Female Viagra Gets FDA boost, unlike FDA birth control approvals. Why?

Donald A. Collins | 11 June 2015
Church and State

An FDA panel has voted to recommend approving Flibanserin.

Whoopie! Women may get “female Viagra” says a June 4, 2015 Wall Street Journal article. Reporter Ed Silverman tells us,

Will there finally be a Viagra for women?

A Food and Drug Administration advisory panel has recommended the first drug to help combat female sexual dysfunction. And Sprout Pharmaceuticals, which owns the pill, hopes agency approval will occur in mid-August.

Thursday’s 18-to-6 vote came with a big caveat—a program is needed to highlight worrisome side effects and interactions with other medicines. But the panel’s vote marks a turning point in women’s health.

The drug has been the focus of a long-running debate over the extent to which female sexual dysfunction is a genuine medical problem, whether medicines should be used for treatment and the extent to which the FDA would approve new drugs amid accusations of gender bias. “This condition has been mired in a lot of folklore and misconceptions,” said Cindy Whitehead, Sprout’s chief executive.

The drug itself has been controversial. Flibanserin has twice been rejected by the FDA. The first time occurred in 2010, when Boehringer Ingelheim owned the medication, and the agency decided the drug wasn’t sufficiently effective. The next rejection came two years ago after the FDA determined flibanserin showed only “modest” benefits in increasing sexual satisfaction.

Sprout responded by joining an online campaign called “Even the Score” that was formed with other drug makers and a coalition of consumer advocacy groups, which tried to pressure the FDA to approve more drugs to treat female sexual dysfunction. The initiative garnered some support in Congress, prompting a few lawmakers to meet with the FDA.

The campaign pushed the notion that the agency had approved more than two dozen medicines to treat erectile dysfunction but none to treat female sexual dysfunction, although the FDA has noted that there are 21 medicines already approved that contain estrogen to treat pain during sexual intercourse and vaginal dryness associated with menopause. These problems, however, are not the same as desire.

In documents filed prior to the meeting, Hylton Joffe, director of the FDA’s Division of Bone, Reproductive and Urologic Products, wrote that the “FDA rejects claims of gender bias” and that such claims “are misleading and inaccurate.” The FDA did, however, provide a path toward approval by allowing Sprout to run short-term studies to test flibanserin for signs of driving impairment after taking the pill as well as its effects when interacting with other medicines.

The FDA advisory panel was underwhelmed, though, with the overall safety and effectiveness data demonstrated in the various studies that Sprout submitted. For instance, dizziness occurred nearly five times among women on the drug compared with a placebo. And sleepiness occurred more than three times as often, while fainting occurred twice as often on the drug.

The panel also expressed concerns over interactions with drinking alcohol. And while the drug showed a statistically significant improvement in the number of satisfying sexual events, the increase in desire was measured on a monthly, not a daily basis. Moreover, panel members noted the improvements were modest.

“It’s exciting we’ll have this in our armorarium… but we all wish it was a better drug,” said panel member Amy Whitaker, an assistant professor in the Department of Obstetrics and Gynecology at the University of Chicago.

“As a feminist, I’m delighted people are taking women’s sexual issues seriously, but recommending approval for this drug isn’t the correct response,” said Cindy Pearson, executive director of the National Women’s Health Network. “This sets a low bar.”

So why am I bothering to report about a product not yet approved to enhance sexual pleasure for women?

Because the irony of this long delayed development perfectly jibes with the record of the FDA in approving birth control methods which would help women NOT have kids after having sex.

Not long ago I reviewed an important book on FDA behavior with regard to approving various methods of birth control. The book as far as I could tell got slight notice among readers and apparently not much at FDA, but that of course is sheer conjecture on my part.

It does seem useful, in light of the effort now, however slow or flawed, to jazz up women’s enjoyment of sex, to replay my review on Amazon of this earlier book which also got notice and praise from another reviewer. So here is that review again to remind readers that with regard to women and matters of sex and reproductive health, science may not be paramount at FDA.

Reproductive Rights and the State

At FDA Science Is Not The Only Criteria For Product Approval
By Donald A. Collins on July 1, 2014

It is particularly useful at this time to highlight with a review a vital well researched book which studies the power of some anti birth control ideologues inside the FDA who have clearly made contraceptive approval very difficult.

This book was earlier reviewed by Kelly C. Cleland in Conscience, the Catholics for Choice magazine, entitled “Business and Politics First, Women Second: The FDA’s Drug Approval Process” about Reproductive Rights and the State: Getting Birth Control, RU 486, and Morning After Pills, and the Gardasil Vaccine to the US Market by Melissa Haussman (Praeger, 2013, 184 pp)

http://digital.graphcompubs.com/publication/?i=175786&p=52

Reviewer Cleland excerpts information from this important 2013 book that likely will frighten anyone who thinks the FDA approval process is based on scientific evidence gathered by well monitored and reputable researchers. Far from it! Examples: “Haussman details the often convoluted processes behind achieving FDA approval and bringing the product to market, highlighting the complex interplay of corporate and political interests that impeded or expedited the availability of each product in the US.”

Or: “In the case of emergency contraception, the agency’s mechanisms were used to impede and stall, rather than facilitate, availability.” Whereas, “in the case of Gardasil, however, these same tools were used to expedite the approval of a new vaccine that had more to do with pressure exerted by the pharmaceutical industry than it did with public health.”

After proving with the Supreme Court’s recent Catholic dominated decisions on abortion clinic access and the right of women to get contraception under the employer health plans of family owned businesses of any size, we know the power of this male dominated monotheistic sect has now accomplished its goal: Deny women and their families basic human rights and the fundamental democratic means to fulfill them.

Earlier this same attitude has lead to the frequent dilution of Roe v Wade in many parts of the USA. In short, these anti choice proponents are delighted to kill women in pursuit of their ideology. Perhaps the greatest irony is the fact that there are women’s groups who work to take away the freedom of choice from members of their own sex. Are they dogs in the manger or just sadly willing to bend their knees to religious dogma which has actually no certain mandate in the Catholic Church’s history?

This book is a must read for anyone contemplating dealings with the FDA.

Former US Navy officer, banker and venture capitalist, Donald A. Collins, a free lance writer living in Washington, DC., has spent over 40 years working for women’s reproductive health as a board member and/or officer of numerous family planning organizations including Planned Parenthood Federation of America, Guttmacher Institute, Family Health International and Ipas. Yale under graduate, NYU MBA. He is the author of From the Dissident Left: A Collection of Essays 2004-2013.

From the Dissident Left: A Collection of Essays 2004-2013

By Donald A. Collins
Publisher: Church and State Press (July 30, 2014)
ASIN: B00MA40TVE
Kindle Store

Back in 1991, the NGO Don Collins founded in 1976, International Services Assistance Fund (ISAF), co-produced a TV quality 22-minute film called “Whose Choice?” which Ted Turner arranged to broadcast on September 21, 1992 in prime time on his then independent Turner Broadcast System (TBS). Other outlets such as PBS and several of its affiliates Collins and his colleagues contacted then refused to run it because of its forthright treatment of the abortion issue, arguing for all women’s right to choose not to have a baby. ISAF has made a new edition of that DVD. The purpose for reissuing this 3rd version of “Whose Choice?” was simply to show the historical urgency that attended those times, still blocked and attacked over 40 years after the Roe v Wade decision in 1973. This video is available for public viewing for the first time.

The Men Behind The War On Women

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