Panel: Female sex patch needs more study: Voted not to recommend approval

[NewHampshireDem]

http://us.cnn.com/2004/HEALTH/12/02/female.patch.ap/index.html

WASHINGTON (AP) -- A hormone patch that works to restore a woman's sex drive should not be approved until additional studies to determine its risk, federal health advisers said Thursday.

The advisers said they were unimpressed with the number of women studied so far as well as the length of the studies.

Procter & Gamble hopes to market the testosterone patch Intrinsa to women whose ovaries have been removed and who have lost their libido. The company told the Food and Drug Administration advisory committee that the drug had not raised safety concerns in clinical trials, and it urged the panel not to delay approval of the first drug for female sexual dysfunction.

However, the advisory committee was unanimous in saying more safety data were needed.


<more>

[cindyw]

1. Good, women should not be taking testosterone.

Only a man would develop a drug that fixes female sex drive by giving them some of what men have. Lqack of sex drive is usually a sign of mental distress, disease or female hormonal imbalance.

[VegasWolf]

8. Actually testosterone is completely natural and necessary in

women, just as estrogen is in men. The bodies have
catalysts that convert it from one form to another.
Its just that relative amounts differ for the sexes.
Just as in men, women's testosterone levels decrease with age.

[Der Blaue Engel]

9. Actually, males do not have a monopoly on testosterone

Women naturally have testosterone as well, and when it's low, bye-bye sex drive.

Check out this article on why it's important for women:

http://www.usdoctor.com/testtwo.htm

I'm suspicious of this FDA ruling. Finally somebody comes up with an alternative for women amidst all this dick-prancing joy dancing over viagra, but for our own good, despite no evidence of harm, they think we should wait.

I could be wrong, but that's what this smacks of to me.

[cindyw]

15. Actually that is not really true. The levels of testosterone are so low in

women it really is not the cause of low sex drive. Women are much more affected by an imbalance of estrogen and progesterone. Viagra may cause unnaturally long erections, but it doesn't cause men's voices to rise or cause them to get moody. Testosterone in women, on the other hand, will cause women to grow a mustache, deepen their voices and broaden their backs. You think a woman has lost her sex drive now? Give her a mustache and broad back.

Put estrogen in Viagra and then call me and tell me to lead myself with more of a male hormone. I really believe that women should not take testosterone unless they are demonstrably low or they have a medical need for it in the dermatological area.

The birth control pill is a much more effective way to affect the libido of a woman. It may take some time to find the right pill, but not having more hair is worth it.

Let me add on edit that there is a reason a woman's libido changes during her cycle. The spike in hormones during the ovulation cycle is a good example of this. And as you may know there is more progesterone at this time. It happens again just before menstration when estrogen falls.

[Der Blaue Engel]

18. I think that's a bit simplistic

This patch was designed for women who have had their ovaries removed, not just for fluctuations in sex drive due to normal hormonal cycles. I think women deserve to have the same options as men. This certainly shouldn't be the only option, but I think we deserve the chance to make these determinations for ourselves.

While it's probably also true that the studies were inadequate, as that is always the pattern with medical/pharmaceutical studies and women, I still feel that the FDA is behaving in a rather paternalistic and moralistic way towards women with this decision. They couldn't get Viagra out there fast enough, despite the fact that there are some significant dangers involved with taking Viagra, and now many men use it recreationally because of its wide availability.

A friend of mine recently started taking testosterone for her non-existent sex drive, and she is now having the time of her life, finally able to enjoy sex after years of lack of physical response. And she is not growing excess hair or having a deepening of her voice. That requires significant levels of the hormone, as any FTM transexual will tell you. My transgendered friends would be overjoyed if it were so simple.

At any rate, the article I posted (http://www.usdoctor.com/testtwo.htm) was largely about post-menopausal women and hormone replacement; I've quoted a bit of it below.

(edited for mistyping "drug" for "hormone")

Excerpt from Testosterone Replacement for Women:

<<"Although women authors including Gail Sheehy and Susan Rako, M.D. have described this deficient testosterone state in women, almost no one talks about it and almost no one does anything about it," states Dr. Lichten. "When women are placed on hormonal therapy, whether birth control of estrogen replacement, their testosterone levels drop dramatically." As physicians, we must listen to our women patients, ask them questions about their sexuality and day-to-day ability to function, and replace testosterone whenever appropriate.

Testosterone is recognized as the hormone of desire: it makes muscles for boys and turns them into sexually functional men. But testosterone is very important to a woman, too. She produces increased amounts of this hormone in her puberty, because testosterone is the precursor to estrogen. Without testosterone, there would be no "woman."

However, physicians see more effects from testosterone deficiency as a woman approaches and enters menopause. The ovaries produce the majority of testosterone and estrogens. With the cessation of 80% of hormonal production, a peri- menopausal woman suffers from estrogen, progesterone and testosterone deficiency. The replacement of estrogen alone does not correct an absent sex drive, loss of muscle tone and general lack of mental get-up-and-go.>>

[cindyw]

20. My answer is not simplistic, I think women should be very careful when

they interrupt their natural hormonal balances with a hormone that natural occurs in low levels. Any post menopausal drug should be given in combination with other hormones. While you may be talking about post menopausal women, women pre-menopause would also take this drug. Young child bearing age women. Bad idea. As for your friend, give it time. Take it from someone who faced taking testosterone at young age. I assure you even cream can give you male features over time.

Not even mention the cancer risks when you introduce hormones into female bodies. The pill has been proven safe in pre-men opausal women. I have not seen the evendence that this is.

[Der Blaue Engel]

25. Anything applied wrongly will cause problems

But there are some very valid uses for this option, and I think it should be out there. Note also that they're talking about a patch, which leads me to suspect it wouldn't be constantly applied.

I also think it should be thoroughly tested, but the FDA is notorious for delaying approval on certain classes of pharmaceuticals and rushing others through, so this ruling gives me reason to believe that this treatment will face a long, uphill battle. Take RU486, for example.

And I'm not sure I followed your comment about taking a medication just because men don't want us to. First, I'm not saying all men are trying to keep this from us, I'm saying the FDA (which mostly likely is also comprised of women) has a bias. Nor would I ever take something just because some man said I couldn't. (Unless it was my dad! :evilgrin: )

[cindyw]

31. I guess I was just trying to say that while the FDA may be making

paternalistic and chauvinistic decisions when it comes to female drugs (sex drive, RU486) vs. Viagra..in this case I think they are right to not allow approval pending more tests.

[cindyw]

23. On the subject of the paternalistic attitude of the FDA I think this

While there may be some of this in the decision and it is not right for men to make decisions for a woman and her body, I also do not think that women should take a medicine just because men think they should not. In this case women should think harder about taking the hormone despite the chauvinistic attitude of the powers that be
.

[VegasWolf]

28. As you mentioned, testosterone normally occurs in women.

Here is a link for a study "Male Hormone Patch Helps Sexual Function in Certain Menopausal Women" published in WebMd. There are sources
in JAMA also.

http://my.webmd.com/content/article/86/99108.htm

[cindyw]

32. I can agree with post-menopausal women using this after further study,

but my feeling is that if it is anything like Viagra, it will not be mainly post-menopausal wome taking it. It will be women in their child bearing years and young women thinking that it is some enhancer. That is how viagra is billed. As an enhancer not a fix for impotence. I fear women thinking this is some safe form of Spanish Fly and losing fertility young or developing cancer. Or having some exhausted woman in her 30's with 2 kids think this patch will fix her marriage and having it get worse for her because now she has facial hair and feels less feminine.

[VegasWolf]

33. Hi Cindy, no the two are entirely different. Testosterone is a

naturally occuring hormone in all mammals as is estrogen.
Viagra is a drug containing sildenafil citrate which acts
to constrict the blood vessels of the penis. I think that
most doctors are very careful with hormone replacement
therapy. Higher doses of testerone must be monitored by
monthly drug tests. But for some post-menopausal women
it does seem to enhance the libido. It becomes a quality of life
issue between her and her doctor.

BTW: Viagra does not have many associated side effects other
than contra-indicated for people with heart issues due to
a sudden drop in blood pressure. Hormone replacement therapy
is much more compilcated.

edit: add BTW

[bobo4u]

35. I like women with broad backs and moustaches...

That's why I married an Italian.

:loveya:

[Piperay]

34. I agree

completely.

[NC_Nurse]

2. I'm surprised...

I thought we had to expedite the procreation of new cannon fodder for the RW fundie agenda.

Now, if they'll just make birth control more effective/safer/easier to use I might not think theyre all full of shit!

[MaineDem]

3. As long as Dad has his viagra that's all that matters

I'm all for making sure things are safe but there's something not quite sitting right with this one.

[NewHampshireDem]

4. That was my initial reaction ...

It seems to fit pretty well with the whole Viagra vs. The Pill insurance controversy. :shrug:

[BiggJawn]

30. My insurance doesn't pay for boner pills.

But they pay for HRT and birth control.
Probably won't pay for the patch if it ever gets approved.

Never occurred to the HR drones that screwing employees are HAPPY employees...

[rodeodance]

5. there were NO control randomized studies --the "gold standard" of good

medical research.

[PassingFair]

6. I believe you must first submit...

to the female circumcision.

I would hope that tests are as extensive (?) as they were for viagra. Whatever, I bet that insurance won't cover it. Last thing the patriarch wants is for the older women to get demanding.

[Malva Zebrina]

7. Wimins is dangerous when they have a sex drive

they are to be feared.

[Keirsey]

10. inadequate studies

To test whether a woman really has a low sex drive, they should pair her with a gorgeous, sexually-generous, younger man. ;)

[DS1]

11. Old white men fear their wives going outside the box for some fresh

hot nookie.

That's my vote on the matter anyway.

[proudbluestater]

12. Drug companies have become obsessed with SEX!

[private_ryan]

13. I'm no doctor but these hormonal things scare me

I wouldn't take estrogen and I wouldn't want my wife or girlfriend to take testosterone. Look what happened to Ann Coulter

[Psephos]

16. LOL n/t

[VegasWolf]

14. Amazing, anything to do with the feamle sex drive is verboten

by this wacko fundie admin, but anything that gets men going
is fine. Who are the men supposed to have sex with in their
minds?

[durablend]

24. Blow up doll...

Just like in real life.

Real women's purpose are for procreation only.

:crazy:

[JohnLocke]

26. What are you talking about?

The disapproved the drug because it was unsafe, not for ideological reasons. I'm surprised that Bush and Bush appointees didn't force the FDA to approve the drug - after all, that would mean millions for Bush's friends in the pharmaceutical industry.

:eyes:

[Stinky The Clown]

17. The real issue here is ......

.... some men want total control of women's bodies.

Have babies, no matter your choice ... and by gawd, thou shalt not enjoy the prep work!

[I Love Alaska]

19. My thoughts exactly!

[patcox2]

21. Fundies don't approve of women enjoying sex.

Or what? Is it political, or is it that there are too many risks from giving post menopausal women testosterone whcih should be explored first?

I wish the drug companies would spend more effort trying to cure killer diseases, and less trying to come up with lifestyle drugs.

[RememberTheCoup]

22. Geez, why are people assuming this is about religious fundamentalism?

Do you really think they are holding up this drug because they don't like the idea of women having sex? I don't have the medical background to comment on the safety of this med, but I do know that drug producers will naturally want to push their products to market as fast as possible and it is up to the FDA to make sure these products have been rigorously tested before that happens. If anything, I would think that under this administration, the testing requirements might become more lax. But it's not like everyone who works for the FDA is a Bushie. More likely they are career medical professionals just trying to do their job.

[Cessna Invesco Palin]

27. For the love of Jeebus.

Jesus fucking christ.

1) The drug has proven to be of questionable safety in P&G's own studies.

2) Perhaps you were asleep when the Vioxx news came out, but the FDA ain't exactly keen to approve drugs of questionable saftey at this particular point in time.

3) Historically, the FDA has gone too far in approving drugs (Vioxx, etc) before they're ready, regardless of their perceived links with feminism or any other -ism.

So please, go ahead and give some of this newfangled drug to your wife or girlfriend, and when she develops severe chronic health problems, you can praise jeebus that at least she's got her libido. While I'm at it, I could even reccomend a few gray-market herbal products that give the same benefits and damage. Quite frankly, it is the supporters of the approval of this drug who have injected their politics into the issue, rather than the other way around (for once.) So please, by all means, fight for the approval of drugs that have serious proven health risks. I thought this was what we were fighting, but I guess I'm not up on the latest ideological poop.

[VegasWolf]

29. They are just thinking "outside the box". Sorry, bad pun! n/t