not a finding that Dr. Bouquot’s theories or hypotheses on NICO are demonstrably untrue, and shall never be proved, but it is a finding that to date the scientific evidence is insufficient to support a finding that NICO is what Dr. Bouquot and Respondent claim it to be.

22. Even if one were to give NICO the benefit of the doubt, Respondent’s diagnostic technique to determine D.T.’s NICO was insufficient by Dr. Bouquot’s own standards. Respondent took only a panographic radiograph of D.T., whereas Dr. Bouquot prescribes triangulation of periapical films. (RE128).

23. D.T., as in the case of his wife S.T., had a clash with Respondent and Respondent terminated his treatment with D.T. Respondent therefore did not complete the treatment he had planned for D.T.; treatment he had regarded as necessary.

24. The third case is Complaint Number 95135, involving, and filed by patient L.C., sometimes identified by use of his other initials, P.C. or L.P.C. (1:103). L.C. first presented to Respondent’s office on or about October 28th, 1993. He was experiencing toothache in the lower left quadrant of his mouth, which is in the area of teeth #18 and #19. (Respondent’s records for L.C.;1:102; 2:25, 26). Respondent also did not arrive at a diagnosis based on thorough examination procedures, or provide an adequate treatment plan for L.C. Part of his treatment of L.C. which ensued is based on diagnostic methods (AK, and the computron) which are unsupported by dental science. (2:29, 30; 21:63). He also used xrays, although their diagnostic quality is to be doubted. (21:64; 9:58, 59). Once more, Respondent’s diagnostic techniques were not up to the standard of care, and his treatment records for this patient are also below standard of care inasmuch as they have no recordation of treatment justification. (5:58, 60, 65, 69, 70; 9:5658). For example, Respondent’s written record of justification for his treatment of L.C.’s tooth #17 (extraction and cavitational surgery) was only another on of his carets. 21:63, 64). Additionally, Respondent’s records lack any indication that he did a periodontal examination of L.C.; any record of diagnosis, or any treatment plan. (1:102, 103). As is his custom, Respondent simply kept his treatment records in his memory. (9:58, 59).

25. Respondent extracted L.C.’s tooth #18. (2:5, 8:29; 21:64, 65). L.C. had been to another dentist, an endodontist (a root canal dentist (8:6)). Dr. Joseph Dovgan. Dr. Dovgan had opined that L.C.’s tooth #18 was a good candidate for root canal surgery. (2:33, 34; SE 12). A root canal is performed when the dentist has diagnosed the patient with a disease of the pulp, a soft tissue in the center of the tooth, commonly called the nerve. Root canal surgery removes the pulp and refills the hollow space thereby created usually with gutta percha. (8:6; 30:14). When L.C. was with Respondent he relayed Dr. Dovgan’s opinion, and Respondent counseled L.C. that root canals contained a toxic substance, and impair the immune system. (2:32). He also made available to L.C. a book written in opposition to root canal treatment. (2:34, 58). The book is entitled Root Canal Coverup, and was written by George E. Meinig, D.D.S., F.A.C.D. It opposes root canals and claims there are serious health side effects produced by them. (RE 154). This testimony is highly credible and believed based on Respondent’s openly stated, record position on root canals. As found in the first Finding of Fact, Respondent does not perform root canals. Further, he recommends against root canals, believing them to be unsafe. In fact, he counsels his patients extensively on his perceived evils of root canals, not only by providing or making available Dr. Meinig’s book, but also providing his patients with a wealth of other antiroot canal publications. He even gives his patients a fifteen to twentyminute lecture on the health dangers presented by endodontically treated teeth. He provides all his patients a packet of information on various areas of dentistry, sometimes even mailing the packet to them, before proceeding with treatment. The written materials he distributes to his patients regarding root canal treatment is wholly in opposition. He provides no information in the packet stating that endodontics is safe. (22:55, 60, 66).

26. Respondent does not stand alone in his antiroot canal opinion, and admitted to the record are some journal articles proffered by him at hearing which he claims demonstrate the veracity of his position on this head. One study used bovine incisors as the model. The results indicated that bacteria were able to penetrate into the tubules of the teeth. (RE 133). Another study similarly took endodontically treated human teeth and inoculated them with Streptococcus gordonii. The bacteria invaded the dentinal tubules. (RE 134). A third study evaluated the comparative antimicrobial effectiveness of three root canal sealers. The study opined which sealer was the most effective, which the least effective, and which the middling sealer. Another study concluded that bacteria have more difficulty invading the dentinal tubules of vital (nonendodontically treated) teeth, than nonvital teeth. (RE137). Endodontically treated teeth are sometimes referred to a nonvital because the treatment leaves the tooth pulpless. Finally, one study relied on by Respondent is entitled “Dental implication of brain abscess in children with congenital heart disease.” (SE A7). Unfortunately the title of this article is misleading to the casual observer. Upon reading so much as the abstract of the article the reader becomes acquainted with the fact that the author’s entitling the article by use of the plural “children” is inaccurate. The study concerns itself with the case history of one eightyearold boy who sadly was afflicted with a congenital heart defect. One anecdotal study, even if soundly done, is insufficient provender to sustain scientific proof. It also bears mention that Respondent highly touts the cleverly titled book The Price . . . of Root Canals, which is Dr. Hal A. Huggins’s compilation of materials by Dr. Weston A. Price, going back to the year 1925. (RE 172). Taking the record as a whole it can be found that Dr. Price is a, if not the, leading progenitor of this theory that root canals are unhealthy. The whole of Respondent’s evidence to convince that root canal surgery is to be avoided cannot begin to withstand the barrage of State’s evidence to the contrary.

27. Properly performed root canal surgery is a very safe, and very effective procedure for treating pulp disease and saving teeth. (30:13,14;SE 23). Eightyfive to ninetyfive per cent of root canals are successful (8:6). The State produced two expert witnesses on the subject of endodontics. Both are, and for many years have been, endodontists. The first was Dr. Stephen Roda; the second was Dr. Leif Bakland. Both are highly credentialed, respected and accomplished in the field of endodontics (SE22, 36), and their testimonies were far and away the most highly credible and persuasive of record concerning the subject of root canals.

28. The State does not dispute that bacteria can remain inside the tooth following endodontic treatment. (8:7). Nor does the State dispute that bacteria in the tooth can migrate into the dentinal tubules. However, if the root canal has been done properly the bacteria there are denied nutrients, cannot grow, and cannot produce an infection. (8:7; 30:16, 17). In some cases of failed root canal treatment bacteria can escape from the tooth (30:20, 21). What happens in the vast majority of those cases is the bacteria will develop a localized inflammation or a dental abscess. (8:7; 30:22). In those rare instances further endodontic treatment can correct the problem. (8:7; 30:26, 27).

29. Dr. Bakland’s direct testimony, taken with the other evidence of record, convincingly discredited the hearsay evidence in Dr. Meinig’s book as the latter’s opinion “that root canal treated teeth can be the source of numerous physical ailments” based on research that was done during “the early part of the [twentieth] century, ” “the dark ages of research.” Dr. Bakland concludes that there is “absolutely no scientific evidence whatsoever” to support Dr. Meinig’s opinion. (30:24). Dr. Bakland similarly dismissed the hearsay statement of Drs. Huggins and Price in The Price. . .of Root Canals, adding his characterization that the opinions therein expressed are “extreme.” (30:25). The opinions Drs. Huggins, Price and Meinig are not only dated, but are unsupported by any credible scientific evidence of record. The State of Colorado revoked Dr. Huggins’s dental license in 1996 for his unprofessional practice relative to silver amalgams, a topic to be addressed infra. (RE Z).

30. There is, however, some credible evidence of record (albeit not entirely undisputed, See: 8:82; RE A2) that in rare cases bacteremias originating in the oral cavity, and in some cases from the area of improperly endodontically treated teeth, can cause bacterial (or infective) endocarditis. (30:11;SE 23; RE Z). A bacteremia is simply “bacteria that get into the blood stream.” (30:12; SE 23). Also, improper endodontics is not the bacteremia’s only passport from the mouth to the bloodstream. Bacteremias are a common occurrence when one flosses one’s teeth, or chews one’s food, regardless of the presence of absence of endodontically treated teeth. (8:81). Unfortunately, Respondent seizes upon the evidence linking bacteremias from endodontically treated teeth to endocarditis (RE G,H,K,L, M, N, and 189), and then attempts to extrapolate from it that bacteremias can migrate from the mouth to all distant parts of the body, and in a whole host of ways adversely affect a person’s systemic health. (11:97; RE A2). this opinion fits within the much broader theory, to which Respondent and a comparatively small minority of dentists subscribe, known as the focal infection theory. While ample scientific evidence exists to make adherence to the position of bacteremias relative to infective endocarditis reasonable, if not entirely undisputed, there is not even nearly enough such evidence to make reasonable Respondent’s subscription to the focal infection theory.

31. The focal infection theory first appeared on the medicodental scene in full flower in 1910, as presented by British physician Dr. William Hunter. (SE 23; RE Z). It caused quite a buzz in the dental world for a few decades, but now is generally held in disrepute, regarded by the majority of dentists and doctors as only an historical curiosity. The theory (its very name suggests lack of scientific proof, else it would be elevated from the realm of the theoretical) posits basically as follows: a focus of infection can release bacteria into the body, which bacteria or their byproducts then can circulate to virtually any distant site or organ of the body and there cause or exacerbate various systemic diseases. (8:8; 11:97; RE Z). The focus of infection for present purposes would be the teeth. So back in the early part of this century the wholesale extraction of endodontically treated teeth and teeth with fillings in them was a widespread phenomenon. The adherents to the focal infection theory believe that endodontically treated teeth are a risk factor in several human diseases including, but not limited to, rheumatoid arthritis, multiple sclerosis, and endocrine imbalances. They believe cavitations (described hereinabove) are risk factors for the same ailments and hyperthyroidism as well. (11:126). Such being the theory it is curious that extractions are favored over root canals by dentists such as Respondent, when one considers that an extraction, being far more traumatic to the patient than a root canal, creates a much greater risk of a bacteremia. (SE 23).

32. Today the focal infection theory is not seriously regarded but by a small minority of dentists including Respondent. The very research methods of the focal infection theorists have been shown to be fatally flawed, calling into question all conclusions thereby reached. (SE 23). Also, it is not merely the testimonies of the State’s experts in this case, Drs. Roda and Bakland, that the focal infection theory is totally bogus (although those do add substantial weight to that finding of fact (See: 8:714; 30:10; RE Z), it appears that the publicists of this theory themselves do not push their product with any significant degree of confidence. One editorial article tendered by Respondent and admitted, contains the following statements: “There is far more to consider than bacterial endocarditis as a consequence of bacteremia of oral origin. There is also some evidence that microbial fractions, rather than whole cells, may play a part, perhaps in some form of immune complex, in systemic forms of inflammation. . .” And: “To date, there seems to be no clear correlation between the fact or level of a bacteremia and the incidence of a linked systemic disease, even for the favorite, endocarditis.” (RE A2, emphases added). There appears in the “Journal of Clinical Periodontology” (1984) the article “Plaque and systemic disease: a reappraisal of the focal infection concept.” (RE A1). (Note here it is not a “theory” but a “concept,” an idea if you will). The authors early on concede that as to proof of the focal infection theory “the accumulated evidence seems contradictory.” They offer that differences in the microbes and differences in their hosts “may provide a possible explanation of the inconstancy of focal infection phenomenon.” They go on to posit “at least 3 separate mechanisms linking secondary, metastatic local or systemic disease to a pathological oral microbial depot.” As to metastatic inflammation due to immunological injury they write: “It is not known whether dental infections are of clinical significance with regard to the pathogenesis of this immunological type of focal infection; the possibility is, however, far from remote.” (Emphasis added.) As to antigenantibody interaction, immune complexes, they write:

“Direct proof of th[e] association [between odontogenic infections with sterile metastatic inflammation] is scanty.” “Yet another possible example of focal infection by immunological injury is. . . .” A third example is provided by an experiment in which it has been shown that uveitis might result from…” “[I]t has been suggested that in some cases meningitis might be the result of immune complex mediated injury secondary to dental foci.” “Although it has to be conceded that proof of a causal relationship of dental foci of infection and metastatic immunological injury is far from complete, the available evidence appears to support such a hypothesis.” Under their subheading of metastatic injury due to microbial toxins, the authors write:

“Although direct proof is lacking, the accumulated circumstantial evidence appears to warrant the tentative conclusion that pain and loss of nerve function might be due to microbial toxins from dental foci.” (RE A1; all emphases added). These are not hardly the type of statements that will naturally induce conviction in the minds of reasonable persons.

33. Moreover, Respondent tendered another evidentiary exhibit to support his putting the focal infection theory into his practice, and the exhibit was admitted as RE A5. Strange as it may seem, this exhibit provides significant additional proof of the State’s position, while at the same time undermines that of Respondent. The exhibit lists a number of abstracts from dental journals on the topic of the focal infection theory. One article concludes, according to the abstract, “The application of modern techniques to these [focal infection] concepts makes them topics of historical interest only.” Another wrote: “The bacteriologic studies of Price [Dr. Weston a. Price, See: RE172, and Finding of Fact ##25, 27, supra] and Rosenow, which formed the foundation for focal infection enthusiasts, could no longer be used to “rationally” support the focal infection theory and the therapeutic wholesale extraction of teeth.” A third article “cites the invalidity of a number of the key bacteriological studies prior to 1940 that were used to help establish the focal infection theory.” A fourth abstract appearing at RE A5 is of a study that “demonstrates that properly cleaned root canals do not contain unhealthy or diseased periapical tissue and are not sites of focal infection.” A fifth writes: “[I]t was concluded that modern nonsurgical endodontic treatment produces a remarkable low incidence of bacteremia. When root canal instrumentation was confined to the root canal, no bacteremia was detected.” A sixth argued “that there is no medical or economic evidence to support the extraction of pulpless teeth.” The author concluded that in the cases that were the subject of her or his study, endodontic treatment was to be preferred over extraction. And, “The increased cost of restoration of missing teeth when teeth are needlessly extracted was also vividly presented.” This evidence goes a long way to help establish the fact that root canal surgery has not the baleful consequences Respondent claims, and that the dwelling place of the focal infection theory seems destined forever to remain at its present location, far outside the area of accepted and reputable medicodental scientific circles.

34. These recent findings of fact regarding endodontically treated teeth and the focal infection theory illuminate the reasons why Respondent counseled L.C. against his allowing Dr. Dovgan or anyone else to perform root canal surgery on L.C.’s tooth #18, and why those reasons were unsound and unprofessional. Endodontic therapy in all likelihood would have saved L.C.’s #18, and that therapy clearly would have been by far the better option for L.C., as salvaging any tooth when possible is categorically better than losing it. However, overcome by the amount of illegitimate information he was provided on the subject by Respondent, L.C. gave way, and opted to have Respondent extract #18, which was done. (2:37, 67).

35. Respondent also performed cavitational surgery on L.C.’s tooth #4, which previously had root canal surgery. (2:38). Respondent’s radiographs of that tooth show no call to have had that surgery performed. (2:61, 62, 65). Nor was #4 giving L.C. any symptoms such as pain. (2:30). Respondent’s reasoning, told to and accepted by a trusting L.C., was that extraction of his #4 tooth might help alleviate the pain L.C. was experiencing in his tooth #19. (2:39). While it is true that in some cases pain can be referred from one tooth to another, pain cannot be referred from a tooth in the patient’s upper right quadrant to a tooth in the lower left quadrant. (5/6:67 68; 8:33, 34). Respondent testified that he extracted tooth #4, based on the diagnosis made with the computronic electrodermal screening and AK, because that tooth was interfering with L.C.’s “electromagnetic system of the body,” “there was an interference focussed [sic] in that area.” (21:78;

27:134, 135). Respondent’s record of this diagnosis was a caret. (21:64). Extraction of #4 was unwarranted, and it did nothing to help L.C.’s tooth #19, in which L.C. eventually had Dr. Dovgan perform root canal surgery, which resolved the problem in #19. (2:39).

36. After extracting #4 from L.C.’s mouth, Respondent placed a bridge from tooth #3 to tooth #5. The bridge was inadequate. It had open margins and the subject areas had periodontal involvement that, to be up to the standard of care, should have been addressed before any bridge was placed there. (4.9, 10, 42, 43; SE 19). Respondent’s treatment records lack any indication that he performed a periodontal examination of L.C. prior to placing the bridge.

37. After having the bridge placed in his mouth, L.C. continued to experience pain. By that time he was inclined to return to Dr. Dovgan, which he did. Dr. Dovgan endodontically treated ##3 and 5, and thereafter L.C. had no problems with those teeth. (2:39;SE 12).

38. Respondent not only extracted L.C.’s ##17, and 18 he also performed cavitational surgeries at those sites. Respondent based these surgeries once again on the results of his diagnosis arrived at with the use of the computron and AK. (27:127132). That these methods within dentistry are not diagnostically sound has already been found. Nothing in Respondent’s treatment records for L.C. or on his radiographs of these areas justify his having performed the cavitational surgeries. (5/6:57, 59).

39. Respondent failed ever to place a bridge at the former site of tooth #18. Such a bridge should have been installed in L.C.’s mouth in order for tooth #15, the tooth that formerly had occluded with #18, then had no tooth opposite, which, in the fullness of time, could lead to serious problems for L.C.’s tooth #15. (9:60,61). Respondent’s defense that he was prevented from placing the bridge owing to the fact that L.C. never returned to him for further treatment is false, as can be seen by Respondent’s own records showing that L.C. did return.

40. Based on the findings of Respondent’s treatment of L.C. it is found that the Respondent’s treatment had a significant negative impact on the quality of L.C.’s life which he can never outlive.

41. The fourth case is Complaint Number 95312, and involves patient D.S. D.S. presented at Respondent’s office on October 22nd, 1990. (27:103). Respondent’s treatment plan for D.S. was to remove all of D.S.’s silver amalgams and crowns. His diagnosis was “that he had several silver fillings, mercury fillings, and they were fairly large.” “He had several large fillings, he had some crowns, he had a crown on the upper right side, he had two crowns on the upper left side, he had two crowns on the lower left side, and on the and that’s all. But the rest were large fillings. Silver mercury fillings.” (27:104). D.S. came to Respondent with the desire for the Respondent to remove the mercury from his mouth which was contained under his crowns and in his silver amalgams. (20:172; 27:;105). However, Respondent made no record notation of this. Even though he believes that information important, he did not write it in the records because “it was so obvious to us.” As always, Respondent did not write down much of anything in his records, but again he put red marks on the tooth chart, meaning to him that the filling needed to be removed, and then after the filling was removed, he erased the red mark and put a blue mark in its place, meaning to him that procedure had been completed. (27:106). Once again it is found that this system of record keeping is below standard of care. Notwithstanding the fact that every one of D.S.’s silver amalgams were serviceable restoration, Respondent thought the treatment of removing all those fillings, as well as areas under the crowns, to rid D.S.’s mouth of mercury was a wise course and the one he proceeded to follow. (21:12; 20:172 27:106). Therein lies another tenet of Respondent’s practice fillings containing mercury in a patient’s mouth can be harmful. As a matter of his practice Respondent declines to use mercury in his restoration, as has already been found. (See: Finding of Fact #1; 20:5). He also, as he did in this case, will remove existing silver amalgams. In counseling his new patients on the use of silver amalgams, besides giving them his opinion of their undesirability, he provides them information contained in his packet of information described earlier herein. The information in the packet, while heavily weighted against the use of silver amalgams, does provide the patient with a bit of information stating that those restorations are safe and effective. (SE 30).

42. That mercury is a toxic substance is not disputed by the parties. (13:24). Nor is it disputed that every dentist should take all reasonable precautions to avoid unnecessary exposure to mercury when treating with dental amalgams. (RE 109; A10; SE 17). Nor is it disputed that what is typically referred to as a silver amalgam (a filling) is an alloy, the content of which is approximately fifty per cent elemental liquid mercury. (3:13). The silver amalgam has been the most popular and effective restorative material in dentistry longer than the past 150 years. Billions of silver amalgams have been placed in patients’ teeth in the United States of America alone. It is estimated and here found that in 1979 approximately 157 million silver amalgam restorations were put into patients teeth. Still, the use of these amalgams has declined in more recent years to numbers between 90 and 100 million annually; however, not because of their falling into ill repute, but because people have been having less cavities. Despite the excellent track record of silver amalgams, from time to time concerns have arisen as to their safety. As early as 1850 some dentists claimed that removing these fillings could miraculously cure chronic diseases in patients. Today, a comparatively small minority of dentists, including Respondent, do not use, and will remove, silver amalgams in the belief that the mercury therein contained poses serious threats to the patient’s systemic health. (21:106; SE 15; RE 111; 118).

43. Respondent produced as an expert witness Dr. Fuller Royal, a physician from Nevada. Dr. Royal advocates the removal of every silver amalgam filling. (19:77). He observed in testifying: “If you took onehalf gram of mercury and dumped it is a tenacre lake, they would condemn that lake. You’re exposing the body to 24 hours a day of mercury vapor. That’s an accumulation of mercury over many years. It’s ridiculous. It makes no sense at all.” (19:62). Dr. Royal’s mercuryinthelake statement does not at all bear on the question of safety of dental amalgams. Further, Dr. Royal utilizes many of the same tools and methods used by Respondent to reach diagnoses, tools and methods which have already been addressed herein and found unreliable in dentistry. (19:20, 26). He also promotes the inaccurate negative opinions of endodontics, a position which has already been discussed and found wanting. (19:37, 40, 76). He was not a convincing witness. (Other of Dr. Royal’s testimony lacking in credibility will be addressed infra in the findings relative to acupuncture.)

44. Respondent also produced as an expert witness at hearing Dr. Boyd E. Haley, a nondentist research scientist and Chairman of the University of Kentucky College of Pharmacy. (13:13, 56; RE 112, 131). Dr. Haley contends that the mercury in silver amalgams is released and enters the body. (13:27). He holds that this mercury can exacerbate exiting Alzheimer’s Disease, Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s Disease), and multiple sclerosis, and that silver amalgams may be a significant risk factor to the onset of ALS and multiple sclerosis. He holds that many neurological diseases can be linked to the presence of silver amalgams in the person so afflicted. (13:35, 36, 44, 45). Dr. Haley also adheres to the focal infection theory. (13:85). Dr. Haley has conducted research on the theory of the harm of silver amalgams. He, along with Murray J. Vimy, Fritz L. Lorscheider, and two other, published their findings in the 1997 edition of “NeuroToxicology.” The research was performed using rats as subjects. They concluded “that chronic inhalation of lowlevel [mercury] can inhibit polymerization of brain tubulin essential for formation of microtubules.” They discerned a similarity between this effect and the condition of brains afflicted with Alzheimer’s disease. (RE 112).

45. Dr. Haley’s colleagues, Vimy and Lorscheider, Department of Medical Physiology and Department of Medicine, Faculty of Medicine, University of Calgary, respectively, conducted other research in this area using sheep as subjects, and their research was published in the journal of the Federation of American Societies for Experimental Biology (FASEB) in 1989. They concluded that dental amalgams “can be a major source of chronic [mercury] exposure.” They also concluded that radioactive mercury in the silver amalgams put into the sheep teeth appeared in various organs and tissues within 29 days. Also in that study Vimy and Lorscheider opined that a “sheep is a suitable experimental model for the purpose of our investigations because it exhibits molar chewing mechanics that are similar to those of humans.” (RE 118). Coming from individuals who claimed to have performed serious research, this statement is astonishing. ADA spokesman and pediatric dentist DR. R. Heber Simmons, referencing the Vimy and Lorscheider study, pointed out a few fact about the sheep which are rather common knowledge. “Sheep. . . . are ruminants, which regurgitate their food and acid from their stomachs and chew on the cud for up to eight hours a day.” (SE 16). Yet Vimy and Lorscheider went on and published their findings from more experiments with sheep. One is in an article appearing in the 1990 edition of the journal of the American Physiological Society. (RE 167). There it is concluded, based on experiments with five pregnant ewes, that use of amalgams “in pregnant women and children should be reconsidered.” (Emphasis added.) Another is in an article appearing in the 1991 edition of the journal of the American Physiological Society. (RE 116). Therein they concluded that exposure to mercury released from dental amalgams “may have the potential to precipitate alteration in renal function.” (Emphases added.) Eventually the dawn broke, and Vimy and Loscheider became skeptical of their own sheep studies. They confessed: “Recently we used an experimental animal model in which sheep received dental amalgam fillings containing radioactive [mercury] tracer. It is unknown whether the frequency of eating, molar chewing pattern, or type of food influenced the degree to which [mercury] was released from sheep dental amalgams, or if the results were directly comparable to humans.” (RE 117). Hence, they turned to monkeys. Still, their conclusion, published in another FASEB journal, after looking at the monkeys, was stated using rather tepid wording: “Advocacy by the dental profession. . . . that [mercury]based silver amalgam is stable and systemically biocompatible is not supported by our animal studies. . . or by the pathophysiological consequences of amalgam usage that we demonstrated.” (RE 117; emphasis added). This is not what one would consider a ringing denunciation, but rather a nonfinding. In 1995, Vimy and Lorscheider were at it again, this time publishing a paper in the FASEB journal detailing “collective results of numerous research investigations over the past decade” (including their own). (RE 111). They concluded that the continuous release of mercury from silver amalgams is the major contributor to mercury body burden, and that the experimental evidence indicates that the amalgams have the potential to induce cell or organ pathophysiology. They do concede in closing that “human experimental evidence is incomplete at the present time.” (RE 111). Professor Lorscheider also coauthored an article published in 1992 in the journal of the Society of Toxicology, in which the question was posed:

“[W]hat, if any, are the longterm health consequences resulting from exposure to mercury [via dental amalgams?]”
Their answer: “we do not yet know the answer to this question.” (RE114).

46. Dr. Robert L. Sibelrud published an article, the contents of which were taken from his doctoral dissertation, in the October, 1989 edition of the “American Journal of Psychotherapy.” (RE 110). Relying heavily on the early work of Vimy and Lorscheider, Sibelrud summarized:”The data here suggest that the release of mercury vapor from dental amalgams may cause mercury toxicity and produce psychological distress symptoms. Dental mercury. . . may be a significant health hazard. Psychotherapists should consider mercury toxicity as a possible cause in the treatment of . . . . ” (Emphases added.)

47. One might suppose that if silver amalgams pose a toxic threat that perhaps dentists themselves who place them routinely over careers spanning decades might contain in themselves some evidence of this. Yet, Respondent’s own evidence discounts that conclusion. In an article published in 1992 in the journal “Clinical Toxicology,” entitled “Toxicity of Mercury From Dental Environment and From Amalgam Restorations,” this conclusion was reached: “The preponderance of currently available evidence indicates that when reasonable precautions are used, the mercury in dental amalgam is not a significant health hazard to most dental personnel or patients.” (RE 115).

48. And finally, Respondent calls attention to the risk of harm to human health occasioned by eating mercuryladen fish (RE 113), and from mercury vapor released when corpses are cremated. (SE 30).

49. The State presented much evidence to support the finding of safety in the use of dental amalgams.

50. One study admitted into evidence is published in 1997 in the journal “Critical Review Oral Biological Medicine.” (SE 32). the authors are J.R. Mackert, with the Medical College of Georgia, Augusta, Georgia, and A. Berglund, with Umed University, Umed, Sweden. It is fitting to mention this State’s evidence first because it convincingly points out the errors in the research methodology of Vimy and Lorscheider, which produced the research upon which Respondent relies. Macker and Berglund established the fact that the mercury exposure method Vimy and Lorscheider used to test their subjects was seriously flawed, and that they first had to skew material assumptions to an extreme degree to be able to arrive at their conclusion.

51. The United States of America, Department of Health and Human Services, in 1993, published an extensive and detailed report on the question of dental amalgam safety. (SE 14). The report was authored by a committee constituted of twelve professionals in various occupational fields that touch and concern the issue. Highlights of the report include the following. “The U.S. Public Health Service believes it is inappropriate at this time to recommend any restrictions on the use of dental amalgam, for several reasons. First, current scientific evidence does not show that exposure to mercury from amalgam restorations poses a serious health risk in human, except for exceedingly small number of allergic reactions.” The committee, in reaching these findings, were not unaware that dental amalgams do in fact release “minute amounts of elemental mercury,” and “that a fraction of the mercury in amalgam is absorbed by the body[.]” “People with amalgam have higher concentrations of mercury in various tissues (including blood, urine, kidney and brain) than those without amalgam. Also, a small proportion of individuals may manifest allergic reactions to these restorations.” However, the committee also noted that mercury is absorbed from many sources, including food (especially fish) and ambient air. The key question presented to the collective mind of the committee was whether the additional amount of mercury the body absorbs from silver amalgams poses a health risk. They concluded that it does not.

52. The World Health Organization released its Consensus Statement on dental amalgams in 1997. (SE 33). That body was agreed that dental amalgam restorations are safe. They noted that “components of amalgam and other dental restorative materials may, in rare instances, cause local sideeffects of allergic reactions. The small amount of mercury released from amalgam restoration, especially during placement and removal, has not been shown to cause any other adverse health effects.”

53. The State produced the expert testimony of Dr. Chakwan Siew, Director of Toxicology at the American Dental Association, in the Research Institute of the Association. (29:10, 11). Dr. Siew received his Ph.D. in Pharmacology in 1974 from the University of Colorado Medical School. He underwent postdoctoral education in Toxicology/Pharmacology at Stanford University Medical School from 19741977. He is extensively published in his field and a member of several professional societies. (SE 31). Dr. Siew’s position, stated in a nutshell, is that silver amalgams are safe. (29:17). He reasons that the amount of mercury that is released from the amalgam “is so small, minuscule, that you it’s not at the range of dose that’s considered to be toxic.” (20:29). Dr. Siew also disagreed with the rat study of Respondent’s expert witness Dr. Haley, noting that the mercury exposure method he employed was faulty in that it exposed the rat subjects to unrealistically high levels of mercury vapor. (29:4048). Dr. Siew also opined that there is no evidence that silver amalgams are a causative or risk agent in the onset or exacerbation of multiple sclerosis, arthritis, or mental illness. (29:48,49,92).

54. Two among the scores of journal articles authored or coauthored by Dr. Siew on the subject of dental amalgam safety are of evidence. (SE 34, 35). Dr. Siew also pointed out the errors of the methodology of Vimy and Lorscheider, as had Macklert and Burglund. (See: Finding of Fact #50, supra).

55. The American Dental Association, as of this hearing, continues to maintain the safety of dental amalgams. (SE 40, 41).

56. There is no convincing scientific evidence, dental, toxicological or other, to support a finding that a dentist who, as a part of his or her practice, places silver amalgams in patients, poses a health risk (other than the aforementioned occasional allergic reaction) to herself, himself, or patients.

57. Facts can be very stubborn things sometimes, and within the issue of dental amalgam safety two repeatedly present themselves to the mind of this factfinder-one in favor of the State and one in favor of the Respondent. They are: for the State: the nearly centuryandthreequarters history of billions and billions of silver amalgams being placed in humans without the transpiration of any more evidence of a danger posed by them than Respondent has produced; and, for the Respondent: mercury is toxic, and some amount of mercury from silver amalgams is released into the mouth and absorbed by the body, albeit an inconsiderable amount. Considering these two facts and the totality of record evidence on this issue, the following additional facts are found.

58. It is not below standard of care, in limited circumstances, for a dentist to remove silver amalgams to rid a mouth of mercury, but it is below the standard of care if the removal is occasioned by the dentist informing and advising the patient that removal of the amalgam will prevent, relieve symptoms, or affect cures of systemic diseases or disorders such as multiple sclerosis, diabetes, arthritis, Alzheimer’s disease, etc. It is also below the standard of care for a dentist to remove silver amalgams as a result of the dentist’s withholding full counsel from the patient as to the lack of scientific evidence that the mercury in the amalgam is, or could be, harmful to the patient.

59. The issue now resolves to a question having a very fine point: If a patient, having an existing silver amalgam, without any allergic reaction thereto, presents to a dentist possessing prior information on both sides of the question regarding safety of silver amalgams, makes a request of the dentist to remove the silver amalgam, which request is entirely prompted by the patient’s opposition to having the mercury in vivo, is it substandard dental care for the dentist then to remove the silver restorative material? In the above factually restricted scenario this factfinder thinks not, provided the dentist first informs that patient fully, including advising of the lack of evidence that removal of the silver amalgams will affect cures, relieve symptoms or avoid onset of diseases or disorders, e.g., multiple sclerosis, diabetes, arthritis, renal failure, or Lou Gehrig’s Disease. A dentist removing and replacing the silver amalgam in this situation is no more below standard of care than a dentist removing and replacing the same silver amalgam because the patient desires its replacement by a more aesthetically pleasing toothcolored material.

60. For that matter, in these situations, removal of silver amalgams from patients who are fearful of having mercury inside their mouth is no more below standard of care than the entire range of cosmetic or aesthetic dentistry. There is no rational basis of distinction to separate the taking of money from a patient to remove mercury from her or his mouth, and taking money from another patient to whiten the tooth surface by a shade or two. While the first patient may be actuated solely by fear, howsoever irrational, of mercury poisoning, the second may be actuated solely by vanity.

61. One might maintain that even in the above limited fact scenario it is below standard of care to remove and replace the silver amalgam because there exists in doing so the risk of harm to the remaining tooth structure, a potential which renders the procedure professionally unjustifiable simply as a means of assuaging the patients fear of having mercury in the mouth. Yet is there not the existence of some potential for harm to any patient’s dentition each time the patient opens wide and the dentist inserts hands, needle and tools, and commences surgery? The undersigned thinks so. Certainly there is an equal potential for harm to the remaining tooth structure in cases of removing and replacing silver amalgams either in the one patient loathing mercury or the other patient loathing unsightliness. There is no good reason to find the former practice unacceptable while freely allowing the later.

62. These recent Findings of Fact (##5661) are not inconsistent with the American Dental Association’s position so far as that group has enunciated on the subject. The ADA stated in its June, 1987 Release (SE 30) that “[T]he removal of amalgam restorations from the nonallergic patient for the alleged purpose of removing toxic substances from the body, when such treatment is performed solely at the recommendation or suggestion of the dentist, is improper and unethical.” This pronouncement was reaffirmed by the ADA in September of 1992, in one of its advisory opinions published in its journal (JADA) that month. (RE A8). And most recently, in May of 1996, the ADA again published its opinion in the JADA of that month, stating such through its General Counsel, Peter M. Sfikas. “[A} dentist who removes amalgam at the request of a patient or a patient’s physician is not necessarily acting unethically.” The dentist can ethically remove serviceable silver amalgams “under certain limited circumstances.” Attorney Sfikas, perhaps because of his education and professional background, did encourage any dentist removing silver amalgams in the limited circumstances discussed, obtain the patient’s informed consent before the procedure is undertaken, and make appropriate record of same. (RE 104).

63. Now return can be made to the specifics of D.S.’s case. D.S., as has been found already, did present at Respondent’s office predisposed to the removal of his silver amalgams out of his concern over their mercury content, and hope that removing them would abate the suffering from allergies he was experiencing (not allergy to the amalgams). (21:12). Respondent made no record of that however. (Respondent’s treatment records of D.S.) D.S. was not allergic to his existing amalgams. (1:86). *At the request of D.S. his silver amalgam restorations were removed. (*The Board amended this finding from that proposed by the Administrative Law Judge by deleting the final two sentences and adding a new sentence to more accurately reflect the records.)

64. Respondent’s treatment records for D.S. contain no periodontal evaluation notes or charting, and review of Respondent’s panorex radiograph indicated D.S. had undergone some significant bone loss. (1:85, 9:49, 50). Respondent’s records do not even indicate any periodontal concerns.

65. Respondent, so far as his records and the evidence indicate, never cleaned D.S.’s teeth, either prior to commencement of treatment or during the course of his treatment. (9:53).

66. The treatment that Respondent performed on D.S. was extensive treatment on over twentyone teeth yet he never took any preoperative study models (diagnostic casts) or performed an occlusal assessment. (1:91; 9:5155). Respondent assessed D.S.’s vertical dimension and occlusion by use of a machine known as a myomonitor. (27:115). A myomonitor is not used by most dentists in Arizona. (20:179). A myomonitor is of value to diagnose temporomandibular disorders, but not as a treatment modality. (9:55; 27:124; SE 29).

67. During his treatment with Respondent, D.S. had major problems with the many restorations placed in his mouth by Respondent. Respondent had to do corrective work on the restorations three times himself, but never provided satisfaction. Subsequent to his treatment with Respondent, D.S. went to no less than four other dentists to rectify Respondent’s work, which required extensive additional treatment. (1:92, 100; 5/6:305; SE9, 10, 11).

68. The fifth case is Complaint Number 95178, and involves patient Mildred Rauen. Ms. Rauen waived her confidentiality as to this proceeding, and expressed her desire to be referred to and addressed by her name. (15:127, 128). She did not file her complaint herself; it was filed by the Board of Dental Examiners after motion to do so was made and carried. (1:14, 63; 25:56, 148). Her case was brought to the Board’s attention by her letter to the Board complaining that Respondent had overcharged her for his treatment. (10:137, 138). The Board, in turn, contacted Respondent, and consequently Respondent refunded money to Ms. Rauen, and the monetary dispute then was resolved. (15:142, 143, 173, 174). However, the Board had other problems with Respondent’s treatment of Ms. Rauen, and pursued those matters.

69. Ms. Rauen is a woman of distinguished years, and when she presented to Respondent she had no upper and only four lower teeth, two on one side which previously had been endodontically treated (##28 and 29), and two on the other side which had been crowned (##20 and 21). (15:177, 178). She was experiencing no dental problems, and the dentures she had were satisfactory to her when she first went to Respondent. (15:177, 178). She suffered from rheumatoid arthritis at the time. Although she did not go to Respondent “counting on” him to cure her arthritis, she was “hoping” that he would (15:144, 183; 20:102). She had heard of the idea that teeth having had root canal surgery can cause bacteremias and result in disease and disorders to the body. (15:180).

70. Respondent did not “promise” Ms. Rauen a cure for her arthritis. (15:145). Respondent did, however, encourage Ms. Rauen in her belief in the possibility that his extraction of her two endodontically treated teeth could “help” or “cure” her arthritis. Respondent did so by his counsel with her and by his habit of providing Dr. Meinig’s book Root Canal CoverUp. (9:41;14:161165; 20:102, 108, 109, 25:38). Respondent’s diagnosis confirming his idea that the root canal teeth were a problem, was arrived at by use of his computron, and AK. (20:107, 27:7981, 83). That neither the computron nor AK has any legitimate use in dentistry, including diagnostic, has already been found. (See:

Finding of Fact ##8, 9). In his testimony relative to Ms. Rauen, Respondent revealed an aspect of his practice that is both curious and explanatory of his scant record keeping. Asked if he recorded in Ms. Rauen’s patient records the results of his AK testing, he responded that he did not. He said, “I don’t normally write that down because I do it so routinely.” (27:79; emphasis added). Thus it is evident that the likelihood of Respondent documenting a given dental practice on a patient declines concomitantly with the increase of his frequency in performing the procedure. That observation alone raises concern. It could reasonably be supposed that far less mischief would be occasioned by a dentist’s remission in recording results of a procedure he or she rarely performs, or only once performed, than failing to record procedures regularly utilized.

71. Respondent extracted Ms. Rauen’s two endodontically treated teeth, and replaced the crowns she had on the other two. (1:62;15: 184). The extractions resulted in absolutely no improvement of Ms. Rauen’s arthritis. (20:112, 113). There is no evidence to establish as fact that Respondent’s dental treatments can cure or alleviate the pain of arthritis. It is not a treatment for arthritis, and the evidence shows Respondent was not treating arthritis, but was making false claims about what his dental treatment could do.
72. Respondent then made a new lower denture for Ms. Rauen which poorly fit. Ms. Rauen’s dentures “rocked back and forth like a seesaw,” and she could not chew with them. (15:170; 20:111).

73. There was no sufficient basis for extraction of the endodontically treated teeth. Facts discounting the idea of Respondent’s that endodontically treated teeth should be removed already have been adequately found herein. There was no other reason for the extraction of Ms. Rauen’s root canal teeth; indeed they were in very satisfactory condition at the time Respondent removed them. (5/6:46, 47: 8:15, 16; 9:37, 40). Extracting these two teeth was below the standard of care. (5/6:283; 9:37, 97) Extracting Ms. Rauen’s perfectly good teeth in this case was even more egregious since doing so left her edentulous on that side, thereby depriving her of the only teeth there that could have served to help stabilize a denture. (9:97). This at least was partly responsible for the “seesaw” effect of her new denture.

74. The State argues that Respondent, in removing teeth ##28 and 29, once again stepped outside the practice of dentistry, and “attempted to treat a medical condition.” (Post Hearing Memorandum, p. 22). However, for the same rationale expressed hereinabove as to that claim in the case of Complaint 95083, S.T. (hyperthyroidism), it is found that Respondent was not practicing outside the scope of dentistry by treating arthritis. He was, again, practicing dentistry, but making false and unsubstantiated claims or representations about what could be accomplished by his dental treatment.

75. Respondent replaced the crowns on Ms. Rauen’s teeth ##20 and 21 because of his diagnosis using the amalgameter. The teeth were not decaying, the crowns were not failing, and there was not other pathological indication for removing the crowns, but the amalgameter told Respondent the crowns were “negative.” (20:103). That the amalgameter is not generally accepted as a diagnostic tool in the dental community has already been found.(See: Finding of Fact #5).

76. Respondent also performed a surgery on Ms. Rauen’s maxillary arch known as a “tissue trim.” (20:106). His records contain no indication of why he did this. They contain only a blue line and the monetary figure of “$750.” (20:106, 107).

77. Respondent’s treatment records for Ms. Rauen are below the standard of care for dentists. (8:16; 9:36, 95). They contain no basis for the treatment done on Ms. Rauen (9:40). They contain no documentation of a clinical examination supporting his treatment. (5/6:46). They contain no periodontal charting. (5/6:45, 46). They contain no diagnosis for any of the treatment plan. (1:69). Nothing in Respondent’s treatment records indicate why he extracted ##28, and 29. The records, such as they are, consist of a “5” and a “15,” which Respondent, but few others, would know as amalgameter readings showing “negativity,” and his little red and blue colors. (20:104, 105).

78. The State complained against Respondent’s use of a testing method performed by a Mr. Jess Clifford in his laboratory in Colorado Springs, Colorado, a method he calls materials reactivity testing. Respondent used this test for evaluation of the compatibility of certain materials he might put inside his patients’ mouth, including Ms. Rauen’s and others in these consolidated complaints. Mr. Clifford’s process claims to test a patient’s blood serum to come up with information about that patient’s individual sensitivities so that least offensive materials can be chosen and used in their treatments. (14:26, 32,40; RE 139, 140, 141, 170). The State attacked the reliability and scientific basis of Mr. Clifford’s test with a hearsay report from a Dr. Siriganian at the United States of America’s Department of Health and Human Services. (SE2). Mr. Clifford testified and produced several documents as well as videotape recording telling of his tests. It became clear from the direct evidence of Mr. Clifford that the exhibit introduced by the State was woefully confused as to what type of testing Mr. Clifford conducts at his laboratory. The letter from Dr. Siriganian criticized tests that Mr. Clifford does not conduct, and is therefore not only hearsay, but irrelevant. Without finding that Mr. Clifford’s testing has a proven scientific basis and is reliable, it is found that the State failed to convince this factfinder that Mr. Clifford’s test has no scientific basis or is unreliable, as alleged.

79. The sixth case is Complaint Number 95083, involving patient M.C. M.C. presented to Respondent on June 21st, 1993. She was experiencing toothache and swelling in her upper right quadrant, specifically tooth #4. She was not in excruciating pain, but she was uncomfortable enough to go to Respondent having no appointment. (1:74, 76; 20:121, 123). Respondent extracted tooth #4 during that first visit. (1:75, 76, 20:122). Tooth #4 was a good candidate for salvage by endodontic treatment. (5:55, 56;8:22). Respondent testified that he advised M.C. of her option to have root canal therapy, but that she chose to have him extract the tooth. (20:122). However, based on all the other evidence of record relative to Respondent’s adamant and passionate belief that root canals are harmful to human health by way of a number of serious maladies, its found that his informing her of her option to have root canal was in keeping with his belief and his counsel to patients on this subject, was, in two words heavily biased. Even M.C. herself testified to the Board in the Investigative Interview of this matter that Respondent told her at the time that he did no do root canals.(SE8). So it should not be a surprise to know that M.C., after listening to Respondent, chose to have #4 extracted. However, it is found that her election was misguided, and not based on informed consent, but on propaganda.

80. Also, rather than take the time during her first visit to perform a full examination or charting of M.C.’s mouth, Respondent had her view a videotape on the danger of silver amalgams, and tested her with his computron. (SE 8; 20:124). Respondent did not perform a comprehensive exam on M.C. until the advanced stages of her treatment on October 5th, 1995. M.C. had some areas of periodontal concern. Respondent’s testimony that he had no time for a comprehensive exam until then is not credible in light of the fact that he found time to show her the antiamalgam movie, and test her with the computron. Performing extensive oral surgery on M.C. in these circumstances, without first completing a comprehensive examination of her mouth, including a periodontal examination, was below the standard of care. (9:46, 47).

81. Respondent drew a red mark on the chart at tooth #4, then after extracting it he made the red mark a blue one, and wrote the dollar amount of his charge for that extraction. (20:122124). *She came to Dr. Lee in pain and elected for extraction over endodontics. (*The Board amended this finding from that proposed by the Administrative Law Judge by deleting the final sentence and adding a new sentence to more accurately reflect the record).

82. Respondent also extracted M.C.’s teeth ##14 and 20 during her later visits to his office. (1:55; 20:135, 140). Respondent’s records contain no documentation of why those teeth were extracted. Respondent testified that he did again advise her as to the possibility of root canal surgery. (20:129, 130, 138, 152). Root canal surgery again was a distinct possibility for M.C.’s teeth ##14 and 20, and could have saved them had her options been timely presented to her in at least a neutral manner. (5/6:53, 55; 9:45, 46, 8:23, 27, 28). But again, the reasonable inference from all the evidence is that M.C. was not neutrally presented her options. Losing her #20 tooth for M.C. meant losing the abutment for her existing bridge. (8:28; 9:46). So not only did Respondent harm M.C. by taking from her a tooth she could have kept, but also by complicating her use of a dental appliance; both of which have degraded the condition of M.C.’s oral health; degradation that shall remain for the balance of her life.

83. Respondent also performed cavitational surgery on tooth #14, and an osteotomy on tooth #20, but nowhere made a record of those surgeries in M.C.’s records. (20:148).

84. Respondent’s records for M.C.’s teeth ##4, 14 and 20 are below standard of care. (5/6:54, 55; 8:23; 9:42, 102; 20:120122, 148, 152).

85. Respondent placed two temporary bridges in M.C.’s mouth; one spanning from #3 to #5, and the other from #12 to #15. (1:79, 80). Subsequent to having these temporary bridges placed in her mouth by Respondent, M.C.’s financial wellbeing took a turn for the worse, resulting in her inability to continue paying Respondent for his treatment as regularly and fully as she had been doing up to that time. She mailed a letter written by her to Respondent informing of this and inquiring of him if there would be the possibility of her paying him in a financially less demanding way. (20:141, 142). As Respondent explained, “[T]he last treatment [of M.C.] was 2894 and we went ahead and called her on 42595, a year and two months, and that’s when we [Respondent and his office staff] decided after she hadn’t paid her bill after a year and two months that we needed to do a followup.” (20:143). The “followup” to which Respondent referred, for all the record knows, was in contemplation not of replacing M.C.’s temporary bridges with permanent ones, but his collection of the money she owed him for his treatment unto that time. Thus it appears and is found from the record that Respondent abandoned his treatment of M.C. at a most crucial point in time. Respondent apparently excuses himself from this professional dereliction of duty in his testimony that when he and M.C. last parted she went possessed of the knowledge that the bridges she then had in her mouth were not permanent. (20:143, 144). Evidently it is the opinion of Respondent that a dentist cannot abandon a patient so long as the patient’s knowledge of her treatment status is current.

86. The seventh case is Complaint Number 96054, involving patient L.B. This complaint was filed by the Board sua sponte after receiving information from L.B. of her treatment by Respondent. L.B. is afflicted with multiple sclerosis, the symptoms of which began to manifest themselves when she was a young woman of eighteen years. Her multiple sclerosis was diagnosed in 1985.(2:6, 7, 4:69; 7:58, 69). Multiple sclerosis, a disease for which there is no known cure, is a slowlyprogressive disease of the central nervous system, characterized by disseminated patches of demyelinization in the brain and spinal cord. (SE 16). L.B.’s first communication was to the Board’s investigator wherein she expressed to him her concerns over the difficulty she was having with Respondent in making financial arrangements for him to complete her treatment. (7:5). She also made other calls to the Board relative to her dentistpatient relationship with Respondent. (7:59).

87. Prior to contacting Respondent for the first time L.B. had been independently exposed to the idea that silver amalgams could be preventing multiple sclerosis patients from at least an amelioration of their symptoms, if not a cure. (4:83). Among those was Dr. Dietrich Klinghardt, an “holistic” physician who testified in Respondent’s behalf in these cases. (4:7074;12:472). She had also gone to see Dr. Bruce Shelton, for the same reason. Dr. Shelton also testified in behalf of Respondent. (16:35071). She did not go to Respondent the first time already prepared to have her silver amalgams removed, but only to see if Respondent could provide her relief some in the medical community until then had not provided her. (4:71).

88. During her first visit to Respondent he provided her with information which gave her to understand that there may or could be a causal connection between her multiple sclerosis and her amalgam fillings. He told her that the mercury in her silver amalgams could travel in her bloodstream to her brain and poison her. (4:7670, 82; 7:32, 34, 35, 66). Even Respondent testified that he told L.B. that the removal of her silver amalgams “may help her with her condition,” and told her “it could very well help her condition.” He testified “I have seen it work so many times that I can’t deny it, but I do not guaranty [sic] anything.” (21:105, 106; 28:11). She had no dental problems when she first went to Respondent. (2:7, 8; 21:107). Her thenexisting amalgams were serviceable. (21:107).

89. Respondent’s suspicions were justified to his way of thinking after he hooked up L.B. to his amalgameter (previously found herein to have no dental diagnostic value; See: Finding of Fact #5) and read its indications. “I showed,” he testified, “with an amalgameter test that she had electrical currents that interfered with the [acupuncture] meridians.” And which of the teeth did the amalgameter say were problems?, Respondent was asked by counsel. “The ones that had the minus electrical charge, and those that had plus.” he answered. (21:106, 107). Respondent told L.B. she needed to have all her silver amalgams removed and replaced. (4:80). Evidently, based on this testimony and the record in these cases as a whole, the amalgameter and Respondent find problems with teeth having silver amalgam restorations with great ease and regularity. Conversely, the record is entirely unacquainted with a single instance of those two not discovering a problem with such a tooth. Respondent’s treatment records contain no indication of any clinically acceptable reason for Respondent to have removed those amalgams.

90. It cannot be too emphatically found as a fact that there is not one scintilla of credible record evidence that multiple sclerosis can be treated, cured or alleviated in any way to any degree by removing silver amalgams. Contrarily, the State produced much credible evidence for the record that Respondent’s treatment has in no way been shown to have a chance to do what he claims it might do. Charles C. Thompson, D.M.D., M.S.D., and member of the faculty of the Oregon Health Sciences University, School of Dentistry, Department of Pathology, published in the AprilJune, 1986 edition of the “Journal of Oral Medicine,” an article on this topic in which he concluded that “There is no bona fide scientific evidence that…mercurysilver amalgam restoration replacement…has any bearing on the course of multiple sclerosis.” (SE 16). Moreover, the Medical Advisory Board of the National Multiple Sclerosis Society likewise has concluded that “there is absolutely no evidence that mercury amalgam fillings have any connection with MS or that their replacement would help patients with the disease.” (SE16). Cruelly, some of the purveyors of the theory of amelioration of multiple sclerosis by silver amalgam removal point to instances where they say the treatment has worked. It should be borne in mind that multiple sclerosis has the unexplained characteristic of marked periods of spontaneous remission, and such is true in multiple sclerosis patients across time and geography, with or without silver amalgams. (SE 16, 30).

91. Based on the evidence of record the State has alleged in L.B.’s case, much like its allegation in S.T.’s case (hyperthyroidism), that Respondent has * exceeded the scope of the practice of dentistry by treating multiple sclerosis. The same type of finding is found here in L.B.’s case as was found in S.T.’s (hyperthyroidism) and Ms. Rauen”s (arthritis). Respondent was not practicing outside the scope of dentistry by treating multiple sclerosis quite simply because he was not treating multiple sclerosis. What he did is no treatment for multiple sclerosis, but a false claim as to what benefits his treatment can affect. (*The Board amended this finding to correct grammar.)

92. L.B. was in a very vulnerable state when she went to Respondent with her hopes for her life’s improvement, and was highly susceptible to Respondent’s claims of his treatment’ possibilities. (7;64, 84, 85). Nothing Respondent did helped with L.B.’s multiple sclerosis. (21:114;; 123). In fact, since treating with Respondent her physical debilitation has progressed. (7:55).

93. L.B. testified at this hearing and, as found by the undersigned’s observation of her demeanor as a witness, gave the following testimony both eloquently and emotionally: “I am here to help [Respondent] relate to his patients better, especially his patients who have diseases that there’s no medical cure for, to not “not to play on the emotions of the people, because that’s cruel…And to create any kind of false hope like that is cruel.” (21:144). Indeed.

94. L.B. had a perfectly healthy endodontically treated tooth #2 when she went to Respondent. (5:75: 4:85). Respondent s radiographs of that tooth indicated nothing wrong with it (except, in Respondent’s opinion, it had been endodontically treated). (21:111). Respondent gave L.B. his counsel on root canal treated teeth. According to L.B. he told her “when you do root canals you interfere with the blood flow in your gums and your teeth and that you could influence, you know, your blood supply going from that area to your brain. It offsets the flow of energy from on part to another.” (4:86). This testimony of L.B. is credible taken with Respondent’s testimony that tooth #2 was not asymptomatic based on the results of his testing the tooth with his computron and AK. (28:12). His computron “showed problems.” (21:110,11). Respondent’s computron serves him about as well as his amalgameter. Again, the computron and AK are not valid diagnostic methods or tools in dentistry as has already been found and discussed. Respondent extracted L.B.’s tooth #2 solely because it had been treated by root canal surgery. (21:111).

95. Respondent’s records contain no diagnosis of tooth #2, nor documentation of a reason why he extracted tooth #2. (5/6:75;8:37).

96. Following the extraction of #2, the Respondent initially intended to place a bridge at teeth ##2,3 and 4. He never did, and the State alleges abandonment. Respondent testified that he did not place the bridge because, it was unnecessary and L.B. elected not to have the bridge. (28:12, 13). There is insufficient evidence of record to support the State’s claim relating to the bridge not being supplied.

97. Respondent also performed cavitational surgery on L.B. in the areas of teeth ##16,17, and 21. (4:89, 90, 96, 97, 105, 106, 111). She had been having no pain the areas where Respondent went ahead and performed the cavitational surgery. (4:91, 106).

98. Respondent’s records contain no evidence supporting the need for the cavitational surgeries. (5?6:71, 72). His only record of any diagnosis and treatment for the cavitational surgeries were his customary precavitational surgery red caret, and postcavitational surgery blue caret. (21:114, 115). The only radiograph he had of #21 had been made four years prior to the surgery on that cavitation. No radiographs were done just before the cavitational surgeries. This omission was below the standard of care. (5/6:72).

99. Respondent filled L.B.’s tooth #26, but his records contain no documentation of his diagnosis supporting that treatment being performed. (9:73, 74). Familiarly by now, Respondent made a red mark on the tooth chart before filling the tooth, and then made the red mark blue after the filling. (21:105, 113, 114).

100. When L.B. began her treatment with Respondent her financial situation was rather rosy, and she was able to pay Respondent $100.00 every month for her treatment, and occasionally $400.00 or $500.00 each visit to his office. (4:92; 7:42, 43; 28:15). Later, her financial situation worsened, and she had to discontinue her treatment with Respondent for approximately two years, the time it took her to pay off her balance with him, and restore her financial situation. (4:93, 94; 7:44, 45; 28:15). When she suspended treatment with the Respondent her teeth had temporary crowns on them placed by Respondent, and they had intended to place permanent crowns. (4:95). When L.B. returned to Respondent to resume the treatment she was informed by his office that she must either pay for the treatment in full or open a dental credit card account. (4:98, 99; 7:47). L.B. was understandably reluctant to begin anew the method of running up charges after she had just paid off previous balances, so she declined to open a credit card account and went to another dentist. That dentist told her she needed to return to Respondent and have him place the permanent crowns in her mouth. (4:100; 7:48). At that point in time L.B. contacted the Board of Dental Examiners for guidance, and was informed by Board Chief Investigator Dr. Larry Pozil that she should return to Respondent and insist on his completing her treatment, including placement of the permanent crowns. She did return to Respondent, and after imparting to him the information she had gathered from the other dentist and Dr. Pozil, Respondent consented to completion of her treatment in exchange for payment made by a financial arrangement more amenable to her, i.e., to pay as she could. (4:414, 101, 103, 104; 7:49, 50, 70, 71, 28:17). Respondent had a duty to complete L.B.’s treatment without changing their financial agreement in the crucial midpoint of her treatment to a method that would make her permanent restorations financially unattainable to her. (9:75). Finding otherwise would very nearly sanction dentistry extortion by condoning a dentist’s treating a patient on affordable financial terms up to the point of temporary restorations, then, when the patient is most dependent on the dentist for continued health care, allowing the dentist to alter the terms and compel the patient either to pay through the nose, search for another dentist who will affordably finish the treatment, or go without permanent dental restoration.

101. Respondent’s records fail to disclose that he ever made any diagnoses in L.B.’s case, as particularly found at Findings ##95, 98, and 99 in this case. Nor do his records show that he ever did a periodontal examination of L.B. Respondent’s treatment records are below standard of care. (2:9, 9:70,71).

102. The eighth case is Complaint Number 96175, involving patient G.P. G.P. was at one time a dental assistant of Respondent’s (24:150). She sought dental treatment from him because she “was very unhealthy, sick all the time. My face was always scarred from we don’t know what and headaches every day, all the time.” (2:15; 24:151, 152). Respondent first removed all G.P.’s silver amalgams, and he removed all her endodontically treated teeth. (24:153, 154). His treatment plan included eventually placing permanent restorations in G.P.’s mouth. (24:177, 178). Respondent never made any study models prior to embarking upon this extensive treatment plan. (2:16). Having such study models prior to G.P.’s treatment would have been advisable (9;80).

103. Respondent extracted some of G.P.’s teeth simply because they had had root canal treatment, and some of her silver amalgams simply because they were silver amalgams. (21:130, 131; 24:153, 154). (Although some of the silver amalgams were breaking down. (21:128)). Unsurprisingly, his tests computron, AK, myomonitor and amalgameter according to him, supported all his treatment. (28:20, 21). Nothing in Respondent’s radiographs or treatment records supports the extractions. (9;78,79; 5/6:76, 78; 8:38, 39).

104. G.P. had continued to treat with Respondent until he terminated her employment with his office. At the time of her discharge from his employment her teeth had been fixed with temporary restorations. (24:155, 177). Subsequently, she found a position with another dentist, a Dr. Chris Lienau, whose office is situated directly across the street from Respondent’s. (24:156, 157). During that time her temporaries, being temporaries, began falling out and falling apart, and she wished to have the treatment completed. (24:181, 182). Respondent never attempted to contact G.P. regarding completion of her treatment by himself or another dentist, his claim of effort to do so notwithstanding. Respondent had her telephone number all the time. (24:183, 184). It is found by inference that under the circumstances of her departure Respondent deemed it more comfortable and more convenient to forget the case.

105. Dr. Lienau, after discovering the circumstances of G.P.’s teeth and how she had left Respondent’s employment in midtreatment, pressured her into signing a complaint against Respondent to be filed with the Board of Dental Examiners. She did sign the complaint and it was filed. (24:150, 157, 158). Dr. Lienau composed the complaint, and G.P. repudiated much of the statements in her complaint at hearing. (24:158, 161163). However, it is true that she signed and filed the complaint, or had it filed, and that she had wished to have her treatment completed by respondent. (24:170, 172, 173, 181, 184).

106. After the complaint was filed, a Board consultative dentist, Dr. Palmer, examined G.P. in August, 1996. He found her temporaries loose and coming off into his hands. (7:8789, 94).

107. Eventually, after her complaint to the Board was filed, Respondent finally completed his treatment of G.P. in 1998. (2:17; 24:182, 183).

108. Respondent’s treatment records of G.P. are below standard of care. (9:77). his recordation of diagnosis and treatment plan was done in the same barely existent manner as with the other patients. (21:130). The records are devoid of any periodontal charting, any TMJ analysis, or that Respondent even examined G.P. before beginning to treat her. (G.P. treatment records; 9:77, 78). Respondent even failed to record the results of his highly valued amalgameter. Respondent attempted to explain that way with the lame excuse that G.P. “was a dental assistant. G. had worked several months with me at the chair. She knew what was involved and ” and knew what we were doing.” (28:20). This as if the sole purpose of patient records is to edify the patient. If such were the case, one could suppose that a dentist performing surgery on a fellow dentist would be excused from keeping any records at all.

109. The ninth and last case is Complaint Number 97341, involving patient N.F. N.F. first presented to Respondent complaining of pain in her tooth #3, which is a tooth of the upper right quadrant of the mouth. (3:8, 24). She had no pain at that time in her lower right quadrant. (3:24, 25). Respondent explained to N.F. that her mouth was very toxic and that her problem could be from the silver amalgams in her teeth. Respondent showed her a videotape calling in question the safety of silver amalgams. (3:8,9). Respondent also advised N.F. that root canals are very bad, and suggested to her that she read Dr. Meining’s antiroot canal book, which she did. She became convinced from Respondent and his suggested literature that root canals are very bad. (3:11, 12, 75, 76).

110. Respondent performed his AK on N.F., and Dr. Bouquot said she had NICO. (3:100; 12:147). Convinced by Respondent that her health demanded the surgery, N.F. consented to Respondent performing four cavitational surgeries on her, in areas ##29,30,31, and 32. Respondent practically dropped a consent form in N.F.’s lap as she was seated in the operatory chair just prior to commencement of the surgery. (2:21; 3:24, 25, 27, 101; 21:142). Respondent relies heavily in these cases, including N.F.’s, that the patient signing a consent somehow exonerates him from responsibility for doing harm to the patients. (3:102, 103). However, as already has been found, it is below standard of care for a dentist to regard a patient as being competent to consent to be harmed by a dentist’s improper surgery or treatment. N.F.’s consent typifies those of the other patients: She consented because she was trusting Respondent’s professionalism. (3:100). The cavitational surgeries were performed October 2nd, 1995. (21:147). The cavitational surgery sites in N.F. were in her lower right quadrant where she was experiencing no pain. (2:24, 25; 3:2426). Respondent’s cavitational surgery provided no pain relief to N.F. in the area where she was hurting, #3. (3:25).

111. Unfortunately for N.F., Respondent’s surgery resulted in a great deal of harm to N.F. in that it caused her to have paresthesia, or a constant numbness in her mouth. When N.F. awoke the next morning after the surgery she discovered that her lower lip was hanging limp. Although paresthesia is a risk incidental to oral surgery, it is rare, and even Respondent advised N.F. presurgery that the chances were 99.9% against a result of paresthesia. (3:30, 31, 103, 21:146). Respondent conceded that the paresthesia was the result of his surgery. (2:22; 3:27; 21:141).

112. N.F. returned to Respondent’s office a week later, October 9th, 1995, to have him remove her sutures. She informed him of her numbness at that time, but Respondent said and did nothing to help the situation. (3;109; 5/6:89, 90). N.F. returned to Respondent’s office for a second followup visit on November 6th, 1995, still suffering with the paresthesia. (N.F. testified rather confusedly that her paresthesia had begun slow improvement by the time of her return to Respondent’s office November, 1995, but elsewhere that her paresthesia did not begin to improve for months postoperative. (3:108, 112).) Still, Respondent did and said nothing to help that condition, and was even “nonresponsive” to N.F., not even “saying he was sorry.” (3:111.112). . Respondent understood in his own mind that most paresthesias resolve within three to six months, so he was going to wait and see what transpired with N.F. (3:28; 21:147, 148). Respondent did not see N.F. from November 6th, 1995, until June of 1996. She was still having paresthesia at that time. Respondent made no referral of her to a specialist. *According to Dr. Ingersoll the window of time was rapidly closing in which the damaged nerve could be repaired. Standard of care would, by that time, have required a referral (5/6:90. (*The Board amended this finding to add information that clarified the finding based on the record.)

113. After June of 1996, Respondent made no attempt to contact N.F. to inquire of the state of her paresthesia. It is evident based on his testimony that he felt no obligation to do so, but that N.F., rather, was somehow obliged, or had a duty as a patient, to contact him if she wanted him to help her with the paresthesia he had inflicted on her mouth. (21:148, 149). Respondent never took any steps to help N.F. with her paresthesia, including refer her to an oral surgeon. (3:29, 30).

114. N.F.’s paresthesia never did resolve, and still she was suffering from it the day she testified at this hearing. (3:44). She has been to other dentists since leaving Respondent, but after one look into her mouth and they declined to accept her as a patient since her dental condition was so “terrible.” (3:40, 41). According to N.F.’s own testimony, since the cavitational surgeries, “I am not the same person since. . . .People naturally have a fear of dentists. And this whole thing has been devastating for me. Absolutely devastating. And it’s been an ongoing thing now since 1994. And I’m back to point zero, only much worse than before. . . I have a lip that’s numb . . . And all of the pain and suffering I have to go through. . . . And all the money that is spent and time that has been spent. And here I am.” (3:159, 160).

115. Naturally, since Respondent had not at all treated N.F.’s tooth #3, the tooth that was giving her pain all along, it was still hurting her, and becoming worse. Rather than refer N.F. to an endodontist, who the record can reasonably infer from other similar cases, might have been able to save the tooth, Respondent straightaway referred N.F. to a dentist in Nevada to have #3 extracted. (2:21, 22; 3:32, 33). That dentist extracted her #3, and performed more cavitational surgery on her. (3:34, 35). Thereafter, N.F. returned to Dr. Lee who wanted to perform additional cavitational surgery on her. (3:38).

116. Respondent’s treatment records of N.F. contain no basis of justification for the four cavitational surgeries he performed on her. (2:23; 5/6:8082). She was having no problem with those areas, and State’s expert witness, testifying while examining Respondent’s panorexes of those sites and seeing no pathology indicated thereon, corroborated that there was no justification for them. (32:71, 72).

117. A great deal of testimony and documentary evidence in these cases was heard and admitted relative to the subject of acupuncture. Some findings regarding that subject need to be made. Respondent offered pages and pages of testimony from witnesses in an effort to prove reliability of AK and the computron and the amalgameter in dentistry, each of which incorporate acupuncture and what are referred to as the acupuncture meridians in their techniques. (See: testimonies of Dr. Klinghardt, 11:16155, and 12:472, and Dr. Royal, 19:1594; SE 28, 30, 39, 40; RE A3, A4, 146, 163). Acupuncture needle therapy by now has been rather well accepted as a method of treating pain. Although Respondent occasionally does use acupuncture needles in his practice as a way to alleviate pain (20:17), that is not a subject of the State’s complaint in these cases. The lion’s share of evidence regarding acupuncture was relative to Respondent’s use of what he claimed to be diagnostic techniques which incorporate, somehow, what are known as the body’s acupuncture meridians, to find that a patient’s endodontically treated teeth and silver amalgams are harmful. (Record as a whole). This is entirely different from a claim that acupuncture needles can help alleviate pain. The evidence offered by Respondent to prove the reliability of his diagnostic techniques not only was unconvincing, but added to the believability of the State’s evidence. Perhaps the two most incredible pieces of evidence on his head were RE 146, the socalled Voll Chart, and the testimony of Dr. royal (the mercuryinthelake man, Finding of Fact #43). This is a chart of the human teeth and shows, according to Dr. Royal, “how those teeth can affect those different organs and systems through which the acupuncture meridians travel.” (19:20, 52). Each particular tooth is claimed to have an affect on particular anatomical areas. For example, Dr. Klinghardt testified that endodontically treating the front teeth can have an adverse affect on one’s kidneys. By extracting front teeth that have root canals a kidney patient can regain normal kidney function. (12:4143). According to Dr. Royal, human tooth #17 corresponds to the peripheral nerves, the left side of the heart, the jejunum, and the ileum. He offered to illustrate his position on the acupuncture meridians by using the Voll Chart and giving testimony of an anecdote of a man who suffered from severe coronary artery disease. He testified, seriously, that “the reason” the man had coronary artery disease “was because the energy that flows out of the heart flows down the heart freeway of energy to the small finger, turns around and then flows back up the body along what is known as the small intestine freeway. The small intestine freeway passes right over these back two wisdom teeth, does a little jig out here, disappears right in the area of the temporomandibular joint.” (19:53). He continued: “What happened there was a block here and just as would happen if a beaver dam were build [sic] on a small stream, a cesspool formed behind that beaver dam of energy. It was backing up into the heart. It was as if this room would have a temperature of 80 degrees and the thermostat were stuck and nobody could get out and you couldn’t change the thermostat. It caused an acceleration of the aging process, a deterioration by virtue of the fact that you could not get rid of the energy that was building, building, building. When the tooth was pulled,immediately it was like blowing up a beaver dam. All of the sudden, there was a surge out of his heart, through that area, with normal circulation through the energy system again and he noticed it immediately.” (19:53, 54). Conspicuously absent from the Respondent’s evidence is an instantiation, from anywhere on earth, of a physician referring a kidney patient to a dentist to have front teeth extracted, or a heart surgeon referring a heart patient to a dentist to have tooth #17 extracted. Respondent’s counsel showed Dr. Royal RE A3 which has on it a depiction of a human face with curvy lines. Asked what that showed, Dr. Royal said, “These are trying to show how energy whirls occur and you wind up with vortexes of energy in certain specific areas of the body.” Dr. Royal never actually explained his “whirls” and “vortexes” or freeways,” or their physiology other than by crossexplaining one by description of another. It was this fantastic testimony of Respondent’s case, and the evidence of the State’s, which, combined with all other evidence of record previously cited, lead to the findings of fact relative to the worthlessness of AK, the amalgameter and the computron as dental diagnostic devices or methods. This evidence of the acupuncture “meridians” also formed the proud centerpiece of Respondent’s positions why endodontically treated teeth and silver amalgams are to be avoided. Considering the record as a whole relative to the socalled acupuncture meridians, State’s expert Dr. Stephen Barrett most aptly termed the concept “complete baloney).” (31:30).

118. Some, but not much, evidence was presented by both parties relative to Respondent’s use of “homeopathic” remedies in his practice, such as Traumeel, and injections of protamine zinc insulin (PZI) and intravenous administering of vitamin C. These substances are not used by most dentists. The State alleges that the use of these substances are without any clinically acceptable justification, but there is insufficient evidence of record to support that allegation. (2:17, 18; 20:130133; 21:151159; 4853). However, whether these substances have any legitimate use or not, Respondent failed to adequately document in his records his administering of them, and that omission is substandard of care in the area of record keeping. (5/6:6870). (A) This hearing was held and these Findings of fact, Conclusions of Law and Recommended Order submitted, under authority of and pursuant to A.R.S. 411092 and A.R.S. 321263. (B) Subject matter jurisdiction is vested at A.R.S. 321201et sequitur. © The standard of proof in these nine consolidated cases is proof by preponderance of the evidence (any amount greater than 50%). See: Cullpepper v. State, 187 Ariz. 431, 930P.2d 508 (App. 1996). (D) The term standard of care, as used throughout these Findings of Fact, is the exercise [of] that degree of care, skill and learning expected of a reasonable, prudent health care provider in the profession or class to which he belongs within the state acting in the same or similar circumstances. A.R.S. 12563. This is the statutory definition of standard of care used in actions relating to health care and, based on the testimonies of experts from both parties in these cases, was the working definition used throughout the hearing. It is also concluded that the standard of dental care for all general practitioners in Arizona, such as Respondent, is the same. (E) From the conclusion immediately preceding erases the next. What should always be kept at the forefront in this Decision and Order are the facts of nine consolidated individual cases, each of which has to do with an individual patient and Respondent’s treatment of her or him. These patients and their treatment from Respondent are what matter, and they should not be misused as cannon fodder in an internecine war being waged within the dental profession. That is to say that at no time should this decision, or any part of it, be misperceived as a pronouncement concerning the respective validity or invalidity, merit or demerit, of the socalled traditional or allopathic dentists on one side, and the socalled integrative, homeopathic, or holistic dentists on the other. Unlike physicians which Arizona legally subdivides into Homeopathic Physicians, A.R.S. 322901, et. seq., Naturopathic Physicians, A.R.S. 321501, et seq., and Allopathic Physicians, A.R.S. 321401 , et seq., and regulates each within its own, Arizona draws no such legal distinction where it licenses and regulates dentists. Seen through the eyes of Arizona, a dentist is a dentist is a dentist. Hence, none of these cases nor any part of this Decision and Order should be misconstrued as a generalized validation or repudiation of Respondents practice in those terms. These cases and this decision consider certain particulars of Respondents practice, i.e., his inadequate treatment, diagnosis, and recordkeeping as a dentist licensed by the State of Arizona. If any among the particulars of his practice which are addressed herein happens to be a procedure utilized in the main by dentists who regard themselves holistic, but rarely or never by dentists who regard themselves allopathic, so much is coincidence which may be taken by some as applying to their own selfcatergorization, but is not a concern of this decision or the current state of Arizona law, neither of which take cognizance of those informal, intraprofessional labels. (F) Respondent urges dismissal of Complaints #95178 (Ms. Rauen) and #97175 (G.P.). It was found in fact that in G.P,’s case the route and method by which the Complainant was brought was unusual. Also, Ms. Rauens testimony might lead one to believe that her enthusiasm for the Complaint process was less than wholehearted. Nevertheless, the Board is statutorily empowered to pursue G.P.’s case based on the facts discovered in its investigation thereof, notwithstanding G.P.s repudiation of most of the substantive content of the Complaint letter composed by Dr. Lineau, and signed by her. A.R.S. 321207.A.9., 321263.1. This is true in cases of where the investigation brings to light unprofessional conduct which is not necessarily expressed or implied within the content of the complaining individuals letter, and in cases where they do. It would frustrate the purpose of the Board of Dental Examiners if they were powerless to proceed against an unprofessional conduct which the complaining member of the public failed to include or which was other than what she did include in her letter to the Board, but which came to light nevertheless. As to Ms. Rauens case, although she did not herself bring the Complaint against Respondents, such is of no consequence. The Board on its own motion may investigate any evidence which appears to show the existence of any of the causes or grounds for disciplinary action as provided in 321263. A.R.S.321263.02. In Ms. rauens case, as was found, such a motion was duly made and carried. (G) Respondent argues that it is improper for the administrative complaint process to resolve the present differences between these parties; that these differences should be ventilated openly in the legislature or in the Board through its rulemaking authority, and the court of public opinion. Respondent observes that the Board, despite the legislative mandate at A.R.S. 321207, has no rules addressing these disputed dental practices. In the absence of such rules, so the Respondents argument goes, this Administrative Law Judge should recommend dismissal, and urge the Board to make rules, or the legislature to pass statutes, in order that future cases such as these can be properly disposed, or completely obviated. Conceding the potential for guidance that could be had from rules bearing on these topics, this ALJ remains of an opinion different than Respondents. Three statutes, A.R.S. 321207.A.13, 1263., and 1201.18, make proper the going forward of these nine administrative complaints, and any such in future, with or without such additional rules or statutes advocated by Respondent. As a matter of law, it would be an improper abdication of his responsibility as an ALJ for this ALJ to recommend dismissal of these cases on the ground urged by Respondent. They were properly brought, jurisdiction vests, and his duty attaches. A.R.S. 411092.01.B. (H) Respondent points out in his posthearing reply memorandum that the methods and devices he employs which were here found unreliable are allowed by Arizona law to be used by naturopathic physicians (A.R.S. 321501.20), homeopathic physicians (A.R.S.322901.1.©, and chiropractors (A.A.C. R476). The practice of dentistry is welldefined and circumscribed by statute. A.R.S. 321202. The practice of dentistry is not homeopathy, naturopathy or chiropractic. What reasons the governing boards of those latter three professions may have found to authorize the use of what they authorize and for what purposes they authorize them is their, their licensees and their patients concern, but not the concern of the Arizona Board of Dentistry. The facts herein found, and the evidence of record which form their bases, all are to do with the use of Respondents devices and methods in the practice of dentistry. Whatever value they may or may not have in other fields, the evidence failed to show they have value in dentistry. (I) Count One of the States charges against Respondent pertain to Complaint 95084, involving patient D.T. Respondents conduct in this case constitutes unprofessional conduct pursuant to A.R.S. 321201.18.(n) as alleged in Count One. That statute deems conduct unprofessional which does or would constitute a danger to the health, welfare or safety of the patient or public. Respondent made no diagnosis justifying the referenced treatment of on D.T., and the treatment was based on inadequate radiographs and insufficient clinical data. Respondents treatment of D.T. endangered and damaged his health, safety and welfare. (J) A.A.C. R4111102.A. makes Respondent the dentist of record to all these nine patients. The first sentence of subsection E. of that rule provides: The dentist of record shall remain responsible for the care of the patient during the course of treatment and shall be available to the patient through the office, an emergency number, an answering service, or a substituting dentist. This rule creates in the dentist of record a duty to follow through to completion a patients treatment, irrespective of the patients obnoxious or irritating manners. Accord: Jackson v. Oklahoma Memorial Hospital, 909 P.2d 765 (Okla. 1995); Ricks v. Budge, 64 P. 2d 208 (Utah 1937). When Respondent terminated D.T. as a patient in the midst of his treatment as found, he breached that duty. (K) Count Two of the States charges against Respondent pertain to Complaint 95083, involving patient S.T. Respondents conduct in this case constitutes unprofessional conduct pursuant to A.R.S. 321201.18.(n) because there was no clinically acceptable justification for the Respondents treatment of S.T., and the treatment was based on insufficient clinical data. Respondents treatment of S.T. endangered and damaged her health, safety and welfare. (L) The State alleges in Count Two that Respondent exceeded the scope of the practice of dentistry by treating S.T.s hyperthyroidism. A.R.S. 321202 does define practicing dentistry. However, based on the facts found hereinabove, it could be concluded only that Respondent was making the ALJ in pleading or posthearing argument how making that claim exceeds the scope or which provision of A.R.S. Title 32, chapter 11, or rules thereunder, proscribes exceeding the scope. It is not among the unprofessional conduct listed at A.R.S. 321201.18.(a)(aa). It is not grounds for disciplinary action at A.R.S. 321263. The value of the statutory definition of practicing dentistry seems to in here in noticing what practices require licensure. See A.R.S. 321261.

CONCLUSIONS OF LAW(A) This hearing was held and these Findings of Fact, Conclusions of Law, and Recommended Order submitted, under authority of and pursuant to A.R.S. 411092 and A.R.S.321263.

(B) Subject matter jurisdiction is vested at A.R.S. 321201 et sequitur.

(C). The standard of proof in these nine consolidated cases is proof by preponderance of the evidence (any amount greater than 50%). See: Cullpepper v. State, 187 Ariz. 431, 930P.2d 508 (App. 1996).

(D) The term standard of care, as used throughout these Findings of Fact, is the exercise [of] that degree of care, skill and learning expected of a reasonable, prudent health care provider in the profession or class to which he belongs within the state acting in the same or similar circumstances. A.R.S. 12563. This is the statutory definition of standard of care used in actions relating to health care and, based on the testimonies of experts from both parties in these cases, was the working definition used throughout the hearing. It is also concluded that the standard of dental care for all general practitioners in Arizona, such as Respondent, is the same.

(E) From the conclusion immediately preceding arises the next. What should always be kept at the forefront in this Decision and Order are the facts of nine consolidated individual cases, each of which has to do with an individual patient and Respondents treatment of her or him. These patients and their treatment from Respondent are what matter, and they should not be misused as cannon fodder in an internecine war being waged within the dental profession. That is to say that at no time should this decision, or any part of it, be misperceived as a pronouncement concerning the respective validity or invalidity, merit or demerit, of the so-called traditional or allopathic dentists on one side, and the so-called integrative, homeopathic, or holistic dentists on the other. Unlike physicians which Arizona legally subdivides into Homeopathic Physicians, A.R.S. 322901, et seq., Naturopathic Physicians, A.R.S. 321501, et seq., and Allopathic Physicians, A.R.S. 321401, et seq., and regulates each within its own, Arizona draws no such legal distinction where it licenses and regulates dentists. Seen through the eyes of Arizona, a dentist is a dentist is a dentist. Hence, none of these cases nor any part of this Decision and Order should be misconstrued as a generalized validation or repudiation of Respondents practice in those terms. These cases and this decision consider certain particulars of Respondents practice,i.e., his inadequate treatment, diagnosis, and recordkeeping as a dentist licensed by the State of Arizona. If any among the particulars of his practice which are addressed herein happens to be a procedure utilized in the main by dentists who regard themselves holistic, but rarely or never by dentists who regard themselves allopathic, so much is coincidence which may be taken by some as applying to their own selfcategorization, but is not a concern of this decision or the current state of Arizona law, neither of which take cognizance of those informal, intraprofessional labels.

(F) Respondent urges dismissal of Complaints #95178 (Ms.Rauen) and #96175 (G.P.). It was found in fact that in G.P.’s case the route and method by which the Complaint was brought was unusual. Also, Ms. Rauens testimony might lead one to believe that her enthusiasm for the Complaint process was less than wholehearted. Nevertheless, the Board is statutorily empowered to pursue G.P.’s case based on the facts discovered in its investigation thereof, notwithstanding G.P.’s repudiation of most of the substantive content of the Complaint letter composed by Dr. Lineau, and signed by her. A.R.S. 321207.A.9., 321263.1. This is true in cases of where the investigation brings to light unprofessional conduct which is not necessarily expressed or implied within the content of the complaining individual’s letter, and in cases where they do. It would frustrate the purpose of the Board of Dental Examiners if they were powerless to proceed against an unprofessional conduct which the complaining member of the public failed to include or which was other than what she did include in her letter to the Board, but which came to light nevertheless. As to Ms. Rauens case, although she did not herself bring the Complaint against Respondent, such is of no consequence. The Board on its own motion may investigate any evidence which appears to show the existence of any of the causes or grounds for disciplinary action as provided in 321263. A.R.S.321263.02. In Ms. Rauens case, as was found, such a motion was duly made and carried.

(G) Respondent argues that it is improper for the administrative complaint process to resolve the present differences between these parties; that these differences should be ventilated openly in the legislature or in the Board through its rulemaking authority, and the court of public opinion. Respondent observes that the Board, despite the legislative mandate at A.R.S. 321207, has no rules addressing these disputed dental practices. In the absence of such rules, so the Respondent’s argument goes, this Administrative Law Judge should recommend dismissal, and urge the Board to make rules, or the legislature to pass statutes, in order that future cases such as these can be properly disposed, or completely obviated. Conceding the potential for guidance that could be had from rules bearing on these topics, this ALJ remains of an opinion different than Respondent’s. Three statutes, A.R.S. 321207.A.13, 1263., and 1201.18, make proper the going forward of these nine administrative complaints, and any such in future, with or without such additional rules or statutes advocated by Respondent. As a matter of law, it would be an improper abdication of his responsibility as an ALJ for this ALJ to recommend dismissal of these cases on the ground urged by Respondent. They were properly brought, jurisdiction vests, and his duty attaches. A.R.S. 411092.02.B.

(H) Respondent points out in his posthearing reply memorandum that the methods and devices he employs which were here found unreliable are allowed by Arizona law to be used by naturopathic physicians (A.R.S. 321501.20), homeopathic physicians (A.R.S. 322901.1.©, and chiropractors (A.A.C. R476). The practice of dentistry is welldefined and circumscribed by statute. A.R.S. 321202. The practice of dentistry is not homeopathy, naturopathy or chiropractic. What reasons the governing boards of those latter three professions may have found to authorize the use of what they authorize and for what purposes they authorize them, is their, their licensees’ and their patient’s concern, but not the concern of the Arizona Board of Dentistry. The facts herein found, and the evidence of record which form their bases, all are to do with the use of Respondent’s devices and methods in the practice of dentistry. Whatever value they may or may not have in other fields, the evidence failed to show they have value in dentistry.

(I) Count One of the States charges against Respondent pertain to Complaint 95084, involving patient D.T. Respondent’s conduct in this case constitutes unprofessional conduct pursuant to A.R.S. 321201.18.(n) as alleged in Count One. That statute deems conduct unprofessional “which does or would constitute a danger to the health, welfare or safety of the patient or public.” Respondent made no diagnosis justifying the referenced treatment of on D.T., and the treatment was based on inadequate radiographs and insufficient clinical data. Respondent’s treatment of D.T. endangered and damaged his health, safety and welfare.

(J) A.A.C. R4111102.A. makes Respondent the dentist of record to all these nine patients. The first sentence of subsection E. of that rule provides: “The dentist of record shall remain responsible for the care of the patient during the course of treatment and shall be available to the patient through the office, an emergency number, an answering service, or a substituting dentist.” This rule creates in the dentist of record a duty to follow through to completion a patient’s treatment, irrespective of the patients obnoxious or irritating manners. Accord: Jackson v. Oklahoma Memorial Hospital,909 P.2d 765 (Okla. 1995); Ricks v. Budge, 64 P.2d 208 (Utah 1937). When Respondent terminated D.T. as a patient in the midst of his treatment as found, he breached that duty.

(K) Count Two of the States charges against Respondent pertain to Complaint 95083, involving patient S.T. Respondent’s conduct in this case constitutes unprofessional conduct pursuant to A.R.S. 321201.18.(n) because there was no clinically acceptable justification for the Respondent’s treatment of S.T., and the treatment was based on insufficient clinical data. Respondent’s treatment of S.T. endangered and damaged her health, safety and welfare.

(L) The State alleges in Count Two that Respondent “exceeded the scope of the practice of dentistry” by treating S.T.s hyperthyroidism. A.R.S. 321202 does define “practicing dentistry.” However, based on the facts found hereinabove, it could be concluded only that Respondent was making a false claim. The State has failed to make clear or at all advise the ALJ in pleading or posthearing argument how making that claim “exceeds the scope” or which provision of A.R.S. Title 32, chapter 11, or rules thereunder, proscribes “exceeding the scope.” It is not among the unprofessional conduct listed at A.R.S. 321201.18.(a)(aa). It is not grounds for disciplinary action at A.R.S. 321263. The value of the statutory definition of practicing dentistry seems to in here in noticing what practices require licensure. See: A.R.S.321261.

(M) Count Three of the States charges against Respondent pertain to Complaint 95178, involving patient Ms. Mildred Rauen. Respondent’s conduct in this case constitutes unprofessional conduct pursuant to A.R.S. 321201.18.(n), because there was no clinically acceptable justification for his treatment of Ms. Rauen, and the treatment was based on insufficient and unreliable clinical data. Further, the denture Respondent made for Ms. Rauen was inadequate, and its inadequacy was occasioned in part by Respondent’s unprofessional treatment of Ms. Rauen. Respondent’s treatment of Ms. Rauen endangered and damaged her health, safety and welfare.

(N) The State also alleges Respondent “exceeded the scope of the practice of dentistry, as defined in A.R.S. 321201, by treating M.R.s arthritis.” The same conclusion of law reached in S.T.s case is reached here relative to that allegation.

(O) Count Four of the State’s charges against Respondent pertain to Complaint 96024, involving patient M.C. Respondent’s conduct in this case constitutes unprofessional conduct pursuant to A.R.S. 321201.18.(n) because there was no clinically acceptable justification for the Respondent’s treatment on M.C., the treatment was based on insufficient and unreliable clinical data, and Respondent ever failed to perform a periodontal evaluation of M.C. during her entire treatment, despite the radiographic indication of periodontal concerns, as charged. Respondent’s treatment of M.C. endangered and damaged her health, safety and welfare.

(P) Respondent breached his duty of continued treatment of M.C. to his refusal to accept her straitened financial situation, and a payment plan more acceptable to that situation. A dentist is not relieved of the duty to complete a patient’s treatment once started either by the patient’s obnoxious personality or penurious finances. A.A.C. R4111102.E.

(Q) Count Five of the States charges against Respondent pertain to Complaint 95312, involving patient D.S. Respondent’s conduct in this case constitutes unprofessional conduct pursuant to A.R.S. 321201.18.(n) * Respondent failed to perform a periodontal evaluation of D.S.despite radiographic and clinical indications of periodontal concerns. The restorative work Respondent performed in D.S.’s mouth was inadequate and required repeated corrections. Respondent’s treatment of D.S. endangered and damaged his health, safety and welfare. (* The Board amended this proposed Conclusion of Law to more accurately reflect the record in this matter.)

(R) Count Six of the States charges against Respondent pertain to Complaint 95135, involving patient L.C. (or P.C. or L.P.C.). Respondent’s conduct in this case constitutes unprofessional conduct pursuant to A.R.S. 321201.18.(n) because there was no clinically acceptable justification for the Respondent’s treatment on L.C., the treatment was based on insufficient and clinically unreliable data, Respondent failed to treat dental problems of which he was aware, and the bridge Respondent placed in L.C.’s mouth was inadequate and resulted in further dental problems for L.C. Respondent’s treatment of L.C. endangered and damaged his health, safety and welfare

(S) Count Seven of the States charges against Respondent pertain to Complaint 96054, involving patient L.B. Respondent’s conduct in this case constitutes unprofessional conduct pursuant to A.R.S. 321201.18.(n) because there was no clinically acceptable justification for the Respondent’s treatment of L.B. and the treatment was based on insufficient and unreliable clinical data. Respondent’s treatment of L.B. endangered and damaged her health, safety and welfare.

(T) The State makes the same charge here that Respondent “exceeded the scope of practice of dentistry” which it also made in Count Two (95083, S.T.) and Count Three (95178, Ms. Rauen). The same conclusion is reached here as was reached in those cases.

(U) Respondent in this case abandoned his treatment of L.B. before it was substantially complete. Conclusions as to the duty of Respondent and all dentists to complete treatment of a patient once undertaken was concluded and discussed supra in the cases of D.T. and M.C. The same conclusion is here reached.

(V) Count Eight of the State’s charges against Respondent pertain to Complaint 96175, involving patient G.P. Respondent’s conduct in this case constitutes unprofessional conduct pursuant to A.R.S. 321201.18.(n) because there was no clinically acceptable justification for Respondent’s treatment of G.P., and the treatment was based on insufficient clinical data.

(W) Respondent also abandoned patient G.P. pursuant to A.A.C.R4111102.E., as the facts proved that he made no reasonable effort to assure she continued her treatment to completion either with him or another dentist. Respondent’s treatment of G.P. endangered and damaged her health, safety and welfare.

(X) Count Nine of the State’s charges against Respondent pertain to Complaint 97341, involving patient N.F. Respondent’s conduct in this case constitutes unprofessional conduct pursuant to A.R.S. 321201.18.(n) because there was no clinically acceptable justification for the Respondent’s treatment of N.F., his treatment was based on insufficient radiographs and insufficient clinical data, and Respondent failed to address N.F.’s paresthesia adequately. Respondent’s treatment of N.F. endangered and damaged her health, safety and welfare.

(Y) Count Ten of the States charges alleges “Respondent failed to maintain adequate treatment records” for each of these nine patients. Respondent’s treatment record maintenance in each of these nine consolidated cases was substandard of care, and thus unprofessional conduct as set forth at A.R.S. 321201.18.(y), which makes unprofessional a dentist’s failure or refusal to “maintain adequate patient records.” See also: A.R.S. 321264.

(Z) Count Eleven of the State’s charges alleges unprofessional conduct by the Respondent pursuant to A.R.S. 321201.18.(t) via A.A.C. R4111102, in that Respondent failed to remain responsible for and complete the scheduled treatment for D.T. (95084), M.C. (96024), L.B.(96054), and G.P. (96175). As already concluded herein, Respondent did breach his duty of continued care imposed by the cited regulation, and thus it is concluded that Respondent’s conduct in these four cases was proscribed by A.R.S. 321201.18.(t) which makes unprofessional a dentist’s violation of any administrative rule adopted under Title 32, Chapter 11 of the A.R.S.

(AA) Count Twelve of the State’s charges alleges unprofessional conduct of the Respondent pursuant to A.R.S. 321201.18.(d) as to all nine of these consolidated cases. That statute makes unprofessional any conduct of a dentist which is “gross malpractice or repeated acts of malpractice.” (Hence, another legal reason to have regarded “standard of care” in these cases to be that definition at A.R.S. 12563.) The record as a whole, and the abovefound findings of fact preponderantly support the conclusion here reached that Respondent violated A.R.S. 321201.18.(d) in all these nine cases.

(AB) Count Thirteen of the States charges alleges unprofessional conduct of the Respondent in L.B.s case (96054) pursuant to A.R.S. 321201.18.(h) because Respondent represented to L.B. that removal of her silver amalgams could improve her multiple sclerosis. That statute makes it unprofessional conduct for a dentist to “[r]epresent[ ] that a manifestly not correctable condition, disease, injury, ailment, or infirmity can be permanently corrected.” The instant record contains a preponderance of evidence to conclude that Respondent did engage in this unprofessional conduct, even though he did not make any “guarantee” to L.B. He did infuse her with significant false hope that his treatment could improve her multiple sclerosis, and that it could do so on a permanent basis. The word “guarantee” is not necessary. The statute uses the phrase “Representing that [multiplesclerosis] can be permanently corrected.” . . . (Emphasis added.) Webster includes three coordinate subsenses of the word “can” which apply to the statute. “Can” means: “know how to, have the skill to; be physically or mentally able to; may perhaps, may possibly.” Webster’s Third New International Dictionary, unabridged, 1993. Therefore, in making his false claims to L.B. relative to what his dental treatment can achieve, Respondent violated A.R.S.321201.18.(h).

(AC) Count Fourteen of the State’s charges against Respondent allege that his use of “PZI, supplements, and/or intravenous medication without any clinically acceptable justification, thereby posing a threat to the health, safety and welfare of his patients.” The within facts are insufficient to support the conclusion here urged by the State. However, they do supply additional evidence of Respondent’s repeated violations of A.R.S. 321201.18.(y) as already concluded hereinabove.

(AD) These conclusions of Respondents unprofessional conduct provide the ground to discipline Respondents License 1555. A.R.S. 321263.1. The gravity, variety and numerosity of the Respondents unprofessional conduct in these nine cases amply support the discipline of license revocation, an action lying within the discretion of the Arizona Board of Dental Examiners. A.R.S.32.1263.01.A.1.

ORDER

Based upon the Findings of Fact and Conclusions of Law as adopted, the Board hereby enters the following Order:

Dr. Terry Lee is hereby CENSURED.

Dr. Terry Lee is hereby placed on PROBATION for a period of five (5) years, with the following terms and condition: (a) CONTINUING EDUCATION Dr. Terry Lee shall obtain education for a total of 48 hours in the following areas: 12 hours crown and Bridge, and 12 hours Occlusion. Courses must be preapproved by the Board’s Chief Investigator and Respondent must file verification of completion. Respondent is required to complete the CONTINUING EDUCATION within TWO (2) years. (b) PEER REVIEW During the term of this Probation, Dr. Terry Lee shall be subject to Peer Review by the Board’s Chief Investigator, who is authorized to conduct quarterly unannounced visits to Dr. Terry Lee’s office. The Investigator shall review Dr. Lee’s diagnostic, treatment and planning skills, as well as recordkeeping. The Investigator shall submit written reports to the Board regarding Dr. Lee’s Diagnosis and Treatment Planning, and Recordkeeping after each quarterly inspection.

REHEARING Please be advised that according to A.R.S. Section 321263.02(E) and 411092.09, an aggrieved party to this matter may petition the Board for a review or rehearing of the matter. If the party wishes to do so, a written petition must be filed with this office no later than thirty days after service of this Order. If no petition is filed in the allotted time, this Order shall automatically become final.

ISSUED this 24th day of February, 1999 at Phoenix, Arizona.

THE BOARD OF DENTAL EXAMINERS OF THE STATE OF ARIZONA

By_______________________________

Julie N. Chapko Executive Director

Copies of the foregoing mailed to:

Dr. Terry J. Lee
Certified Mail Receipt No. ________________

BDE Certified Mail
Receipt No. ________________

Charles G. Brown

Date Mailed:__________________

By: ________________________________

This page was revised om February 13, 2005.



Lawsuits against Trump University Settled

Trump University—also known as the Trump Wealth Institute and Trump Entrepreneur Initiative LLC—was an American company that ran a real estate training program from 2005 until 2010. It was owned and operated by The Trump Organization. In 2016, New York Attorney General Eric Schneiderman announced that Donald J. Trump had agreed to settle three lawsuits …

Trump University—also known as the Trump Wealth Institute and Trump Entrepreneur Initiative LLC—was an American company that ran a real estate training program from 2005 until 2010. It was owned and operated by The Trump Organization.

In 2016, New York Attorney General Eric Schneiderman announced that Donald J. Trump had agreed to settle three lawsuits which charged that he and his associates had misrepresented the nature and value of real estate courses offered by Trump University. The settlement includes payment of $21 million to settle two California class-action suits and $4 million to New York State to be used to (a) reimburse former students who were not parties to the class-action suits and (b) if funds remain, to pay up to $1 million for costs and/or penalties for Trump University’s failure to obtain a license from the New York’s Education Department. Trump admitted no liability, but Schneiderman’s press release minced no words:

In 2013, my office sued Donald Trump for swindling thousands of innocent Americans out of ​millions of dollars through a scheme known as Trump University. Donald Trump fought us every step of the way, filing baseless charges and fruitless appeals and refusing to settle for even modest amounts of compensation for the victims of his phony university. Today, that all changes. Today’s $25 million settlement agreement is a stunning reversal by Donald Trump and a major victory for the over 6,000 victims of his fraudulent university.

The third amended complaint in the California case brought by Sonny Low included these allegations against Trump University:

  • In 2010, Trump University changed its name to Trump Entrepreneur Initiative after the New York Department of Education insisted that the use of the word “university” was misleading and violated New York’s Education Law and the Rules of the Board of Regents. However, because the corporation was named Trump University when this lawsuit was filed, it is referred to as Trump University throughout the pleadings.
  • Trump University’s purported mission was to “train, educate and mentor entrepreneurs on achieving financial independence through real estate investing.” However, rather than operating like a university or college, it functioned like an infomercial, selling non-accredited products, such as sales workshops, luring customers in with the name and reputation of its founder and chairman, Donald Trump.
  • Trump and his “University” promised “mentorships” said to be the “next best thing” to being Donald Trump’s next “Apprentice.” However, these promises were empty. The primary lesson Trump University taught its students was how to spend more money by buying more Trump Seminars.
  • Contrary to defendants’ representations, many of the seminar instructors and mentors were not experienced in real estate—in fact, many had little to no personal real estate experience, and most had not engaged in the vast majority of the real-estate techniques they taught. Most were professional salespeople, hired for their ability to deliver a hard-sell sales presentation and paid exclusively on commission based on the percent of sales they delivered.
  • Representations made to consumers about the Trump Seminars were standardized. When consumers made calls to or received calls from Trump University, they spoke with a member of the Trump sales team. Each member of the sales team was given a five to six page sales script, and was required to stick to the script word-for-word.
  • The in-person seminars were also highly standardized. Speakers used the same slide presentation, the same script, and even had detailed  instructions for the presentation that even specified where the speakers and coordinators should stand, the temperature of the room, and the music to be played during the introduction (“Money, Money, Money” from the Apprentice show).
  • Insiders at Trump University have confirmed that the whole purpose of the free seminar was to get people to sign up for the $1,500 seminar, the purpose of the $1,500 seminar was to get people to sign up for the $35,000 seminar, and the entire purpose of that seminar was to get people to sign up for additional seminars, products, and books. Instructors were taught to be “armed with objections and rebuttals” and to “work the room with special attention to team members in possession of a credit card that needs to be run.”
  • In attempting to publicly defend its reputation, Trump University had the audacity to compare itself to Harvard University—claiming that it did not guarantee real estate success, just as Harvard cannot guarantee a Rhodes scholarship. Comparing Trump University to Harvard University is a bit like comparing a snake oil salesman to a brain surgeon. First, Harvard is clearly an accredited institution while Trump is not; Harvard professors are educated in their field, while Trump instructors and mentors were trained in sales, not real estate; and when Harvard students pay for a four-year education, they receive four years of teaching, whereas Trump students who paid for a one-year real estate education received three days of a hard-sell sales presentation.
  • Although prospective students were told that Donald Trump was intimately involved in developing the program and selecting the instructors, this was not true.
  • Defendants enhanced, misrepresented and in certain instances, completely fabricated student testimonials.

The class action plaintiffs were represented by the law firm of Robbins Geller. Although the firm was entitled to collect millions of dollars for its work, it waived attorneys fees to ensure the maximum possible recovery for the former students. After the agreement was signed, one former student objected and filed an appeal that delayed execution of the settlement until 2018, when the appeal was denied.

Additional Information
Relevant Documents
New York State against Donald J. Trump et al.
Art Cohen vs. Donald J. Trump
Sonny Low (formerly Tarla Makaeff) vs. Trump University at al.


Pamphlets from Sherman College of Chiropractic (1976)

In 1976, Sherman College of Straight Chiropractic published 15 pamphlets that promoted subluxation-based chiropractic: Chiropractors Do Not Treat Disease Why Chiropractic Is Different There’s Nothing Wrong with Me, I Feel Fine! Chiropractic Questions and Answers Your Children Deserve Chiropractic Care Cooperation. . . Because You Care, It Works The Spine, Your Life Depends on It …

In 1976, Sherman College of Straight Chiropractic published 15 pamphlets that promoted subluxation-based chiropractic:

  • Chiropractors Do Not Treat Disease
  • Why Chiropractic Is Different
  • There’s Nothing Wrong with Me, I Feel Fine!
  • Chiropractic Questions and Answers
  • Your Children Deserve Chiropractic Care
  • Cooperation. . . Because You Care, It Works
  • The Spine, Your Life Depends on It
  • Healing Takes Time
  • The Intelligence within You
  • Chiropractic Today for a Better World Tomorrow
  • Treatment, Cures and Chiropractic
  • Health Assurance
  • Drug Abuse
  • Family Chiropractic Care
  • Your Body’s Warning System

To read the full text of 13 of these pamphlets, click here. The basic ideas that run through them include:

  • Health exists when every part of your body is functioning properly. That can occur only when 100% of vital nerve energy is flowing.
  • Chiropractors maintain the nervous system free of interference, allowing the body to function properly and be healthy.
  • Interference with the nervous system frequently occurs in the spine where a vertebra is jolted out of position and causes pressure on nerves (a subluxation).
  • The task of the chiropractor is to locate (analyze) such subluxated spinal bones and to correct (adjust) their position to eliminate these impingements on the nerves.
  • The bones of the spine can be guided back into their proper positions with the help of a skilled practitioner . . . With the aid of a skillfully-delivered force, your body can return the out-of-place vertebra to its proper position. Pressure on the nerve is relieved, the nerve is once more able to transmit its messages, the organ or cell once more receives proper instructions, and the entire body is restored to a state of full health.
  • The chiropractor is the only person of the healing professions who is able to systematically locate and reduce pressure on spinal nerves. He or she is,
  • Most medical procedures are aimed at relieving or covering up symptoms.

These ideas are not compatible the body of knowledge related to health, disease, and health care that has been widely accepted by the scientific community.



Chiropractic Pamphlets from the National Chiropractic Association

The National Chiropractic Association, which was formed in 1930 merged with a smaller group in 1963 to become the American Chiropractic Association. The pamphlets shown are undated but appear to have been published during in the 1950s: Chiropractic Care for Spinal Disc Injuries “Tractor Back” and Other Farm Injuries Chiropractic Care of Children Correct Posture …

The National Chiropractic Association, which was formed in 1930 merged with a smaller group in 1963 to become the American Chiropractic Association. The pamphlets shown are undated but appear to have been published during in the 1950s:

  • Chiropractic Care for Spinal Disc Injuries
  • “Tractor Back” and Other Farm Injuries
  • Chiropractic Care of Children
  • Correct Posture Will Pay Health Dividends.

Chiropractic Care of Children asserts  that “chiropractors have records of thousands of cases of subluxations . . . occurring in very early infancy,” that “your child should be given the advantage of periodic examinations and corrective treatment,” and that “maintaining the mechanical integrity of the body . . . . assures vibrant health.”

The posture pamphlet suggests that more than 70% of school children have “spinal defects or postural distortions to some degree,” that these can lower the body’s resistance to disease, and that “a spinal examinations may show a condition, which, if not corrected will lead to heart impairment a year, or even ten years from now.”

Click here to read the full text of these pamphlets.



Ty Bollinger Unmasked

Ty Bollinger, who operates TheTruthAboutCancer Web and Facebook page, advises people not to wear face masks to protect against COVID-19. This article explains why I believe he should be ignored. The main way that COVID-19 infections spread from one person to another is  through saliva droplets or aerosols expelled when an infected person breathes, talks, …

Ty Bollinger, who operates TheTruthAboutCancer Web and Facebook page, advises people not to wear face masks to protect against COVID-19. This article explains why I believe he should be ignored.

The main way that COVID-19 infections spread from one person to another is  through saliva droplets or aerosols expelled when an infected person breathes, talks, sings, coughs, or sneezes. Saliva droplets are heavier than air and will settle on the ground or nearby surfaces. Aerosols form when smaller droplets evaporate faster than they fall to the ground, leaving virus particles to float through the air. COVID-19 transmission can occur if viral particles land in the mouth or nose of nearby people or are inhaled into their lungs. Spread is more likely when people are close to each other (within about 6 feet). Masks can reduce the spread [1]. Having more than one mask is a good idea so you can have a clean one available each time you go out [2].

The virus can also be transmitted by touching the nose or mouth after contact with a contaminated surface. That’s why washing your hands is recommended.

How Masks Work (Real Facts)

Protection by masks depends on the type of mask and how it is worn. Respirator masks must meet U.S. National Institute for Occupational Safety and Health N95 classification of air filtration by catching at least 95% of airborne particles. When tightly fitted so that inhaled and exhaled air go through them, rather than around them, N95 masks provide considerable protection to both the wearer and others in the vicinity. Surgical masks, dust masks, and home-made masks provide much less filtering of inhaled air but can prevent wearers from touching their face with hands that may be contaminated. As observed in a recent experiment [3], they can also prevent or reduce transmission:

This picture, from the journal Science, sums up what cloth masks can do:

In March, when the incidence of COVID-19 was rapidly rising, public health officials urged people not to try to buy N95 masks because front-line health-care workers needed them more. In April, however, when it became clear that COVID-19 could be spread by infected people without symptoms [4], the U,.S. Centers for Disease Control and Prevention (CDC) updated its recommendation this way:

We now know from recent studies that a significant portion of individuals with coronavirus lack symptoms (“asymptomatic”) and that even those who eventually develop symptoms (“pre-symptomatic”) can transmit the virus to others before showing symptoms. This means that the virus can spread between people interacting in close proximity—for example, speaking, coughing, or sneezing—even if those people are not exhibiting symptoms.  In light of this new evidence, CDC recommends wearing cloth face coverings in public settings where other social distancing measures are difficult to maintain (e.g., grocery stores and pharmacies) especially in areas of significant community-based transmission [5].

A subsequent study found that masks made from combinations of commonly available fabrics, if properly fitted, could provide considerable protection against the transmission of aerosol particles [6]. Epidemiological data also show that places that implemented universal masking policies did better than those that did not [7].

Bollinger’s “Facts”

The key question about any public health measure is whether it  is likely to do more good than harm. Bollinger would like you to believe that wearing a cloth face mask is more likely to cause harm.

On May 29, 2020, Bollinger’s Truth about Cancer Web site published what he called “12 FACTS that we KNOW” about masks and said that wearing a mask to protect against coronavirus infection is like “installing a screen door in a submarine.” He also said that “forcing healthy people to wear masks is “at best misguided and at worst criminal, given the known data.” [8]

Each of his alleged “FACTS” is followed by one or more links to reports or videoclips that supposedly back them up. Checking, however, I found that none of the linked materials actually validated what he said. In fact, most of the references he cites have have nothing whatsoever to do with the use of cloth face masks.

On March 8, 2020, Anthony Fauci, M.D., Director of the National Institute of Allergy and Infectious Disease, said this during an interview with CBS’s “60 Minutes”:

The masks are important for someone who is infected to prevent them from infecting someone else. . . . Right now, in the United States, people should not be walking around with masks. . . . When you’re in the middle of an outbreak, wearing a mask might make people feel a little bit better and it might even block a droplet, but it’s not providing the perfect protection that people think that it is. Often there are unintended consequences—people keep fiddling with the mask and touching their face. . . .  When you think of masks, you should think of healthcare providers needing them and people who are ill. . . . When you look at the films of foreign countries and see 85% of the people wearing them—that’s fine. I’m not against it. [But} it could lead to a shortage of masks for the people who really need it.

This was not an anti-mask message.  It was about reserving N95 masks for health-care workers. But Bollinger’s “Fact 9” eliminated the highlighted portions and titled the video clip “Dr. Fauci now says no masks . . .” 

Dr. Fauci at Coronavirus Task Force presentation on May 15, 2020

Bollinger’s “Fact 10” links to a similar message in early March from U.S. Surgeon General Jerome Adams, M.D, about the need to reserve N95 masks for health-care workers. Since early April, Drs. Fauci and Abrams have been recommending that cloth masks be used when leaving home for essential errands. (The picture to the right shows Dr. Fauci wearing a mask at a White House  Coronavirus Task Force presentation on May 15 Presenting these outdated video clips out of context is dishonest [9]. I am pleased to report that on May 9th, after learning about the misrepresentation, CBS blocked further viewing.

Bollenger in Further Context

Bollinger’s Web sites describe him this way:

Ty Bollinger is a happily married husband, the father of four wonderful children, devoted Christian, best-selling author, medical researcher, talk radio host, health freedom advocate, former competitive bodybuilder and also a certified public accountant. After losing several family members to cancer (including his mother and father), Ty refused to accept the notion that chemotherapy, radiation, and surgery were the most effective treatments available for cancer patients. He began a quest to learn all he possibly could about alternative cancer treatments and the medical industry. Ty has now made it his life mission to share the most remarkable discovery he made on his quest: the vast majority of all diseases (including cancer) can be easily prevented and even cured without drugs or surgery. Ty speaks frequently to health groups, at seminars, expos, conferences, churches, and is a regular guest on multiple radio shows and writes for numerous magazines and websites. Speaking from personal experience and extensive research, Ty has touched the hearts and changed the lives of thousands of people around the world [10].

Put another way, even though he has no relevant educational background, Bollinger would like you to believe that talking with offbeat practitioners and their patients, has made him smarter than all of the world’s medical and scientific experts put together. Just buy his reports—and buy into his conspiracy theories—and you can be just as smart.

Real experts, of course, give him low marks for credibility. Drs. Harriet Hall, William M. London and David Gorski have dissected and debunked dozens of his cancer-related claims [11-13]. NewsGuard, which rates news and information Web sites, has concluded that The Truth about Cancer site and Facebook pages repeatedly promote “unproven and potentially dangerous cancer treatments” and “egregiously false content about COVID-19.” [14]

Bollinger concerns me because his advice about masks can kill people and a lot of people seem to pay attention to him. In March 2020, the Facebook page was reported to have more than 1.1 million followers. In addition to criticizing masks, he is spreading false information to discourage use of a COVID-19 vaccine when one is developed.

The Bottom Line

Cloth masks should be worn to protect people around you if you are infected but do not have symptoms. They will reduce the spread of COVID-19 virus and make communities safer. Wearing one is a sign of strength, good judgement, and good citizenship.

References
  1. Huang S. COVID-19: Why we should all wear face masks—there is new scientific rationale. Medium.com Web site, March 26, 2020.
  2. Maragakis LL. Coronavirus: How to care for your face mask. Johns Hopkins Medicine Web site,  May 1, 2020.
  3. Anfinrud P and others. Visualizing speech-generated oral fluid droplets with laser light screening. New England Journal of Medicine 382:2061-2013, 2020.
  4. He X and others. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nature Medicine 26:672-675, 2020.
  5. Recommendations regarding the use of cloth face coverings, Especially in areas of significant community-based transmission. CDC announcement, April 3, 2020.
  6. Konda A and others. Aerosol filtration efficiency of common fabrics used in respiratory cloth mask. ACS Nano 14:6339-6347, 2020.
  7. Prather KA and others. Reducing transmission of SARS-CoV-2. Science, May 27, 2020.
  8. Bollinger T. “To Mask or NOT to mask?” . . . THAT is the question! The Truth about Cancer Web site, May 29, 2020.
  9. Spencer SH. Outdated Fauci video on face masks shared out of context. FactCheck.org, May 9, 2020.
  10. About Ty Bollinger. The Truth About Cancer home page, accessed June 2, 2020.
  11. Hall H. “The Truth About Cancer” series is untruthful about cancer.” Science-Based Medicinem Nov 17, 2015.
  12. London WM. Untruths about cancer in the failed “quest for cures.” Six-part series, James Randi Educational Foundation, Nov/Dec 2014.
  13. Gorski D. How can we combat misinformation from “chemo truthers”? Science-Based Medicine, January 27, 2020.
  14. thetruthaboutcancer.com. NewsGuard. March 11, 2020. (Viewing this requires installing a free NewsGuard browser extenstion.)


Chiropractic Promotional Materials from the National Health Education Society

The National Health Education Society (N.C.E.S) marketed subluxation-based chiropractic promotional materials for more than 60 years. Government records indicate that it was registered as a business corporation in Louisiana in 1959 and in Georgia as a foreign business corporation from 1971 through 2018, when it was dissolved. It was founded in 1954 by Earl W. …

The National Health Education Society (N.C.E.S) marketed subluxation-based chiropractic promotional materials for more than 60 years. Government records indicate that it was registered as a business corporation in Louisiana in 1959 and in Georgia as a foreign business corporation from 1971 through 2018, when it was dissolved. It was founded in 1954 by Earl W. Powell, Ph.D. and was operated in its later years by Powell’s wife Elizabeth and then by Hal Crowe, Sr., D.C., who also practiced in Brunswick, Georgia. Its publications, which I acquired in the 1970s and 1980s, included:

  • Voice for Health, which it described as a “chiropractic layman’s magazine” with the largest circulation in the world and used by thousands of chiropractors throughout the world.
  • Voice for Health cassette tapes for waiting room use
  • Nerve charts which claimed that more than 100 “conditions that supposedly “follow a pressure on, or interference with” spinal nerves
  • T-shirts with messages such as “Universal Intelligence – Chiropractic Dept” and “Empowering Extraordinary Health”
  • A booklet called “That You May Know,” a simply-worded overview of subluxation-based chiropractic
  • Pamphlets that advocated periodic spinal checkups and adjustments:
    • Industrial Injuries (1952)
    • Whiplash Neck Injury (1962)
    • Spinal Exercise (1962)
    • You Can Help Yourself to Better Health
    • Best Foot Forward: What Chiropractic Can Do for Your Child
    • Your Life Is Priceless
    • Your Living Health (a series of philosophical pamphlets)
    • Health Is Wealth

All asserted that chiropractors adjust areas of spinal misalignment to restore nerve flow. Health Is Wealth explained subluxation theory this way:

The cause of the disease is in the person afflicted. Adjustments correct conditions that produce it. The function of every organ in the body is controlled by the brain, through impulses, which are transmitted over nerves. Any impingement, or pinching of the delicate nerve fibers, interfering with the free flow of nature’s life-giving force, results in impaired or abnormal function. This is disease.

This interference is produced by vertebrae which are out of their normal position, pressing upon nerves at the point where they pass out from the spinal cord to vitalize various organs of the body. The trained chiropractor—expert in his knowledge of the spine—locates the exact point of interference, and by adjusting the subluxated (misaligned) vertebra, removes the cause. Normal condition—health—is the result.



Answers to Questions about Chiropractic

Dr. Homola is a second-generation chiropractor who has dedicated himself to defining the proper limits on chiropractic and to educating consumers and professionals about the field. His 1963 book Bonesetting, Chiropractic, and Cultism supported the appropriate use of spinal manipulation but renounced chiropractic dogma. His 1999 book Inside Chiropractic: A Patient’s Guide provides an incisive …

Dr. Homola is a second-generation chiropractor who has dedicated himself to defining the proper limits on chiropractic and to educating consumers and professionals about the field. His 1963 book Bonesetting, Chiropractic, and Cultism supported the appropriate use of spinal manipulation but renounced chiropractic dogma. His 1999 book Inside Chiropractic: A Patient’s Guide provides an incisive look at chiropractic’s history, benefits, and shortcomings. Now retired after 43 years of practice, he lives in Panama City, Florida.

General Questions
Neck Manipulation
Scope of Chiropractic
Need for Treatment
X-Rays
Pregnancy and Childbirth
Chiropractic and Children
Chiropractic Techniques
Chiropractic Devices
Complications of Treatment
Chiropractic Education
Consumer Protection
Interprofessional Relations

This page was revised on March 20, 2018.



Report of the Chiropractic Study Committee to the Governor’s Health Planning and Policy Task Force (Wisconsin, 1972)

In 1972, when the Wisconsin legislature was considering whether to modify how chiropractors were regulated in Wisconsin, a 3-person committee was appointed to investigate and make recommendations. The trio reviewed pertinent literature; met with representatives of chiropractic and medical organizations; visited Palmer College of Chiropractic in Davenport, Iowa; and conducted surveys of chiropractors, osteopaths, and …

In 1972, when the Wisconsin legislature was considering whether to modify how chiropractors were regulated in Wisconsin, a 3-person committee was appointed to investigate and make recommendations. The trio reviewed pertinent literature; met with representatives of chiropractic and medical organizations; visited Palmer College of Chiropractic in Davenport, Iowa; and conducted surveys of chiropractors, osteopaths, and medical doctors.

The Palmer College visit was especially revealing. The report noted:

  • The faculty-student ratio was too low for effective teaching.
  • Teaching in the basic sciences was done by persons who themselves lacked adequate training. Among 27 listed as full faculty members, none had Ph.D. degrees and only two had masters degrees.
  • Library facilities were inadequate. There were no journals of the basic sciences. The only bound periodicals were Scientific American and Newsweek. Circulation records indicated that withdrawals for student use were “almost nonexistent.”
  • Lecture presentations appeared to be “programmed . . . with an emphasis on rote learning,”  There was no evidence that students were required or encouraged to do independent research, and the school had no research projects underway.
  • The student body apparently did not find the curriculum demanding. Many held full-time jobs.
  •  High school graduation was sufficient for admission. No college work was required.
  • Overall, the educational deficiencies were “too pervasive to permit an adequate educational experience.”

The Study Committee was composed of Gilda B. Shellow (Chairman), a Milwaukee attorney; William L. Blockstein, Ph.D., of Madison, professor of pharmacy at the University of Wisconsin; and Robert B. Durkin of Milwaukee, vice-president of the Milwaukee County Labor Council, AFL-CIO, and a board member of the Wisconsin State Labor Council, AFL-CIO. Their report concluded:

It is the responsibility of concerned and informed leaders in both government and science to protect less sophisticated citizens against ineffective or dangerous health practices. At the point in history when the right of all members of society to quality medical care has finally been recognized, when medicine is beginning to scrutinize itself tor optimum quality of care through both peer and lay review, it is anachronistic to permit an academically unrecognized, scientifically unproven and medically uncontrolled method of health care to infringe on that right and impair that optimum quality of care.

The report recommended that Governor’s Task Force (a) oppose any legislation that would require coverage of chiropractic in insurance programs and (b) urge Wisconsin’s government to “implement programs to educate citizens regarding the nature of chiropractic theory, its lack of scientific validity, and the potential hazards connected with its use.”

Click here to read the full report.



Chiropractic Pamphlets from JoCo Publications (1972-1974)

The pamphlets listed below were published by JoCo Publications. I have not been able to find any information about the company’s history. Why Chiropractic First (1974)( Drugs Offer Only Temporary Relief (1972) Children Are Subjected to Tremendous Shocks (1972) The pamphlets argue that chiropractic care is superior to medical care because chiropractors can detect diseases …

The pamphlets listed below were published by JoCo Publications. I have not been able to find any information about the company’s history.

  • Why Chiropractic First (1974)(
  • Drugs Offer Only Temporary Relief (1972)
  • Children Are Subjected to Tremendous Shocks (1972)

The pamphlets argue that chiropractic care is superior to medical care because chiropractors can detect diseases before symptoms develop and can treat virtually anything. Their claims are among the most preposterous I have seen.

Why Chiropractic First asserts that cancer, arthritis, diabetes and many other diseases all “have their roots and a beginning in the mal-functioning of the nervous system of the body.” It also claims: “When there is no disturbance or pressure present in the nervous system and the body is functioning up to its capacity, then and then only can you be sure that the body is able to resist disease and will be symptom free.”

To read the pamphlets, click here



Chiropractic Pamphlets from Wilbro Publications (1952-1962)

The pamphlets listed below were produced by William R. Brown, D.C., doing business as Wilbro Publications in Muncie, Indiana. To see them, click here. Industrial Injuries (1952) Whiplash Neck Injury (1962) Spinal Exercise (1962) All asserted that chiropractors adjust areas of spinal misalignment to restore nerve flow. Industrial Injuries contains a drawing that relates more …

The pamphlets listed below were produced by William R. Brown, D.C., doing business as Wilbro Publications in Muncie, Indiana. To see them, click here.

  • Industrial Injuries (1952)
  • Whiplash Neck Injury (1962)
  • Spinal Exercise (1962)

All asserted that chiropractors adjust areas of spinal misalignment to restore nerve flow. Industrial Injuries contains a drawing that relates more than 25 health problems to locations on the spine where “slipped vertebrae . . .  create nerve pressure”



Chiropractors Sparring over Immune-Boosting Claims

Many chiropractors claim that spinal misalignments—which they refer to as “subluxations”—can lower resistance to disease and that periodic spinal manipulation (which they call “adjustments”) can improve immunity by correcting the subluxations. In 1949, chiropractic’s developer, B.J. Palmer, wrote about this in a discussion of smallpox vaccination: Physicians admit some people are immune; others are fertile …

Many chiropractors claim that spinal misalignments—which they refer to as “subluxations”—can lower resistance to disease and that periodic spinal manipulation (which they call “adjustments”) can improve immunity by correcting the subluxations. In 1949, chiropractic’s developer, B.J. Palmer, wrote about this in a discussion of smallpox vaccination:

Physicians admit some people are immune; others are fertile culture grounds. Some resist better than others. Those who resist are stronger and more able to “throw off germs,” etc. And where does this resistance come from? . . . . An individual with a subluxation will resist less; and one without will resist more [1].

The percentage of chiropractors who still think this way is unknown but appears to be slowly decreasing. The colleges that aim to be science-based have abandoned it. The U.S.-based International Chiropractors Association (ICA), with 1,369 U.S. and 350 foreign members listed in its online directory, appears to be the largest group that espouses Palmer’s teachings. The World Federation of Chiropractic, which represents chiropractic organizations in about 89 countries, does not. On March 19, 2020, it stated:

No credible, scientific evidence that spinal adjustment/manipulation has any clinically relevant effect on the immune system was found. Available studies have small sample sizes and a lack of symptomatic subjects. At the time of writing, there exists no credible, scientific evidence that would permit claims of effectiveness for conferring or enhancing immunity through spinal adjustment/manipulation to be made in communications by chiropractors [2].

On March 20, the ICA issued a report that stated:

The ICA has previously provided clear reminders to its members of the importance of not advertising in any form the suggestion that chiropractic can cure, treat, prevent, or mitigate COVID-19 because the evidence to substantiate such a claim does not exist. The evidence does not exist because the research on COVID-19 and chiropractic has not been conducted [3],

However, it added—in boldface type—that “Chiropractic supports the whole person” followed by a quote from B.J. Palmer that “While other professions are concerned with changing the environment to suit the weakened body, chiropractic is concerned with strengthening the body to suit the environment.” This was followed by seven pages that (a) discussed studies of “immune function and chiropractic,” (b) claimed that chiropractors got “fantastic results from patients” in the 1918 influenza epidemic, and (c) concluded:

As an essential health care provider, the chiropractor is in a unique position to assist their patients during this time of heightened stress. Although there are no clinical trials to substantiate a direct causal relationship between the chiropractic adjustment and increased protection from the COVID-19 virus, there is a growing body of evidence that there is a relationship between the nervous system and the immune system. As a service to chiropractors around the world, and their patients, the ICA has committed to developing and maintaining this library of relevant scientific evidence.

The International Chiropractors Association calls upon all our colleagues within the profession to join with us in seeking greater research resources for our academic institutions. An increase in funding allotted through the current emergency pandemic appropriation and in future years will lead to the necessary clinical research required to validate the role of doctors of chiropractic in promoting health and vitality by stimulating a healthy immune response. 

One week later, the ICA posted a revised report that added a few more references [4].

Simply put, these reports are ingenious pieces of double-talk that say: “We know that chiropractic can help people with serious viral diseases, but we are not claiming this (wink-wink) because the clinical trials needed to prove this have not yet been done.” This message is misleading because clinical trials are unlikely to take place without a logical reason (such as preliminary evidence a plausible rational) to do them. The idea that chiropractors are in a “unique position” to help patients deal with the COVID-19 epidemic is also baloney.

In May, more than 150 chiropractic researchers from eleven countries criticized the ICA for suggesting that chiropractic care (primarily spinal manipulation), can have a meaningful impact on immune function. The researchers also called on regulatory authorities and professional leaders to take appropriate political and regulatory action against “direct or indirect unsubstantiated claims that spinal adjustments can boost immunity, or benefit patients with infectious diseases, especially coronavirus infections.” [5]

These sentiments were echoed by an international team of chiropractic students who wrote:

If disciplinary actions are not taken by regulatory bodies, public perception will continue to be that all chiropractors agree with the false claims made by a small, yet vocal minority. This inaction will result in the continual spread of these unfounded beliefs. We are concerned for the profession that we will be entering, as the profession’s reputation will be tarnished if swift action is not taken against these chiropractors. While we appreciate and support the regulatory bodies who have begun to take action against these dangerous claims, we call for further action and decisiveness. . . . We feel it is time for the profession to act before it is too late; . . . reporting such behaviour in order to protect the public interest and assist with regulatory enforcement [6].

Questionable Web Site Claims

In May 2020, I searched with Google for chiropractic Web sites that contained the words COVID-19, coronavirus, adjustment, adjusted, immune, immunity, and/or subluxation. I found 126 clinics that offered services from a total of 263 chiropractors, of which 16 were ICA members. The claims included:

  • “Your immune system is your #1 defense against all bacterial and viral infections. . . . Regular chiropractic adjustments have been proven to boost your immune system”
  • “Measures to Minimize COVID-19 infection: 1. Receive regular frequent chiropractic adjustments to enhance your entire body performance including your immune system.”
  • Studies have shown getting adjusted improves your immune system by 200-400% each time you come in!
  • “One of the main causes of immune system problems comes from subluxations (compression of nerve pathways). Chiropractors may use a variety of spinal manipulation to help relieve this compression and in turn may boost your immune system!”
  • Now more than ever, you should be getting ADJUSTED. In times of immune system suppression, a patient should have their nervous system examined for subluxation several times per week to ensure they are free of interference.
  • “Evidence shows that people who receive regular adjustments report stronger immunity after beginning Chiropractic care.”
  • “The best weapons for the coronavirus and the flu begins with building a string immune system. . . . Evidence shows that people who receive regular adjustments report stronger immunity after beginning Chiropractic care.”
  • “Proactively boosting your immune system through chiropractic can help keep you healthy and strong during this time.”
  • “GET ADJUSTED! It is now more important than ever to stay on track with your weekly chiropractic adjustments. PREVENTION of sickness and dis-ease is key! In fact, we have several practice members receiving extra adjustments this month, to boost their immune system. We are eager to keep you well-adjusted through this time. With specific, neurologically-based chiropractic care, should you contract any illness, your healing and recovery times will experience a boost.”
  • The fact is, by boosting and strengthening your immune system right now, you can almost STOP any virus from entering your body (not just COVI D-19).”

To see the other pages I found, click here.

The Joint Chiropractic, a franchising company with 575 chiropractic clinics nationwide, uses a more subtle pitch. The last suggestion on its page titled “4 Easy & Helpful Ways to Fight Coronavirus” states:
See the Chiropractor

Chiropractic care focuses on the function of the central nervous system, which just so happens to regulate every single function in your body. Regular chiropractic adjustments focus on the removal of spinal joint dysfunctions that can impact how your central nervous system communicates with the rest of your body. When your body is able to communicate freely and efficiently, then every system can work optimally to help you stay healthy. You cannot control the Coronavirus (or the flu or common cold either!) but what you can control are the things you do to support your own health. There’s no new way to outsmart a virus, all you can do is go back to the basics to help you stay healthy.

Though mild compared to most others I have found, this passage is still misleading. The nervous system does not control every single function in the body. Regular chiropractic adjustments do not promote general health. And chiropractors cannot enable the  body to “communicate efficiently and freely.” Overall, the passage falsely suggests that something uniquely chiropractic can make you less vulnerable to COVID-19.

Government Enforcement Actions

Enforcement agencies worldwide are giving high priority to COVID-19-related schemes and scams. The actions against taken so far against chiropractors or their clinics include the following:

  • The College of Chiropractors of British Columbia, the regulatory body of British Columbia chiropractors, has issued a public notice that it is inappropriate for chiropractors to promote treatment or supplements as a means to boost the immune system and imply that this will prevent infection from the novel coronavirus.
  • The  College of Chiropractors of Ontario has sent 74 cease-and-desist orders to chiropractors who had advertised such claims.
  • The Oregon Department of Justice has secured a consent agreement that prohibited Sandra Johnson, D.C., of Bend Oregon from making promotional claims about products that refer to coronavirus or COVID-19.
  • The U.S. Attorney’s Office for the District of Texas has obtained a temporary restraining order to stop Ray L. Nannis, D.C., d/b/a Optimal Wellness Solutions from advertising that his sublingual homeopathic products can prevent and treat COVID-19 infections.
  • The U.S. Federal Trade Commission (FTC) has ordered Mathew Martinez, D.C., who operates the Absolute Health Clinic in Bristol, Washington, to stop advertising that stem cell therapy, intravenous vitamins C and D, and various other “immune-boosting” supplements can treat or protect against COVID-19 infections.
  • The FTC has ordered Epigenetics Healing Center (operated by Jay Goodfinder, D.C.) to stop claiming that intravenous treatments of vitamin C, vitamin D and glutathione and supplements of garlic, pycnogenol, and vitamin B12 are effective against COVID-19.
  • The FTC has ordered Tulsa Chiropractic Rehab to stop claiming that high-dosage vitamin C and various other supplements could protect them against COVID-19.
  • The FTC has ordered Fuller Life Chiropractic (operated by Ronald Dean Fuller, D.C,) to stop claiming on its Web site that “correcting subluxations through specific scientific chiropractic adjustments help to ensure that your nerve system, and, therefore, your immune system are functioning as close to their maximum innate potential as possible” and “increases your defenses against outside pathogens and increases your potential to stay healthy.”
  • The FTC has ordered Eric Nepute, D.C. to stop claiming that intravenous vitamin C  protect against COVID-19 by “supercharging” your immune system and that spinal adjustments “makes your immune system work better.”

The FTC actions are noteworthy because the agency usually takes 1-2 years to process complaints, but the above cases—as well as more than 100 others that did not involve chiropractors—were launched in less than a month. The Fuller and Nepute cases are additionally significant because they attack the core chiropractic immune-boosting claim discussed in this article. It will be interesting to see whether the FTC acts against the clinics that I found.

If you see any Web site which claims that chiropractic
methods—directly or indirectly—can prevent or
treat COVID-19, please send me an e-mail.

References
  1. Palmer BJ. The Bigness of the Fellow Within. Chiropractic Fountainhead, Davenport, IA, 1949, p 607.
  2. The effect of spinal adjustment/manipulation on immunity and the immune system: A rapid review of relevant literature. World Federation of Chiropractic, March 19, 2020.
  3. International Chiropractors Association. Immune function and chiropractic: What does the evidence provide? International Chiropractors Association, March 20, 2020.
  4. International Chiropractors Association. Immune function and chiropractic: What does the evidence provide?—Revised. International Chiropractors Association, March 28, 2020.
  5. Côté P and others. A united statement of the global chiropractic research community against the pseudoscientific claim that chiropractic care boosts immunity. Chiropractic & Manual Therapies 28:21, 2020.
  6. Plener J and others. Chiropractic students call for action against unsubstantiated claims. Chiropractic & Manual Therapies 28:26, 2020.


Facebook Should Do More to Combat Vaccine Misinformation

In 2019, about two months after receiving a prod from Congressman Adam Schiff (D-CA), Facebook announced that it would tackle vaccine misinformation by reducing its distribution and steering Facebook users to authoritative information. Its strategies included (a) reducing its search and newsfeed ranking of pages that spread vaccine misinformation, (b) rejecting ads that include vaccine …

In 2019, about two months after receiving a prod from Congressman Adam Schiff (D-CA), Facebook announced that it would tackle vaccine misinformation by reducing its distribution and steering Facebook users to authoritative information. Its strategies included (a) reducing its search and newsfeed ranking of pages that spread vaccine misinformation, (b) rejecting ads that include vaccine misinformation, (c) minimizing the spread of anti-vaccine content through Instagram (which Facebook owns), and (d) removing access to fundraising tools for pages that spread misinformation. The company is also exploring ways to share trustworthy information about vaccines when people come across misinformation on this topic [1]. Currently, cell-phone users looking for information about vaccination—even if they search for “vaccination risks”—get the message shown to the right which encourages them to visit the World Health Organization Web site.

Congressman Posey’s Responses

Congressman Bill Posey (R-FL), who is a member of the House Liberty Caucus, does not like what Facebook is doing. In March 2018, he expressed concern to Facebook CEO Mark Zuckerberg that “limiting the feee speech of Americans who present safety concerns about vaccinations” would be a form of “bullying.” Posey’s letter was headlined: “IF VACCINES DO NOT CAUSE INJURIES, WHY HAS THE VACCINE INJURY TRUST FUND PAID OUT $4,061,322,557.08 FOR VACCINE INJURIES?” [2] In October 2019, during Zuckerberg’s testimony at a hearing on an unrelated matter, Posey said:  “Over four billion has been paid out by the fund. For thousands of people. Shouldn’t people have information to make an informed choice?” [3,4]

The National Vaccine Injury Compensation Program (VICP) is a no-fault program enacted in 1986 to deal with an epidemic of lawsuits that threatened the continued availability of childhood vaccines. The U.S. Health Resources and Services Administration (HRSA) has reported that from 2006 to 2017, (a) over 3.4 billion doses of vaccines covered by the VICP were distributed in the United States, (b) 6,314 petitions were adjudicated by the Vaccine Court, and (c) of those, 4,328 were compensated. This means for every 1 million doses of vaccine that were distributed, approximately 1 individual was compensated. However, the HRSA also noted that about 70% of the total compensation awarded by the VICP came as result of a negotiated settlement between the parties in which HHS had not concluded, based upon review of the evidence, that vaccines caused the alleged injuries [5]. Those numbers are powerful evidence of safety.

Posey claims to support vaccination of young children. But the Orlando Sentinel has documented a steady flow of anti-vaccine sentiments and statements that include the idea that vaccines cause autism [6]. In 2013, he appeared as a panelist at the AutismOne Conference, which, for many years, has promoted the gamut of autism-related quackery.

In 2013, 2015, and 2017, Posey introduced the Vaccine Safety Study Act, which would  direct the the Secretary of Health and Human Services to conduct or support a comprehensive study to compare overall health outcomes, including risk of autism, in vaccinated populations and unvaccinated populations in the United States. In addition to being a waste of scarce research dollars, the study envisioned by the bill would not be possible to perform because the unvaccinated populations identified in the bill tend to avoid doctors, which means that their health status cannot be adequately documented.

That alleged link between autism and immunizations has been thoroughly debunked by scientific studies, including nine completed by 2012, that found no link between thimerosol-containing vaccines and autism as well as no link between the measles, mumps, rubella (MMR) vaccine and autism in children [7]. Nor has any link been demonstrated by court proceedings. In 2009. the Omnibus Autism Proceeding, which may have encompassed the most thorough health-related investigation in U.S. judicial history, found no link [8]. But in 2015, during an interview with a Sentinel reporter, Posey said he had spoken with mothers whose children stopped speaking after being vaccinated and his belief that “It can’t be coincidental.”

All of this makes me wonder whether Posey is willing to base his judgments on facts. Despite harping about possible vaccine-autism link for more than seven years, he doesn’t seem able to grasp the fact that the question has been scientifically settled—there is no link. It is also settled that the benefits of currently used vaccines vastly outweigh their risks.

The “Backfire Effect”

I believe that the best way to get health information is to identify and rely on trustworthy sources such as one’s own physician, government agencies, and major professional and voluntary organizations.

Many people form their beliefs about health matters by searching the Internet for different points of view and following what seems to be most sensible to them. However, without formal education, separating facts and misinformation can be difficult. Paul Offit, M.D., who heads the infectious disease department at Children’s Hospital of Philadelphia, has noted:

it’s hard to unscare people. I think once you’ve scared them, it’s hard to unscare them. . . . You can do all these studies and spend tens of millions of dollars looking at vaccinated or unvaccinated groups, that received MMR with thimerosal or didn’t. That’s certainly reassuring to look at these studies, but I think from a parent standpoint, they’re still thinking, “You know, maybe even if this is a possibility, I just want to avoid this vaccine. . . . It’s, frankly, hard as a scientist to watch these hypotheses like “MMR causes like autism” get raised, watch them be frankly refuted by the science, and watch the fear that was created just not go away. I think it’s been an enormous disservice to our children and it’s caused a lot of suffering that didn’t need to be caused [9]

A recent study found that four types of educational programs intended to debunk claims of a link between vaccines and autism actually increased parental misperceptions and reduced parental intention to vaccinate  [10]. This phenomenon—termed the “backfire effect”—has been shown to occur when beliefs are based on ideology rather than on facts. [11]. I have made similar observations while advocating for community water fluoridation. In many situations, limiting misinformation may be more effective than trying to counter it with logic. This can be accomplished by curbing the spread of scare statements through the mass media.

Steven Novella recently noted: “The antivaccine movement has proven immune to facts and reality. If someone insists on being so at odds with established medical facts, the best response is to marginalize them.” [12] I agree.

Why Facebook Deserves Our Thanks

I believe that Facebook has the right idea. False health-related ideas can cause serious harm. Freedom of speech does not give people an unlimited right to harm others. In the United States, freedom of speech means that the government cannot prosecute people for expressing their opinions. It does not give people the right to cause direct harm by falsely shouting “fire” in a crowded theater or making false and defamatory statements about people. Nor does it give people an unlimited right to spread false health claims.

In a democracy, there is very little regulation of non-commercial speech—and rightly so. However, it is clear that misinformation related to vaccination, fluoridation and other public health matters can cause harm and even death. (In fact, the World Health Organization included “vaccine hesitancy” in its list of ten threats to global health for 2019 [13].) So I believe that Facebook can ethically decide not to be a conduit for harmful health information. I doubt that it would be practical to try to censor statements or discussions made on “individual” Faccbook pages. But I believe it would be ethical as well as practical to remove the pages of groups whose purpose is to attack proven public health measures or promote quack cures. These groups can be judged not only by the content of their pages but by the extent to which they are organized for action that goes beyond mere discussion.

Will Facebook harm our society by restricting the flow of health misinformation? I don’t believe so. Facebook plays an extremely important role in helping people share ideas and experiences. That value will not diminish. People who want to share harmful ideas or organize campaigns will still have many other ways to do so. Facebook can perform a great public service by making it harder for anti-public health groups to mislead people and organize their noxious campaigns. In addition, marginalizing them will, by itself, send a powerful educational message. If I were running Facebook, I would remove the pages of all groups that oppose public health measures.

Alexis Madrigal believes that identifying Facebook’s most troublesome anti-vaccine pages is not difficult. Using repeated searches with the word “vaccine” between January 2016 and February 2019, he found that just seven pages generated nearly 20% of the anti-vaccine content that was widely shared: Natural News, Dr. Tenpenny on Vaccines and Current Events, Stop Mandatory Vaccination, March Against Monsanto, J.B. Handley, Erin at Health Nut News, and Revolution for Choice [14]. I would remove them also. If you know of other harmful pages, please send their URLs to me.

Additional Reading
References
  1. Combatting vaccine misinformation. Facebook, March 7, 2019, April 26, 2019, and Sept 4, 2019.
  2. Posey B. Letter to Mark Zuckerberg, March 4, 2019.
  3. Posey B. Questioning of Mark Zuckerberg at a hearing before the House Financial Services Committee, Oct 23, 2019.
  4. Merlan A. Mark Zuckerberg’s Congressional testimony got sidetracked by a weird exchange about vaccines. Vice, Oct 29, 2019.
  5. VICP data & statistics. Health Resources & Services Administration, June 6, 2019.
  6. Powers S. Rep. Posey at center of vaccine-autism fight. Orlando Sentinel Aug 21, 2015.
  7. Vaccines do not cause autism. CDC Web site, reviewed March 26, 2020.
  8. Barrett S. Omnibus Court rules against autism-vaccine link. Autism Watch, Oct 6, 2010
  9. Offit P. Sound advice. Interview recorded in April 2009.
  10. Nyhan B and others. Effective messages in vaccine promotion: A randomized trial. Pediatrics 133:e835-842, 2014.
  11. Nyhan B, Reifler J. When corrections Fail: The persistence of political misperceptions. Political Behavior 32:303-330, 2010.
  12. Novella S. MMR is safe and effective. Science-Based Medicine, May 6, 2020.
  13. Ten threats to global health in 2019. WHO Web site, accesses April 27, 2020.
  14. Madrigal AC: The small, small world of Facebook’s anti-vaxxers: Squelching vaccine misinformation might be easier than the platiorm makes it seem. The Atlantic, Feb 27, 2019.


Chirobase Mission Statement and FAQs

Mission Statement Accurate information about chiropractic is not easy to get. Most publishers, editors, and broadcasters are unwilling to examine this topic in-depth and to publish critical information. As a result, most reports reaching the public express what chiropractors would like people to believe. The purposes of this site are: To provide comprehensive information about …

Mission Statement

Accurate information about chiropractic is not easy to get. Most publishers, editors, and broadcasters are unwilling to examine this topic in-depth and to publish critical information. As a result, most reports reaching the public express what chiropractors would like people to believe. The purposes of this site are:

  • To provide comprehensive information about chiropractic history, theories, and current practices.
  • To encourage and support the use of science-based practices by chiropractors.
  • To identify and oppose the use of unscientific practices by chiropractors.
  • To warn about inappropriate chiropractic care.
  • To advise about how to deal with charges for unnecessary services.
  • To help people seeking appropriate chiropractic care to locate it.
  • To pinpoint the risks involved in pursuing a chiropractic career.
Frequently Asked Questions

Why was Chirobase started?

The news media rarely look closely at the chiropractic marketplace. “Positive” views are readily available from chiropractors and their organizations. We thought it would be useful to create a publicly available archive that discusses chiropractic’s problems. The name “Chirobase” stands for “Chiropractic Database.”

Some of the reports on Chirobase were published many years ago.
What is their relevance to chiropractic today?
Hasn’t chiropractic changed for the better?

We think it is useful to view chiropractic in full historical perspective. In 1968, the U.S. Department of Health, Education, and Welfare concluded that chiropractic theory and practice were not based upon scientific knowledge and that chiropractic education failed to prepare the practitioners to make adequate diagnoses and provide appropriate treatment. Although chiropractic education and practice have improved considerably, serious problems remain.

Why focus on chiropractors? Why don’t you
talk about the serious problems in medicine?

One has nothing to do with the other. Medicine’s shortcomings do not justify chiropractic quackery.

Doesn’t every profession have its rotten apples?

Yes, but we believe the percentage of chiropractors engaged in dubious practices is very high—much higher than it is in medicine and dentistry, for example. Chiropractors are the only professionals we know that promote courses and books on how to mislead people.

Isn’t the information on Chirobase unbalanced?

The key consideration should be whether the information is accurate, which it is. We provide many links to chiropractic Web sites to enable browsers to explore the full range of prochiropractic viewpoints. We also invite individual chiropractors to furnish comments that we can post. If you would like to suggest additional sites to which we should link, please notify us.

Aren’t you being unfair to chiropractors
who practice ethically and competently?

One of our goals is to help consumers evaluate individual chiropractors. To do this, we have posted guidelines describing both proper and improper care. We strongly support science-based chiropractic care. Chiropractors who believe our guidelines are valid can list their names in our referral directory so that prospective patients seeking such care can locate them. We have also posted a feature article describing what a rational chiropractor can do for people.

Do you have any advice for people who
are considering a chiropractic career?

It is a very risky choice because (a) most chiropractors do not practice legitimately, (b) the field is overcrowded and getting worse, and (c) chiropractic incomes (in real dollars) have been falling steadily since the early 1990s. Medicine, osteopathy, and physical therapy are much better choices. For scientifically minded individuals who still wish to become chiropractors, the Southern California University of Health Sciences (formerly Los Angeles College of Chiropractic) is probably the best school.



A Skeptical Look at the Healy “Bioresonance” Device

The Healy is a medical device that can be clipped to the users clothing. It supposedly interacts with the body through electrodes that are worn on the wrist, clipped to the ear, or temporarily attached to the skin with adhesive. Its operation is controlled via Bluetooth by a software application that is installed on a smartphone. …

The Healy is a medical device that can be clipped to the users clothing. It supposedly interacts with the body through electrodes that are worn on the wrist, clipped to the ear, or temporarily attached to the skin with adhesive. Its operation is controlled via Bluetooth by a software application that is installed on a smartphone. In 2020, Healy World announced that it would begin multilevel marketing of Healy devices in the United States [1].

Background History

Bioresonance therapy is based on notions that (a) every cell in the body has its own electromagnetic frequency and that (b) diseases can be cured by correcting abnormal frequencies by various means. The idea that diseases could be cured by radiofrequency energy was originally exploited by Albert Abrams, M.D., (1864-1924) whom the American Medical Association labeled the “dean of gadget quacks.” In the 1920s and 1930s, Royal Rife claimed that his devices to have developed a device that could destroy microorganisms by vibrating at their “resonant frequency.” Rife derivatives are still marketed.

Proponents attribute the development of bioresonance therapy to Franz Morell, a German physician who spent years investigating the use of electroacupuncture devices and helped Hans Brügemann develop one called the BICOM [3]. A brochure from from BICOM’s manufacturer states that Brügemann coined the term “bioresonance therapy” in 1987 to describe the BICOM’s action [2]. Professor Edzard Ernst believes that Brügemann and subsequent bioresonance promoters have used “pseudo-scientific language . . . . as an attempt to present nonsense as science.” [3]. A recent study of two current BICOM equivalents found that they (a) failed to diagnose serious diseases in two seriously ill patients, (b) produced a clean bill of health for a corpse, (c) diagnosed a host of nonexistent health risks nine healthy volunteers, (d) generated no real differences between a wet towel and the volunteers, and (e) had wildly variable results with repeated tests of the wet towel and liver pate [4].

The Healy is said tio be a portable descendant of the BICOM device. The Healy GmbH Web site attributes its development to Marcus Schmieke and Nuno Nina:

Marcus Schmieke, born 1966, is the inventor and developer of the Healy™ and TimeWaver® products. For many years Marcus had been thinking about how to let everyone benefit from the possibilities of the TimeWaver technology in a compact and simple way. What he had in mind was a device that everyone could use every day, something compact, simple and practical. A little companion that watches over our health and can help in an innovative way to prevent problems and support healing.

Nuno Nina is a Portuguese researcher and holistic healer. Nuno runs seven private clinics, most of them in Portugal. His field of work is mainly frequency applications and cell biology. Nuno’s experience with thousands of clients has enabled him to compile the theories and findings from his research in the form of a collection of 144,000 so-called “Gold Frequencies.” When he first came into contact with the TimeWaver technology years ago, he immediately suggested combining it with the possibilities of frequency therapy to create something greater than the sum of its parts [5].

Fanciful Claims

A Facebook page associated with Healy states:

The human body is made up of 100 trillion cells, each requiring healthy cell voltage to stay alive. Quantum physics teaches us there’s no difference between energy and matter. Therefore, we are nothing but energy. Quantum physics teaches us everything within us is the result of motion-creating resonance. The resonance is important to understanding how subtle energy directs and maintains health and wellness in human beings.

Imagine a portable wearable technology designed for total heath, inside and out to assist with energetic imbalances by directing cell communication and increasing cellular energy (ATP) by 500%. By doing so, we can bring the body back to homeostasis (balance). Our cells constantly communicate through resonant frequency much like tuning to the precise channel on your radio or TV. The difference in tuning the station to 102.3 or 102.4 is the difference in a clear signal vs static (signal disruptor). The magic is in the resonance.

Like anything, your cells act as transmitters and receivers. How your cells transmit and receive communication is imperative and can directly impact your health through their signal calling. In the same way, you can disrupt a good signal through poor unhealthy lifestyle, environmental factors etc. you can intentionally disrupt a bad signal (symptomatic poor health). Focusing on healthy frequency communication between cell function can impact your health, vitality, and your brain in ways you can’t possibly imagine [6].

Another affiliated site adds:

Through the science of quantum physics, the Healy can measure your individual frequency via a quantum sensor – then deliver back to you customized and specific frequencies to realign your cellular, emotional and/or energy centers back into bioenergetic balance. To put it more simply, Healy can talk directly to your cellular energy. It can ask your cells what they need to heal and then deliver the exact frequencies your cells asks for—or “resonates with”—to heal [7].

A Healy video commercial says :

Stay connected to the Cloud via your smartphone. Healy has access to thousands of  therapists and clinicians who can supply you with the optimal frequencies. Now possible for everyone. We believe that all this is just the beginning of a new era—an era in which the bioenergetic regeneration of cells will be just as important to humans as a healthy diet and sufficient exercise today [8].

A “Healy Programs” brochure promises more than a hundred benefits, including:

  • Activation of the body’s bioenergetic defense system.
  • Bioenergetic calming of the mucous membranes
  • Bioenergetic balancing to help relieve allergic reactions
  • Bioenergetic balancing of visual ability, the hormonal system, the nervous system
  • Bioenergetic stimulation of the body’s energy supply, cell metabolism, mental clarity, the reproductive organs, the body’s excretory processes, the follicles, and the nail bed
  • Bioenergetic regulation of thyroid function and  hormonal balance
  • Bioenergetic promotion of liver metabolism, toxin transport, the lymphatic system, and the beta state
  • Energetically balancing the immune system in cases of infections
  • Bioenergetic optimization of lung function,
  • Bioenergetic reduction of tensions
  • Balancing energetic interference fields in scars
  • Supports inner balance . . . to aid recovery from nicotine addiction.
  • Regulation of bladder energy control
  • Stimulation of the energy field of the spleen and pancreas [9],

Most of Healy’s marketing materials carry a disclaimer to the effect that “Healy and its applications are not acknowledged by orthodox medicine due to a lack of scientific proof in accordance with scientific standards.” It should be noted, however, that claims for the Healy are not merely unproven. There is no logical reason to believe that the  “frequencies” proponents describe are actual physical forces. But that doesn’t stop them from suggesting that they provide great health benefits.

Regulatory Status

Devices with 510(k) clearance from the FDA can be legally marketed in the United States for the purposes for which they are cleared. To obtain such clearance, the manufacturer must show that the devices is substantially similar to a device that the FDA has previously cleared or approved [10]. It is not necessary to prove that the device works. In 2019, the Healy received FDA 510(k) clearance as a Class 2 medical device:

for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis [11].

The 510(k) application described it as substantially similar to Omron’s Avail, which is a respectable transcutaneous electrical nerve stimulation (TENS) device that is cleared for the symptomatic relief of various types of pain. TENS devices are postulated to relieve pain by releasing endorphins and/or blocking the transmission of pain through local nerves [12]. If the Healy can deliver electric currents that enable it to function like a TENS device, it would be legally marketable for that purpose. However, it is not cleared for any of the uses related to “bioresonance” that dominate the company’s marketing materials. Any claims that the Healy can be used to prevent, mitigate, cure or treat a disease would be illegal.

Healy might argue that its claims about frequencies and “energetic balance”  should not be regarded as medical claims. In fact, the Healy World Web site states that “Healy also has non-medical applications that use individualized frequencies to help balance your mind and body and relieve stress in support of wellness but not for the treatment of disease.” However, intended use is determined by the context in which a claim is made. The courts have concluded that the use of “artful language” does not change the significance of illegal acts that amount to the same thing [13,14]. If asked, I believe the courts would conclude that Healy’s claims that mention organs or diseases are medical claims that are illegal without FDA approval. Moreover, the Federal Trade Commission Act requires advertising to be truthful and not misleading—and the FTC, if it acts, generally requires that health-related claims be supported by adequate scientific evidence (typically at least two controlled clinical trials), which Healy admits it does not have.

Several sites are claiming that the Healy is FDA-approved. That is not correct. Approval requires evidence of safety and effectiveness demonstrated by clinical trials. The people claiming approval may not understand the difference between approval and clearance. Or maybe they were misled by the “Certificate of Approval” issued by Harrington Consulting, the company that submitted Healy’s 510(k)  application. The certificate accurately describes the clearance, but the word “approval” might mislead some people.

The Bottom Line

Healy devices are claimed to help a wide spectrum of health problems. Their use is based on notions that may sound scientific but lack real scientific support. The FDA has cleared Healy devices for sale in the United States for temporary relief of pain, but claims made for them go far beyond what the clearance allows. Healy’s marketers even admit that there is no scientific proof that they work as advertised.

References
  1. Welcome to Healy World. Healy World Web site, accesses May 12, 2020.Web site
  2. Brugemann H. The fascinating development of bioresonance therapy: Discoveries, research, ideas and hard work. Peper presented at the 45th International Congress for Bicom Users, Fulda, Germany, April 29 to 1 May 1, 2005.
  3. Ernst E. Bioresonance: A study of pseudo-scientific language. Forsch Komplementärmed Klass Naturheilkd 11:171–173, 2004.
  4. Ernst E. Bioresonance: A new and hilariously ingenious study. Edzard Ernst blog, April 9, 2020.
  5. BICOM 2000: The Number 1 in Bioresonance. Published by REGUMED Regulative Medizintechnik GmbH, Gräfelfing, Germany, Aug 3, 2005.
  6. This is why we developed Healy. Healy GmbH Web site, accessed May 1, 2020.
  7. This is frequency therapy! Float Space Web site, accessed May 12, 2020.
  8. Healy healing frequencies – Healy frequency overview. Posted to YouTube, April 2, 2020.
  9. Healy programs, June 17, 2019.
  10. Yellin AK. What are 510(k) clearance and premarket approval? Device Watch, Jan 9, 2009.
  11. 510(k) Summary: K191075, May 26, 2019.
  12. Electrical stimulation for pain. Aetna Clinical Policy Bulletin 0011, March 10, 2020.
  13. Notices of judgment under the Federal Food, Drug, and Cosmetic Act. D.D.N.J., F.D.C. 3381-3383, issued Aug 1951.
  14. Memorandum. USA v Daniel L. Allgyer, U.S. District Court for the Eastern District of Pennsylvania, Case No. 11-02651, Feb 2, 2012.


Genova Diagnostics Settles False Claim Act Violations

Genova Diagnostics Inc., a clinical laboratory services company based in Asheville, North Carolina, has agreed to pay up to approximately $43 million to resolve allegations that it violated the False Claims Act, including claims that it billed  for medically unnecessary lab tests [1]. The settlement resolved allegations that the company: (a) improperly submitted claims to …

Genova Diagnostics Inc., a clinical laboratory services company based in Asheville, North Carolina, has agreed to pay up to approximately $43 million to resolve allegations that it violated the False Claims Act, including claims that it billed  for medically unnecessary lab tests [1]. The settlement resolved allegations that the company: (a) improperly submitted claims to Medicare, TRICARE, and the federal employee health program for tests that were not medically necessary, (b) engaged in improper billing techniques, and (c) violated the Stark law, which prohibits physicians from referring patients for certain designated health services paid for by Medicare to any entity in which they have a financial relationship.

The alleged misconduct was brought to light by former Genova vice-president and chief medical officer Darryl Landis through the whistleblower provisions of the False Claims Act. Landis was represented by the law firm of Womble Bond Dickenson of Winston-Salem, North carolina. The suit was filed against Genova Diagnostics, Inc.; GNVA Holdings Inc,; Levine Leichtman Capital Partners V, L.P.; Lauren Leichtman, Aaron Perlmutter, and Chris Smith. The allegations included:

  • Genova markets a variety of unconventional laboratory tests to the functional medicine market, including test panels that relate to hormones, food allergies, nutrition, and gastrointestinal bacterial targets.
  • There is insufficient evidence that these are medically necessary and therefore eligible for Medicare or Medicaid payment.
  • through Requisition Forms, the defendants knowingly forced physicians to order a large number of tests on each Panel which are not individualized for patients, which results in the ordering of and Genova’s billing of Medicare and Medicaid for tests that are medically unnecessary and not relevant to the diagnosis or treatment of patients.
  • From July 1, 2015 through June 30, 2017, Genova, with the knowledge or and at the direction of its owners, managers, and board of directors, has fraudulently submitted claims for payment for and received over $21 million in reimbursements from Medicare for the Panels. During that time period, it also has submitted claims for payment for and received Medicaid reimbursements from the State of North Carolina for the Panels.
  • Genova also made payments to three phlebotomy vendors that violated the Stark Law [2].

Under the settlement, Genova has agreed to pay approximately $17 million, through the surrender of claim funds held in suspension by Medicare and TRICARE, plus up to an additional $26 million if certain financial contingencies occur within the next five years, for a total potential payment of up to $43 million [3]. Genova also entered into a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General. Among other things, the CIA requires Genova to establish and maintain a compliance program and engage an independent review organization [4]. Dr. Landis will receive roughly $6 million as part of the settlement.

The Tests at Issue

The lawsuit challenged three types of tests, which it described this way:

  • GI Effects Comprehensive Panel. A panel of fecal stool tests that assesses 46 different biomarkers of gastrointestinal function, including 24 commensal bacterial targets found in the gastrointestinal system. In 2017, Genova’s Web site claimed that the test provided “immediate, actionable clinical information for the management of gut health” and individuals with “leaky gut symptoms”; celiac disease; inflammatory bowel disease (IBD); diabetes; obesity; cardiovascular disease; celiac and other malabsorption disorders; mood disorders; autism; and autoimmune disorders; and other conditions.
  • IgG Food Antibody Panel. A food sensitivity test that “helps identify those with true IgE-mediated allergies as well as IgG-mediated food intolerances.” In 2017, Genova’s Web site claimed that the test was ideal for patients who may suffer from delayed reactions/sensitivities to specific foods. It may also provide insight on intolerances, or non­immune responses, to certain foods.”
  • NutrEval Panels. These test over 100 organic acids, amino acids, fatty acids, micronutrients, and other elements in an individual’s blood and urine. In 2017, Genova’s Web site promoted the NutrEval Test FMV (First Morning Void) test as “an advanced diagnostic tool to guide nutritional therapies, often augmenting and speeding recovery of complex chronic conditions” the site claimed that the NutrEval Plasma test, would “reveal nutritional imbalances or inadequacies.” The site recommended both NutrEval Panels for individuals who suffer from mood disorders, fatigue, digestive complaints, chronic pain, inflammatory conditions, cardiovascular risk, and weight issues.

The complaint also indicates that Dr. Landis was hired in 2012 to be its chief medical officer and tasked with developing medical necessity evidence for its tests. At that time, the company regarded him as an expert in medical policy, research, and evidence-based care. After he joined the company, he helped develop a strategy that would enable Genova to establish the medical necessity for various tests, and Genova budgeted $1 million for a clinical evidence study to be conducted. However, a change in ownership and management “focused its money and efforts on marketing and the increasing of profits, and shifted its focus away from the costly development of medical necessity evidence for Genova’s panel tests. Dr. Landis “repeatedly raised concerns about and warned . . . about the weak to non-existent clinical support for the medical necessity of Geneva’s panel tests . . . and the resulting impropriety of Genova’s Medicare and Medicaid billing of those tests.” When Dr. Landis warned that the company might be liable for fraud, he was gradually marginalized within the company and was ultimately fired.

No Admission of Liability

This Settlement Agreement states that it is neither an admission of liability by Genova nor a concession by the United States that its claims are not well founded. Further, Genova denied all the allegations and denied that it engaged in the alleged misconduct. After the agreement was announced, a company spokesperson released the following statement:

We were contacted by the government and responded to questions on federal program billing on certain of our tests. We conducted our own thorough investigation and are confident in the medical necessity of our tests and that Genova acted completely appropriately. While we believed that Genova would have prevailed, we are pleased to avoid considerable distraction and expense by resolving this matter without any admission of guilt or wrongdoing. We could not be more excited for what the future holds as Genova Diagnostics has for more than 30 years meaningfully improved the lives and well-being of patients, particularly those with chronic conditions for whom other medical approaches have had poor and costly results. The value of our diagnostic tests has been demonstrated and recognized time and time again by a growing body of medical research, and by a customer base including more than 10,000 annual prescribing primary care and specialty physicians, as well as some of the most prestigious medical institutions in the world [5]

It is not unusual for defendants accused of health fraud to be permitted to agree to take corrective action without admitting that they did anything wrong. In this case, the prosecutors achieved their goal of stopping the false billing and recovering improperly billed money, and defendants were happy tto be able to say that they were not proven to have done anything wrong. The likely harm to consumers who underwent the challeneged tests was not relevant.

Dozens of laboratories in the United States provide unproven tests through offbeat practitioners [6]. The Federal Trade Commission could investigate the truthfulness of claims made for such tests. The FDA and other laboratory regulators could investigate their clinical validity, State licensing boards could investigate whether practitioners who administer such tests provide adequate care to their patients. Unfortunately, few such investigations are conducted.

References
  1. Testing laboratory agrees to pay up to $43 million to resolve allegations of medically unnecessary tests. USDOJ press release, April 27, 2020.
  2. First amended complaint. USA and State of North Carolina ex rel. Darryl Landis, M.D., v. Genova Diagnostics, Inc and others. U.S. District Court for the Western District of North Carolina. Case No. 1:17-cv-341, filed May 8, 2018.
  3. Settlement agreement, filed April 27, 2020.
  4. Corporate integrity agreement between the Office of Inspector General and Genova Diagnostics, April, 2020.
  5. Asheville lab to pay up to $43 million to resolve unnecessary test claims. ABC News 13, April 27, 2020.
  6. Barrett S. Laboratories doing nonstandard laboratory tests. Quackwatch, March 12, 2019.


FDA Warning Letter to Blue Ridge Silver

  Recipient: Steven Griffin CEO Blue Ridge Silver 7595 Valley Blvd Blowing Rock, NC 28605United States Issuing Office: Center for Food Safety and Applied Nutrition United States WARNING LETTER VIA OVERNIGHT DELIVERY RETURN RECEIPT REQUESTED February 5, 2019 Blue Ridge Silver Steven Griffin, CEO 7595 Valley Blvd Blowing Rock, NC 28605 RE: 566247 Dear Mr. Griffin:           This …

 

Recipient:

Steven Griffin
CEO
Blue Ridge Silver
7595 Valley Blvd
Blowing Rock, NC 28605United States

Issuing Office:

Center for Food Safety and Applied Nutrition
United States

WARNING LETTER

VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED

February 5, 2019

Blue Ridge Silver
Steven Griffin, CEO
7595 Valley Blvd
Blowing Rock, NC 28605

RE: 566247

Dear Mr. Griffin:          

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.blueridgesilver.com in October 2018 and has determined that you take orders there for your BLUE RIDGE SILVERTM Colloidal Silver products. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the claims observed on your website that provide evidence that your products are intended for use as drugs include the following:

On the page of your website, titled “Promises”:

  • You quote an article titled, “Use of Colloids in Health and Disease” as stating that “all fungus, virii, bacterium, streptococcus, staphylococcus, and other pathogenic organism are killed in three or four minutes.”
  • “. . . [I]onic silver significantly promotes . . . the regeneration of damages tissues within the body.”

On the page of your website, titled “Frequently Asked Questions”:

  • Hippocrate, the father of modern medicine, used silver to treat ulcers.”
  • “Argyrol, a mixture of silver suspended in gelatin, was the first line of defense for American and Allied troops during WWI who were exposed to STDs, especially gonorrhea.”
  • “What are some Modern Uses for Colloidal Silver? . . . antiseptic for treating burn victims . . . prevent[ing] neonatal conjunctivitis”
  • “ . . . [T]he ionic form of colloidal silver ingested by millions of people across North America [is used to] fight off or prevent infections, colds, flus, and even help heal serious chronic degenerative diseases.”
  • “In the 1920’s and 30’s, colloidal silver was widely used to treat many infectious diseases for those who could afford it.”

Under the “News” tab of your website, your article titled “Can Using Colloidal Silver Help You Prevent Dementia?”:

  • “Experts think oral bacteria may spread to the brain . . . and may contribute to the type of plaque that’s been linked to Alzheimer’s.‘
  • [citing an article from MensHealthWire.com] “Dementia and mental confusion has also been linked to poor oral hygiene. A recent study showed that people who had cases of gingivitis or periodontal disease tended to exhibit sings [sic] of early Alzheimer’s, dementia or extreme mental confusion.”
  • “ . . . [G]ood oral health habits – including regular oral colloidal silver usage to keep populations of problematic oral pathogens at bay — can lower your risk of heart-related ailments.”
  • “ . . . [C]olloidal silver is a proven effective method for preventing the buildup of bacterial plaque.”
  • “ . . .[A]ccording to a 1999 study conducted at Brigham Young University, the bacterium Streptococcus mutans, which is a major cause of dental plaque and tooth decay, was inhibited and destroyed using 5ppm of colloidal silver. In fact, in the study colloidal silver was demonstrated to be as good at destroying the bacteria as five different classes of antibiotics, including: the tetracyclines, fluorinated quinolones (Ofloxacin), thepenicillins [sic], the cephalosporins (Cefaperazone) and the macrolides (Erythromycin).”
  • “. . . [A]ntimicrobial silver is also effective against yeast and fungal oral pathogens”
  • “. . . [C]olloidal silver can be used to keep oral bacteria at bay. . . . [R]ecent information [shows] . . . the ability of oral bacteria to trigger the onset of dementia…”

Under the “News” tab of your website, your article titled “Colloidal Silver and Mycoplasmas Infections”:

  • “ . . . [H]igh dosages of colloidal silver are reported to have been used to control mycoplasmas infections. . . . The list of disease that can be caused or triggered by mycoplasma infection is long and includes rheumatoid arthritis, lupus, multiple sclerosis, Lou Gehrig’s disease (ALS) . . . Alzheimer’s disease, heart disease, and even certain forms of cancer!”
  • “Other mycoplasma-triggered diseases can include Gulf War Syndrome/Gulf War Illness, Chronic Fatigue Syndrome (CFS), chemical sensitivity,  HIV/AIDS, and Alzheimer’s.”
  • “ . . . [One researcher, Dr. See, has had] success using ultra-small particle colloidal silver to treat patients with chronic degenerative disease associated with mycoplasmas pathogens. In published reports Dr. See says he has witnessed . . . patients with known mycoplasmas infections turn from positive to negative with the use of ultra-small particle colloidal silver.”

Under the “News” tab of your website, your article titled “Colloidal Silver Kills Cancer: Info Resources”:

  • “ . . . [T]here are now over 50 medical studies demonstrating silver to be effective against cancer cells (and tumors) . . . ”
  • “ . . . [F]rom time-to-time I get testimonials from readers saying they’ve either cured their cancer, or have gotten their cancer under control (i.e., the cancer is still there, but is no longer spreading) by using colloidal silver.”
  • “ . . . [M]ore than 50 preliminary clinical studies . . . demonstrate[ ] the ability of silver help stop cancer cells”
  • This article cites to several publication that refer to disease use and that imply treatment or prevention of a disease (see 21 CFR 101.93(g)(2)(iv)(C)):

o    “Silver Kills Some Cancer Tumors Better Than Chemotherapy, Says British Researchers”

o   “Colloidal Silver Kills Human Breast and Liver Cancer Cells”

o   “Silver Induces Cervical Cancer Cells to Destroy Themselves”

o   “Study: Silver Nanoparticles Kill Cancer Cells Resistant to Chemotherapy Drugs”

Under the “News” tab of your website, your article titled “The Clear Evidence that Silver Aids the Body in Many Vital Functions”:

  • “ . . . [A] new medical study . . . demonstrates silver’s incredible ability to quench free radical activity in brain cells . . . As respected drug and nutritional formulator George Foss stated regarding this eye-opening new study: ‘It certainly could have tremendous benefits for victims of Alzheimer’s and other forms of dementia.’”

Under the “News” tab of your website, your article titled “Singer Kris Kristofferson’s ‘Alzheimer’s Disease’ Ordeal & Colloidal Silver”:

  • “ . . . a natural treatment for Lyme Disease”
  • “‘Two studies have been conducted with colloidal silver and effectiveness against Borrelia burgdorferi.’”
  • “[Researcher] Dr. Farber later claimed to have witnessed ‘a 100% killing effect of the Lyme pathogen, Borrelia burgdorferi, ‘within less than five minutes of exposure’ to colloidal silver preparation.”

Under the “News” tab of your website, your article titled “Using Colloidal Silver for Kidney Infections”:

  • “Colloidal Silver just might be the next germ-fighting wonder drug. And not just for the serious threats making headlines. It’s also effective against bacterial infections like strep throat, viruses like the flu, and fungal infections like Candida.”
  • “. . . [A] pilot study during the mid-1990s that included human patients suffering from terminal AIDS . . . established solid evidence showing just how quick and effective silver ions can be in the treatment of Candida as well as HIV. . . . The researchers found . . . colloidal silver was capable of killing pathogens and purging the bloodstream of germ defenses in order to restore the immune system.”
  • “ . . . [C]olloidal silver . . . may be effectively uses as an alternative to antibiotics.”
  • “I sincerely recommend that everyone have … colloidal silver in their home as an antiseptic, antibacterial and antifungal agent.”

Additionally, your website contains evidence of intended use in the form of personal testimonials recommending or describing the use of for BLUE RIDGE SILVERTM Colloidal Silver products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

Under the “News” tab of your website, your article titled “Singer Kris Kristofferson’s ‘Alzheimer’s Disease’ Ordeal & Colloidal Silver”:

  • “I have a friend who was on colloidal silver for his cancer treatment. The other methods did not work for him. Chemo and radiation. But he got silver and his cancer tumors shrunk and went away. He is fine now.”
  • “ . . . I have suffered with Rheumatoid Arthritis for approximately 7 years now.  . . . Then I discovered the Colloidal Silver phenomenon. So six weeks ago I decided to purchase a colloidal silver generator, some silver rods and a book about the subject. . . . The first thing I noticed after a week of taking it was that my asthma symptoms (I got the asthma 2 yrs ago following a flu shot-which I will never take again!) were getting better. The phlegm associated with it was actually loosening up and moving. Then on the second week I started realizing that my badly swollen wrists were getting better. . . . By the third week I noticed that my tendons, ligaments and veins were starting to become more apparent (rather than hiding in a mass of inflammation). I am now on my fifth week and I can actually press my fingertips into my wrists (synovial area) without much pain. I can also reach out further and lift heavier objects. I can also twist my wrist a lot more. The mobility is far from what it used to be but much better (I probably have some damage in there that restricts full movement). The asthma is also diminishing.”

Under the “News” tab of your website, your article titled “Using Colloidal Silver for Kidney Infections”:

  • “. . . I just used colloidal silver for a kidney infection for three days . . . and my fever is gone . . .. I have a kidney disease that harbors infection in my kidneys continuously, and through the years, I have become resistant to a lot of the heavy antibiotics . . .”
  • “My sister began using it and her kidney infection cleared right up . . .”
  • “I have a cousin that is 8 months pregnant. She got a bladder infection, went to the doctor and the doctor gave her antibiotics. Infection got worse and she ended up with a kidney infection. . . . 6 days after she started taking the colloidal silver – infection 100% gone.”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your BLUE RIDGE SILVERTM Colloidal Silver products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your BLUE RIDGE SILVERTM Colloidal Silver products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].

Further, according to 21 CFR 310.548, any OTC drug product containing colloidal silver ingredients that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a “new drug” within the meaning of section 201(p) of the Act for which an approved application is required for marketing, without which such product is also misbranded under section 502 of the Act [21 U.S.C. 352].

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all products marketed by your firm comply with all requirements of federal law, including FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

We also note that some of your colloidal silver products are marketed as nasal sprays. However, the Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) [21 U.S.C. § 321(ff)(2)(A)(i)] as a product that is “intended for ingestion.” Because oral spray products are intended to enter the body directly through the mucosal tissues at the back of the throat, they are not dietary supplements and are not foods.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your written reply should be directed to Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov.

Sincerely,

/S/

William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition



British Advertising Standards Authority Upholds Complaint against Wayne Hardwick

Wayne Hardwick Number of complaints: 1 Complaint Ref: A18-4680 Background Summary of council decision: Two issues were investigated, both were Upheld. Ad description A website and leaflet for Body Resonance, seen on 2 October 2018: a. The website bodyresonance.co.uk, included on its home page a subheading “Helping with…” with text underneath that stated “This is …

Wayne Hardwick

Number of complaints: 1

Complaint Ref: A18-4680

Background

Summary of council decision:

Two issues were investigated, both were Upheld.

Ad description

A website and leaflet for Body Resonance, seen on 2 October 2018:

a. The website bodyresonance.co.uk, included on its home page a subheading “Helping with…” with text underneath that stated “This is a holistic approach, rather than just targeting a symptom, our aim is not to supress or mask a symptom but remove the cause. Bioresonance can help diagnose and relieve many painful and debilitating conditions”. Underneath that were six picture boxes with text underneath each which stated respectively “Allergies”, “Weight loss”, “Skin Conditions”, “Serious Illness”, “Intestinal Disorders” and “Parasites”. Under the category “Allergies”, the following conditions were included: itching, rash, stomach pain, diarrhoea, vomiting, itchy eyes, sneezing to asthma attacks and allergic shock. Under the category “Skin Conditions” the following conditions were included: neurodermatitis and chronic eczema. Under the category “Intestinal Disorders” the following conditions were stated: Crohn’s disease and ulcerative colitis. Under the category “Parasites” the following condition was stated: Lyme Disease. Another section of the website “Testimonials” included claims from clients. One testimonial stated “The Bio Resonance machine diagnosed me with a severe Candida overgrowth in my gut, amongst a few other things! I was advised to change my diet completely after the machine picked up a few food intolerances. I had treatment sessions with the machine to invert the overgrowth and boost my immunity allowing my body to return to a healed, healthy state”. Another stated “Thank you so much, an underlying heart condition picked up after months getting nowhere with Doctors! Banged me on Blood Pressure medication without finding the cause, with your help I’m now in the system with a cardiologist now listening to me”. At the bottom of the web page under the subheading “Downloads” was a link to “Brochure”. The document, under the subheading “Treatment”, stated “Bio resonance is used for treating conditions such as fatigue, allergies, digestive disorders, insomnia, pain due to arthritis, fibromyalgia, asthma, hay fever and many more. It is particularly successful for treatment and diagnosis of Lyme disease”.

b. On the front of the leaflet, at the top, it stated “Tired of feeling ill?” Beneath that, text stated “The Body Resonance clinic looks at the possible causes for your health issues using our state of the art Bicom Body Scanner. Bio Resonance is a non-invasive gentle therapy that targets the root cause of your condition and helps to rebuild a weakened immune system. The scanner moves through each organ in the body detecting and referring diagnostic information using frequencies emitted by every single cell. These are matched with stored data to allow and assist diagnosis. We can help conditions such as: Allergies, Arthritis, Skin conditions such as Eczema, Smoking addictions, Lyme disease, Digestive and bowel complaints, Fibromyalgia/ Fatigue, Lack of sleep, Hayfever, And so much more …”. Text on the other side of the leaflet stated “Our Bicom Body scanner reads the bodys [sic] electromagnetic frequencies and identifies any harmful pathogens. The scanner can be seen working in front of you as we explain what possible problems are present. We then treat any harmful pathogens that could lead to future illness along with any other complaints you identified to us prior to treatment”.

Issue

The complainant challenged whether:

1. the ads discouraged essential treatment for Crohn’s disease, underlying heart conditions, allergic shock, ulcerative colitis, asthma, arthritis and smoking addictions for which medical supervision should be sought; and

2. the claims that Bioresonance could treat and/or diagnose neurodermatitis, chronic eczema, candida, diarrhoea, Lyme disease, digestive and bowel complaints, fibromyalgia/fatigue, hayfever, insomnia and lack of sleep were misleading and could be substantiated.

Response

1. Wayne Hardwick t/a Body Resonance said there was a medically trained person who worked on the clinic, but as they offered a holistic therapy, that person was not required.

2. Body Resonance said that Bioresonance had been successfully used as a treatment for more than 50 years and that it did not require medically certified staff to treat patients. They said all of the research and trials of Bioresonance treatment had been carried out by the machine manufacturer “REGUMED BICOM” in Germany.

Body Resonance provided a review, assessed by one scientist, of 14 Bioresonance studies which included summaries of each study and a score of their quality. They also provided a paper that included five other studies.

Assessment

1. Upheld

The CAP Code stated that marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment was conducted under the supervision of a suitably qualified health professional. The ads featured the conditions Crohn’s disease, underlying heart conditions, allergic shock, ulcerative colitis, asthma, arthritis and smoking addictions. We considered those conditions were ones where medical supervision should be sought, and therefore advice, diagnosis or treatment needed to be conducted under the supervision of a suitably qualified medical professional.

We noted that we had not seen evidence that Bioresonance was provided under the supervision of a suitably qualified health professional. We considered that in absence of such a professional it could therefore discourage essential medical treatment. For those reasons, we therefore concluded that the claims breached the Code.

On that point ads (a) and (b) breached CAP Code (Edition 12) rule 12.2 (Medicines, medical devices, health-related products and beauty products).

2. Upheld

We considered consumers would understand from ads (a) and (b) that Bioresonance could treat or diagnose neurodermatitis, chronic eczema, candida, diarrhoea, Lyme disease, digestive and bowel complaints, fibromyalgia/fatigue, hayfever, insomnia and lack of sleep. We therefore considered that a suitable body of evidence would be required to support each of the claims.

We considered the paper which briefly reviewed 14 studies, did not appear to have been peer-reviewed and lacked sufficient, if any, detail regarding the methodology, statistical significance or analysis of results that we expected of a robust clinical trial or academic review. Many of the studies in the document were also unrelated to conditions listed in the ad. We therefore considered that it was insufficient to substantiate any of the ads’ claims.

The second paper included five studies about Bioresonance; however, four of the studies were non-human studies and the one human study did not address any of the conditions in the ads. We therefore concluded, in the absence of sufficient evidence, that the claims that Bioresonance could treat those listed health conditions were misleading.

On that point ads (a) and (b) breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health-related products and beauty products).

Action

We told Wayne Hardwick t/a Body Resonance not to claim or imply that Bioresonance could treat conditions unless they held adequate evidence to demonstrate that was the case. We also told them not to reference conditions for which medical supervision was necessary.

CAP Code (Edition 12)

12.1     12.2     3.1     3.7