Mo’ Money, Mo’ Problems
Posted by Osagie K. Obasogie April 6, 2007
Biopolitical Times
"Everyone has a price," goes the adage. Before last week, the FDA apparently thought this wasn't true for physicians, biomedical researchers, and others serving on advisory committees that give expert opinions on pending drug approvals. Last Wednesday, however, the FDA released draft guidelines to curb growing concerns that pharmaceutical companies may be greasing the wheels by giving advisory committee members exorbitant gifts and cash.
This is certainly an important first step to building confidence and integrity in the drug review process. But, what boggles the mind is why the FDA still thinks anything up to $50,000 is an appropriate amount for an advisory committee member to take and still give "impartial" advice. Put it this way: even under the revised rules, an advisory committee member could still take $49, 999.99 from Pfizer, Eli Lily, and other drug companies and then suggest that the FDA approve their drug applications the next day.
The Economist recently ran a special report on the etiquette of bribery, and a person more cynical than I might think that the guidelines laid out here are not unlike meeting a guy in a back alley with a stuffed brown envelope. And, evidence of committee members' substantial conflicts of interest in addition to their remarkably high 'yes' votes does little to dissuade this perception. Given the mounting evidence that, for example, doctors' behaviors can be skewed by gifts as small as a ballpoint pen or a ham sandwich, in what world is it ok to allow government advisors to take what Tony Soprano would call '50 large' before rendering decisions? How does it promote public health to allow public servants (albeit temporary ones) to take this kind of money from the private industries they are charged to regulate?
This is certainly an important first step to building confidence and integrity in the drug review process. But, what boggles the mind is why the FDA still thinks anything up to $50,000 is an appropriate amount for an advisory committee member to take and still give "impartial" advice. Put it this way: even under the revised rules, an advisory committee member could still take $49, 999.99 from Pfizer, Eli Lily, and other drug companies and then suggest that the FDA approve their drug applications the next day.
The Economist recently ran a special report on the etiquette of bribery, and a person more cynical than I might think that the guidelines laid out here are not unlike meeting a guy in a back alley with a stuffed brown envelope. And, evidence of committee members' substantial conflicts of interest in addition to their remarkably high 'yes' votes does little to dissuade this perception. Given the mounting evidence that, for example, doctors' behaviors can be skewed by gifts as small as a ballpoint pen or a ham sandwich, in what world is it ok to allow government advisors to take what Tony Soprano would call '50 large' before rendering decisions? How does it promote public health to allow public servants (albeit temporary ones) to take this kind of money from the private industries they are charged to regulate?