‘Viagra for Women’ Is Backed by an F.D.A. Panel
By ANDREW POLLACK

After an intense lobbying campaign, a federal advisory panel recommended approval of what would become the first drug to treat a lack of sexual desire in women.

The move was immediately hailed by some women’s organizations as a step toward sexual equality by, in effect, giving women their counterpart to Viagra, the widely prescribed drug for male erectile dysfunction.

By a vote of 18-6, the advisory committee to the Food and Drug Administration favored approval of the drug, flibanserin, for women whose lack of sexual desire was not attributable to other causes such as disease or relationship troubles, providing that certain steps were taken to limit the risks of the drug. Doctors might be required, for instance, to inform patients of potential side effects — like low blood pressure, fainting, nausea and dizziness — and physicians might have to become certified to prescribe the drug.

The controversial campaign by some women’s groups to win federal approval was waged under the banner Even the Score, which accused the F.D.A. of gender bias because it had approved Viagra and other drugs to help men have sex while leaving women without options. The participants in the campaign had been brought together by a consultant to Sprout Pharmaceuticals, the developer of flibanserin.

That campaign, which packed the advisory committee meeting room with the drug’s supporters, in addition to some new data from clinical trials, apparently helped tip the balance for flibanserin, which has been rejected twice by the F.D.A. The first time, in 2010, came after a similar advisory committee had voted unanimously against approval.

Now the drug could be approved by Aug. 18, the F.D.A.’s deadline for making a decision. The agency usually follows the advice of its advisory committees. But Thursday’s vote was closer than the numbers indicate, making it less clear how the F.D.A. will respond. Several committee members said they voted “yes” with great misgivings because of the drug’s modest benefit and possible side effects.

“The unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product with strong limitations seems to be the right step at this point,” said Tobias Gerhard, a committee member and expert on drug safety at Rutgers University in New Jersey.

Susan Scanlan, chairwoman of the Even the Score coalition, hailed the vote, saying in a statement, “Today, we write a new chapter in the fight for equity in sexual health.” Groups in the coalition include the National Council of Women’s Organizations, Jewish Women International and Nurse Practitioners in Women’s Health.

But some other women’s groups and individuals have criticized Even the Score as a distasteful attempt to use women’s rights as a cover to get an undeserving drug approved.

“To approve this drug will set the worst kind of precedent — that companies that spend enough money can force the F.D.A. to approve useless or dangerous drugs,” Dr. Adriane Fugh-Berman of Georgetown University told the committee Thursday. She is the director of PharmedOut, a project that questions the influence of drug companies on the practice of medicine.

In his introductory remarks at the start of Thursday’s meeting, Dr. Hylton V. Joffe, director of the division of bone, reproductive and urologic products at the F.D.A., said the agency “firmly rejects” the accusations of gender bias. He said that no drugs had been approved for either men or women to treat loss of sexual desire. (Viagra treats erectile dysfunction, not low sexual desire.)

He said the agency recognized that there were people who would benefit from treatments for low desire. The question was whether the benefits of flibanserin, which the F.D.A. called “numerically small but statistically significant,” were meaningful enough, given the side effects.

Flibanserin, a pink pill taken once a day at bedtime, would be approved for premenopausal women suffering a lack of sexual desire that causes them distress. Sprout said Thursday that about 7 percent of premenopausal women have this condition, called hypoactive sexual desire disorder.

The drug works by influencing the level of certain chemicals in the brain such as serotonin and dopamine.

Three clinical trials testing flibanserin were consistent in their results. The women who took part were having an average of two to three of what they defined as “sexually satisfying events” per month when the studies began. Once they started taking the drug, the number of such events increased, but by only about one event per month more than for women in the trial who got a placebo.

Women getting flibanserin also reported on monthly questionnaires that they felt more desire, although the difference compared with a placebo was only about 0.3 points on a scale ranging from 1.2 to 6.0.

Michele Orza, the consumer representative on the committee, voted against approval, saying that women with low desire “deserve better.”

The side effects of most concern to the F.D.A. were low blood pressure and fainting. While these were rare in the clinical trials, they seemed to raise the risk of accidental injury, with one woman having a concussion when she fell.

Moreover, the risk of such side effects increased when the women drank alcohol or took certain other medications, like fluconazole, which is used to treat conditions like vaginal yeast infections, and birth control pills.

Sprout agreed not to advertise to consumers on television and radio for 18 months, so that there would not be a huge rush at first to use the drug.

Thursday’s meeting, at the F.D.A. campus in Silver Spring, Md., included nearly two hours of testimony from the public, an unusually large amount, with most speakers urging approval. Many were from organizations in the Even the Score coalition or doctors who treat sexual dysfunction. Their remarks were loudly applauded, as was the final vote in favor of approval.

Some women with low sexual desire told of how the condition affected their lives and threatened their marriages, and said they resented being told that their problems were not medical but were caused by relationship problems or their busy schedules.

“Today is my son’s first birthday, and I’m missing it because I am here desperately looking for help to recover what I have lost — a vital and beautiful part of my marriage,” said Katherine Campbell, whose travel expenses from Indiana were paid for by Sprout.

“Critics say the improvement might only be modest, but, oh, what I would give for even a modest improvement,” said Ms. Campbell, who has not tried flibanserin.

Supporters of the drug said that failure to approve it would discourage the pharmaceutical industry from pursuing treatments for female sexual disorder, and that lack of an approved medicine would only cause women to use other drugs off label or seek help from dubious supplements hawked on the Internet.

Several speakers opposed approval, saying the data had not changed much from when the drug was rejected. Dr. Fugh-Berman of PharmedOut called flibanserin “a mediocre aphrodisiac with scary side effects.” She said that the clinical trials were restricted to healthy women, but that if approved the drug would be used by a wider range of women, resulting in “an epidemic of adverse events.”

Sprout was formed by pharmaceutical industry veterans Cindy and Robert Whitehead, a married couple, to acquire flibanserin after the initial developer, Boehringer Ingelheim, gave up following the first F.D.A. rejection. The privately held company, based in Raleigh, N.C., has raised $50 million.

Asked why the drug looks poised for approval this time after being rejected twice before, Ms. Whitehead said it was a change in the conversation “really putting the patient voice at the center of it.”

首款女性威而鋼 上市露曙光

美國的一個顧問小組4日建議美國食品藥物管理局（FDA）核准綽號「女性威而鋼」的藥物flibanserin上市，理由是它有助於提升女性的性慾。

如果FDA核准，flibanserin將成為第一種用於促進女性性慾的上市藥物。FDA可不理會該小組的建議，但通常接受；FDA預定8月決定。

該小組表示，藥廠必須採取額外的風險控管措施，以確保醫師只對有需要的婦女開立這種處方藥，以及這些婦女知道可能必須承擔哪些風險。Flibanserin主要鎖定停經前的婦女，主要副作用包括噁心、暈眩與嗜睡。

代表FDA的專家克莉絲汀娜．張表示：「以數字而言，療效太小。」她並要求該小組審慎評估好處與風險的證據。她說，安全疑慮包括疲倦、嗜睡、暈倒、血壓偏低，以及可能與避孕藥、酒精產生不良的相互影響。

出席這項聽證的其他專家另提到，這種療法可能被濫用為「約會強暴藥物」。此外，在一項動物實驗中，flibanserin曾經導致乳癌的罹患率提高。

專家又說，擁有flibanserin 的美國萌芽製藥廠（Sprout Pharmaceuticals）必須向醫師說明它的潛在風險，同時進行後續研究。

FDA的專家表示，flibanserin的效果並不顯著，然而FDA有必要核准有助於解決女性性慾問題的藥物。印第安那大學金賽研究所的茱莉亞．海曼表示：「臨床實驗結果並不顯著。然而另一方面，如果臨床問題達到特定程度，即使不顯著的效果也可能產生相當的差別。」

Flibanserin最初由德國百靈佳殷格翰藥廠（Boehringer Ingelheim）研發，並曾分別於2010與2013年申請上市，但未獲核准。專家當時表示，如與安慰劑比較，flibanserin的效果並不顯著。該藥廠後來將flibanserin賣給萌芽製藥廠。

原文參照：
http://www.nytimes.com/2015/06/05/business/panel-backs-a-drug-to-increase-womens-sex-drive.html

2015-06-05．聯合晚報．A6．國際焦點．編譯陳世欽