Lyme Policy Wonk

The IDSA has set the review panel date for July 30th. None of the other calendar dates have changed. The applications for the panel are due April 17th, document submissions are due April 24th, and selected presenters will be notified by May 15th. If you intend to apply to present or are making a document submission, please let me know and send me a copy of your application or submission at johnson.lorraineb@gmail.com

JAMA is having a personality conflict with itself. After publishing 3 very strong articles on the ethics in guidelines development, it has asked those who question ethics violations in JAMA’s publications to keep quiet about them. In JAMA’s view, conflict violation in its journal should be discussed only if and when JAMA decides to discuss them. This sounds like a policy designed to silence whistle blowers at a time when we need more whistles and fewer muzzles. Not surprisingly, the Association of Health Care Journals has come out against JAMA on this one.

Sometimes someone does something so wonderful. Really! Something so wonderful that you have to stop, take a breath, exhale, and look again. In this world, the world of patients with Lyme disease, it happens rarely. And, when it does, we need to acknowledge it, and, more importantly, we need to acknowledge those who do the right thing no matter what. When someone outside this community steps up to bat for us, well, we should just stop what we are doing and give thanks. Here is my thank-you to Dr. David Volkman. (p.s. you can write one too)

Merrill Goozner continues his insightful beat on conflict of interest articles by JAMA this year. Count them, one, two, three by JAMA–THIS YEAR–SO FAR–AND ITS ONLY MARCH! Does this mark a trend? A turning point for conflicts of interest in Lyme disease? In medicine? Do medical societies have an obligation to hold certain truths to be self evident–that patient concerns come before industry interests and ties?

When is an open hearing not an open hearing? How do you give the appearance of being open without, well, actually being open? How do you deal with the issue of public accountability in Lyme disease guidelines when you would rather not? I'd say the IDSA open hearing, which excludes the public from participating, but allows them to "view" the proceeds from a safe distance probably fits the bill. And that, my friends, is what the IDSA intends to do. Hold a public hearing that fits the "form" but not the "substance" of a public hearing. In this way–the IDSA does not have to face the patients whose lives it is destroying. This is a one sided communication device–something the patients are quite used to, but something the IDSA should set aside in favor of accountable transparency. If you are going to talk the talk , you ought to walk the walk. Let's call this hearing what it is– one more way to "silence the sick".

Yes, we have an extension! Yes, it is official! Yes, Yes, Yes. . . .(don't get me going)

The IDSA has a new schedule for the Lyme disease guidelines review process—applications are open—submissions of contested recommendations are extended—hearing date is not set. A table of the scheduled events follows. The open public hearing turns out to be, well, not quite so open (no one but presenters can attend?). The IDSA plan here is to air it live over the internet on the IDSA website and hightail it out of town.

David Volkman, Emeritus Professor of Medicine and Pediatrics at SUNY, Stony Brook, and previously Senior Investigator with the National Institute of Allergies and Infectious Diseases, has submitted the attached letter to the IDSA pursuant to its document submission process. He has performed both clinical and bench research in Lyme disease since 1985. Given his impeccable credentials, outlined in the first paragraph of his letter, his submission should carry considerable weight with the panel. Among other things, he points to the suppression of research and stifling of the types of investigative inquiry necessary to begin to address pressing issues for Lyme patients—the need for better testing, the need to acknowledge persistence and start looking for treatment protocols that help patients get better, the need to keep surveillance definitions outside the arena of patient diagnosis, the need to acknowledge the usefulness of PCR testing, and the need to avoid prophylaxis regimens that may promote chronic Lyme. His letter smells a little bit like “courage” to me—a pretty rare commodity these days.

The IDSA is expected to extend the time period for document submissions to the 24th of April. Jennifer Padberg expects to post a new calendar of events early next week, at which time she also expects the application process for presenters to be opened. The presentation date will likely be pushed until summer. Presenters will be selected by the IDSA, the ombudsman, and the Connecticut Attorney General. ILADS-affiliated speakers will be permitted an equal amount of time for presentations. I will post more news as it becomes available.