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Despite the limitations of current formulations, is it more important to bring a compound to market and then allow the public to decide?
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Diana Blithe, PhD
Yes, public decision is important
Absolutely, it is more important to take a compound to market and allow the public to decide. The perfect use rate for oral contraceptives for women is generally around 99% or so, but the typical use rate is somewhere around 92%, and a lot of women discontinue the method. So, working toward a male pill that has the same efficacy and perfect use of 99% is maybe too high a bar. If a woman can’t take a hormonal contraceptive or use an IUD, her options for pregnancy prevention are limited to less effective methods such as diaphragms or condoms.
So, 99% perfect use rate for a male method would be optimal, but would a method with a 92% typical use rate still provide protection? The answer is yes, it would protect her at least as well as many available female methods.
Additionally, there has been talk about whether or not the hormonal methods in development are effective in every man and there’s been a 100% response goal. Many times the response rate is only 95% and experts worry about the 5% of non-responders.
But, it is simple to identify that a person is a non-responder, so we wouldn’t say, ‘you’re a non-responder, but go ahead and use the method.’ We would tell that person, ‘it’s not working for you; you shouldn’t feel that you’re protected.’ So there are many ways to slice this apple.
Diana Blithe, PhD, is the Program Director for the Contraceptive Development Research Centers Program and the Male Contraceptive Development Program, CRHB, CRP, NICHD.
Christina Wang, MD
Many options are needed
What we need is to have many options for people to choose from to suit their specific needs. People should decide for themselves, but the contraceptive agents we take to market should be efficacious and have the least number of adverse effects that are known at that time.
The contraceptive efficacy should be comparable to female contraceptive methods. Efficacy rates of about 98% are high with the male hormonal contraceptives that are in clinical studies, and the contraceptive efficacy rate that’s achieved by hormonal methods is somewhere close to 97% or 98%; this is with perfect use.
The method failure rate reported in the WHO study was somewhere around 2%; in other words, two out of 100 men will not respond. So, if we can find those men and exclude them, then this is a reasonable method that could work. There won’t be anything that works for all men, but it will be possible for us to have something that works for most men — that’s what we’re going for.
Christina Wang, MD, is the Program Director in the General Clinical Research Center at Harbor-UCLA Medical Center and Los Angles Biomedical Research Institute and a Professor of Medicine at David Geffen School of Medicine at UCLA.