NY Times reports: F.D.A. Says Bayer Failed to Reveal Drug Risk Study

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TheNew York Times is reportingthat Bayer failed to tell the FDA about results from a clinical trial that revealed their drug Trasyol may have serious risks.

According to a story in the Houston Chronicle:

The company says it did not reveal the data at a Sept. 21 FDA meeting held to assess the safety of Trasylol “because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology,” according to a company statement. “This was a mistake on the company’s part.”

The NY Times summarized:

Bayer’s study was performed by a contract research organization. But Bayer did not inform the F.D.A. that the study was being done, even though that is routine practice.

It examined hospital records of 67,000 patients, 30,000 of whom received Trasylol. The rest got other drugs. It concluded that the patients given Trasylol were at greater risk.

Such studies, however, are fraught with statistical and other problems. Patients given Trasylol may have been sicker than those given other drugs. Their worse outcomes would be explained not by problems with Trasylol but by their own illness.

The revelation comes on the heels of the Institute of Medicine’s long awaited evaluation of drug safety problems at the FDA.

The timing bolster’s calls for broad reform of our drug safety system:

Senator Charles E. Grassley, Republican of Iowa and chairman of the Senate Finance Committee and a longtime critic of the F.D.A., said Bayer’s behavior proved that the agency was largely toothless.

“The remedy is mandatory reporting of all clinical trials and real teeth for the F.D.A. to do its job in holding drug companies accountable,” Mr. Grassley said.

Senator Grassley, along with Senator Chris Dodd, had called for disclosure of the results from clinical trials in legislation filed a year and a half ago.

Since then, the Chair, Senator Mike Enzi, and ranking member of the Senate HELP committee, Senator Ted Kennedy, have introduced their own legislation that includes disclosure of some clinical trial results. We applauded the committee leaders’ legislation, while calling for strengthening of several provisions, including assuring the results of all clinical trials are disclosed to the public, doctors, and researchers.

We’ll see if this most recent announcement compels needed drug safety reform forward.