Addyi Update

Article taken from page 6 of March/April Newsletter 2018

By Negar Esfandiari and Kara Cotto

In 2015, Valeant, a pharmaceutical giant known for price gouging and shady business practices paid $1 billion in cash for a flawed sexual enhancement drug marketed to women with so-called “acquired generalized hypoactive sexual desire disorder.” The drug, flibanserin, is sold under the name “Addyi,” and is described as the female version of Viagra. Despite the huge amounts of money involved, the drug’s a bust. It’s crucial for women to understand the small pink pill’s dangerous side effects and high risks, and how consumers are being manipulated by drug  company marketing.

Numerous factors can decrease women’s libido, including significant life events like having children, breastfeeding, environmental changes, job dissatisfaction, unemployment, relationship problems, aging, illness, and others. These experiences commonly create stress that can be a major driver behind decreased sexual desire and/or satisfaction. Women can experience a decline in libido without these life circumstances, of course. But, when that happens, it is vital to consider other causes before jumping for the prescription pad. For example, medications for severe depression, anxiety, and high blood pressure can have a negative effect on libido.

The pharmaceutical industry, however, is working hard to medicalize women’s loss of libido, branding it a health-related dysfunction that needs to be fixed with a pill. This is dangerous. Pharmaceutical companies have invested astonishing amounts of money in Addyi’s promotion despite the fact that its effectiveness, reliability, and safety are all highly questionable.

Addyi was previously owned by Sprout Pharmaceuticals. After twice rejecting it, the Food and Drug Administration (FDA) approved flibanserin for prescription use in 2015. The NWHN opposed the approval, because the research behind the drug is shaky, at best. Only 10-20 percent of women in flibanserin’s clinical trials reported experiencing a benefit from the drug. It’s also complicated to use, unlike Viagra. Viagra addresses a physical problem by releasing blood flow in men who have difficulty with erectile dysfunction, and is taken prior to sexual activity. Flibanserin works completely differently; it targets neurotransmitters in the brain and women have to take it every day. And, it has pretty serious side effects. Addyi essentially functions as sedative; a number of women in the clinical trials actually lost consciousness after taking flibanserin, and suffered concussions as a result. So, the daily prescription must be taken at night, to reduce the risk of injury from fainting and falling (or crashing one’s car!). And, because of Addyi’s apparent interactions with other drugs, including alcohol, the FDA required the manufacturer to do a series of post-approval studies and instructs women that it is unsafe to drink alcohol while taking it.

As a result of the serious hazards associated with the drug, the FDA issued a “Black Box” warning for Addyi, the strictest drug warning.

The drug is doing so poorly in sales that Valeant eliminated dozens of sales representatives who marketed Addyi. Yet, Addyi boosters are not giving up on the low-performing drug.

Back to 2015. That year, Valeant purchased Addyi from Sprout for $1 billion. Yes, you read that correctly: $1 billion was invested in a drug that is neither effective nor safe. But, after making this heavy investment in Addyi, Valeant announced last year that it was selling Addyi back to Sprout for practically nothing. In fact, Valeant is actually loaning Sprout $25 million to help start its manufacturing operations.

Since the FDA has limited ability to act as a watch guard on already-approved drugs, it’s up to women’s health advocates like the NHWN to provide facts about the flibanserin’s dangers. We will continue to advocate for thorough testing to ensure that all approved drugs are both safe and successful.  As long as Addyi hasn’t been withdrawn from the market, we’ll continue to pressure the FDA to ensure that the overdue safety tests are finally completed, and that any potential ads don’t mislead women about the usefulness of this drug.

 

Negar Esfandiari is a graduate of the George Washington University, where she studied English and Women’s, Gender and Sexuality Studies. She is the NWHN Communications intern for Spring 2018.

Kara Cotto is a senior at Old Dominion University in Norfolk, VA, pursuing a Bachelor’s degree in Digital Communications and Psychology. She was the NWHN Communications intern for Fall 2017.