The FDA is facing much controversy as it considers approval for a new drug promoted as a treatment for women with low sexual desire. Private investors have a $50 million bet riding as an FDA advisory committee considers whether to recommend approval of flibanserin (ADDYI), a Sprout Pharmaceuticals drug marketed to enhance sexual desire and decrease emotional distress in women with hypoactive sexual desire disorder (HSDD). The Food and Drug Administration’s PDUFA review date is set for August 18, 2015.
According to Forbes Magazine, “the drug has modest efficacy and a side effect profile whose clinical relevance has been debated. High responders to the drug have taken to writing pieces supporting the drug’s approval while critics of the pharmaceutical industry say that flibanserin is another example of profit-driven manufacturing of a questionable disorder.”
A slick and misleading “equal rights” campaign financed by the drug company was developed to influence the FDA decision, implying that the drug must be approved to give women the same right as men to have a libido enhancing drug. With approval appearing likely, the agency is about to risk the lives of millions of women by approving the dangerous new drug. Flibanserin (ADDYI) is a medicine designed to increase female sexual libido but which has shown questionable efficacy and serious adverse effects.
It’s been dubbed by proponents as the “female Viagra.” However, critics are calling it the “little pink problem,” since ADDYI’s own studies prove it doesn’t work and could kill you. Now, with the FDA’s final decision arriving, nearly 200 of the country’s top scientists are demanding that the FDA do its job and protect America’s women from this risky drug.
Dr. Jeanmarie Perrone said about the drug “The benefits are modest, maybe less than modest, but I think that puts it in company with other approved drugs, unfortunately.” This statement at an FDA advisory panel meeting in June resulted in chuckles, perhaps due to the panelists’ awareness that great efficacy is not required for drug approval, in a culture of financial pressure to facilitate profits for pharmaceutical manufacturers.
The FDA is expected to formally approve ADDYI this week. According to Jenny Thompson of the Health Sciences Institute, ADDYI never met a clinical trial it couldn’t fail. It didn’t work as an antidepressant, and even Sprout’s efforts to resurrect the medication as a libido-boosting pill for women were repeatedly rejected by the FDA. When the FDA – which has in the past often approved useless and dangerous drugs – won’t put its approval on something, you know it’s really a dud, says Thompson.
So instead of making ADDYI’s approval about science, Sprout made it about politics. The company lined up feminist groups for a campaign called “Even the Score” that included pseudo TV documentaries and carefully planned demonstrations claiming a sex pill for women was about equal rights. Apparently, the misleading propaganda worked. The FDA advisory panel that had previously rejected ADDYI signed off on recommending it with some reservations by a vote of 18-6 in June 2015, and the FDA is expected to give its full blessing in August 2015.
Nearly 200 university researchers, drug experts and non-profit scientists have written the FDA two letters demanding that ADDYI be rejected. One letter, signed by Dr. Leonore Tiefer from the New York University School of Medicine, along with 133 other scientists and sex therapists, claims the theory used to support ADDYI’s application has been completely debunked.
The second letter, led by Dr. Adriane Fugh-Berman and a who’s who of researchers that includes the editor of the Annual Review of Sex Research, warns that prescribing the drug to women with heart problems or who are social drinkers would bring about “an epidemic of serious adverse events.” Sprout’s own research shows that ADDYI can cause fainting, nausea, dangerous drops in blood pressure that could make a heart condition worse, and serious interactions with alcohol. Considering that sexual activity often accompanies the use of alcoholic beverages this interaction is a critical one that women and their sexual partners need to be aware of.
The push for ADDYI is nothing but “a brilliant marketing strategy that pressures FDA and gets around laws preventing the promotion of drugs prior to regulatory approval,” Dr. Fugh-Berman said. This drug isn’t mainly about helping women and it was never about equal rights. It’s a matter of what drug companies consider is their right to profit with risky products that are often unnecessary and of limited benefit while leaving the uninformed public dealing with the unpleasant consequences. For women seeking to improve sexual desire and satisfaction there are many safe, non-drug approaches, including psychotherapy, sex therapy, diet and herbal aids, lubricants, hypnotic suggestions, healing of past sexual trauma and emotional blocks, and sensual meditations.