LYMEPOLICYWONK: Voting Violations–Which Way IDSA, the Right Way or the Might Way?

Byldoadmin

First, the Action Plan in the antitrust Settlement Agreement states that:

The principle function of the Review Panel shall be to make an individual determination whether each of the recommendations in the 2006 Lyme disease guidelines is medically/scientifically justified in light of all of the evidence and information provided. (Section 3a)

The Action Plan requires that panel determinations require a 75% supermajority vote.  Here, 6 out of 8.  Second, the Action Plan requires that “based on the weighing of the evidence”, the panel recommend one of three options for the treatment guidelines: no change, partial change or a complete rewrite.  You cannot get to step two without first determining whether each of the recommendations is medically/scientifically justified.  How could you decide whether to revise the guidelines without weighing the evidence supporting each guideline recommendation?

Moreover, this interpretation of the Action Plan is, in fact, endorsed by the IDSA in its internal memo from Jennifer Padberg to the panel.  The memo states:

Each Panel member must vote on each recommendation within the 2006 Guidelines.  Upon completion of voting on the individual recommendations in the 2006 guidelines, each Panel member must vote on an overall recommendation for the guidelines as follows: no changes. . ., sectional revision. . .or complete rewrite.

The plain language of this memo requires two steps, first the weighing of the evidence for each recommendation based on a supermajority vote, second “upon completion of the voting on the individual recommendations in the 2006 guidelines” a vote on whether to change the guidelines in whole, part or not at all. 

The memo further endorses the supermajority vote required to uphold each guideline recommendation:

All votes require supermajority support (75% or more). Hence, a minimum of seven [now 6 with the resignation of Dr. Duray] panel members must vote in favor of a recommendation in order for the panel to deem it supported by the evidence.

I think the path is pretty clear.  The 4 to 4 vote means that there was not a supermajority that felt the recommendation was supported by the weight of the evidence.  How important is that?  Well, ask a Lyme patient who was not diagnosed and treated timely because of the flawed diagnostic tests and you will see that flawed Lyme tests can destroy lives.  It’s as simple as that. 

And, depending on when you ask them, the IDSA will admit this. For example, on June 25, 2009, the IDSA sent a letter to Waxman that stated in part “ IDSA believes that specific and more sensitive diagnostic tests for Lyme disease are needed.“

Well, ok, then.  This process should reflect that and the IDSA should get out of the way and let the panel do its job.

You can download a copy of the IDSA settlement agreement, action plan, Jennifer Padberg’s memo, and the letter from the Connecticut Attorney General calling upon the IDSA to correct this voting violation at the link below my previous blog post on this topic, “IDSA Violates Settlement Agreement Voting Procedures“.

You can follow additional comments on Lyme policy at www.lymepolicywonk.org.  You can contact Lorraine Johnson, JD, MBA at lbjohnson@lymedisease.org.

Similar Posts

  • LYMEPOLICYWONK: IOM Workshop—Where Do I Draw the Line on Fairness?

    I thought I might share with the community why I believe the IOM process is too one sided to further patient interests. I am disheartened by the fact that the Lyme community is facing another stacked panel (4 of 6=IDSA) and most of the speakers who have key presentations are IDSA physicians. As far as patients are concerned, the IDSA does not know how to run a clean review process. It only knows how to root for the team. The IDSA’s review panel on Lyme disease did little more than whitewash its controversial guidelines. More after the jump. . .

  • Lyme disease: Losing your innocence in science

    Having Lyme means losing your innocence, utterly, in science. It's true. I am remembering the night I explained evidence-based medicine to a friend whose daughter had Lyme. I explained that in Lyme evidence-based medicine was a “tool” for persuasion in a polemic argument. He was stunned. His daughter had Lyme. He believed in science. He had trouble, real trouble, getting his daughter diagnosed and treated. He knew the problems of Lyme from the inside out. But it hadn’t occurred to him that science wasn’t “pure” science. That researchers followed their bias, their pet theories, their commercial interests in designing and interpreting studies. It was an interesting moment with this sharp and concerned father while he tried to understand the depth of the problem in Lyme. It was a moment when innocence is utterly lost for the first time to those who know how the system of science “ought” to work.

  • LymePolicyWonk: IDSA Lyme disease survey results out! What’s important to patients?

    Over 6,100 responded to our IDSA survey within one month! That’s YOU being engaged. Everyone who has worked on this project has been deeply touched by your responses. In addition to answering our survey questions, over 1,700 patients offered their thoughts in a tiny comment box. I have to say, I was unprepared for the depth of responses offered. I know that those of us who reviewed the comments teared up. You may too.

  • LYMEPOLICYWONK: IDSA Calls for 10 New Antibiotics by 2020

    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.

  • LYMEPOLICYWONK: LDo Lyme Impact and Cost Survey Draws Over 1,500 Responses

    I want to extend my thanks to the 1,500 people who have already responded to the new LDo survey. This overwhelming response comes on the heels of our email notice sent yesterday. I also want to thank all of the organizations that have reposted our survey and urge those who have not responded yet to do so. Finally, I want to encourage those taking the survey to take the time to complete it fully. Some of the questions used come from government surveys that are used to determine the impact of different illnesses on the patients affected. These comparisons are very useful to understand how Lyme disease is similar or different from other diseases. This survey addresses many issues which are unknown in the Lyme community. For example, how many patients with chronic Lyme disease have co-infections? How many have adverse reactions to antibiotics? How many patients are currently on oral antibiotics? How many on IV antibiotics? Answers to questions like these are central to understanding what we need to do to improve the quality of life for Lyme patients throughout the nation. To take the survey, go to LymeDisease.org and click the “Take Patient Survey” button.