FDA Evaluation of Drugs Is Flawed, a Threat to the Public Health

The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 8 No. 1 • January 2005

FDA Evaluation of Drugs Is Flawed, a Threat to the Public Health

“Another concern regarding the FDA’s evaluation of experimental cancer therapeutics is that there is no specific distinction within the FDA for therapeutics aimed at acutely lethal versus chronic diseases. Thus, immunotherapies for chronic arthritis are evaluated alongside those for pancreatic cancer, which has a two-year mortality rate of over 97%. This lack of division based on disease severity can lead to an imbalance in risk-benefit judgments in regulating the development of novel approaches to treat lethal cancers.”1

  1. Pardoll and Allison. Cancer immunotherapy: breaking the barriers to harvest the crop. Nature Med 10(9):890 (2004).

Comment: One outcome of the risk-benefit imbalance mentioned above is the recent “discovery” that Vioxx® and other (e.g., Celebrex®) selective COX-2 inhibitors increase the risk of heart attacks. While used for the treatment of arthritis, COX-2 inhibitors are effective in the treatment of the many kinds of cancer in which COX-2 is upregulated and where the additional risk of heart attack may be acceptable when the risk of death from the cancer is greater than that from a heart attack. There was early evidence1 that selective COX-2 inhibitors, because they inhibit the COX-2-dependent manufacture of prostacyclin (PGI2), an important anticlotting factor, while not inhibiting the COX-1-dependent manufacture of thromboxane A2, an important proclotting factor, could pose an increased heart attack risk. The FDA should have realized this and gone slowly on approving selective COX-2 inhibitor drugs for chronic diseases, such as arthritis, or requiring more label warnings; the fact that they didn’t is a frightening example of the agency’s incompetence. (Just watch, though. The failure of the agency in recognizing the potential risks of the COX-2 class of drugs will be used by the FDA and its Commsymps as the basis for new demands for new FDA powers and a bigger budget. Only in government does massively lethal failure result in massive funding increases.)

  1. For example, see Cheng et al. Role of prostacyclin in the cardiovascular response to thromboxane A2. Science 296:539-41 (2002).

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