Talk:Flibanserin/Archive 1

Stucture
Note there is some confusion as to the structure of flibanserin, with some sources showing the 4-trifluoromethyl isomer instead of 3-. However the patent literature shows the 3- isomer as the correct one (e.g. see US 7183410) Meodipt (talk) 01:22, 9 August 2009 (UTC)

Effect on women only?
It seems strange that neurotransmitter adjustments would be sex-specific. Do we have any information on why, chemically, this effect is observed only in women? Vectro (talk) 15:17, 6 January 2010 (UTC)
 * Considering the gender distinction, if somebody sees a citable note somewhere regarding treatment of intersexed people (who often have physiological libido issues), it would be worth putting an explicit link into the article for people trying to research this to bring to their doctors. 108.15.130.5 (talk) 21:35, 25 May 2010 (UTC)

BMJ 2014
Interesting article in the BMJ about the marketing campaign to get flibanserin approved, which explains where the eventhescore.org web site comes from. The astroturf grassroots campaign might be more notable than the drug itself.

http://www.bmj.com/content/349/bmj.g6246.short Feature Too Much Medicine Evening the score on sex drugs: feminist movement or marketing masquerade? BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g6246 (Published 17 October 2014) Cite this as: BMJ 2014;349:g6246 Ray Moynihan

A thrice failed antidepressant is at the centre of a new marketing campaign to win approval for what could become the world’s first blockbuster sex pill for women. Frustrated by the drug’s repeated rejection, proponents have orchestrated a fierce attack, accusing the regulator of unfairness, and enlisting support from several well connected women’s organisations in the US. Critics counter that the campaign is exceedingly misleading, that it targets a desire disorder that does not exist, and that approval could see widespread overprescribing of a drug with marginal benefits and real safety concerns.

Leonore Tiefer, the sex therapist who initiated the New View campaign to oppose the medicalisation of women’s sexual problems in 2000, is alarmed about this latest company backed campaign. “Even the Score is hijacking feminist language of choice and fairness,” Tiefer says. “It’s disrespectful of the FDA, it’s insulting to feminism, and it misleads the public.” Tiefer wrote a long letter to the president of the National Organization for Women, Terry O Neill, one of the women featured on the Even the Score website, offering to meet and discuss the issues, but Tiefer got no reply.

--Nbauman (talk) 08:39, 18 October 2014 (UTC)
 * http://jama.jamanetwork.com/article.aspx?articleID=2389384
 * Viewpoint | July 06, 2015
 * Evaluation of Flibanserin: Science and Advocacy at the FDA
 * Walid F. Gellad, Kathryn E. Flynn, G. Caleb Alexander.
 * JAMA. Published online July 06, 2015. doi:10.1001/jama.2015.8405
 * 3 panelists who voted no explain why. Free online. --Nbauman (talk) 04:46, 11 July 2015 (UTC)

Even the Score members
I wonder if any of these supporters of the drug have published information about it.
 * Association of Reproductive Health Professionals
 * National Association of Clinical Nurse Specialists
 * National Organization for Women
 * National Consumers League
 * International Society for the Study of Women's Sexual Health
 * Society for Women's Health Research
 * The Women’s Research & Education Institute
 * HealthyWomen
 * Women's Health Foundation
 * American College of Nurse-midwives
 * American Social Health Association
 * National Council of Women's Organizations
 * Red Hot Mammas
 * Change for Health and Gender Equity
 * Nurse Practitioners in Women's Health
 * Change for Health and Gender Equity
 * The Institute for Sexual Medicine
 * Black Women's Health Imperative
 * National Hispanic Medical Assocation
 * Jewish Women International

 Blue Rasberry  (talk)  15:09, 19 August 2015 (UTC)
 * Society for Women's Health Research was getting money from Wyeth-Ayers, the manufacturers of hormone replacement therapy, and promoting HRT efficacy and safety. http://www.sourcewatch.org/index.php/Society_for_Women%27s_Health_Research


 * See Hormone replacement therapy (menopause) (BTW, something really should be done about the Hormone replacement therapy page.) --Nbauman (talk) 21:33, 19 August 2015 (UTC)

A critical source from the Financial Times
The FT has a podcast, the Alphaville pocast that is run by the journalists of the Alphaville section of the FT and, as far as I can tell, fully part of its editorial system, where they discuss news that has happened in the past week. This Friday they dedicated 20m of the podcast to discussing the drug and it's approval, doing so in a highly critical fashion, I think this may be a valuable source to this article:

http://ftalphaville.ft.com/2015/08/21/2138011/alphachat-the-chinese-economy-and-the-dodgy-flibanserin-fine-the-female-viagra/

158.143.43.36 (talk) 12:03, 21 August 2015 (UTC)
 * We do not typically use podcasts as sources. Doc James  (talk · contribs · email) 16:51, 22 August 2015 (UTC)
 * Not even a podcast that is composed exclusively of journalists from the FT, a reliable source by all means, under the banner of the FT (specifically their Alhpaville section), hosted within the FT itself? I would assume that all means that it's under the editorial control of the FT, thus having the veneer of reliability, but sounds I'm mistaken in my beliefs, could you clarify which of my assumptions is mistaken? I'm genuinely curious.


 * In addition, if the podcast is not satisfactory, an article on the FT (http://www.ft.com/cms/s/0/61cc0de6-461f-11e5-b3b2-1672f710807b.html), discusses many issues that the approval process had:


 * Sprout did have any new information on the effectiveness of the drug, just some more safety reports. According to the article, one of the studies, that focused on the effects of combining Flibanserin and alcohol, was tested in only 25 patients, 23 of them being male, which one doctor on the review panel commented as being '“inexplicable” given that the drug is being developed for women.`


 * and


 * The article also discusses how Dr Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, and who voted against the drug fears that both the campaign and the coverage that the media has given will result in 'large numbers of women who do not suffer from HSDD getting the drug “off label”. “The advocacy campaign was unprecedented in terms of its magnitude and composition, and the way in which it enlisted policymakers and advocacy groups,” he says. “The hype may impact the way the science is perceived: there is tremendous potential for widespread off-label use.”`158.143.43.36 (talk) 11:13, 26 August 2015 (UTC)

Direct Quotes
The following direct quotes were removed per WP:IMPARTIAL and have now been restored by DocJames


 * A representative of PharmedOut said "To approve this drug will set the worst kind of precedent — that companies that spend enough money can force the FDA to approve useless or dangerous drugs."[36] One researcher said that the members of the FDA advisory committee "were emotionally blackmailed by the Even the Score campaign".[37] The director of the National Women's Health Network said that "Even The Score is full of lies, knowing willful lies."[38]

WP:IMPARTIAL, which is part of Wikipedia's NPOV POLICY, states the following:


 * Wikipedia describes disputes. Wikipedia does not engage in disputes. A neutral characterization of disputes requires presenting viewpoints with a consistently impartial tone; otherwise articles end up as partisan commentaries even while presenting all relevant points of view.... Neutral articles are written with a tone that provides an unbiased, accurate, and proportionate representation of all positions included in the article. The tone of Wikipedia articles should be impartial, neither endorsing nor rejecting a particular point of view. Try not to quote directly from participants engaged in a heated dispute; instead, summarize and present the arguments in an impartial tone.

I realize that the approval of this drug was very unpopular in some quarters. But the inclusion of these caustic direct quotes seems to me to be in direct violation of the cited passage above, even more so because they are not offset by other viewpoints. In fact, I don't see how "try not to include direct quotes from participants engaged in a heated dispute" could possibly be any clearer.


 * "U.S. Rep. Jackie Speier, D-Calif., and 10 other members of Congress signed a letter to the FDA saying: "We firmly believe that access to health care should be a fundamental right, regardless of whether you are a man or a women." http://www.usatoday.com/story/news/nation/2015/08/18/fda-acts--flibanserin/31840455/


 * The same article notes that approval was supported by the National Organization for Women, which is further expanded on here: "We live in a culture that has historically discounted the importance of sexual pleasure and sexual desire for women," Terry O'Neill of the National Organization for Women told NPR. "And I fear that it's that cultural attitude that men's sexual health is extremely important, but women's sexual health is not so important" that is keeping the FDA from approving the drug." http://www.slate.com/blogs/xx_factor/2015/02/18/female_viagra_is_not_the_fix_and_the_fda_s_rejection_of_flibanserin_is_not.html


 * Daniel Caralat: "But often in medicine, that’s exactly what we have to work with: mildly effective medications with side effects. Flibanserin may be mediocre, but it’s not ineffective. I look forward to cautiously prescribing it to those women in my practice who might benefit from it." http://carlatpsychiatry.blogspot.com/2015/08/flibanserin-5-things-to-consider-before.html


 * Lisa Larkin, Director of Women's Health at University of Cincinatti Women's Health Center (no funding from Sprout), who states that she routinely seems women self-medicating for sexual desire issues, and sees the approval as important for safety considerations to reduce self treatment with unsafe and/or untested alternatives. http://www.forbes.com/sites/davidkroll/2015/06/14/the-true-significance-of-flibanserins-modest-boost-to-female-sexual-desire/ — Preceding unsigned comment added by 2605:E000:1C0C:808F:2117:65D6:6022:45AB (talk) 17:24, 30 August 2015 (UTC)

As presented, there is 100% condemnation of this drug among authoritative sources (outside of paid advocates). When did NOW become a non-entity whose opinion on women's issue is not worthy of mention? The approval of this drug by a unanimous vote of the FDA advisory committee and by the FDA itself is a complete mystery to the reader, as Wikipedia makes it clear that it is simply a dangerous and ineffective drug pushed through by paid advocates, and that this is something that all observers agree on.

I'd like to further note that the efficacy summary that is the subject of a lengthy quote in the opening effectiveness paragraph was taken from the 2010 FDA Adcom briefing document and is not the most up-to-date FDA summary of the drug's efficacy. Specifically, it includes results from only 2 of the 3 Phase 3 studies that were conducted, the third having been performed per an FDA-recommended design. The most up-to-date FDA summary states (http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/drugsafetyandriskmanagementadvisorycommittee/ucm449090.pdf)


 * "Flibanserin has demonstrated consistent and meaningful efficacy in the treatment of HSDD. That efficacy is evident across all measured symptoms, on validated instruments across multiple time points, and in a pre-specified responder analysis. The treatment effect has been deemed meaningful by patients."

I am personally unaware of why the FDA's efficacy summary changed between 2010 and 2015, whether due to new data, a different requested label by the manufacturer, or a simple change of opinion about the same dataset. I haven't followed this that closely. Nonetheless, the inclusion of the negative 2010 quote but not the more positive, more recent summary is unusual to say the least, and it is difficult to come up with an explanation for it that does not involved cherry-picking for POV purposes.

I understand that this was a very controversial approval, but this is not the place to editorialize. Let's write an encyclopedia article and not a screed.

2605:E000:1C0C:808F:2117:65D6:6022:45AB (talk) 15:05, 30 August 2015 (UTC)

Removing links to partners
An IP removed a link to one of the community organizations which received funding and gave support for the approval of this drug. I wonder what partner organization Wikipedia articles should say about their relationship to this drug.  Blue Rasberry  (talk)  15:21, 18 November 2015 (UTC)