ldoadmin

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.

Someone I know. OK, a young woman whose father called me and who then met me at a support group. OK, a father who called me because my husband played tennis with a co-worker of his. Well, you know how small this world is when you meet someone else with a “rare” (shrug, smile, wink) condition like Lyme. Anyway, this person (drum roll) –Silver Feldman– who missed a large chunk of high school because of Lyme and who turned 21 this last month took a graphic design class. Guess what her topic was? Don't you just love it when people give back to the community?

The parallels between breast cancer and Lyme disease are not obvious, are they? I was surprised by them myself. Breast cancer patients have two treatment options (sound familiar?). Mastectomy removes the entire breast, while the newer procedure, a lumpectomy removes only the tumor and immediately surrounding tissue. Consider this: lumpectomies used to be controversial and were opposed by an entrenched medical establishment. It’s hard to imagine, isn’t it? Even harder to imagine is that women had to pass legislation in 20 states to obtain the right to choose between lumpectomy and a radical mastectomy. Physicians were afraid to perform lumpectomies for fear of losing their license. We have passed legislation in 3 states so far protecting physicians who treat Lyme in defiance of the IDSA guidelines from medical board action. But, wait there's more..

Have you been following the news lately? So much about health care reform and guidelines revisions that appear to be blatant cost containment issues shrouded in statistical mumbo jumbo. The basis for the revisions to mammograms and cervical cancer screening (is it a coincidence that these are both female specific diseases?) is that it ‘makes sense’ based on a pure statistical analysis of lives saved and costs. Let me tell you something. Statistical lives matter only to those crunching numbers, read insurance companies (close read, ah well that would be the government, sigh). The personal life is everything. I don’t mind losing 1 in a 1,000, but I do mind losing my mother, my daughter, my sister. How about you? So how does this relate to Lyme disease you may be asking?

Patients think that the IDSA guidelines are harmful to their health because physicians, hospitals, and insurers rely on them to deny patients access to the care they vitally need to restore their health. Patients believe that the IDSA guidelines violate one of the cardinal rules of medicine, “First do no harm.” Depriving seriously ill patients of treatment is an egregious harm. But do the IDSA guidelines violate their own rules? Indeed, they do.

Now that two studies have shown that IDSA guidelines are generally long on opinion and short on evidence, what should the IDSA guideline panel do? The study by Lee, discussed in yesterday's blog, found that IDSA frequently makes strong recommendations, but that these strong recommendations are supported by strong evidence only 15% of the time. Dr. Maloney found that the majority of recommendations in the IDSA Lyme guidelines were based on the weakest level of evidence–expert opinion. Shouldn't clinical judgment only be suppressed when there is strong evidence? That's what the American Academy of Pediatrics says in its guidelines on making guidelines.

Doing a guideline review process correctly and vigilantly is important. It is also a difficult goal to pull off. The 2006 IDSA guideline development process was flawed, as Connecticut Attorney General Richard Blumenthal found in the antitrust investigation. That panel was hand-picked to represent a particular viewpoint on treating Lyme disease and it cherry- picked the evidence or interpreting the evidence in a manner that supported a preconceived viewpoint. When science is unclear or unfolding rather than acknowledging that fact, guidelines sometimes rely on 'expert opinion' to fill the evidence gaps. This is a big problem because evidence based guidelines are presumed to be based on evidence, not opinion. Substituting the 'expert opinion' of someone on a guideline panel is no better, (actually, it is worse) than leaving the matter open and allowing the treating physician to use their own expert opinion.