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It’s been more than two years since FDA scientist David Graham told a Senate panel that the FDA was “incapable of protecting America against another Vioxx.” Now he tells a House panel that “nothing has really changed.”

20-year veteran FDA scientist told the House Subcommittee on Oversight and Investigation recently that the FDA is “incapable of protecting America against another Vioxx, and that since then nothing has really changed” in the FDA’s approvals process.

The subcommittee, chaired by Bart Stupak (D-MI), has been engaged in a series of hearings to evaluate the FDA’s ability to safely approve new drugs and provide post-marketing surveillance, with a jaundiced eye aimed at Big Pharma as well. The hearing was titled: “Ketek Clinical Study Fraud: What Did Aventis Know?”

Dr. David Graham told panel members that the FDA’s Center for Drug Evaluation and Research (CDER) “regards industry as the agency’s main client” rather than considering broad public safety as its mandate. It was Graham’s testimony in 2004 that helped lead to Merck’s arthritis drug Vioxx being pulled off the market in September of that year. Asked about other drugs that the FDA has mishandled, Graham told the subcommittee that atypical anti-psychotic medications to sedate nursing home residents kill roughly 15,000 people a year, and that the weight gain and diabetes dangers posed by Zyprexa, used to treat schizophrenia and bipolar disorder, was known for years to Eli Lilly, the drug’s maker.

Another physician, Dr. David Ross, who has worked on the CDER’s pre-approval side for a decade, said that the antibiotic Ketek, made by Sanofi Aventis, was approved in spite of the fact that the FDA knew it could “kill people from liver damage and that tens of millions of people would be exposed to it.” Ross testified that his FDA bosses forced him to ease back on his unfavorable review of Ketek.

The antibiotic Ketek, approved in April 2004, has been linked to liver failure and other adverse side effects, and the FDA announced in February that Ketek was no longer approved to treat sinusitis or bronchitis because its potential risks outweigh any benefits for these fairly benign conditions. It remains on the market to treat only pneumonia acquired outside a hospital or nursing home.

Mark Senak in his EyeOnFDA blog says the FDA is “in the stew”, and that the FDA leadership “may not believe that they are running for office. They are mistaken. They are running for an office called public confidence. And right now, as for the past few years, the agency is losing that essential race.”

Clearly there are problems with the FDA’s approvals policies and post-marketing controls. When you add Big Pharma’s propensity for unethical practices into the mix, such as withholding or altering clinical trial data, there is no question but to bring about serious changes in the way drugs are tested, reported and approved for public use.

Anything else continues the betrayal of public trust.

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