Researcher Provides Undisclosed Data to FDA

Posted on October 8, 2006  Comments (0)

Companies conduct medical studies and then provide their research to government authorities (the FDA in the USA) to receive approval to market the drugs. Medical studies are complicated, in the best of circumstances. But the financial pressure on companies to bias the results so that they gain approval can be great. There need to be vigorous enforcement to counter the danger of bias rising from the hope companies have for the drugs.

Harvard Researcher Forced Bayer to Give Drug Data

“It calls into question the honesty of Bayer and the honesty of the pharmaceutical industry in general,” says John Teerlink, director of the heart failure clinic at the San Francisco Veterans Affairs Medical Center.

“I think the public health has been harmed in two ways,” said Teerlink, who is a member of the FDA panel that met to review Trasylol. “One, we didn’t have complete information to make our decision. But secondly, it calls into question a process that all of us depend on.”

Alexander Walker, a professor at Harvard’s School of Public Health, told the FDA he conducted a study that analyzed the safety of Bayer’s Trasylol and which confirmed an earlier study that the drug increased the risk of kidney failure, heart attacks and strokes. Good job.

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