Direct to Consumer Advertising: Free Speech or Costly Consequences?

An article by Miriam Shuchman, M.D. in the New England Journal of Medicine to be published in Perspective section of the May 31,2007 issue but available now on the the NEJM website [note: may not be available without subscription] explains why it is unlikely that any regulations or laws to stop direct to consumer advertising would survive court review in terms of the Constitution free speech clause As long as the FDA approves the drug for use, public advertising cannot be suppressed. The issue and the consequences is reflected in today’s news about the heart attack risk with the popular diabetic drug Avandia. The long-term benefits and long-term risks are unknown at the time of FDA approval and there is no energetic but only casual attempts to obtain information regarding the long-term benefits and risks after the drug is released to the general public.

Examples of delayed disclosures of risks with subsequent removal from the market after extensive direct to consumer advertising and use are numerous and in recent times included the classic example of Vioxx. The New England Journal of Medicine article gives another example; the case of Zelnorm and how the suggestive direct to consumer TV advertising simply put more individuals at risk. Here is an extract:

“In February, Novartis submitted a review to the FDA that pooled data from 29 clinical trials of Zelnorm (tegaserod), its drug for women with irritable bowel syndrome. The company's analysis showed that among patients treated with the drug, 0.1% had a heart attack, a stroke, or severe chest pain, and one patient died, whereas the rate among patients taking a placebo was 0.01%, and none died. Though the drug has been on the market for more than 4 years, the FDA withdrew it this past March because it didn't consider the drug's benefits sufficient to justify exposing patients to even low risks of a cardiac event. By that time, Zelnorm had become a popular treatment for irritable bowel syndrome despite having limited effectiveness. Why? Perhaps its success had something to do with its highly visible television ad campaign: attractive young women pulled up their shirts to reveal their bellies inscribed with the slogan ‘I feel better.’ Although the drug was only 5 to 10% more effective than placebo for women and was not shown to work at all for men, the belly-baring ad seems to have worked wonders: U.S. doctors wrote 2.1 million prescriptions for Zelnorm in 2005.”

Free speech is one thing but, similar to calling “fire” in a crowded theater when there is no fire, calling a drug as safe and effective in the media when there has been no proof of its safety and efficacy in long term studies is in my opinion speech that is not free to be expressed and not in the best interest of those who hear the speech. ..Maurice.