Lyme Policy Wonk

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.

IDSA guidelines are long on opinion and short on science. This is the stunning conclusion made by an infectious disease specialist at Drexel University, Dong Lee, MD in a poster presentation at the recent IDSA annual conference. Dr. Lee’s analysis is based on a broad review of 30 guidelines published by the IDSA between 1994 and 2009. More than half of the recommendations made by the IDSA in these guidelines were not supported by science.

50% of the 272 speakers at the October 2009 IDSA annual meeting who disclosed conflicts, had ties to one or more of the five leading vaccine companies: Merck, GlaxoSmithKline, Sanofi Pasteur, Wyeth, and Novartis. Vaccine related financial ties with key members of the IDSA Lyme panel prompted the Connecticut Attorney General antitrust investigation into the development of the IDSA Lyme guidelines. Patients remain concerned about these interests because the IDSA guidelines placed commercial interests of vaccine manufacturers above patient care.

I have been reviewing the IDSA transcripts and reread Dr. Arthur Weinstein’s testimony. Yesterday, I discussed Weinstein’s argument that chronic Lyme should be considered a somatic disorder in my post and concluded that his assertion is no more than an unproven hypothesis that should have no role in the treatment of patients. Today I tackle the second major assertion in his testimony—namely that one of the problems with diagnosing patients with chronic Lyme is that it delays early diagnosis and treatment for somatic disorder. The big question, of course, is whether the diagnosis of somatic disorder bears any fruit for patients or whether it is instead a dead end road to nowhere.

I have been reviewing the IDSA transcripts and reread Dr. Arthur Weinstein’s testimony. Weinstein testified in support of the IDSA Lyme guidelines at the IDSA hearing on July 30th. He argued that chronic Lyme disease is a ‘somatic’ disorder involving a “serious amplification of symptoms” and states that he “doesn’t pretend to know the etiology (cause) of the pathophysiology”. He does though assert that the serious amplification of symptoms is associated with patients who have more psychiatric morbidity and is fostered by the labeling the disease “chronic Lyme” by advocacy groups and others that believe in a traditional medical cause for symptoms. This post is part of a twofer. Today, I ask if Weinstein is right that post treatment Lyme disease is a somatic disorder or if this is simply his pet theory. Tomorrow, I ask if the somatic disorder diagnosis provides patients with good patient care.

Having Lyme means losing your innocence, utterly, in science. It's true. I am remembering the night I explained evidence-based medicine to a friend whose daughter had Lyme. I explained that in Lyme evidence-based medicine was a “tool” for persuasion in a polemic argument. He was stunned. His daughter had Lyme. He believed in science. He had trouble, real trouble, getting his daughter diagnosed and treated. He knew the problems of Lyme from the inside out. But it hadn’t occurred to him that science wasn’t “pure” science. That researchers followed their bias, their pet theories, their commercial interests in designing and interpreting studies. It was an interesting moment with this sharp and concerned father while he tried to understand the depth of the problem in Lyme. It was a moment when innocence is utterly lost for the first time to those who know how the system of science “ought” to work.