Debate Forum: 06/23

Forum Center: There’s a pill for that

Women may soon have pharmaceutical arousal option

By Sarah Sidlow

A little pink pill? Ladies, we may just be one step closer.

Last week, a Food and Drug Administration (FDA) advisory committee approved a pharmaceutical called flibanserin, a drug designed by Sprout Pharmaceuticals to boost the low sexual desire of otherwise healthy women.

But before this latest wonder-drug winds its way into your bathroom drawer (how’d that get there?!), it has to get through the big dogs.

The FDA typically follows the recommendations of its advisory committees, but not always—and the FDA has already rejected the drug twice, unintentionally writing a narrative that has all angles of sex-specific intrigue.

Sprout stands by its double-blind clinical trials, claiming its results are absolutely conclusive of the fact that flibanserin is effective in generating sexual desire in women who claim to have lost it, and want it back.

In fact, supporters of flibanserin and the female-focused movement it represents are asking: “what took you so long?” They blame systemic sexism for the gap between developments like Viagra, a leading erectile dysfunction drug (which the FDA approved in 1998), and this one, designed to address intimacy concerns for women.

The FDA denied Sprout Pharmaceutical’s bid last October to begin marketing flibanserin, and FDA committee members are still wary. The FDA’s hesitations allegedly range from the efficacy of Sprout’s studies to the potential side effects like dizziness and nausea, to the unknown interactions with other drugs, like birth control.

Some are even concerned about its possible use as a “date rape” drug.

Still other opponents of flibanserin claim it’s unclear how prevalent desire issues really are among women, and whether they can be treated pharmaceutically. Statistics range from 10 percent to 40 percent of the female population that suffer from some kind of sexual dysfunction, but it is not even clear how “dysfunction” is defined in these cases, or what its cause may be.

The acronyms to know are FSIAD (Female Sexual Interest/Arousal Disorder) or HSDD (Hypoactive Sexual Desire Disorder). The danger, opponents claim, is that clinically, interest and arousal are horses of different stripes—and should not be lumped into one category for treatment.

While the cause of non-arousal may be hormonal, many women, some experts claim, lose their desire as a result of our deadline-driven, multi-tasking, twenty-first century world. Sprout, these opponents claim, may be creating a medical need where one doesn’t really exist, as a way to market their product.

The biggest argument: flibanserin doesn’t work like Viagra, which helps blood flow into the erectile tissue of a man’s penis, once he’s already aroused. Instead, flibanserin corrects an imbalance on the levels of certain neurotransmitters such as dopamine and serotonin, in an effort to create arousal.

But others, bolstered by women’s groups, argue that this is all part of a communal mindset that must change. A female sexual-dysfunction drug is a matter of sexual equality, they claim. And it’s a shame that the first of its kind has yet to be approved, when 26 different options exist for men with erectile dysfunction.

Many claim studies on women and arousal have taken place since the 1970s, after the major sexual liberation movement of the ’60s gave women their first little capsule of success: the birth control pill.

Now, arousal-enhancing drugs like flibanserin are essential, proponents claim, because women diagnosed with low sexual desire have had nowhere to turn but to unproven and unregulated treatments—with dangerous results. On the flip side, a few stories from flibanserin’s clinical trials have begun circulating, boasting phenomenal results—much to the delight of Sprout, its trial subjects, and their husbands.

This battle of the sexes is slated for an FDA decision in the next few months.

Reach DCP Editor Sarah Sidlow at Editor@DaytonCityPaper.com

Debate Forum Question of the Week:

Do women need a “female Viagra”?

Debate Left: Give me the good stuff

Response By Jennifer Hanauer Lumpkin

Yep.

There, that’s the short version. Oh, you want me to back that up a bit? Well, since you asked nicely…

Sexual experience isn’t just different between women and men, it’s also different between every woman and every single other woman. The question isn’t really “Do women need a ‘female Viagra’?” but rather “After having explored non-drug options with her partner and health care professional, would this individual woman benefit from a medication that may increase her interest in sex?” And if it turns out the answer is yes, then let’s scratch out that ’script for flibanserin and get to the healing!

But you can’t. Not yet, anyway. So, why isn’t flibanserin out there yet? It can’t just be the name, which trips off my tongue with all the grace of a newborn giraffe. What’s the holdup, Bub?

It’s been a long road for this little pink pill. First, it had to be determined that there was a legitimate need and a significant want for a pharmaceutical answer to FSIAD and HSDD, and then a pharmaceutical company had to bend over and pick up the mantle. I’m a little stumped as to how in the name of orgazmo flibanserin is coming down the pike 17 years after Viagra. But we’re here now, so no sense in dwelling on the gaping potholes of patriarchy that appear to have slowed our commute (to those who say we’re “rushing to find a drug,” uh, erm, I mean … seriously?). This whole world just went and got itself in a big damn hurry, didn’t it Brooks? Let’s not seat you in the emergency exit row, okay?

And there are people—even a fair number of women, I was surprised to find out—who disagree that this is even a medically treatable ailment, that it’s just Big Pharma stirring up profit margins by preying on women’s bedroom insecurities. OK, sure, I have no doubt that one of the biggest industries in America is setting up its designer lemonade stand right at the edge of an oasis-free desert, but that doesn’t mean the poor souls out there aren’t thirsty. There are still people who believe depression is something you should just be able to walk off. While I suppose that could possibly be true for a slim margin of sufferers, I know several of those who have leveled off their life with selective serotonin reuptake inhibitors, like Zoloft, who would beg to differ.

libanserin has tried and failed to get the FDA’s go-ahead in the past, but now it sits poised for approval following a buttload of testing. Why are there still factions resisting this move forward?

Don’t tell me it’s because of the side effects. Dizziness? Please. That’s a possible side effect for Viagra, too, in addition to things like upset stomach, irregular heartbeat and, oh yeah, sudden vision loss. People are willing to accept (or ignore) all manner of side effects to get what they want. Remember Olestra, the fat substitute for savory snacks that first popped its head up in the early ’90s? They got FDA approval on the condition that foods containing it had a warning label telling people it might make them experience loose stools. Loose. Stools. And yet people still gobbled it up, because the ability to enjoy some guilt-free potato chips outweighed the possibility of getting the squirts. You best believe that if I ever find myself in a low-libido situation, I’ll certainly be willing to take on a little dizziness if it means getting some of the magic back in my carpet ride.

Anal leakage and a case of the woozies are at the tame end of the spectrum as far as what the FDA gives the OK on, anyway. I take FDA-approved Stelara for psoriatic arthritis, and possible side effects include upper respiratory infections, ulcers and cancer. CANCER. Yeah, I weighed my options and decided that risking an occurrence of non-Hodgkin lymphoma was worth it to get some relief from this chronic autoimmune disease that’s turned my body against itself. There might not be enough benefit there to outweigh the cons for YOU, so may I suggest that YOU don’t take the medication. Further, how about if you don’t stand in the way of my doing what I feel is right for my body and quality of life. I’ll do you the same courtesy.

Having read the research and discussed treatment options with my doctors, I have methodically come to conclusions about which meds are right for me and my ailments. And I believe, perhaps naively (though I like to think “optimistically”), that other people are capable of going through that same systematic process and coming to their own educated conclusions about what medications are right for them, if any. To say that they can’t is one, kind of snotty, and two, representative of the kind of pessimism regarding humanity that keeps Lockheed Martin in business. Whoops. Lost a little of my audience there, didn’t I? That’s okay, ya’ll will come back around after the little woman gives you that certain look and spends the rest of the night making you feel like the stallion/mare you are, all thanks to that little pink pill she had the option of popping.

Jennifer Hanauer Lumpkin is a writer and amateur cartographer living in Dayton, Ohio. She has been a member of PUSH (Professionals United for Sexual Health) since 2012 and is currently serving as Chair. She can be reached at JenniferHanauerLumpkin@DaytonCityPaper.com or through her website at jennerlumpkin.com.

Debate right: Jagged little pill

Response By Paula Johnson

Opposing the FDA’s potential approval of flibanserin is to be on the side of feminism.

And why is that? In this case, it’s about a drug being created for a disease that doesn’t exist for the sake of making a profit. Sprout Pharmaceuticals’ brilliant marketing campaign “Even the Score” began years before the drug was fully developed, co-opting the language of feminism to convince women this drug will fix us. Even members of congress were enlisted to testify to the FDA on the drug’s behalf. It’s about an appalling lack of understanding of female sexuality or, more insidiously, a willful misrepresentation of it. If the truth were told, there would be nothing to sell.

It’s been done to us before, and that’s what the outcry should be about. How about that time formula companies undermined our confidence in ourselves and our bodies by convincing us to buy their product and feed our babies artificially? To be fair, it’s also been done to men with the overprescribing of testosterone. That campaign convinced men to ask their doctors about “Low T”—a marketing term developed to describe men with low testosterone levels caused naturally from getting older. Seven years and $9.7 billion in sales later, the FDA is finally pushing back due to the number of heart attacks and strokes caused by it.

Understanding this issue centers around the definition of normal female sexual response. What is that and how is that determined? Wouldn’t we all like to know? It’s time for the acronyms to figure it out. Let’s start with HSDD, Hypoactive Sexual Desire Disorder, defined as a persistent lack of sexual interest, lack of desire to be sexual, lack of motivation, lack of fantasies. Essentially, not wanting sex. Then there’s Secondary HSDD, defined as women who previously had normal sexual arousal but for no medical or physical reason no longer do. These are the women who participated in the flibanserin trials. HSDD has now been changed to FSIAD (Female Sexual Interest and Arousal Disorder) by the American Psychiatric Association. Stay with me for the explanation why because it’s key to understanding this whole thing.

What secondary HSDD (the drug trial subjects) doesn’t account for is something called responsive sexual desire. According to Dr. Emily Nagoski of Smith College and author of “Come As You Are: The Surprising New Science That Will Transform Your Sex Life,” responsive desire is a normal healthy way to experience sexual desire. “We have grown up being told that the only normal way to experience sexual desire is spontaneous, out of the blue anticipation of pleasure. And so when that goes away, we feel like we’re broken, like we must be doing something wrong.”

Over the last 20 years, we now recognize responsive desire is what’s normal. This is desire that emerges in response to the pleasure—to the touching, to the skin-to-skin contact, to the love and trust and relaxation you feel with a partner. It’s vastly different from the male testosterone-driven ready anytime state. And so it’s the recognition of responsive desire which has led to the change to FSIAD. This much narrower distinction exists to describe the vastly smaller number of women who legitimately suffer severe sexual dysfunction and for whom a pill like flibanserin should be developed.

What’s most effective in treating women who think they have low libidos? Education on what’s normal. Individual and couples counseling, focusing on mindfulness training to teach couples about putting pleasure and sensation of the center of sexual well being instead of spontaneous wanting or craving. Allowing women (and men) to understand that every sexual encounter doesn’t have to end in intercourse. Anxiety and depression management. It’s not just a woman’s problem; it’s a couple’s issue.

An industry index measuring sexual desire and satisfaction shows that scores for mindfulness and psycho-education interventions are much higher than the outcome scores for flibanserin. As to Sprout’s drug trial, women were excluded if they had any therapy of any kind, including individual or couple’s therapy. And though it might sound facetious and simplistic, The Washington Post reported that women whose spouses shared equally in household chores reported the highest sexual satisfaction and the highest number of sexual encounters. The idea of excluding all else for consideration and instead encouraging women to simply swallow a little pink pill is what’s truly offensive. Just pat us on the head with a paternalistic, “There, there. It will all be fine.”

Flibanserin is not a one-off pill like Viagra, a pill which treats in a physical way, increasing blood flow to erectile tissues. Flibanserin affects the brain’s neurotransmitters dopamine and seratonin thought to regulate sexual arousal. This is a drug regimen women would take on a daily basis, not when they want to have sex.

The frustration of being ignored by the medical establishment is real. Women have been dying of heart attacks for years because our symptoms present differently than men’s. And for women who legitimately suffer from sexual dysfunction, a drug to alleviate that condition would be a blessed relief. But this isn’t it. What looks like a victory for equality should be exposed for what it truly is: mass market manipulation of our psyches to get to our pocketbooks. Marketing that created a disease that doesn’t exist to sell a product which was created for that very purpose. Still sound like a victory for women?

Reach DCP writer and food critic Paula Johnson at PaulaJohnson@DaytonCityPaper.com

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Sarah Sidlow
Reach DCP editor Sarah Sidlow at SarahSidlow@DaytonCityPaper.com.

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