Wednesday, June 03, 2009

Expensive Medicine

When do "proprietary information" and "trade secrets" trump safety? Apparently when ever PHARMA decides they do, at least for at least the last decade or so. The Food and Drug Administration has been holding back information on drugs and devices it has approved lest it violate laws obviously intended to protect formulations, not the dangers of using the drugs discovered in clinical trials. That stance might very well be changing, according to this article from the NY Times:

For years, the Food and Drug Administration has withheld information about drugs and medical devices from the public when their makers cite trade secrecy — even in cases where the agency suspects that the products are causing serious illness or death.

Now the new leadership at the F.D.A. may change that. The Obama administration plans to announce on Tuesday that it is setting up a task force within the agency to recommend ways to reveal more information about F.D.A. decisions, possibly including the disclosure of now secret data about drugs and devices under study. ...

...the goal is to open up a system in which the agency failed to inform the public that a widely prescribed heartburn drug was especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers.

“Many people have been harmed over the last decade because the F.D.A. has treated clinical trial results of drugs and devices as trade secrets,” said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who has campaigned for the release of such information.

The past "cautious" approach of the FDA would be laughable if it hadn't resulted in the death of the very people the agency had been charged to protect. I can't think of a single reason why the complete results of a clinical trial shouldn't be required of the pharmaceutical company applying for FDA approval of a drug and shouldn't be made available to the physicians who might prescribe the medication and to the patients who might be taking it. If there have been side affects from the formulation, whether minor or significant, the public has the right to know that, even if we may not have the right to know the exact chemical formulation in the drug itself.

In a follow-up editorial, the Times agrees:

At the insistence of industry, and its claims of proprietary information, the F.D.A. often sits on data that raise questions about a drug’s safety or therapeutic value. The consequences for some patients can be severe. ...

The agency is hemmed in by laws restricting its ability to release trade secrets and internal agency records. But there seems little doubt that it has been overly cautious and that public safety has suffered as a result.

Well, duh!

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