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.
Flowers and candy are a much more powerful combination than any drug.
I think decreasing drive in both men and women is God's way of saying, "You had your turn at bat, now go do something useful before you die."
Also, I sometimes wonder if there are some young wives of older men who don't find Viagra a terrible curse. They probably married old granpa money bags for the dough and now have to sleep with the bag of bones. Thanks to the li'l vanity pill, there's only one part of him that isn't wrinkled - well, some of the time.
Errr????? One of those hormones is testosterone.
You are really showing your ignorance. Really.
Not to mention, love and affection.
Exactly how?
Testosterone level is directly and irrefutably correlated
to the problems described...
Body builders who artificially increase the levels of testosterone sometimes reach a level that they cannot tolerate...and suffer rage attacks and sexual side effects.
This is all well known.
Some pedophiles can be helped by a single round of anti-androgens as it gives them a taste of what it is like to be free of the testosterone and it's disturbing effects on them.
This hormone is extremely powerful and has wide rangingeffects on the mind.... why is it so hard to believe that such a substance has bad side-effects in an unfortunate few??
There may be future side effects of testosterone supplementation but pedophilia is definitely not one of them. As far as rage goes most people are much more pleasant to be around when their T levels are NORMAL. Low or high levels can result in increased anger.
The benefits of supplementation on the quality of life are irrefutable. Better sleep, relief of sleep apnea (in some cases it worsens), more stable mood, improved stamina etc. Don't listen to a bunch of media hype or doctors with no experience in it. Listen to a doctor who actually actively practices it.
So... you are saying that testosterone has no relationship to sexual perversion? Really? None at all? Hmmmm...
So, you then believe that the same individual that somehow mysteriously becomes a dangerous sexual predator would have become one even if they had never been exposed to testosterone? This is preposterous :-)
Do you believe that someone just wakes up one day and says "I think I will (fill in whatever perversion you like here) today! maybe I will like it. again preposterous.
Are some people simply slated by fate to become perverts? Is it "written" that they will be so? Are they simply spawn of the devil? Are they dangerous perverts before puberty? (no) So when does fate step in and change them? hint: It's not fate, satan, or an evil nature...it's some people's inability to cope with testosterone.
Why do females represent only the tiniest fraction of sexual perverts?
Is it their devine "sugar and spice" nature?
Is it simply ordained by God that women are spared?
Or is it their generally low level of testosterone?
Tell me how applying a testosterone patch daily or even more than once a day (some will abuse this) is so different from male exposure to the same hormone?
Being an M.D. is no guarantee that one always knows what they are talking about.
If testosterone supplements can have no effect on pedophilia...then would prescribing testosterone to a known pedophile whose levels were dropping be a wise thing? Would you under any circumstances prescribe testosterone for such an individual? And if not, why not?
Please.. use a little logic here...testosterone is directly linked to pedophilia..to argue otherwise is simply silly in the extreme.
You really have to get a grip. GET A GRIP!!!! Taking testosterone will not turn a normal woman or man into a pedophile period. Any statement to the contrary is totally ludicrous - STUPID. A pedophile is a pedophile. A normal male or female doesn't want to diddle little boys or girls regardless of their testosterone level.
That point of view is plain wrong.
If testosterone supplements can have no effect on pedophilia...then would prescribing testosterone to a known pedophile whose levels were dropping be a wise thing?
Let's see do we want their sex drive increased when they diddle little children?? I think you can figure that one out!!
But the question is will Testosterone turn a normal man or woman into a pedophile? You say so without the least evidence. Show me one study where NORMAL men or women are turned into PEDOPHILES by testosterone supplementation and I will admit I am wrong. Otherwise admit you are wrong.
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.