BBC Radio 4’s excellent series The Report has a very interesting show this week investigating the controversy around the approval and use of flibanserin (now sold in the United States under the trade name Addyi, and often referred to as the “female viagra”). Flibanserin is used to treat hypoactive sexual desire disorder.
Unlike viagra, which simply stimulates blood flow to help one maintain an erection, flibanserin is supposed to increase a woman’s desire for sex. It originally was developed as an antidepressant and then was put forward as a treatment for hypoactive sexual desire disorder.
As is the way of such things, and as the documentary pointed out, the Diagnostic and Statistical Manual (DSM) has since changed and through the waving of the American Psychiatric Association’s magical wand, hypoactive sexual desire disorder vanished and has been replaced in the fifth edition of the DSM with two new disorders: male hypoactive sexual desire disorder and female sexual interest/arousal disorder.
Before I get into the meat of the post, a quick aside: the asexual community have pointed out rather an interesting thing about hypoactive sexual desire disorder (and its spinoff conditions) is that not feeling sexual desire shouldn’t automatically be pathologised—doing so kind of puts asexuals in the same place gay people were when homosexuality was considered by psychiatrists to be a disorder. Given the long and rather sad history of attempts by the medical profession to pathologise sexual minorities—the legions of gay men zapped, drugged and generally tortured for the crime of loving other men is testament to the extreme folly of that approach—we should hope that the current generation of medics faced with the messy complexity of human sexuality deal with it in a more caring, open and tolerant way than they did in the past.
Anyway, back to The Report. In the programme, Melanie Abbott examines the gender politics around the approval of flibanserin. The producer of the drug, Sprout Pharmaceuticals, were supported in their bid for FDA approval by a campaign called Even the Score, an umbrella campaign supported by a whole host of different organisations including the feminist campaigning group, the National Organization for Women (NOW). The Report points out that both Even the Score and critics of the approval of flibanserin ended up using the rhetoric of equality: Even the Score talks about “women’s sexual health equity”. Before the approval of flibanserin, Even the Score’s website noted that the “FDA has approved 26 drugs marketed for the treatment of male sexual dysfunctions, compared to zero [now one] to address the most common form of female sexual dysfunction”.
A critic of the approval of flibanserin quoted on the programme called Even the Score an “astroturf” campaign funded by Sprout Pharmaceuticals. An astroturf campaign from a pharmaceutical company? Whatever next? Next you might suggest that a pharmaceutical company might manipulate the patent system for profit or that they might drastically ramp up the prices of drugs in order to profiteer off patients who have no choice but to buy their products or die a grisly death? Or, slightly less drastically, that they might engage in manipulation of data, hiding of trial results, selective statistical fiddling and an overly friendly (one might even say incestuous) relationship with regulators. You’d have to be some sort of loon to believe that, obviously.
Anyway, The Report spoke to the CEO of Sprout Pharmaceuticals, Cindy Whitehead, and asked her a pretty simple question which, if answered clearly, would show how not-astroturf-ish Even the Score was:
How much money did Sprout put into Even the Score?
We don’t disclose any of our financial investments to coalition efforts, medical societies, or any of the other groups we work with on education.
Abbott follows up:
Wouldn’t it be fairer for people watching this story for them to know how much?
It’s a very interesting perspective that people seem so particularly interested in this—in this patient advocacy movement when I don’t see that same level of interest in advocacy movements for conditions like diabetes or breast cancer.
Well, that’s a fair point. And I mean nobody bangs on endlessly about the transparency and behaviour of, say, breast cancer awareness groups for slightly dodgy relationships with big companies, or for excessive and expensive trademark enforcement against other charities.
Here Whitehead reveals exactly why transparency is needed throughout the pharmaceutical industry. Perhaps Even the Score is a perfectly legitimate grassroots organisation. There are surely women who suffer from sexual desire problems and there may even be a case that women’s sexual healthcare is treated as an afterthought compared to men’s sexual healthcare. Female sexual and reproductive health is certainly demonised, mythologised and judged a whole lot more often than male sexual health is.
But while the relationship between pharmaceutical companies and patient advocacy groups (and medical societies, and charities) remains both cosy and extremely shady, cynics have every right to look askance at any campaign group whose interests align with that of a pharmaceutical company sponsor. Patient advocacy groups will speak very loudly about NICE not approving drugs but keep eerily silent about the high prices charged by the manufacturers. One must not bite the hand that feeds.
Back in 2013, a leaked email that was originally sent between drug companies showed that they planned to use patient groups as a key part in fighting against campaigns to require them to open up trial data, even though such transparency will allow doctors to better inspect data, spot anomalies, do unplanned group analysis, and better find side effects. This demonstrates the kind of relationship that exists between drug companies and patient advocacy groups. Without clear disclosure of the money given to patient advocacy groups, one must be somewhat skeptical of them.
The Report also mentioned that Cindy Whitehead used to run marketing at Slate Pharmaceuticals while her husband Robert was Slate’s CEO (before Cindy took over as CEO of Sprout, can you guess who was running Sprout?), they were marketing Testopel, a testosterone pellet for in men with hypogonadism. They received a massive dressing down from the FDA for their marketing materials, which included suggestions that it could be used as part of treatment for a whole variety of things that the FDA hadn’t been given evidence for including erectile dysfunction, type II diabetes, HIV, depression and even just as a way to improve sexual and athletic performance. The FDA also stated that Slate’s website for Testopel contained misleading and unsubstantiated claims regarding the cost of the medication, pain and side effects.
If you are looking for more of the tell-tale signs of pharma industry fun and games, have a read of this piece in The Atlantic. It notes how flibanserin’s clinical trial processes have changed over the years, going from asking patients about the desire they felt every day, to asking them about the desire they’ve felt over the last four weeks. A cynical person might suggest that changing your way of measuring outcome over time when you find out it gives you more promising results isn’t exactly kosher. But, as Cindy Whitehead said, why just pick on flibanserin? Fiddling outcome metrics and jumping between primary outcome measures when they give you pesky inconvenient data is just routine, just as rather uncomfortable funding arrangements with supposed patient advocacy groups is. We shouldn’t necessarily pick on Sprout or flibanserin—the problems of the pharmaceutical industry are systemic and widespread, and the pharmaceutical industry is keen on ensuring reform efforts (like AllTrials) is kept slow and watered down if it can’t be killed off entirely.
Anyway, if you are interested in the interplay between politics, healthcare, sexuality and the pharmaceutical industry, it is well worth listening to this week’s episode of The Report.