I hope the FDA stops this drug approval process in its tracks. The birth control pill was something women needed. This one they don't. Making up a malady where one does not exist, is the game the pharmaceutical companies like to play. But will the FDA go along? Will women?
Ever since Viagra met blockbuster success in 1998, the drug industry has sought a similar pill for women.
Now, a German drug giant says it has stumbled upon such a pill and is trying to persuade the Food and Drug Administration that its drug can help restore a depressed female sex drive. The effort has set off a debate over what constitutes a normal range of sexual desire among women, with critics saying the company is trying to turn a low libido into a medical pathology. ...
There is no dispute that some women have a depressed level of sexual desire that causes them anguish. Boehringer cites a condition — hypoactive sexual desire disorder — that is included in the Diagnostic and Statistical Manual of Mental Disorders, a reference book for psychiatrists and insurers.
But many experts say that unlike sexual dysfunction in men — which has an obvious physical component — sexual problems in women are much harder to diagnose. And among doctors and researchers, there is serious medical debate over whether female sexual problems are treatable with drugs. Some doctors advocate psychotherapy or counseling, while others have prescribed hormonal drugs approved for other uses.
There is also debate over how widespread hypoactive sexual desire disorder actually is among women. The medical literature, including articles in the prestigious New England Journal of Medicine, indicate numbers above 10 percent, but such studies have been financed by drug companies.
Critics say Boehringer’s market campaign exaggerates the prevalence of the condition and could create anxiety among women, making them think they have a condition that requires medical treatment.
“This is really a classic case of disease branding,” said Dr. Adriane Fugh-Berman, an associate professor at Georgetown University’s medical school who researches drug marketing and has studied the campaign. “The messages are aimed at medicalizing normal conditions, and also preying on the insecurity of both the clinician and the patient.”