From the wires: The FDA has just completed a fresh set of guidelines that will permit pharmaceutical companies to tell doctors about unapproved uses of their medicines—in effect, giving big pharma carte blanche to hawk unapproved drugs.
Specifically, the new regulations allow drug companies to “distribute copies of medical journal articles that describe unapproved uses” of their drugs to all the doctors they want.
Technically this reg isn’t new; it was in place until 2006, then lapsed until industry lobbyists made sure it was proposed again last year, despite heavy criticism from Democrats and drug industry critics. And now, conveniently one week before the Bush administration draws its final, sputtering breath, the rule has made its way back into the final FDA guidelines.
Big pharma spokespeople pooh pooh the reg as nothing more than a formality: “Physicians need timely access to the latest medical information to keep abreast of the best practices in patient care,” said Alan Bennett, an attorney representing the pharmaceutical industry.
It’s true that these journal articles are required to be peer-reviewed—though whether that means anything remains to be seen:
The reliability of medical journal articles came into question earlier this year when drugmaker Merck & Co. Inc. was accused of ghostwriting several articles about its painkiller Vioxx, which was withdrawn from the market in 2004 for safety reasons.
Reports published in the Journal of the American Medical Association alleged that Merck paid academics to take credit for articles which were actually written by the company. Merck denied the allegations, calling them false and misleading.
For every one step forward, two steps back.
Related:
RB: Bye Bye Freebies! Drug Companies Ax Free Goodies to Doctors
RB: Is Nothing Sacred? Nobel Prize Engulfed in Drug Company Scandal
RB: Clinic to Reveal All Doctor-Drug Industry Ties on the Web
January 15th, 2009 at 5:37 pm
So the pharmaceutical companies shouldn’t be allowed to report studies to doctors showing that aspirin, though a marketed pain reliever, also works to prevent heart attacks as a non-conventional therapy?
Assuming there are actual legitimate studies showing the efficacy of the alternative uses for the drugs, I see no problem with this, it just makes fiscal sense if you can get a doctor to sell your drug for multiple uses.
Of course, I am naive and assume that some university research isn’t done with an ulterior motive.
January 15th, 2009 at 7:32 pm
Assuming there are actual legitimate studies showing the efficacy of the alternative uses for the drugs, I see no problem with this, it just makes fiscal sense if you can get a doctor to sell your drug for multiple uses.
The problem is that they could, for instance, create a pill for the temporary relief of symptom A, write a paper showing its effectiveness for problem B, then market it as a sustained regimin for problem B without doing the long-term studies on patient wellbeing.
That is a HELL of a loophole, and on e that could very easily get people killed.
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