Since they were first published in 2000, the Infectious Diseases Society of America (IDSA) guidelines for diagnosis and treatment of Lyme disease have been the subject of intense controversy, including an antitrust investigation by the state of Connecticut and hundreds of protests.
Advocacy groups say the IDSA guidelines misrepresent science and restrict access to care for patients with chronic Lyme disease. They say additional harm occurs when patients are denied insurance coverage for evidence-based treatment options that could help them regain their health.
Advocates have complained that IDSA guidelines authors have been engaged in a long-running misinformation campaign to promote the IDSA guidelines and discredit research that contradicts the evidence and recommendations of the guidelines.
Much of the propaganda is produced by the shadowy Ad Hoc International Lyme Disease Group, which consists of Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) employees and most authors of the IDSA guidelines.
Two Standards of Care
Controversy over Lyme disease has sharply divided the medical community, resulting in two competing standards of care that disagree on most aspects of the disease, including diagnosis and treatment.
The center of the debate is over the existence of chronic Lyme, also referred to as "persistent infection," which means that some Lyme bacteria can tolerate and survive antibiotic treatment.
The view enforced by IDSA is that Lyme disease is easy to diagnose and simple to treat with a limited course of antibiotics. According to the IDSA guidelines, chronic Lyme does not exist and long-term antibiotic treatment is not warranted. The IDSA guidelines were developed in close coordination with the CDC and are followed by most physicians and used by insurers to determine limits on coverage.
The alternative paradigm, represented by the International Lyme and Associated Diseases Society (ILADS), maintains that Lyme disease is a serious national medical problem of epidemic proportion that needs to be researched, diagnosed and treated more aggressively and often requires long-term treatment beyond the limits set by IDSA. The ILADS guidelines recognize chronic Lyme disease and recommend that the "duration of therapy be guided by clinical response, rather than by an arbitrary treatment course."
Both guidelines are listed by the National Guidelines Clearinghouse, although unlike the ILADS guidelines, the IDSA guidelines do not comply with the Institute of Medicine Standards for Developing Trustworthy Clinical Practice Guidelines or the Grading of Recommendations Assessment, Development and Evaluation Working Group system for grading quality of evidence and strength of recommendations. In addition to being contested by dozens of advocacy groups, IDSA guidelines are contested by physicians, scientists and lawmakers.
In 2008, Connecticut Attorney General Richard Blumenthal, now a US senator (D-Connecticut), conducted an antitrust investigation of IDSA based on allegations of abuses of monopoly power and exclusionary conduct. In a May 2008 press release, Blumenthal said:
The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests - in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies - to exclude divergent medical evidence and opinion.
The resulting guidelines harm large numbers of patients who are misdiagnosed or otherwise denied treatment because of restrictions imposed by the guidelines.
Solid Science Tips the Balance
There are now hundreds of peer-reviewed articles that support the ILADS viewpoint. Lyme bacteria are called spirochetes because of their spiral shape. Spirochetes can drill through tissue to reach immunoprivileged sites (with less immune activity), including the central nervous system (brain and nerves) and collagen dense tissues, such as tendons and cartilage (joints) and the heart.
When conditions are unfavorable for growth, such as when the spirochetes are under attack by antibiotics, they can evade treatment by changing into dormant forms that remain viable by mooching nutrients but do not cause inflammation unless they receive signals to reactivate. With little or no metabolic activity, such as protein synthesis or replication, there is nothing for an antibiotic to disrupt. Bacteria that are capable of surviving targeted antibiotic therapy for any reason are referred to as "persisters." Some forms of Lyme persisters are also called "round bodies" because the spirochetes change from an elongated spiral to a more compact round form.
According to a July 2014 article in Emerging Microbes & Infections, "Frontline drugs such as doxycycline and amoxicillin kill the replicating spirochetal form of B. burgdorferi quite effectively, but they exhibit little activity against non-replicating persisters ..."
The April 2013 article "Review of Evidence for Immune Evasion and Persistent Infection in Lyme Disease" describes how Lyme can evade the immune system and survive antibiotic treatment. Mechanisms include varying its outer surface proteins to confuse the immune system and participating in biofilm communities, which protect it from antibiotics.
Biofilms are colonies of bacteria bound together by a DNA-containing gel of nutrients protected by an ultra-thin calcified shell. Groups of bacteria within the biofilm specialize to handle metabolic functions. Biofilms are considered a hallmark of chronic infections by many scientists.
Pathologist Alan MacDonald, Eva Sapi and other researchers have documented biofilms of Lyme bacteria, both in the lab and in human tissue. The presence of Lyme biofilms was confirmed by atomic force microscopy and DNA probes.
IDSA Gatekeepers at Major Journals
Research published in scientific journals goes through a process called peer review to determine if the material meets the editorial and scientific standards of the publication. Peer review is part of the scientific process intended to weed out flawed research and highlight the best science.
In the case of chronic Lyme disease, reviewers with serious conflicts of interest are able to prevent articles that support the ILADS point of view from being published.
According to information compiled in the 2008 antitrust investigation, IDSA panelists and others who endorse the IDSA guidelines sit on the editorial boards of 20 major medical journals, including The New England Journal of Medicine and Lancet Infectious Diseases, where they can use their positions to prevent publication of studies that challenge their views on chronic Lyme.
Several members of the current IDSA guidelines panel published a flurry of papers in advance of the upcoming guidelines review process, with the apparent intent of relying on their own articles as the "evidence" requisite to assure the guidelines are "evidence-based." However, many of these articles were published in IDSA's own journal, Clinical Infectious Diseases, which further subverts the peer-review process.
An example is the July 2015 article "Poor Positive Predictive Value of Lyme Disease Serologic Testing in an Area of Low Disease Incidence," which includes current guidelines panelists Paul M. Lantos and Gary P. Wormser as co-authors.
Although unethical, this practice is not necessarily illegal. However, it shows that the peer-review system has the potential to suppress good science that conflicts with a reviewer's opinions.
IDSA panelists frequently point out that much of the information about Lyme disease published on the internet is inaccurate or misleading. This may be true, but it's also true of much of the clinical research cited by IDSA in its guidelines.
In a New York Review of Books article "Drug Companies & Doctors: A Story of Corruption," former editor of The New England Journal of Medicine Dr. Marcia Angell writes, "It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines."
Misinformation From IDSA Panelists
In addition to controlling access to the major medical journals, the guidelines' authors have misinformed the public about Lyme disease through a series of published statements and media interviews.
One example occurred during a July 8, 2015, "Diane Rehm Show" on Lyme disease, when an IDSA physician, Dr. Sunil K. Sood, made a series of inaccurate and misleading statements about key aspects of the disease.
Sood specializes in pediatric infectious disease and is chairman of pediatrics at Southside Hospital North Shore-LIJ Health System. He also serves on the panel that is tasked with updating the IDSA guidelines for Lyme disease.
During the show, Sood said, "What we know for certain is that the persistent symptoms are not due to the persistence of the Lyme bacterium in the body." This statement is contradicted by a growing number of peer-reviewed studies that demonstrate persistent infection in both humans and animals after short-term antibiotic treatment.
If Sood knows this for certain, he's either ignorant of all this research or he's being deceptive. Culture confirmed cases of persistent infection in humans after short-term antibiotic treatment show that chronic Lyme disease is a very real and widespread problem.
Landmark studies by Barthold, Yrjänäinen, Embers, Hodzic, Lewis and Baumgarth indicate that dormant forms survive without causing inflammation unless they receive signals to reactivate. Signals thus far known to reactivate the Lyme bacteria include getting bit by another tick and immunosuppressant drugs, such as corticosteroids. According to Sood, a bull's-eye rash is present in "90 percent of cases." There is little evidence to support this claim; however, there is plenty of evidence that shows large numbers of patients never see a rash.
Sood also said that ticks must be attached "48 to 72 hours" to transmit the disease. This is contrary to the latest research, which shows that Lyme can be transmitted in less than 24 hours, and that no minimum attachment time has been conclusively established. Misinformation of this type has the potential to harm patients who trust experts to provide accurate information. Imagine if patients take this information as gospel and do not seek treatment because a tick has been attached for less than 48 hours. Imagine if they or their doctors discount the possibility of Lyme disease because they did not see a bull's-eye rash.
Organized Propaganda Campaign by Ad Hoc Lyme Group
Unfortunately, Dr. Sood is not an exception. Misleading information that has been refuted by good science has been published in a series of peer-reviewed articles by IDSA panelists.
The Ad Hoc International Lyme Disease Group was formed in 2005 by CDC and NIH employees and 14 authors of the IDSA guidelines. CDC emails released in 2012, in response to a Freedom of Information Act (FOIA) request by science writer Kris Newby, show how the Ad Hoc Group has been covertly setting government policy on Lyme for the past decade.
The 2007 article "A Critical Appraisal of 'Chronic Lyme Disease'" in The New England Journal of Medicine lists the Ad Hoc Group under contributing authors. The article goes to great lengths to discredit the concept of chronic Lyme.
The authors cite NIH-funded, double-blind, randomized, placebo-controlled trials in claiming "there is substantial risk, with little or no benefit, associated with additional antibiotic treatment for patients who have long-standing subjective symptoms."
A rigorous biostatistical review of the NIH trials, published in an independent peer- reviewed journal, determined that "long term treatment can be beneficial" and explains that "significant findings and errors may arise when disagreement and uncertainty exists in the medical community, as is the case with Lyme disease." The review concludes, "It is incorrect to draw strong conclusions regarding antibiotic retreatment in patients with persistent symptoms of Lyme disease based on the NIH-sponsored randomized controlled trials."
The supplementary information for The New England Journal of Medicine article recommends that "The physician should arm, them [patients] with an explanation of the antibiotic-responsive nature of this infection and its lack of persistence." This recommendation flies in the face of definitive peer-reviewed studies on persistence that suggest otherwise.
The most recent of the NIH trials was a primate study by Monica Embers in which investigators recovered intact Lyme spirochetes from rhesus macaques (a class of monkeys) treated with the IDSA recommended antibiotic regimen, using "xenodiagnosis," where sterile ticks are attached to the patient for a period of time and then tested for Lyme.
It's hypothesized that chemicals secreted by the ticks wake up the dormant spirochetes and draw them toward the site of the bite. Similar studies have yet to be conducted in humans, but the Embers study provides the strongest evidence to date that short-term antibiotics will not always eradicate the Lyme bacteria.
Another more recent example of collaboration by members of the Ad Hoc Group is the July 2015 article, "Unorthodox Alternative Therapies Marketed to Treat Lyme Disease," authored by IDSA guidelines panelists Paul M. Lantos, Eugene D. Shapiro, Paul G. Auwaerter, John J. Halperin and Gary P. Wormser, along with Phillip J. Baker, a former NIH official, and Edward McSweegan, a former NIH Lyme program officer who currently serves as program manager for the NIH Global Virus Network.
Baker is the executive director of the American Lyme Disease Foundation, a nonprofit organization that according to advocates is a front for IDSA that masquerades as a patient organization. Baker was responsible for management of two of the NIH trials on Lyme disease.
Patients Under Attack
In addition to attempting to discredit research and researchers, IDSA panelists have attacked patients and patient advocacy groups in a series of public statements and in articles published in influential medical journals.
One such article, "Antiscience and Ethical Concerns Associated with Advocacy of Lyme Disease," co-authored by members of the Ad Hoc Group, vilifies Lyme patient advocates and accuses them of being part of an "antiscience movement."
The article claims there is "no microbiological evidence for persistence of B. burgdorferi," and that "Lyme disease activists have created a parallel universe of pseudoscientific practitioners, research, publications, and meetings."
The article also attacks ILADS directly and says, "Several physician members of ILADS - including current and former officers - have been sanctioned by state medical licensing boards."
The authors fail to mention that many of these physicians were providing patients with evidence-based treatments that conflicted with the IDSA guidelines, and were reported to the medical boards by IDSA physicians rather than by patients.
The article attacks efforts by advocacy groups to pass legislation and says the leaders "lobby for legislation to promote their perception of chronic Lyme disease and to protect LLMDs (Lyme Literate Medical Doctors) from licensing boards."
This is especially ironic since IDSA employs professional lobbyists to oppose this type of legislation, and at its 2004 annual meeting, passed a resolution to "oppose patient legislative initiatives."
A recent example of attacks on patients came from IDSA spokesperson and Johns Hopkins physician Paul G. Auwaerter, M.D., who says patients with chronic Lyme symptoms dabble in conspiracy theories. "When you don't understand something," Auwaerter said in an April 2015 interview with the Allentown Morning Call, "you try to insert a framework that makes sense to you."
Rather than address the problem, the recurring theme from IDSA-aligned researchers is that Lyme patients and advocacy groups are the problem.
According to Holly Ahern, microbiology professor at SUNY Adirondack and vice president of Lyme Action Network, "Rhetorical attacks on patients, advocates and physicians who treat chronic Lyme patients do nothing to advance the science or help patients. This is exactly the tactic used in the 1980s to marginalize AIDS patients and advocates, when the infectious nature of that disease was still under dispute."
In an email (obtained by FOIA) to Barbara Johnson, Ph.D., a CDC researcher aligned with the IDSA panelists, Durland Fish, Ph.D., professor of epidemiology at Yale University and core member of the Ad Hoc Group, wrote, "This battle cannot be won on a scientific front. We need to mount a socio-political offensive."
"For whatever reason, the IDSA panelists view this as a 'war' that must be won at all cost," Ahern said. "Unfortunately, Lyme disease patients and their families are the civilian casualties of this war."
Physicians - and particularly specialists and researchers - have a professional obligation to keep up with science in their fields.
According to the American Medical Association code of ethics, "A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public ..."
Rather than advancing scientific knowledge and making relevant information available, IDSA panelists are ignoring good science and withholding relevant information from patients, colleagues and the public.
Time for Change
The effect of this decades-long propaganda campaign is that an entire class of chronically ill patients is discriminated against by a medical society that has lost sight of patient-centered care.
Many of these very sick patients are forced to take the initiative and learn on their own about relevant science and evidence-based treatment options prohibited by the IDSA guidelines. Something is terribly wrong when large numbers of chronically ill patients have to do their own research because widely followed treatment guidelines do not provide an acceptable standard of care.
For more than three decades, the voices of chronic Lyme patients and the doctors who treat them have been drowned out by academic physicians who have controlled the debate. We need to stop this injustice and give this rapidly growing epidemic the attention and funding it urgently needs.
IDSA issued the following statement in response to a request for comment on this article:
IDSA is committed to ensuring that people with Lyme disease receive the best possible care, based on the best science available. We deeply sympathize with patients who are suffering. We believe more research and better tests are needed. Our position is that long-term use of antibiotics in the treatment of Lyme disease has been shown to have no benefit and is indeed dangerous. IDSA is currently working with the American Academy of Neurology and the American College of Rheumatology and other medical societies to develop a new guideline on Lyme disease, with input from the public.
Dr. Sood did not respond to a request for comment.