Critical Clinical Trial Hidden From Advisory Committee

A Food and Drug Administration announced Friday that one of its advisory committees did not receive crucial clinical trial data from Bayer when it considered the safety of a blood-clotting drug last week. The trial showed Trasylol, which is usually given before heart operations to reduce bleeding, might have increased mortality. The advisory committee eventually ruled the drug's risks did not outweigh its benefits. Details of the story can be found in today's New York Times.

How could something like this happen? The government goes to great expense to hold a public meeting to discuss possible problems with a drug used during already dangerous operations. Then, a week later, a clinician who conducted a trial for the firm calls up the FDA with the additional information, which the company, according to today's Reuters account, "mistakenly" failed to tell the agency about. "Bayer said it did not share the information with the FDA immediately because there were questions about the study's methodology and the findings were preliminary," the Reuters report said.

When I first heard about this yesterday, I thought to myself, isn't this like hiding evidence in a criminal trial?

Fortunately, there's a quick and easy solution to these "oversights." Congress must step in immediately and attach an amendment to the FDA appropriations bill that says every clinical trial conducted on any approved drug or any drug up for approval must be registered with the agency prior to the enrollment of any patients. Failure to do so should lead to immediate withdrawal of the drug from the market until the newly revealed data can be properly evaluated.

With such a publicly available database, the FDA should have no problem locating all the available clinical trial data when it sits down to evaluate a drug's safety and efficacy.

Congress had the chance to pass such a bill the past two years, but it did nothing (yes, I know, this sounds like the "do nothing Congress" slogan now being used by the Democrats; but if the shoe fits . . . ).