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A Prescription for Peril

March 30, 2004

The story of drug makers' two-decade struggle to keep cold medicines and diet products laced with phenylpropanolamine, or PPA, on store shelves highlights the need for Congress to create stronger firewalls between drug industry funding and research.

As Times staff writers Kevin Sack and Alicia Mundy reported Sunday, since at least 1982 the Food and Drug Administration knew this stimulant could cause some people to suffer cardiovascular effects, cerebral hemorrhage and cardiac arrhythmias. A landmark study designed -- and thereafter concealed -- by the industry concluded as much in 1999.

Still, the agency only began to take pusillanimous steps toward pulling the drug off the shelves in late 2000.

In their defense, drug makers blame the FDA. Typical is this comment by Robert G. Donovan, the former head of Sandoz Consumer Health Care, a drug maker that knew the dangers of PPA at least as far back as 1984: "My assumption was that if there was an issue of safety, supported by sound evidence, that the Food and Drug Administration would exercise their responsibility and take the product off the market."

The FDA counters that the industry hampered it. Because the agency does not sponsor research, its officials say, it must rely on the industry to investigate the safety of its own products. And because the industry managed to delay publication of research, there was insufficient evidence of PPA's dangers to take it off the market or demand label warnings.

Congress must step in, recognizing that people are dying while fingers are pointing.

Congress, ideally, would create an Office of Clinical Research, a federal institute to act as an ethical buffer. Funded in part by industry dollars that now flow directly to individual scientists (thus corrupting their results), the institute would test new drugs against older ones. New drugs now are compared only with inert pills or placebos in clinical trials designed by pharmaceutical firms. As envisioned by medical policy experts such as Drummond Rennie, a deputy editor of the Journal of the American Medical Assn., the institute would reserve its seal of approval only for drugs that prove superior to existing drugs.

Congress is unlikely to act so boldly in this election year, but it should at least hold hearings to examine why the Food and Drug Administration gives drug firms such sway. Though it may be appropriate to let them help design studies, their influence should end there. And drug firms should not dictate timing of a study's release.

Legislators also should ask why, when PPA's dangers became clear, the agency did not move it to prescription-only status. This lapse is especially troubling with a nonessential, replaceable over-the-counter drug. It's also disconcerting how this case shows the FDA lacks a sound system for doctors and hospitals to raise alarms about "adverse events" in patients using drugs, like PPA, that long have been available over the counter.

Whether with easily obtained drugs like PPA, or with problem prescription items like the diabetes treatment Rezulin, or with its shaky regulation of herbal nostrums, the FDA shows itself to be more industry lapdog than safety sentinel.

That's a prescription for danger that Congress and the White House must remedy.

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