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Massachusetts Liberal

Observations on politics, the media and life in Massachusetts and beyond from the left side of the road.

Tuesday, June 05, 2007

Who's watching the watchers?

One of the little publicized outrages of the Bush administration is the behavior of the Food and Drug Administration, the agency charged with protecting our health and well-being by watching over the food we eat and the medicines we take.

But apparently the folks at the FDA have other ideas -- as reflected in this Boston Globe story that takes a look at a Cleveland Clinic cardiologist who is taking on the FDA.

And what reward does Dr. Steven Nissen get for studies calling into question the safety of a number of FDA-approved drugs? The same as that reserved for liberals who oppose Bush's war or conservatives who oppose Bush's immigration plan.

In a word -- slimed.

Years before Vioxx was pulled from the market in 2004, Nissen pointed to its heightened heart attack and stroke risks. In 2005, as the FDA was on the verge of approving Pargluva, a diabetes drug known generically as muraglitazar that works like Avandia, Nissen pointed out cardiovascular problems, effectively killing the drug's development. And he also rallied other federal advisers to prod the FDA to put its harshest warnings on attention- deficit hyperactivity disorder drugs, like Ritalin and Adderall, due to cardiovascular risks.

Such public stands have unleashed a firestorm of criticism. FDA spokesman Douglas Arbesfeld, in an e-mail to reporters days after Nissen's Avandia analysis was published by the New England Journal -- derisively dubbed him "St. Steven," and wondered whether his feet were made of clay.

Arbesfeld, responding to a Boston Globe question about the e-mail message, said the correspondence -- sent using his FDA e-mail address -- reflected his personal views and not the agency's.

This is an agency where the fox is literally guarding the hen house. The big pharmaceutical companies pay to the FDA to consider their products. Ever wonder why we have problems like the Vioxx nightmare?

Let's not forget the FDA's role in preserving the food supply. There's that same fox in the hen house feel to the discovery that animal feed imported from China is tainted with melamine -- a contaminant that has been found in a variety of pet foods.

Well, too bad for Fido, you might think. But for those heartless souls among you, consider this item. Or this. How long before it does make its way to us?

OK, still not convinced (or maybe thinking the FDA is doing its job closing the barn door after the great escape?) How about the failure to regulate human food supplements?

No wonder those who are profiting off the FDA's hands-off approach to human health and safety are trying to smear him, suggesting, heaven forbid, that he might be a candidate for FDA Commissioner under a Democratic president.

Can't have that now, can we, someone watching out for taxpayers when there is big money to be made. Just ask the head of the Pharmaceutical Research and Manufacturers of America, who hired former GOP House Committee Chairman Billy Tauzin to do their bidding. Or the Biotechnology Industry Organization, who scarfed up former GOP congressman Jim Greenwood to handle their lobbying.

So, do you really want to take that prescription? Or eat that cookie? Just checking.

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