| This thread has been locked, it will not receive new replies. |
|
Locked on 12/03/2004 11:53:54 AM PST by Admin Moderator, reason:
Under review. |
Posted on 12/03/2004 10:06:10 AM PST by JesseHousman
Federal health advisors said there is not enough data to ensure a hormone patch for female sexual dysfunction is safe for long-term use.
A much-touted patch designed to restore a woman's sex drive isn't ready to hit the market until more studies are done to determine the drug's safety, a federal advisory committee recommended Thursday.
''I think it's to everybody's good to wait a little bit,'' said Dr. Larry Lipshultz, a urologist and a member of the Food and Drug Administration's advisory committee for reproductive health drugs.
The panel, which voted unanimously for the postponement, said the study of 1,095 women was too small, and panel members questioned the promised benefit of the drug. Intrinsa, developed by Watson Pharmaceuticals Inc. and licensed to Procter & Gamble, was created for women made menopausal after their ovaries were surgically removed.
Intrinsa uses a skin patch to deliver testosterone, a hormone that menopausal women often lack and that boosts the sex drive.
Clinical trials found subjects given Intrinsa had satisfying sex an average of once more every four weeks than did those given a placebo.
''I don't want to expose several million American women to heart disease and stroke in order to have one more sexual experience a month,'' said committee consultant Dr. Steven Nissen, a cardiologist.
The panel's decision isn't a disapproval of Intrinsa but a recommendation to the FDA to reject the drug when the agency makes its decision later this month.
The Women's Health Initiative, a program established by the National Institutes of Health, found that postmenopausal women taking the hormones estrogen and progestin had higher risks of heart attack, stroke and breast cancer.
Reaction to the decision was swift.
''Oh my God! I am so surprised,'' said Dr. Marc Gittelman of The Miami Center for Sexual Health. Gittelman had been involved in some of the clinical trials and touted Intrinsa as ``a huge breakthrough . . . in addressing women's problems with sexual health.''
Its adverse effects, he said, were minimal, citing oily skin, potential acne and a deepening of the voice.
Barbara Brenner of San Francisco's Breast Cancer Action, however, was relieved with the decision.
''Cancers have been linked to hormone exposure; anytime someone says we need to treat some condition with hormones our antenna goes up,'' the education and advocacy organization's executive director said. ``Women who get testosterone, for whatever reason, have an increased risk of breast cancer reoccurence.''
Thursday, the panel heard testimony from three of four women who developed breast cancer during the clinical trials were using Intrinsa. ''If there is any chance that that patch contributed to that outcome, and there is growing evidence it did, this is craziness,'' Brenner said.
Intrinsa, often referred to as ''female Viagra,'' works differently from the capsule given to men with erectile difficulties. Unlike Viagra, which increases blood flow to the penis to enhance a man's ability to have sex, Intrinsa increases a woman's desire for sex. Removal of ovaries can cause women's testosterone levels to drop by 50 percent.
Intrinsa is not designed to for use by women who are still capable of bearing children.
About 3 million women whose ovaries were removed would have been eligible to use the Intrinsa patch, said Procter & Gamble.
''The next step is to work closely with the FDA to provide additional safety data from the just about completed studies in naturally menopausal women,'' Proctor & Gamble's Tom Millikin said. `Although we are disappointed about the outcome we are pleased that they recognized the need for a treatment option for hypoactive sexual desire disorder in surgically menopausal women.''
Meanwhile, poor Bob sits at his Watergate apartment twiddling his "thumbs" while Lizzie takes the floor.
Men just don't want girls to have fun.
Whatever happened to good old fashioned Booze?
Sure we do. Give me your number.
So this is a legal date rape drug?
Patch? Patch? We don' need no stinkin' patch!
I believe there is a way for a woman to recieve testosterone from a man, but I am not going to give oration to that theory here, no way.
you can call me old fashioned - imo if women only worked p/t or not at all and paid more attention to home and children maybe the world would be a better place, women would not be sooooooooo stressed out effecting their libidos, men would be happy, homes would be clean, homecooked meals would be commonplace instead of a cardboard box or a paperbag surprise, kids would learn love and respect, etc. etc. etc. jmho!
Know what I mean?
Yeah. Years ago I used to ply all my dates with lots of booze. Then I'd fall asleep and they'd go home.
I don't know Sally.
My husband told me this patch was to help me quit smoking but all it does is make me horny as a toad.
HA!
I am halfway through year six of my honeymoon with RobRoys woman. 8^>
End of line...
I agree, escape. Jose Cuervo and a Barry White CD. Works every time...
Hey Honey....you always wanted a tatoo on your butt....try this neat little stick on tattoo patch....see how it looks.....yeah thats it......and here's another one...its a little bigger....
I think you should ask the women before you start making decisions for them.
I have this recurring nightmare about being accosted by Helen Thomas and Janet Reno in a dark alley, each holding a shotgun to my head. "Get it up," they say, "or you're dead."
This would mean Hillary would approach normal.
Had Lizzie stayed home and took proper care of old Bob there would be no need for Viagra.
Now all the old geezers in the nursing homes are getting this as prescribed medicines and they're driving the old widows crazy.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.