By Kari Christianson
Program Director, DES Action USA
Pink Viagra – Really?!
The Food and Drug Administration has been seeking input from women about the condition “Female Sexual Dysfunction.” This is a fairly new term for low libido in women and has not been recognized by the American Psychiatric Association. The FDA wants to hear from women about their experiences with this condition and the treatments they have tried.
DES Action USA sent a letter to the FDA outlining our concern about the safety and efficacy of any drug intervention for women, let alone for a dysfunction only recognized by the pharmaceutical industry.
So why is DES Action concerned about this type of drug? For one thing, we know from experience what can happen when the FDA approves a drug that is not sufficiently tested for safety and effectiveness. In the case of the anti-miscarriage drug, diethylstilbestrol (DES), millions suffer with cancers, infertility and other health consequences in what is known as the DES Tragedy. Therefore, we speak with some authority on why the FDA should move cautiously on approving drugs, and especially the one under consideration for female sexual dysfunction.
Gender Equity? What About Side Effects Equity?
In something of an open secret, the pharmaceutical company that is looking for FDA approval of its ‘Pink Viagra’ pill has worked behind the scenes to create a movement in support of its drug. Some groups (often with funding from the drug industry) have asked whether the FDA is holding women’s sexual satisfaction to a different standard, because several drugs have already been approved for male sexual dysfunction. As a population already harmed by an FDA-approved drug, we at DES Action wonder if political and media attention is the reason for the FDA first denying, then reconsidering drugs for a female health or disorder issue, without enough attention to safety and effectiveness.
This gender equity argument ignores the real safety difference between any drug that has been under consideration for female sexual disorder and the drugs that have been approved for men. All but one of the ones approved for men are taken on an as-needed basis, whereas a drug for women, a so-called ‘Pink Viagra,’ works in the brain on the central nervous system. This type of medication requires daily, long-term use. And what would the daily use mean? Certainly the FDA would need to subject a drug of this type to extensive safety scrutiny. The long-term health of women, as well as generational exposure through pregnancy during a long-term treatment, requires cautious evaluation.
DES Action’s online community of DES Daughters has shared information about non-drug hormone-free alternatives and natural remedies that effectively deal with vaginal dryness. That’s one of the leading reasons for sexual discomfort and disinterest. This sharing of our on-going health and sexuality experiences is itself something of a remedy. By hearing what others are experiencing, we learn about ourselves, what is common, what is normal, and what we can do to relieve symptoms of vaginal dryness safely and inexpensively, without pharmaceutical intervention. There are options besides getting another prescription filled.
No one, particularly the FDA, should be in a rush to “fix” women’s bodies via drugs. DES Daughters are living proof that good intentions and poor research lead to disaster, potentially for generations to come.
You can share your thoughts with the FDA, which is taking comments at http://www.regulations.gov/#!submitComment;D=FDA-2014-N-1413-0001 until Dec 29, 2014. At the top indicate: Docket ID: FDA-2014-N-1413 and state that you are writing to comment for the Oct. 27, 2014, Patient-Focused Drug Development meeting on Female Sexual Dysfunction. Then, go ahead and tell the FDA how you feel about this.
