Proctor and Gamble sought allowance of post-marketing trials of the hormone patch Intrinsa, in order to bring the testosterone hormone to market where 3 million women who have had their ovaries removed would be P&G's primary buyers. However a FDA advisory panel, made up primarily of physicians, denied P&G's request citing concerns that in clinical trials cardiovascular safety issues weren't sufficiently tested. This is in part due to a not-for-profit organization's findings that postmenopausal women who take hormones are more likely to develop heart disease -- the number one killer of women in the U.S..
P&G apparently hasn't learned enough from Merck's recent Vioxx woes, if a medicine that turns out to be unsafe goes to market every personal injury lawyer in the nation will soon be filing lawsuits in every state of the nation. Although the potential profits of a drug that can cure sexual dysfunction are great, the potential losses from punitive damage awards could easily be more devastating than the benefits.
P&G needs to be patient and get a safe drug to market and enjoy the fruits with less risk of law suits and health problems for customers.
The article was found at: http://www.cnn.com/2004/HEALTH/conditions/12/03/sexual.disfunction.ap/index.html