Thursday, September 9, 2010

My long post on Donald Light's study of the safety and benefits of new drugs:

--prompted a rebuttal from Thomas Sullivan on the "Policy and Medicine" blogsite:

Now, if I can say this without sounding patronizing, if Mr. Sullivan (who's CEO of a medical communications/education company) were a student in one of my ethics courses and turned in this essay for a grade, I'd give him high marks. A skill that's all too rare among students is that of being able to characterize your opponent's case fairly and cogently before you start to argue against it. I think this post by Mr. Sullivan is exemplary for a good faith efort to summarize both my and Light's arguments before launching any counter-attack.

That said, Mr. Sullivan still finds reasons to negate my main point--that whereas the burden of proof has previously been placed on us pharmascolds to prove that the current way the industry markets new drugs/devices causes more harm than benefit, really the pharmapologists ought to have the burden placed on their shoulders to prove that new drugs are really all they are cracked up to be. Since he had presumably only my summary of Light's paper and not the voluminous citations Light provides, I don't see how he can be confident that Light's case is poorly supported. His own case seems to be based on the self-evident wonderfulness of new medical "breakthroughs" such that no argument or facts are needed, we just feel warm and fuzzy all over when these are mentioned. Only an extreme viewpoint, according to Sullivan, would argue, as Light does, that since the R&D budget of the US drug industry rose from $19B to $47B between 1998-2008, that it's disappointing that fewer than 10-15 % of new drugs are properly categorized as therapeutic advances over existing drugs(for example).

My reactions to Sullivan's criticism can be summarized by highlighting a few of his concluding comments:

"The theories proposed by Dr. Light, while interesting, completely ignore the fact that all drugs and treatments inherently have risks and benefits, the weight of which are decided during the approval process, and subsequently when a doctor and patient choose. " The "weight" of risks and benefits is all too often not addressed by the FDA approval process. The typical new drug is approved by being shown to be superior to placebo, not the currently available drugs for that condition. The safety data on which approval relies usually comes from short-term follow-up of a few thousand subjects, when many drug adverse reactions require long-term follow-up of 10,000-20,000 people to detect. When a doctor chooses for a patient, that presumes that the physician has access to a scientifically valid body of literature (unless, of course, the doc simply asks the handy detail rep for advice). See just about every other post on this blog for examples of how the drug industry works to distort the available literature to assure that marketing and not science is best served.

"To suggest that industry is preying on the elderly and exposing populations to risks because industry wants to make profits is misguided. The goal of industry in working with patients and collaborating with doctors is to improve patient outcomes." Dr. Light is a sociologist and so is in the business of describing the world, not passing moral judgments about who's "preying" on whom. He describes a set of financial incentives and argues that drug companies naturally pursue the lines of behavior that maximize their profits under those incentives. According to Dr. Light's analysis, these incentives are such that trying to improve patient outcomes commonly means losing revenue, and he suggests you don't usually see companies acting that way. Let's turn the incentives issue around. Mr. Sullivan presumably is all in favor not merely of collaboration between medicine and industry (the point of his blog), but the sort of collaboration that puts money into docs' pockets. Now, the conflict-of-interest rules that he finds so onerous would all go away instantly if only docs were happy to collaborate with industry simply for the knowledge that they were "improving patient outcomes" and not so as to profit personally. But presumably Mr. Sullivan would argue to keep the money flowing, out of concern that physicians wouldn't have enough incentive to be truly innovative in their discoveries if they were not paid generously. So why imagine that physicians are slaves to financial inducements, but drug companies can ignore financial incentives and put the patient first?

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