How labeling a drug ‘female Viagra’ is misleading women.
Flibanserin treats female sexual desire, but it’s nothing like Viagra.
By Lucy Goodchild van Hilten June 14, 2016 Elsevier Connect.
When Pfizer scientists Andrew Bell, David Brown and Nicholas Terrett developed sildenafil in the 1990s as a treatment for angina, they could not have expected the impact it would have on men’s health. The drug works by dilating blood vessels as a response to constricted blood flow, but it doesn’t just have an impact on the heart; sildenafil also causes erections.
Better known as Viagra, the drug has become a household name since it hit the market in 1998. But while it transformed the intimate relationships of millions of men with erectile dysfunction, questions soon emerged about a female equivalent – why were women’s sexual problems being ignored?
Now the media has hailed a new drug – flibanserin – as the answer. Dubbed the “female Viagra,” flibanserin is designed to treat female hypoactive sexual desire disorder (HSDD). The problem is it’s nothing like Viagra; it acts on the brain, not the blood vessels, and it actually seems to be less effective than first hoped.
Misleading labels.
Despite the differences, there is one similarity between flibanserin and sildenafil: they ended up being approved to treat a condition that wasn’t the original target of their development. In the case of flibanserin, this was depression. Clinical trials showed that the drug was not effective as an antidepressant, but during the trials some prosexual results were observed.
The US Food and Drug Administration (FDA) approved flibanserin, under the name Addyi, in August 2015 to treat low sexual desire in premenopausal women. But according to Dr. Heidi Collins Fantasia, Assistant Professor at the University of Massachusetts Lowell School of Nursing, the effects of flibanserin are not all that striking, with women reporting an average of 0.5 to 1 additional satisfying sexual events per month. In a new paper published in Nursing for Women’s Health , she examines the evidence supporting the drug and looks at its potential impact on nursing practice:
It does work, but it’s not like you take this medication and the effects are going to be widespread and immediate. One counseling point when speaking to women is that they really need to know what to expect. When a man takes Viagra he gets an erection; it doesn’t work like that with this drug. Flibanserin needs to be taken every day, and even after taking it for the recommended time the results might be very small or it may not work at all. Taking the side effects into account, is it worth it? That will be an individual decision for each woman.
The potential side effects are significant. Hypotension, possibly leading to fainting, dizziness, fatigue and sedation have all been reported. And hypotension increases with alcohol, so women taking flibanserin are not supposed to drink at all. Because of these side effects, and the fact that the clinical trials were limited to premenopausal women, have led the FDA to put some tight restrictions on its use. The price tag is equally restrictive at $400 to $800 a month.
The FDA has also put a moratorium on direct-to-consumer advertising for the first 18 months, and doctors who want to prescribe it and pharmacists who want to dispense it must first take an online test. Regardless, there has already been a lot of “off-label” prescribing, particularly in postmenopausal women. Dr. Anne Katz, a sexuality counselor at CancerCare Manitoba in Winnipeg, Manitoba, Canada who has written a commentary on female desire in Nursing for Women’s Health , believes this could muddy the water:
I’ve already seen anecdotal evidence of one particular physician who has been a huge supporter of the drug and being paid by this drug company, talking about post-menopausal women using flibanserin. I’ve even seen post-menopausal women on TV talking about how it’s helped them – this is all off-label use, which can only serve to confuse our understanding of the impact of this drug.
So what impact will the drug have? According to Dr. Collins Fantasia, any attention it brings to the issue of female sexual health is positive:
There hasn’t been a lot of focus on women’s sexual health. Attention to these issues is a good thing and will help open the dialogue. Women who may have been struggling with this for years but not brought it up to a provider, so that attention will definitely move it forward. Does it mean everyone needs to take medication? Probably not. But it does help raise awareness and start the conversation that maybe more people are experiencing a sexual problem that they have been reluctant to discuss with their health care provider.
And Dr. Katz pointed out the efficacy of flibanserin may be less powerful that the effect of simply taking a pill:
One of the issues with these kinds of drugs is the placebo effect is huge. So if you put a woman in the trial and she may be getting the experimental drug that she knows is meant to increase her libido, that in itself can increase her libido. So let’s just give women Smarties.
Creating a condition.
An estimated 12 percent of women will report a sexual problem at some point in their lives, such as a problem with sexual desire, like HSDD. Women with HSDD have low or no interest in sex, causing difficulties in their intimate relationships. It is a self-reported problem – it’s not something that’s simple to diagnose, and there is no test, so our understanding of the HSDD is actually quite low.
One criticism of flibanserin is that it’s being used to treat a problem that exists on a continuum and isn’t as clear-cut as the developers may have led people to believe – low sexual desire might be a problem for one woman, but not at all for another. Indeed, many people consider themselves asexual – in this case, lack of desire is a sexual orientation, not dysfunction. “There is no set norm for how much interest you are supposed to have in sex,” said Dr. Collins Fantasia. What might work for one couple is not ok for another couple. This gets to be the difficulty behind receiving this diagnosis, and thinking ‘do I need to treat it with a medication?’”
In her commentary, Dr. Katz describes a flawed study that suggests almost half of women may have some sort of sexual dysfunction; this plays right into the hands of the manufacturers. In fact, in her article Dr. Collins Fantasia points out: “some health care providers have questioned whether this disorder has been created merely to sell a product and increase pharmaceutical profits.
The pharmaceutical company that developed flibanserin recognized the dearth of drugs for female sexual problems and supported a “grass-roots” campaign called “Even the Score” to rally women in support of developing treatments. It might look like a problem of fairness on the surface, but it all boils down to money, said Dr. Katz:
They made it a gender issue, but in the end it’s about profit. 52% of the population did not have a pro-sexual drug. You’ve got a group of drugs for male arousal, but nothing for women’s sexual problems. The pharmaceutical industry is there to make profits for its shareholders, and this was one way to do that.
A different view of desire.
Applying the same approach used to treat male sexual arousal dysfunction – medication – to the more complex, less well understood female sexual desire problem may not be the right course of action, as Dr. Katz explained:
We live in a fairly male-centric world. Male sexuality is perhaps easier to understand because it’s more visual. When a man is aroused, you know he’s aroused; when he has an orgasm it is usually accompanied by ejaculation, so it’s clear something has happened. The female sexual response is anatomically and physiologically more hidden. And then you’ve also got the overlay of women’s sexuality being viewed as evil, suspect, something to be denied and forbidden. Even though it’s 2016, some of those remnants still cloud the discourse on sexuality.
Effectively, we’re treating women’s sexual desire as if it’s problematic, because it doesn’t suit men. Women bought into this hook, line and sinker, said Dr. Katz.
Look at women’s magazines, there are often things in them about how to increase your desire, portraying women’s sexuality in a way that it’s disordered or dysfunctional. It’s not. I work in oncology as a certified sexuality counselor. Many of the things we do to people with cancer impact on them and their view of themselves as sexual beings; often women come in and say ‘my desire is out the window, what happened?’
It’s not just about hormones, sexuality happens in the context of our lives. So if you are parenting young children or your own parents, if you’ve got a stressful job, if you’ve got multiple jobs, if you’re studying and working at the same time, if your partner is helping you around the house … that all affects whether you are going to be interested.
On top of that, for women, sex has a price: every sexual encounter is a potential pregnancy. So physiologically the body interprets sex as having that outcome, and the physical response could be to avoid it if the woman isn’t strong enough for a baby. Essentially, low libido could be a protective mechanism. Dr. Katz continued:
Sexual response is different for a woman. We now understand libido – interest in sex – is responsive in many women. If the circumstances are right, there is some initiation, the woman feels good about herself and has the time, that’s when desire kicks in. Women aren’t walking around all day looking for sex, and women’s sexual desire is not necessarily a medical problem in need of pharmaceutical treatment.
What’s confusing the discourse is flibanserin being labeled “female Viagra” by the media. Viagra treats arousal, which involves nervous impulses causing the blood vessels in the genitals to relax and let blood in. Flibanserin treats desire, which is controlled by the brain. It interacts with serotonin and dopamine receptors in the brain, which are involved in sexual desire, but it’s still unclear how this increases desire.
For now, flibanserin can only be prescribed by well-briefed healthcare providers, and it is licensed for restricted use in pre-menopausal women who don’t drink and aren’t taking any other medications. But when the moratorium on advertising is lifted, the potential market opens up and the drug could have an impact – be it positive or negative – on many more women. Is it likely to lead to big changes? Dr. Katz doesn’t think so:
I don’t think this is going to save relationships, frankly. For me in many ways it’s an issue of context: what is the context of your life and relationship? This thing you’re seeing as a sexual problem, is it really a problem? Will the context of your life be altered by taking medication every day, which has side effects, for perhaps a minor increase in sexual activity? We should really look inward at what the woman wants, not at what society tells her she should want.
Dr. Collins Fantasia agrees that the decision remains with the woman:
If women are experiencing some type of sexual problem by all means they should bring it up with their provider. Whether this is the answer will be an individual decision for women, considering safety, side effects, cost and whether women are interested in trying this.
Ultimately, flibanserin is unlikely to be the miracle drug Viagra turned out to be, not only because of the fundamental differences between them but also those between the issues they are intended to solve.
Read the articles.
Elsevier has made these articles freely available until July 7, 2016:
The authors.
Dr. Heidi Fantasia is an assistant professor in the College of Health Sciences, School of Nursing at University of Massachusetts Lowell. She is also employed as a women’s health nurse practitioner for a Title X Family Planning and STD clinic in northeastern Massachusetts. Her research interests explore the intersection of violence and the reproductive health of women, including sexual consent, sexual coercion, and contraceptive use. Dr. Fantasia is on the editorial advisory board for the journal Nursing for Women’s Health and is the editor of the journal’s pharmacology column. She is the author of over 50 publications, including peer-reviewed manuscripts, books, and book chapters. Dr. Fantasia received a BSN from Salem State University and MS and PhD from Boston College. She completed a postdoctoral fellowship at Boston College prior to joining the faculty at the University of Massachusetts.
Dr. Anne Katz is the certified sexuality counselor at CancerCare Manitoba and Clinical Nurse Specialist at the Manitoba Prostate Centre. In these roles she counsels men and women with a history of cancer who are experiencing sexual and relationship challenges. She also supports couples through recurrence and treatment decisions at that point. She is the fertility preservation counselor for the organization and also runs a sexual rehabilitation program for women after radiation therapy.
Dr. Katz is the editor of the Oncology Nursing Forum , the premier research journal of the Oncology Nursing Society. She was inducted into the American Academy of Nursing in 2014. She has been an invited speaker at multiple international conferences and meetings and is the author of 12 books for health care providers and consumers on illness and sexuality as well as cancer survivorship. Two of her recent books have won prestigious awards.
The journal.
Nursing for Women’s Health publishes the most recent and compelling health care information on women’s health, newborn care and professional nursing issues. As a refereed, clinical practice journal, it provides professionals involved in providing optimum nursing care for women and their newborns with health care trends and everyday issues in a concise, practical, and easy-to-read format. It presents the practical application of evidence and innovation within the most important women’s health, obstetric and neonatal topics, including cardiovascular, reproductive and perimenopausal health, cancers in women, nutrition, aging well, normal and high-risk labor and birth, and newborn care. This journal is published by Elsevier.
Lucy Goodchild van Hilten.
After a few accidents, Lucy Goodchild van Hilten discovered that she’s a much better writer than a scientist. Following an MSc in the History of Science, Medicine and Technology at Imperial College London, she became Assistant Editor of Microbiology Today . A stint in the press office at Imperial saw her stories on the front pages, and she moved to Amsterdam to work at Elsevier as Senior Marketing Communications Manager for Life Sciences. She’s now a freelance writer at Tell Lucy.
Follow me on Twitter .
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How labeling a drug ‘female Viagra’ is misleading women
