Tuesday, January 19, 2010

Why the FDA is more probusiness than ever

It's nice to see that Massachusetts anesthesiologist Scott Reuben has plead guilty to faking medical research and agreed to pay restitution fees for his fraud. But there is one aspect of his plea agreement with federal prosecutors (which he signed last week in the hopes of a more lenient sentence) that troubles me: why is he paying $420,000 in restitution fees to the very drug companies that benefited handsomely from his faked research and rewarded him with speaking fees? (Reuben's plea deal was first reported in The Day).

To recap, Reuben, an anesthesiologist at Baystate Medical Center in Springfield, fabricated positive data on at least 21 studies of drugs, mostly painkillers such as Vioxx, Bextra and Celebrex; background here. Reuben received research grants from the makers of these drugs, and he was also getting lucrative speaking fees from at least two of the companies: Pfizer (which makes Bextra and Celebrex) and Merck (Vioxx). And now he is required to pay Pfizer $296,000, $16,000 to Wyeth, (now owned by Pfizer), and $49,375 to Merck, all in restitution for taking their money and then faking positive findings about their drugs. Rich, huh? I'm sure these companies are laughing all the way to the bank.

On an equally disturbing note: Jim Dickinson, the editor of FDA Webviews, an industry newsletter that follows the agency, has concluded that the FDA is more pro-business than at any time in 35 years. According to Gooznews, Dickinson writes:
It has taken almost a generation, but by now, the pro-industry infiltration of FDA's culture is firmly entrenched. Not only is collaboration in product reviews officially encouraged, but good relationships across the regulatory fence hold the prospect of a possible future career in a well-paid industry job.

And what does Dickinson blame for this tectonic shift in the federal agency's culture? The same culprit I singled out in Side Effects: the Prescription Drug User Fee Act, passed in 1992. I reported that industry user fees now account for more than than half of the FDA's entire drug review budget and as a result, the agency has become increasingly beholden to the very industry it is supposed to regulate. Or, to quote Dickinson:
User fees at FDA are the primary villain, because they allowed the industry to dictate the changes at the FDA in programs, procedures and practices. It will be impossible for the Obama administration to reverse the trend because as long as the user fees are in place the industry has the upper hand.


Fid said...

It's brilliant isn't it.

Pay someone to 'big up' one of your products... even though there really is no evidence to suggest that product is safe. Then, let the individual take the fall... not only that, you get your money back that you paid the person in the first place!

I think the phrase 'bigger picture' has never been more apt than it is in this particular case.

Imagine if an airline paid a specialist to say good things about one of their aircraft - then, some time later, the aircraft blows up mid-air. An investigation shows vital flaws in the engine mechanism, they also find that the airline knew of this.

Are we expected to believe that the specialist would be the only one hauled over the coals for concealing this evidence?

Pharma are a law unto themselves Al.

Michael Kirsch, M.D. said...

If the allegations against the physician are true as reported, then he should be vigorously prosecuted and should never practice medicine again. This was not an isolated ethical lapse, but a pattern of repeated deceipt and fraud. Fraudulent medical research wastes money and lives. www.MDWhistleblower.blogspot.com