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Real men… drop out of drug trials

A clinical trial was stopped because an independent safety committee deemed that the risks of the study outweighed the benefits. Normally this would be seen as good ethical practice and a sign that clinical trials are becoming safer – but because this trial was for a male hormonal contraceptive, which was proving to be effective, the premature ending of this trial has been twisted into a battle of the sexes.

The problem is that the adverse side effects resulting in the termination of the study were: acne, muscle pain and mood disorders – some or all of these symptoms may be familiar to women already taking hormonal contraception. Upon this realization several articles were published criticizing men for their apparent inability to deal with the same symptoms women have to put up with daily.

But are these symptoms really the same? Of the 320 men in the trial 45% developed acne, if you compare this with female contraceptives – the pill actually reduces acne for 70% women, whereas the IUD seems to increase acne but only in 6.8% of women.

Still, cancelling a study for a few extra spots does seem rather dramatic; a depression rate of 2% however, mustn’t be ignored. During the study there was one suicide (which is uncomfortably explained-away as a consequence of academic pressure and not related to the contraceptive), one attempted suicide and one diagnosis of depression. The latter are declared as related to the study.

Of course there are also concerns around a link between use of the contraceptive pill and depression in women, particularly in adolescents. One study suggests an additional 0.5% of adolescents may develop depression if they are on the pill. However Dr. Gunter, an OB/GYN who wasn’t involved in the trial, cleverly points out that “anyone telling women not to use the pill because it’s possible an additional 0.5% of adolescents could develop depression….[should also be warning] these same women that they should certainly not be getting pregnant as 15% of women develop post-partum depression.”

Cancelling a study for a few extra spots does seem rather dramatic; a depression rate of 2% however, mustn’t be ignored.

Despite the side effects experienced from the contraceptive 75% men in the study would use it if it became available. This may sound mighty heroic but men as a collective certainly need to show more willingness when it comes to sharing the responsibility for birth control. Currently more money is invested in research on sterilising pets than male contraception. This is because pharmaceutical companies are sensitive to the fact that a male contraceptive will never be as profitable as a female contraceptive due to a lack of demand. So whilst dropping out of a clinical trial doesn’t make you a wimp, happily letting someone else take on the burden of birth control isn’t what heroes are made of either.

IMAGE: NHS Therapy Services

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