The Patient-Centered Care Advocacy Group has filed a citizen petition with the U.S. Centers for Disease Control and Prevention (CDC) asking it “to end the preferential treatment it extends to the Infectious Diseases Society of America (IDSA) guidelines for diagnosis and treatment of Lyme disease.”
In 2013, The New Yorker dubbed the term “The Lyme Wars” to describe the unusual battle with Lyme disease patients and the doctors who treat them on one side, and the national organization of infectious diseases specialists that decries prolonged antibiotic treatment as harmful on the other. It’s three years later, and the conflict wages on despite a great number of developments that have been made in the meantime.
Yesterday, the Patient-Centered Care Advocacy Group, a Washington, D.C.-based not-for-profit organization that supports Lyme disease patient care, filed a citizen petition with the U.S. Centers for Disease Control and Prevention (CDC) asking it “to end the preferential treatment it extends to the Infectious Diseases Society of America (IDSA) guidelines for diagnosis and treatment of Lyme disease.” The petition was filed in accordance with the Administrative Procedure Act (APA), which governs the conduct of the federal government.
According to the petition, the CDC provides preferential treatment to IDSA by endorsing and promoting IDSA’s 2006 guidelines for Lyme disease, while withholding information from healthcare providers and the general public about more comprehensive guidelines for Lyme disease published in 2014 by the International Lyme and Associated Diseases Society (ILADS).
As I reported in February, the IDSA Lyme disease treatment guidelines were removed from the federal National Guidelines Clearinghouse (NGC). The NGC is an initiative of the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services, which is used as a reference for physicians and healthcare practitioners in treating patients. The NGC removed the IDSA guidelines, which have served as primary practice guidelines for physicians to date, because they were deemed “outdated and not in compliance with current standards,” according to Lorraine Johnson of LymeDisease.org.
Following the removal of the IDSA guidelines by the NGA, the IDSA posted a statement on its website noting that the guidelines currently are undergoing review, and that at least two personnel, Dr. Charles Ericsson and Dr. Cameron Wolfe, respectively, were removed from the project. The IDSA notes that Ericsson’s removal was due to “personal and professional reasons unrelated to the nature of this specific guideline.”
Patient Centered Care Advocacy Group founder Bruce Fries said that, “despite the fact that the IDSA guidelines are not compliant with current standards and are based on outdated science that has been discredited by a growing body of research, the CDC continues to endorse and promote them while withholding information about competing guidelines from ILADS, which contain information on evidence-based treatments that could improve the health of thousands of chronically ill patients throughout the world.”
Fries notes what he believes are conflicts of interest, observing that “the CDC officials who provide and defend the preferential treatment are also members of IDSA, the organization receiving the preferential treatment–a glaring and long-standing conflict of interest.”
Fries’s claim echoes findings by former Connecticut Attorney General Richard Blumenthal’s 2008 antitrust investigation of the IDSA Lyme disease treatment guidelines, which uncovered “serious flaws in the Infectious Diseases Society of America’s (IDSA) process for writing its 2006 Lyme disease guidelines and the IDSA has agreed to reassess them with the assistance of an outside arbiter.” Blumenthal’s report, which can be read here, discusses a number of alleged conflicts of interest among IDSA personnel. Among the conflicts of interest, the investigation found that “the IDSA blocked appointment of scientists and physicians with divergent views on chronic Lyme who sought to serve on the 2006 guidelines panel by informing them that the panel was fully staffed, even though it was later expanded.”
Unlike the ILADS guidelines, Fries says, the IDSA guidelines do not comply with the National Academy of Medicine Standards for Developing Trustworthy Clinical Practice Guidelines or with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group standard for rating evidence and recommendations.
In a 2013 issue of the International Journal of General Medicine, author Keith Berndston reviewed current scientific literature on the persistence of Borrelia burgdorferi (Bb, the bacterium that causes Lyme disease) following standard short-term antibiotic treatment and concluded:
Based on well-designed post-treatment animal studies and ongoing delineation of Bb’s mechanisms for host immune evasion and persistence, we can reasonably conclude that some, possibly many, chronic LD patients suffer from symptoms related to persistent infection with Bb. As inevitably happens in the evolution of scientific ideas, new research proves that the reality is more complex than we thought, and the time has now come to move beyond the divisiveness of the past into a more reality-based paradigm for research, education, and patient care. The question is no longer whether LD can survive an antibiotic challenge in order to become a persistent infection. High quality studies show not only that it happens, but they also show how it happens, and why we should not feel surprised that it happens. Our task in the new era is to determine which patients suffer from persistent LD, and to keep pressing for evidence-based wisdom to guide the physicians called upon to treat them.
Ericsson, the former IDSA Lyme disease guidelines reviewer, disagrees with this research, having told Reuters in March that there is a “nail in the coffin in the controversy over chronic Lyme disease, or whatever you want to call it when people who have had Lyme disease have residual symptomatology.”
“You can treat the inciting agent until the cows come home,” Ericsson said, “and nothing will change.”
In other words, Ericsson and similarly minded IDSA member physicians believe confidently in the face of over 700 research studies to the contrary that the Lyme Wars are settled–that there is no such thing as persisting or chronic Lyme, and that, therefore, patients should not receive ongoing treatment.
Those who oppose this perspective, including ILADS specialists, Lyme patients, many lawmakers and other advocates, call for increased investment in Lyme and associated tickborne disease research and treatment on a patient-by-patient basis.
Ericsson’s replacement on the panel according to the IDSA, Dr. Jeffrey Parsonnet, was a coauthor of a 2006 IDSA Lyme Disease Review Panel who findings were published in the medical journal Clinical Infectious Diseases. That panel determined that “the 2006 [IDSA] Lyme disease guidelines were based on the highest-quality medical and scientific evidence available at the time and are supported by evidence that has been published in more recent years,” and that “it is expected that the IDSA will review the 2006 Lyme disease guidelines on a regular basis to consider any new evidence that would warrant a substantive change to the current recommendations.”
Despite the claim, the IDSA guidelines were not reviewed “on a regular basis”–or at all between 2006 and 2016, when they were removed.
One of the reasons the NGC removed the IDSA practice guidelines is that they had not been reviewed since the 2006 review–a decade ago–and did not reflect any scientific investigation from within the past decade. The NGC requires that “the guideline must have been developed, reviewed, or revised within the past five years, as evidenced by appropriate documentation (e.g., the systematic review or detailed description of methodology)” in order to be included in its clearinghouse.
Fries notes that the IDSA guidelines do not reflect any of the existing evidence that shows persistent infection (chronic Lyme). Further, Fries’s group opposes the CDC’s ongoing endorsement of the two-tiered ELISA and Western blot blood tests for Lyme disease, despite studies showing that these tests are only between 18 and 67 percent sensitive–meaning that as many cases of Lyme disease may go undiagnosed by these blood tests as those that are identified by them.
“IDSA claims the test is accurate and most patients are cured with 2-4 weeks of antibiotics,” reads a statement by the Patient-Centered Care Advocacy Group. “By contrast, the ILADS guidelines recognize the existence of chronic Lyme and recommend that the duration of therapy be guided by clinical response, rather than by an arbitrary treatment course.”
The National Academy of Medicine report, Clinical Practice Guidelines We Can Trust, cites the 2006 IDSA Lyme guidelines to illustrate the problems of conflicts of interests, lack of transparency, and scientific bias in guidelines development.
Fries says that “because of restrictions imposed by the 2006 IDSA guidelines, thousands of patients are harmed by misdiagnosis and denial of medically necessary treatment. CDC’s failure to provide equivalent exposure for competing guidelines from ILADS compounds the harm by omitting information that could help these severely ill patients recover from this devastating disease.”
The petition points out that CDC’s preferential treatment of IDSA violates the Standards of Ethical Conduct for Employees of the Executive Branch, which states that “Employees shall act impartially and not give preferential treatment to any private organization or individual.”
“Because of CDC policy failures, mismanagement and violations of federal law, hundreds of thousands of Lyme patients experience a greatly diminished quality of life,” Fries says. He calls it “a tragedy compounded by financial hardships from out-of-pocket costs and lost income. The burden on individuals as well as on our economy is enormous, the suffering is widespread and much of this is preventable.”
An online version of the petition is available at Change.org.