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Work Progresses on Male Contraceptives, but Hurdles Remain
JAMA ( IF 63.1 ) Pub Date : 2017-10-03 , DOI: 10.1001/jama.2017.10302
Rita Rubin

The first female contraceptive pill came on the market more than a half-century ago, but don’t expect to see sales of a male counterpart any time soon. For now, birth control options under men’s control remain limited to withdrawal or condoms, both of which have relatively high failure rates due to imperfect use, or vasectomy—highly effective but considered irreversible. It’s easy to assume that the dearth of male contraceptives stems from men's long-time dominance in research laboratories and pharmaceutical company boardrooms. After all, the men in positions of power probably preferred to leave the responsibility for birth control up to women, who had more at stake with an unwanted pregnancy. But the explanation is more complex than that. True, pharmaceutical companies don’t appear to be interested in developing male contraceptives, but economics seems to be the main factor. Reluctant Drug Makers Attracting large pharmaceutical companies’ interest has been difficult for a number of reasons. Drug makers don’t regard contraceptives as potential blockbusters, like Pfizer’s cholesterol-lowering atorvastatin, which racked up more than $100 billion in sales in less than 15 years after its 1997 debut. Pfizer manufactures such female contraceptives as Alesse and Lo/Ovral, but “male contraceptives are not one of our strategic areas for research and development,” a Pfizer spokesman told JAMA. “I think the reason pharma is out of the development business right now for male methods is they see the regulatory risks as too high...from a financial standpoint,” said Stephanie Page, MD, PhD, a section head in the division of metabolism, endocrinology, and nutrition at the University of Washington School of Medicine. A male method would have to be at least as effective in preventing pregnancy as birth control pills (which are about 91% effective with typical use), said Gregory Kopf, PhD, director of research and development for contraceptive technology innovations at FHI360, formerly Family Health International, a nonprofit headquartered in Durham, North Carolina. Given that women’s birth control methods are highly effective and many are available as inexpensive generics, it’s unlikely a drug company could charge enough for a male contraceptive to cover the entire expense of research and development, although consumers might be willing to pay a premium for the first available male contraceptive, Kopf said. Liability is also a concern with contraceptives, said endocrinologist Christina Wang, MD, professor of medicine and assistant dean in clinical and translational sciences at the David Geffen School of Medicine at UCLA, who is working on a transdermal hormonal contraceptive for men. “You are not treating a disease. You are dealing with healthy men and women.” So while patients with cancer are willing to tolerate chemotherapy drugs’ adverse events for the possibility of a cure, the safety bar is much higher for contraceptive drugs.

中文翻译:

男性避孕药的工作取得进展,但障碍依然存在

第一种女性避孕药在半个多世纪前上市,但不要指望很快就会看到男性避孕药的销售。目前,男性控制下的节育选择仍然仅限于戒断或避孕套,这两种方法由于使用不当或输精管切除术而具有相对较高的失败率 - 非常有效但被认为是不可逆转的。很容易假设男性避孕药的缺乏源于男性在研究实验室和制药公司董事会中的长期主导地位。毕竟,掌权的男性可能更愿意将节育的责任留给女性,因为意外怀孕对她们的影响更大。但解释比这更复杂。确实,制药公司似乎对开发男性避孕药不感兴趣,但经济似乎是主要因素。不情愿的制药商 由于多种原因,很难吸引大型制药公司的兴趣。制药商并不将避孕药视为潜在的重磅炸弹,比如辉瑞的降胆固醇阿托伐他汀,它在 1997 年首次亮相后不到 15 年的时间里销售额就超过了 1000 亿美元。辉瑞生产诸如 Alesse 和 Lo/Ovral 之类的女性避孕药,但“男性避孕药不是我们研发的战略领域之一,”辉瑞发言人告诉 JAMA。“我认为制药公司现在退出男性方法的开发业务的原因是他们认为监管风险太高......从财务角度来看,”医学博士,医学博士斯蒂芬妮佩奇说,她是该部门的部门负责人。代谢、内分泌、和华盛顿大学医学院的营养学。FHI360 避孕技术创新研发主管 Gregory Kopf 博士说,男性避孕方法至少必须与避孕药一样有效(通常使用避孕药的有效性约为 91%)。 Health International 是一家总部位于北卡罗来纳州达勒姆的非营利组织。鉴于女性的避孕方法非常有效,而且很多都是廉价的仿制药,因此制药公司不太可能对男性避孕药收取足够的费用来支付研发的全部费用,尽管消费者可能愿意为这种避孕药支付高价。科普夫说,第一个可用的男性避孕药。内分泌学家克里斯蒂娜·王医学博士说,责任也是避孕药具的一个问题。加州大学洛杉矶分校大卫格芬医学院医学教授兼临床和转化科学助理院长,他正在研究一种男性经皮激素避孕药。“你不是在治疗疾病。你正在与健康的男人和女人打交道。” 因此,虽然癌症患者愿意忍受化疗药物的不良事件以寻求治愈的可能性,但避孕药的安全性要高得多。
更新日期:2017-10-03
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