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Commentary

Commentary: A safer Vioxx? Try this remedy
Joe Torg, The Philadelphia Inquirer, 2-23-05

Torg, an orthopedic surgeon in Philadelphia, says that in late 2000 he prescribed Vioxx to 8 patients, six of whom later developed high blood pressure. After asking Merck for more information on this side effect, he was notified that there was evidence that it did, indeed, have an effect on blood pressure in susceptible patients.

Nonetheless, Merck didn't acknowledge an increased risk of heart attack or stroke with Vioxx until it withdraw the drug in 2004, despite the fact that there is a “well-established correlation between high blood pressure and stroke” and heart attacks.

Torg notes that there was a very simple solution to the Vioxx problem: “Monitor the patient’s blood pressure. If hypertension develops, discontinue the drug.”

The source of the problem in this instance—and probably others—is twofold. First, the FDA’s passive reporting system used for documenting drug adverse events. Shifting to a mandatory system would allow the FDA and manufacturers to correlate drug treatments with rare but significant adverse effects like this one and adjust information to patients and doctors quickly and easily.

Second, is the FDA’s insistence on using randomized clinical trials to vet all drug safety and efficacy concerns. This leads the agency and industry to pretend that if a problem doesn’t show up in a clinical trial, it doesn’t exist. The over reliance on clinical trials when there are other faster methods available—sophisticated datamining, genetic modeling of drug toxicity—undermines public confidence in both the agency and industry.

Revising the clinical trial model—for instance, increasing the use of biomarkers as suggested in the FDA’s Critical Path project—would go a long way towards improving drug safety.



Project FDA.
  
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