FDA Advisory Panel OK’s Antidepressant as “Female Viagra”

Holy Hormones Journal: Leonore Tiefer, founder of the New View Campaign, and guest on a recent radio show Leonore Tiefer, PhD: The Marketing of Female Sexual Dysfunction (FSD), was a guest author on this article. This new drug – once an antidepressant denied by the FDA because of a lack of safety studies, has now been repackaged as a “female Viagra,” and made it past an FDA advisory panel – say what?

Also please note that when Dr. Tiefer was on my show in April, we were using the term FSD – female sexual dysfunction disorder – but today, a new term was being blasted in the media and that is HSSD or “hypoactive sexual desire disorder.” God forbid that label makes it into our medical charts.

pinkpillSprout Pharmaceuticals who is behind this campaign has been using ‘feminist’ jargon and the equality platform – stating that even though women have a higher incident rate of sexual dysfunction they do not have any drugs on the market to treat it, whereas men have multiple options. Sadly, this is the mentality to push this drug onto the market. Bastardizing feminist principle. Serious? So we do not have a nod for equality in any other aspect of our lives, but when it comes to sex dysfunction and antidepressant drugs to increase our libido we do? Who really benefits here?

Thea Cacchioni, assistant professor of women’s studies at the University of Victoria in British Columbia was on NPR on Friday, June 5,  blasting the campaign stating that the “push to get flibanserin approved is more about marketing than about science. She is writing a book called “Big Pharma, Women, and the Labor of Love.”  Source

Of course it is a marketing ploy. Just like Gardasil, the HPV vaccine – I mean who heard of HPV before the vaccine came on the market? Merck was given a pharmaceutical award for creating a market out of thin air.

The same marketing ploy held true for the first “extended cycle” birth control pill that came on the market in 2003. This new version of the oral contraceptive pill – one that changed a woman’s menstrual cycle to produce only four periods each year – had been approved by the FDA. The new pill was be marketed under the brand name Seasonale and was the  first product approved for this combination of contraception and menstrual suppression.

The coming out of Seasonale was heralded by a New York newspaper as being the social event of the season (no pun intended).  Limos, and a black tie reception – promo materials about the first pill that suppressed menstruation for months at a time.

What’s In? Winter White, and Labradoodles,” said one news release. “What’s out? A monthly period.”

The coming-out party for the extended-cycle birth control pill was choreographed as carefully as a wedding. Pleated pink invitations were mailed out weeks in advance. The event was held in November at a hip Manhattan loft space filled with installation art; black cars idled out front waiting for guests to depart. “Sex and the City” author, Candace Bushnell was a guest speaker. As they left, reporters were handed lavender press kits suggesting clever ways to convey the message that monthly periods are, well, so last year.

The largest uncontrolled experiment in medical history.

And these marketing tactics are still used today. Why would the FDA uphold the risk for potential side effects associated with this drug when it was being fast-tracked as an anti-depressant – but now they are are ignoring them because the pill has been packaged for FSD or HSSD or whatever?

Women on Flibanserin were more likely to experience dizziness, sleepiness, nausea, fatigue and insomnia, and withdrew early from the trials more often, mainly because of these side effects.

Here is the deal. Viagra targets the nerves around the penis. PERIOD. Flibanserin targets the neural pathways in the brain. It is an anti-depressant. PERIOD. A woman needs to be on it daily, while a man take Viagra when he wants to have sex. PERIOD.

How will this drug interfere with oral contraceptives? Alcohol or other drugs? Will this drug be abused and dropped into a woman’s cocktail at a party? What if the woman has been already been prescribed an anti-depressant for her depression and is now being prescribed an anti-depressant for her libido?

Is this really want you want?

I am going to go with what Jessica Valenti wrote in a recent article:

If a woman isn’t interested in sex, the problem quite possibly isn’t with her.

We shouldn’t push dubious ‘pink Viagra’ pills on women and call it emancipation

An FDA panel voted on Thursday to recommend approving Flibanserin, despite the agency rejecting it twice before due to safety concerns

Is it really sexist to want to protect women from harm? For the last few years, some women groups have been lambasting the US Food and Drug Administration

GERMANY - JULY 04: Woman takes a pill, Symbolic picture for: Medicine, medicine costs, pharmaceutics. (Photo by Ulrich Baumgarten via Getty Images)

GERMANY – JULY 04: Woman takes a pill, Symbolic picture for: Medicine, medicine costs, pharmaceutics. (Photo by Ulrich Baumgarten via Getty Images)

(FDA) because it has so far refused to approve Flibanserin, the so-called “pink Viagra” for women’s sexual problems. Campaigns like “EventheScore” and “WomenDeserve” say the regulator has rejected the drug in the past because of alleged gender bias. But where is the fault in wanting to protect women from potential side effects from an at-best marginally effective drug treatment?

On Thursday, two key FDA advisory committees voted to recommend that the watchdog approve Flibanserin, a drug designed to treat hypoactive sexual desire disorder. While the FDA is scheduled to make a final decision in August, this recent news is already being called a “historic decision” by EventheScore – but it is no such thing.

Despite its moniker, Flibanserin is nothing like Viagra. It must be taken every day, potentially for years, rather than, as with Viagra, just when a person wants to have sex. Flibanserin is more similar to antidepressants, with effects that don’t kick in for weeks. Its aim is to treat low desire, but there is no biological marker or threshold for abnormally low desire. What might feel low for one woman could be normal for another. EventheScore claims: “a biological lack of desire to have sex negatively impacts 1 in 10 American women”. This is pure fiction.

To be diagnosed with “hypoactive sexual desire disorder”(or what is now called “female sexual interest/arousal disorder”, in the latest manual of psychiatric diagnoses), a person needs to report “significant distress”, but this overlooks the fact that desire for sex is intricately bound into a person’s life and relationships. If a woman is depressed, is going through tough times with her aging parents or has just had a baby and is sleep-deprived, she can easily feel less interested in sex than previously. If her partner is unsympathetic or pressures her, distress would be expected. Defining unequal interest in sex between partners as a female dysfunction is hardly a boon for women’s equality.

Read full article…

 

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.