WASHINGTON — (CNN) A new review of the “little pink pill” for women with low sexual desire says the drug doesn’t work very well — but some doctors and patients who’ve been using the treatment disagree.
The drug, Addyi, or flibanserin, has been on the market since October.
“The data presented in this review suggests that the meaningful change caused by flibanserin is minimal,” according to the team of Dutch researchers.
The researchers looked at eight studies on Addyi that together included nearly 6,000 women. They said for women using the drug, the number of additional “satisfying sexual events” averaged out to about 0.5 per month, or on average, in six additional “satisfying sexual events” per year.
The agency asked Sprout Pharmaceuticals, which makes Addyi, to do more studies on the interaction between Addyi and alcohol.
An editorial accompanying the article, published in JAMA Internal Medicine, questioned the FDA’s approval of the drug. “The FDA approved a marginally effective drug for a non-life-threatening condition in the face of substantial — and unnecessary — uncertainty about its dangers,” wrote Dr. Steven Woloshin and Dr. Lisa Schwartz at the Center for Medicine and the Media at the Dartmouth Institute for Health Policy and Clinical Practice.
The researchers said the drug had significant known side effects, such as dizziness, sleepiness, and nausea.
The FDA approved Addyi last August with a “black box warning” to highlight the risks of severe low blood pressure and fainting when patients drink alcohol, take certain drugs, or have liver problems.
‘I was amazed’
Some doctors and patients who’ve been using Addyi say the drug has been helpful. There are no other FDA-approved treatments for women suffering from low sexual desire.
Dr. Lauren Streicher, medical director of the Center for Sexual Medicine at Northwestern Memorial Hospital in Chicago, said the results cited in the Dutch study are averages, and while Addyi doesn’t work for everyone, many of her patients have benefited from it.
She says she’s written Addyi prescriptions for about 10 women, and three or four have emailed her back to say it’s worked. “They say, ‘Oh my God, this has changed my life. Things are wonderful,’” Streicher said.
Jodi Cole, a 33-year-old stay-at-home mother from Porter, Oklahoma, said before she started taking Addyi, she didn’t want to have sex with her husband, Matt. “I love my husband and I believe God created emotional and sexual intimacy as key components of marriage. So we had sex, usually a couple of times a week. And while I was willing, part of me dreaded it. Every time,” Cole wrote in an email to CNN.
Cole said she started taking Addyi in November, and within six weeks felt a difference. “I was amazed,” she wrote. “I actually enjoyed being intimate and for the first time in a long time felt that connection with Matt.”
She said for her it wasn’t about increasing the quantity of sex she was having, but rather the quality. “What (Addyi) does is give just enough support so I can think about that part of our relationship with anticipation of pleasure rather than anxiety,” she wrote. She understands Addyi can have side effects, but said women should be able to choose to take it just as men choose to take Viagra despite its side effects.
“I should be able to choose whether the side effects are worth the benefit,” she wrote.
The controversy over Addyi
Seldom has one pill raised such controversy among medical professionals.
Doctors who treat women with low libidos tore apart the JAMA study. Streicher, an associate professor of clinical obstetrics and gynecology at the Northwestern University Feinberg School of Medicine, said the study drew “erroneous conclusions.”
The International Society for the Study of Women’s Sexual Health went even further, calling the study “a great disservice to the millions of pre-menopausal women suffering from (hypoactive sexual desire disorder).”
The doctors had several problems with the study’s methodology, including that three of the eight studies the Dutch researchers analyzed were not published. When studies are published, they go through a peer review process to assess whether the study methodology is sound.
One of those studies used a dosage of the drug that was half as high as what the FDA approved.
Dr. Loes Jasper, one of the authors of the Dutch analysis, said she and her colleagues removed the results from that study and still found that Addyi’s affects were minimal.
She said she and her colleagues included the results of the unpublished studies because sometimes negative studies of a drug don’t get published.
“We included all published and unpublished studies to capture a complete overview of the benefits and risks of flibanserin, without bias,” Jaspers wrote in an email to CNN.
According to the FDA, which looked at three clinical trials of Addyi that included about 2,400 women, about 10% more patients treated with Addyi reported meaningful improvements in satisfying sexual events, sexual desire, or reduced distress compared to women taking a placebo.
In their editorial, Woloshine and Schwartz said Sprout and others put pressure on FDA to approve the drug.
“While it is unclear how strongly politics influenced the decision, it is clear that the science was weak,” they wrote. “We all need a drug approval process that delivers good decisions based on adequate evidence.”
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