‘Female Viagra’ Only Modestly Increases Sexual Satisfaction, Study Finds
Half of one satisfying sexual encounter a month. That is the average benefit a woman gets when she takes the new female libido drug, sometimes called the “female Viagra,” researchers reported Monday.
Last year the Food and Drug Administration approved the drug, flibanserin, making it the first drug available to treat low sexual desire in women. It was promoted by a group of women’s rights activists who argued it was unfair that men had numerous drugs to boost sexual function while women had nothing.
该药物名叫氟班色林(flibanserin)，去年获得了美国食品和药品监督管理局(Food and Drug Administration, F.D.A.)的批准，从而成为了第一种用于治疗女性性欲低下的药物。这是一群女权主义者大力敦促的结果。她们认为，男人们有好多药物可以促进性功能，而女人们却什么都没有，太不公平。
But public health groups and some other women’s groups contended that the science did not justify its approval. The drug’s effects were modest, they said, and not worth side effects such as sleepiness, dizziness, fatigue and nausea. And the risk of some side effects increased with alcohol consumption.
In the new study, published in JAMA Internal Medicine, researchers found benefits that were slightly more modest than those submitted to the F.D.A. during the approval process. The researchers analyzed eight studies of about 5,900 women, using a method that involved pooling the data. They concluded that treatment with flibanserin, now marketed as Addyi, resulted in “one-half of an additional sexually satisfying encounter per month.” (The study did not define what “one-half” of a sexually satisfying encounter was.)
在发表在《美国医学会期刊：内科学》杂志(JAMA Internal Medicine)上的一项新研究中，研究人员发现，该药物的效益比审批过程中提交给F.D.A.的材料中显示的略低。研究人员采用数据汇总等方法，分析了涉及5900名妇女的八项研究。他们的结论是：接受氟班色林（商品名为Addyi）治疗的女性“一个月里满意的性行为次数平均可以增加半次”（该研究并未给“半次”满意的性行为做出定义）。
That result was not very different from original findings of three clinical trials submitted to the F.D.A. as support for the drug’s approval. Those trials found that once women started taking the drug, they had an average of about one additional satisfying sexual encounter a month, on top of the two to three they were having already. That result lifted the benefits above the bar of being scientifically meaningful, but barely. Still, it was enough for the agency’s approval.
In a statement, Dr. Tage Ramakrishna, the chief medical officer at Valeant, the company that now owns the drug, said that the new analysis confirmed the findings of the clinical trials and “provided little additional context.” He said the way the analysis was done, combining data from a number of different studies, carried “less statistical weight” than the randomized trials .
The drug was approved last June, after twice being rejected by the agency over several years. In the clinical trial results submitted, women taking the drug also reported on monthly questionnaires that they felt more desire, although the difference compared with a placebo was also meager — only about 0.3 points on a scale ranging from 1.2 to 6.0.
Experts who had opposed the drug’s approval said the JAMA analysis, which confirmed that the drug increased the risk of dizziness, sleepiness, nausea and fatigue, underscored the meagerness of the benefit.
“An additional half a satisfying sexual encounter a month — is that meaningful?” asked Dr. Adriane Fugh-Berman, the director of PharmedOut, a project at Georgetown University that questions the influence of drug companies on the practice of medicine. “I think only the women can answer that, but perhaps they already have with their lack of enthusiasm for getting prescriptions.”
“一个月平均可增加半次满意的性行为——这有意义么？”安德莱内·傅柏曼(Adriane Fugh-Berman)博士问道，他在乔治城大学(Georgetown University)领导了PharmedOut项目，质疑制药公司对医疗实践的影响。“我认为这个问题只有妇女们自己才能回答，但或许她们的兴趣缺缺已经表明了她们的态度。”
The drug is not selling well. As of early January, Addyi was generating only 240 to 290 prescriptions a week, according to a report last week by David Maris, an analyst at Wells Fargo Securities, who cited the prescription tracker IMS Health as the source of the data. Mr. Maris estimated that sales of Addyi were running at a rate of $11 million a year, well below the $100 million to $150 million in sales that Valeant said it hoped to achieve this year.
这种药物并不畅销。上周富国银行集团(Wells Fargo Securities)的分析师戴维·马里斯(David Maris)在一份报告中指出，根据艾美仕市场研究公司(IMS Health)的处方跟踪数据，截至1月初，一周里只有240到290张Addyi的处方开出。马里斯先生估计，Addyi的年销售额约为每年1100万美元，远低于Valeant公司的预期——今年达到1亿至1亿5000万美元。
Still, some said the drug helped. Dr. Lauren Streicher, an associate clinical professor of obstetrics and gynecology at the Feinberg School of Medicine at Northwestern Memorial Hospital in Chicago, said a number of her patients have taken the drug and reported significant increases in libido. None has discontinued use because of side effects, she said.
不过，也有人说这种药有些用处。西北大学费恩柏格医学院（obstetrics and gynecology，位于芝加哥）的妇产科临床副教授劳伦·施特赖歇尔(Lauren Streicher)博士说，她的一部分患者在服药后报告性欲显著上升。她还说，没有人因副作用而停药。
The analysis was undertaken by researchers in Europe, but one of the study’s authors, Dr. Ellen Laan, an associate professor in the Department of Sexology and Psychosomatic Obstetrics and Gynecology at the Academic Medical Center at the University of Amsterdam, has been an opponent of the drug. Last year, she helped organize a letter to the F.D.A. opposing the approval and signed another letter to Congress that said the argument about gender equality was “misleading and dangerous.”
前述新分析由欧洲的研究人员完成，但该研究的作者之一，荷兰阿姆斯特丹大学(University of Amsterdam)学术医学中心(Academic Medical Center)的性学和心理妇产科系(Department of Sexology and Psychosomatic Obstetrics and Gynecology)副教授埃伦·拉恩(Ellen Laan)博士一直对该药物持反对态度。去年，她协助组织致函F.D.A.反对该药物通过审批，并在给国会(Congress)的另一封信上签名，表示那些声称该药物的审批关乎性别平等的论调“误导人心，十分危险”。