[NYTr] EU's Hormone Patch Stirs Uneasy Debate in US

[All the News That Doesn't Fit]

Womens eNews - Sep 10, 2007
http://www.womensenews.org


EU's Testosterone Patch for Women Stirs Uneasy Debate in US

By Frances C. Whittelsey - WeNews correspondent

(WOMENSENEWS)--The arrival on the European market of a female-targeted
testosterone patch to treat low sex desire caused by menopause is
raising new questions in the United States about why there is no
equivalent product on pharmacy shelves. Opponents say that there is
good reason why, and the patch is not ready for U.S. approval.

The European Medicines Agency--the European Union's equivalent of the
U.S. Food and Drug Administration--approved sales of Procter and
Gamble's Intrinsa testosterone patch last year, and it went on sale
this spring. The patch is intended for women distressed by low sexual
desire after surgical removal of their ovaries and uterus.

Three years ago, the FDA turned down Procter and Gamble's application
for U.S. approval of Intrinsa because of inadequate safety data while
also concluding that it was effective. Instead U.S. women who want
testosterone rely on products for men or creams specially mixed by
pharmacists.

Cincinnati-based Procter and Gamble estimates that 15 to 20 percent of
prescriptions written for men's testosterone products are used by women.

About 621,000 U.S. women a year undergo hysterectomies, more than any
other country, most often to remove uterine fibroids (benign tumors) or
because of endometriosis, which causes tissue to grow outside the
uterine lining. Of U.S. women alive today, 22 million have undergone a
hysterectomy and about 75 percent lost their ovaries along with their
wombs.

Removal of the ovaries means plunging immediately into menopause. These
women, plus those in natural menopause, represent a potential
testosterone market of billions of dollars. By age 60, 1 in 3 U.S.
women will have had a hysterectomy.

Testosterone in women, as in men, stimulates sexual desire and affects
the level of sexual pleasure besides contributing to muscle and bone
mass and general good health. Half a woman's testosterone is lost if
her ovaries are removed (the other half is produced by the adrenal
glands); natural menopause gradually decreases testosterone levels by
one-third. Estrogen supplements suppress the effects of the remaining
testosterone, a side effect that has long been downplayed.

'Medicalization of Menopause'

The testosterone patch is now for sale in England, Germany, France and
Italy, but

Leonore Tiefer, a critic of what she calls the "medicalization of
sexual desire and menopause" opposes the product. She and other critics
believe that the six-month clinical trials conducted by Procter and
Gamble are "inadequate to assess the risks of extended" treatment.

A sex therapist and clinical associate professor of psychiatry at New
York University, Tiefer relies on education and counseling to help
women improve their sexual desire and experiences. A member of FDA
advisory committees that recommend approval or rejection of new drugs,
Tiefer described the European approval process as less stringent than
the FDA's.

Because there are no long-term safety studies, the European drug agency
has required Procter and Gamble to label Intrinsa with a special
warning to that effect, and is monitoring use of the hormone.

Testosterone supplements for women are controversial not only because
of safety questions but also because sexual desire in women results
from a complex mix of physical, social and emotional factors.

Barbara Bartlik, a psychiatrist and sex therapist at Weill-Cornell
Medical Center in New York, said she is eager to see the patch approved
for the United States. "When patients who are low in testosterone get
supplemented, there's a world of difference. They have a spark of
interest back." That, she said, can encourage women to work on other
problems, such as relationship difficulties, that might be interfering
with their sex lives.

Testosterone also makes arousal and orgasm easier to achieve and more
satisfying, Bartlik said. She prescribes a trial of testosterone cream
that is compounded to order by pharmacists.

Not the 'Pink Viagra'

Some media reports have called the patch the new "pink Viagra," but the
company's studies have shown that to be a misnomer. In contrast to
Viagra, which can take effect in minutes, testosterone patch users take
weeks before experiencing an uptick in sexual interest.

Two clinical trials conducted by Procter and Gamble involving about
1,000 women over six months also found that Intrinsa's libido effect
was fairly subtle, with users reporting one more sexual experience per
week than before enrolling in the trial.

Of great interest to critics like Tiefer is the limited quantitative
sexual benefit for patch users, who reported just one additional
satisfying sexual experience a month than those who received a placebo
patch. Both groups were also helped by discussing their sexual problems
with physicians and often their partners.

Concerns over the safety of Intrinsa linger, especially in light of the
negative findings of the U.S. government's Women's Health Initiative in
regard to estrogen supplements. The women in the testosterone trials
were also receiving estrogen.

Dr. Johna Lucas, medical director for women's health at Procter and
Gamble, said the safety data submitted in the approved application to
the European Medicines Agency did not differ "materially" from the
information provided to the FDA.

A spokesperson for the company declined to say whether the company has
renewed its FDA application for approval.

Women's health advocates are adamant that longer-term studies are
needed before another hormone is approved for use.

"We'd be delighted if they (Procter and Gamble) would come back with
information about the testosterone patch that defined the risks," said
Cindy Pearson, executive director of the National Women's Health
Network, a nonprofit in Washington, D.C. "Define the risks, that's all
we're asking for."

Hysterectomies Supply Drug Market

Nora Coffey, is founder of the Philadelphia-based Hysterectomy
Educational Resources and Services Foundation, which provides public
education about the surgery. She would like to limit the testosterone
market by eliminating almost all hysterectomies because removal of the
uterus and ovaries is the equivalent of male castration. She believes
hysterectomies should be performed only on women with life-threatening
problems and not for symptoms like excessive menstrual bleeding.

Seventy-five percent of 930 hysterectomized women who completed a
questionnaire for the foundation reported "diminished or absent sexual
desire" and nearly 60 percent reported "diminished or absent orgasm."

"So what if you could take something (testosterone) that made you
desire sex," said Coffey, "but then what? You will not experience the
uterus and pelvis filling with blood and the uterine contractions that
occur during orgasm."

In July, the Journal of Sexual Medicine published an "add-on study" to
Procter and Gamble's original clinical trials of Intrinsa.

According to the study's lead author Sheryl Kingsberg, slightly more
than half the women said the increase in sexual activity of one
experience per week was meaningful and beneficial. Eighty percent said
they would like to continue treatment. Not every patch user responded
to the treatment, and those who did not said they would not want to
continue. The study was financed by Procter and Gamble.

Kingsberg believes the FDA should approve the patch. "We seem to have a
different standard for tolerating risk-benefit for women than men, and
risk-benefit for anything related to women's sexuality," she said.
"Women's sexuality is considered almost a life-style choice rather than
a health issue. Certainly the women thrown into menopause very young
and even women who go into menopause in their 50s, they are not so
ready to give up on their sexual lives."

[Author and journalist Frances Cerra Whittelsey writes about consumer
and women's issues and the environment from her home in Huntington Bay,
Long Island. She has previously written about testosterone deficiency
in the context of women's cancer treatment.]

For more information:

HERS Foundation: - http://hersfoundation.com

Leonore Tiefer's New View Campaign, Challenging the Medicalization of
Sex: - http://www.fsd-alert.org

Susan Rako Web site with testosterone deficiency symptoms: -
http://susanrako.com/testost.htm

Copyright 2007 Women's eNews.