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Congress should build more independence and authority into U.S. drug-safety oversight to protect consumers from potential risks of medicines such as Merck & Co.'s Vioxx painkiller, a researcher said in a medical journal.

The Food and Drug Administration's units that clear new drugs for sale and monitor safety after approval should be independent of each other, and an office should be created to issue risk warnings, Wayne Ray said.

Ray, a Vanderbilt University researcher, expressed his views in today's issue of the New England Journal of Medicine. Consumers should lobby their senators and representatives to enact the changes, he said.

Ray's article adds to calls for changes at the FDA since the September 2004 withdrawal of Vioxx because of heart risks. Ray will present his points at Tuesday's meeting of the federally chartered Institute of Medicine, which was asked by the FDA to evaluate the agency's safety oversight and recommend changes.

Consumers "may be taking their medicines with a false sense of security," Ray said. "People should not put up with a system that does not protect them. They should ask Congress for change."

The Institute of Medicine, created by Congress to advise federal agencies, convened a panel that will release a report in midyear with recommendations for changes at the FDA.

Ray's article comes as the FDA is forging ties with the University of Arizona as a partner in the Tucson-based Critical Path Institute, a nonprofit institute that is studying ways to speed approval of new drugs while boosting drug-safety monitoring. The UA also hosts the Center for Education and Research on Therapeutics, one of seven FDA-affiliated academic centers whose mission is to improve drug therapy and reduce adverse events caused by drug interactions.

Drugs are approved for sale to millions of patients based on studies done with a few thousand patients, said Ray, who served as an expert witness in trials for liability cases involving Vioxx and Bayer AG's Baycol cholesterol drug. Consumers also may not realize how little authority the FDA has to update prescribing information given to doctors on drugs, he said.

"Subsequent litigation generates billion of dollars in legal fees and settlements that ultimately become part of the cost of new medications," Ray said. "This haphazard process does not benefit the public health, the medical profession or the pharmaceutical industry."

Calls for changes include an article in the New England Journal in September from Harvard researcher Jerry Avorn, who said the FDA hasn't taken lessons on drug safety from the withdrawal of Vioxx. More than a year elapsed between the publication of research in 2000 suggesting a Vioxx heart risk and the inclusion of those findings in the prescribing information for the medicine.

The Journal of the American Medical Association in November published University of Michigan researcher Howard Markel's paper criticizing the FDA as being too close to the drug industry and citing the handling of Vioxx as an example.

The FDA now has one center that approves medicines, tracks their safety and decides what information to give doctors and consumers about drugs. Ray suggests splitting those functions and also creating a Center for Drug Information that would have more effective authority to tell doctors about emerging information on drug risks.

Senate Finance Committee Chairman Charles Grassley, an Iowa Republican, has proposed creating a separate Center for Post-marketing Drug Evaluation and Research at the FDA. The agency now has an Office of Drug Safety housed within its Center for Drug Evaluation and Research, which also approves medicines.

Ray proposes funding the new functions he suggests through a tax on pharmaceutical sales that would allow the FDA more independence than the fees drug makers pay now with their applications for clearance.

The United States also should consider phasing in sales of new medicines, Ray said. People who took part in drug studies would be the first to get new medicines, with wider release allowed after the potential risks of a drug are better known, he said.