Reducing drug industry influence at the FDA is much easier than it looks

Experts without borders

Three years ago the FDA cracked down on drug industry influence in FDA decision making.

Well… “cracked down” might be overstating it. Let’s put it like this: They adopted slightly less generous rules for experts to qualify for FDA panels.

That was a potential win for consumers. Less industry influence means less chance of another Vioxx fiasco where thousands of lives are put in jeopardy.

But now, some of the highest placed FDA officials want to soften the 2008 rules. They claim that it’s simply too difficult to find qualified experts with no ties or minimal ties to Big Pharma.

Too difficult? Really? Cry me a river. I’ve got evidence that paints a completely different picture.

It appears that Big Pharma wants its influence back, and it looks like FDA top dogs are ready to shrug their shoulders and cave in.

How hard did they look?

A few months ago, one highly placed FDA official had this to say about recruiting for advisory panels: “FDA staff should search far and wide for experts who have the requisite knowledge without conflicts of interest.”

Far and wide! Go to the ends of the earth to track down the elusive expert with no ties to Big Pharma!

But more recently, a top FDA official told Congress that the agency may have to relax the 2008 conflict of interest rules because of the difficulty in finding competent experts.

Here’s what’s troubling: Both of those statements were made by the same person — FDA commissioner Margaret Hamburg.

Hamburg’s recent comment is backed up by Janet Woodcock, head of the agency’s Center for Drug Evaluation and Research. Pharmalot reports that Woodcock also wants to soften the 2008 rules.

That includes a key rule that excludes any expert who has a financial conflict of interest of more than $50,000.

Let’s think about that. Right now, under the “tough” 2008 rules, you can receive $49,000 from a drug company, but that isn’t officially recognized as a conflict of interest.

And not only that, but we’re being told that qualified experts who take less than $50,000 are hard to find.

Wow. That’s seriously disturbing.

Or it would be if we didn’t have evidence that experts without industry ties are readily available.

According to a 2009 Harvard study, a little over half of academic researchers have at least a passing relationship with industry. Of course, that means that NEARLY HALF of academic researchers have no industry ties.

So when Hamburg suggested that her staff search far and wide, they didn’t have to hack through jungles or climb mountains. All they had to do was throw a brick into a crowd of academic researchers and their chance of hitting one with zero industry connections was about the same as hitting one carrying a large bag of industry cash.

Experts without Big Pharma ties are out there if you want them, FDA.

But you have to actually want them.

Sources:
“FDA Panel On Bone Drugs And Conflicted Members” Ed Silverman, Pharmalot, 9/9/11, pharmalot.com

“Participation Of Academic Scientists In Relationships With Industry” Health Affairs, Vol. 28, No. 6, November/December 2009, healthaffairs.org