{"id":2955,"date":"2015-09-25T09:16:35","date_gmt":"2015-09-25T08:16:35","guid":{"rendered":"https:\/\/blogs.bmj.com\/medical-ethics\/?p=2955"},"modified":"2015-09-25T09:16:35","modified_gmt":"2015-09-25T08:16:35","slug":"flibanserin-and-regulatory-failure","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/medical-ethics\/2015\/09\/25\/flibanserin-and-regulatory-failure\/","title":{"rendered":"Flibanserin and Regulatory Failure"},"content":{"rendered":"<p style=\"text-align: justify\"><em><strong>Guest Post by\u00a0Adriane Fugh-Berman<\/strong><\/em><\/p>\n<p style=\"text-align: justify\">On August 18th, 2015, the <span style=\"color: #0000ff\"><a style=\"color: #0000ff\" href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm458734.htm\" target=\"_blank\">FDA approved flibanserin<\/a><\/span> (brand name Addyi), a purported aphrodisiac that can drop blood pressure so precipitously that users sometimes pass out and require medical intervention to regain consciousness.\u00a0 The labelling for flibanserin indicates that it is for:<\/p>\n<blockquote>\n<p style=\"text-align: justify\">the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:<\/p>\n<p style=\"text-align: justify\">\u2022 A co-existing medical or psychiatric condition,<\/p>\n<p style=\"text-align: justify\">\u2022 Problems within the relationship, or<\/p>\n<\/blockquote>\n<p style=\"text-align: justify\">\u2022 The effects of a medication or other drug substance.<\/p>\n<p>Focus for a moment on \u201cLow sexual desire that causes marked distress or interpersonal difficulty\u201d. \u00a0So a woman upset by a belittling spouse who wants sex more often than she does is eligible for a prescription drug? \u00a0It gives a whole new meaning to the term \u201cdrugs of abuse.\u201d\u00a0 Note that even if the putative patient isn\u2019t distressed, she is still eligible for being drugged if her partner is creating interpersonal difficulty. \u00a0Here\u2019s a thought &#8211; why not sedate him instead?<\/p>\n<p>Not every partner is a jerk, and there are certainly women distressed by loss of libido, but flibanserin isn\u2019t the answer for these women either. \u00a0As an aphrodisiac, it\u2019s no great shakes; its predominant mechanism may simply be sedation. \u00a0Flibanserin increased \u201csexually satisfying events\u201d by less than one event a month (the event, by the way, need include neither an orgasm nor a partner).<\/p>\n<p>The labeling of flibanserin reveals the absurdity of this \u201cdisease\u201d and its treatment.<!--more-->\u00a0 In fact, hypoactive sexual desire disorder (HSDD) was invented by pharmaceutical manufacturers. \u00a0<span style=\"color: #0000ff\"><a style=\"color: #0000ff\" href=\"http:\/\/jme.bmj.com\/content\/41\/10\/859.short\" target=\"_blank\">We have written about<\/a><\/span> how continuing medical education was used to establish this invented disease in the minds of clinicians. Stress, fatigue, boredom, children, medications, and a plethora of other factors unfixable by a pill can contribute to reduced libido.<\/p>\n<p>Nonetheless, flibanserin is on its way to the US market, and will be available in mid-October.\u00a0\u00a0Flibanserin must be taken every day, and users must swear off alcohol as long as they are taking the drug.\u00a0 On the upside, if one drinks to unwind, flibanserin may be a fair substitute: a single dose of flibanserin is as sedating as four shots of alcohol. \u00a0The U.S Food and Drug Administration was so concerned about potentially severe adverse effects when flibanserin was mixed with alcohol that they required the drug manufacturers to test the combination. \u00a0In a stunning act of corporate nose-thumbing, Sprout Pharmaceuticals performed the alcohol-flibanserin interaction\u00a0 study in 25 subjects\u00a0 \u2013 only two of whom were women.<\/p>\n<p>At the FDA advisory committee meeting that considered the drug in June 2015, the company claimed, implausibly, that they couldn\u2019t identify more than two women who drank enough to fit eligibility requirements: more than 5 drinks a week. \u00a0That\u2019s right; they couldn\u2019t find more than two women who regularly had a glass of wine with dinner. \u00a0Although men are less susceptible to adverse effects of alcohol than women, the flibanserin cocktail felled several &#8211; four of the men in the alcohol interaction study fainted or experienced a steep drop in blood pressure.<\/p>\n<p>The FDA will require prescribers to warn women not to consume alcohol with flibanserin, but alcohol is not the only interactor. \u00a0Birth control pills, migraine medications, yeast medicines and many other medications increase flibanserin levels, increasing the risk of adverse events.<\/p>\n<p>Less than 48 hours after flibanserin was approved, the drug was purchased by Valeant Pharmaceuticals for a billion dollars. \u00a0An\u00a0 invented disease has spawned a real, and dangerous, treatment. \u00a0Real money is at stake, and promotional efforts\u00a0 are likely to be robust. \u00a0The FDA has failed American women in approving this drug. \u00a0We can only hope that drug regulatory bodies elsewhere resist the siren call of flibanserin.<\/p>\n<p style=\"text-align: justify\"><em>Read the full paper <span style=\"color: #0000ff\"><a style=\"color: #0000ff\" href=\"http:\/\/jme.bmj.com\/content\/41\/10\/859.short\" target=\"_blank\">here<\/a><\/span><\/em>.<\/p>\n<p><!--TrendMD v2.4.8--><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Guest Post by\u00a0Adriane Fugh-Berman On August 18th, 2015, the FDA approved flibanserin (brand name Addyi), a purported aphrodisiac that can drop blood pressure so precipitously that users sometimes pass out and require medical intervention to regain consciousness.\u00a0 The labelling for flibanserin indicates that it is for: the treatment of premenopausal women with acquired, generalized hypoactive [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/medical-ethics\/2015\/09\/25\/flibanserin-and-regulatory-failure\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2153,511,443,2745,2022,576],"tags":[304],"class_list":["post-2955","post","type-post","status-publish","format-standard","hentry","category-guest-post","category-in-the-news","category-jme","category-professionalism","category-reproduction","category-the-art-of-medicine","tag-public-health"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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