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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 1,756 members listed in its online membership 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 plus a franchise chain that represented 575 clinics, most of which had between 2 and 6 chiropractors on their staff. 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 pages that I found, click here.

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 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 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 case is additionally significant because it attacks 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



British Advertising Standards Authority Upholds Complaint against Bioresonance Totnes

Person unknown t/a Bioresonance Totnes Number of complaints: 1 Complaint Ref: A18-457357 Background Summary of Council decision: Two issues were investigated, both of which were Upheld. Ad description A poster for Bioresonance Totnes, seen on 26 June 2018, featured the text “We offer Bioresonance scans and treatments in Totnes and nearby. Bioresonance works by scanning …

Person unknown t/a Bioresonance Totnes

Number of complaints: 1

Complaint Ref: A18-457357

Background

Summary of Council decision:

Two issues were investigated, both of which were Upheld.

Ad description

A poster for Bioresonance Totnes, seen on 26 June 2018, featured the text “We offer Bioresonance scans and treatments in Totnes and nearby. Bioresonance works by scanning the body’s electromagnetic field and gathering information signals which then provide an insight into the body’s condition. After the scan you’ll receive a 7 page health report which includes: Express-scan on the functional state of all 47 organs and systems in the body, Performance score for each individual organ, Detection of energy blockages, parasites and inflammation, Condition of chakras, Aura image, Spinal health, Physiological age (real age), Vitamin and mineral deficiencies”. Text at the bottom of the poster stated “£45 for first time diagnosis scan. £35 concessions”.

Issue

The complainant challenged whether the claims:

  1. that the Bioresonance device was effective in the diagnosis of medical conditions and ailments complied with the CAP Code; and
  2. “detection of … parasites” and “spinal health” complied with the Code.
Response

Person(s) unknown t/a Bioresonance Totnes did not respond to the ASA’s enquires.

Assessment

The ASA was concerned by Bioresonance Totnes’ lack of a substantive response and apparent disregard for the Code, which was a breach of CAP Code (Edition 12) rule 1.7 (Unreasonable delay). We reminded them of their responsibility to provide a substantive response to our enquiries and told them to do so in future.

  1. Upheld

The CAP Code required that medicinal or medical claims and indications were made only for a medicinal product that was licensed by the MHRA or under the auspices of the European Medicines Agency (EMA) or for a CE-marked medical device. We noted that a medicinal claim was a claim that a product or its constituents could be used with a view to making a medical diagnosis or could treat or prevent disease, including an injury, ailment or adverse condition. With that in mind, we considered that the ad featured the medicinal claims “detection of … parasites” and “spinal health”.

Because the ad made medicinal claims for a product that we had not seen evidence to demonstrate was a CE-marked device, we concluded that the claims breached the Code.

On that point, the ad breached CAP Code (Edition 12) 12.1 and 12.1  (Medicine, medical devices, health-related products and beauty products).

  1. Upheld

We noted that the ad included a number of claims, such as “Bioresonance scans and treatment … provides an insight into the body’s condition”. The ad also stated that the Bioresonance device could “…scan on the functional state of all 47 organs and systems in the body, performance score for each individual organ, detection of energy blockages and inflammation, condition of chakras, aura image” and provide a physiological age (real age).

. We considered that consumers would interpret the ad to mean that the Bioresonance device could detect those health conditions and ailments.

In the absence of any evidence in support of the claims, we concluded that the claims had not been substantiated and were misleading.

On that point, the ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 Substantiation) and 12.1 1 (Medicine, medical devices, health-related products and beauty products).

Action

The ad must not appear again in its current form. We told Bioresonance Tones to ensure that they did not make medical claims for a product, unless it was a CE-marked medical device and they held evidence to demonstrate that it was effective in detecting the various conditions and ailments listed in the ad. We referred this matter to the CAP Compliance team.

CAP Code (Edition 12)

12.1     3.1     3.7



Lyme-Related Government Actions

This page lists providers of dubious Lyme-related products and/or services who have been subjected to various types of government action. Those marked with an asterisk (*) lost or surrendered their medical license(s) as a result. Click on their links to access the details. The LymeScience Web site has stories about victims and other news related …

This page lists providers of dubious Lyme-related products and/or services who have been subjected to various types of government action. Those marked with an asterisk (*) lost or surrendered their medical license(s) as a result. Click on their links to access the details. The LymeScience Web site has stories about victims and other news related to Lyme quackery.

Licensing Board Actions Related to Nonstandard Lyme Practices
Licensing Board Actions for Other Reasons
Research Misconduct
Criminal Prosecutions
FDA Warning Letters (Illegal Claims for Products)
FDA Warning Letters (Illegal Device Claims)
Actions in Foreign Countries
For Additional Information


COVID-19 Schemes, Scams, and Misinformation

Thirty years ago, as AIDS and chronic fatigue syndrome came to national attention, John Renner, M.D. observed that most of the quack cancer clinics began offering the same “treatments” for AIDS and chronic fatigue syndrome—a tendency he coined “rascal rollover.” Today, dubious pitchmen have “rolled” into COVID-19. Here’s a handy compilation of advice, enforcement actions, …

Thirty years ago, as AIDS and chronic fatigue syndrome came to national attention, John Renner, M.D. observed that most of the quack cancer clinics began offering the same “treatments” for AIDS and chronic fatigue syndrome—a tendency he coined “rascal rollover.” Today, dubious pitchmen have “rolled” into COVID-19.

Here’s a handy compilation of advice, enforcement actions, and trustworthy information sources related to the coronavirus pandemic. For up-to-date news and scientific developments, visit the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). Fraudulent products can be reported to FDA-COVID-19-fraudulent-products@fda.hhs.gov. Other COVID-19 frauds can be reported to FTC Complaint site or the Disaster Fraud Hotline at (866) 720-5721. The FTC publishes a running total of COVID-19-related complaints it receives. To see the latest total, click the most recent date.

Terminology

COVID-19, which is short for Coronavirus Disease 2019, is the name of the disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). An article in the International Journal of Biosciences describes how the COVID-19 outbreak developed.

Schemes and Scams
  • Prevention scams: Many individuals and companies are claiming that their dietary supplements, herbal, and/or homeopathic products can prevent disease by “supporting,” “boosting” or “strengthening” the immune system.” Many chiropractors and acupuncturists are making similar claims about their procedures. All such claims should be ignored.
  • Testing Scams: Scammers are selling fake at-home test kits or going door-to-door performing fake tests for money
  • Treatment scams: Scammers are selling fake vaccines, medicines, tests, and cures for COVID-19. Ignore electronic offers for a COVID-19 vaccine, cure, or treatment. Remember, if there is a medical breakthrough, you will not hear about it for the first time through an email, online ad, or other unsolicited sales pitch.
  • Supply scams: Scammers are claiming they have in-demand products, like cleaning, household, health, and medical supplies.  When an order is placed, the scammer takes the money and never delivers the order. To avoid being victimized, check online reviews of any company offering COVID-19 products or supplies. Avoid companies whose customers have complained about not receiving items
  • Charity scams: Scammers are fraudulently soliciting donations for non-existent charities to help people affected by the COVID-19 crisis.  Scammers often use names that are similar to the names of real charities. Research any charities or crowdfunding sites soliciting donations in connection with COVID-19 before giving. Remember, an organization may not be legitimate even if it uses words like “CDC” or “government” in its name or has reputable looking seals or logos on its materials. Be wary of any business, charity, or individual requesting payments or donations in cash, by wire transfer, gift card, or through the mail. Do not send money through any of these channels. The (FTC) Web site has additional tips on avoiding charity frauds.
  • Phishing schemes: Scammers, posing as local contact tracers or national and global health authorities such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), are sending fake emails or texts to trick the recipient into sharing personal information, including account numbers, Social Security numbers, or login IDs and passwords. Never give your personal or financial information to someone unless you are absolutely sure they are legitimate. Make sure that the anti-malware and anti-virus software on your computer is operating and up to date. Do not click on links or open email attachments from unknown or unverified sources.  Doing so could download a virus onto your computer or device. If you are eligible for a payment, you will receive a payment directly from the IRS. Do not pay anyone who promises that they can expedite or obtain a payment or a loan for you. If you are eligible for relief, you will not need to make any up-front payment or pay any fee to receive a stimulus payment. You will not be charged any “processing fees.”
  • App scams: Scammers are creating mobile apps designed to track the spread of COVID-19 to insert malware that will compromise users’ devices and steal personal information.
  • Provider scams: Scammers pretending to be doctors and hospitals that have treated a friend or relative for COVID-19 and demand payment for that treatment.
  • Insurance scams: These include (a) low-cost “corona insurance,” (b) additional Medicare coverage, (c) worthless travel insurance, and (d) fake policy-cancellation notices intended to gather personal information or lead to links that install malware.
  • Investment scams: Scammers are promoting the stock of small companies, which have limited publicly-available information, using false or misleading claims that the companies’ stock will increase dramatically due to the COVID-19 outbreak, such as claims that a company can prevent, detect, or cure COVID-19. The U.S. Securities and Exchange Commission (SEC) is warning about online promotions, including on social media, claiming that the products or services of publicly-traded companies can prevent, detect, or cure coronavirus and that the stock of these companies will dramatically increase in value as a result.
  • Grandparent scams: Scammers pose as panicked grandchildren in trouble, urging you to wire money immediately. They’ll say they need cash to help with an emergency – like paying a hospital bill or needing to leave a foreign country. Resist the urge to act immediately no matter how dramatic the story is. Verify the caller’s identity by asking questions that a stranger couldn’t possibly answer. Call verifiable contacts to check the story. Don’t send money you can’t get back from scammers: cash, gift cards, or money transfers.
  • Taxpayer relief scams: The Internal Revenue Service urges taxpayers to be on the lookout for emails, text messages, websites, and social media attempts that appear to come from the IRS and ask you to verify or provide your financial information so you can get a coronavirus economic impact payment or your tax refund faster. Scammers may use words like “Stimulus Check” or “Stimulus Payment.” They may mail a bogus check, perhaps in an odd amount, then tell the taxpayer to call a number or verify information online in order to cash it. Suspicious messages that appear to be from the IRS or an organization closely linked to the IRS, such as the Electronic Federal Tax Payment System (EFTPS), should be forwarded to phishing@irs.gov. For more information go to the Report Phishing and Online Scams page and the Coronavirus Tax Relief page on IRS.gov.
  • Price gouging: Individuals and businesses selling essential goods, like hand sanitizer, for significantly higher prices than in a non-emergency setting.
U.S. Federal Actions
State and Local Actions
Foreign Actions
Trustworthy Information


Dr.London is a professor of public health at California State University, Los Angeles, editor of Consumer Health Digest, and a scientific and technical consultant to the Committee on Skeptical Inquiry.



Government Actions against Richard A. Marschall, N.D.

Naturopath Richard A, Marschall operated the Natural Healing Clinic in Port Angeles, Washington. for many years. In 1998, the Washington Board of Naturopathy disciplined him for unprofessional conduct that involved treating an out-of-state patient he had not examined for “functional hypothyroidism”—an alleged condition sometimes referred to as “Wilson’s Syndrome.” In 2010, Marschall was criminally convicted …

Naturopath Richard A, Marschall operated the Natural Healing Clinic in Port Angeles, Washington. for many years. In 1998, the Washington Board of Naturopathy disciplined him for unprofessional conduct that involved treating an out-of-state patient he had not examined for “functional hypothyroidism”—an alleged condition sometimes referred to as “Wilson’s Syndrome.” In 2010, Marschall was criminally convicted of illegally marketing a growth hormone product (HCG) for weight loss. In 2013, in response to this conviction, the board disciplined him again. In 2015, he surrendered his naturopathic license. In 2017, he was convicted again for illegally marketing HCG. In 2018, in response to this conviction, the board revoked his license with no right to reapply for it. In April 2020, he was charged with a federal felony related to his attempts to promote a misbranded drug as a prevention for COVID-19. This article describes these enforcement actions in detail.

Wilson’s Syndrome

For more than 20 years, “functional hypothyroidism” has been promoted as “Wilson’s Syndrome,” a term concocted by E. Denis Wilson, M.D., who practiced in Florida in the early 1990s. The syndrome’s supposed manifestations include fatigue, headaches, PMS, hair loss, irritability, fluid retention, depression, decreased memory, low sex drive, unhealthy nails, easy weight gain, and about 60 other symptoms. Wilson claims to have discovered a type of abnormally low thyroid function in which routine blood tests of thyroid are often normal. He states that the main diagnostic sign is a body temperature that averages below 98.6° F (oral), and that the diagnosis is confirmed if the patient responds to treatment with a “special thyroid hormone treatment.” [1]

In 1992, the Florida Board of Medicine fined Wilson $10,000, suspended his license for six months, and ordered him to undergo psychological testing [2]. Although he does not appear to have resumed practice, his ideas are still promoted by the Wilson’s Syndrome Foundation.

Wilson’s syndrome is not recognized by the scientific community as a legitimate diagnostic entity. In 1999, the American Thyroid Association issued a strongly worded statement that concluded:

  • The proposed basis for “Wilson’s syndrome” is inconsistent with well-known and widely-accepted facts about thyroid hormone production, metabolism, and action.
  • The diagnostic criteria for “Wilson’s syndrome”—nonspecific symptoms and body temperature measurement—are imprecise.
  • There is no scientific evidence that T3 therapy is better than a placebo would be for management of nonspecific symptoms, such as those that have been described as part of “Wilson’s syndrome,” in individuals with and normal thyroid hormone concentrations,
  • T3 therapy results in wide fluctuations in T3 concentrations in blood and body tissues. This produces symptoms and cardiovascular complications in some patients, and is potentially dangerous [3].

Note: Although “Wilson’s Syndrome”—as defined by Dr. Wilson—is a bogus diagnosis, there is a Wilson’s disease, a rare condition caused by a defect in the body’s ability to metabolize copper.

Disciplinary Action in 1998

In May 1994, a local newspaper reported that Marschall had learned about “Wilson’s Syndrome” by studying Wilson’s publications and had consulted Wilson by phone. The article said that Marschall was treating more than 200 Wilson’s Syndrome patients and that the cost of the initial diagnosis, including the blood test, was $400 [4]. Court documents filed on September 30, 1997, by Washington’s Secretary of Health state:

  • In 1994, Marschall “met” Patient A, a California resident, through an online computer service and discussed Patient A’s health concerns via the online service. Soon thereafter, Marschall mailed the patient a personal history form, a fee schedule, a patient/physician contract to read and sign, and instructions on how to take her temperatures. After reading Patient A’s completed personal history form and temperature log, he diagnosed the patient as suffering from a thyroid problem and determined treatment for that diagnosis in a telephone conversation with the patient.
  • Marschall never performed a physical examination of Patient A and did not order or perform the standard laboratory tests used for appropriate diagnosis of thyroid malfunction. Despite this, in January 1994, he prescribed a synthetic thyroid hormone (liothyronine) that was mailed to patient A from Bellgrove Pharmacy in Bellevue, Washington.
  • In 1995, Marschall diagnosed and treated between 75 and 100 long-distance patients for “functional hypothyroidism” solely via telephone, online computer services, and/or by mail. He prescribed liothyronine for at least five of them who resided in states other than Washington.
  • The standard recommended dosage of liothyronine is between 25 and 75 micrograms per day. Marschall prescribed dosages as great as 300 micrograms per day, with about 25% of his “functional hypothyroidism” patients receiving doses greater than 200 micrograms per day. Excessive ingestion of liothyronine is hazardous and can result in death. Unprofessional conduct, as defined by Washington’s laws and regulations, includes conduct that “creates an unreasonable risk that a patient may be harmed.” [5]

During the proceedings, Marschall claimed that he had based his diagnosis of Patient A on laboratory records obtained from the Kaiser Foundation Hospital/Kaiser Permanente Medical Group. However, Kaiser personnel stated that the records were not requested until 1998, and Patient A stated that she had not signed any release for Marschall to get her records [6].

In 1998, the Washington State Department of Health suspended Marschall’s license for 30 months with the provision that he could continue practicing if he did not treat out-of-state patients without physically examining them and treating them in tandem with a health-care professional from the state where the patient resides. He also agreed to pay a $3,000 administrative fine and to permit a Health Department investigator to audit records and review what he was doing twice a year for a two-year period [7]. The proceedings did not address whether “Wilson’s syndrome” is a genuine entity or whether the factual details in the complaint were accurate.

Criminal Prosecution

In February 2009, customs agents intercepted a package of human chorionic gonadotropin (HCG) that was addressed to Marschall from India. To be properly labeled, HCG must contain a warning that it has not been demonstrated effective for the treatment of obesity. The FDA then sent Marschall a detention notice which said that the drug was improperly labeled and would be released to him only if he provided a good reason to believe that the product complied with the law. He replied:

I am an endocrinologist, a hormone expert. I use Human Chorionic Gonadotropin to treat infertile patients. I require it in 5,000 units ampules most of the time. Some times use 10,000 unit ampules which I can get from American pharmaceutical manufacturers. But American manufacturers do not make 5,000 unit ampules. HCG has only a 60 day shelf life so when I need 5,000 unit ampules to treat over a longer period of time I must purchase them from pharmaceutical manufacturers who make it that way and they happen to be in other countries. I have been in practice 23 years and I have a lot of experience with HCG. The HCG that I get from these suppliers works just as well as the HCG I get from US manufacturers and cost about the same.

I hope you will release my shipment soon, I have several patients in need of treatment. If I can answer any other questions you have please email me [8].

The FDA did not release the shipment to Marschall. In July 2009, customs agents detained a similar HCG shipment and sent Marschall another detention notice. Despite these notices, Marschall ordered (and received) illegally manufactured HCG from a compounding pharmacy in Florida—which FDA investigators found by searching the trash picked up at his clinic. In 2010, federal agents searched Marschall’s clinic and seized computers, patient files, and dozens of boxes of HCG. During the search, Marschall falsely told FDA official that he prescribed HCG for infertility. However, his Web site stated that he used it for weight-loss. (In fact, in 2009 and 2010, the site claimed that users of his HCG-Slim program would “lose a pound a day and keep it off for life.”) In 2011, Marschall was charged with one count of causing the introduction of misbranded drugs. [9].Shortly afterward, he entered a guilty plea in which he acknowledged that he had lied to the FDA [10]. The court sentenced him to 2 years supervised release and ordered to provide 250 hours of community service and pay a $2,000 fine plus a $100 special assessment. At the sentencing hearing, Marschall told the judge:

It is clear to me that I made a mistake by ordering HCG over the Internet. I will say in my defense that HCG is something that has been used in the world since the 1930s, and it has been used for heart disease and rheumatoid problems, prostatic hypertrophy, for immune system disregulation, as well as for weight loss. I have been using it for all those different things.

So when my sources in America were unable to provide me—and I contacted every possible compounding pharmacy from California to the East Coast to try to get HCG through my normal channels. I never ordered off of the Internet for any other reason than this.

I felt, knowing that it was at least a misdemeanor to do so, that in my belief system, according to the philosophy I was trained under at the University of Santa Clara, you can break a civil law in pursuit of a higher moral law. So in my opinion, in my belief at the time, getting HCG for patients who had benign prostatic hypertrophy, who were struggling with cancer as well as weight problems and an inability to get pregnant and heart disease and several of the conditions that this amazing compound, this natural compound was providing benefit for, if they couldn’t supply—if the three American manufacturing suppliers couldn’t provide it for me and the Canadians had documented safety evidence for their HCG, which is what they told me and what I was aware of from other sources and other patients who were getting it from the same place, then I did break the law and I did do that.

And as soon as—I guess you might say some people would have said to me that you are a victim of your own success, meaning about the 13th clinic that I could ascertain by 2008 to provide HCG for any reason, other than undescended testicles and infertility which the FDA has approved it for. I was training other doctors around—some of my fellow naturopathic doctors who are endocrinology trained in our own way.

They started ordering, and we couldn’t get it domestically, so in fact we got it this way, not just myself, but as many Americans do, when they can’t get their own pharmaceutical drugs that they either can’t get or afford, they do it through that way. I was looking for another source and within just several months, it came available in Florida. And at the time the FDA actually took my HCG, they took domestic HCG from my clinic, a thousand dollars worth which they never returned, and it only has a shelf life of six months, so that’s the case.

I guess if I had to do it over again, I wouldn’t have done it. It was a mistake. Look what it has gotten me into here. Even with the benefit of these patients, I broke the law. So I don’t intend to ever do that again, ever [11].

Further Government Actions

In 2012, following his conviction, the Washington Department of Health (DOH) charged Marschall with unprofessional conduct [12 ]. The charges included (a) improperly representing himself as a “bariatric endocrinologist” and (b) being convicted for trafficking in human chorionic gonadotropin (HCG), which he was illegally prescribing as a weight loss drug. The charges were settled with an agreed order under which:

  • Marschall admitted that between 2008 and 2010, he prescribed HCG to approximately 170 patients who lived outside of Washington State and had never seen him in person.
  • The DOH fined him $10,000, suspended his license for at least one year, ordered him to take continuing education courses in ethics, endocrinology, and obesity.
  • Marschall was ordered to remove references to HCG from his Web site and indicate that all new patients must be examined during their initial visit.
  • If his license is reinstated, he must serve seven years on probation with semi-annual record audits for one year and annual audits for four years [13].

In 2014, while his license was under suspension, the board learned that Marschall was still holding himself out as a practicing naturopath, soliciting patients, and prescribing drugs. In fact, pages on archive.org indicate that he continuously advertised naturopathic services at his Natural Healing Clinic until at least the end of 2014 [14]. In September 2015, he signed an agreed order that required him to pay a $5,000 fine and permanently cease and desist from practicing naturopathy in the State of Washington without a requisite health credential [15]. However, he continued doing business as “Rick Marschall, N.D.” at his Natural Healing Clinic. The clinic Web site stated:

After 31 years I have retired from prescriptive practice. I have let go of my license to practice medicine or naturopathic medicine in the State of Washington and I am not licensed to prescribe prescription drugs in the State of Washington or plan to do so anywhere else. I have learned how to help people with significant health challenges in a more effective, sustainable and inexpensive way without the need for drugs for most issues. Read on and then call me at no charge to discuss whether this diet and lifestyle change is of interest to you [16].

The treatments mentioned on his site included “nutritional counseling,” “sex hormone balancing,” “constitutional homeopathic energy medicine,” but government investigators found that he was still prescribing HCG to patients. In 2017, Marschall pleaded guilty to introducing misbranded drugs into interstate commerce and was fined $2.000 and sentenced to two months in prison to be followed by one year of supervised release. Documents in the case state:

  • Between February 2014 and February 2017, Marschall prescribed HCG to about 60 individuals for weight loss.
  • Marschall obtained the HGH from various compounding pharmacies by lying about the states of his license and DEA registration number.
  • In September 2016, two Washington Department of Health investigators went undercover as patients and listened as Marschall touted HCG for weight-loss and described how he would set up a program of injections for them.
  • Later that fall, Marschall communicated via email with an undercover FDA criminal investigator, conducted a one-hour telephone screening, and, without meeting or examining the patients, mailed HCG to her at a cost of $550 for a one-month supply [17,18].

In 2018, Marschall signed an agreed order under which Marschall admitted that he had been practicing naturopathy illegally since 2013. The order also “permanently enjoined from the practice of naturopathic medicine, and from representing himself as a naturopathic physician or using the initials ‘ND’, the title ‘doctor’ or ‘naturopath’, or any other similar title, without the requisite health care credential [19]. However, he continued to market himself himself a “health coach” and “retired” naturopath.

In March 2020, FDA criminal investigators began reviewing complaints from the public about postings on Facebook and a website linked to Marschall which claimed that a “Dynamic Duo” of substances could kill viruses, including the coronavirus. A few days later, an FDA undercover investigator phoned Marschall  and was told that one of the substances “doesn’t boost the immune system, it just kills the virus” and the other would boost the production of white blood cells that attack infections. The agent bought some “Dynamic Duo,” which came with documents which stated that the products “can crush 30 different viral infections, including those in the Corona family, (like in China Corona-19), 40 different bacterial infections, 25 different fungal infections and 20 different parasitic infections like amoebas.” Marschall is charged with introducing misbranded drugs into interstate commerce [20].

If Marschall is convicted, I hope the court can devise a sentence that will persuade him to permanently stop selling any type of health product, service, or advice.

References
  1. Wilson ED. Wilson’s Syndrome: The Miracle of Feeling Well, 2nd edition. Orlando, Florida: Cornerstone Publishing Co., 1991.
  2. Disciplinary actions: E. Denis Wilson (MD #0048922) Longwood Florida, 2/12/92). Board of Medicine 8(2):10, 1992. Florida Department of Professional Regulation, Tallahassee, Florida.
  3. American Thyroid Association statement on “Wilson’s Syndrome.” Revised Nov 16, 1999.
  4. Dawson M. ‘Miracle’ cure has side effects. Peninsula Daily News, Port Angeles, Washington, May 8, 1994.
  5. State of Washington, Department of Health, Naturopathy Program. Statement of charges. Docket No. 97-09-B-1045 NT, Sept 30, 1997.
  6. State of Washington, Department of Health, Naturopathy Program. Amended statement of charges. Docket No. 97-09-B-1045 NT, April 17, 1998.
  7. State of Washington, Department of Health, Naturopathy Program. Stipulated findings of fact, conclusions of law, and agreed order. Docket No. 97-09-B-1045 NT, July 20, 1998.
  8. Petroff K. Application for a search warrant. The Natural Healing Clinic. March 1, 2010.
  9. Information. U.S.A. v Richard Marschall. U.S. District Court. Western District of Washington at Tacoma, Case No. CR11-5222BHS, April 22,, 2011.
  10. Plea agreement. U.S.A. v Richard Marschall. U.S. District Court. Western District of Washington at Tacoma,Case No.. CR11-5222BHS, May 9, 2011
  11. Transcript of September 26, 2011 sentencing hearing. USA v. Richard Marschall. U.S.A. v Richard Marschall. U.S. District Court. Western District of Washington at Tacoma,Case No.. CR11-5222BHS. .
  12. Statement of charges. In the matter of Richard A. Marschall. Washington Department of Health Board of Naturopathy, Sept 17, 2012.
  13. Stipulated findings of fact, conclusions of law and agreed order. In the matter of Richard A. Marschall. Washington Department of Health Board of Naturopathy, Nov 15, 2013.
  14. Natural Health Clinic home page, archived Dec 30, 2014.
  15. Stipulated findings of fact, conclusions of law, and agreed order to cease and desist. In the matter of Richard A. Marschall. Washington Department of Health, Secretary of Health, Case No. M2015-742, Sept 21, 2015.
  16. Natural Healing Clinic home page, as archived 1917-1919.
  17. Plea agreement. U.S.A. v. Richard Marschall. U.S. District Court for the Western District of Washington. Case No. 3:17-cr-05226, filed July 6, 2017.
  18. Government’s sentencing memorandum. U.S.A. v. Richard Marschall. U.S. District Court for the Western District of Washington. Case No. 3:17-cr-05226, filed Oct 13, 2017.
  19. Stipulated findings of fact, conclusions of law and and agreed order. In the matter of Richard A. Marschall. Washington Department of Health, Board of Naturopathy, Case No. M2017-857, Oct 19, 2018.
  20. Complaint for violation of Title 21, U.S. Code, Sections 331, 333. U.S.A. v. Richard Marschall, Case No. MJ20-5097, April 29, 2020.


Why Bioresonance Hair Testing Is Preposterous

Several companies claim that bioresonance hair tests can detect nutritional deficiencies; overexposure to heavy metals; and food and environmental intolerances and that the test results will provide a roadmap to better health. Tests are available for pets as well as for humans. This report explains why I believe these claims are preposterous. What Is Bioresonance …

Several companies claim that bioresonance hair tests can detect nutritional deficiencies; overexposure to heavy metals; and food and environmental intolerances and that the test results will provide a roadmap to better health. Tests are available for pets as well as for humans. This report explains why I believe these claims are preposterous.

What Is Bioresonance Testing?

Bruce Copen Laboratories, headquartered in Munich, Germany, describes itself as “the world’s leading company in the field of Quantum Response Technology.” The company was founded by Bruce Copen (1923-1998), who is described on the company’s Web site as a “mastermind” and “radionics pioneer” who founded the British Radionics Association and edited the British Journal of Radiesthesia [1]. The site further states:

  • Copen developed a device that could determine which of 2600 homeopathic remedies could help the patient.
  • Following his death, the current management developed a series of computer-based devices that went beyond his original technology.
  • The latest of the devices—called the Multiple Analytical Resonance System (MARS III)—Is “based on “the science of Quantum Entanglement.” [1]

To perform a bioresonance hair analysis, a hair sample is placed into the input well pictured on the right. Then, according to the company: “an energetic facsimile . . .  is matched and then made into reports” that indicate “where the client’s energy field is blocked or distorted and on which energy level is going on this imbalance.” [2]

Radionics is a pseudoscience based on the notion that diseases can be diagnosed and treated by tuning in on radio-like frequencies allegedly emitted by disease-causing agents and diseased organs. The theory behind it originated with Albert Abrams, M.D. (1864-1924), who developed thirteen devices claimed to detect such frequencies and/or cure people by matching their frequencies. Abrams made millions leasing his devices and was considered by the American Medical Association to be the “dean of gadget quacks.” [3]

I do not believe that placing a hair sample in the input well will influence the output from the device because (a) hair does not emit “frequencies” and (b) the “energy fields” claimed by Abrams and his followers do not exist. It is also well established that the composition of body hair—when measured in a standard chemical laboratory—does not reflect the body’s nutritional status or reveal “intolerances.” [4]

In 2009, the U.S. Food and Drug Administration included the MARS III in an import alert that covered “all radionic instruments intended for use in diagnosis of internal diseases” coming from Bruce Copen Laboratories or the Sussex College of Technology. That ban is still in effect [5].

Copen’s Diploma Mill

I addition to marketing radionics devices, Copen sold bogus credentials from the “Sussex College of Technology.” I learned about this when I helped the FBI investigate an American cancer quack named Gregory Caplinger. Evidence in the case revealed that Copen, who operated from his home in East Sussex, issued degrees and transcripts in return for modest payments. When questioned by a Scotland Yard detective, Copen said that Caplinger had obtained a “doctor of science degree in biochemistry and immunology” in 1987 by taking a correspondence course and later sent $70 with a request for transcript that included eight courses plus a dissertation that garnered 58 credit hours. Copen stated that the correspondence course had cost about $400 but he had retained no record of its duration. He also mentioned that he himself had become “doctor of homeopathy” in 1952 by taking a correspondence course. The UK’s Education Reform Act of 1988 stopped Copen from issuing “degrees,” but he continued to issue diplomas [6]. Caplinger was convicted in 1990 of wire fraud and money laundering and was ultimately sentenced to 12 years in prison [7].

Bioresonance Hair Test Results

The MARS III Quantum Response System is used to provide reports to people who mail hair samples to companies that solicit through the Internet. One such company—Modern Allergy Management LLC, of Pensacola, Florida—calls its procedure “hair intolerance testing.” Its Web site states that its $95 “MAM 750 Gold Standard test” can show which of 750 items items can “cause you a reaction due to having an intolerance.” [8] The tests are said be to processed by Biostar Technology S.R.O. in Prague, Czechoslovakia. Sample reports posted to the company’s Web site include the following claims:

  • The nutritional deficiencies test indicates the extent to which vitamins and minerals are retained after consumption  It classifies retention as “high” (excess retention), “best” (ideal), “fair” (normal), or “need” (low retention, for which supplementation “may prove beneficial”).
  • The test for heavy metals, describes “levels of intolerance” to various items as high, medium, or low, but acknowledges that the test is “unable to determine the amount of any substance present in the body.”
  • The environmental and food intolerance test reports classify items as Level 3, Level 2, or Level 1.

Healthy Stuff Online, Ltd., of Indialantic, Florida, offers MARS III radionic testing of hair samples against 400, 600, or 800 food and nonfood items. Its Web site states that the device “captures and diagnoses electromagnetic signals coming from the body. The cost, which depends on the number of items, ranges from $70.00 to 104.99. The site acknowledges—in small print—that “Conventional medicine does not currently recognise Bioresonance as it has not been subject to significant scientific research.”

Affordable Allergy Test , LLC of Laurenceville, Georgia, claims that its 5Strands Affordable Testing “utilizes . . .  bioresonance technology to identify temporary imbalances causing symptoms such as upset stomach, headaches, bloating, joint pain, water retention, paw biting, excessive hair loss, hot spots, itching.” A sample report, which the company sent to someone who inquired, provided the following results:

  • The Level 3 lists of food and environmental intolerances include 87 that are “very likely to cause noticeable symptoms,”
  • The Level 2 lists of food and environmental intolerances include 96 that “may result in reactions such as itchy skin, runny nose, watery eyes, etc.,”
  • The Level 1 lists of food and environmental intolerances include 116, which, “while there may be no noticeable symptoms, may potentially cause issues with ingestion or exposure over time.”

In a YouTube video, one of the company’s co-founders says that the testing provides “a road map to conduct an elimination plan” by avoiding all of the Level 3 and Level 2 items for and choosing from among the hundreds of other items on the master list for 6-8 weeks [9]. However, the idea that more than 300 food items should be suspect is absurd, and the idea that an elimination diet should begin with hundreds of possible foods is even more absurd. Elimination diets, if medically indicated, should begin with only a few foods, with suspected foods added every few days to see whether they cause trouble. People considering an elimination diet would be better served by keeping a careful dietary history and consulting a dietitian or other appropriately trained professional [10].

The video also advises that (a) eating a food every single day should be avoided because that can lead to “intolerance due to overconsumption,” and (b) many people become deficient in oxygen because they don’t eat enough “fruits and vegetables that contain oxygen.”

Although 5Strands’ reports are similar to those of Modern Allergy Management, I do not know whether they use the same testing device. When asked what device they used, a 5Strands representative replied: “We are unable to share the specifics regarding the machines that we utilize or any other specifics regarding our testing as it involves sensitive intellectual property.”

Better Business Bureau Reports

Between November 8, 2018 and December 31, 2019, the Better Business Bureau (BBB) received 23 complaints about Modern Allergy Management. Most said that the test result took too long to arrive or did arrive at all. A few thought that the results could not possibly be correct—the most notable of these was from a mother who said that her six-year-old son’s test report recommended giving him a “male vigor sex-enhancement supplement.” [11] Based on the number of complaints, the BBB gave the company a “C” rating. Affordable Allergy Test, LLC and Healthy Stuff Online have no BBB ratings.

If you have undergone bioresonance hair testing and would like to share
your experience with me and/or discuss how to seek a refund, please
e-mail me a copy of your scan with a brief summary of what happened.

References
  1. From classic radionics to bioresonance. Bruce Copen Laboratories Web site, accessed April 21, 2020.
  2. MARS III. Bruce Copen Laboratories Web site, accessed April 21, 2020.
  3. Barrett S. Be wary of radionics devices. Quackwatch, Dec 27, 2011.
  4. Barrett S. Commercial hair analysis: A cardinal sign of quackery. Quackwatch, August 31, 2018.
  5. Detention without physical examination of fraudulent and deceptive medical devices. FDA import alert 80-06, Jan 7, 2020.
  6. Sussex Police report, Oct 18, 1990.
  7. Barrett S. Gregory Caplinger and his cancer scam. Quackwatch, Feb 7, 2019.
  8. MAM Exclusive Gold Standard 750 Intolerance Test. Modern Allergy Testing Web site, accessed April 21, 2020.
  9. Standard Package Test Report—5Strands—Food Environmental Nutrition—FAQ’s.  YouTube video, posted Oct 25, 2019.
  10. Gordon B. What is an elimination diet? Academy of Nutition anbd Dietetics Web site, Aug 13, 2019.
  11. BBB report on Modern Allergy Management LLC, accessed April 23, 2020.


Federal Judge Blocks Sale of Fake COVID-19 Treatment

A federal district judge has ordered Ray L. Nannis, D.C., to stop marketing a homeopathic “treatment” for COVID-19. The civil complaint (show below) states: Nannis, who operates Optimum Wellness Solutions, in Richardson, Texas, had advertised homeopathic sublingual products  as both a “C-19 vaccine” and a “treatment, reducing severity and duration of symptoms, should you test …

A federal district judge has ordered Ray L. Nannis, D.C., to stop marketing a homeopathic “treatment” for COVID-19. The civil complaint (show below) states:

    • Nannis, who operates Optimum Wellness Solutions, in Richardson, Texas, had advertised homeopathic sublingual products  as both a “C-19 vaccine” and a “treatment, reducing severity and duration of symptoms, should you test positive.”
    • During a call from a government agent, Nannis insisted that his products could provide protection from the novel coronavirus—“more so than any other vaccine out there right now”—and  would also minimize the symptoms of those who were infected.
    • Although cautioning that he could not “technically” describe the products as a “cure” for coronavirus due to FDA restrictions, Nannis said that it “basically” and “for all intents and purposes” was a cure.

Alleging that Nannis was facilitating a “predatory” ongoing wire fraud scheme to exploit the COVID-19 pandemic, the government sought injunctive relief under the Anti-Fraud Injunction statute.


IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
DALLAS DIVISION


UNITED STATES OF AMERICA,

Plaintiff,

v.

DR. RAY L. NANNIS, P.C., dba OPTIMUM
WELLNESS SOLUTIONS, a Texas corporation;
and DR. RAY L. NANNIS, an individual,

Defendants.

Civil Action No. 3:20-cv-00940-B

 


COMPLAINT FOR TEMPORARY RESTRAINING ORDER,
PRELIMINARY INJUNCTION, AND PERMANENT INJUNCTION

The United States of America brings this action against Defendants Dr. Ray L. Nannis, P.C. dba Optimum Wellness Solutions (Optimum) and Dr. Ray L. Nannis (Dr. Nannis) for injunctive relief pursuant to 18 U.S.C. § 1345 to prevent an ongoing fraud on the public.

INTRODUCTION

  1. Defendants are conducting a predatory wire fraud scheme exploiting the current COVID-19 pandemic.
  2. Defendants maintain a purported treatment office in Richardson, Texas, where they provide, among other things, chiropractic, homeopathic, and other natural treatments.
  3. Defendants have made numerous false claims on the Internet and to prospective customers that they can provide a homeopathic product that will prevent, mitigate, or otherwisentreat COVID-19 and/or the novel Coronavirus.
  4. There are currently no known FDA approved vaccines or drugs to treat COVID-19 and/or the novel Coronavirus.
  5. The United States seeks to prevent continuing and substantial injury to victims ofthis fraudulent scheme by bringing this civil action under 18 U.S.C. § 1345 to enjoin Defendants’ ongoing facilitation of wire fraud in violation of 18 U.S.C. § 1343.

JURISDICTION AND VENUE

  1. The Court has subject matter jurisdiction over this action under 18 U.S.C. § 1345 and 28 U.S.C. §§ 1331 and 1345.
  2. Venue is proper in this district under 28 U.S.C. § 1391(b)(2) because a substantial part of the events or omissions giving rise to the claim occurred in this district.

THE PARTIES

  1. Plaintiff is the United States of America.
  2. Defendant Optimum is a professional corporation organized under the laws of the State of Texas and headquartered in Richardson, Texas.
  3. Defendant Dr. Nannis is an individual residing in Plano, Texas. Dr. Nannis serves as Optimum’s Director, President, Secretary, Treasurer, and Registered Agent. Dr. Nannis is a chiropractor licensed in Texas. Dr. Nannis is not a medical doctor, does not have a medical degree, and is not licensed as a physician in Texas or any other state.

FRAUDULENT SCHEME

  1. On March 30, 2020, Special Agent Gabriel Marchal of the United States Secret Service visited the account “OptimumWellnessSolutions” located on the public website Facebook. Agent Marchal located posts on Facebook promoting Defendants’ Richardson location and encouraging consumers to visit Defendants to use their services. As of the date of this filing, all of the posts referenced below appeared on Optimum’s Facebook account.
  2. Multiple posts that appear on Optimum’s Facebook account falsely state that a homeopathic product can prevent, mitigate, or otherwise treat COVID-19 and/or the novel Coronavirus. For example, in a March 19, 2020 written post, Defendants describe a “Corona-19 Homeopathic Vaccine remedy,” explaining that “Coronavirus-19 can be treated effectively with safe, non-toxic, sublingual Homeopathic and other natural remedies.” In the same post, Defendants wrote that these “Homeopathic COVID-19 remedies are now available, through Optimum Wellness Solutions and help build immunity against the virus. Please reserve your homeopathic . . . ASAP to pick up the remedies that will help protect yourself and your loved ones.” In a subsequent March 30, 2020 video post on Optimum’s Facebook account, Dr. Nannis explains that they now “have a homeopathy available,” suggesting that it could have a “90% protection” rate against COVID-19. In an April 1, 2020 video post on Optimum’s Facebook account, Dr. Nannis further touts the availability of the “homeopathy,” explaining that it can prevent COVID-19 or “if you do get sick, it’s going to make it very very very minimal.” In an April 16, 2020 video post on Optimum’s Facebook account, Dr. Nannis states that Optimum’s “homeoprophylactic” provides “the best protection” against contracting COVID-19.
  3. On March 30, 2020, Agent Marchal called Optimum at a number identified on the Optimum website and Facebook account. Agent Marchal inquired with someone in the Optimum office regarding the alleged homeopathy for COVID-19, and was told that Dr. Nannis would call Agent Marchal back to discuss the homeopathy. Dr. Nannis called Agent Marchal later on March 30, 2020. At that time, Agent Marchal spoke with Dr. Nannis regarding the purported “Coronavirus-19” homeopathic product described on Optimum’s Facebook account.
  4. During the call, Dr. Nannis stated that due to the FDA—seemingly alluding to the Federal Food & Drug Administration—he could not say that the homeopathy he sold through Optimum would “cure” the novel Coronavirus and/or COVID-19. Despite acknowledging the strictures placed on such representations by the FDA, Dr. Nannis nonetheless stated during his call with Agent Marchal that the homeopathy he was offering through Optimum should provide 90% protection against the novel Coronavirus. Dr. Nannis further claimed that, if someone became infected with the novel Coronavirus and/or COVID-19, the homeopathy he was offering would minimize any associated symptoms. Dr. Nannis offered to sell this homeopathy to Agent Marchal for $95 per dose. Dr. Nannis offered to ship the homeopathy directly if Agent Marchal provided his credit card information.
  5. The claims made by Defendants are false and fraudulent, as the participants in the scheme either know or consciously avoid knowing the fact that there is no known effective medical cure or treatment for COVID-19 and/or the novel Coronavirus.
  6. As of April 14, 2020, agents have observed consumers patronizing Defendants’ Richardson location, indicating that the scheme is ongoing.
  7. Victims suffer financial losses from the wire fraud scheme facilitated by Defendants, and victims further suffer harm via potential exposure to the novel Coronavirus and/or COVID-19 by unnecessarily visiting Defendants’ location to obtain a treatment that does not work.18. Absent injunctive relief by this Court, Defendants’ conduct will continue to cause injury to victims.

COUNT ONE
18 U.S.C. § 1345

  1. The United States re-alleges and incorporates each of the preceding paragraphs as though fully set forth herein.
  2. By reason of the conduct described herein, Defendants have violated, are violating, and are about to violate 18 U.S.C. § 1343 by facilitating a scheme and artifice to defraud and obtain money or property by means of false or fraudulent representations with the intent to defraud, and, in so doing, use interstate wire communications.
  3. Upon a showing that Defendants are committing or about to commit a violation of 18 U.S.C. § 1343, the United States is entitled, under 18 U.S.C. § 1345, to seek a temporary restraining order, a preliminary injunction, and a permanent injunction restraining all future fraudulent conduct. The Court may also grant such other relief it deems just and proper to prevent a continuing and substantial injury to victims of the fraud scheme.
  4. As a result of the foregoing, the Court should enjoin Defendants’ conduct under 18 U.S.C. § 1345.

PRAYER FOR RELIEF

WHEREFORE, the United States requests judgment in its favor and against the Defendants, including the following relief:

  1. That the Court issue an order, pursuant to 18 U.S.C. § 1345, pending a hearing and determination of the United States’ application for a preliminary injunction, that Defendants, and their agents, officers, and employees, and all other persons or entities in active concert or participation with it, must immediately cease offering to treat, cure, prevent, or otherwise mitigate the impact of the novel Coronavirus or COVID-19, and remove, delete, and take down any representations by Defendants regarding the same.;
  2. That the Court issue a preliminary injunction, pursuant to 18 U.S.C. § 1345, on the same basis and to the same effect;
  3. That the Court issue a permanent injunction, pursuant to 18 U.S.C. § 1345, on the same basis and to the same effect; and
  4. All such further relief as may be just and proper.

Dated: April 16, 2020

Respectfully submitted,
ERIN NEALY COX
United States Attorney
By: _______________________
ANDREW S. ROBBINS
Assistant United States Attorney
New York Bar No. 4836508
KENNETH G. COFFIN
Assistant United States Attorney
Texas Bar No. 24076986
1100 Commerce Street, Third Floor
Dallas, Texas 75242-1699
Telephone: 214-659-8646
Facsimile: 214-659-8807
Andrew.Robbins@usdoj.gov
Kenneth.Coffin@usdoj.gov
Counsel for the United States


Kenneth Stoller, M.D. Facing Disciplinary Action

The Medical Board of California appears likely to discipline Kenneth Stoller M.D. for writing unjustified vaccination exemptions for ten children. The Accusation, shown below, states: He routinely performed genetic testing as a basis for determining whether a child should be exempted from required vaccinations, even though no genetic variations have been proven to accurately predict vaccine …

The Medical Board of California appears likely to discipline Kenneth Stoller M.D. for writing unjustified vaccination exemptions for ten children. The Accusation, shown below, states:

    • He routinely performed genetic testing as a basis for determining whether a child should be exempted from required vaccinations, even though no genetic variations have been proven to accurately predict vaccine responses.
    • He routinely obtained and relied upon unverified patient and family histories without obtaining medical records or do proper investigations.
    • Issued exemptions for all vaccines, even though there is no component that is common to all vaccines
    • His medical records were inadequate in that they contained only scant and vague patient and family histories, lacked vaccine-specific evaluations, contained diagnoses not supported by the findings or by medical science, and omitted reference to prior medical records and/or primary care physicians.

Stoller, who trained primarily as a pediatrician, is best known for his advocacy of hyperbaric oxygen therapy. In 2019, the San Francisco City Attorney served a subpoena that sought Stoller’s medical records for all vaccine exemptions he had written since 2016 (the year that California enacted SB 277 to eliminate non-medical vaccine exemptions for school entry). Stoller filed a lawsuit to quash the subpoena. That suit is still pending.


XAVIER BECERRA
Attorney General of California
JANE ZACK SIMON
Supervising Deputy Attorney General
LAWRENCE MERCER
Deputy Attorney General
State Bar No. 111898
455 Golden Gate Avenue; Suite 11000
San Francisco, CA. 94102-7004
Telephone: (415) 510-3488
Facsimile: (415) 703-5480
Attorneys for Complainant

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

In the Matter of the Accusation Against:

Kenneth Paul Stoller, M.D.
2448 Guerneville Road, Suite 800
Santa Rosa, CA 95403

Physician’s and Surgeon’s Certificate No. A 41183

Respondent


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Case No. 800-2017-034218

ACCUSATION

PARTIES

1. Kimberly Kirchmeyer (Complainant) brings this Accusation solely in her official capacity as the Executive Director of the Medical Board of California, Department of Consumer Affairs (Board),

2. On or about September 10, 1984, the Medical Board issued Physician’s and Surgeon’s Certificate Number A 41183 to Kenneth Paul Stoller, 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 December 31, 2019, unless renewed,

JURISDICTION

3. This Accusation is brought before the Board, under the authority of the following laws. Alt section references are to the Business and Professions Code (Code) unless otherwise indicated.

4. Section 2220 of the Code states:

Except as otherwise provided by law, the Board may take action against all persons guilty of violating this chapter. The Board shall enforce and administer this article as to physician and surgeon certificate holders, including those who hold certificates that do not permit them to practice medicine, such as, but not limited to, retired, inactive, or disabled status certificate holders, and the Board shall have all the powers granted in this chapter for these purposes including, but not limited to:

(a) Investigating complaints from the public, from other licensees, from health care facilities, or from the Board that a physician and surgeon may be guilty of unprofessional conduct. The Board shall investigate the circumstances underlying a report received pursuant to Section 805 or 805.01 within 30 days to determine if an interim suspension order or temporary restraining order should be issued. The Board shall otherwise provide timely disposition of the reports received pursuant to Section 805 and Section 805.01.

(b) Investigating the circumstances of practice of any physician and surgeon where there have been any judgments, settlements, or arbitration awards requiring the physician and surgeon or his or her professional liability insurer to pay an amount in damages in excess of a cumulative total of thirty thousand dollars ($30,000) with respect to any claim that injury or damage was proximately caused by the physician’s and surgeon’s error, negligence, or omission.

(c) Investigating the nature and causes of injuries from cases which shall be reported of a high number of judgments, settlements, or arbitration awards against a physician and surgeon.

5. Section 2234 of the Code 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.

(d) Incompetence.

6. Section 2266 of the Code states:

The failure of a physician and surgeon to maintain adequate and accurate records relating to the provision of services to their patients constitutes unprofessional conduct.

OTHER STATUTES

7. Health and Safety Code section 120325 provides:

In enacting this chapter, but excluding Section 120380, and in enacting Sections 120400, 120405, 120410, and 120415, it is the intent of the Legislature to provide:

(a) A means for the eventual achievement of total immunization of appropriate age groups against the following childhood diseases:

    1. Diphtheria.
    2. Hepatitis B.
    3. Haemophilus influenza type b.
    4. Measles.
    5. Mumps.
    6. Pertussis (whooping cough).
    7. Poliomyelitis,
    8. Rubella.
    9. Tetanus.
    10. Varicella (chickenpox).
    11. Any other disease deemed appropriate by the department, taking into consideration the recommendations of the Advisory Committee on Immunization Practices of the. United States Department of Health and Human Services, the American Academy of Pediatrics, and the American Academy of Family Physicians.

(b) That the persons required to be immunized be allowed to obtain immunizations from whatever medical source they so desire, subject only to the condition that the immunization be performed in accordance with the regulations of the department and that a record of the immunization is made in accordance with the regulations.

(c) Exemptions from immunization for medical reasons.

(d) For the keeping of adequate records of immunization so that health: departments, schools, and other institutions, parents or guardians, and-the persons immunized will be able to ascertain that a child is fully or only partially immunized, and so that appropriate public agencies will be able to ascertain the immunization needs of groups of children in schools or other institutions.

(e) Incentives to public health authorities to design innovative-and creative programs that will promote and achieve Juli and timely immunization of children.

8. At all relevant times, former Health and Safety Code section 120370 provided, in pertinent part:

(a) If the parent or guardian files with the governing authority a written statement by a, licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature arid probable duration of the medical condition or circumstances; including,. but not limited to, family medical history, for which the physician does not recommend immunization, that child shall be exempt from the requirements of Chapter 1 (commencing with Section 12Q325, but excluding Section 120380) and Sections i20400, 120405, 120410, and 120415 to the extent indicated by the physician’s statement.

FACTUAL ALLEGATIONS

9. At all relevant times, Respondent Kenneth P. Stoller, M.D., was a physician and surgeon with a specialization in pediatrics at his office in San Francisco, California.

10. In 2015, the California Legislature amended Health and Safety Code section 120325 to eliminate personal beliefs as a basis for exemption from required immunizations for school-aged children. As a consequence, school-aged children not subject to any other exception were required to have immunizations for 10 vaccine-preventable childhood illnesses as a condition of public school attendance.

11. Beginning in 2016, Respondent began issuing medical exemptions to school-aged children.

12. Patient 1, a 4-month old male, was seen by Respondent on or about August 9, 2016. Patient 1 had a medical history significant for a congenital heart defect, and reports of vomiting, shortness of breath and difficulty gaining weight. Respondent’s records state a history of present illness (HPI) as the parents’ concern about an adverse event from immunization (AEFI). Respondent did not document an examination or record vital signs. His plan was to test for HLA DRBl/DQBl genes. Based on subsequent testing, Respondent concluded that the HLA-DRBl *13 allele was absent and that the child had an HLA DRBI 03 allele, which genetic polymorphisms Respondent concluded would likely make him a vaccine non-responder to the vaccines for measles and hepatitis B. Albeit he had not identified any vaccine contraindication or precaution, as defined by the Centers for Disease Control and Prevention and/or the American Academy of Pediatrics, Respondent issued a medical exemption for Patient 1 that was global, i.e. applying to all vaccines, and permanent in duration.

13. Patient 2, a 2.5-year-old female, was seen by Respondent on September 27, 2018. The examination documented for Patient 2 was within normal limits and her medical history was unremarkable for any contraindications or precautions for any vaccines. Nevertheless, Respondent issued a temporary medical exemption based upon the history of a sibling who reportedly had an AEFI after his 6-month immunizations and had thereafter developed a learning disability. Although the temporary exemption stated that the child would be undergoing an “Adverse Event Risk Assessment,” no further testing or evaluation was performed and/or documented.

14. Patient 3, the 4.5-year-old male sibling of Patient 2, was also seen by Respondent on September 27, 2018. The parents reported that they believed Patient 3 had developed dyspraxia/apraxia after receiving a set of six immunizations at age 6 months. They reported that the morning after he received the vaccines, Patient 3 was found lying in “a puddle of blood and vomitus.” Respondent described the reported event variously as “near SIDS,” “near exsanguitory” and an “acute encephalitic response” or AEFI. Respondent did not obtain the child’s pediatric records, nor did he investigate further. Respondent’s plan was to perform genetic testing, however, such testing is not documented and apparently was not done. Respondent issued a temporary exemption from all required vaccinations.

15. Patient 4, a 4-year old female, was seen by Respondent on December 14, 2015. At that time, the child’s mother reported that the child had not had any immunizations and that the mother was concerned that the child might have a genetic predisposition to adverse reactions to vaccinations, based upon a family history of autoimmune illnesses and relatives with neurodevelopmental issues and autism. Respondent did not obtain or review any past medical records. On or about April 29, 2016, Respondent issued a medical exemption letter for Patient 4. In that document, Respondent stated that Patient 4 “has genetic issues” and as a result, “she is at high risk of adverse events to vaccination so that vaccinations are not considered safe.” As with Patient 1, discussed above, the exemption is permanent and barred administration of any and all vaccines. In his “Adverse Event Risk Assessment Report,” Respondent stated that the basis for his conclusion that vaccines were unsafe for the child was that “the patient has the IRFl/MTHFR/IL-4 polymorphism.” In a subsequent interview, Respondent acknowledged that genetic polymorphisms are not recognized by the CDC as medical contraindications to vaccination.

16. Patient 5, a 6-year old female, was seen by Respondent on December 18, 2017. Prior to that visit, as was his custom and practice, Respondent conducted a telephone interview with the child’s father. In that interview, the HPI was stated as the parent’s concern that the child would be at risk of an adverse vaccine reaction based upon a sibling with “post vaccine auto-immune issues including but not limited to chronic joint pain and allergies to various foods, gluten and metals.” Respondent’s plan was to perform genetic testing, for which the parents were instructed to purchase “23 and Me” a direct-to-consumer ancestry and genetic testing product. Respondent then interpreted the raw data to conclude that the child had multiple polymorphisms on multiple genes which he stated were related to adverse risks from vaccinations. Respondent issued a permanent exemption from all vaccinations for the child, which stated that “vaccination is not considered safe due to [Patient 5’s] specific genetics.”

17. Patient 6, a 12-year old male child and sibling of Patient 5, underwent the same evaluation as his sister and received a permanent and global exemption from all vaccinations based upon genetic polymorphisms.

18. Patient 7, a 5-year old female, was seen by Respondent on January 3, 2018. Prior to that visit, in a telephone consultation, the child’s parents had attributed the child’s dyspraxia and speech delay to previous vaccinations and requested a genomic assessment. Respondent concluded that the child had polymorphisms on 8 of 12 genes associated with adverse event following immunization (AEFI), specifically IRFl and SCNlA and “a cousin with documented AEFI (VAERS).” No medical documentation relating to the cousin is contained in Respondent’s chart. The exemption is permanent and applies to all required vaccines.

19. Patient 8, a 12-year old female, was seen by Respondent on December 7, 2017. That was preceded by an August telephone consultation with the child’s parents. which Respondent summarized as a discussion of her prolonged encephalitic reaction and “stroke” related to a Hepatitis B vaccine. Patient 8 was given a permanent exemption from all vaccinations based upon her “unusual history” and on polymorphisms on HLA DRBl AND SCNlA genes.

20. Patient 9, a 12-year old female, was evaluated by Respondent on January 3, 2018. The visit was preceded by a September 13, 2017 telephone call from the child’s mother in which the mother stated that the child needed an exemption within ten days or “she can’t go to school.” In a telephone consultation that took place on the following day, Respondent made note that the child has “immediate family ‘members with multiple autoimmune diseases and who seems to have gone thru a multiple year period of having very compromised health post vaccination including but not limited to multiple URI/LRI, asthma, atopia and otitis infections.” A temporary exemption was issued as to all vaccines and, after testing, a permanent and global exemption was issued based on double mutation on the HLA DQBl and double mutation on the IRFl gene, which Respondent stated “play such a strong roll [sic] in having untoward immune reactions to foreign substances and biotoxins.”

21. Patient 10, a 5-year old female, was seen on March 8, 2018. During an earlier telephone consultation, Patient l0’s mother had requested that the child be screened for genetic risk from vaccines and she related a family history of “auto-immune issues” and an older sibling who developed “overt neuro-behavioral delays” after receiving vaccines. The mother complained that the school nurse “sees it as her job to protect the community from unvaccinated children.” The same at-home genetic test resulted in findings of multiple polymorphisms and Respondent opined that the child was at increased risk of an AEFI and ‘should be permanently exempted from all required vaccinations.

FIRST CAUSE FOR DISCIPLINARY ACTION
(Gross Negligence/Repeated Negligent Acts/Incompetence)

22. Respondent Kenneth Paul Stoller, M.D. is subject to disciplinary action pursuant to section 2234 and/or 2234(b) and/or 2234(c) and/or 2234(d) in that Respondent engaged in unprofessional conduct and was grossly negligent and/or repeatedly negligent and/or incompetent in his care and treatment of the patients described in paragraphs 12 and 15 through 21 above, which are incorporated herein.

23. Respondent routinely performed genetic testing for the purpose of determining whether a child should be exempted from required vaccinations. Genetic testing in order to determine vaccine response or risk for adverse events following immunization is not recommended by the Centers for Disease Control and Prevention (CDC) or the American Academy of Pediatrics (AAP). The standard of care for a primary care provider and specialist is to follow national standards for pediatric vaccination practices and immunization recommendations from the CDC, issued through the Advisory Committee on Immunization Practices, and the American Academy of Pediatrics, as summarized in The Red Book. Genetic variations in the population are normal and to be expected. While some differences exist, at the present time, no allele serves as a marker that accurately predicts vaccine response. A permanent exemption for all vaccines based on the polymorphisms described by Respondent is not supported by medical and scientific evidence and constitutes grounds for disciplinary action pursuant to the statutes set forth in paragraph 22.

SECOND CAUSE FOR DISCIPLINARY ACTION
(Gross Negligence/Repeated Negligent Acts/Incompetence)

24. Respondent Kenneth Paul Stoller, M.D. is subject to disciplinary action pursuant to section 2234 and/or 2234(b) and/or 2234(c) and/or 2234(d) in that Respondent engaged in unprofessional conduct and was grossly negligent and/or repeatedly negligent and/or incompetent in his care and treatment of the patients described in paragraphs 12 through 21 above, which are incorporated herein.

25. Respondent routinely obtained and relied upon unverified patient and family histories, including but not limited to autoimmune disorders, asthma, gluten sensitivity, inflammatory bowel disease, Hashimoto’s disease and other conditions not generally accepted to constitute precautions or contraindications to vaccines. The standard of care for a primary care provider and specialist is to follow national standards for pediatric vaccination practices and immunization recommendations from the CDC, issued through the Advisory Committee on Immunization Practices, and the American. Academy of Pediatrics, as summarized in The Red Book. The conditions described in Respondent’s records are not considered precautions or contraindications for routine immunizations by the CDC or AAP. The histories obtained by Respondent are typically scant and insufficiently documented as accepted diagnoses. To document an existing or family history of a condition or reaction without specification of the condition, the person who had the condition and their relation to the patient, and the specific vaccine or vaccine component that the condition or reaction related to, is not standard medical charting. In some cases, Respondent recorded a history of potentially very serious events, such as near SIDS, near exsanguination or acute encephalitis, but he did not obtain the pertinent medical records or otherwise investigate. Respondent’s provision of medical exemptions based on conditions not generally accepted as medical precautions or contraindications, his inadequate documentation of patient and family histories and failure to obtain records and/or investigate potentially very serious events fall below the standard of care and constitute grounds for discipline pursuant to the statutes set forth in paragraph 24 above.

THIRD CAUSE FOR DISCIPLINARY ACTION
(Gross Negligence/Repeated Negligent Acts/Incompetence)

26. Respondent Kenneth Paul Stoller, M.D. is subject to disciplinary action pursuant to section 2234 and/or 2234(b) and/or 2234( c) and/or 2234( d) in that Respondent engaged in unprofessional conduct and was grossly negligent and/or repeatedly negligent and/or incompetent in his care and treatment of the patients described in paragraphs 12 through 21 above, which are incorporated herein.

27. Respondent routinely issued exemptions that applied to all vaccines. There is no component that is common to all vaccines. A severe reaction to an earlier dose of a specific vaccine may be a contraindication for another dose of that vaccine or to a dose of a related vaccine that also contains the same constituents, but not to all vaccines. Similarly, a moderate or severe acute illness might be a temporary precaution, resulting in deferral of immunization, but not a permanent, global contraindication to all vaccines. Respondent’s issuance of vaccine exemptions which are not specific to a particular vaccine and are permanent and global falls below the standard of care and constitutes grounds for discipline pursuant to the statutes set forth in paragraph 26 above.

FOURTH CAUSE FOR DISCIPLINARY ACTION
(Inadequate Records)

28. Respondent Kenneth Paul Stoller, M.D. is subject to disciplinary action pursuant to section 2266 in that Respondent failed to maintain adequate and accurate records. As stated above, Respondent’s records contain only scant and vague patient and family histories, lack vaccine-specific evaluations, contain diagnoses not supported by the findings or by medical science and omit reference to prior medical records and/or primary care physicians.

PRAYER

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 A 41183, issued to Respondent;
  2. Revoking, suspending or denying approval of RRespondent’s authority to supervise physician assistants and advanced practice nurses;
  3. Ordering Respondent, if placed on probation, to pay the Board. the costs of probation monitoring; and
  4. Taking such other and further action as deemed necessary and proper;

DATED: July 29 2019

_________________________
KIMBERLY KIRSHMEYER
Executive Director
Medical Board of California
Department of Consumer Affairs
State of California
Complainant



Ron Kennedy, M.D. Facing Disciplinary Action

The Medical Board of California appears likely to discipline Ron Kennedy, M.D. for writing unjustified vaccination exemptions for three children. In one case, as described in the Accusation below, he relied upon a family history of autoimmune, respiratory and what he termed “neuropsychiatric disorders.” In the other two cases, his exemptions were based upon a …

The Medical Board of California appears likely to discipline Ron Kennedy, M.D. for writing unjustified vaccination exemptions for three children. In one case, as described in the Accusation below, he relied upon a family history of autoimmune, respiratory and what he termed “neuropsychiatric disorders.” In the other two cases, his exemptions were based upon a family history of several illnesses occurring at variable times after a variety of vaccines. None of these is a medically valid reason for avoiding vaccination. 

As part of its investigation, the Medical Board subpoenaed Kennedy’s records for the children who were the subjects of the complaint. It also subpoenaed the records of all of the children in the Mendocino school district for whom Kennedy had written exemptions. Kennedy filed suits to block the subpoenas. In the first case, the Superior Court said he must comply, and the ruling was upheld by the California Court of Appeals. In the other case, the Superior Court refused to quash the subpoenas, but the appeal is still pending.

Kennedy operates the Anti-Aging Medical Clinic in Santa Rosa, California. He also operates a large Web site called The Doctors’ Medical Library, which contains hundreds of articles that promote offbeat methods and ideas. Its article on vaccinations, which has been online for at least 20 years, portrays vaccines as dangerous and ineffective.

Kenneth Stoller, M.D. and Tara Zandvliet, M.D. are facing similar charges.


XAVIER BECERRA
Attorney General of California
JANE ZACK SIMON
Supervising Deputy Attorney General
LAWRENCE MERCER
Deputy Attorney General
State Bar No. 111898.
455 Golden Gate Avenue; Suite 11000
San Francisco, CA. 94102-7004
Telephone: (415) 510-3488
Facsimile: (415) 703-5480
Attorneys for Complainant

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

In the Matter of the Accusation Against:

Ron Kennedy, M.D.
2448 Guerneville Road, Suite 800
Santa Rosa, CA 95403

Respondent


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Case No. 800-2017-030287

ACCUSATION

PARTIES

1. Christine J. Lally (Complainant) brings this Accusation solely in her official capacity as the Interim Executive Director of the Medical Board of California, Department of Consumer Affairs (Board),

2. On or about October 24, 1975, the Medical Board issued Physician’s and Surgeon’s Certificate Number C 36809 to Ron Kennedy, 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 July 31, 2021, unless renewed,

JURISDICTION

3. This Accusation is brought before the Board, under the authority of the following laws. Alt section references are to the Business and Professions Code (Code) unless otherwise indicated.

4. 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.

5. Section 2234 of the Code 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.

(d) Incompetence.

6. Section 2266 of the. Code states:

The failure of a physician and surgeon to maintain adequate and accurate records relating to the provision of services to their patients constitutes unprofessional conduct.

OTHER STATUTES

7. Health and Safety Code section 120325 provides:

In enacting this chapter, but excluding Section 120380, and in enacting Sections 120400, 120405, 120410, and 120415, it is the intent of the Legislature to provide:

(a) A means for the eventual achievement of total immunization of appropriate age groups against the following childhood diseases:

    1. Diphtheria.
    2. Hepatitis B.
    3. Haemophilus influenza type b.
    4. Measles.
    5. Mumps.
    6. Pertussis (whooping cough).
    7. Poliomyelitis,
    8. Rubella.
    9. Tetanus.
    10. Varicella (chickenpox).
    11. Any other disease deemed appropriate by the department, taking into consideration the recommendations of the Advisory Committee on Immunization Practices of the. United States Department of Health and Human Services, the American Academy of Pediatrics, and the American Academy of Family Physicians.

(b) That the persons required to be immunized be allowed to obtain immunizations from whatever medical source they so desire, subject only to the condition that the immunization be performed in accordance with the regulations of the department and that a record of the immunization is made in accordance with the regulations.

(c) Exemptions from immunization for medical reasons.

(d) For the keeping of adequate records of immunization so that health: departments, schools, and other institutions, parents or guardians, and-the persons immunized will be able to ascertain that a child is fully or only partially immunized, and so that appropriate public agencies will be able to ascertain the immunization needs of groups of children in schools or other institutions.

(e) Incentives to public health authorities to design innovative-and creative programs that will promote and achieve Juli and timely immunization of children.

8. At all relevant times, former Health and Safety Code section 120370 provided, in pertinent part:

(a) If the parent or guardian files with the governing authority a written statement by a, licensed physician to the effect that the physical condition of the child is such, or medical circumstances relating to the child are such, that immunization is not considered safe, indicating the specific nature arid probable duration of the medical condition or circumstances; including, but not limited to, family medical history, for which the physician does not recommend immunization, that child shall be exempt from the requirements of Chapter 1 (commencing with Section 120325, but excluding Section 120380) and Sections 120400, 120405, 120410, and 120415 to the extent indicated by the physician’s statement.

FACTUAL ALLEGATIONS

9. At all relevant times, Respondent Ron Kennedy, M:D., was a physician and surgeon providing medical care at his Anti-Aging Medical Clinic. in Santa.Rosa, California. Respondent is not a pediatrician and at all relevant times he was not the primary care physician for the three children discussed herein.

10. In 2015, the California Legislature amended Health and Safety Code section 120325 to eliminate personal beliefs as a basis for exemption from required immunizations for school-aged children. Consequently, school-aged children not subject to any other exception were required to have immunizations for 10 vaccine-preventable childhood illnesses as a condition of public school attendance. After the statutory amendment became effective, the Medical Board began receiving complaints from schools, primary care providers and parents that physicians were issuing medical exemptions from required vaccinations that did not appear to have a bona fide medical basis.

11. Beginning in 2016, Respondent began issuing medical exemptions from required vaccinations to school-aged children. In 2017, the Immunization Coordinator at the Sonoma County Department of Public Health Services reported receipt of multiple complaints from schools and preschools expressing concerns about permanent medical exemptions issued by Respondent.

12. On August 17, 2017, the Board received a complaint from a school nurse that Patient 11 presented a Vaccine exemption from Respondent that did not appear to be valid, The complaint stated that Patient 1 was a female Student entering the 7th Grade, who previously had a personal belief exemption and, after the personal belief exemption was eliminated, presented a permanent medical exemption from all required vaccinations issued by Respondent. The complaint stated that the child’s school records did not contain any medical information that would support a vaccine exemption.

1Patient names are redacted to protect privacy interests.

13. On June 24, 2019, pursuant to a court order, the Board obtained Respondent’s records for Patient 1. Respondent’s records stated that Patient 1 “has always enjoyed good health.” He also documented that the child had previously been exempted from vaccines .based on personal beliefs. and that her parents, who opposed vaccinations, were consulting Respondent for the purpose of obtaining a medical exemption. Patient 1’s personal history was negative for any condition that would contraindicate any vaccine: Respondent’s review of systems was normal. Respondent’s physical examination was within normal limits, with only mild myopia noted.

14. On the date of his evaluation, July 17, 2017, Respondent gave Patient 1 a “Medical Vaccine Exemption” that was permanent and applied to all vaccines, The basis for the vaccine exemption, as documented on the form and in Respondent’s records, was a, family history of obsessive compulsive disorder in mother, ADD in father, ADHD in brother, and depression and anorexia nervosa in sister; as well as a variety of other disorders in extended family. The exemption form, which was otherwise boilerplate, contained Respondent’s handwritten annotation that the reason for the exemption was “autoimmune, respiratory, neuropsych illness in family.”

15. On or about November 29, 2017, the Medical Board received a complaint from the father of Patients 2 and Patient 3; male children aged 3 years and 1 year of age. The children’s parent complained that Respondent had provided the children with vaccine exemptions without his consent and without a bona fide medical reason. Pursuant to a court order, the Board obtained the. children’s pediatric records from their primary care. provider at Kaiser Permanente. The pediatric records were significant for no documented allergies or medical problems that might be a precaution or contraindication to a specific vaccine. the children’s father reported that prior to Respondent’s issuance of vaccine exemptions the children had received some immunizations and did not have any adverse reactions.

16. On June 24,2019, pursuant to court order, the Board obtained Respondent’s records for Patients 2 and 3. Respondent’s records for Patient 2 contain a history from the mother that Patient 2 was “sick” after previous vaccinations; however, the mother also apparently provided Patient 2’s immunization record that indicated that the child had received vaccinations and had no significant medical problems. Respondent reported the physical examination of the child as normal. Nonetheless, he issued a vaccine exemption on September 26, 2017. According to his medical records, the exemption issued based upon a maternal family history of a variety of events occurring after immunizations to her and to various relatives. The reasons stated for the exemption are indicated by checked boxes on the form for “neuropsychiatric illness, allergic illness, vaccine reaction or-injury.” The exemption is permanent and global, applying to all vaccines. Respondent’s records for Patient 3 are similar in content and refer to Patient 3 as a “normal one year old child.” Respondent also issued a permanent exemption from all vaccines. or Patient 3.

17. On January 8, 2018, after the children’s father demanded that he do so, Respondent rescinded his vaccine exemptions for Patients 2 and 3.

18. The Board obtained medical records for Patients 2 and 3 relating to their subsequent pediatric care: Both children ultimately received their scheduled vaccinations without event.

FIRST CAUSE FOR DISCiPLINE
(Gross Negligence/Repeated Negligent Acts/Incompetence)

(Inappropriate Rationale-for Medical Exemption)

19. Respondent Ron Kennedy, MD. is subject to disciplinary action under sections 2234 and/or 2234(6) and/or 2234(c) and/or 2234(d) in that Respondent engaged in unprofessional Conduct, was grossly negligent and/or committed repeated acts of negligence and/or was incompetent in his care and treatment of Patients 1, 2 and 3. The circumstances are as follows:

20. Respondent based his vaccine exemptions on factors not considered contraindications or precautions by the guidelines issued by the Centers for Disease Control and Prevention or the American Academy of Pediatrics. In the case of Patient 1, Respondent relied upon a family history of autoimmune, respiratory and what respondent termed neuropsychiatric disorders. In the case of Patients 2 and 3, Respondent based his exemptions upon a family history of ‘several illnesses occurring at variable times after a variety of vaccines, albeit such the history does not indicate that vaccines caused the illnesses. The standard of care for a. primary care provider; consultant and specialist-is to follow national standards for pediatric vaccination practices and immunization recommendations from the CDC, issued through the Advisory Committee on. Immunization Practices, and the American Academy of Pediatrics, as summarized in The Red Book. Neither a family history of disorders, such as that documented by Respondent for Patient I, nor a family history of various illnesses at various times after a variety of vaccines, such as that documented by Respondent for Patients 2 and 3, constitute contraindications or precautions recognized by the CDC or AAP; hence Respondent’s exemptions fall below the standard of care,

SECOND CAUSE FOR DiSCIPLINE
(Gross Negligence/Repeated Negligent Acts/Incompetence)
(Global Vaccine Exemptions)

21. Respondent Ron Kennedy, M:D. is subject to disciplinary action under sections 2234 and/or 2234(b) and/or 2234(c) and/or 2234(d) in that Respondent engaged in unprofessional conduct, was grossly negligent and/or committed repeated acts of negligence and/or was incompetent in his care and treatment of Patients 1, 2 and 3. The circumstances are as follows:

22. Respondent issued exemptions to all vaccines. There is no ingredient common to all vaccines. There are some specific contraindications apply to individual vaccines: and some precautions, such as an acute illness, might require temporary deferral of immunization until the. illness has resolved. Patients 1, 2 and 3, as documented in Respondent’s records, did not have any contraindication or precaution, as defined by the CDC and AAP that would exempt them from any recommended vaccine. Providing an exemption to all vaccines falls below the standard of care.

THIRD CAUSE FOR DISCIPLINE
(Gross Negligence/Repeated Negligent Acts/Incompetence)

(Permanent Vaccine Exemptions)

23. Respondent Ron Kennedy, M.D. is subject to disciplinary action under sections 2234 and/or 2234(b) and/or 2234(c) and/or 2234(d) in that Respondent engaged in unprofessional conduct, was grossly negligent and/or committed repeated acts of negligence and/or was incompetent in his care and treatment of Patients 1, 2 and 3. The circumstances are as follows:

24. Respondent issued exemptions that were permanent in duration. Permanent exemptions to specific vaccines are appropriate when contraindications are present and not expected to be temporary, for example a severe allergic reaction, e.g. anaphylaxis, after a previous dose or to a vaccine component, or severe immunosuppression and live-vaccines. As stated above, a temporary condition, such as an acute illness, might be a precaution until the illness resolved. Patients. I, 2 and 3, as documented in Respondent’s records, did not have any events or conditions recognized by the CDC or AAP as n.medical basis for a permanent exemption from immunizations. Providing a permanent exemption falls below the standard of care.

FOURTH CAUSE FOR DISCIPLINE
(Inadequate and Inaccurate Records)

25. Respondent Ron Kennedy, M.D. is subject to disciplinary action under section 2266 in that he failed to maintain adequate and accurate records, As. set forth above, Respondent’s records fail to document a: medical indication for the vaccine exemptions that he issued, Histories inadequately documented and objective findings do not support the plan for vaccine exemptions. Respondent failed to obtain prior medical records from the children’s treating pediatricians. His exemptions are boilerplate, list multiple conditions without specification and exempt the children even from vaccines no longer routinely used.

PRAYER

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 C 36809, issued to Ron Kennedy, M.D.;
  2. Revoking, suspending or denying approval of Ron Kennedy, M.D.’s authority to supervise physician assistants and advanced practice nurses;
  3. Ordering Ron Kennedy, M.D., if placed on probation, to pay the Board. the costs of probation monitoring; and
  4. Taking such other and further action as deemed necessary and proper;

DATED: JAN 29 2020

_________________________
CHRISTINE J. LALLY
Interim Executive Director
Medical Board of California
Department of Consumer Affairs
State of California
Complainant



Dieter’s Brews Make Tea Time a Dangerous Affair

A cup of hot herbal tea may feel soothing to the soul, but instead of soothing the body, some herbal teas can make you sick. This is especially true with so-called dieter’s teas—herbal teas containing senna, aloe, buckthorn, and other plant-derived laxatives that, when consumed in excessive amounts, can cause diarrhea, vomiting, nausea, stomach cramps, …

A cup of hot herbal tea may feel soothing to the soul, but instead of soothing the body, some herbal teas can make you sick.

This is especially true with so-called dieter’s teas—herbal teas containing senna, aloe, buckthorn, and other plant-derived laxatives that, when consumed in excessive amounts, can cause diarrhea, vomiting, nausea, stomach cramps, chronic constipation, fainting, and perhaps death.

In recent years, FDA has received “adverse event” reports, including the deaths of four young women, in which dieter’s teas may have been a contributing factor.

As a result, FDA is advising consumers to follow package directions carefully when using dieter’s teas and other dietary supplements containing senna, aloe, and other stimulant laxatives. Consumers should seek medical attention for persistent diarrhea, abdominal cramps, and other bowel problems to prevent more serious complications.

The agency may consider requiring manufacturers to place a warning about the products’ potential side effects on the products’ labels. Some manufacturers already are doing so voluntarily.

These products—bought in health food stores and through mail-order catalogs, for example—often are used for weight loss based on some consumers’ belief that increased bowel movements will prevent absorption of calories, thus preventing weight gain. However, a special committee of FDA’s Food Advisory Committee concluded in 1995 that studies show that laxative-induced diarrhea does not significantly reduce absorption of calories. This is because the laxatives do not work on the small intestine, where calories are absorbed, but rather on the colon, the lower end of the bowel.

Juice drinks and tablets also may contain stimulant laxatives. FDA usually regulates these products as foods under the Federal Food, Drug, and Cosmetic Act. If the products are represented as dietary supplements, they are regulated under the Dietary Supplement Health and Education Act of 1994.

Stimulant Laxatives

The stimulant laxative teas and dietary supplements FDA is most concerned about contain one or more of the substances senna, aloe, rhubarb root, buckthorn, cascara, and castor oil. These plant-derived products have been used since ancient times for their ability to promote bowel movements and relieve constipation. Several, such as cascara, senna and castor oil, also are available as over-the-counter drug laxatives and are regulated as drugs.

Some of these substances also are used in much smaller quantities as natural flavorings in other foods. As such, they are regulated by FDA as food additives or “generally recognized as safe” substances. FDA has not received any information suggesting that these substances pose a hazard when used in the amounts normally needed to provide flavoring.

Except when used solely as flavorings, the names of these plant substances appear in the ingredient list on the label of these products. Dieter’s teas and similar products often list the substances at or near the top because they often are the main ingredients. FDA proposed in December 1995 to require manufacturers to declare dietary ingredients, including proprietary blends, in descending order of predominance by weight on product labels. In the proposed rule, the substance would have to be given by its common or usual name: for example, Tinnevelly senna followed by its Latin name, Cassia angustifolia.

The names of many dieter’s teas suggest the products can promote weight loss, although the labeling does not specifically state how. The labeling also may fail to mention that these herbal products contain laxatives, which, when misused, can have serious effects.

Most consumers who use dieter’s teas and similar products know that the products have laxative properties, according to health professionals familiar with the products, even though the product labeling does not specifically state the term “laxative.” Instead, the labeling may promote the product as a natural bowel cleanser. Sometimes it may not reflect the laxative qualities at all.

The product labels may not directly state that the products are for weight loss, although some allude to it. For instance, some products use the terms “dieter’s,” “diet,” “trim,” or “slim” in their names. Others may carry information on weight-loss practices, mentioning consumption of the product along with the weight-loss practices. Some of the teas are labeled as “low-calorie.” Unless sweetened, they provide essentially no nutrients and no calories.

According to Ara DerMarderosian, Ph.D., professor of pharmacognosy (study of medicinal products in their crude, or unprepared, form) and medicinal chemistry at the Philadelphia College of Pharmacy and Science, users favor the products because they believe that the products may cost less and taste better than over-the-counter laxatives and because they are easy to buy. In addition, he said, people with eating disorders, such as bulimia and anorexia nervosa, may like the products because they act quickly and produce loose, watery stools. Unfortunately, this practice is not only useless for losing weight but can be dangerous for people on severely restricted diets.

Writing in the January 1996 American Druggist, DerMarderosian and his colleague Sharon Brudnicki, a registered pharmacist also with the Philadelphia College of Pharmacy and Science, noted that some users like dieter’s tea and other stimulant laxatives for their purported “body cleansing” ability.

DerMarderosian was a member of the FDA Food Advisory Committee’s 1995 special task group on stimulant laxative substances in food.

Adverse Effects

Reports filed with FDA indicate that users tend to experience adverse effects when they misuse the products by, for example, steeping the tea longer than product labeling recommends or drinking more than the recommended amount. The reports indicate three types of adverse events:

  • Short-term: stomach cramps, nausea, vomiting, and diarrhea lasting several days. These symptoms are likely to occur in first-time users who drink more than the recommended amount.
  • Chronic: chronic diarrhea, pain and constipation due to laxative dependency, which causes a sluggish bowel. In one report to FDA, a person who reported using herbal products with stimulant laxatives for decades suffered severe pain and constipation from loss of colon function and required surgery to remove the colon. People who develop chronic problems usually have used these types of products for years.
  • Severe: fainting, dehydration and electrolyte disorders (for example, low blood potassium, a condition that can cause paralysis, irregular heartbeat, and possibly death). People who develop severe problems tend to be those who are nutritionally compromised, partly as a result of drastic reductions in food intake-for example, rigorous weight-loss dieters and people with the eating disorders anorexia nervosa and bulimia. Four deaths reported to FDA involved women with a history of such medical problems. According to information presented at a 1995 meeting of FDA’s Food Advisory Committee, these herbal stimulant laxatives may have been a contributing factor in their deaths.
Label Warning

At the 1995 meeting, the advisory committee’s task group agreed that dietary supplements containing stimulant laxatives can have adverse effects and that a label statement would be helpful in warning consumers about the risks and reducing the incidence of these adverse effects. The group proposed this label warning:

“NOTICE (or WARNING): Contains herbs (insert name of herbs) that can act as stimulant laxatives. Prolonged steeping time can increase the risk of adverse laxative effects, including: nausea, vomiting, abdominal cramps, and diarrhea. Chronic use of laxatives can impair colon function. Use of laxatives may be hazardous in the presence of abdominal pain, nausea, vomiting, or rectal bleeding. Laxative-induced diarrhea does not significantly reduce absorption of food calories. Acute or chronic diarrhea may result in serious injury or death.”

The full advisory committee concurred with the recommendations.

California has taken steps to require a similar warning label statement on all food products containing stimulant laxatives sold in that state. Some manufacturers have begun to carry the state’s drafted warning statement on their food products. FDA will monitor products sold nationally to be sure that their labels carry information similar to that required in California.

Consumer Action

The California warning advises all users of these types of dietary supplements to:

  • Read and follow package directions carefully.
  • Stop using the product if diarrhea, loose stools, or stomach pain develop.
  • See a doctor if frequent diarrhea develops.
  • See a doctor before using the product if the user is pregnant, nursing, taking medication, or has a medical condition.

Consumers should report adverse effects associated with use of laxative teas or supplements to FDA by calling or writing to their local FDA office, listed in the blue pages of the telephone book under U.S. Government, Department of Health and Human Services, Food and Drug Administration. They also may write to FDA at 5600 Fishers Lane, HFC-160, Rockville, MD 20857.

The report should include:

  • name, address and telephone number of the person who became ill
  • name and address of the doctor or hospital providing medical treatment
  • description of the problem
  • name of the product and store where it was bought.

Consumers also should report the problem to the manufacturer or distributor listed on the product’s label and to the store where the product was bought.

FDA encourages health professionals to report serious adverse reactions, too, if the reaction appears related to the patient’s use of dieter’s teas or similar products. Health professionals can call FDA’s MedWatch adverse event and product problem hot line at (1-800) FDA-1088.


Paula Kurzweil was a member of FDA’s public affairs staff. This article was originally published in the July-August 1997 issue of FDA Consumer magazine.



Index to Quackery-Related GAO Reports

The United States Government Accountability Office (GAO)  monitors and audits government spending and operations, tracks how the legislative and executive branches of the government use taxpayer dollars, and provides its findings directly to Congress. It was established as the General Accounting Office by the Budget and Accounting Act of 1921 and assumed its current name in …

The United States Government Accountability Office (GAO)  monitors and audits government spending and operations, tracks how the legislative and executive branches of the government use taxpayer dollars, and provides its findings directly to Congress. It was established as the General Accounting Office by the Budget and Accounting Act of 1921 and assumed its current name in 2004. The reports listed below are relevant to topics discussed on our Web sites.

Dietary Supplements and Herbs
Diagnostic Testing
Diploma Mills
Drug Products
Health Insurance
Research
Miscellaneous Health Problems


Will Continued Adjustments Help Me or Wear Down My Spine?

Question I’ve been going to chiropractors for 14 years. Once-a-month treatment has turned into weekly manual and or activator type adjustments. I’ve been told that I have degeneration with retrolisthesis of 4, 5, and 6 cervical vertebrae, mid back and pelvic misalignment issues due to scoliosis, muscular tension, improper posture, and repetitive motions at work. …

Question

I’ve been going to chiropractors for 14 years. Once-a-month treatment has turned into weekly manual and or activator type adjustments. I’ve been told that I have degeneration with retrolisthesis of 4, 5, and 6 cervical vertebrae, mid back and pelvic misalignment issues due to scoliosis, muscular tension, improper posture, and repetitive motions at work.

There are times I feel I’m in a vicious cycle and this will always be part of my life and it is wearisome. There are times I want to just stop all these adjustments and just let my body do what it wants to and just live with the results. We all have to have something, right?

I like your reality based thinking, from what little I’ve read about you. Can the spine ever change its course with manipulation or not? In my 14 years, I believe there is improvement when I don’t do the things that aggravate it. Will continued adjustments wear down the spine, making it weaker over time and worse? The adjustments don’t hold. It doesn’t take much movement on my part and I hear a pop in my neck or back. That has happened after so many adjustments.

Answer

It’s okay to get an occasional hands-on spinal manipulation if such treatment relieves back-related musculoskeletal symptoms. But repeated or regular spinal manipulation will not change the alignment of the vertebrae and it will not prevent degenerative changes or prevent the development of health problems. If symptoms worsen after a few treatments, or if symptoms persist after a few weeks of treatment, the treatment should be discontinued.

When you are told that “the adjustment did not hold,” that is an excuse offered when the treatment was not effective or has aggravated symptoms, perpetuating unnecessary or possibly harmful treatment. Use of an Activator instrument is not a helpful treatment and is not an adequate substitute for appropriate use of manipulation. I would advise against manipulation of the vertebrae in your neck, since the risk of stroke caused by injury to vertebral arteries outweighs any known benefit.

My advice would be to discontinue use of manipulation and see how you get along. In some cases, symptoms that have been aggravated by ongoing, unnecessary spinal manipulation will subside. As we age, all of us will develop degenerative changes that might benefit from occasional manual therapy or a self-help program. But regular spinal manipulation will not correct or prevent the degenerative changes of wear and tear or aging. You should not continue with the services of any chiropractor who suggests that you need ongoing spinal manipulation to prevent or correct vertebral “subluxations.”

____________________

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.

This article was posted on November 17, 2017.



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.



Pamphlets from Palmer College of Chiropractic (1970s)

During the 1970s, Palmer College of Chiropractic, which was the largest chiropractic school at that time, published about fifty 6-page pamphlets that chiropractors could distribute in their offices. Most claimed that the health problem described in the pamphlet would resolve after the chiropractor located and adjusted the supposedly relevant spinal misalignment, which the pamphlets referred …

During the 1970s, Palmer College of Chiropractic, which was the largest chiropractic school at that time, published about fifty 6-page pamphlets that chiropractors could distribute in their offices. Most claimed that the health problem described in the pamphlet would resolve after the chiropractor located and adjusted the supposedly relevant spinal misalignment, which the pamphlets referred to as “subluxations.” The back page of the pamphlets said: “Rather than administering drugs, your chiropractor determines if neurological complications are at the root of the problem; then he works to eliminate this basic cause, thus restoring and maintaining health. . . . It is to your great advantage to visit your doctor of chiropractic on a regular basis.” This was poor advice because chiropractors did not have sufficient training to diagnose or treat most of the conditions the pamphlets described. To access the pamphlets I collected, click here.



Ross Stewart Ordered to Stop Unlicensed Medical Practice

In 2017, the Texas Medical Board ordered Ross Stewart. Ph.D., to stop practicing medicine without a medical license and said that future violations could trigger a penalty of up $5,000 per violation and/or each day of a continuing violation. The agreed order (shown below) stated that he was treating customers with an undetermined substance that …

In 2017, the Texas Medical Board ordered Ross Stewart. Ph.D., to stop practicing medicine without a medical license and said that future violations could trigger a penalty of up $5,000 per violation and/or each day of a continuing violation. The agreed order (shown below) stated that he was treating customers with an undetermined substance that purportedly contained stem cells grown from the customer’s blood but was actually a saline solution with vitamins. The order also said that he “sought to circumvent the law by having customers join the ‘Turtle Healing Band’ allegedly an Oklahoma Native American Tribe, and signing unenforceable waivers purporting to release him from liability.” The Turtle Healing Band, which I have investigated, is part of a network of entities that issues credentials intended to help practitioners avoid government regulation.

Stewart is licensed as a Professional Counselor. At the time the Texas Medical Board became concerned, he owned and operated the Brain & Body Wellness Center) in Dallas, Texas, which reportedly was closed in response to the board’s action. He subsequently represented himself, at Parkinson’s Clinic International LLC, as an “applied clinical nutritionist” who provided treatment based on the theories and methods of Marty Hinz, M.D. Most of Stewart’s current services were being provided through interviews using Skype or FaceTime, after which he recommended dietary supplements that he sells.

In 2019. the North Central Texas Better Business Bureau concluded that changes made to www.parkinsonsclinicinternational.com since the medical board’s action were “insufficient to alert reasonable consumers that Parkinson’s Clinic International is not a medical clinic and that Dr. Stewart is not authorized to treat Parkinson’s disease in the state of Texas.” The BBB also noted that “the address of the ‘Clinic’ is not a medical facility, but is a residential dwelling located in Dallas, Texas.”

While the BBB was investigating, I asked the Texas Medical Board to determine whether Stewart was still practicing medicine without a license. In April 2020, I found that he was again doing business as the Brain & Body Wellness Center, but the company’s Web site no longer displayed medical claims. I don’t yet know whether my complaint has been settled.


IN THE MATTER OF

ROSS M. STEWART

|
|
|
BEFORE THE

TEXAS MEDICAL BOARD

AGREED CEASE AND DESIST ORDER

On the 3 day March , 2017, this matter was heard before the Texas Medical Board (the Board). Ross Stewart (Respondent), through his counsel Amy Wellborn, waived any right to a hearing and instead agrees to the entry of this Order. Upon the recommendation of the Board’s staff and with the consent of Respondent, the Board makes the following findings of fact and conclusions of law.

FINDINGS OF FACT

The Board finds that:

  1. Respondent received all notice required by law and all jurisdictional requirements have been satisfied.
  2. Respondent is not licensed to practice medicine in the State of Texas.
  3. Respondent engaged in the unlicensed practice of medicine by treating customers ,with an unknown substance purportedly containing stem cells grown from their blood.
  4. The unknown substance did not contain stem cells grown from the customer’s blood; instead, the solution was a saline solution with vitamins.
  5. Respondent engaged in the unlicensed practice of medicine by claiming that this unknown substance could cure medical conditions ranging from Parkinson’s Disease to a broken heart.
  6. Respondent billed customers for injections of the unknown substance while failing to maintain billing and medical records.
  7. Respondent had a personal and professional relationship with Felon Joe DiRuzzo who is serving a four-year sentence for similarly injecting customers with unknown substances purportedly containing stem cells grown from their blood samples. At least one of these customers died as a result.
  8. Respondent sought to circumvent the law by having customers join the “Turtle Healing band”, allegedly an Oklahoma Native American Tribe, and signing unenforceable waivers purporting to release him of liability.
  9. Respondent has cooperated in the investigation of the allegations related to this Order. To avoid further investigation, hearings, and the expense and inconvenience of litigation, Respondent agrees to the entry of this Order and to comply with its terms and conditions.

CONCLUSIONS OF LAW

  1. The Board has jurisdiction over the subject matter and Respondent pursuant to the TEX. OCC. CODE, Title 3, Subtitle B, the Medical Practice Act (Act).
  2. Texas Occ. Code § 165.052(a) authorizes the issuance of cease and desist orders to individuals who are unlicensed by the Board if it appears that the individual is violating the Act, Board rules, or any other statute or rule relating to the practice of medicine.
  3. Section 151.002(a)(12) of the Act defines a physician as a person licensed to practice medicine in this state.
  4. Section 165.052(b) of the Act provides that a violation of an Order under Section § 65.052(a) constitutes grounds for imposing an administrative penalty under TEX. OCC. CODE, Title 3, Subtitle B, Chapter 165, Subchapter A, which allows for an administrative penalty of up to $5,000 for each violation to be assessed, and each day of a violation continues constitutes a separate violation.
  5. Section 165.151 of the Act provides that a person commits an offense if the person violates the Act, or any rule of the Texas Medical Board.
  6. Section 165.159 of the Act provides that a person commits an offense if the person practices medicine without complying with the registration requirement imposed by Texas Occupations Code Ann., Title 3, Subtitle B.
  7. Sections 165.101 and 165.103 of the Act provide that any violation of this Order constitutes grounds for imposing a civil penalty of up to $1,000 for each violation, and for recovery of the reasonable expenses of litigation, by action of the Attorney General, and each day a violation continues constitutes a separate violation.
  8. Board Rule 187.84 authorizes the Board to impose an administrative penalty for violation of a cease and desist order, or refer the matter to the Attorney General to institute action for: an injunction against violation of the order; any administrative penalty assessed by the Board; a civil penalty in accord with Section 165.101 of the Act; expenses in accord with Section 165.103 of the Act; and any other remedy provided by law.

ORDER

Based on the Findings of Fact and Conclusions of Law, the Board ORDERS that:

  1. Respondent is prohibited from practicing medicine in the State of Texas without a license issued by the Texas Medical Board.
  2. Respondent shall cease and desist any unlicensed practice of medicine in the State of Texas from and after the date of Respondent’s signature below.
  3. Respondent shall immediately cease and desist from advertising, offering to treat, treating, or assisting another in treating anyone in the State of Texas with stem cells.
  4. Any violation of this Order constitutes grounds for imposing an administrative penalty of up to $5,000 for each violation, and/or each day of a continuing violation, of the Medical Practice Act.

RESPONDENT WAIVES THE RIGHT TO A HEARING PURSUANT TO THE MEDICAL PRACTICE ACT SECTIONS 165.052 AND 164.002(a) AND 22 TEX. ADMIN. CODE, CHAPTER 187, AS APPLICABLE, AND ALL RIGHTS PURSUANT TO THE ADMINISTRATIVE PROCEDURE ACT, TEX. GOV’T CODE, CHAPTER 2001, JNCLUDING THE RIGHT TO NOTICE AND HEARING, AND TO ANY FURTHER HEARINGS OR APPEALS TO THE BOARD OR TO ANY COURT IN REGARD TO THIS ORDER. RESPONDENT AGREES TO THE ENTRY OF THIS ORDER AND AGREES THAT THIS IS A FINAL ORDER.

I, ROSS M. STEWART, HAVE READ AND UNDERSTAND THIS ORDER. MY SIGNATURE BELOW IS VOLUNTARY. THIS ORDER CONTAINS THE ENTIRE AGREEMENT AND TIHERE IS NO OTHER AGREEMENT OF ANY KIND, VERBAL, WRITTEN, OR OTHERW1SE. I HAVE SIGNED THIS ORDER ON THE 10TH DA Y OF FEBRUARY , 2017.

_______________________
Ross M. Stewart, Ph.D, P.C.
Respondent

SIGNED AND ENTERED by the presiding officer of the Texas Medical Board on this 3 day of March, 2017.

_________________
Sherif Z. Zaafran, President
Texas Medical Board

This article was revised on April 8, 2020.



Disciplinary Actions against Dr. Maher Hanna

In 1999 and 2000, the College of Physicians and Surgeons of Saskatchewan (CPSS) found Dr. Maher Hanna guilty of unprofessional conduct. The CPSS Web site provides the following details: In 1999 Dr. Hanna entered guilty pleas to four charges of unprofessional conduct. He admitted that he: Was untruthful to the College when he responded to …

In 1999 and 2000, the College of Physicians and Surgeons of Saskatchewan (CPSS) found Dr. Maher Hanna guilty of unprofessional conduct. The CPSS Web site provides the following details:


In 1999 Dr. Hanna entered guilty pleas to four charges of unprofessional conduct. He admitted that he:

  • Was untruthful to the College when he responded to a concern that the CV of a physician who he had employed to work in his clinic had been falsified;
  • Failed to maintain the standards of the profession in relation to medical records for 10 patients;
  • Failed to follow the College’s bylaws with respect to his chelation practice;
  • Was untruthful in advising the College that he was fully compliant with the College’s chelation bylaw.

Dr. Hanna’s license had previously been revoked in relation to another matter. He was suspended for a six-month period that overlapped the period of his license revocation. He was ordered to pay costs of $16,272.


In 1999, Dr. Hanna entered guilty pleas to four charges of unprofessional conduct. He admitted that he:

  • Provided false information to a preliminary inquiry committee that he did not perform chelation therapy after February 17, 1998;
  • Provided false information to a preliminary inquiry committee that he had recorded symptomatology leading to the diagnosis of ADHD in patients charts;
  • Prescribed Ritalin in a manner that did not meet the standards of the profession;
  • Submitted accounts to Medical Care Insurance Branch for spirometry services when he had not provided the necessary services to be entitled to bill for such services.
  • Dr. Hanna was suspended for a further 5 months and required to pay the costs of the investigation and hearing in the amount of $12,361.

In 2000, Dr. Hanna entered a guilty plea to charges of unprofessional conduct that he:

  • Breached an undertaking to post a sign notifying patients that he required a chaperone for examinations of female patients;
  • Breached an undertaking that female patients would sign a document confirming that a chaperone was present for interactions with him;
  • Billed for medical services which he did not provide.

The penalty imposed was:

  • a suspension for six months;
  • a fine of $10,000;
  • a prohibition on practicing medicine unless there was another physician present in the clinic when Dr. Hanna was seeing patients in the clinic;
  • a prohibition against treating female patients unless a chaperone approved by the College was present;
  • an order that a physician approved by the College verify, on a monthly basis, that Dr. Hanna had complied with the terms of his undertaking and restrictions;
  • an order to repay Medical Services Plan for improper billings.

The CPSS Web site indicates that Dr. Hanna’s license ended in 2002.



John G. Hoffmann, M.D., Disciplined for Unprofessional Conduct

In 2015, the Wisconsin Medical Examining Board concluded that John G. Hoffmann, M.D., had endangered a patient by failing to properly monitor antibiotics he had prescribed for “chronic Lyme disease” and an antifungal drug he had prescribed for “abdominal candidiasis.” Hoffmann is part of a small network of so-called “Lyme literate doctors” who attribute a …

In 2015, the Wisconsin Medical Examining Board concluded that John G. Hoffmann, M.D., had endangered a patient by failing to properly monitor antibiotics he had prescribed for “chronic Lyme disease” and an antifungal drug he had prescribed for “abdominal candidiasis.” Hoffmann is part of a small network of so-called “Lyme literate doctors” who attribute a multitude of common symptoms to “chronic Lyme disease,”which they assert should be treated with many weeks or months of intravenous antibiotic treatment. The scientific medical community rejects these concepts. The board ‘s order (shown below), to which Hoffmann consented, said that if he wants to treat any patient for Lyme disease, he must follow FDA guidelines. He was also ordered to take 10 hours of continuing medical education.


STATE OF WISCONSIN
BEFORE THE MEDICAL EXAMINING BOARD


IN THE MATTER OF DISCIPLINARY
PROCEEDINGS AGAINSTJOHN G. HOFFMANN, M.D.,
RESPONDENT.
:
:
:
:
:
FINAL DECISION AND ORDER

000430


Division of Legal Services and Compliance Case No. 14 MED 015

The parties to this action for the purpose of Wis. Stat.§ 227.53 are:

John G. Hoffmann, M.D.
Post Office Box 248
Waupaca, WI 54981

Wisconsin Medical Examining Board
P.O. Box 8366
Madison, WI 53 708-8366

Division of Legal Services and Compliance
Department of Safety and Professional Services
P.O. Box 7190
Madison, WI 53707-7190

The parties in this matter agree to the terms and conditions of the attached Stipulation as the final disposition of this matter, subject to the approval of the Medical Examining Board (Board). The Board has reviewed this Stipulation and considers it acceptable.

Accordingly, the Board in this matter adopts the attached Stipulation and makes the following Findings of Fact, Conclusions of Law and Order.

FINDINGS OF FACT 1. Respondent John G. Hoffmann, M.D. (DOB July 26, 1950), is licensed in the state of Wisconsin to practice medicine and surgery, having license number 26569-20, first issued on February 1, 1985, with registration current through October 31, 2017. Respondent’s most recent address on file with the Wisconsin Department of Safety and Professional Services (Department) is Post Office Box 248, Waupaca, Wisconsin 54981.

2. Respondent is a general practice physician and is not board certified.

Disciplinary History

3. The Board has previously taken the following actions in regards to Respondent’s license to practice medicine and surgery in Wisconsin:

a. On October 22, 1997, the Board suspended Respondent’s license for not less than five years, with a provision for consecutive three month stays of suspension contingent upon compliance with, among other conditions, enrollment and successful participation in a drug and alcohol treatment program, submission to drug and alcohol screens, and submission of quarterly practice and therapy reports. The order was imposed because Respondent consumed alcohol while on call and treated a patient after consuming at least four alcoholic beverages.

b. On March 3, 1998, the Board ordered the suspension be stayed for one month and that Respondent appear before the board on April 22, 1998.

c. On April 30, 1998, the Board stayed the suspension for three months.

d. On September 24, 1998, the Board extended the stay of suspension for an additional three months.

e. On December 18, 1998, the Board denied Respondent’s request for another three month stay and suspended his license for violating the terms of his limited license.

f. The Board reinstated the stay on January 20, April 1 and October 2, 1999.

g. On June 22, 2000, Respondent notified the Board of his intent to retire from the practice of medicine and his wish to surrender his registration, and the Board accepted Respondent’s surrender of his registration to practice and the right to renew it.

h. On June 8, 2004, the Board reinstated the limited license of Respondent.

i. On June 26, 2006, the Board ordered a full reinstatement of Respondent’s license.

j. On May 21, 2008, the Board ordered Respondent to undergo an assessment to evaluate his ability to practice medicine at his current practice. It was also ordered that Respondent not order, prescribe, or administer any opioid or opiate for more than 30 days in any 12 month period for any patient.

k. On November 16, 2011, the Board suspended Respondent’s license pending the outcome of a disciplinary proceeding.

l. On January 18, 2012, the Board ordered the summary suspension of the Respondent’s license and registration to be continued and stayed if Respondent did not accept any new patient and complied with terms and conditions including a professional mentor, a self-study CME program, and successfully passing the SPEX exam.

m. On October 17, 2012, the Board dismissed a pending complaint against the Respondent after he completed a neuropsychological evaluation and was found to have no cognitive deficits.

Current Case

4. On March 27, 2013, Respondent first saw Patient A for continued treatment of what was charted as “Lyme Disease – documented.” Respondent documented “chronic” Lyme disease with treatment since 2011 and abdominal candidiasis (intestinal).

5. Respondent prescribed Ceftin 500mg BID, Clindamycin 300mg BID every other day, and Diflucan 20 mg on days when not taking Clindamycin, with the plan to continue Patient A on these drugs and dosages. Respondent did not order Patient A undergo regular labs while on this medication regiment.

6. On January 6, 2014, Patient A saw another physician who became concerned with Respondent’s care and treatment of Patient A, specifically Respondent’s plan to maintain Patient A on the above-described antibiotics and antifungals, and without regular lab testing. The provider subsequently filed a complaint with the Department which initiated this matter.

7. Respondent’s treatment of Patient A’s Lyme disease fell below the minimal standard of competence by his plan to maintain Patient A on high dosages of antibiotics and antifungals, and his failure to order regular labs.

8. In resolution of this matter, Respondent consents to the entry of the following Conclusions of Law and Order.

CONCLUSIONS OF LAW 1. The Wisconsin Medical Examining Board has jurisdiction to act in this matter pursuant to Wis. Stat. § 448.02(3), and is authorized to enter into the attached Stipulation pursuant to Wis. Stat. § 227.44(5).

2. By the conduct described in the Findings of Fact, Respondent John G. Hoffman, M.D., engaged in unprofessional conduct pursuant to Wis. Admin. Code § Med 10.02(2)(h) (Nov. 2002) by any practice or conduct which tends to constitute a danger to the health, welfare, or safety of patient or public.

3. As a result of the above conduct, John G. Hoffmann, M.D., is subject to discipline pursuant to Wis. Stat. § 448.02(3).

ORDER1. The attached Stipulation is accepted.

2. Respondent John G. Hoffmann, M.D., is REPRIMANDED.

3. The medicine and surgery license issued to John G. Hoffmann, M.D., (license number 26569-20) is LIMITED as follows:

a. Respondent shall only treat Lyme disease in accordance with FDA-approved guidelines. This limitation is permanent.

b. Within nine (9) months of the date of this Order, Respondent shall successfully complete ten (10) hours of continuing medical education on the topic of Lyme disease and its treatment.

c. Respondent shall be responsible for obtaining the course(s) required under this Order, for providing adequate course(s) descriptions to the Department Monitor, and for obtaining pre-approval of the course(s) from the Wisconsin Medical Examining Board, or it designee, prior to commencement of the course(s).

d. The Board or its designee may reject any course(s) and may accept a course(s) for less than the number of hours for which Respondent seeks approval.

e. Within thirty (30) days of completion of each educational component, Respondent shall file an affidavit with the Department Monitor stating under oath that he has attended, in its entirety, the course(s) approved for satisfaction of this requirement along with supporting documentation of attendance from the sponsoring organizations.

f. Respondent is responsible for all costs associated with compliance with this educational requirement.

g. None of the education completed pursuant to this requirement may be used to satisfy any other continuing education requirements that have been or may be instituted by the Board or Department.

4. Within 90 days from the date of this Order, John G. Hoffmann, M.D., shall pay COSTS of this matter in the amount of $740.00.

5. Proof of successful course completion and payment of costs (made payable to the Wisconsin Department of Safety and Professional Services) shall be sent by Respondent to the Department Monitor at the address below:

Department Monitor
Division of Legal Services and Compliance
Department of Safety and Professional Services
P.O. Box 7190, Madison, WI 53707-7190
Telephone (608) 267-3817; Fax (608) 266-2264
DSPSMonitoring@wisconsin.gov6. Violation of any of the terms of this Order may be construed as conduct imperiling public health, safety and welfare and may result in a summary suspension of Respondent’s license. The Board in its discretion may in the alternative impose additional conditions and limitations or other additional discipline for a violation of any of the terms of this Order. In the event Respondent fails to timely submit payment of costs as ordered or fails to submit proof of successful completion of the ordered education as set forth above, Respondent’s license (no. 26569-20) may, in the discretion of the Board or its designee, be SUSPENDED, without further notice or hearing, until Respondent has complied with payment of the costs and completion of the education.

7. This Order is effective on the date of its signing.

WISCONSIN MEDICAL EXAMINING BOARD

by:_________________
A Member of the Board
Date:12/16/15
STATE OF WISCONSIN
BEFORE THE MEDICAL EXAMINING BOARD

IN THE MATTER OF DISCIPLINARY
PROCEEDINGS AGAINSTJOHN G. HOFFMANN, M.D.,
RESPONDENT.
:
:
:
:
:
STIPULATION

000430


Division of Legal Services and Compliance Case No. 14 MED 015Respondent John G. Hoffmann, MD., and the Division of Legal Services and Compliance, Department of Safety and Professional Services stipulate as follows:

1. This Stipulation is entered into as a result of a pending investigation by the Division of Legal Services and Compliance. Respondent consents to the resolution of this investigation by Stipulation.

2. Respondent understands that by signing this Stipulation, Respondent voluntarily and knowingly waives the following rights:

  • the right to a hearing on the allegations against Respondent.er which time the State has the burden of proving those allegations by a preponderance of the evidence;
  • the right to confront and cross-examine the witnesses against Respondent;
  • the right to call witnesses on Respondent’s behalf and to compel their attendance by subpoena;
  • the right to testify on Respondent’s own behalf;
  • the right to file objections to any proposed decision and to present briefs or oral arguments to the officials who are to render the final decision;
  • the right to petition for rehearing; and
  • all other applicable rights afforded to Respondent under the United States Constitution, the Wisconsin Constitution, the Wisconsin Statutes, the Wisconsin Administrative code, and other provisions of state or federal law.

3. Respondent is aware of Respondent’s right to seek legal representation and has been provided an opportunity to obtain legal counsel before signing this Stipulation.

4. Respondent agrees to the adoption of the attached Final Decision and Order by the Wisconsin Medical Examining Board (Board). The parties to the Stipulation consent to the entry of the attached Final Decision and Order without further notice, pleading, appearance or consent of the parties. Respondent waives all rights to any appeal of the Board’s order, if adopted in the form as attached.

5. If the terms of this Stipulation are not acceptable to the Board, the parties shall not be bound by the contents of this Stipulation, and the matter shall then be returned to the Division of Legal Services and Compliance for further proceedings. In the event that the Stipulation is not accepted by the Board, the parties agree not to contend that the Board has been prejudiced or biased in any manner by the consideration of this attempted resolution.

The parties to Stipulation that the attorney or other agent for the Division of Legal Services and Compliance and any member of the Board ever assigned as an advisor in this investigation may appear before the Board in open or closed session, without the presence of Respondent, for purposes of speaking in support of this agreement and answering questions that any member of the board may have in connection with deliberations on the Stipulation. Additionally, any such advisor may vote on whether the Board should accept this Stipulation and issue the attached Final Decisiion and Order.

7. Respondent is informed that should the Board adopt this Stipulation, the Board’s Final Decision and Order is a public record and will be published in accordance with standard Department procedure.

8. The Division of Legal Services and Compliance joins Respondent in recommending the Board adopt this Stipulation and issue the attached Final Decision and Order.

________________________________
John G. Hoffmann, M.D., Respondent
Post Office Box 248
Waupaca WI 54981
License no. 26569-20
Date: 11/13/15
________________________________
Joost Kap, Prosecuting Attorney
Division of Legal Services and Compliance
P.O. Box 7190
Madison, WI 53707-7190
Date: 11/24/15

This page was posted on July 17, 2017.



Chiropractic Pamphlets Subtitled “What Will Chiropractic Do for It?”

These pamphlets made claims that were typical of chiropractic during its early years. Each falsely alleges that the underlying cause of the condition was impingement (“subluxation”) in the spine that created interference with the normal flow of “life force” or “nerve energy”  between the brain and the cells of the organ involved. Adenoids: What will …

These pamphlets made claims that were typical of chiropractic during its early years. Each falsely alleges that the underlying cause of the condition was impingement (“subluxation”) in the spine that created interference with the normal flow of “life force” or “nerve energy”  between the brain and the cells of the organ involved.

  • Adenoids: What will Chiropractic Do for It?
  • Epilepsy: What will Chiropractic Do for It?
  • Goiter: What will Chiropractic Do for It?
  • Multiple Sclerosis: What will Chiropractic Do for It?

To read these pamphlets, click here.

In April 2020, Amazon.com had six others in the series for sale with the same subtitle: appendicitis, headaches, nervousness, neuritis, sciatica, and stomach trouble. The pamphlets themselves did not identify their author or publisher, but the Amazon seller said the author was Dr. D.L. Hultgren and “guessed” that they were published in 1940.

Three pamphlets from the series were mentioned in legal documents from a case in which the Illinois Supreme Court in upheld a criminal conviction of chiropractor Roger E. Richardson for violating the Illinois Medical Practice Act. In 1957, the Illinois Supreme Court upheld lower court verdicts that Richardson had violated the Act by diagnosing an undercover investigator with two “subluxated vertebrae” and displaying pamphlets for epilepsy, skin eruptions, and tonsillitis.



Chiropractic Pamphlets from Dynamic Communications (1970s)

Applied kinesiology is a pseudoscientific approach based on the notion that every organ dysfunction is accompanied by a specific muscle weakness, which enables diseases to be diagnosed through muscle-testing procedures. Between 1976 and 1978, Systems DC, of Pueblo Colorado developed 56 patient-education pamphlets for explaining applied kinesiology to chiropractic patients. Dynamic Communications, Inc., located at …

Applied kinesiology is a pseudoscientific approach based on the notion that every organ dysfunction is accompanied by a specific muscle weakness, which enables diseases to be diagnosed through muscle-testing procedures. Between 1976 and 1978, Systems DC, of Pueblo Colorado developed 56 patient-education pamphlets for explaining applied kinesiology to chiropractic patients. Dynamic Communications, Inc., located at the same address, was named as the publisher. To see the pamphlets and how they were marketed to chiropractors, click here.

  • Action! Gait Mechanism
  • Allergies
  • Arthritis
  • Blood Pressure
  • Bursitis/Tendonitis
  • Can Adults Unknowingly Harm Children?
  • Carpal Tunnel Syndrome: Wrist/Hand Problems
  • Children and Athletics
  • Children and Natural Health Care
  • Cholesterol
  • Closed Ileocecal Valve
  • Correct Lifting
  • Cranial Respiratory Function
  • Diaphragm
  • Diet for Hypoglycemia and Sugar-handling Stress
  • Digestive Disturbances
  • Early Nerve Organization: A Lifetime of Health for Your Child
  • Fatigue
  • Foot and Ankle Stability
  • Foot Pronation
  • Foot Rehabilitation
  • Functional Hypoadrenia
  • Headache
  • Hyperkinesis (Hyperactivity in Children)
  • Hypoglycemia and Sugar-handling Stress
  • Idiopathic Scoliosis
  • Infections
  • Intervetebral Disc
  • Is It a Good Shoe?
  • Knees
  • Laboratory Use in Natural Health Care
  • Learning Disability
  • Mental and Emotional Health
  • Nerve Education
  • Nerves
  • Open Ileocecal Valve
  • Postural Evaluation in Childen
  • Shoulder
  • Some Thoughts about Nutrition
  • Stress
  • Tarsal Tunnel Syndrome
  • Temporo-mandibular Jaw Joint
  • The Colon’s Effect on Your Health
  • The Spine — An Integrated Structure
  • The “Total Person” Concept of Health
  • This Is More Important Than Getting Well
  • Thyroid
  • Triglycerides
  • Uniquely Feminine
  • Whatever the Health Problem, Look to Your Feet. They May Have the Answer!
  • Your Back: How to Care for It
  • Your Child’s Feet

The most revealing of the pamphlets—This Is More Important Than Getting Well—is a sales pitch for chiropractic “maintenance care” throughout life. It  falsely asserts that (a) our modern culture creates structural problems that interfere with nerve function, (b) the vast majority of the American population is suffering from some type of nutritional deficiency, (c) the mental stresses of today cause hormonal imbalance that can create neurologic imbalance, and (d) health problems just beginning to develop can be found and treated before they cause actual disease.