Questionable Diagnosis and Treatment
Edward McSweegan, Ph.D.
Lyme disease is the most common tick-borne disease in the United States. For 2016, the Centers for Disease Control and Prevention (CDC) recorded 26,203 cases as confirmed and 10,226 cases as probable . The infection is caused by Borrelia burgdorferi, a spiral-shaped bacterium (spirochete) named after Dr. Willy Burgdorfer, the public health researcher who discovered it in 1982. The infection is often contracted during warm-weather months when ticks are active. The spirochete enters the skin at the site of the tick bite. After incubating for 3-30 days, the bacteria migrate through the skin and may spread to lymph nodes or disseminate through the bloodstream to organs or distant skin sites.
|Ixodes scapularis is the most common tick vector in the northeastern and midwestern U.S. The picture shows (from left to right) the nymph, adult male, and adult female. The spot on the thumb shows the relative size of the nymph.||
Lyme disease frequently presents with a skin rash called erythema migrans (EM) and common flu-like symptoms of fever, malaise, fatigue, and muscle and joint pains. The characteristic EM rash is a flat or raised red area that expands, often with clearing at the center, to a diameter of up to 20 inches. However, it does not always occur, which can make the diagnosis more difficult, especially when the patient is not aware of having been bitten by a tick. Other early signs may include small skin lesions, facial nerve paralysis, lymphocytic meningitis, and heart-rhythm disturbances. Early infections usually are cured by two to four weeks of orally administered antibiotics (amoxicillin or doxycycline). However, if untreated or inadequately treated, neurologic, cardiac, or joint abnormalities may follow. Worldwide, Lyme disease has been directly responsible for fewer than two dozen deaths .
The disease is named after the town of Old Lyme, Connecticut, where researchers recognized its nature in 1975. In Europe, associations between tick bites and several skin diseases had been known for decades, but it was not understood that various conditions were part of a single illness. Since its nature was clarified, Lyme disease has emerged as a significant source of public controversy . Some people claim to be persistently infected with B. burgdorferi and suffering from debilitating symptoms as a result.
Many infectious agents can cause chronic infections or can be difficult to eradicate with standard antibiotic treatments. Unfortunately, it is often difficult to diagnose such infections and, in the case of Lyme disease, it is difficult to know what percent of cases persist in the form of chronic infections. Other possibilities for persistent symptoms include: autoimmune-like reactions in which the body attacks its own organs and tissues; physically damaged or scarred organs and tissues from an earlier infection; another tick-borne infection such as babesiosis or ehrlichiosis; and re-infection by B. burgdorferi .
In 2015, 95% of confirmed cases of Lyme disease were reported from just 14 states: Connecticut, Delaware, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, and Wisconsin. The map to the right illustrates the distribution of confirmed cases in 2016.
Of course, symptoms occurring long after the onset of Lyme disease also can be coincidental. A long-term study of 212 Connecticut residents suspected of having Lyme disease found incidences of pain, fatigue, and difficulty with daily activities to be similar to 212 age-matched controls without Lyme disease . As noted in an accompanying editorial:
After a median follow-up of 51 months, patients with a diagnosis of Lyme disease that met the national surveillance case definition developed by the Centers for Disease Control and Prevention (CDC) had the same profile of symptoms and the same quality-of-life indicators as age-matched controls without Lyme disease. Thus, recognition and treatment of clear-cut Lyme disease resulted in a return to baseline with no measurable sequelae. On the other hand, patients who were reported to have Lyme disease but who did not meet the CDC's case definition of Lyme disease had increased symptoms and worsening quality-of-life indicators. The implication is that many of these individuals really did not have Lyme disease and therefore did not respond to the treatment .
Limitations of Laboratory Tests
The diagnosis of Lyme disease should be based primarily on an evaluation of a patient's symptoms and the probability of exposure to the Lyme spirochete. Laboratory evaluation is appropriate for patients who have arthritic, neurologic, or cardiac symptoms associated with Lyme disease, but it is not warranted in patients who have nonspecific symptoms, such as those of chronic fatigue syndrome or fibromyalgia .
Matthew J. Rusk, MD, and Stephen J. Gluckman, MD, of the University of Pennsylvania summarized the diagnostic situation, noting that “A true-positive test result consists of a positive enzyme-linked immunosorbant assay [ELISA] or immunofluorescent assay [ILA] followed by a positive Western blot. However, positive results do not prove that [the] patient has Lyme disease and have little predictive value in the absence of characteristic symptoms” .
The FDA agreed and outlined a two-step algorithm for laboratory testing . In a 1997 FDA Public Health Advisory, it advised physicians that:
“The results of commonly marketed assays for detecting antibody to Borrelia burgdorferi (anti Bb) . . . may be easily misinterpreted . . . . Although package inserts for some commercial assays describe their intended use ‘to aid in the diagnosis of Lyme disease,’ this statement does not fully reflect current knowledge . . . and many such assays yield potentially misleading results. . . . Assays for anti-Bb frequently yield false-positive results because of cross-reactive antibodies associated with autoimmune diseases or from infection with other spirochetes, rickettsia, ehrlichia, or other bacteria such as Helicobacter pylori.”
Several years ago, a diagnostic laboratory marketed a one-step Lyme Antigen Urine Test [LUAT], data for which were presented at Lyme advocacy meetings and published in the journal of a Lyme advocacy group. The LUAT, however, was found to return a high rate of false-positive test results and has been discredited .
In February 1999, the FDA approved the PreVue B. burgdorferi Antibody Detection Assay, an "in-office" test that provided results within an hour. The test results are similar in accuracy to those of the ELISA test, but must be confirmed with a Western blot test done by a laboratory.
In May 2001, the FDA approved another ELISA test called C6. It was the first diagnostic tool to use a synthetic hybrid molecule derived from the surface of the Lyme spirochete. A positive C6 test appears to correlate well with acute cases of Lyme disease . In addition, it detects all B. burgdorferi genotypes, but does not appear to cross-react with a related tick-borne pathogen, B. lonestari, which is associated with a Lyme-like infection called (Southern Tick-Associated Rash Illness (STARI) .
In 2005, concerns about inappropriate laboratory testing prompted the CDC and FDA to issue a warning about “commercial laboratories that conduct testing for Lyme disease by using assays whose accuracy and clinical usefulness have not been adequately established. These tests include urine antigen tests, immunofluorescent staining for cell wall-deficient forms of Borrelia burgdorferi, and lymphocyte transformation tests. In addition, some laboratories perform polymerase chain reaction tests for B. burgdorferi DNA on inappropriate specimens such as blood and urine or interpret Western blots using criteria that have not been validated and published in peer-reviewed scientific literature” . The CDC noted, “patients are encouraged to ask their physicians whether their testing…was performed using validated methods and whether results were interpreted using appropriate guidelines.”
Some private practice physicians incorrectly diagnose Lyme disease in patients and subsequently treat them with inappropriate and ineffective regimens. Some of these treatments are described below.
Malariotherapy and ICHT
Malaria is a parasitic disease that typically involves bouts of fever that may reach 40°-41°C (104°-106°F). Before the antibiotic era, patients in the late stages of syphilis were sometimes given malaria in the hope that a high fever would kill the spirochetes responsible for syphilis. The practice was never subjected to controlled studies and was abandoned decades ago when antibiotics became widely available. Over the years, some Lyme patients have allowed themselves to be injected with blood containing a malaria parasite, Plasmodium vivax . Persons seeking such treatments usually had to travel to Mexico. However, in one case, a Texas resident acquired P. vivax-contaminated blood from an unknown source, injected himself, then treated himself with the antimalarial drug chloroquine . There is no evidence that malaria cures Lyme disease (or any other disease for that matter). Moreover, patients who receive malaria-containing blood face significant risks of serious illness or death caused by malaria itself, transfusion reactions, or an infection by other pathogens that might be in the blood. Malariotherapy is far more dangerous than a common case of Lyme disease.
Another form of fever therapy administered to patients who are alleged to have chronic Lyme disease is intracellular hyperthermia therapy (ICHT). A chemical such as 2,4-dinitrophenol (DNP) is administered to the patient. According to one Web site devoted to Lyme disease and ICHT:
The net result of ICHT uncoupler therapy causes the mitochondria to be converted from efficient "powerhouses" of energy production to "chemical furnaces", heating cells from the "inside-out." The Lyme spirochetes are subjected to such an amount of heat over a prescribed time that they cannot survive. In essence, ICHT maybe considered a form of therapeutic "pasteurization."
Hyperbaric Oxygen Therapy (HBOT)
High-pressure (hyperbaric) oxygen is legitimately used to treat deep sea divers suffering from decompression sickness ("the bends") and smoke inhalation, and to help treat several other conditions. There are 300 hyperbaric facilities in the United States. Some of these facilities have been used to treat AIDS, chronic fatigue syndrome, and Lyme disease. The Lyme patients subjecting themselves to long hours in these small chambers apparently hope that high-pressure oxygen will enhance oxygen-dependent immune mechanisms and kill spirochetes lurking beyond the reach of antibiotics.
Is HBOT effective against Lyme disease? At far as I know, it has not been subjected to clinical testing for that purpose. One Lyme patient writing on the Internet said, "After 30 hours of therapy [at $4,000] in 90-minute doses I had no positive results for chronic Lyme treatment." Another online patient wrote, "The director of the clinic is refusing to refund . . . me. This money was for some of the dives I was scheduled to take, but was unable to because I was sick." At best, HBOT is an experimental treatment for some infectious diseases. It is one of several treatments not recommended by the Infectious Diseases Society of America (IDSA) .
Many colloidal silver and silver salt preparations have been touted as cures for AIDS, chronic fatigue, herpes, TB, syphilis, lupus, malaria, plague, acne, impetigo, and many other diseases. Lyme disease is just the latest target. A 1996 Federal Register notice stated the "FDA is not aware of any substantial scientific evidence that supports the use of . . . colloidal silver ingredients or silver salts for these disease conditions." The same notice stated that "human consumption of silver may result in argyria—a permanent ashen-gray or blue discoloration of the skin, conjunctiva, and internal organs" . Despite these warnings, some websites devoted to Lyme disease or colloidal silver products display misleading reports about laboratory experiments in which colloidal silver killed spirochetes. One such report is a letter from Dr. Burgdorfer, the discoverer of the Lyme spirochete. The letter merely reports on a pilot study using colloidal silver to kill spirochetes in a test tube and states that additional laboratory and human studies are underway. Many silver and Lyme advocates have used the letter to suggest that colloidal silver has been proven effective against Lyme disease. However, no study has shown that colloidal silver is safe or effective for treating people with Lyme disease (or anything else).
A quack electromagnetic frequency device from the 1930s also has been resurrected for use in treating Lyme disease. These rife machines are marketed through the Internet. As one website claims, “rife machine therapy is an affordable, life-saving treatment option. Lyme Literate Medical Doctors (LLMDs) often refer their patients to rife machines if antibiotics fail.” These devices are based on the false notion that disease-causing agents and diseased tissues emit radio-like frequencies that can be detected and cured by matching their frequencies.
Other quack treatments for Lyme disease include injections of hydrogen peroxide, and bismacine. In 2006, the FDA issued a warning about the use of "bismacine" for treating Lyme disease. The situation came to the FDA's attention after a patient died as a result of bismacine treatment. The errant doctor, John R. Toth, M.D., of Topeka, Kansas, surrendered his medical license in 2005 and is serving a 40-month prison sentence for manslaughter related to the death . FDA inspectors eventually uncovered a network of shady practitioners who were making bogus diagnoses of Lyme disease and using illegal "dietary supplements" to treat their victims. The situation came to light in December 2008 when Toth; Robert W Bradford; C.R.B., Inc. (d/b/a American Biologics); and C.R.B.'s chief operating officer Brigitte G. Bird were charged with a total of 25 counts of conspiring to violate federal food and drug laws and defraud individuals seeking medical care. The indictment states that Bradford, C.R.B., and Bird marketed bogus Lyme disease products and a microscope falsely claimed to diagnose the disease and that Toth had used the system in his office. In 2009, Carole Bradford was added as a co-defendant. In a separate case, Carl E. Haese, owner/operator of The Haese Clinic of Integrative Medicine in Las Cruces, New Mexico, has been charged with fraud in connection with using Bradford's system .
Overuse of Intravenous Antibiotics
Many Lyme disease activists insist Lyme disease is a difficult-to-treat, chronic infection that requires long-term consumption of powerful antibiotics. (See common beliefs about Lyme disease at the American College of Physicians.) Although decades of medical practice and recent clinical trials suggest otherwise , many Lyme patients still undergo expensive, long-term intravenous antibiotic treatments.
Outpatient intravenous therapy is a multi-billion-a-year business. It remains largely unregulated and can cost patients thousands of dollars per week. Price gouging, drug markups, kickbacks, and self-referral of patients by physicians with financial ties to infusion companies have occurred. In 1995, for example, Caremark, Inc., pled guilty to mail fraud charges for entering into illegal contracts with physicians by paying them to refer Medicaid patients to use Caremark's infusion products . In Michigan, prosecutors charged a physician and Caremark employees with scheming to over bill Blue Cross/Blue Shield for drugs and equipment for patients with Lyme disease .
More recently, Forbes magazine reported on the dangerous and expensive practices of so-called “Lyme Literate Doctors” (LLMD) who rely on powerful, long-term antibiotics to treat patients for presumptive Lyme disease .
The long-term intravenous antibiotic therapy administered to Lyme patients sometimes has disastrous results. During the early 1990s, the CDC described 25 cases of antibiotic-associated biliary complications among persons with suspected disseminated Lyme disease . All patients had received intravenous ceftriaxone for an average of 28 days for suspected Lyme disease. (Ceftriaxone can form precipitates in the presence of bile salts. The resulting "sludge" can block the bile duct.) Twelve patients subsequently developed gallstones. Fourteen underwent gall-bladder-removal surgery to correct bile blockage. Twenty-two developed catheter-associated bloodstream infections. Yet most of the patients lacked documented evidence of disseminated Lyme disease or even antibodies to B. burgdorferi. In 2000, physicians reported the death of a 30-year-old woman who died from an infected intravenous set-up that had been left in place for more than two years. She was being treated for a case of "chronic Lyme disease" that could not be substantiated .
The risks and costs associated with such treatments were analyzed in a 1993 report whose authors concluded that for most patients with a positive Lyme antibody titer and only symptoms of fatigue or nonspecific muscle pains, the risks and costs of intravenous antibiotic therapy exceed the benefits . Yet fourteen years later, these conclusions continue to be ignored by patients and physicians alike.
In an Internet newsgroup posting, a woman described being on intravenous antibiotic, Rocephin, for 4 weeks, developing gallstones, and switching to another antibiotic regimen for three more weeks. She also described a sudden high fever, anemia, low white cell count, systemic pain, heart rhythm disturbance, and neurologic symptoms. Such descriptions are common among devout Lyme patients and provide an unsettling view into the desperate and dangerous measures some people will take to treat suspected Lyme disease. The woman ended her account by writing that she had switched her medication to ciprofloxacin. This is a powerful antibiotic with side effects that may include acute psychosis and other neuropsychiatric reactions . Other online “antibiotic addicts” have confessed to using veterinary and aquarium antibiotics when they could not get physician prescriptions .
Another patient writing on the Internet said he was treated at a Mexican clinic where the doctor admitted that he and his staff knew little about Lyme disease. The patient wrote, "I started on IV Rocephin (two grams a day), and later added oral azithromycin. My symptoms did improved, but I soon hit a treatment plateau. We then tried IV doxycycline, but this made me sick to my stomach." He went on to describe a long list of other drugs (IV Claforan, Cefobid/Unisyn, Premaxin, a second round of Cefobid/Unisyn, and IV Zithromax), followed by bouts of "severe diarrhea" and phlebitis. Three months and some $25,000 later, DMSO was added to another infusion of Zithromax.
Yet, the drug-seeking behaviors of self-described chronic Lyme patients and the prescribing practices of many “Lyme Literate doctors” remain at odds with published research. Investigators carried out two treatment trials of patients claiming to suffer from chronic Lyme disease. They reported that “treatment with intravenous and oral antibiotics for 90 days did not improve symptoms more than placebo" . Additional studies in Europe and the U.S. similarly found that: oral doxycycline is as effective as intravenous ceftriaxone in treating late-stage central nervous system infections [29,30]; and additional antibiotics are not beneficial in improving cognitive function in patients with post-treatment chronic Lyme disease .
In October 2006, the Infectious Diseases Society of America published guidelines for effective intravenous (and oral) antibiotic regimens to treat various manifestations of Lyme disease . The European Concerted Action on Lyme Borreliosis (EUCALB) also has published recommendations for treating Lyme disease with various oral and intravenous antibiotics.
Published treatment guidelines provide important navigation aids for both physicians and patients. If you don’t like the guidelines, however, there is nothing to stop you from making up your own. That’s what one group of doctors did recently. They posted a set of Lyme disease diagnosis and treatment guidelines on a website, and then proceeded to follow the guidelines they had drafted. They referred to their guidelines as “evidence-based,” but there is no evidence that the rationale for the guidelines has ever been validated in clinical trials or published in the professional literature, and there is no evidence that the guidelines have been endorsed by recognized medical societies such as the American Academy of Pediatrics or the American College of Physicians.
Indeed, the composers of these guidelines (copies of which they offered for $15) are a handful of private practice physicians and Lyme patient advocates. Some of these doctors have been disciplined by their state medical licensing boards. Many are not trained in infectious diseases and most have no research experience with Lyme disease. Still, that did not prevent them from having their guidelines listed in the National Guideline Clearinghouse or using that web listing to suggest their guidelines are clinically appropriate and professionally endorsed. (The Clearinghouse listing is a directory, much like a phone book, which neither endorses nor evaluates those listed. Unfortunately, this fact is not readily evident to patients looking for online information.)
In 2016, yet another study confirmed the futility of long-term antibiotic therapy for people with symptoms attributed to "chronic Lyme disease." This study involved 252 patients who received two weeks of standard antibiotic treatment followed by 12 weeks in which they received either doxycycline, another antibiotic, or a placebo. The three groups demonstrated no significant differences in outcome . An accompanying editorial concluded that, "Patients with subjective, vexing symptoms attributed to Lyme disease should not anticipate that even longer courses of antibiotics will produce relief, a finding that is in concert with results from previous trials."  Hoiwever, the treatment is not merely ineffective. In 2017, five cases were reported in which intravenous treatment for "chronic Lyme disease" resulted in the development of serious infections .
Many patients who believe they have a chronic or persistent Lyme infection are willing to endure considerable discomfort in their effort to get rid of their symptoms. This behavior is fostered, in part, by the misguided belief that antibiotic therapies are not working unless they make the patient feel worse. These patients typically refer to this condition as "herxing," a colloquial term for the Jarisch-Herxheimer (J-H) reaction. This reaction is an acute response to the release of toxic or biologically active molecules from certain types of bacteria in the presence of some antibiotics.
About 10% of patients treated for early Lyme disease experience a J-H reaction involving chills, fever, muscle pains, rapid heartbeat, and slight lowering of blood pressure during the first 24 hours of antibiotic therapy. These symptoms usually last for several hours, and require little more than aspirin and bed rest. Yet many Lyme newsgroup participants write about a "herx" beginning days or weeks after the start of antibiotic therapy, and "herxing" for weeks at a time—often in a cyclic fashion." Herxing" events have even been likened to an "exorcism" that is "a necessary evil to be endured." Some of these patients are likely to be suffering from the side effects of their inappropriately prescribed antibiotics. It is also safe to assume that the mistaken belief that Lyme treatment involves temporary worsening will lead some people to neglect other illnesses. Neurological symptoms, blurred vision, gastrointestinal upset, vomiting, and palpitations, for example, should be reported to a physician, not posted on the Internet with a request for comments.
Fear, ignorance and Internet rumors have also created an environment for expanding the mythology of Lyme's protean properties far beyond scientific fact or medical observation. For example, some Internet postings and websites suggest that Lyme can be acquired through sexual contact.
"I think that Lyme is also a STD [sexual-transmitted disease]," said one newsgroup poster. Another wrote, "I've talked to many couples who claim they transmitted to each other through sexual contact. I believe I gave it to my wife."
At least a few LLMD appear to be telling patients that Lyme is sexually transmitted and therefore their family members should be tested. One person reported to Quackwatch that a family member had been tested and told that the test was positive and that a 4-5 month course of antibiotics was necessary.
There is no basis for such advice or beliefs. Lyme infections are acquired from the bite of an infected tick. People are "dead end" hosts and do not spread Lyme infections to others.
The topic of pregnancy and Lyme is also rife with rumor and unnecessary fear. A recent review of case reports and other research found no specific patterns of fetal malformation or adverse events in pregnancy . In addition, the authors noted that “larger epidemiological and serological series have consistently failed to demonstrate an increased risk to pregnant women who develop Lyme disease if they receive appropriate antimicrobial therapy.” Attempts to demonstrate venereal, transplacental and contact transmission of Lyme spirochetes in hamsters also have failed .
The risk of acquiring Lyme disease from a blood transfusion is also very low. This was demonstrated in a study of patients in Connecticut whose antibodies were measured six weeks after they received multiple transfusions during cardiothoracic surgery. Of 155 subjects, 149 received a total of units of packed red blood cells and 48 received a total of 371 units of platelets. No patient developed antibodies to B. burgdorferi or clinical evidence of Lyme disease .
In contrast, a case of perinatal transmission of human granulocytic ehrlichiosis (HGE) was reported in the New England Journal of Medicine . Like B. burgdorferi, HGE is transmitted by the Ixodes tick, and simultaneous infections with both pathogens have been reported.
The fact that Lyme disease is readily curable has not discouraged the formation of over a hundred support groups and nonprofit foundations, some with ties to intravenous services, Lyme diagnostic labs, and physicians specializing in private Lyme disease practices. These groups and their ardent followers have used the Internet and other media to barrage politicians and the general public with misinformation, dire personal stories, rumors, and exaggerated claims about thousands of people being maimed, killed and bankrupted each year by Lyme disease. The core message is that Lyme is a deadly chronic disease that requires long-term antibiotic therapy paid for by insurance companies.
Despite the alleged frequency of chronic Lyme disease, clinical trials funded by the National Institutes of Health (NIH) were hampered by a lack of patients who met evidence-based medical criteria for Lyme disease. A third trial at Columbia University had to modify its patient entry criteria in order to find enough patients to carry out the study. The reality is Lyme remains a common bacterial infection that is antibiotic-responsive, nonfatal, non-communicable, and geographically- and seasonally-limited in range.
Still, support groups and individual patients have created numerous websites that contain unsubstantiated claims, inaccurate medical information, and personal testimonies for the dubious treatments described above. Indeed, the Internet has provided a powerful mechanism for organizing patients and presenting poorly documented information to the public and the press [39,40]. And as the owner of one Lyme diagnostic lab recently said, “Patients, because of the Internet, have become my best salesmen” .
Internet newsgroups also have posted violent polemics against physicians and researchers who disagree with their claims and concerns. Research reports that run counter to the claims of Lyme activists are denounced and their authors accused of incompetence and financial conflicts of interest. Magazines and news organizations whose stories on Lyme disease are not sufficiently hysterical are barraged with e-mail complaints and urged to contact certain organizations for "the truth." Protests have been organized to denounce Yale University because, according to the protesters, Yale "ridicules people with Lyme disease, presents misleading information, minimizes the severity of the illness, endorses inadequate, outdated treatment protocols, excludes opposing viewpoints, and ignores conflicts of interest."
Researchers have been harassed, threatened, and stalked . A petition circulated on the Web called for changes in the way the disease is routinely treated and the way insurance companies cover those treatments. Less radical groups have had their meetings invaded and disrupted by militant Lyme protesters. In October 2006, the New Jersey-based Lyme Disease Association (LDA) led a series of protests at NY Medical College to denounce the updated Lyme disease treatment guidelines published by the IDSA. The LDA organized another online petition against the guidelines, and a related LLMD organization demanded the treatment guidelines be retracted. Evidently, they were worried the guidelines would be accepted by insurance companies and therefore cut into their private practice profits . In 2012, the LDA's online referral directory included 65 medical doctors and 12 osteopaths.
In November 2006, Lyme activists persuaded the Connecticut Attorney General, Richard Blumenthal, to file a Civil Investigative Demand (CID) to look into possible anti-trust violations by the IDSA during the drafting of the treatment guidelines . A few weeks later, the activists persuaded Congressional Representative Chris Smith (R-NJ) to write a letter to the CDC Director questioning the CDC’s support of the IDSA guidelines and suggesting CDC needed to show support for alternative guidelines developed by activists and the private practice, for-profit physicians who treat them.
The CDC declined to do so. Moreover, few lawyers and physicians believe Blumenthal’s quixotic use of anti-trust law to intimidate a nonprofit professional society into changing or withdrawing voluntary clinical guidelines is going to affect the treatment of Lyme disease. Yet, these events demonstrate the power of Internet-connected activists to mobilize political power in order to question evidence-based medicine and peer-reviewed scientific research.
Not content to suppress evidence-based medicine through litigation and legislation, some Lyme organizations also have tried to raise funds for their own research on hyperbaric oxygen treatments, pregnancy-related Lyme, and a clinical trial of chronic Lyme patients. Others have organized "scientific" meetings and journals to present anecdotal reports and opinions from physicians friendly to their cause.
Several years ago, a Lyme Disease Buyers Club marketed vitamin and nutrient supplements (e.g., flax seed oil, evening primrose oil, coenzyme Q10, garlic, B-complex) to Lyme patients. The club indicated, "10 percent of each sale will go to Lyme disease research and advocacy projects." However, the initial proceeds went to a Lyme disease advocacy group (Lyme Alliance) in Michigan. The group filed an amicus brief supporting a court appeal by Joseph Natole, Jr., M.D., whose state medical board had sanctioned him for inappropriately managing patients with actual or suspected Lyme disease. According to a report on the Alliance's website: the court ruled against the doctor; his license was suspended for three months; he was fined $50,000; and he was subsequently indicted and pleaded guilty to federal charges of over billing insurance companies.
The Alliance later circulated a petition stating that, "Lyme disease can and does exist as a chronic illness with persisting infection, and that the disease is greatly underdiagnosed and undertreated." The petition demanded that, "Physicians who are on the front lines of Lyme disease patient care not be harassed, persecuted or made to fear for their medical practices because they do not adhere to the conservative "short term" care for Lyme disease."
That defiant battle cry still echoes today. Activists continue to file petitions and organize protests in support of any physician willing to provide them with a positive Lyme disease diagnosis and long-term access to antibiotics. Activists often attend state medical board hearings in support of their physicians and flood state legislators with demands for legislative protection of their doctors .
Legal and Regulatory Actions
Since 2005, several so-called “Lyme Literate” doctors have been accused of wrongdoing:
- In 2008, a Kansas doctor was sentenced to prison for manslaughter for administering bismacine injections that killed a patient he was treating for supposed Lyme disease. Bismacine contains high amounts of bismuth, a metallic chemical that can be poisonous and is not approved by the FDA.
- In South Carolina, the widow of a man who died of prostate cancer filed suit against a Lyme doctor who gave her husband intravenous hydrogen peroxide and falsely diagnosed him as having Lyme disease. The doctor also prescribed testosterone, which caused his cancer to rapidly advance, resulting in his death about six weeks later.
- In North Carolina, the Medical Board suspended a physician's license for one year after finding he departed from prevailing methods of treating Lyme disease. The 12-member board also concluded he did not adequately inform patients that his treatment method, which includes months or years of intravenous antibiotics, is unorthodox. Five patients, including the widower of a woman who died of morphine poisoning while under his care, testified for the prosecution.
- In New Jersey, a doctor and former member of the Governor's Lyme Disease Advisory Council took money from Lou Gehrig's disease patients for a stem-cell treatment that she could not—and did not—perform, according to a federal indictment. The doctor and her assistant were charged with 11 counts of conspiracy, mail fraud, wire fraud and money laundering.
- Another New Jersey doctor was indicted on charges of conspiracy to defraud the United States, income tax evasion, and willful failure to account for and pay IRS employee taxes at two Lyme disease treatment centers. After a jury convicted him of income tax evasion, he was sentenced to 41 months in prison and ordered to pay a fine of $7,500 plus restitution of $246,791.
- In 2014, in Arizona, an osteopathic physician was reprimanded, assessed $1,500 plus costs, and ordered to stop diagnosing and treating Lyme disease. The action was based on the board's conclusion that he had diagnosed and treated a patient for nonexistent Lyme disease.
- In 2016, the Florida Board of Medicine revoked the license of a "Lyme specialist" after concluding that he had improperly diagnosed and unjustifiably treated seven patients with Lyme disease, Bartonellosis (a bacterial infection), and/or Babesiosis (a parasitic infection) and failed to keep adequate records. The Board also imposed a $30,000 fine and assessed costs.
Despite the deaths and the prosecutions, support for LLMDs remains strong among activist groups, even as some of these doctors attempt to expand the range of diseases that can be blamed on B. burgdorferi and, therefore, treated with long-term antibiotics. Some of these diseases include complex or degenerative illnesses such as autism, multiple sclerosis and amyotrophic lateral sclerosis.
A Lyme Vaccine
After a decade of research, and pressure from patient advocates and Congress , the FDA licensed the first vaccine for Lyme borreliosis on December 21, 1998. The vaccine, called Lymerix, was derived from a recombinant version of the bacterium’s OspA lipoprotein. Lymerix was intended for "at-risk" individuals between the ages of 15 and 70 years. Given in three separate injections, the vaccine appeared to be effective in preventing infections.
Yet, after years of pre-license clinical trials and three years of commercial sales, the manufacturer, GlaxoSmithKline, pulled the vaccine off the market on February 26, 2002. The company cited poor sales and a projected low demand  as the basis for their decision to end production and distribution of Lymerix.
The demise of Lymerix has not ended research on new Lyme vaccine candidates and vaccines against tick vectors. It may be difficult, however, to field-test new vaccines due to anti-vaccination organizations and the lingering hostility of Lyme activists to a vaccine .
Ironically, many of the original advocates for a vaccine turned against Lymerix as soon as it hit the market. Citing its less than perfect efficacy and anecdotal evidence of vaccine-induced arthritis and other injuries, they crowded FDA hearings with tales of personal injury, flooded the Internet with anti-vaccine tautologies, and joined lawsuits seeking compensation from Glaxo and Pasteur Mérieux Connaught, the maker of a second, but never licensed vaccine .
Despite the lawsuits and the website tales of personal anguish, repeated studies failed to find any evidence of specific adverse events associated with Lymerix . A CDC study published in the February 2002 issue of Vaccine also failed to detect any "unexpected or unusual patterns" of adverse reactions to vaccination . (Reports of adverse reactions to Lymerix, and other vaccines, can be searched for on the Vaccine Adverse Event Reporting System (VAERS) website.)
It is interesting to note the results of a 2002 survey of parental attitudes toward Lymerix . The survey authors found that respondents in Nassau County, New York indicated they would "definitely" or “likely" request Lymerix for their children (23% and 65% respectively). The positive response to Lymerix may be because most survey respondents got their information about Lyme disease and the vaccine from a friend or an advertisement (49% and 44%, respectively). The Internet was not identified as a source of information. Yet, the survey found that most respondents were "surprisingly misinformed" about Lyme infections. For example, they considered Lyme infections to be a chronic, difficult-to-treat disease.
"Chronic Lyme disease" remains the favored term of support groups and patient advocates, but has no basis in medical fact or practice . The endless public repetition of this misleading mantra may have influenced parental opinions in favor of vaccination as a means of preventing a chronic infection that does not exist. The option to vaccinate ended on February 26, 2002.
Interestingly, a recent study of patients presenting with recurrent signs of Lyme disease suggests that they are being repeatedly infected and not “relapsing” from a persistent infection . The study authors noted, “People experiencing recurrent episodes [of Lyme] tended to have frequent contact with vector ticks. Prompt administration of standard antibiotic therapy…reliably eliminates persistent infection and prevents relapse.” This is just what the vaccine was designed to do.
In 2004, two infectious disease specialists at the University of Connecticut reviewed the quality of online information about Lyme disease . Most of the websites they surveyed contained inaccurate or incomplete information. One of the authors, Henry Feder, told Reuters Health, “The problem is that some of these sites may have had an agenda other than education. They make the unusual seem common.” As the authors noted in their paper, “The challenge for medical providers is to convince worried patients . . . that some of the Internet-recommended testing and treatment . . . is inappropriate. This convincing can take multiple visits, debate, compromise and time.”
The steady flood of Lyme disease misinformation prompted Kent Sepkowitz, the director of infection control at Sloan-Kettering, to vent similar feelings in the New York Times (May 10, 2005). He wrote: “The vast, lumpy terrain of Lyme disease is a confusing place for doctor and patient alike. According to some, Lyme is able to cause any imaginable symptom, yet laboratory diagnosis remains famously elusive. This combination of plasticity and stealth makes it a convenient explanation for any ailment that otherwise makes no sense.”
Despite the Internet noise, fundraising letters from activists, and intimidating lawsuits, it is not difficult to find accurate information about Lyme disease. Most state health departments provide free brochures or direct online information. Good sources include:
- U.S. Centers for Disease Control and Prevention (CDC)
- American Lyme Disease Foundation (ALDF)
- Infectious Diseases Society of America’s Lyme Disease Treatment Guidelines
- University of Rhode Island's Tick Encounter Resource Center
- European Union Concerted Action on Lyme Borreliosis (EUCALB)
- Aetna Coverage Policy Bulletin 0215: Lyme Disease
- AMMI Canada Position Statement on the Diagnosis and Treatment of Persistant Symptoms Attributed to Lyme Disease
The Bottom Line
- Lyme disease, when diagnosed early, is readily treatable with oral antibiotics.
- Positive antibody tests, by themselves, do not provide a sufficient basis for diagnosing Lyme disease. The diagnosis should be based on the overall clinical picture, including medical history and physical findings.
- Negative antibody testing after the first few weeks strongly suggests that the patient does not have Lyme disease.
- Many patients with chronic, nonspecific symptoms (such as headaches, fatigue, muscle aches, mental confusion, or sleep disturbances) mistakenly believe they have Lyme disease.
- Intravenous antibiotic therapy, when given appropriately, should not last more than a month. It should not be given unless oral antibiotic therapy has failed and persistent active infection has been demonstrated by culture, biopsy, or other bacteriologic technique.
- Malariotherapy, intracellular hyperthermia therapy, hyperbaric oxygen therapy, colloidal silver, dietary supplements, and herbs are not appropriate measures for treating Lyme disease. Doctors who recommend them should be avoided.
- Reported Lyme disease cases by state or locality, 2002-2016. CDC Web site, accessed Oct 7, 2012.
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Dr. McSweegan is a microbiologist who lives and works in Maryland, but has spent many summers in Old Lyme, Connecticut. Between 1993 and 1995, he managed a federal Lyme disease research program. The original version of this article was reviewed by Judith N. Barrett, M.D., Luther Rhodes III, M.D., Marvin Rosenthal, M.D., and John H. Renner, M.D.
This article was revised on June 28, 2017.