Rep. Maurice Hinchey Blasts FDA role on Prozac Documents

As reported on the Record Online

Revelations about high rates of suicide and violence connected with the anti-depressant Prozac highlight serious problems with U.S. drug development, Rep. Maurice Hinchey said yesterday.

Hinchey is reviewing documents that apparently were not given to federal researchers during the approval process for Prozac conducted by the federal Food and Drug Administration. The drug is produced by the Eli Lilly and Co.

"The documents seem to show that clearly there was an awareness of the risks associated with the use of the drug and that that information was available to Lilly and perhaps to the FDA 16 years ago," Hinchey said.

The documents surfaced first in the Jan. 1 issue of the British Medical Journal. The documents suggested Eli Lilly officials were aware of the problems and tried to minimize their potential impact, the article said.

Eli Lilly spokesmen could not be reached for comment yesterday but issued a statement to the British journal: "The safety and efficacy of Prozac is well studied, well documented, and well established."

More than 50 million people have been prescribed the drug worldwide, the company said. Hinchey questioned whether the company had withheld the damaging information from the FDA and the public as Prozac was being approved.

The British journal said it would turn the documents over to the FDA for its review. A spokesperson for the federal agency said yesterday that it had not yet received the documents.

The new documents about what Lilly and the FDA might have known come at a time when the drug approval process, which the FDA oversees, is under fire. The drug Vioxx was pulled from the market recently when high rates of heart problems were connected with it, for example. Some anti-depressants like Prozac were only recently connected to high rates of suicide as well.

Hinchey, who is on the House Appropriations Committee, blasted the FDA. "This case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA-approved drugs so that patients and their doctors, not the drug companies, decide whether the benefits of taking a certain medicine outweigh the risks," he told the medical journal. This is not the first time the Saugerties Democrat has taken on the FDA.

Last year, Hinchey attacked Daniel Troy, the chief counsel for the agency. Troy was a former law clerk of failed candidate for U.S. Supreme Court Robert Bork. He represented pharmaceutical and tobacco industries in legal battles with the FDA, but that was before he took over as its chief lawyer.

Hinchey accused Troy of favoring drug company interests over that of the public, even going so far as seeking out legal cases and coordinating how the federal agency could best help the companies. Troy denied any bias but resigned his post in November. Hinchey said he was sure the pressure he applied to Troy played a role in the resignation.

But Troy's resignation will not end the agency's problems. The media focus is intensifying, and he plans to request an internal investigation of what the FDA knew about the Prozac data, Hinchey said.

"We have been led to believe we have the most complete safety procedure of any country in the world," he said. "But we may have to confront some illusions and myths here about the efficacy of our processes. We have to change them so they are the best and safest in the world."

The controversial documents can be found online here in PDF format