LYMEPOLICYWONK: New Lyme Disease Culture Test Could be Game Changer

I was surprised. I had just settled into my long read of the 217 page new Institute of Medicine report on guideline reform (Clinical Practice Guidelines, We Can Trust, 2010), when the report took an amazing left turn. No, this is not the IOM report on Lyme disease (no telling when that comes out). This is the one on the need for medical guidelines reform in general—not just for Lyme disease. The IOM points to the Connecticut Attorney General investigation into the IDSA Lyme guidelines and says: “This case highlights the need for standardization and transparency in all aspects of systemic data collection and review, committee administration, and guideline development, so that questions about these issues do not detract from the science. [Guideline developers]. . . must be aware of the many, varied observers who will consider their development processes,
particularly when their recommendations are likely to be controversial.” That’s a public slap on the wrist to the IDSA and it matters.

The IDSA recently reaffirmed its beleaguered Lyme guidelines with a panel it selected of IDSA members. (Aren’t we all surprised?) Turns out the CDC can’t be quick enough to endorse the IDSA after the IDSA vindicated itself. Overly clubby, don’t you think? The IDSA’s cavalier dismissal of 1600 pages of peer reviewed evidence rebutting its guidelines recommendations actually took my breath away. Now, it seems that the NIH is handing the “hot potato” of a “state of the science” review of Lyme disease that it is mandated to do by law to an “independent” government group, the Institute of Medicine— which, also, surprise-surprise, is composed mostly of IDSA members (according to my sources 4 of 6 members), in what seems like a saga of deniable accountability. (I would so love to be wrong on this.)

I have gotten some thoughtful comments on my blog posts about the Institute of Medicine’s upcoming Lyme “state of the science” workshop. I want to share my thoughts about why CALDA pulled out of the process and why we will stay out unless there is dramatic change in the program. Whether it is best for groups to participate in a process even though it is biased is always a judgment call that depends on how biased the process is—in short whether you do more harm than good by staying in. CALDA pulled out because we represent Lyme patients and do not believe that we should legitimize a highly biased process by participating in it. We do not believe this is in the best interests of patients. Let me break this down a bit in terms of what is happening at the IOM workshop to explain why I believe it is highly biased.

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.

LymeDisease.org’s recently published survey found that patients with chronic Lyme disease reported low quality of life. They had more days that were bad physically than the general population and than most other diseases. They suffer high rates of unemployment and disability. Even those who are able to work, often must stay home ill or reduce their hours. At work, many say they were unable to concentrate. The survey paints a graphic picture of lost productivity among those with chronic Lyme disease.