LYMEPOLICYWONK: LymeDisease.org launches new patient survey on the Impact and Cost of Lyme Disease.

When studies fail to take heterogeneity into account, researchers can leap to the wrong conclusion. In a recent open-access article, Dr. Fallon and colleagues describe the four NIH trials, the Krupp Stop-LD study, the Klempner seronegative study, the Klempner seropositive study, and Fallon neurologic study and make a key point. There are considerable differences between chronic Lyme patients (so-called patient heterogeneity) that need to be addressed in study design to improve what he calls the signal to noise ratio. If a study does not address heterogeneity, the results may simply reflect “garbage in, garbage out.”

Last week, I posted a blog regarding the IDSA stealth front organization, the American Lyme Disease Foundation (ALDF). I pointed out that the organization masquerades as a patient organization or an independent source of information, but is really just the members of the IDSA Lyme guidelines panel and a couple of businessmen. I highlighted the fact that Dr. Phil Baker who was responsible for overseeing the Lyme clinical trials at the NIH prior to his retirement is now the Executive Director at the ALDF. I also raised questions about his management of two NIH trials under his watch, the Klempner trial and the Embers trial. Both trials were funded around the same time. Klempner, which concluded that chronic infection did not persist and that treatment was ineffective, was published in 2004. Embers, which found persistent infection notwithstanding treatment, was not published until almost ten years later. During the interim, the Klempner trial was relied on by the IDSA to deny patients treatment for chronic Lyme and no one mentioned that the companion study, the Embers trial, was still pending. Dr. Baker took issue with my post (see below), and I respond.