Adventures in Ethics and Science

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“Why don’t they make a birth control pill for men?”

There are important considerations from medical ethics that might explain why a birth control pill for men has not happened yet.


You’d think that there would be an ethical impetus for the development of a birth control pill for men, given that men (or at least, their sperm) are a necessary component of human reproduction and that men have an interest in controlling their fertility, too. Men might view such a pill as a useful option. The question is whether that benefit outweighs the potential risks.

The Belmont Report (which lays out the U.S. government’s guidelines for the protection of human research subjects) notes that ethical treatment of humans requires beneficence, which includes maximizing the possible benefits and minimizing the possible harms of a particular intervention. In biomedical research, these risks and benefits are usually understood in biomedical terms — what will happen to your health with the intervention or without it. If an intervention introduces too much risk of harm, or too little chance of benefit given the potential harm, it crosses an ethical line.

For the female partner in human reproduction, this means tallying the possible health consequences of taking the pill against the possible health consequences of pregnancy. From this point of view, even if oral contraceptives increase your chance of weight gain, blood clots, and stroke, the potential harms of the pill are less than the potential harms of pregnancy itself (which include high blood pressure, gestational diabetes, and death, not to mention weight gain).

For the male partner in the equation, the consideration of risks and benefits is complicated by the fact that men don’t get pregnant. As such, any potential harms that come from a male contraceptive would count against the ethical use of that contraceptive, since there is no impact on a man’s health (at least from a straightforward physiological perspective) from impregnating someone. This is part of the reason it’s possible for men to be fathers without knowing that they are fathers. The analogous situation hardly ever happens with mothers.

In short, unless the male contraceptive provides some clear health benefit to the male taking it, researchers will judge that the possible harms outweigh the possible benefits.

Indeed, this kind of assessment may explain why the human papillomavirus (HPV) vaccine was initially tested for use just on girls, even though males get HPV, spread it to their sexual partners, and can get warts or even penile cancer from it. While bothersome, genital warts are less harmful than cervical cancer, the most serious female consequence of HPV, and penile cancer is much rarer than cervical cancer. But researchers are now testing HPV vaccines on males in the hopes that the potential harms will be even lower than the (comparatively) low potential harms of HPV.

It looks like an attempt to avoid putting an undue burden on men (by offering them a pill with more direct health risks than health benefits) ends up saddling women with an undue burden as far as the responsibility for avoiding pregnancy. Maybe this means that our evaluation of risks and benefits needs to take more account of social factors — including the real (if not physiological) benefit a man could get from knowing he will not unintentionally impregnate his partner.

Comments

  1. #1 Bardiac
    January 10, 2008

    If my memory serves, the pill was originally designed as a way to help women deal with problems related to ovulation and periods. So it was all about some specific benefits related to solving specific problems.

    Preventing pregnancy was a side benefit, the one we now emphasize.

    So we need a male pill that solves a real and perceived male “problem” and also temporarily renders sterility. If Viagra did it, we’d have a winner!

  2. #2 llewelly
    January 10, 2008

    It looks like an attempt to avoid putting an undue burden on men …

    If the medical community actually applied this man-as-an-island thinking consistently, they’d never have developed useful solutions to infectious disease. There are dozens of diseases to which a small portion of the population is immune, yet are nonetheless carriers. Yet in nearly all cases, the option of not treating the carriers is not seriously considered. Just call a spade a spade.

  3. #3 Janet D. Stemwedel
    January 10, 2008

    Llewelly, you’re right that there are clear instances where the individual taking the risk by receiving the intervention is not the one that experiences the most benefit from the intervention. Vaccinating small children against rubella, for example, was driven in part by the ghastly effects when pregnant women contracted rubella — lots of very damaged babies were born (and before Roe v. Wade made legal termination of these tragic pregnancies an option). So the main benefit, arguably, went to the women and to the not-yet-born children (who couldn’t be vaccinated for obvious reasons).

    Still, not getting rubella was a benefit for the kids getting the vaccine. They’re not taking on a risk with no benefit to their health at all.

    This is not to say that we shouldn’t be less individualistic in looking at risks and benefits, nor that risks and benefits should only be understood in physiological terms. Rather, I’m pointing out that while vaccination may stretch the man-as-an-island framework for weighing risks and benefits, I don’t think it entirely breaks that framework.

  4. #4 Richard
    January 10, 2008

    (I’ve a follow-up here.)

  5. #5 bob koepp
    January 10, 2008

    An interesting argument, but I doubt that it’s very reflective of the motivations of researchers or potential end-users. Even in the case of hormomal contraceptives for women, _medical_ risks and benefits (i.e., effects on health status) are usually not the main factors motivating use or non-use. Contraceptives are usually not prescribed on the basis of medical indications, or they wouldn’t be nearly as widely used as they in fact are.

  6. #6 coathangrrr
    January 10, 2008

    It seems that you could go further and say not only that women are the beneficiaries of birth control, but also that they will take on additional risk in the case of male birth control. Assuming that the pill is not perfect, which is a reasonable assumption, then when it fails to prevent pregnancy there might be side-effects for the fetus and mother. In this case you could make an argument that it would be a pretty harsh penalty for a woman to pay just because a man doesn’t want a child at the moment.

  7. #7 daedalus2u
    January 10, 2008

    But what about vasectomy? Didn’t there need to be clinical trials to determine if it was safe and effective? Certainly there are real risks of side effect, it is surgery after all.

    If the benefit of becoming infertile is sufficient to justify the ethics of an irreversible surgical procedure, certainly it must be enough to justify a male contraceptive.

    As for research into male contraception, how much benefit does research into female contraception provide to the individual females involved in the research? I don’t think very much.

    What is important is the reliability of the method. Research into effectiveness of male contraceptives can use other endpoints, such as sperm count, rather than pregnancy. Presumably there needs to be compensation of females for failures in research on female contraception (if that is the measure of effectiveness (but I doubt that a study would use that as the endpoint)). If actual pregnancy is used as an endpoint in male contraception research, then the female partner would have to be a participant in the research and would have to give informed consent and be compensated accordingly.

  8. #8 Donalbain
    January 11, 2008

    I am not a medical ethicist, but does the principle of beneficence only apply to weighing health benefits and risks? Because there most certainly ARE risks involved in being a father. For instance, there is a definite risk to my wallet if I ever do such a thing.

  9. #9 Nileema Conlon Vaswani
    January 12, 2008

    There are various ethical issues to consider when determining the moral permissibility of a male contraceptive pill. The obvious question of pregnancy, on a purely risk-benefit analysis, lowers the need for such a pill as men do not get pregnant. But the very fact, as pointed out by the author, that men can become fathers without even knowing it might provide a reason to at least consider the male contraceptive pill.

  10. #10 ReMaines
    January 13, 2008

    daedalus2u makes an interesting point: the female partner’s risk. A study of male contraception could be constructed in which the subjects of the study were couples–the risk/benefit equation would then be applicable to both. Couples in which the woman has risk factors contraindicating the use of hormonal contraceptives would be an obvious choice as a study population. The ethical risk/benefit equation would look a little more balanced in that case, and likely be acceptable to the institutional review boards and funding agencies that review research involving human subjects.

  11. #11 hip hip array
    January 22, 2008

    Er, are you actually unaware of all the current research on chemical contraceptives for men? Don’t they make the “issue” discussed above moot? The WHO has conducted a study of a depot formulation of progestin plus a testosterone derivative that has proved very effective, and University of Washington researchers have developed and are testing an oral formulation of progestin and a GNRH inhibitor, if I recall correctly. There’s potentially a large market among married couples and men who do not trust their partners to faithfully use the pill or an IUD (i.e., men in couples in which the woman wants a child and the man does not).

  12. #12 hip hip array
    January 22, 2008

    A reference in case anyone is interested:

    J Clin Endocrinol Metab. 2003 Oct;88(10):4659-67. Links
    Contraceptive efficacy of a depot progestin and androgen combination in men.

    Turner L, Conway AJ, Jimenez M, Liu PY, Forbes E, McLachlan RI, Handelsman DJ.
    Department of Andrology, Concord Hospital, and ANZAC Research Institute, University of Sydney, Sydney, New South Wales 2139, Australia.

    WHO studies provided proof of concept for hormonal male contraception using a prototype androgen-alone regimen. Combined testosterone plus progestin regimens offer more practical promise, but no contraceptive efficacy studies have been completed. The objective of this study was to establish the proof of principle for depot hormonal androgen/progestin combination as a male contraceptive. We performed a contraceptive efficacy study of 55 healthy men in stable fertile relationships seeking a change in contraceptive method. Testosterone (four 200-mg implants, every 4 or 6 months) and 300 mg depot medroxyprogesterone acetate, im, every 3 months were administered. Once sperm output was suppressed (<1 million/ml for 2 consecutive months), men entered a 12-month contraceptive efficacy period, ceasing other contraception. The main outcome measure was contraceptive failure (pregnancy) rate. No pregnancies occurred in 426 person-months (35.5 person-years; 95% confidence limits for contraceptive failure rate, 0-8%/annum), superior to the first year failure rate of condoms, the only reversible male method. Sperm density fell rapidly, so 94% of men entered the efficacy phase by 3 months, with only 2 of 55 (3.6%) men not sufficiently suppressed to enter efficacy. A few men treated with testosterone implants at 6-month intervals demonstrated androgen deficiency symptoms and/or escape of gonadotropin and spermatogenic suppression between months 5 and 6; after a protocol amendment, all men receiving testosterone implants at 4-month intervals avoided androgen deficiency or loss of gonadotropin and sperm output suppression. Recovery was complete (median, 3.6 months to sperm reappearance and 5.0 months to 20 million sperm/ml) in all but one man with an incidental testicular disorder. Discontinuations were for protocol-related reasons (n = 15) or altered personal circumstances (n = 12), but there were no serious adverse effects related to drug exposure. The first male contraceptive efficacy study using a prototype depot androgen/progestin combination demonstrates high contraceptive efficacy with satisfactory short-term safety and recovery of spermatogenesis. Further studies of purpose-developed products are required to extend the overall safety and efficacy experience with depot androgen/progestin combinations, the most promising approach to hormonal male contraception.

  13. #13 MissPrism
    February 23, 2008

    Surely “benefit” doesn’t just mean physical benefit- otherwise how could Viagra be permitted? A reliable male oral contraceptive would have social and psychological benefits for a lot of men, so one could balance those personal benefits against physical health risks.

  14. #14 Azkyroth
    February 24, 2008

    Isn’t this the sort of “problem” that comes up in science fiction stories due to badly programmed AIs with simplistic directives?

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