Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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A Young Woman's View of Flibanserin ("Pink Viagra"), FSD, and Pharma

A Young Woman's View of Flibanserin ("Pink Viagra"), FSD, and Pharma | Pharmaguy's Insights Into Drug Industry News |
The push for flibanserin and its treatment of hypoactive sexual dysfunction disorder in women not only makes a mockery of the drug approval process. It marks a dangerous emboldening of the trend towards medicalizing women’s sexuality and a step away from women’s equality in the bedroom.

FSD [Female Sexual Dysfunction] is a textbook example of pharmaceutical company disease-mongering. By creating FSD and promoting a medicalized view of women’s sexuality, pharmaceutical companies successfully established a market for drugs to treat low desire in women. The greatest offense, however, is the lack of scientific data and research backing FSD, a condition whose legitimacy is shaky at best. In fact, there is still very little that is known about the biological processes governing women’s sexuality.

Let’s not let Big Pharma fundamentally change how we view our bodies and sex lives. Let’s refuse to settle for a pill that denies us the emancipatory process of engaging in a much needed conversation and reconceptualizing of sexual desire in all genders.

The worst side effect of all is the drug’s association of loss of desire with a female dysfunction. Not only does this fault women for unfulfilling sexual unions, it treats sexual desire as an individual phenomenon that is gifted to someone else rather than something to be cocreated through partnership. Even the model of consent that is frequently taught continues to view sexual desire as something that is requested and then given, often a woman’s acceptance to a man’s invitation.

Pharma Guys insight:

CLARA JANE HENDRICKSON - the author of this piece - is a rising College senior from San Francisco studying political science at UPenn.

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Will FDA Approval the "Pink Pill" Now That Peggy Hamburg Isn't Commissioner?

Will FDA Approval the "Pink Pill" Now That Peggy Hamburg Isn't Commissioner? | Pharmaguy's Insights Into Drug Industry News |

It's been in the works for years: a pill to help women with low sex drives. Women who've tested it love it. So, why hasn't it been approved? CBS 2's Erin Kennedy explores the controversy.

Amanda Parrish, a busy working mother of four, says sex was often the last thing on her mind.

“It got to where I’d be one of those women who would try to maybe be asleep before he got to bed,” Parrish said.

Her doctor diagnosed HSDD or hypoactive sexual desire disorder.

The prescription: enter a clinical trial of flibanserin, a little pink pill designed to boost a woman’s low libido.

Amanda got results.

“At the end of a long day even if I had worked and even if I had gotten the kids fed there was a desire there that previously had not been there,” she said.

“It actually balances out dopamine and serotonin so that women have more sexual thoughts, more fantasies,” said Northwestern Medicine’s Dr. Lauren Streicher, describing how it works in the brain.

So, if flibanserin worked for Amanda and 45 percent of women in the studies, why has it been rejected twice by the FDA?

Experts noted it didn’t work much better than a placebo and others say therapy, not a drug, should be the first choice for busy, stressed-out women.

Outspoken critics, like Dr. Adriane Fugh-Berman, director of Georgetown University’s research project PharmedOut, are also concerned about side effects.

“15 percent of the women in flibanserin trials dropped out because of side effects of sedation and nausea and fatigue,” Dr. Fugh-Berman.

“It’s my hope that the FDA approves it. I’ll be the first in line to get it,” said Amanda Parrish.

Earlier this year, Sprout Pharmaceuticals, which makes flibanserin, submitted new research on the pill’s impact on driving ability to the FDA. Those results showed no adverse effect.

The FDA holds another hearing concerning the pink pill’s approval next month.

Pharma Guys insight:

A coalition of consumer advocacy groups and drug makers launched an online campaign – complete with a petition – to pressure the FDA to approve more drugs to treat female sexual dysfunction. Called Even The Score, the crusade claimed that there are more than two dozen drugs available to help men combat sexual problems, but none for women. Is FDA sexist? Read more:

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FDA Should Approve the "Pink Pill" Only If Safety Concerns are Reduced, Says NYT Editorial

FDA Should Approve the "Pink Pill" Only If Safety Concerns are Reduced, Says NYT Editorial | Pharmaguy's Insights Into Drug Industry News |

A federal advisory panel has recommended that the Food and Drug Administration approve the first drug to treat a lack of sexual desire in otherwise healthy women. Some women’s groups are hailing this as a breakthrough in gender equality, a start to closing the gap between men, who have numerous drugs to treat sexual dysfunction, and women, who have none. But the panel’s recommendation was laced with so many caveats that it seems clear that this particular drug — flibanserin — is only marginally effective and carries some risk of serious adverse effects.

The advisory committee’s recommendation was applauded by Even the Score, a coalition of women’s groups and other organizations which is supported by Sprout, but the move was deplored by the National Women’s Health Network, which complained that Sprout had not provided enough data for women to make an informed decision. The F.D.A. should only approve the drug if strong measures are taken to reduce safety concerns.

Pharma Guys insight:

"Women who took flibanserin, for example, reported having one more sexually satisfying event per month than women who got a placebo." - women taking 100 milligrams of flibanserin nightly reported an average of 4.5 satisfying sex acts per month, up from 2.8 acts during a four- week test period used to establish a baseline for comparison. Women taking a placebo reported 3.7 satisfying sex acts, compared to 2.7 acts during the baseline period." 

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Woman's Health Expert Suggests Placebo Works "Almost As Well" as Flibanserin to Increase Sexual Desire in Women

Woman's Health Expert Suggests Placebo Works "Almost As Well" as Flibanserin to Increase Sexual Desire in Women | Pharmaguy's Insights Into Drug Industry News |

There's yet another pharmaceutical campaign on the offensive, hoping to convince women with sexual problems that a drug called Flibanserin will cure them. This compound is a central nervous system formula originally studied as a remedy for depression. As in the past, a massive and highly organized PR effort to create enthusiasm for Flibanserin is in high gear before the drug gets approved by the Food and Drug Administration. I witnessed this campaign firsthand at an FDA meeting in October.

Flibanserin was rejected by the FDA in 2009 when proposed by a Big Pharma company, Boehringer Ingleheim, and has been rejected twice recently when proposed by a newbie Little Pharma, aptly named Sprout Pharmaceuticals. Flibanserin has not been shown to have a significant effect relative to a placebo, and there are safety concerns about long-term effects.

Now here's the new twist. Sprout and its allies in the sexual medicine community are claiming the FDA is sexist for not approving this drug. There is a media campaign called Even the Score, bringing attention to the claim that men have sex drugs and women need gender equity for those drugs, too. They even recruited some national women's organizations to bring this argument to bear on the FDA and got some high-profile congresswomen to send a formal letter to the FDA officials demanding gender equity.

On Oct. 27, the FDA held a public meeting in Silver Spring, Md., and invited women to participate in telling their stories about their symptoms and existing methods they use to deal with the challenges. I signed up to be on the panel.

Imagine my surprise when a luxury late-model bus pulled up to the curb at the FDA hearing as I was arriving. About 40 women got off the bus, all wearing green scarves and big lapel buttons promoting their "women deserve" campaign. I later learned it was an all-expenses paid trip for them, complete with swag bags handed out when they exited the bus. By contrast, I arrived in a 10-year old car, ate a cereal bar for breakfast and lunch, and paid for my own budget hotel room.

Pharma Guys insight:

Karen Hicks is an adjunct professor of women's health and human sexuality at Lehigh University. In the 1980s, she was the founder of the Dalkon Shield Information Network and subsequently wrote a book, "Surviving the Dalkon Shield IUD: Women vs. the Pharmaceutical Industry," about her experiences.

Ms. Hicks said "The clinical trials for Flibanserin excluded most women with some-22 different serious medical conditions and included only women who had been in a stable relationship for at least one year. The clinical trial results showed a very modest increase in satisfaction and inadequate outcomes on negative side effects." She proposed that the placebo in the trial should be used instead: "After all, in those clinical trials for Flibanserin, the placebo worked almost as well as the drug."

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