LYMEPOLICYWONK: IOM Report: ’Tis neither here nor there. Or?
The Institute of Medicine (IOM) has released its long awaited report on Lyme disease. So should we celebrate or despair? I think there is room for a little of both. We should certainly celebrate the tone of the report, which characterizes the session as “a walk in the woods” to start dialogue and we should celebrate the contributions made by those who attended and participated, whether as patients, advocacy groups, researchers or physicians. I think these people did their very best to represent a side of Lyme disease that is not often given public voice. We should also recognize the contribution to a better process that was achieved by the three groups who pulled out of the hearing (CALDA, LDA, and Time for Lyme). This action resulted in Dr. Benjamin Luft of Stony Brook University being added to the agenda and may have also added to the “tone” of the report. What we should not lose sight of though, is that a civil tone and the inclusion of some patients’ testimony are not enough. This is a debate about science. Debates are about equal time, opportunities to rebut, and not excluding opposing viewpoints. That did not happen here. And, what the IOM left out or left unchallenged harms patients. Our biggest hits were in diagnosis, the exclusion of the topics chronic Lyme and treatment, and the complete exclusion of any physicians from ILADS. Let me drill down into the details.
Diagnosis: Dr. Maria Aguero-Rosenfeld, of New York University, who until recently worked with Dr. Gary Wormser, was handed the topic of laboratory diagnosis, with no rebuttal time allotted. She presented her flawed analysis of diagnostic tests as being just about perfect in late disease, claiming that they are 97-100% sensitive for late Lyme arthritis and late neurologic Lyme disease. She rests this conclusion on a study by Bacon which involving a total of 33 and 11 patients, respectively who all tested positive—but, here’s the thing. These patients had to test positive to be included in the study in the first place, so the fact that they again test positive is no surprise. This is circular reasoning. Here’s a quote from the study itself: “For late disease, the case definition requires at least one late manifestation and laboratory confirmation of infection, and therefore the possibility of selection bias toward reactive samples cannot be discounted.” But the IOM gave no opportunity to rebut Dr. Aguero-Rosenfeld.
Chronic Lyme disease: There could have been a debate about the causes of chronic Lyme disease—allowing full airing of both the view that it represents persistent infection and the view that it represents a post-infective heightened immune response with no underlying infection. This was not done. The topic of persistence in humans was not on the menu. Or was it? The IOM gave Dr. Afton Hassett of the University of Michigan a full 20 minutes to present her view that chronic Lyme disease was perhaps a somatoform illness (meaning, not caused by bacteria, not treatable and probably associated with psychiatric illness). Sure, both Drs. Fallon and Donta, who were only allotted 10 minutes to cover entire topics, took issue with Hassett’s view. But this is not balance. I don’t mind that the IOM gave Drs. Wormser, Aguero-Rosenfeld, and Hassett an opportunity to speak. I do mind that the IOM did not give opposing viewpoints equal time.
Here’s what happened to treatment of persistent Lyme disease: It was not on the agenda. Is this because it was regarded as too hot to handle? Too divisive? Or, excluded from the disease definition and, hence, off topic? I don’t know.
Why were ILADS physicians excluded from presenting? I suppose it could be argued that the ILADS physicians are not researchers or scientists and so had no standing in the debate. But aren’t we really talking about medicine? To exclude those who treat the vast majority of patients is to leave out any information about how patients actually respond to treatment. It points out the weakness of limiting testimony to researchers who, with the exception of Dr. Donta, do not treat patients with chronic Lyme. Besides, some ILADS physicians conduct research despite busy practices (Stricker, Cameron, Phillips and Shor) and many have read and critically analyzed the research. The formal exclusion of all ILADS physicians may “delegitimize” their viewpoints. I’m also concerned because seven of the speaking slots were given to researchers who were authors of either the IDSA current guidelines or copycat guidelines (authored by panels that overlapped those of the IDSA and published by the American Academy of Neurology and New England Journal of Medicine). I am concerned that viewpoints that were research grant “disadvantaged” were not properly acknowledged.
What’s the final conclusion? I appreciate the fact that there was a workshop and the establishment of a tone that could open some space for dialogue. I also believe that the failure to provide a rebuttal for Dr. Aguero-Rosenfeld’s assessment of testing and Dr. Hassatt’s view on somatoform disorders was harmful to patients. I would like to see more dialogue on the science, in a process that is truly mindful of presenting balanced scientific viewpoints.
You can follow additional comments on Lyme policy at www.lymepolicywonk.org. You can contact Lorraine Johnson, JD, MBA at firstname.lastname@example.org.