Interesting: some of organisations behind call to address “unmet need” of trt for female “FSD” are pharma. companies http://t.co/mQVDc1UB0Q
— Cynthia Graham (@cygraham_graham) June 5, 2014
See, it’s an organization that wants the FDA to approve a medication for women’s sexual dysfunction, because there are 26 for men and 0 for women. They want to “even the score.” Get it?
Of the 12 organizations identified on their about page, two are Sprout Pharmaceuticals (who now own Flibanserin) and Paladin pharmaceuticals.
Then there’s HealthyWomen.org, whose board of directors is dominated by people working for pharmaceutical companies or with backgrounds in the pharmaceutical industry (Christine Verini: Eisai Inc.; Virginia Valenze: Novartis; Linda M. Richardson: Sanofi-Aventis; Saralie Slonsky “has developed strategies to launch—and sustain support for—a multitude of prescription and OTC pharmaceuticals”; Oxana K. Pickeral “is an active participant in the pharmaceutical innovation community”) and whose site is sponsored in part by Pfizer, and states that it “welcomes partnerships with industry leaders, including pharmaceutical companies, consumer product companies, managed care companies, hospitals and health systems and media establishments.”
And Hisandherhealth.org and EmpowHer are all part of the same same “Vibrance Associates, LLC,” and the medical director of their “female sexual function site” is Jennifer Berman, well-known as a paid advocate of pharmaceutical treatment of women’s sexuality.
So, about half. About half of the organizations involved are directly linked to the pharmaceutical industry.
Do I think they mostly have women’s best interest at heart, despite potentially also having a profit motive? Yes. I think they’re good people who believe that a drug is what women need. I mean, it’s hard to disagree with their “about” statement:
Even the Score is a campaign for women’s sexual health equity is leading the fight for safe, FDA-approved treatment options for women’s sexual health dysfunction, and for the rights of women to make decisions on their treatment options with their doctors.
It’s also hard to disagree “that women have the right to make their own informed choices concerning their sexual health.”
However, I find it pretty easy to disagree “that gender equality should be the standard when it comes to access to treatments for sexual dysfunction.” I think it’s pretty inarguable that safety and efficacy should be the standards when it comes to access, approval, and every other aspect of pharmaceutical treatment. Gender equality is in the mix, for sure, but I’d rather have no drugs than an unsafe and/or ineffective drug.
Nor do I agree “that the approval of safe and effective treatments for women’s sexual dysfunction should be a priority for action by the FDA.” The reason I don’t agree with that is because “Even the Score” ignores the fact that there are NONPHARMA interventions THAT WORK – which is more than any drug can claim.
I’ve said before sex doesn’t have to be THE SAME in order to be FAIR. Similarly, a health intervention doesn’t have to be the same, it just has to WORK – and if what works for one group is different from what works for another group, so be it.
So let’s talk about “the score.”
First of all, I don’t know where the “26:0″ score comes from. I emailed the Even the Score folks, asking for a list of the 26 drugs, but have not received a response yet. I’ll let you know if I do. However, according to a 2013 report from the European Association of Urolology, there are three (PDF, p. 20), and a meta-analysis comparing different drugs compared 5: sildenafil, udenafil, tadalafil, vardenafil, and avanafil. So there might be 26 individual formulations, brands, combined drugs, and slightly-altered-so-as-to-keep-copyright drugs, but really there’s three… or five… and they’re all PDE5 inhibitors. And some of them don’t work very well.
According to this meta-analysis of five different PDE5-Is, the two most effective are tadalafil and vardenafil. Now, the biggest result I could find was this Turkish study of men taking SSRI’s, in which “92% of the tadalafil [(brand name: Cialis)] group thought the treatment had improved their erections and sexual activity compared with 8% of the placebo group (P < .001).” More typically, in this study of tadalafil in a general population, “67 subjects (45.9%) in the tadalafil group and 21 subjects (31.3%) in the placebo group” improved significantly.
And according to this meta-analysis on vardenafil (brand name: Levitra), “A total of 69% of men receiving vardenafil reported that treatment improved their erections compared with 26% of men allocated to the placebo group.”
So there are some examples of how the most effective drugs perform.
When we get down to the less effective PDE5-Is, according to this meta-analysis, udenafil (brand name: Zydena) “was efficacious in 55% of patients with ED 8-12 hours after administration” (p. 138, ”Comment” section of the paper). And that’s a drug with FDA approval. So it’s not like the standards for efficacy are ridiculously high.
(Oh, and while we’re at it? Medication combined with therapy is more effective than medication alone. FYI.)
So. I don’t know what” the score” actually is, I don’t even know how we would go about calculating it. But if we count “interventions that work,” rather than only counting “interventions with potential profit for pharmaceutical companies,” the score is way, way closer.