LYMEPOLICYWONK: Tee Time for Lyme

Lyme disease is a controversial illness—as anyone with the disease knows. The controversy arises because there is medical uncertainty about the best way to diagnose and treat the disease, poor quality diagnostic tests, and very little treatment research. Out of this uncertainty, two approaches to treating the disease have emerged: one advanced by the Infectious Diseases Society of America (IDSA) and the other advanced by the International Lyme and Associated Diseases Society (ILADS). But both of the approaches are not equal in the eyes of patients. One leaves patients without treatment options when short term therapy fails, as it does all too often. The other provides patients with the option of receiving additional care.

In August last year, I blogged about new FDA guidance on laboratory developed tests and how these might restrict access to diagnosis and care for Lyme patients. Many patients with Lyme disease rely on laboratory developed tests, for example, the IGeneX western blot. Since that time, I have met with the FDA twice and LymeDisease.org conducted a survey which drew close to 8,000 responses. The results of that survey were presented to the FDA in our meetings and by Dr. Elizabeth Maloney at the FDA public hearing in January. On January 29th, LDo submitted official public comments to the FDA proposal.

Talk about exaggeration. No really–at the hearing. Dr. Carol Baker asked Dr. Wormser the $200 question: Why exaggerate if the truth will do? She was talking about the use in the guidelines of words like "vast majority" when the real percentage was 65%. And her question was why not let percentages speak for themselves? If the truth is 65%–why not simply say 65%. Is it just me, or does Wormser sound irritated at the question? His response after a drill down is that he would not use the expression "vast majority" to refer to anything less than say–90%. Excuse me? Did I hear that right? 90%. Really? Ok, let's break it down for him.

A recent article in the Greenwich Times addressing the "improper voting procedure” of the IDSA review panel contains a response from IDSA spokesman John Heys that the IDSA is "committed to ensuring the review panel conducts its review to the requirements of that action plan." Sounds a little boiler plate, huh? The next statement by Blumenthal though is more telling. He says that his office has yet to receive a response to the letter. That does not sound like much of a commitment. One has to wonder why it was necessary to write the letter of non-compliance in the first place and why the IDSA's only response to date has been to the press? "We hope there will be a response forthcoming shortly," Blumenthal said. So do we, so do we. . .