Florida dermatologist Dr. Leslie Baumann, who was the lead investigator on clinical trials of Dysport, an antiwrinkle treatment that was approved by the FDA last April, has received a warning from that agency for remarks she made to the media about the drug before it was approved. Pharmaceutical companies are not permitted to promote the use of a drug before the FDA approves it (and they are not allowed to promote it for uses other than those approved by the FDA, even after approval is obtained), and that includes the doctors who run their trials, even if those doctors aren’t directly employed by the drug company.

Does anyone else notice how ASININE that is?

Who in hell would know more about how good a drug is than the chief investigator of the clinical trial? Dr. Baumann has direct experience with the drug, which is more than any government paper-pusher can say.

The New York Times paraphrases Thomas W. Abrams, head of DDMAC (the division of the FDA that monitors drug advertising and marketing):
But an investigator should not promote any unapproved prescription drug — or an unapproved use of an already approved drug — as being safe or effective if the agency has not yet deemed it to be so, he said.Right. Because the opinion of someone who has seen firsthand what the drug can do doesn’t count, but the opinion of bureaucrats who have never worked with the drug does.

The Supreme Court may have given us a victory for freedom of speech last month, but let’s not forget how the muzzle on talking about drugs is getting tighter and tighter. Doctors and pharmaceutical companies have just as much right to speak freely about drugs as unions and corporations have to speak about politics.

reasonpharm.blogspot.com