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More Delays in Lyme Guidelines Revisions

Posted Jan 10 2010 4:02pm

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The Infectious Diseases Society of America (IDSA) has missed its target date of December 31, 2009 for rendering a decision on whether it will rewrite its Lyme disease medical guidelines, which according to a group of leading Lyme disease specialists, “ mislead clinicians and result in poor patient care .”

Diana Olson, IDSA VP of Communications, said that the medical evidence review panel, which has met over a dozen times in 2009, is aiming to release recommendations “as early as possible in the new year.” If a rewrite is called for, the IDSA revision would be completed in “several months to a year or more”, leaving suffering Lyme patients in treatment purgatory for four years since the scientific integrity of the guidelines was first questioned.

The reevaluation of the IDSA Lyme guidelines was driven by an antitrust investigation led by Connecticut Attorney General Richard Blumenthal. During his 17-month investigation, Blumenthal found substantial conflicts of interest among the 2006 guidelines authors, who held commercial interests in Lyme-related diagnostic tests, vaccines, and insurance. In addition, he found that this panel had suppressed scientific evidence and excluded opposing views.

In December, Senator Chuck Grassley launched an investigation into the conflicts of interest of 33 other medical societies , saying in a press release, “These organizations have a lot of influence over public policy, and people rely on their leadership. There’s a strong case for disclosure and the accountability that results.”

During the 2.7 years since the IDSA Lyme guidelines investigation began, IDSA leadership has shown a consistent lack of concern, remorse or urgency in correcting possible inaccuracies and biases in the 2006 Lyme guidelines.

As soon as Blumenthal’s investigation was announced, IDSA’s conflict-riddled panel launched a far-reaching campaign to disseminate their 2006 recommendations across the U.S. medical information network through physician continuing education (CME), medical textbooks, infectious disease board certification courses, online resources, and medical school lectures. So, even if the IDSA guidelines are revised immediately, it could take a year or more to remove flawed diagnosis and treatment recommendations from the system.

Furthermore, rather than censuring the guidelines chairman, Gary Wormser, M.D., for violating the IDSA’s conflicts-of-interest policies by holding “a bias regarding the existence of chronic Lyme” and handpicking “a likeminded panel without scrutiny by or formal approval of the IDSA’s oversight committee,” the IDSA leadership awarded Wormser the IDSA’s 2007 Society Citation for being “a bold champion for rational, evidence-based medicine.”

To add insult to injury, three days after the mandated evidence hearing, which according to many observers was an evidence-based victory for Lyme patient advocates , former IDSA president Anne Gershon denied any IDSA wrongdoing , saying, “IDSA’s signing the agreement was not, as [Blumenthal] alleges, an admission of guilt, but an effort to end a fruitless investigation.”

Gershon went on to say, “The notion that the authors had financial conflicts of interest is absurd to anyone who has read the guidelines, which recommend generic tests and a short course of generic drugs.”

Lyme disease policy expert, Lorraine Johnson, J.D., M.B.A., explained why this IDSA statement is misleading: “People in the Lyme disease community know that conflicts of interest were a big issue in the Lyme vaccine. We also know that the narrow disease definitions that suited the vaccine trials the best, hurt patients by denying and delaying diagnosis to patients with Lyme.”

Johnson provided details on the author conflicts in a recent article in the Journal of Medical Ethics :

“The most influential panelists on the IDSA guidelines panel had commercial interests related to Lyme vaccines, diagnostic tests, and insurance. Some of the panelists had been involved in the development of the first Lyme vaccines—had run the clinical trials for these vaccines–vaccines which were withdrawn from the market after patients reported serious neurologic side effects. Some had been sued as part of a class action lawsuit or served as expert witnesses for the vaccine manufacturer. Some of the panelists acknowledged they owned Lyme diagnostic tests or were working on the second generation of Lyme vaccines, which are still under development.”

In the meantime, as the number of U.S. Lyme cases grows by about 30% per year , Lyme patients are trapped between a broken health care system and biased medical guidelines that are being used by insurance companies to deny treatment.

Here’s to hoping that Senator Grassley and CT Attorney General Blumenthal (who is now running for the Senate) will put some legislative teeth into making “non-profit” medical societies like the IDSA more accountable for patient welfare and less beholden to vaccine and drug manufacturers.

Photo caption: At the July 30, 2009 Lyme evidence hearing, ILADs submitted 300 pages of analysis and 1,300 pages of peer-reviewed research contesting the IDSA Lyme Guidelines recommendations.

For an overview of the Lyme controversy, watch the UNDER OUR SKIN trailer http://underourskin.com/watch.html

For a detailed timeline of the IDSA Lyme Guidelines investigation, IDSA_Investigation_Timeline .

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