Panel to Review Drug for Low Female Sex Drive

December 2, 2004

(Knowing the life-threatening disaster that was hormone replacement therapy,

we are about to walk right into another one. Funny, like 'urinary

incontinence' and the ssris prescribed for that 'disorder,' I was once again

unaware that post-menopausal women were clamoring for sex drive enhancing

drugs! Who knew! Clearly this is a public health priority! More deserving

of research and development and marketing and 'public awareness' campiagns

for...real diseases? Like AIDS, heart disease, basic health and dental

care, prenatal care, etc. These creeps! On the one hand, we have 100

million in tax dollars spent of deadly 'abstinence only' programs, and on

the other there is millions being spent so more and more people can have

more and more sex! This country would rather you die of AIDS than learn to

wear a condom, then brainwashes you with sexual imagery everywhere you turn

, even framing the normal process of againg as a sexual issue with--guess

what--a product to sell you! They say HIV is RAMPANT in the retirement

communities of South Florida in the over-50 age group. In Broward, Dade,

etc. the numbers were 1 in 6 over 50 are HIV positive. I'm for one am

sickened that teenagers cannot get even basic health education, yet drug

companies are pushing this garbage. This is not medicine.)

http://www.nytimes.com/2004/12/02/health/02patch.html?hp & ex=1102050000 & en=802285\

d5f286d61b & ei=5094 & partner=homepage

Panel to Review Drug for Low Female Sex Drive

By ANDREW POLLACK

Published: December 2, 2004

Procter & Gamble

Procter and Gamble's Intrinsa patch, which is worn on the abdomen, delivers

a steady stream of testosterone.

Men have Viagra and other pills to fight sexual impotence. Now women might

soon have something roughly equivalent.

Procter & Gamble will try today to persuade a federal advisory panel to

recommend approval of the first drug to increase a woman's sex drive.

The company plans to tell the committee, which advises the Food and Drug

Administration, that the drug Intrinsa increases the sexual desire of women

and the frequency with which they have " satisfying " sex. Some experts say

approval of Intrinsa would bring a new era in the handling of women's sexual

problems.

" It's a big breakthrough in acknowledging there are medical aspects to

sexual dysfunction in women, " said R. Berman, director of the

Female Sexual Medicine Center at the University of California, Los Angeles,

and a consultant to Procter & Gamble. " It's not all in our heads. "

But Intrinsa might not sail smoothly toward a positive recommendation from

the advisory committee, which will meet in Gaithersburg, Md. The F.D.A.'s

own staff, in its review of the data, questioned whether the benefits of

Intrinsa were " clinically meaningful " because the drug increased the number

of times women had satisfying sex by only once a month compared with a

placebo.

In documents posted on the F.D.A. Web site yesterday along with the

company's data from clinical trials, the agency's reviewers also said they

had concerns about the long-term safety of the treatment, which consists of

the hormone testosterone.

Other hormone therapies, involving estrogen and progestin, were widely used

in the past by women after menopause, but were later found to raise the risk

of heart attacks, strokes and breast cancer, they wrote. Intrinsa has been

studied for longer than a year only in a small number of women.

The F.D.A. staff often tends to be more critical of drugs than the advisory

panels, which are made up mostly of practicing physicians.

Elaine Plummer, a spokeswoman for Procter & Gamble, said the company was

" prepared to address those questions " at the meeting.

The shares of Procter & Gamble gained $1.18 yesterday, to close at $54.66.

Part of that run-up could be a result of positive economic news about

consumer spending that spurred strong gains in the overall stock market.

Intrinsa, which Procter & Gamble developed with Pharmaceuticals,

involves a patch, worn on the abdomen, that delivers a steady stream of

testosterone. While that hormone is usually associated with men, women also

make lesser amounts of it and it helps stimulate sexual desire. Some women

already use testosterone products approved for men, but those products

contain far too much testosterone for women, experts said.

Women produce about half their testosterone in their ovaries, so Procter &

Gamble is initially seeking F.D.A. approval for Intrinsa as a treatment for

women who have had their ovaries removed. It said that 17 to 30 percent of

the 10 million women who have undergone such surgery have " hypoactive sexual

desire disorder, " meaning low sex drive that they find distressing.

But the company is also testing the drug in women who undergo natural

menopause.

In clinical trials, women who used Intrinsa had an increase in the number of

" satisfying episodes " of sex to five a month, from three. But women who

received the placebo also had an increase - to four a month, from three. The

definition of satisfying sex was left to the women, who kept log books

during the clinical trials.

Some experts say they worry that Intrinsa will be used as a means of

enhancing sex by women who are not post-menopausal or do not suffer from

hypoactive sexual desire disorder.

" The off-label uses of this is obviously where they are heading, " said

Leonore Tiefer, a psychologist and sex therapist at New York University.

While Viagra is also misused, she said, it is taken occasionally while the

Intrinsa patch would be worn continuously, posing more possible risk from

side effects.

Dr. Tiefer said she did not believe that " hypoactive sexual desire disorder "

was even a condition that could be treated with drugs. " There's an endless

number of reasons that people can lose their sexual desire " she said.

Intrinsa, she added, is a " not-well-understood drug for a

not-well-understood condition. "

But Sheryl A. Kingsberg, a psychologist at Case Western Reserve Medical

School, disagreed.

" This is not a manmade disorder to create a market, " said Dr. Kingsberg, who

was an investigator in the Intrinsa clinical trials and is paid by Procter &

Gamble to educate physicians about sexual dysfunction. " Women come into my

office every day complaining they've lost sexual desire and they want it

back. "

While Intrinsa is sometimes popularly called the " female Viagra " it is not

really equivalent. Viagra deals with a physiologic problem involved in

arousal while Intrinsa is meant to restore desire.

" Desire was not the problem for men - erections were, " said Dr. Kingsberg.

" For women, desire really is the problem. " Indeed, Pfizer, which makes

Viagra, gave up trying to broaden the drug's use to women this year, saying

it did not work.

But Intrinsa and other drugs for women are like Viagra in that manufacturers

hope they will attain big sales. Viagra had sales of $1.9 billion worldwide

last year and analysts estimate sales of Intrinsa will be several hundred

million dollars a year.

About 10 companies now developing drugs for female sexual dysfunction,

whether other forms of testosterone like gels and sprays, or other drugs.

They include small companies like BioSante, Cellegy, and Vivus. But Procter

& Gamble appears to have at least an 18-month lead.

Procter & Gamble has said it wants to expand more into prescription drugs,

which carry higher profit margins than products like Tide detergent, Crest

toothpaste and Pampers diapers.

Prescription drugs last year accounted for $1.67 billion of the company's

$51.4 billion in revenue, a spokesman said. The company currently sells

seven prescription drugs, according to its Web site, with the biggest seller

being Actonel, for osteoporosis. It also sells over-the-counter medicines,

including Prilosec for heartburn.

December 2, 2004