Sprout Pharmaceuticals, the maker of so-called "Female-Viagra," looks to have slipped the Food and Drug Administration (FDA) a roofie. The company convinced regulators to approve Addyi, the first drug marketed to increase sexual desire in women. The pink pill had been rejected twice because it's barely effective and carries severe adverse effects. The lesson for drugs firms: a public relations campaign can be successful at changing the mind of a watchdog.
While sexual ennui may be a real problem, Sprout's pink pill is a poor antidote. It only helped about 10 per cent more patients than a placebo in clinical trials, increasing the number of times they had sex by 0.5 to one time per month. Worse, the FDA will require the drug to carry its stiffest warning - a black box on packaging that cautions the drug can cause severe low-blood pressure or fainting. It also advises patients not to drink or use certain drugs such as birth control pills while on Addyi. That seems unlikely in practice, as the statistical correlations between alcohol, birth control and sex are high.
Given high risk and minimal efficacy, the FDA should have rejected Addyi a third time. But a lobbying group called 'Even the Score' mounted an attack with the claim that 26 therapies had been approved for male sexual problems, while none were passed for female dysfunction.
There are two snags with this argument. First, there are no drugs for low desire among men either - so the FDA wasn't unfairly favouring one gender over another. Second, drugs like Viagra have a simple, well-understood biological mechanism, and are highly effective at increasing the physical ability required for intercourse. The underpinnings of desire, however, are complex, poorly understood and consequently difficult to control. It's simply easier to unclog a pipe than start a nuclear power plant.
'Even the Score' was founded by a consultant to Sprout and funded by the company. Sure, the campaign for approval found fallow ground in social media and letter-writing to a mostly male Congress. Real gender disparities do persist in medicine, such as the fact most clinical trials are on men. This wasn't one. The successful Addyi campaign shows that drug-makers can sway regulators with public lobbying when their science isn't persuasive.
While sexual ennui may be a real problem, Sprout's pink pill is a poor antidote. It only helped about 10 per cent more patients than a placebo in clinical trials, increasing the number of times they had sex by 0.5 to one time per month. Worse, the FDA will require the drug to carry its stiffest warning - a black box on packaging that cautions the drug can cause severe low-blood pressure or fainting. It also advises patients not to drink or use certain drugs such as birth control pills while on Addyi. That seems unlikely in practice, as the statistical correlations between alcohol, birth control and sex are high.
Given high risk and minimal efficacy, the FDA should have rejected Addyi a third time. But a lobbying group called 'Even the Score' mounted an attack with the claim that 26 therapies had been approved for male sexual problems, while none were passed for female dysfunction.
More From This Section
'Even the Score' was founded by a consultant to Sprout and funded by the company. Sure, the campaign for approval found fallow ground in social media and letter-writing to a mostly male Congress. Real gender disparities do persist in medicine, such as the fact most clinical trials are on men. This wasn't one. The successful Addyi campaign shows that drug-makers can sway regulators with public lobbying when their science isn't persuasive.