Procter & Gamble
Procter and Gamble's Intrinsa patch, which is worn on the abdomen, delivers a steady stream of testosterone.
Posted on 12/02/2004 9:38:05 PM PST by neverdem
A federal advisory panel voted unanimously yesterday that the first drug to enhance the sex drive of women should not be approved because of a lack of information about its long-term safety.
Members of the committee said that the possible risks of the drug - a patch containing the hormone testosterone developed by Procter & Gamble - outweighed what some saw as only a modest benefit in increasing desire and the frequency of sex.
"I am not devaluing the importance of this symptom and its treatment," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and a panel member. "But I also don't want to expose several million American women to the risk of heart attack and stroke, with their devastating consequences, in order to have one more sexual experience per month."
The Food and Drug Administration, which convened the meeting, will have the final say on the hormone patch, which is called Intrinsa. But the agency usually follows the advice of its advisory panels, which are made up of outside experts.
The discussion at yesterday's meeting suggests that the agency may be turning more cautious about drug approvals after the recent withdrawal from the market of the widely used pain reliever Vioxx. Critics have said the agency has been lax about safety issues, like the risk of heart attacks and stroke from Vioxx.
Indeed, Intrinsa appears to have been rebuffed not by any known safety problems - the agency's staff review said the short-term effects of the drug "appear relatively benign" - but rather by its backers' inability to rule out possible long-term effects like breast cancer and heart problems.
The F.D.A. and many committee members said it was possible that testosterone therapy might have the same risk, including breast cancer and heart attacks, as therapies using the hormones estrogen and progestin.
The side effects of those hormone therapies were found in large clinical trials, but not until millions of women had used those drugs for years. Whether such risks exist for Intrinsa, they said, cannot be known because only a small number of women have used the patch for more than one year.
Procter & Gamble, known more for consumer products than for drugs, said in a statement after the meeting that it planned to work closely with the agency "on a practical approach to provide additional safety data."
The number of cases of sexual dysfunction in women has been estimated in the millions. As a result, the first successful drug for the disorder could become a big seller, as Viagra has been for male erectile dysfunction.
Procter & Gamble was seeking approval for Intrinsa in women who have had their ovaries removed. But it is also studying the drug for use in naturally menopausal women, a much larger potential market.
In clinical trials, the drug increased the number of sexual experiences the women characterized as satisfying to about five a month from three. Placebos increased the number to four a month. The drug also increased women's sexual desire and decreased their distress about their lack of desire, as measured by questionnaires.
The F.D.A. staff questioned whether the benefits were "clinically meaningful," but in Procter & Gamble's favor, the committee voted by a margin of 14 to 3 that they were.
In testimony to the committee, groups including the American Association of Clinical Endocrinologists and Hyster Sisters, a support group for women who have undergone hysterectomies, urged approval of the drug. They said low sexual desire is a serious problem that can damage a woman's self esteem, relationships and overall quality of life.
"Unless you have experienced the lack of sexual desire you cannot completely understand the feeling of frustration and the sense of inadequacy I have," said Roslyn Washington of Silver Spring, Md., who tried Intrinsa in a clinical trial.
But Public Citizen, a watchdog group, and Breast Cancer Action, a patient advocacy group, among others, argued that the drug was too risky to be approved, especially since it would probably be used widely by women of various ages.
Jonathan Tobert, a consultant who represented the pharmaceutical industry as a nonvoting member of the committee, said requiring a huge trial to rule out long-term risks would be impractical and set a precedent that would make it difficult for other drugs to be approved.
Procter & Gamble
Procter and Gamble's Intrinsa patch, which is worn on the abdomen, delivers a steady stream of testosterone.
For a minute there, I thought the wife participated in the study. But then I saw that the experience was already 3 times a month and realized that's way to high - at least that I know of.
Within limits, of course.
Yeah, well most likely some woman is going to take the drug, then complain about sexual harassmant when some guy hits on her.
It's just a steroid. The health drawbacks of steroids are well known.
Just what we need -- bald bearded women with increased sex drive. That's appealing.
Just tape a wallet on any man's chest.
Must...stuff...back...vomit...projectile...
Need a Helen Thomas pic?
Or diamonds
Heh! Too much of a good thing??
Women don't need this crap. What they do need is better care and monitoring of their hormones through proper testing of their levels as they approach menopause.
Okay let you off THIS time... can't be sure next time ;-)
FReepmail me if you want on or off my health and science ping list.
Between Vioxx and the SSRI antidepressants, the moral of the story for the FDA is twice burned, thrice shy.
At this rate, the FDA will make it even harder to get a drug to the market. Why is our government deciding which drugs each of us can chose to take? Whether it's Vioxx, SSRI's or sexual stimulants, each of us must do a cost/benefit analysis before taking any medication. In a free market, things would be very different. In a controlled economy, the government assumes the role of the authoritarian protector of its incapable citizens.
LOL
This testosterone patch for women is a really bad idea :-(
Testosterone has terrible side effects on a small percentage of people (male and female) who are exposed to it.
Rage,rape and pedophilia are just a few...
Women are NOT immune to these side effects.
Testosterone is both angel and devil.... it drives males to great feats and discoveries....but an unfortunate few are driven over the cliff.
Limited clinical trials of this patch on women have likely not hit upon someone who has had a bad reaction...but if millions start using these then I bet we see some strange things.
Testosterone patches for men is a good way to regulate hormone levels in someone who suffers from testosterones bad effects. But in order to do this the natural souce must be eliminated first...yup..that's right..ouch. But it would cure those who suffer from rage and uncontrollable sexual perversions while allowing for normal libido (at the right time)
Men who have a bad reaction to testosterone live their entire lives under the influence of a mind-altering drug that they cannot easily escape...this must be a nightmare existence :-(
It occurred to me treating women with testosterone might,in addition to the reported risks,increase the odds of having "sexually imbalanced" or gay offspring.
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.