A customer complaint that his Viagra had not been dispensed led me, with the help of my street-facing CCTV camera, to discover his wife had dumped his Viagra tablets into the street wastepaper bin as she left the pharmacy with his monthly medicines. I’m not sure how common this phenomenon might be. Nor am I sure how the average, long suffering, partner of a 60-year-old, overweight male with minimal personal hygiene and bearing a strong resemblance to a church gargoyle, might respond to a guaranteed “night of prolonged passion”.
I was thinking of this as I joined Irwin for dinner following our industry sponsored meeting in Berlin – yes Big Pharma still do this type of thing but less so these days. Irwin’s recent claim to fame -he has a list of many he told me – was his contribution to the FDA licensing, in the US, of the female sexual desire drug flibanserin (Addyi).
Irwin was initially taken aback by my cynicism of the drug but he raised to the challenge in his attempt to convince. As we talked I saw the real Irwin and understood why he had so irritated me in our earlier meeting. He instinctively knows what most people want and he uses his considerable interpersonal skills and influence to push people in his direction knowing the unbelievers will eventually be forced to follow.
For me the flibanserin story is one of the darkest of modern drug regulation and I still feel FDA should be ashamed they allowed it to market. People power and a perverted view of equality forced FDA, a respected drug regulator, to concede to a public-relations on-slot and in doing so diminished its objectivity and reputation.
Flibanserin was developed as an antidepressant but performed poorly in early trials. Its main action suggests it might make humans happier while less inhibited but the evidence is poor. As dopamine is the desire chemical it was postulated flibenserin, increases brain dopamine levels, might improve sexual desire and since most men don’t seem to have much of a problem desiring sex, the focus for flibenserin was on women who apparently do. Studies in 11,000 women, claimed eminent sex doctors including Irwin, showed it was a major breakthrough. Others such as the FDA and Pharmed Out – a group committed to exposing overhype by Big Pharma- said the opposite.
In a simple model; there is a disease and there is a drug, with few side effects, that treats the disease. Where this is tested and shown to be the case the drug gets a license. It might be sexist to say but in this case the condition – the disease –comes from the controversial Diagnostic and Statistical Manual of Mental Diseases (DSMMD) which, to be fair, has been accused of inventing diseases on more than a few occasions. The disease in question, “hypoactive sexual desire disorder” (HSDD), is questionable but since the DSMMD says it’s a disease this provides justification for a drug cure. First we need some means to measure the condition and for HSDD the measure is the “satisfying sexual event” score. The score, for women with HSDD, is 2.75 events per month (pretty bad apparently). In the study women keep a diary record while they take flibenserin or a placebo. Results showed that those taking the drug improved their score from 2.75 to 4.5 while those taking a sugar-pill went up from 2.75 to 3.7. There were off course some side-effects in the flibenserin group including an impressive fall in blood pressure if alcohol was also taken.
Boehringer, the company who developed the drug, gave up the fight for a license in 2010 and sold on to Sprout Pharmaceuticals. Their forceful CEO Cindy Whitehead went all out. Rather than plan new studies to improve the data she went the PR route. “Even the Score” was her lobby group and was made up of national women’s organizations with the support of the Journal of Sexual Medicine of which Irwin is the editor-in-chief. Women’s sexual needs were being ignored; men have Viagra etc. for God sake therefore FDA had a gender bias in drug regulation and so flibenserin was to “Even the Score”. JAMA was not impressed seeing drug licensing hijacked by consumer advocacy groups. Pharmed Out called it “the worst kind of precedent”.
On getting a license Sprout sold immediately to Valeant Pharmaceuticals for $100 million. Charlie Munger of Hathaway (Warren Buffet’s Company) called Valeant’s business model “deeply immoral” in that they buy sale-rights to old but essential medicines and pump up the price. Flibenserin since it entered the Valeant stable has not been very successful. In the month following launch in 2015 only 227 prescriptions had been issued. Addyi is costly at $780 a month, alcohol must be stopped and doctors wishing to prescribe must do on-line training. Irwin claims he has 50 people on the drug.
Irvin’s passionate advocacy for female desire problems failed to convince me that Dan’s wife was suffering from any form of clinical syndrome especially one that would be resolved by a drug. Female Passion, and I am not an expert in this area, is not something that can easily be medicalised.
Terry Maguire is a pharmacist in Belfast