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Letter Regarding Lancet Ad

September 5, 1996

David Kessler, M.D., J.D.
Commissioner, Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Kessler:

Enclosed is an article I have written which will appear in the Lancet this Saturday, September 7th. It discusses the demeaning way, inside the drug industry, that physicians are viewed, brainwashed and conquered. By identifying the hippocampus as the "prescription-writing center of the brain", McAdam, advertising its marketing/mesmerizing skills to drug company marketing departments, offers to help sell drugs to doctors by brainwashing them into believing whatever drug is being advertised is superior.

As you know, there are two main remedies to these slick campaigns, aimed at causing doctors to make prescribing decisions that are frequently not based on an objective weighing of the benefits and risks of drugs. The first is to try to immunize physicians against these often false and misleading advertising campaigns by much more education--in medical school, residency and after--to build a foundation of scientifically- based knowledge for prescribing decisions. The second remedy, as mentioned in the article, is FDA enforcement to stop false and misleading advertising campaigns which you, yourself, have stated can result in "needless injury or even death".

That there are widespread violations of FDA drug advertising regulations is not only documented by outside reviewers, who previously found that in 92% of ads there were potential violations, but in current information we have obtained from the FDA. During FY 1995, the last full year for which there are data, the FDA sent 163 letters to drug companies, each concerning actual violations of FDA advertising law and regulations, most asking companies to immediately discontinue the advertising. There were usually several violations per letter and the drugs with violative advertising include widely prescribed drugs in this country. Examples include:

1/ Wellbutrin ( Burroughs Wellcome antidepressant): 12/94 FDA letter asking company to stop distributing false and/or misleading materials which do not give adequate balance to the well-documented risk of seizures (one "relatively obscure footnote") in comparison to 10 bulleted points about its effectiveness.

2/ Sporanox (Janssen antifungal drug): 5/95 FDA letter asking company to immediately discontinue use of journal ads which mislead doctors into thinking the drug is safer than it is by stating the drug has an "Excellent Safety Profile" although the drug carries a "significant box warning and adverse event profile."

3/ Felbatol (Wallace Labs anticonvulsant): 5/95 FDA letter stating that the company's "promotional Dear Doctor letter....fails to adequately communicate the risks associated with Felbatol therapy" [these risks include aplastic anemia and liver failure].

Since these ads are not required to be sent to the FDA before publication and since the FDA has limited resources to police these ads after they appear, the violations in these 163 letters are just the tip of a very dangerous iceberg. In addition to trying to recruit a larger FDA staff to work on this serious problem, I urge you to issue more official "warning letters." These letters, although asking companies to stop their ad campaigns were not, technically, warning letters. I also urge you, especially in cases of repeated violations, to use criminal prosecution to send the message that such violations are not acceptable.

I would be glad to meet with you and your staff to discuss this further.

Sincerely,

Sidney M. Wolfe, M.D.
Director, Public Citizen's Health Research Group

Attachments referred to in this document are available from Health Research Group

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