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The accelerated pace of pharma abandonment of research and development in family planning and fertility: will reproductive health technology be frozen in time?

2007; Elsevier BV; Volume: 87; Issue: 4 Linguagem: Inglês

10.1016/j.fertnstert.2006.11.003

1556-5653

Jerome F. Strauss, Guatam Chaudhuri,

Science, Research, and Medicine

The development of accessible methods for family planning and successful treatments for female and male infertility can arguably be placed among some of the greatest scientific and medical achievements of the 20th century. Products can always improve, but in the case of contraceptives and fertility drugs, this may no longer be true because big pharma has lost interest over time, and recently benign neglect has turned to outright hostility. This is not so surprising when one considers that the methods that currently are available are effective and safe; birth rates have dropped in the developed world, in some cases to below replacement level, and in some countries, 1 of every 50 children is born through assisted reproduction. Beyond the efficacy of the technology, the return on investment in family planning and fertility research is not as great as that in other areas, and the potential liability is high. Finally, there are no incentives to stay in these therapeutic areas. Contraceptives are really public health drugs, but they have not enjoyed the same status as vaccines. No wonder the companies that held franchises in branded products, such as Searle, Ortho-McNeil, and Wyeth, either have dropped product development as a result of mergers, or in the case of the latter two, have quietly dismantled their contraception research and development programs. This isn’t just a US phenomenon; it is global. The innovative collaboration between Organon and Schering to develop a hormonal male contraceptive appears to be unraveling. Moreover, the future of Schering’s research in contraceptive development, which has been a key focus of the company for decades, may be uncertain as Schering is integrated into Bayer. The impending acquisition of a large stake in Serono by Merck KGaA may take yet another player in fertility out of the action. As a consequence of these changes, a generation of reproductive scientists with skills in product development will evaporate, and the expertise to train new scientists in this area will be gone. The hoped-for nonhormonal female and male contraceptive methods are barely alive, and viable targets and products that were in development in companies now moving away from contraception and fertility treatments may never see the light of day. The desertion of contraceptive development comes on the heels of an Institute of Medicine report in 2004 on the future of contraceptive research (1Nass S. Strauss III, J.F. New frontiers in contraceptive research: a blueprint for action. National Academy Press, 2004Crossref Google Scholar). That report restated the unmet needs and the case for more research in this area, an argument that has been made on multiple occasions and that has highlighted new opportunities. Although the report predicted that big pharma would remain cool despite suggested strategies to promote contraceptive development, the accelerated pace of departure of pharma was not anticipated. But it isn’t just contraceptive development that is suffering; the bloom is definitely off the rose in reproductive and women’s health, as reflected in the reorganization of women’s health divisions within a number of the large US pharmaceutical companies. Blame is not to be placed exclusively at the feet of pharma executives; in fact, academe also deserves a good share of it. Many new concepts for contraception and fertility treatments arose from universities and research institutes. The failure of the specialty of obstetrics and gynecology to embrace basic research has contributed to a dry pipeline and to a bleak future in this scientific and clinical area. The change we describe has been rapid and sudden as well as a great source of concern to those of us interested in the improvement of family planning methods, the development of better fertility treatments, and reproductive health in general. If the recent trends do not reverse, we may be frozen in time, left only with contraceptive technology and fertility treatments developed during the last century. The US government does not have the interest or the will to intervene, the National Institutes of Health do not have the money to replace the lost investments by pharma, and academic obstetrics and gynecology will need years to train the research workforce to prime the pipeline. What’s to be done? We will have to place our trust in the existing NIH-supported contraceptive development and infertility research centers, and committed individuals, including those recently released from companies that are eliminating their reproductive-health discovery programs, to keep on target. Even with the long time horizon, academic obstetrics and gynecology has got to get moving and produce researchers with expertise in this area. Small pharma and biotech need to step up to the plate. Moreover, what is likely to be the salvation of the field of family planning and fertility treatments should be considered: a concerted effort to outsource research and development and product development to countries such as Brazil, China, and India, which have contraceptive and reproductive health needs and emerging biotech and pharmaceutical industries. There is “mostly dead,” which is slightly alive, and there is “all dead” (2From the movie, “The Princess Bride”, 1987. Directed by Rob Reiner, from the book by William Golden.Google Scholar), and we are quickly approaching the all dead state where Miracle Max can no longer be of help.