LYMEPOLICYWONK: You can observe a lot by watching: Breast Cancer & Lyme Disease

Why do we do what we do? Sometimes we win, but there are many, many (too many) bumps in the road on the way to success. How do we keep our perspective in the face of an adversary that seems unrelenting—vested, no entrenched, in a medical dogma that leaves patients on the side of the road? A medical society that believes that the views of patients are really–(really?) not relevant to the question at hand? I, for one, want to walk the road of other diseases that have been abandoned and forsaken by the medical establishment. But my road (and those of other illnesses), leads to success. And success–is all about the journey. Touching lives one by one until our day in the sun.

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.”

For those who haven’t read, the recent New York Times article, "Plenty of Guidelines, but Where's the Evidence?" by D. Sanghavi, M.D., I suggest you check it out. Sanghavi discusses the problems caused by centralized guidelines in medicine particularly when there is an evidence gap—when guidelines are based on opinion rather than a careful review of all of the evidence. And, this issue of centralization of medicine through guidelines is becoming more important as the push for national health care heats up.

Antitrust law is concerned with constraints of trade that foreclose consumer choice. Guidelines developed by medical specialty societies that have monopoly power (like the IDSA) can become de facto legal standards for the practice of medicine. When they foreclose treatment options and the exercise of clinical judgment, they constrain consumer choice.

Typically, laws are passed in the United States through a democratic process that allows many groups to have a voice in the law before it is passed. Antitrust laws make an exception to guidelines or standards that are developed by groups that have expertise in an area (for instance, computer chips and medicine) so long as they play fair. The reason for this exception is that the level of expertise required in these areas makes it reasonable for "experts" rather than laymen to be setting the rules.

A terrific article by Jerome Groopman, “Health Care: Who Knows Best”, appeared in the New York Times about the healthcare bills. Groopman’s article discusses how healthcare should be implemented in terms of guidelines and notes that there are two choices. The first is through mandates. The second is through “nudging” consumers in the right direction, but leaving the final choice to the consumer. (This approach is advocated by the author of the book Nudge, who is an advisor to Obama.) If this sounds like the Lyme debate, you are catching the drift. As we know, the distinction between mandatory guidelines that do not permit physicians and patients to make choices and guidelines that permit individuals to make their own choices, even if they are unpopular, can determine whether a patient has the opportunity to get well. The question boils down to this: Do the experts know best or do some decisions simply belong to the patient and the treating physician?