The Food and Drug Administration took a pair of mini steps in the right direction last week when it created a Drug Safety Oversight Board and gave qualified approval to continued use of such COX-2 inhibitors as Vioxx and Celebrex. But there's still room for improvement.

Although the oversight board was billed as an independent panel, critics of the agency and its monitoring of drug safety labeled it "a hoax" because members will be drawn from the FDA and other government agencies. Absent are outside medical experts, patient and consumer advocates who have criticized the agency's insular nature and close ties to the pharmaceutical industry.

It is fair criticism. Outside experts are part of the FDA's regular drug advisory panels, why not this one? Their views are needed because, as Health and Human Services Secretary Mike Leavitt said, "The public...want(s) more oversight and openness." Independent, outside expertise and a public presence should be required on any oversight board created to monitor drug safety before and after pharmaceuticals hit the market. The FDA needs to expand the board or change its membership to include such representatives.

A separate advisory panel decided to keep COX-2 inhibitors available to consumers in spite of increased chances of heart attacks and stroke, noting that such painkillers have medical value in carefully controlled circumstances.

Among its recommended restrictions were a ban on direct-to- consumer advertising, putting a Black Box warning of the most severe type on bottles and packages, and giving patients written notice of risks. The FDA is not obligated to adopt the panel's recommendations, but usually does so on controversial matters.

Though the use of Vioxx, Celebrex and Bextra would be limited, the panel acknowledged that they are needed by persons with severe arthritis. Still, patients needing painkillers should try naproxen and other supposedly less-threatening substances before taking a COX- 2 inhibitor.

Dr. Alastair Wood, who chaired the advisory group, said physicians need to be "more thoughtful" about prescribing such drugs, adding, "It would be a brave man or woman" who gave them to a heart patient.

The FDA still can neither conduct independent clinical trials of drugs or order manufacturers to do so. It lacks the power to ban advertising. The advisory panel opposed ads for the three COX-2 inhibitors, unless written by the FDA or a neutral source, but it can not technically enforce a ban.

We do not need a repeat of the mass advertising that created such a groundswell for these drugs that physicians felt pressured to prescribe them. It was like playing Russian roulette with lives.

Congress needs to provide stronger oversight of the FDA while expanding the agency's powers and giving it the resources to conduct independent drug tests on its own as well as control advertising of pharmaceuticals.

Sen. Charles Grassley, R-Iowa, chair of the committee that held public hearings on COX-2 inhibitors and FDA's dependence on manufacturers for safety tests, has noted ad nauseum that the agency is still not open or transparent enough. Drug safety issues should be a higher priority and more resources are needed to independently monitor pharmaceuticals safety.

The need is obvious, it is time for government to respond.

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