In “Does Big Pharma Believe in Autonomy?” Stuart WG Derbyshire correctly notes that some women want to use emergency contraceptive (EC) pills as their regular contraceptive method, and that such a method is not currently on the market. But his conjecture that “big pharma” is keeping such a method out of women’s hands in order to exercise “moral” control is simplistic. Our belief is that big pharma is not particularly interested in morality, but rather in markets. We are cautiously optimistic about such a pericoital pill and think it warrants further research. It would meet the needs of millions of women currently not using a contraceptive method due to infrequent sex, and has some appealing characteristics.
Yet, having spent considerable time thinking about how such a pill could be made available, we recognize that there are a number of challenges before this “routine” use of emergency contraception (which would then cease to be an “emergency” method) can become widespread. To truly mainstream such a pill, it would have to be approved by a stringent regulatory agency, such as the US Food and Drug Administration or the European Medicines Agency. The regulatory process necessitates clinical trials, which would need to show adequate efficacy and safety and would be quite expensive. It is unclear whether such a method could, in fact, be approved or whether any pharmaceutical company would be willing to make this substantial investment.
In the absence of a clinical trial and a labeled and regulated pericoital pill, a move towards a “multipack” approach appears be underway: In the United States, a drugstore chain recently started selling emergency contraception in a two-pack, and an online emergency contraception vendor sells three-packs. In Malaysia, a well-known international manufacturer sells its emergency contraception in five-packs, and there are probably other such “multipack” versions of EC available in other markets. Selling emergency contraceptive pills in this way encourages advance planning and makes it easier for women to use them more than once, destigmatizes repeat or routine use of emergency contraception and may offer a price that allows some women to use this pill several times a month.
This already ongoing move towards a pericoital contraceptive method raises an important research agenda, separate from the clinical trial: Will women who take this pill and then experience menstrual disruption be able to detect pregnancies promptly? Will women use this method instead of more effective methods, or instead of condoms that might prevent sexually transmitted infections? Will women use it to back up natural family planning strategies? Can it be provided at an affordable price? These crucial questions are unlikely to be addressed by the pharmaceutical industry. Are the donor, nonprofit and academic sectors ready to step in?
ELIZABETH WESTLEY, MPH
International Consortium for Emergency Contraception
New York, NY
ELIZABETH RAYMOND, MD, MPH
Gynuity Health Projects
New York, NY