Sunday, November 9, 2008

Big Pharma, The FDA, And You--Guess Who Loses?

If the FDA approves a drug and its warning label, should the drug manufacturer be shielded from ANY liability when the drug harms or kills people? Wyeth Pharmaceuticals, maker of the anti-nausea drug Phenergan, is asking The U.S. Supreme Court to do just that in a pending lawsuit. In this case, a Vermont musician had her arm amputated after given the drug for a migrane. Apparently,there are 3 ways to give this drug, and the method used to administer the drug in the musician's case can cause gangrene. And she is the 20th person to have an arm amputated due to this drug.

Wyeth's defense? Hey, we warned of this on the drug label, and the FDA approved the warning. The woman now missing her arm claims: maybe you should have warned physicians NOT to adminster the drug in this manner if a simple anti-nausea drug is going to cause people to lose their arms due to gangrene, and you KNOW ABOUT IT.

The drug manufacturers' efforts to obtain 100% immunity for drugs it introduces to the public has its roots in the Bush administration's efforts to protect the pharmaceutical industry from any lawsuits as long as the FDA approves the drug. But here's the rub, as poimted out by a recent editorial in The Boston Globe:

In the past, the FDA never claimed, as it does now, that its approvals of drugs or their labels should protect drugmakers from liability. This change in policy, which was opposed both by former FDA commissioners and current career FDA staff, is part of the Bush administration effort to free industry generally from tort suits. Former commissioner David Kessler's argument against pre-emption is that the FDA sees relatively little test data on a new drug once it is on the market.

Protecting drug companies is only part of an orchestrated effort by the Bush adminstration to protect big business from liability in a variety of situations. Sound familiar? It should. We heard it with Wall Street, didn't we? "Government stay out of the markets--they can regulate themselves." And for eight years now, this same administration has been saying: "And no lawsuits either--it's not good for business." Isn't this the same administration that has been bemoaning a lack of societal "personal responsibility and accountability?"

Here is the essence of the last eight years: a whole truckload of risks (your financial risks in the market, what you eat, what you drive and the drugs you take) has been transferred from corporations to you.

Now sit back and think about all the drugs put out on the market over the years that caused massive harm or killed people, and were either recalled or withdrawn from the market. Does it make you feel safe to know that all these drugs were approved by the FDA? Well what if the FDA gets it wrong? And what if the drug manufacturers either failed to adequately test a drug or withheld data from the FDA?

My guess is that this Supreme Court, one of the most conservative and business friendly in years, will rule in favor of Wyeth. If that happens, hopefully the new Congress will react by passing a law prohibiting the drug industry from avoiding its legal accountability if drugs "approved" by The FDA turn out to be dangerous.

This is not some anti-corporation rant. Corporations employ millions of people in this country and are a vital cog in the economic wheel. They deserve to make billions if they perform their due diligence and take reasonable measures to put useful and safe products on the market. That's the American way. But they shouldn't get a free legal pass when they cut corners by hiding behind a government agency that gets it wrong, or didn't have the capacity to get it right.

Otherwise, "personal responsibility and accountability" is just a one way street...


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