ldoadmin

I’ve been getting a lot of email lately about the IDSA. Most of it is about the voting issues, but some of it is about other things they have done to “game the system”. Here’s a list of the top 10 questions patient ask me about the IDSA that begin with the word “why”? As Mark Twain says, “few things are harder to put up with than the annoyance of a good example”—or in this case, ten good examples of why the Lyme community should question the advice to “trust us, we’re the experts” when it comes to the IDSA. Let me know if you think there are any “whys” I left off the list.

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.

This is a chart of the relative importance of different stakeholders to big Pharma. (Click chart to enlarge.)
I was really struck by how little weight patients were given (9%) compared to specialists (47%) and compared to key opinion leaders (21%).
So if you take specialists and add key opinion leaders to that, 68% of drug companies thought that key opinion leader who are specialists would have the
most influence on their company over the next 2 years. Wow! And, look at the lowly role of the general practitioner

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. . .

Responding to patient concerns, the President of ILADS, Dr. Robert Bransfield today delivered a letter to the IDSA calling upon the organization to remove barriers to guidelines change. The letter follows patient complaints to ILADS about the IDSA voting process, which were uncovered by the Connecticut Attorney General in the oversight of the IDSA Lyme guidelines review process. According to the Attorney General, the voting process used by the IDSA was in violation of the terms of the antitrust Settlement Agreement. The Attorney General has called upon the IDSA to redo the vote using the proper voting procedures. Text of the ILADS letter follows the jump.

On Monday, February 1, 2010, the Connecticut Attorney General sent a letter to the IDSA expressing “concern” over “improper voting procedures” used by the IDSA in the Lyme guidelines review voting process. The IDSA may soon approve hearing determinations based on this improper voting procedure. The Attorney General requested that the IDSA redo the vote to comply with the Settlement Agreement. The four-page Attorney General letter was released in response to a Freedom of Information Request made on behalf of patient groups for information regarding the IDSA’s compliance with the Settlement Agreement.

There is a lot of flurry in the Lyme light about the IDSA recent letter in opposition to the physician protection bill pending in the New Hampshire physician protection legislation. This legislation follows on the heels of legislation already passed in California, Connecticut, and Rhode Island. Like breast cancer patients before them (who passed legislation in 20 states to secure the right to make treatment choices), Lyme patients are appealing to legislators to preserve their right to receive treatment for Lyme disease. The IDSA claims that its guidelines are not mandatory, but to my ears this sounds like double-speak. And, the newly elected President of IDSA, Dr. Whitley essentially admits as much when he complains about lab tests that are not “regulated” by the IDSA guidelines. What makes IDSA think that it has the “right” to regulate lab tests? Who says? How genuine is IDSA when it claims that its guidelines are really just “discretionary”? Come on, guys, one or the other, but you can’t play both sides of this issue with a straight face. Maybe we have to fall back to Lincoln or Bush, take your pick, about how many people you can fool.

A terrific article by Jerome Groopman, “Health Care: Who Knows Best”, appeared in the New York Times about the healthcare bills. Groopman’s article discusses how healthcare should be implemented in terms of guidelines and notes that there are two choices. The first is through mandates. The second is through “nudging” consumers in the right direction, but leaving the final choice to the consumer. (This approach is advocated by the author of the book Nudge, who is an advisor to Obama.) If this sounds like the Lyme debate, you are catching the drift. As we know, the distinction between mandatory guidelines that do not permit physicians and patients to make choices and guidelines that permit individuals to make their own choices, even if they are unpopular, can determine whether a patient has the opportunity to get well. The question boils down to this: Do the experts know best or do some decisions simply belong to the patient and the treating physician?