Since they were first published in 2000, the guidelines that most doctors follow for the treatment of Lyme disease have been the subject of intense controversy, including an antitrust investigation by the state of Connecticut and hundreds of protests.
Doctors rely on "clinical practice guidelines" to determine how best to treat patients, and insurance companies use them to decide what treatments to cover. The Centers for DiseaseControl Prevention (CDC) and the Infectious Diseases Society of America (IDSA) worked closelyto develop the controversial IDSA guidelines for diagnosis and treatment of Lyme disease.
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 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 that needsto be researched, diagnosed, and treated aggressively. The ILADS guidelines recognize chronicLyme and recommend that the "duration of therapy be guided by clinical response, rather than by an arbitrary treatment course."
Despite serious flaws, the CDC continues to promote the IDSA guidelines, extending preferential treatment to them, while omitting information about the guidelines set forth by the InternationalLyme and Associated Diseases Society.
In addition to causing harm to patients, CDC's preferential treatment and participation in clandestine advisory meetings with authors of the IDSA guidelines violates federal law.
Science Is on the Side of ILADS
There are now hundreds of peer-reviewed articles that support ILADS position. 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.
One of the earliest cases of chronic Lyme was confirmed by a CDC laboratory that culturedLyme bacteria from cerebrospinal fluid obtained from patient Vicki Logan, who had undergone intensive antibiotic treatment and ultimately died from the disease after treatment was suspended.
One of the most serious issues with the IDSA guidelines is the requirement that a positive test result be achieved prior to issuing a Lyme diagnosisunless other objective symptoms, such as the bulls eye rash, are present. There is plenty of evidence that large numbers of patients never see a rash. At least eight peer-reviewed studies that show the CDC endorsed two-tier test for Lyme disease misses more than half the cases.
Another major limitation of the two-tier test is CDC's restrictive definition of Lyme disease. The CDC criteria does not cover all strains of Lyme and excludes the OspA and OspB (outer surface proteins) "bands" specific to Lyme, which were omitted to keep the failed LYMErix vaccine from generating false positive test results.
Why does the CDC continue to defend the IDSA's view of Lyme disease as an acute bacterial infection curable with short term antibiotics, when the preponderance of the evidence shows that position to be wrong? Why does the CDC continue to defend and promote a test that misses more than half the cases?
The CDC's Preferential Treatment of the IDSA Guidelines
In at least two places on the CDC website and at least five printed brochures CDC provides references to the 2006 IDSA guidelines for Lyme disease, which are almost a decade out of date and are non compliant with federal standards, while providing no mention about the 2014 ILADS guidelines for Lyme, which are based on current science and are compliant with current standards.
CDC's rule regarding the IDSA guidelines is published in the following statement on the CDC website, in answer to the question: "Why does CDC only link to one set of treatment guidelines?"
"CDC believes that the Infectious Diseases Society of America (IDSA) guidelines currently represent the best available synthesis of the medical literature on the diagnosis and treatment of Lyme disease. The IDSA, with input from CDC experts and other doctors, has developed and published Lyme disease treatment guidelines."
How can these outdated, critically flawed guidelines represent the best available synthesis of the medical literature?
A Violation of the Law
CDC's preferential treatment of IDSA violates the federal law that governs the conduct of Executive Branch employees.
"Employees shall act impartially and not give preferential treatment to any privateorganization or individual."
Why is the CDC giving favorable treatment to guidelines from IDSA that are a decade out of date and noncompliant with current standards, while excluding mention of the more current and fully compliant guidelines from ILADS?
CDC's preferential treatment of IDSA adversely impacts the health of thousands of chronically ill patients who are harmed by misdiagnosis and denial of medically necessary treatment because of restrictions imposed by the IDSA guidelines.
CDC's failure to provide equivalent exposure for the ILADS guidelines compounds the harm by limiting access to information about evidence-based treatments that could help these severely ill patients recover from this devastating disease.
In addition to the harm to patients' health, CDC's actions and omissions contribute to the financial hardships of patients who must pay out of pocket for medically necessary treatment because of the CDC's preferential treatment of the IDSA guidelines.
IDSA emphasizes the guidelines are voluntary, but CDC's endorsement is effectively an official seal of approval, so many physicians feel compelled to comply and insurance companies are supported in refusing to cover non-IDSA compliant care.
The CDC's Participation in Clandestine Meetings
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 for the award winning documentary Under Our Skin, provide evidence the Ad Hoc Group has been covertly setting government policy on Lyme in violation of federallaw.
According to Congressional testimony by Lorraine Johnson, JD, MBA of LymeDisease.org, who reviewed the emails, the Ad Hoc Group "composed of members of the Infectious Diseases Society of America (IDSA), a medical specialty society, along with members of the Centers forDisease Control & Prevention (CDC) and the National Institutes of Health (NIH), has been acting in violation of fundamental principles of ethics. This group has been covertly setting governmentLyme policy, intentionally excluding other stakeholders, running afoul of government open meeting standards, and deliberately subordinating the public interests to those of a privatemedical society."
The CDC emails show that a clandestine conference of the Ad Hoc group was held in May 2005 at Westchester County Medical Center in Valhalla, NY.
According to Johnson's testimony:
"No public notice was given and the meeting was clandestine. The participant list for the meeting, chaired by Dr. Wormser included principally IDSA researchers and CDC employees…"
Attendees included IDSA guidelines panelists Mario E. Aguero-Rosenfeld, Paul G. Auwaerter, Johan S. Bakken, Linda K. Bockenstedt, Raymond J. Dattwyler, J. Stephen Dumler, Durland Fish, John J. Halperin, Mark S. Kempler, Peter J. Krause, Robert B. Nadelman, Eugene D. Shapiro, Sunil K. Sood, Gerold Stanek, Allen C. Steere, Franc Strle, and CDC employees Barbara J.B. Johnson and Paul S. Mead.
According to Johnson: the Ad Hoc group, "which subsequently added two members of the NIH, Drs. Philip Baker and Edward McSweegan, to its membership ranks, proceeded to work on IDSA projects and government policy projects regarding Lyme disease. A second clandestine meeting, also chaired by Dr. Wormser, was held on January 15th and 16th, 2007 at Westchester Medical Center."
The participation of CDC and NIH employees in clandestine meetings of the Ad Hoc groupviolates The Federal Advisory Committee Act (FACA), public law 92-463.
Sec. 10 (a) of FACA states that "Each advisory committee meeting shall be open to the public," and "records, transcripts, minutes, appendixes, working paper, drafts, studies, agenda, of other documents shall be available for public inspection."
Other than documents obtained via FOIA, no records have been made available for public inspection.
Conflicts of Interest
CDC is allowing IDSA, a private organization, to determine federal policy on Lyme disease, and endorsing critically flawed guidelines that have been adversely influenced by well-documented conflicts of interest and biases.
In testimony for an August 1993 Senate oversight hearing, Lyme Disease: A Diagnostic and Treatment Dilemma, Dr, Joseph J. Burrascano, Jr., MD, described the issue in detail:
"There is a core group of university-based Lyme disease researchers and physicians whose opinions carry a great deal of weight. Unfortunately many of them act unscientifically and unethically. They adhere to outdated, self-serving views and attempt to personally discredit those whose opinions differ from their own. They exert strong ethically questionable influence on medical journals, which enables them topublish and promote articles that are badly flawed. They work with government agencies to bias the agenda of consensus meetings, and have worked to exclude from these meetings and scientific seminars those with alternate opinions. They behave this way for reasons of personal or professional gain, and are involved in obvious conflicts of interest."
In its unilateral support of the IDSA guidelines as the sole standard of care for Lyme disease, theCDC has elevated the guidelines to the status of national healthcare policy.
Why does the CDC, a public agency tasked with protecting the health of US taxpayers, promulgate the IDSA guidelines as policy, particularly when it can be demonstrated that the guidelines authors disallow, ignore, or reject a very large body of scientific evidence that contradicts their narrow view of the this disease?
The CDC's Failure to Protect Public Health
The Centers for Disease Control and Prevention is responsible for promoting the "health and quality of life by preventing and controlling disease, injury, and disability."
In testimony before the Connecticut Department of Public Health and the Connecticut Attorney General's Office in 2004, Dr. Paul Mead, chief of epidemiology and surveillance for the CDC's Lyme disease program, outlined a strategy to address the rapidly growing epidemic of Lymedisease. Dr. Mead's testimony included plans to improve awareness, prevention, diagnostics and treatment.
By all accounts CDC has failed miserably in these key areas.
Lyme disease continues to rapidly spread, with a 320% increase in the number of high risk counties from 1992 to 2012. The number of new cases annually acknowledged by CDC has increased dramatically from just 10,000 in 1995 to more than 300,000 in 2013 when CDC updated its figures to reflect new studies. Treatment regimens endorsed by CDC and IDSA leave up to 36 percent with persistent symptoms.
CDC has had 40 years to address this epidemic. It's now 22 years after the 1993 Senate hearing and 11 years after Dr. Mead's testimony. The limited progress made has been significantly outpaced by the harm to patients from CDC's preferential treatment of the critically flawed IDSA guidelines.
The IDSA Guidelines: Up for Review
On March 9, 2015, IDSA released a project plan to update its guidelines. There have been no indications from IDSA indicating that any significant changes will be considered. To the contrary, some of the panelists have recently published a series of articles that strongly suggest the past IDSA position on the diagnosis and treatment of Lyme disease will not change.
Even if the new guidelines reflect current science and are fully compliant with federal standards, preferential treatment would still be illegal. In the interim, the preferential treatment is much more serious, because of the ongoing harm to large numbers of patients.
This Speakout post was excerpted from a petition that calls on CDC to end it preferential treatment of IDSA. A digital copy of the entire petition is available here.