An Overview of the IDSA Lyme Guideline
Review Hearing
by Tina J. Garcia
The Ronald Reagan Building and International Trade Center in beautiful Washington, DC was the site for an historic medical hearing held on Thursday, July 30, 2009 hosted (through legal agreement) by the Infectious Diseases Society of America (IDSA). The IDSA, along with Connecticut Attorney General Richard Blumenthal and an independent ethics ombudsman, selected the Review Panel, which consisted of nine physicians and researchers. The Panel convened to hear testimony from sixteen physicians and researchers and two patient advocates on the subject of Borrelia burgdorferi infection, commonly known as Lyme disease.
This unprecedented hearing was the result of an antitrust investigation initiated at the end of 2006 by Connecticut Attorney General Richard Blumenthal. The investigation looked into the process used by the Infectious Diseases Society of America in the formulation of their 2006 Practice Guidelines for Lyme disease.
The nine-member Review Panel was selected to review evidence submitted to them for and against revision of the 2006 guidelines entitled "The Clinical Assessment, Treatment, and Prevention of Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis: Clinical Practice Guidelines by the Infectious Diseases Society of America." The Review Panel was also charged with hearing evidence and testimony at the Hearing.
Attorney General Blumenthal has stated on several occasions that his investigation looked at the process whereby the guidelines were formulated and was not carried out to make any determination regarding medicine or science. An agreement was signed on April 30, 2008 between the Attorney General and the IDSA, and the July 30th Hearing was a condition of that agreement.
http://www.ct.gov/ag/lib/ag/health/idsaagreement.pdf
In a May 1, 2008 Press Release from the AG, Mr. Blumenthal stated the following with regard to his investigation:
"The IDSA guidelines have sweeping and significant impacts on Lyme disease medical care. They are commonly applied by insurance companies in restricting coverage for long-term antibiotic treatment or other medical care and also strongly influence physician treatment decisions."
"Insurance companies have denied coverage for long-term antibiotic treatment relying on these guidelines as justification. The guidelines are also widely cited for conclusions that chronic Lyme disease is nonexistent. "
"This agreement vindicates my investigation -- finding undisclosed financial interests and forcing a reassessment of IDSA guidelines," Blumenthal said. "My office uncovered undisclosed financial interests held by several of the most powerful IDSA panelists. The IDSA's guideline 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."
Blumenthal added, "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."
http://www.ct.gov/ag/cwp/view.asp?a=2795&q=414284
Throughout Blumenthal's investigation, spokespersons from the IDSA have criticized him for what they consider to be interference in medicine and science. This accusation is unfounded, as the AG did not investigate the medicine and science. What he did in his antitrust investigation was look into the process whereby the IDSA Guidelines were formulated, the IDSA's adherence to their own Conflicts of Interest Policy, how the 2006 Guidelines Committee was selected and exclusion by the Guidelines Committee of those with opposing views. The 2006 Guidelines Committee exhibited bias through exclusion of a worldwide body of scientific research, a result of which may be proven to serve their numerous financial interests. Those financial conflicts are outlined in the AG's May 1, 2008 press release.
Most recently, Anne Gershon, current President of the IDSA, responded to AG Blumenthal's article in The Day, by saying in her opinion that, "IDSA's signing the agreement was not, as he alleges, an admission of guilt, but an effort to end a fruitless investigation that was costing our organization (and presumably Connecticut taxpayers) thousands of dollars." (Emphasis added).
What Gershon revealed here is that it's all about the money! Lyme patients have known for years that the CDC and IDSA agenda is all about the money. And that does not mean the money being made from treating sick and dying patients with long term antibiotics. It means the money being made by the small group of CDC and IDSA physicians and so-called researchers who authored the IDSA guidelines currently under scrutiny by the independent review panel. Their money is made through consistent and numerous research grants from NIH and CDC, patents for diagnostic test kits, vaccine development, clinical trials and royalties on biotechnology related to Borrelia burgdorferi.
http://www.jemsekspecialty.com/shownews.php?id=21
http://www.theday.com/re.aspx?re=05e8c026-d09d-4061-bc47-bd33c45f0130
As I stated in my testimony to the review panel, "The denial of chronic Lyme infection in the IDSA Guidelines
causes patients to question Lyme vaccine development.” Acknowledging chronic Lyme infection would extend the time needed for vaccine clinical trials and approval. Stating that chronic Lyme infection doesn't exist and sweeping suffering patients under the carpet is one way to avoid this problem.
Why the focus on a vaccine instead of expanded treatment protocols, studies of congenital, blood transfusion and sexual transmission and correction of the vaccine-friendly Dearborn two-tiered testing criteria?
The horrible truth -- is the secret that is being kept from the public, a secret that the worldwide Lyme community already knows, because we're living it -- that Lyme disease is a very serious and complex infection, and a lot of money is being made through the manipulation of this disease, through research funds, patents for test kits and vaccine development resulting in
the medical neglect of thousands, if not millions, of suffering people."
What is also interesting is The Day's Editor's note at the end of Gershon's opinion: "Editor's note: The writer, a physician, is president of the Infectious Diseases Society of America."
Let me add an addendum to that note from the Journal of Infectious Diseases, 2008:
"Potential conflicts of interest: A.A.G. lectures and consults on varicella zoster virus vaccines for Merck and GlaxoSmithKline when invited, receives research support from Merck, and has a contractual relationship with Merck through the Varicella Zoster Virus Identification Program. S.L.K. is a member of the Merck Vaccine Advisory Board.”
Gershon also stated in her opinion: "We hope the review will put to rest the tired old allegations and put the focus where it belongs: making sure that people with Lyme disease get treatment that is safe, effective, and supported by sound medical evidence."
Please, Anne, let's get real. In reality, the only treatment afforded Lyme patients, through use of the IDSA Guidelines, is NO TREATMENT! Give up the old Lyme party line; it's not working anymore. The top is broken; it's no longer spinning, Anne. You came on the scene late, and all you can do now is pick up the pieces and place them in the scrapbook. You're Annie-Come-Lately and you need to look around the room. The party is over, the guests have departed and Elvis has left the building!
Back to the Hearing
After reading many comments in news articles made by the IDSA Guideline authors and spokespersons, along with their revealing appearances in the film Under Our Skin, I was quite surprised by their presence when I saw them mingling prior to the hearing. I had expected an intimidating and commanding presence, as they so often portray in the statements they make about their self-appointed status as Lyme disease experts. However, what I noticed were diminished countenances, and my next comment may come as a surprise to those who are familiar with my stance against the "Lyme Medical Cartel." I must tell you that their appearances and presentations actually brought me to unexpected moments of pity as their true colors were displayed at the podium. There certainly was no commanding presence shown by these individuals, who, despite their expressions of concern and sympathy, have nothing to offer the Lyme patient community.
They have offered us no alternatives as far as treatment is concerned. Their standard response is that those suffering from chronic Bb infection, which they know has been documented in the literature, is that we are suffering from something else entirely. This is what I refer to as an "erroneous diagnosis from afar." This is an unfounded diagnosis made by a small group of troublemakers on a large group of patients, whom they have never examined and whose medical records they have never reviewed.
The time has come for these troubled souls to sit in the corner away from the rest of the class. They have pursued their agenda long enough, disrupting the flow of pertinent and factual medical information being disseminated in medical schools throughout the world. This is a serious offense and one that deserves serious punishment. As far as I'm concerned these bad little schoolboys and schoolgirls should be expelled and denied re-admittance until they agree to follow medical and scientific rules.
One final note on the CDC and IDSA Guideline authors – this is one of the most important statements I made to the Panel and to the world in my presentation at the Hearing:
”So, despite the recommendations in their Guidelines to the contrary, the most influential Guideline authors have published that Bb is not eradicated
after a short course of antibiotics and that chronic Lyme infection persists post treatment.
On behalf of suffering patients, I would ask that the CDC and IDSA Guideline authors and their other spokespersons stop making fraudulent public statements that chronic Lyme infection does not exist, due to the fact
that the IDSA Guideline authors themselves proved years ago, that Bb is a persistent chronic infection.”
I was impressed with the body of research and case histories presented that portrayed the actual scientific and clinical scenario encountered by physicians and patients. Although I am obviously biased on behalf of patients and Lyme-treating physicians, the slides prepared by the ILADS presenters obviously contained more research than those from the IDSA.
It felt good to know that we had the actual science to support our position, whereas the majority of statements from the IDSA presenters were not supported by research. It was apparent that the IDSA presenters tossed about statements that had no supporting documentation whatsoever. For instance, Gary Wormser referred to a study that demonstrated a "pre-infection emotional state" of which he failed to provide us with a reference to the alleged study.
The members of the review panel, on the other hand, were very cordial and professional, and it was apparent to me that they were fitting together the pieces of the Lyme disease puzzle to be able to draw conclusions about the most-unusual circumstances surrounding diagnosis and treatment of this disease. After presenting information to them and having been approached by several of the panel members afterwards, I have the utmost respect for this group of physicians and researchers and remain optimistic that the panel will seriously consider fairly all perspectives, especially those of the patients.
Lime Green Ribbons Everywhere
Thanks go to Gregg and Monte Skall of the National Capital Lyme and Tick-Borne Disease Association and their dedicated Board and patient members, who worked tirelessly the week of the Hearing, preparing Washington, DC and the surrounding area for the media. They tied thousands of lime green ribbons all around the area, up and down Wisconsin Avenue in Washington, in front of the NIH and all the radio and television news offices.
Thanks to their efforts, the media did take notice and interviewed members of the International Lyme and Associated Diseases Society (ILADS) and several local physicians and patients, some of whom traveled from out of state.
I witnessed the dedication of the volunteer board members and patients, who gave so much of themselves in time and energy to pull off this last-minute project. I extend my heartfelt gratitude to National Capital Lyme
(www.natcaplyme.org) for all they have done for the Lyme patient community. The people who run this organization, and those who contribute as members, are some of the finest people I have ever met.
I was hoping to be interviewed by the television media, but it didn't happen. If I had been able to speak to the media, I would have thanked the physicians and patients who provided the means whereby I could travel to DC to speak on their behalf at the hearing. My heart is overflowing with gratitude and love for all of you, especially the mothers of children with Lyme, and I want you to know how much it meant to me to be able to tell our story - your story - and what a wonderful opportunity it was to relay the suffering and address the pertinent issues that are preventing us from obtaining adequate diagnosis and treatment of Bb infection.
To all the physicians and patients - this was a cherished memory in my life, one that I will carry with me forever. Thank you for your moral and financial support. Please think carefully about what you can do to reach out to help other Lyme patients. There are so many who need our help, and as I said in my presentation, many patients have asked for assistance. Please find it in your hearts to set aside a small amount each month, even a $10 monthly pledge to L.E.A.P. will do a lot, if all patients and physicians contribute. We must work together and help each other, because we're the only ones we can depend upon. Thank you.
Tina J. Garcia, Founder, Lyme Education Awareness Program www.leaparizona.com.
