Volume 3   Issue  36                        November   2004

                 

Drug Safety Second to Profit
Wilmington Star, November 10, 2004
Americans no longer can assume that the prescription drugs they swallow are safe. That's especially true of the latest pills, often highly advertised.

We can assume instead that manufacturers are pressing the Food and Drug Administration to approve profitable new drugs – and that the FDA not only is cooperating, but then paying too little attention to whether those drugs hurt patients.

One measure of the agency's laxity is that for more than a year, it has allowed its top drug-safety job to remain vacant. Under pressure from Congress, which is responding to disclosures about anti-depressants, flu vaccine and Vioxx , the FDA says it will fill that job.

Congress is quick to criticize, as always, but Congress itself shares the blame. A decade ago, during the heyday of Newt Gingrich, it started bullying the FDA to please the pharmaceutical industry, which has been so generous with its "campaign contributions."

Accordingly, drugs are being approved more quickly and more money is being made. Not by coincidence, more people are being hurt or even killed. One FDA researcher guesses that Vioxx alone may have killed nine times more people than the terrorists on Sept. 11.

Some FDA scientists have feuded with their bosses about whether doctors and the public should be told more about the potential dangers lurking in medicine cabinets.

But the acting director of the agency's Center for Drug Evaluation and Research insists such disputes are rare. "It doesn't represent the culture," he says, "so we don't really think there is a need for an overwhelming cultural change."

Tell that to the injured. Tell it to the bereaved.

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