Ever since Viagra met blockbuster success in 1998, the drug industry
has sought a similar pill for women.
Now, a German drug giant says it
has stumbled upon such a pill and is trying to persuade the U.S. Food and Drug
Administration that its drug can help restore a depressed female sex drive. The
effort has set off a debate over what constitutes a normal range of sexual
desire among women, with critics saying the company is trying to turn a low
libido into a medical pathology.
On June 16, an FDA staff report
recommended against approving the drug, saying the maker, Boehringer Ingelheim,
had not made its case and that the benefits of the daily pill did not outweigh
its side effects, which included dizziness, nausea and fatigue.
That staff report came ahead of a
meeting by an FDA advisory panel of experts who are to vote on whether to
recommend that the agency approve the pill, which would be the first drug aimed
specifically at a low sex drive in premenopausal women.
FDA staff reports carry weight but
do not always sway how advisory panels vote, and advisory votes do not always
predict what the FDA might finally decide.
Some analysts forecast that if the
drug does reach the market, it could have annual sales in this country of $2
billion – or about equal to the current combined annual U.S. sales of the men’s
drugs Viagra, Levitra and Cialis.
In the past month, Boehringer has
been trying to lay the consumer groundwork with a promotional campaign about
women’s low libido, including a website, a Twitter feed, a Discovery Channel
documentary and a publicity tour by Lisa Rinna, a soap opera star and former
Playboy model, who describes herself as someone who has suffered from a
disorder that Boehringer refers to as a form of “female sexual dysfunction.”
There is no dispute that some women
have a depressed level of sexual desire that causes them anguish. Boehringer
cites a condition – hypoactive sexual desire disorder – that is included in the
Diagnostic and Statistical Manual of Mental Disorders, a reference book for
psychiatrists and insurers.
But many experts say that unlike
sexual dysfunction in men – which has an obvious physical component – sexual
problems in women are much harder to diagnose. And among doctors and
researchers, there is serious medical debate over whether female sexual
problems are treatable with drugs. Some doctors advocate psychotherapy or
counselling, while others have prescribed hormonal drugs approved for other
“It’s a dicey, difficult problem,”
says Dr. Jeffrey T. Jensen, a medical professor and director of Women’s Health
Research Unit at the Oregon Health Sciences University.
Critics say Boehringer’s market
campaign exaggerates the prevalence of the condition and could create anxiety
among women, making them think they have a condition that requires medical
“This is really a classic case of
disease branding,” said Adriane Fugh-Berman, an associate professor at
Georgetown University’s medical school who researches drug marketing and has
studied the campaign. “The messages are aimed at medicalizing normal conditions
and also preying on the insecurity of both the clinician and the patient.”
Boehringer developed the drug,
flibanserin, as an antidepressant, but it failed to lift depression. The company
says it learned serendipitously that the pill, taken daily for weeks, could
restore female libido.
Peter J. Piliero, Boehringer’s
director of medical affairs in the United States, says the lack of libido to
the point of distress is a serious problem for some women.
“This is a real disease,” Piliero
said in an interview. “There’s an unmet medical need among premenopausal women
to have a treatment.”
Boehringer says the drug reduces
the brain chemical serotonin, which can blunt sexual desire, and increases
dopamine and norepinephrin, which improve desire, he said. By acting on a
woman’s brain, it takes a different approach from hormonal drugs or the action
of Viagra for men, which increases blood flow.
Boehringer’s application for FDA
approval said that its two key 24-month studies, of 1,323 premenopausal women
who said they suffered distress over lack of libido, had found small but
statistically significant improvements. The FDA staff report, though, said that
Boehringer’s data had not sufficiently demonstrated a second criteria the
agency had set for approving such a drug – specifically, that women also report
an increased level of sexual desire. The FDA required daily self-reporting by
the women in the studies; Boehringer said it had provided monthly reports.
Leonore Tiefer a psychologist and
professor at New York University who has researched the topic of female sexual
desire for more than a decade and plans to testify to the FDA panel, said
Boehringer had gone too far with its publicity effort.
She said that if the drug were
approved, she worried that “the much larger group of women without any medical
reason for their sexual distress will inevitably be misinformed and misled into
thinking that there is a pill that can get them the sex life they read about,
the one they think everyone else is having.”