Editorial: Irresponsible proposal

Friday, Dec. 7, 2007 | 7:29 a.m.

The Food and Drug Administration is considering easing regulations to allow pharmaceutical companies more leeway to talk to doctors about using drugs in ways not approved by the agency.

A proposal circulating inside the agency would allow companies to give doctors studies published in medical journals about "off-label" uses for drugs. Doctors occasionally use drugs for unapproved treatment based on such studies, and although they might be successful, the drugs have not been thoroughly vetted for such use.

In the 1980s two drugs approved to treat irregular heartbeats were used off-label to treat patients who had suffered heart attacks after articles appeared in medical journals touting the treatment. Later studies, however, showed patients using those drugs after heart attacks had a death rate twice as high as those on placebos.

In a letter to the FDA chief, Rep. Henry Waxman, D-Calif., said allowing the drug companies to hand out medical journal studies could present "a distorted picture of a drug's safety or effectiveness."

Waxman, the chairman of the House Committee on Oversight and Government Reform, noted that medical journals have unwittingly given credibility to several flawed studies. For example:

As a result of studies such as these, doctors may be duped into treating patients with drugs that are dangerous or nonessential. It is unconscionable that the FDA is thinking of shirking its responsibility by allowing such behavior to be legal.

Pharmaceutical companies should not be allowed to use subterfuge to sell more drugs. If they want to pitch their drugs for unapproved uses, they should get them legally approved.

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