Tuesday, January 13, 2009

NYT Aces Its Editorial on FDA

Those who haven't yet become convinced that the medico-industrial complex has lotsa lotsa rotten goings-on would do well to look at the Times's analysis of the FDA and how big pharma has managed to turn it into a virtual rubber-stamp organization instead of one devoted to genuine oversight. There's plenty to chew on despite eight terse paragraphs, but the one that interests me the most is this one:

The inspector general found that fewer than 1 percent of the doctors who helped oversee clinical trials reported any financial conflicts — such as consulting payments, honoraria, grants, patents or stock options — that might influence their studies. That number seems unbelievably low given credible estimates that one-fifth to one-third of all doctors have such conflicts. [my emphasis]

Thus: if you expect your physician to be making unbiased judgements about the medications they administer or the surgical equipment they utilize, you have a one-in-five to one-in-three chance of being sorely disappointed. But it's much better than that, because the above paragraph is talking about the financial conflicts of interest of the physicians who participate in the studies that allow drugs to be brought to the marketplace--in other words, the people running the studies to evaluate the worthiness of a drug or device are themselves potentially biased, being favorably predisposed by receiving "honoraria" and whatnot. This means that, even if the other 66-80% of docs who try to maintain some disinterestedness carefully evaluate a new medication, they may be reading already-biased studies in the dozens of journals so chirpily-quoted by the local drug reps when they go to hand out their candy & pens & invitations to the local Bistro Foo-Foo for a "talk" on that very drug. And spending lots of time & energy trying to chase down the financial conflicts of interest by the people who publish a study showing the effectiveness of Drug X is not high on the priority list of most busy & harried private-practice physicians.

At professional gatherings Doc Rubin stays very quiet about his thoughts on the relationship between the pharmaceutical industry and physicians--and staying quiet for Doc Rubin is a challenge of immense proportions--because he has discovered through casual conversation that his views are considered to be radical to the point of loony-toonicity, such that he would be regarded by many of his professional peers as a red-loving fruitcake in their midst. Doc Rubin's crazy opinions? That physicians should never accept any gift or enticement whatsoever, and that they should never attend "dinner lectures" at fancy restaurants sponsored by pharmaceutical companies. That the only paycheck that is acceptable for a physician is that derived from caring for patients. That the moment one does any of these things I have proscribed against, one has in effect violated his or her Hippocratic Oath. In short, that there should be a firewall between companies aiming to profit from patient care, and the patients themselves.

I think such policies would cover about 90% of today's conflict issues (wouldn't cover what to do about grant money from drug companies, which is a tougher nut to crack and of which I don't necessarily disapprove), but don't expect any change on that anytime soon. If there is a shift in the policies, it will have to come externally; the medical establishment is far too comfortable with the current arrangement to agitate for change.

(Hospitals and departments, at least in the northeast where I work, are actually doing pretty well implementing conflict-of-interest changes. In many academic and private hospitals, for instance, drug reps cannot "sponsor" educational activities like Grand Rounds, and Conflict Disclosure forms--Doc Rubin himself had to fill one out when he gave a Grand Rounds talk at a community hospital--are becoming standard. But those yummy drug-rep dinners on a night after work, especially for those hard-working less-well-paid residents who are grateful for the bon-bons? Those will keep going, and as long as they are effective in shaping and changing physicians' prescribing habits, you can bet that the gravy train will continue, ad nauseam as it were.)

Keep in mind that Doctor Rubin considers himself persuaded by several principles of capitalism. He believes that those who bring innovative and new drugs to the market should be rewarded, and rewarded amply, for their ingenuity. Not only that, he has come to embrace many of the qualities of yuppiehood he sneered at in his youth: a love of good food and wine, life in the suburbs, a car with leather seats. (He'll never join a country club, but still this a dramatic depature from his collegiate days when he really did have a Marxist bent.) But the good doctor only wants to taste from the fruits of the good life by serving his patients or by living off his grant money, and he's highly skeptical about the puffed-up claims of the drug industry about how many wonderful medicines they've created in the past, oh, say, two decades. I'd guess that just under half of all docs share, in a vague way, those convictions. But nobody wants a family fight, so unless Congress gets involved, the current arrangement will remain the status quo.

1 comment:

  1. Oh the stories I could tell, of the evil goings-on within big pharma, but since the documents I've seen were as a lawyer suing said evil companies, I can't reveal details. The Nexium example above is just one of many examples of pharmaceutical companies trying to manipulate their patent protection in order to make lots and lots more money. There are also companies that switch their drug from a capsule to a tablet just as the patent is about to expire, accompanied by bogus claims of how the tablet is far superior. (Suspiciously, the same company that tried this later claimed that capsules are better, for a different drug that it needed to protect...) And that doesn't even address the issues of companies hiding side effects (think Vioxx), pushing off-label uses that may be risky, and other lovely practices. That said, I myself benefit from many advances, so their work is not all bad. Yet there must be a better way...