Femininity and Drugs?

Just as the concepts of Recovery, Citizen Scientists and pretty well everything else can be captured by pharmaceutical industry, so also feminism and claims of sexism are now being hijacked by industry as marketing tools.

FDA are accused of being sexist in not licensing a ‘female Viagra’. This claim is being used to mobilize pressure on them to license a pharmaceutical solution which will bring into being the linked diagnosis of ‘female sexual dysfunction’ (FSD).

There is sexism in the FDA. But this is better illustrated by looking at the Ambien story where the failure to require an analysis of the effects and side effects of this drug dis-aggregated by gender meant women have been overdosed for over a decade with this drug.

Ambien (zolpidem) is a commonly prescribed sleeping tablet. The same dose gives a doubling of blood levels in women compared with men. In 1992, the data were included in the FDA review of the drug. But there was no recommendation for a differential dosing of this drug until January 2013. The example of Ambien should mean there is a requirement for safety or efficacy analyses of all new drugs by gender. This is the issue for women.

This post is by Leonore Tiefer, Chair NewViewCampaign.org.

“Female sexual dysfunction” – on the docket again!

Ever since Viagra was approved for erectile dysfunction in 1998, Big Pharma has been looking for a similar blockbuster drug to market to women. Sales would be huge because much research shows women are often frustrated and dissatisfied in their sexual lives.

However, despite testing hormones, vasodilators, and central nervous system agents, despite testing patches, pills, gels, pellets, lotions and intranasal sprays, Big Pharma has failed to produce clinical trial data showing sufficient safety and effectiveness to impress the FDA. That’s where the situation stands at the moment.

The industry continues to pressure the FDA using a variety of extraordinary public relations campaigns. Who can forget “sexbrainbody.com” in 2010 or “Yourvoiceyourwish.com” in 2013.

The most recent, “Eventhescore.org” 2014, claims that the FDA is “sexist” because sexuality drugs have been approved for men but not women. The false facts behind this argument (not to mention the outrageous hijacking of feminist political language) has not prevented the involvement of various professional organizations, women’s rights groups, and even women congresspeople. Our group created a petition to challenge the deceptive “Even the Score” PR campaign about so-called gender bias at the FDA.

Please SIGN and circulate – http://www.ipetitions.com/petition/end-deceptive-pr-about-womens-sexual-health

But the PR campaign is not the only important “female sexual dysfunction” event this fall. As part of a new initiative on “Patient-focused drug development“, the FDA is having a series of 2 day meetings during 2013-2015 – and one on “female sexual dysfunction” is scheduled in Silver Spring, Maryland for October 27/28, 2014.

It won’t focus on a specific drug, but rather on hearing from female patients about their experiences – the severity of their distress, their specific symptoms, how their symptoms affect their daily life and mood, what they’ve tried and how things worked out. Here’s the specifics about the meeting – it’s free and open to the public. Drs and drug companies will be bringing patients to tell their stories, and the main organizing effort of the New View Campaign will be to recruit ordinary people to tell stories about how they resolved or ameliorated their sexual problems through non-medical interventions — reframing their problems, sexuality workshops, couple therapy, individual counseling, reading/study, consciousness-raising, use of vibrators and lubricants, a new partner, online learning, prayer, whatever.

The FDA is reaching out to learn what women are suffering and experiencing, what they are trying in the way of remedy, and how it’s working out. This is a worthwhile endeavor, but not if the only people who show up were brought by doctors and drug companies to sing the praises of medical solutions for women’s problems with pleasure, desire, arousal, and sexual satisfaction.

There will be opportunities for “patients” and “experts” not only to speak from the floor but to submit written statements. The New View is collecting letters and statements similar to the letters we brought to the FDA Advisory committee hearing on flibanserin in 2010. (The FDA voted against this unsafe and ineffective central nervous system drug.) The 2nd day of the hearing (Oct 28) will be devoted to scientific issues/dilemmas that are important in clinical trials – definition, measurement, trial endpoints, etc. Our statement/letters can address these issues, too.

We are also developing a bibliography of recent empirical studies about effective non-medical treatments and ineffective medical treatments (e.g., hi discontinuation rates for ED drugs). Take a look at the bibliography from the flibanserin hearing – we want to add studies published since 2010.

As we did for the hearings on Intrinsa (2004 – the first “female sexual dysfunction” drug, a testosterone patch, also rejected by the FDA) and flibanserin, we will produce FACT SHEETS to be used by the FDA, the press, and scholars and students.

Here are some possible topics for our fact sheets:

1. Sexual normalcy,
2. The history of “fsd” medical treatments,
3. The disappointing effort of the DSM-5 to fix the nomenclature,
4. Placebo effects,
5. User discontinuation of sex drugs and explanations,
6. The confusing world of “fsd” questionnaires,
7. Pre-approval marketing initiatives.

Don’t be flim-flammed by Big Pharma’s PR campaigns with their Cheshire Cat sympathy for women’s sexual distress. There are many safe and effective interventions already available for women’s sexual problems. Please contact our group if you would like to be involved info@newviewcampaign.org, and please sign our petition with your full name – ignoring the request for $ – it’s $ for ipetitions not for us!