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PHARMA: John Mack on the Pharma Elephant in the FDA’s front room

John Mack has an excellent article in his Pharma Marketing Blog called FDA Advisory Panels: Elephants in the Room. I’m glad he wrote this so I don’t have to.  The news is that 10 of the 29 panelists had active ties (i.e. money) to Pfizer and Merck, and that those 10 voted in favor of keeping Vioxx and Bextra on the market.  As both those votes were pretty close, the quote unquote unbiased panel members voted to remove them from the market, and the quote unquote biased panel members were responsible for the swing vote, which by the way resulted in bumping up Merck’s stock some 15%.

But  as Mack points out, there’s really no one who works closely with pharmaceutical development who can possibly avoid taking money from pharma in one way or another. Either they are advocates who are paid to promote the drug (key opinion leaders) or they are having their research supported by one pharma or another.  Or they are developing their own products and are hopeful of pharma support in the future. And of course these are open government panels so every pharma knows who’s for you or against you! 

This deal was made back in the early 1980s when the biotech industry emerged and scientists were allowed to take their government-supported research into the private sector. Since then the dividing line between government-supported and conducted research and the private sector has more or less disappeared. To put it back firmly into place so that there are "unbiased government experts" available with no ties to the industry they are making decisions about would be a huge reform. Not one that, even post-Vioxx, there seems to be much appetite for. So realistically these conflicts of interest will continue by necessity and we’ll just have to rely on the personal integrity of those involved and look hawkishly for pharma’s reaction to individual votes.

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