LYMEPOLICYWONK: Expired Drugs—Are they Effective, Safe?

One of the problems with the IDSA reviewing its own guidelines is that it is not an independent process. The IDSA selected the panel, paid the ethicist, and sets the ground rules. And, now we have the IDSA manipulating the voting process to achieve a goal–protection of the IDSA professional reputation–that conflicts with the goal of providing quality patient care. Think about it. The vote on the lab test requirement for diagnosis was 4 to 4. 4 to 4 means there was NO consensus. Yet the IDSA chalked this up as a victory on its side by ignoring the two step vote requirement and flipping the supermajority vote in its favor. The IDSA is essentially saying 4 to 4 means the IDSA wins on this point. To the fox guarding the chicken coop, this makes perfect sense. Let me drill down into the detail so that what the IDSA did here is clear.

The Connecticut Attorney General is reviewing the IDSA report to determine whether the IDSA has complied with the terms of the antitrust Settlement Agreement. Attorney General Richard Blumenthal's initial review of IDSA voting procedures on the guideline recommendations found the IDSA violated the agreement by rigging the vote to favor no change in the guidelines. We have been informed that both Washington State Attorney General and the Attorney General in Pennsylvania have sent letters to the IDSA requesting that they comply with the Settlement Agreement voting procedures. In addition, US Legislator Chris Smith and US Senator Chris Dodd also wrote the IDSA expressing "deep concern" regarding the IDSA voting procedures. Faced with this scrutiny, the IDSA recast its vote on all recommendations to comply with the agreement–with a major exception. They refused to redo the vote on the one recommendation that required that diagnosis of Lyme could only be made if there is a positive blood test. This vote is critical because even under the initial flawed voting procedure the vote split 4 to 4 which means there was no consensus on the requirement that diagnosis be confirmed by positive lab tests. The Attorney General is currently reviewing the IDSA report to determine whether the IDSA has complied with the Settlement Agreement. The press release of the CT AG is set forth below. I encourage those concerned to contact the CT AG Office and let them know that you want the vote redone on the major issue of lab test confirmation for diagnosis. Details follow.

Why do we do what we do? Sometimes we win, but there are many, many (too many) bumps in the road on the way to success. How do we keep our perspective in the face of an adversary that seems unrelenting—vested, no entrenched, in a medical dogma that leaves patients on the side of the road? A medical society that believes that the views of patients are really–(really?) not relevant to the question at hand? I, for one, want to walk the road of other diseases that have been abandoned and forsaken by the medical establishment. But my road (and those of other illnesses), leads to success. And success–is all about the journey. Touching lives one by one until our day in the sun.

Today, ILADS sent a letter to the IOM expressing its concerns about the lack of balance in the panel and the speaker list for the Lyme State of the Science conference. Not surprisingly, it was concerned primarily about the exclusion of ILADS physicians from presenting at the conference and with the large roles handed to Dr. Wormer, chair of the IDSA Lyme guidelines panel, and Dr. Aguera-Rosenfeld, who until recently worked at NYMC with him, are both known to have biased views regarding the diagnosis and treatment of Lyme disease. Exclusionary conduct on the part of the IDSA has prevented the type of scientific debate that is essential to understanding where the science in Lyme disease rests. ILADS took issue with the large roles handed to the IDSA in the diagnosis and treatment issues at the conference, stating: “There is a significant disconnect between IDSA and the community of physicians who treat Lyme disease. There is also an urgent need for transparency in recognizing the limitations of the existing Lyme research. The bulk of the research on Lyme treatment has been controlled by IDSA researchers. Their research is based on sample populations that do not reflect those seen in clinical practice.” Lyme treatment research has been plagued by sample sizes that are too small to measure clinically relevant treatment effects and that do not reflect the types of patients seen in clinical practice. The link to the ILADS letter follows the jump. . .

It's about going from the abstract to the concrete. Getting out the stop watch and thinking about just how long is 15 minutes. It's enough time to eat lunch or do an errand. But how long is 15 minutes in words? I haven't had to give it much thought until recently. It turns out 15 minutes translates into a number of words. In speeches the pace is generally between 120 and 160 words per minutes. So, if you do a scripted speech for 15 minutes, you have between 1,800 and 2,400 words. Now, if I could only master the art of speed read and teach the panel to speed listen, we'd be off to the races!