Infectious Diseases Society of America Review Panel Issues
Final Report on Lyme Disease Guidelines
The Infectious Diseases Society of America (IDSA) Lyme Disease Review Panel issued its Final Report on Lyme disease. This was the result of an April 30, 2008 Agreement made between the IDSA and Connecticut Attorney General Richard Blumenthal. The Agreement was the result of an antitrust investigation initiated by the Connecticut AG in 2006. AG Blumenthal stated the following in his May 1, 2008 Press Release:
"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. In today's healthcare system, clinical practice guidelines have tremendous influence on the marketing of medical services and products, insurance reimbursements and treatment decisions. As a result, medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards.”
The Action Plan of the Agreement called for an independent panel to review medical research, along with testimony presented at a hearing held on July 30, 2009 in Washington, D.C. Although the Panel made a number of recommendations for revision, they voted that those revisions do not need to be applied to the current Guidelines. Lyme disease patients and Lyme-treating physicians question why the Panel did, indeed, make recommendations for revisions, but voted that those revisions not be considered until the next time the Guidelines are updated by the
IDSA.
Tina Garcia of Lyme Education Awareness Program, a non-profit in Mesa, Arizona, is a Lyme patient and advocate who was bitten by a tick south of Cordes Junction, Arizona in 1998. She has suffered with the disease for 11.5 years. Tina was one of eighteen presenters selected by the CT Attorney General and the IDSA Review Panel to testify at the July 30, 2009 hearing in D.C. As a representative of the worldwide Lyme patient community, Tina submitted medical research to the Review Panel and testified that the IDSA Practice Guidelines actually prevent patients in Arizona, the rest of the United States, Canada and Europe from receiving diagnosis and treatment.
“At the hearing last year, I spoke to several of the Panel members,” Tina claims. “One Panel member told me the situation with the Guidelines did not sit well with him, as it appeared that it was a ‘Good ‘ol Boys Network.’ I agree. There are two important recommendations for revision made by the Review Panel that would address current problems with testing.”
The important revisions Garcia is referring to are the following:
“Expansion of the background section to include an overview of the currently available diagnostic tests for Lyme disease, including the advantages and limitations of the currently recommended 2-tier serological tests. Formal recommendations about the utility and appropriate use of alternative tests should be added, with accompanying discussion and references. Such alternative tests should include the following:
Cerebrospinal fluid (CSF)
serology
PCR of blood, CSF, and v synovial fluid
Serum C6 peptide
Inclusion of the VIsE band in the IgG Western blot
Directly addressing whether some patients with late Lyme disease may be seronegative before treatment
Garcia explains, “Despite the fact that the Centers for Disease Control and Prevention (CDC) has stated for years that Lyme diagnosis should be based upon history and symptoms, the CDC and IDSA contradict this statement through insisting that Lyme patients test positive on two separate lab tests (2-tier). The first is a screening test called an ELISA, but this test is known to be lacking in its sensitivity and specificity -- it misses up to half of all cases. Yet, patients are required to test positive on the ELISA and if we’re lucky enough to get a positive result, we must also test positive on a second test called a Western blot.
The problem is that these are antibody tests and Borrelia burgdorferi, the bacterium that causes Lyme disease, has been shown by the CDC to be an intracellular pathogen that has the ability to evade the immune system. Therefore, antibody tests cannot always appropriately indicate whether or not a person is infected. I’m glad that the Panel recommended that other tests be included in the Guidelines, also.”
These recommendations, however, will not be included in the Guidelines right now and Garcia contends that the delay in revising the Guidelines constitutes medical neglect.
“The truth about the IDSA Guidelines is that they accommodate some of the Guideline authors’ collaboration with the CDC in the development of a Lyme disease vaccine. It would take years and years for vaccine clinical trials to be conducted if those developing the vaccines acknowledged persistent Lyme infection. That is an inconvenient truth for these vaccine developers. It would be great if a safe and effective Lyme vaccine was developed. However, it is inhumane to sweep so many suffering patients under the carpet and deny them treatment in order to bring a vaccine to market. In addition, the Lyme community should insist that the Institute of Medicine's Lyme and Tick-borne Diseases State of the Science Committee instruct CDC to immediately correct the fraudulent Dearborn testing standard that was based upon research performed by Allen Steere in Europe – he inappropriately used high-passage, lipid-free strains. Those who created the Dearborn testing standard knowingly used Steere’s skewed research, so that the Dearborn standard would be geared more toward the testing of vaccine recipients instead of patients.
The inappropriate use of this fraudulent testing standard in vaccine development and trials and in the clinical setting causes those with naturally-acquired infection to fall through the carefully-designed cracks deliberately built into the Dearborn standard. This has resulted in the medical neglect of thousands of suffering Lyme patients!
Tina Garcia expressed her disbelief with the situation when she said, “Sometimes I can’t help but wonder whether those who are committing this medical negligence are receiving guidance from beyond – from the Angel of Death -- Dr. Josef
Mengele.”
By the way, it is interesting to note that the Chairwoman of the IDSA Lyme Disease Review Panel, Dr. Carol Baker, served concurrently as Chair of the CDC’s Advisory Committee on Immunization Practices.”
The Review Panel also made the following recommendation:
When the 2006 Lyme Guidelines are next updated, the Review Panel suggests that consideration be given to changing the phrase “no convincing biologic evidence” to something more specific, such as “Reports purporting to show the persistence of viable B. burgdorferi organisms after treatment with recommended regimens for Lyme disease have not been conclusive or corroborated by controlled studies.” It has been proposed by some that there are hardy, drug-tolerant reservoirs of B. burgdorferi, including intracellular cystic forms. To date, this has not been shown to correlate with symptom persistence, nor has eradication of these forms been shown to correlate with symptom improvement.
