GAITHERSBURG, Md. (Reuters) - Procter & Gamble's skin patch to boost sex
drive in women may pose serious long-term risks and should not be approved
without further study, critics told a U.S. advisory panel on Thursday.
Proponents hope the patch called Intrinsa will prove to be a counterpart to
Pfizer Inc.'s popular male impotence pill Viagra. No medicines are U.S.-approved
for treating sexual problems of women.
P&G's patch delivers a steady dose of testosterone, one of the hormones
that spurs sexual desire. Opponents said they were worried months or years of
testosterone therapy, which was studied in combination with estrogen, may be
dangerous.
The hormones estrogen and progestin were prescribed to women for years as
hormone replacement therapy (HRT) following menopause before risks of heart
disease and breast cancer came to light.
Studies of Intrinsa so far are "grossly inadequate to assess the risk of
extended treatment. I hope we don't have to go through another HRT scandal to
learn this again," said Leonore Tiefer, a New York University School of Medicine
psychologist.
The advisory panel, a group of experts from outside the U.S. Food and Drug
Administration, is expected to vote later Thursday on whether to recommend
approval for Intrinsa. The FDA usually follows the advice of its panels.
P&G said its research showed Intrinsa helped women who were distressed by
a lack of sexual desire and produced no serious side effects during 24-week
trials. The company has proposed studying Intrinsa's safety for five years after
approval.
"We feel very strongly the efficacy and safety data are adequate to support
approval," Joan Meyer, P&G's senior director for new drug development, told
the panel.
Roslyn Washington, who was treated with Intrinsa in clinical trials, said low
libido had left her feeling "frustration and a sense of inadequacy."
Intrinsa produced "a noticeable increase in my libido, and I would like to
experience those feelings again," she said.
P&G studied about 1,000 women who said they were bothered by low sex
drive and, on average, reported three satisfying sexual experiences per month.
The number increased to five for women who were treated with Intrinsa, but also
rose to four for women given a dummy patch.
"Is an increase in approximately one sexually satisfying encounter a month
... worth the possibility of an increase in breast cancer or coronary artery
disease?" asked Dr. Sidney Wolfe, head of Public Citizen's Health Research
Group. He urged the FDA panel to reject the drug.
The FDA is under fire for paying scant attention to the safety risks of some
drugs and is expected to closely consider potential risks of Intrinsa.
FDA staff reviewers said they were concerned the manufacturer's proposed
five-year study would be inadequate to find serious risks.
P&G is aiming initially at a narrow group of about 2 million women who
have undergone removal of their ovaries, the source of half the body's
testosterone, and are bothered by a lack of sexual desire.
Some critics worry the company will launch a flashy advertising campaign that
will interest many more women.
Shares of Cincinnati-based P&G, maker of consumer products including Tide
detergent and Crest toothpaste, were up 78 cents, or 1.43 percent at $55.44 on
the New York Stock Exchange.