Who will Guard Us From the Guardians?

by on November 10th, 2004

It’s been a bad year for the FDA when it comes to Congress. Their latest bout with Capitol Hill has them defending how they handled the flu shot shortage. Congress demanded a lot of materials showing the FDA did their job overseeing the troubled flu vaccine factory the British shut down.

Now why wouldn’t our Hired Hands on the Hill simply take the FDA at it’s word? Could be an increasingly bad track record.

Weeks before Merck & Company pulled Vioxx off the market because of a link to heart attacks, one of your watchdogs in the federal government had already sounded the alarm – and was promptly told to shut up.

Dr David J. Graham is associate director for science in the FDA Drug Center’s Office of Drug Safety. He found a link between the anti-arthritis drug and 27,785 heart attacks and deaths over four years. People like Dr. Graham are supposed to look out for you. He raised the alarm about Vioxx. His superiors told him to keep quiet. They were looking out for Merck & Company.

The Food & Drug Administration has two purposes that are increasingly at odds: They are supposed to protect the people and promote the food and drug industries.

This is common among government agencies. The FAA, for instance, both regulates airlines and promotes civil aviation.

This is a delicate balancing act – worthy of the Flying Wallendas. Dual duty agencies have to weigh the safety of the public against the concerns of the industry they’re supposed to protect us from and promote at the same time. But it’s the little guy, who can’t afford lobbyists, that takes the fall when that high wire act flops.

This is the second such case with the FDA this year. Earlier, they were accused of withholding information from Congress that showed a link between antidepressants and teen suicides. Both Senator Charles Grassley (R-IA) and Rep. Joe Barton (R-TX) complained about that in letters seeking explanations or investigations.

This is a federal agency that opposes reimporting pharmaceutical drugs from Canada claiming they can’t vouch for their safety. But the FDA won’t vouch for the lack of safety in drugs like Vioxx and antidepressants prescribed to teenagers.

I’d be willing to take my chances on a bus to Toronto.

Terry Turner