Richard Epstein on Conflict of Interest Rules that Kill Innovation
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We at MPT have written extensively about how the FDA's and other groups' conflict of interest rules, which have the effect of discounting or ignoring information connected in any way to the drug and device industry, are not only short-sighted, but counterproductive (see here, here, and here for just a few of the more recent examples). Now, via Richard Epstein, we learn that some of the biggest critics of these rules are patients themselves:

"In addition to the endless regulatory hoops mandated by the FDA for marketing approvals, a significant, and wholly unnecessary, part of this protracted slow-down [in new drug development] stems from sharp limits on conflict of interest waivers for the agency's vital advisory committees that help the FDA review new medicines, which Congress imposed on the agency, with excessive zeal, in 2007. Rather than coming from industry, complaints about onerous conflict-of-interest rules have come primarily from patients groups representing the users and consumers of pharmaceutical products, for whom new drugs and devices often spell the difference between life and death. ...

"This prohibition has not only left about 20 percent of the FDA's many committee positions vacant but also led to a pool of 'experts' less qualified than those disqualified, by virtue of the simple fact that they are so pre-eminent in their fields that industry seeks out their advice and services. ...

"Quite simply, the current FDA conflict of interest rules regard doctors and scientists with any financial connections with drug and device manufacturers as corrupt shills, who should be banished from its sacred precincts. Yet it takes an all-too-tolerant position to such 'pure' advisors like Sidney Wolfe, from Public Citizen, who has served on the FDA's Drug Safety and Risk Management Advisory Committee since 2008, despite being an avowed enemy of the industry and a close ally to plaintiff's lawyers who launch multibillion dollar class action suits against drug companies - and who contribute generously to Public Citizen's coffers."

Now, it's not completely true that FDA has never ruled out someone for a so-called "intellectual conflict". Indeed, Sidney Wolfe himself was once prevented from voting on the disposition of a class of birth control pills containing the hormone drospirenone because a Public Citizen publication had warned against using those products. And a prominent cardiologist had once been invited and then "disinvited" from participating in an advisory committee hearing on the blood thinner prasugrel because the doctor had made disparaging comments about the drug.

Still, in the latter case, FDA later acknowledged that it should not have excluded the cardiologist for having a possible "intellectual bias". And though Wolfe was only permitted to sit on the advisory committee panel considering drospirenone as a non-voting member, he continues to vote on numerous other products despite having campaigned for more than 30 years against the evils of the pharmaceutical industry.

The point remains, conflict of interest allegations almost invariably run in one direction: against drug and device manufacturers and not their critics. The only time it seems the critics are willing to overlook a drug industry conflict is when the otherwise conflicted party is joining in on the criticism of another manufacturer's product.

Consider one particularly ironic case that I wrote about previously: U.S. Sen. Charles Grassley (R-Ia.) has been a frequent critic of FDA for not being harsh enough on industry conflicts of interest. But, at the same time, Grassley has frequently relied upon Cleveland Clinic cardiologist Steven Nissen to pursue their joint campaign against the diabetes drug Avandia. But it turns out that Nissen just happens to be one of the investigators on a study purporting to show that Avandia's closest competitor, Takeda Pharmaceutical's drug Actos, is superior to Avandia because it doesn't increase cardiac risk. And, as it turns out, Takeda provided $25,000 in funding to Nissen's Cleveland Clinic team to conduct the Actos study.

If the tables were turned, and it was Takeda's product that Grassley wanted banned, would he have relied so easily on Nissen's judgement that Actos was safe? Steven Nissen is a highly regarded scientist, and I am aware of no credible evidence that his views on Avandia or Actos have been biased by the funding from Takeda. But you could bet your bottom dollar that, in such a case, Nissen's views would not only be discounted, they'd probably be ridiculed as nothing more than "bought and paid for science".

Ultimately, conflicts of interest can never be eliminated, though they can and should be managed. But it seems clear that the way Congress and the FDA are trying to manage them has been a dismal failure.


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