Last Friday, 28 patients filed a federal antitrust lawsuit against the Infectious Diseases Society of America, eight health insurance companies, and seven medical doctors, Courthouse News reported yesterday, “because health insurers are denying coverage with bogus guidelines established by their paid consultants, who falsely say the disease can always be cured with a month of antibiotics.”
Contrary to the often-reported claim that Lyme disease affects people almost exclusively from Washington, D.C. to New England, and in the Great Lakes region, the lawsuit’s plaintiffs represent a wide expanse of the United States, hailing from Alabama, Arkansas, Connecticut, Florida, Georgia, Iowa, Ohio, Michigan, Minnesota, Nevada, Pennsylvania, and Texas.*
Among the lawsuit’s allegations:
In the 1990s, the Insurance Defendants decided that treatment of Lyme disease was too expensive and “red-flagged” Lyme disease. The health insurance industry made a concerted effort to deny coverage for treatment of Lyme disease. The Insurance Defendants enlisted the help of doctors who were researching, not treating, Lyme disease. The Insurance Defendants paid these IDSA Panelists large fees and together they developed arbitrary guidelines for testing Lyme disease.
Once these arbitrary guidelines were decided, the Insurance Defendants could, and did, deny coverage for patients if they did not meet their new stringent Lyme testing protocols. Since most Lyme patients would not test positive under the new protocols, the Insurance Defendants could deny coverage for many people suffering from Lyme disease.
Additionally, the Insurance Defendants, with the help of the paid IDSA Panelists, decided that long term antibiotic treatment was not necessary and all Lyme disease patients could be cured in less than a month. By August of 1992, the Insurance Defendants had imposed an intravenous antibiotic limit of twenty-eight days.
By the mid 1990’s, the Insurance Defendants began paying large consulting fees to the same Lyme IDSA Panelists who helped them develop their arbitrary guidelines. The Insurance Case 5:17-cv-00190-RWS Document 1 Filed 11/10/17 Page 10 of 53 PageID #: 10 11 Defendants paid these Lyme IDSA Panelists to enforce their new stringent testing protocols and maintain the 28-day treatment requirement. These doctors began publishing papers on the “Lyme hysteria” and the “Pseudo Lyme” problem.
The lawsuit names a number of medical doctors, all representatives of the Infectious Diseases Society of America. Among them are:
Dr. Gary P. Wormser, Dr. Raymond J. Dattwyler, Dr. Eugene Shapiro, Dr. John J. Halperin, Dr. Robert B. Nadelman, Dr. Leonard Sigal, and many others were paid large sums of money by the Insurance Defendants in consulting fees, in expert witness fees, and to review, and deny, insurance coverage claims related to Lyme disease.
This new lawsuit is not the first antitrust suit filed against the Infectious Diseases Society of America. In 2006, the Office of the Connecticut Attorney General filed an antitrust investigation to determine whether conflicts of interest may have affected the development of the IDSA’s clinical practice guidelines for Lyme disease. Findings of that investigation determined in 2008 that:
“significant procedural deficiencies related to the IDSA’s development of its 2006 Guidelines” and found that the panel and the IDSA failed to ensure that the guideline development comported with due process, as required by antitrust law when persons (or their association) involved in standard setting have an economic interest in the outcome. In particular, the AG said the panel “improperly ignored or minimized consideration of alternative medical opinion and evidence regarding chronic Lyme disease, potentially raising serious questions about whether the recommendations reflected all relevant science.” (More specific determinations can be found here.)
As a result of the 2008 settlement, the IDSA agreed to form a new panel of medical experts to review its Lyme disease diagnostic and treatment guidelines. In 2010, the IDSA publicly stated that its review panel found no need to amend its 2006 Lyme disease guidelines.
Ten years later, in February of 2016, the federal National Guidelines Clearinghouse (NGC, a national database of clinical treatment guidelines) removed the 2006 IDSA guidelines from its database, for failing to comply with federal requirements by not updating its guidelines against the most current science. The Poughkeepsie Journal reported that “The clearinghouse sets a five-year limit for guidelines, after which they must be updated or removed. That should have happened in 2011, Lyme-care advocates argued.”
Lyme disease guidelines from the International Lyme and Associated Diseases Society (ILADS) were accepted by the NGC in 2014 and to date remain the only approved guidelines for diagnosis and treatment of the disease in the NGC database. The ILADS guidelines differ from the IDSA guidelines in significant ways, including giving physicians greater discretion regarding how to diagnose and treat Lyme disease based on a broad spectrum of research, whereas the IDSA guidelines offer strict one-size-fits-all diagnostic and treatment guidelines that Lyme disease patient advocates argue are not sufficient for treating all patients. Lyme disease specialists argue that abundant research supports the use of antibiotics beyond 14 days to treat cases of Lyme disease whose symptoms do not respond to short-term antibiotic treatment, whereas the IDSA claims that scientific evidence does not support the notion of chronic or persisting Lyme disease.
Both the IDSA and the CDC suggest that patients whose symptoms become progressively worse following short-term antibiotic treatment should seek a different diagnosis, even in cases in which patients have sought diagnosis for years and then experience remission of many or most symptoms following a chronic Lyme diagnosis and treatment.
The IDSA’s 2006 guidelines continue to be endorsed by the CDC. The CDC asserts that the IDSA’s guidelines “continue to provide comprehensive, accurate information that patients can use in their health care decisions.” The CDC does not acknowledge the ILADS guidelines on its website.
IDSA Guidelines, Specialists Promoted by Many Medial Organizations
Questions of potential conflicts of interest and adherence to outdated science are cause for medical doctors and patients alike to become better acquainted with debates about Lyme disease, including the major “players” and the debates over whether or not chronic or persisting Lyme disease exists.
On Monday, the American Academy of Pediatrics published a brief article called “Know myths, facts about Lyme disease,” which features interview excerpts from Eugene Shapiro (one of the medical doctors named in the new federal antitrust lawsuit), whom the AAP designates as a Lyme disease expert. Shapiro was among 18 individuals who presented to the 2010 IDSA guidelines review panel triggered by the Connecticut antitrust settlement.
Shapiro also co-authored recommendations for the treatment of nervous system-based Lyme disease published in the journal Neurology, along with Gary Wormser, a defendant in the new federal antitrust lawsuit. While the antitrust lawsuit is based on alleged financial conflicts of interest—specifically, the suit alleges that Shapiro and Wormser “were paid large sums of money by the Insurance Defendants in consulting fees, in expert witness fees, and to review, and deny, insurance coverage claims related to Lyme disease.” The American Academy of Neurology includes this disclaimer at the end of the co-authored article:
The American Academy of Neurology is committed to producing independent, critical and truthful clinical practice guidelines (CPGs). Significant efforts are made to minimize the potential for conflicts of interest to influence the recommendations of this CPG. To the extent possible, the AAN keeps separate those who have a financial stake in the success or failure of the products appraised in the CPGs and the developers of the guidelines. Conflict of interest forms were obtained from all authors and reviewed by an oversight committee prior to project initiation.
The AAP article, Shapiro, and opinions attributed to the AAP generally, reflect the IDSA position on Lyme disease.
The article implies, but does not state outright, that chronic manifestations of Lyme disease do not exist, and asserts that chronic Lyme is not a medical diagnosis. (Note: the distinction is important, as whether or not “chronic Lyme disease” is an accepted diagnosis is a matter of semantics and of established literature, whereas chronic, persisting infection or symptoms of Lyme disease are matters of science and patient experiences.) According to the article, Shapiro states that “many health problems can cause pain and fatigue”—which certainly is true; however, Shapiro conspicuously does not explicitly state that persisting Lyme disease specifically does not cause chronic pain and fatigue. This is, however, the implication made by the article.
The AAP recommends against ordering Lyme disease blood tests and antibiotics for children who do not present with a characteristic Lyme disease rash or facial palsy. According to the CDC, the erythema migrans (EM) appears among 70 to 80 percent of infected patients; one study among patients in Maine found that only about 43 percent of Lyme-positive patients found a rash following infection.
Given the AAP/Shapiro recommendation not to test or treat children who do not present with the rash, between 20 and 50 percent of children who have contracted Lyme disease could “slip through the cracks” and go untreated.
Parents and guardians of children should be aware that while the cause or causes of chronic/persisting Lyme disease are hotly debated by medical agencies and organizations, there is no debate about severe neurological, cardiac, joint and other damage caused by untreated Lyme disease over time. “Chronic Lyme disease” refers to Lyme infections that have persisted following (usually) IDSA treatment guidelines, and not to late-stage Lyme disease infection.
Like its biological relative syphilis, the bacterium that causes Lyme disease, Borrelia burgdorferi, presents in a series of symptomatic stages. Upon initial infection, patients generally experience flulike symptoms, including joint pain and sometimes facial palsy, and the majority are thought to show an EM rash at the site of infection. These symptoms pass after a couple of weeks; however, this does not mean that the infection has passed. As with syphilis, Lyme progresses to secondary and tertiary infectious phases, in which the disease harms organs and infects the central nervous system—generally without being noticed until severe symptoms emerge as late disseminated Lyme disease, which may strongly mimic rheumatoid arthritis, multiple sclerosis or even ALS, Alzheimer’s disease, and severe psychiatric disorders, including schizophrenia. It is worth restating that late-stage Lyme disease is a matter of established scientific fact, and is not contested by any health agency or organization.
Given that even the CDC—which has been strongly criticized by the Lyme disease patient advocacy community for its handling of Lyme disease—asserts that 20 to 30 percent of patients do not show an EM rash following infection, the AAP recommendation not to perform blood tests for Lyme disease or to administer antibiotic treatment to children who have been bitten by a tick and subsequently develop fatigue, joint and nerve pain consistent with Lyme disease, potentially could result in 20 to 30 percent of infected children not receiving treatment and progressing to severe late-stage Lyme disease.
Answering this concern, a spokesperson for the AAP wrote that “Lyme Disease is covered in a chapter of the Red Book, a physician’s resource, and is considered AAP policy.” The Red Book is a publication of the AAP, which bills itself as “the authority on pediatric infectious diseases.” In its chapter on Lyme disease, the Red Book cites exclusively papers published by IDSA affiliates, including but not limited to Raymond Dattwyler, Eugene Shapiro, and Gary Wormser, all of whom are defendants in the new federal antitrust lawsuit.
Canadian Parliament Condemned IDSA Guidelines in 2014 Law
Lyme disease patients, medical doctors who treat them, and Lyme advocates have long stated great concerns that the IDSA guidelines may impede diagnosis and treatment of Lyme disease. In 2014, the parliament of Canada passed legislation titled the Federal Framework on Lyme Disease Act, S.C. 2014, c. 37, which states extraordinary concerns among its preamble (emphasis is mine):
Whereas recent research further demonstrates the persistence of Borrelia spirochetes after antibiotic treatment that follows the guidelines used in Canada (Embers et al., 2012) and indicates that current serology does not adequately describe the diversity of Borrelia bacteria existing in Canada and that the general understanding of, and practices for dealing with, Lyme disease are no longer sufficient or in line with emerging evidence of how the disease operates (Ogden et al., 2011);
Whereas the current guidelines in Canada are based on those in the United States and are so restrictive as to severely limit the diagnosis of acute Lyme disease and deny the existence of continuing infection, thus abandoning sick people with a treatable illness;
And whereas the 2010 report prepared for the Provincial Health Services Authority of British Columbia entitled Chronic Lyme Disease in British Columbia, A Review of Strategic and Policy Issues concluded that current diagnostic testing for Lyme disease is inadequate and advocated placing the highest priority on the development of reliable diagnostic testing for the disease and on educating physicians so they can recognize the symptoms of Lyme disease and treat patients in a manner that is medically appropriate, including treatment with antibiotics as justified;
The “current guidelines” referred to in the legislation are the 2006 IDSA guidelines.
Taken in sum, multiple antitrust lawsuits, patient protests, the need for an association of Lyme disease specialists (ILADS) to develop its own alternative diagnostic and treatment guidelines, and the Canadian parliament’s order for Canada to cease following the guidelines endorsed by the U.S. CDC—a major break from Canada’s norm—because these guidelines force healthcare providers to “[abandon] sick people with a treatable illness” compel a thorough journalistic and legal investigation into potential conflicts of interest and into current scientific medical research, including research beyond that which is promulgated by the CDC.
The new antitrust suit is an indication that more attorneys may begin to take patients’ claims seriously and investigate their complaints. Whether news organizations and journalists have the interest and lack of bias to seriously investigate Lyme disease remains a separate debate.
The most reasonable way to address “the Lyme wars” might be though dedicated scientific investigation. With over 300,000 new cases per year among Americans, Lyme is among the most prevalent and is the fastest-growing infectious disease in the country. However, for reasons unknown, the federal government invests only a token amount of money in Lyme disease research, with approximately $75 federal research dollars spent per Lyme patient, compared to $68,000 per HIV patient and $220,000 per Zika virus patient.
The Lyme Disease Debate From All Sides
From the IDSA:
From the CDC:
From National Capital Area Lyme Disease Association Legal Counsel:
From LymeDisease.org:
Two Lyme disease specialists:
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*(Note: In October, the Patient Centered Care Advocacy Group filed a complaint with the U.S. Centers for Disease Control and Prevention about language on its website stating that “ “Lyme disease is the most commonly reported vectorborne illness in the United States. In 2015, it was the sixth most common Nationally Notifiable disease. However this disease does not occur nationwide and is concentrated heavily in the northeast and upper Midwest.” The CDC revised its website to read that “Lyme disease is the most commonly reported vectorborne illness in the United States. In 2015, it was the sixth most common Nationally Notifiable disease,” responding “We agree that the term “occur” is subject to misinterpretation and that the sentence can be clarified.” The disease does occur among people nationwide; the Bay Area Lyme Foundation notes that Lyme disease has been found in 42 of 58 California counties, and the foundation’s Wendy Adams has discussed how false or misleading information about Lyme disease distribution hampers Lyme disease treatment among California patients.)