FDA sued for concealing information about its expert advisors

FDA sued over hiding info on its ‘expert’ drug consultants

It’s like a game of hide-and-go-seek – one we always lose.

For years the FDA has been relying on so-called “advisory panels” to help it make life-or-death decisions about whether to approve new drugs.

These are doctors and researchers who are supposed to be top experts in their fields. We’ve been promised that they’re independent, but many of these panel experts are hiding a deep, dark secret.

They’re in the pockets of the same drug companies whose products they’re recommending.

And the FDA is doing everything it can to make sure we never know a thing about it.

The big, black marker

Their headquarters may be a few miles apart. But it looks like the FDA is picking up plenty of tricks from the CIA.

That’s especially true when it comes to using a big, black marker to redact information the FDA doesn’t want us to know.

And those black markers have been working overtime when it’s time to share information about these advisory panel members.

When it’s considering a new drug, the FDA typically asks for help from these outside experts to review applications. And even though the FDA doesn’t have to follow the advice they give, it usually does.

So you would think that any of them with close ties to Big Pharma would be shown the door.

Yeah, you would think. But that’s usually not the case.

Take Vioxx, for example. That’s the painkiller that was finally taken off the market – but not until over 60,000 people died from strokes or suffered heart attacks while taking it.

And when the FDA asked its expert committee over a decade ago if it should continue to keep Vioxx out of circulation or bring it back, the panel voted overwhelmingly that the deadly drug should return.

Later, it was uncovered that most all of those “yes” votes came from doctors who took money from Merck, the company that made Vioxx. (Thank goodness this was one of those rare times the FDA didn’t take its committee’s advice!)

But that kind of conflict of interest has become pretty much business as usual at the FDA. And as you may have guessed, it matters a lot.

One study found that in any typical expert committee, at least 13 percent of the members have a financial stake in the company making the drug they’re voting on. And, those pharma-connected specialists voted “yes” for those drugs a giant 84 percent of the time!

So it’s easy to see why the FDA is so intent on hiding anything it can about these docs. And that even goes for the information these experts write about themselves.

When the group Public Citizen wanted to find out more information on these expert committee members, it was shocked to find out that the resumes the advisers had supplied to the agency had large portions of them blacked out when they were posted online.

The FDA hid information about these experts’ colleagues, grants they had received (which may have some from Big Pharma), and even information about their degrees.

The only excuse the FDA would give for this censorship was that it involved “confidential information” and releasing it would be an “unwarranted invasion of privacy.”

But since these documents came straight from the horse’s mouth, that makes little sense.

It’s clear that the FDA is bending over backwards to hide connections between these experts and drug companies – connections we all have the right to know about.

The whole thing is so bizarre, in fact, that Public Citizen has filed a lawsuit against the FDA, asking that it restore these resumes exactly as they were written.

As the group’s attorney commented, this whole situation shows that the FDA “favors secrecy over disclosure.”

But that hardly comes as a big shock.

The only surprise here is the lengths to which the FDA will go to keep those secrets.

Sources:
“FDA sued for hiding too much info about its expert panel members” Ed Silverman, April 28, 2016, Stat, statnews.com