Nearly three years after obtaining the Food and Drug Administration’s approval, the sexual desire drug Addyi — commonly but inaccurately referred to as “female Viagra” — is finally hitting the shelves. And while some of the barriers to access have disappeared, the controversy surrounding the drug has not. But what is it about this pill that causes such a stir? Is this a case of a drug not being safe or a question of valuing women’s sexual desire? In short, it’s complicated.
The little pill that could
Let’s back up a bit, because this story starts long before this week. Addyi — the brand name for flibanserin — is the first drug approved to treat low libido in women.* After being rejected by the FDA in 2011 and 2013, it eventually gained approval in 2015 thanks in part to a vocal coalition of women’s health and rights groups collectively known as Even the Score, which lobbied on behalf of the drug.
So why hasn’t it officially hit the market until now? After purchasing Sprout Pharmaceuticals Inc. (the company behind Addyi), Valeant Pharmaceuticals International Inc. dealt with a distribution scandal unrelated to Addyi that ultimately brought the rest of the company down too, Bloomberg reported. Then, in December 2017, following a lawsuit, Valeant handed Sprout back to its former CEO and the drug’s original champion, Cindy Eckert.
And now, six months later, Addyi is available with a prescription from risk evaluation and mitigation strategy-certified clinicians, including those available through a telemedicine service available through the drug’s website.
What does Addyi aim to do?
The FDA approved Addyi to treat acquired, generalized hypoactive sexual desire disorder in women who have not gone through menopause. In these cases, their low sex drive is troubling to them and is not caused by a medical or mental health issue, relationship difficulties or the side effects of another medication or drug use.
This is also a good time to address the “female Viagra” moniker, which was assigned by the media and is not an accurate way of describing the drug. While Viagra works by increasing blood flow to the penis, Addyi works with neurotransmitters in a person’s brain, Dr. Jessica Shepherd, an OB-GYN, tells SheKnows. “It’s an erection issue versus a libido issue,” she explains.
In other words, what Addyi is treating is more complex than a physical issue. Addyi and Viagra provide two different responses to two different issues. Essentially, Addyi works like an antidepressant (and was initially created to be one) by altering levels of chemicals that reduce inhibition and increase excitement.
Why is Addyi so controversial?
Here’s where things get interesting and where the conversation becomes about more than just the safety and efficacy of a drug, tapping into the deeply ingrained sexism and paternalism in medicine.
When the FDA decides to approve a drug or when a physician chooses to prescribe it (and a patient decides to take it), one of the key factors at play is determining whether the benefits of the medication outweigh the risks. Anyone who has ever seen a commercial for any prescription drug knows that each comes with its own list of side effects — that’s a given. But in order for a drug to be considered for use, its benefits have to outweigh the side effects and risks.
According to the FDA, the most common side effects of Addyi are dizziness, sleepiness, nausea, fatigue, insomnia and dry mouth. If these sound familiar, it’s because they are also the side effects of countless other medications.
Addyi also has what is referred to as a "black box warning" — intended to draw attention to serious or life-threatening risks — saying that those who take the drug must not drink alcohol. Shepherd thinks that this was “a little overkill” and that if you look at medications and their side effects in general (especially when it comes to alcohol use) “any one can have a black box warning if you think about it.” Interestingly, Eckert notes, in Canada no such warning regarding alcohol consumption was required on the packaging.
Valuing women’s sexual desire & pleasure
But it wasn’t just the side effects that were cause for concern to some: The FDA’s approval of the drug in 2015 also raised questions about how effective it actually is. And that’s where things get really complicated. Because unlike Viagra — where it’s clear when the drug is working because someone is able to get an erection when they normally couldn’t — there is no equivalent marker for female sexual desire.
That is only exacerbated by the fact that even in 2018, many people don’t recognize women’s sexual pleasure as valuable or even legitimate. If you assign no value to the benefit (in this case, women’s sexual desire and pleasure) in a risk vs. benefit analysis, then as Eckert puts it, “any risk would be too great.”
Of course, Viagra and other erectile dysfunction drugs also come with their own set of side effects; the difference is that we trust men enough to allow them to make their own medical decisions.
Along the same lines, a lot of people — doctors included — don’t understand how sexual desire works. All too often, if a woman expresses having a low sex drive, she’s told to buy sexy lingerie or read Fifty Shades of Grey or relax, when in fact, we’ve known for some time (since 1977, specifically) that there’s a neural basis for low libido, Eckert explains.
To be clear: Having a sex drive doesn’t mean being turned on and ready to go 24 hours a day, seven days a week; it’s normal for desire to ebb and flow. Much like an antidepressant isn’t designed to make a person feel euphoric — but instead return to feeling “normal” — Addyi’s aim is to allow women to return to whatever level of sexual desire had been normal for them in the past.
“[The drop in libido] is causing personal distress; it’s causing relationship distress,” Eckert says. “For them, it made no sense to me that they didn’t have access to a medical treatment option even though it exists.”
This brings us back to how we know if Addyi is actually effective. In one study, published in JAMA Internal Medicine in 2016, women who took the drug had an average of 4.4 “satisfying sexual experiences” a month versus 3.7 for women on the placebo and 2.7 before the trial started. This may not seem like a big difference, but according to Eckert, the FDA’s approval benchmarks — like “satisfying sexual experiences” — are all male metrics imposed on a drug intended for women, so it makes sense that the numbers aren’t exactly earth-shattering.
On top of that, Eckert explains that when you look at the data from some of the 11,000 women involved in Addyi’s clinical trials, you’ll read cases when, for instance, a woman reports having a sexual fantasy for the first time in years and then sending a sexy text message to their partner. Is that a measurable orgasm? No. But for people who lost their ability to even fantasize, this is a step in the right direction.
Who (if anyone) should take Addyi?
As a practicing OB-GYN, Shepherd says that she sees “the benefit of having a tool like this” for patients with hypoactive sexual desire disorder.
“I do think that the benefit outweighs the risks, and it should be back on the market because we don’t have much at all to tackle this issue,” she says.
However, it’s important to keep in mind that Addyi is not meant to treat all types of sexual issues — just hypoactive sexual desire disorder, which has a specific set of symptoms described in the Diagnostic and Statistical Manual of Mental Disorders, Shepherd notes. It’s not a magical pill that will turn someone who has always had a relatively low sex drive into Samantha Jones.
Aside from dispelling misconceptions about the drug, one of Eckert’s other goals is to make Addyi more accessible. In addition to making it available through a telemedicine consultation with a doctor, she also cut the cost of the drug back to her original prices of $25 per month for someone with insurance to a maximum of $99 per month for someone paying out of pocket (after Valeant significantly marked it up).
And even if you’d never need or consider taking Addyi, there are still gains being made by having this conversation about women’s sexual desire, Shepherd notes — especially if it means reducing some of the guilt or shame that may surround these issues.
Ultimately, though, it comes down to trusting women to make their own informed decisions about their bodies and health care. No drug works for everyone or comes without side effects — at least now, women have one more choice for attempting to have a satisfying sex life, as well as an excuse to talk about it.
*Not everyone born with female genitalia identifies as a woman, and not all people who identify as women have a vulva/vagina. But for the purpose of this article, the terms “female” or “woman” will be used to describe a person with a vagina, vulva and uterus, while “male” or “man” will be used to describe people with a penis.
Source: Read Full Article