A company called Sprout pharmaceuticals was bought last week for $US1 billion. Not bad for a company which, according to the New York Times, was created in 2011, has 34 employees and has had $US100 million invested since its inception.
The company was formed to acquire the rights to a drug, which has been rejected by the FDA.
How does this happen?
And what is this drug, which was abandoned by its original makers, which was rejected twice, and with no new scientific basis has now been approved? It is flibanserin, better known erroneously, as pink Viagra.
I say erroneously because whatever else this fairly useless (more on why later) drug is NOT, repeat NOT analogous to Viagra and its like. To understand why, it is necessary to do a quick recap on human biology.
In male sexuality there are two aspects, being interest (desire) and capability. To have intercourse requires blood to flow to the penis, making it erect. Medications like Viagra relax the blood vessels allowing more blood to flow to the penis hence allowing erections to last longer and possibly be harder. This does not work in everyone who takes it and there are side effects. The tablet is only taken on an as you need to basis.
It does not stimulate libido or desire. Thus if a man wants to have sex but is not able to get an erection tablets may help. They do not make someone want to have sex.
Contrast flibanserin, related to a class of antidepressants. It is supposed to stimulate desire or interest in sex. It is in no way shape or form a “pink Viagra”. Thus we see lesson one in marketing of drugs; create a perception. Because both are for matters to do with sex, lets just ignore that they have nothing else in common.
The FDA rejected the drug twice for very simple reasons. It does not actually achieve much and side effects can be serious. Trials showed an increase in sexually satisfying events of around 0.7 per month for women taking the drug compared to placebo. And the drug must be taken every day (whereas Viagra is taken only as needed). Side effects include low blood pressure to the point of fainting. To cap it off women must not consume alcohol whilst taking it.
Does this sound like a wonder drug?
But the campaign to get it approved skirted around the lack of benefit and problems of side effects by playing the gender card. To argue that it was discriminatory for the drug not to be approved, the company funded a “movement” called even the score. If men have Viagra women need something. This movement was well described by critics as astroturfing. It looks like a real movement but is not real (just as astroturf is not real turf.)
In addition lack of interest in sex was medicalized as Hypoactive Sexual Desire Disorder (HSDD). Thus the drug is not just for a lifestyle issue but a “real disease”. This adds to the discrimination case. After all not getting an erection was medicalized into “Erectile dysfunction” in the 1990’s prior to Viagra coming to market.
So it presented as a “win” for equality to have a twice-rejected drug approved. One that has little actual effect has potentially nasty side effects, and which must be taken everyday. All the while women who for a variety of reasons (tiredness, genuine illness, relationship issues to name but three) have a different level of interest in sex to their partners are told they have an illness.
The approval by the FDA of this drug represents the most egregious example of marketing and political correctness triumphing over any vague notion of medical science.
Given the payday, which followed for those behind this marketing triumph, we can expect to see more of the same.
Dr Joe Kosterich M.B.B.S is an author, speaker, media presenter and health industry consultant, who wants you to be healthy and get the most out of life. Dr Joe also gives practical, motivational health talks for the general public and organisations where he is known as “An independent doctor who talks about health”.
His latest book “60 minutes to Better Health” is available on Amazon.
Medical Doctor, author, speaker, media presenter and health industry consultant, Dr Joe Kosterich wants you to be healthy and get the most out of life.
Joe writes for numerous medical and mainstream publications, is clinical editor at Medical Forum Magazine, and is also a regular on radio and television.
Joe is Medical Advisor to Medicinal Cannabis Company Little Green Pharma, Chairman of Australian Tobacco Harm Reduction Association and sits on the board of Arthritis and Osteoporosis WA. He is often called to give opinions in medico legal cases.
He has self-published two books: Dr Joe’s DIY Health and 60 Minutes To Better Health.
In 2024 due to public demand he commenced a podcast, Dr Joe Unplugged, which can be accessed via Spotify, Apple or YouTube.
Through all this he continues to see patients as a GP each week.
