LYMEPOLICYWONK: IDSA Hearings Delay has Lyme Patients on Tenterhooks

A couple of weeks ago, I suggested you look the “pistols at dawn” action at the OK Corral between IDSA president, Dr. Ann Gershon, and Dr. Stricker and me on the IDSA guidelines, antitrust law, and Lyme disease. Drum roll. . .The reply by Dr. Sticker and me is now posted on the Journal of Medical Ethics website. This lively debate is a breath of fresh air to the Lyme community.

This week I spoke on a panel before an international audience of researchers, healthcare policy makers, and physicians at the HTAi (Health Technology Assessments International) conference in Washington DC. The topic was putting the patient at the center of healthcare. Dr. Karen Facey from the University of Glasgow asked the panel two questions: 1) what would effective engagement of patients in research look like, and 2) what is the biggest barrier to patient engagement in research. Let me explain why these questions are important to patients with Lyme disease.

Yesterday, the CDC officially announced that it “recommends that laboratory tests cleared or approved by FDA be used to aid in the routine diagnosis of Lyme disease.” This is a shame. Waiting for FDA approval suppresses innovation in Lyme testing and furthers the interests of those who have vested interests in the current flawed lab tests which miss as many cases as they detect. Neither of these is good for patients.

If you don't read medical journals or medical ethics journals, you may have missed a comment made by Dr. Ann Gershon in the Southern Medical Journal. She is responding to an article by Susan Ronn that was published together with an editorial by me and Dr. Stricker. It took me a couple of times reading this, but I think she made a promise based on a dare. She says: "If and when there is credible evidence of the existence of chronic Lyme disease and of the benefits of long-term antibiotic therapy to treat it, IDSA WILL NOT HESITATE TO CHANGE ITS GUIDELINES TO REFLECT THIS EVIDENCE."

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.

An important study by Dr. Stephen Barthold and Dr. Ben Luft was recently published. The title sounds a bit bleak, but don’t let the title fool you: “Ineffectiveness of Tigecycline against Persistent Borrelia burgdorferi”. This study is about how the little guy (Borrelia burgdorferi) always wins and survives despite antibiotic treatment—here tigecycline. To my mind, the findings on persistence are much more important than the finding that tigecycline doesn’t do the job. When one antibiotic doesn’t work, you try another, and if that one doesn’t work, well, you try another or you kick it up a notch and start trying combination antibiotics, like they do with tuberculosis. You don’t fold up the tent and go home because active infection requires antibiotic treatment. And, you won’t ever find out which antibiotic or combinations of antibiotic work, until you try them. So, roll up your sleeves, we have some work to do here.