Shifting sands of time–IDSA calendar revisions at hand
Most of you know the hearing on July 30th before the IDSA hearing panel was about "contested recommendations" in the IDSA 2006 guidelines. These are recommendations and language in the IDSA guidelines that we contest or take issue with. They are important because they provide the road map for what the IDSA hearing panel must review. Contested recommendations must be evaluated by the panel. In order to remain in the guidelines, a supermajority (7 of the 9 panel members) must find that the contested recommendation is supported by the medical/scientific evidence presented at the hearing or otherwise submitted.
I suppose it was inevitable. The IDSA, due to inattention (hey, it happens with age), lack of oversight, control, or, shall we say, “iron fist” over its members, permits not one, but TWO poster sessions at its last annual meeting that point out that—drum roll—the IDSA guidelines across the board (not just Lyme guidelines) are just—well, not based on science or evidence for the most part. Thomas File, the author of this article, is on the board of the IDSA and he is with Summa Health System: He takes the IDSA defense and explains why evidence is not necessary for evidence based guidelines..
What are we to make of the recently launched journal “Ticks and Tick-Borne Diseases” that includes on its editorial board five members of the IDSA Lyme guidelines panel? Dr. Wormser, who chaired the IDSA Lyme guidelines panel, is an associate editor of the journal. Do you think that they might have a bias or might exclude others points of view? If so, is this peer review or is it censorship?
A recent article by Dr. Fallon and colleagues reviews the findings of the four clinical trials and accurately lays out the state of the science in chronic Lyme research. This is important because future research needs and policy decisions are determined by the state of the science. If there is definitive science that tells us whether treatment for chronic Lyme works, there is no need for additional science and guidelines may justifiably take a hard line on treatment options. Otherwise, we are dealing with science in the making, more studies are needed, and treatment guidelines should be more flexible.
In a press release issued at the end of last year, the IDSA called on the US and European Union to develop 10 new antibiotics by the year 2020. IDSA President Richard Whitley said that “creating a stable research infrastructure for antibiotic development” was essential to provide physicians with the tools necessary to effectively treat patients. That’s good news for the Lyme community because unacceptably high treatment failures occur with all current antibiotics used to treat Lyme disease and the rate of development of new antibiotics has been low. Pharmaceuticals have not been interested in developing new antibiotics because they do not generate the level of profit that drugs that are taken by a broad demographic over the course of a lifetime, like cholesterol medication, do. This is the good news. Now for the bad news.
Yesterday, I was honored to speak at the US Department of Health and Human Services’…