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July 2000 The ICCR at 30: Pursuing New Contraceptive Leads For almost 30 years, some of the world’s top reproductive health scientists have gathered at the Population Council to discuss their progress in developing new contraceptives and reproductive health products for women and men. This network of distinguished scientists and clinical investigators is the International Committee for Contraception Research (ICCR). Working closely with colleagues at the Council’s Center for Biomedical Research (CBR), they conduct multicenter clinical trials to test the safety, efficacy, and acceptability of Council-developed products. The ICCR was created out of the need to advance beyond the birth control pill. By 1970, American pharmaceutical companies, having produced the Pill, were no longer interested in developing new contraceptives. “Companies were not looking at products for the world at large,” says Sheldon J. Segal, Distinguished Scientist at the Population Council. “It was a paradox: the less developed countries needed a range of contraceptives, but the financial incentive to develop these new methods rested in developed countries. Thus, there was a need for a public-sector institution for which the bottom line would be to improve methods available for the world’s diverse population.”
That public-sector institution was the Population Council. And the vehicle that Segal—then director of the Council’s biomedical division—created to expand contraceptive options for women and men around the world was the ICCR. The group was formed in late 1970 and early 1971, with clinicians selected for their commitment to reproductive health care and their track records in the conduct of clinical trials involving contraceptive products. The Rockefeller and Ford Foundations gave a total of $5 million as start-up money. The ICCR was designed to provide a noncommercial, international mechanism for identifying, developing, and testing new contraceptive leads. The original members, who met four times a year, were from Austria, Brazil, Chile, Finland, Sweden, and the United States. The group, which now convenes in April and November each year, currently includes members from Australia, Chile, the Dominican Republic, France, Germany, Japan, Scotland, and the United States. Elof Johansson, a Council vice president and director of the Center for Biomedical Research, chairs the ICCR meetings. A former ICCR member himself for many years—one of the original group, in fact—Johansson says he appreciates the group’s qualities more as chairman than he did when he was a member. He describes the ICCR as the “medical department for CBR and the Population Council. If we did not have the ICCR, we would need to add much more costly medical expertise to our staff. The clinicians also contribute basic research. Many research organizations and pharmaceutical companies are trying to copy the ICCR concept.” The new executive director for contraceptive development at CBR is Regine Sitruk-Ware, an endocrinologist with academic, research, and pharmaceutical company experience. An ICCR member from 1984 to 1989, Sitruk-Ware says she “shares and endorses the Council’s philosophy to improve the health of women all over the world.” Fostering a unique development process Mishell, who is also editor of the journal Contraception, says he has continued to be an ICCR member because of the “uniqueness of the development process—having the laboratory and the clinical studies in one group.” The ICCR’s most notable achievements, he says, were Norplant®, the copper IUD in all its forms (the most widely used IUD in the world), and the vaginal ring. Horacio B. Croxatto’s relationship with the Population Council spans more than 30 years. Croxatto, of the Instituto Chileno de Medicina Reproductiva (ICMER) in Santiago, Chile, started as a fellow in the Council’s biomedical laboratories in January 1966, doing implant studies in animals and testing the properties of different hormones. His work was instrumental in the development of subdermal implants as a delivery system for hormones. “At that time we saw implants as a major advantage, a step forward in contraceptive development. It was obvious that replacing daily pill intake with long-acting implants” could be a good choice for many women. “Contraceptives are not perfect,” Croxatto says. “They never will be, but you can refine them and make them better.” Croxatto describes the ICCR as a “fantastic organization for scientists interested in contraceptive development, women’s health, and reproductive health in general. The staff and consultants are very talented, motivated, and dedicated to the common objective of reproductive health.” Over the years, Croxatto has made important contributions to understanding the basic physiology of female reproduction and to elucidating the mechanisms of action of various contraceptive methods. Rebeca Massai, a colleague of Croxatto’s at ICMER, is an ICCR consultant. The ICCR meetings, she says, provide “an opportunity to share information with people who have a different perception of research. It is an incentive to keep working because knowledge of the whole picture gives the work a broader perspective. “Chilean women like to participate, and in the process they learn about their rights and how to ask for information—it is a great stimulus for them to know they are increasing women’s options.” The ICMER clinic is participating in clinical trials of vaginal rings, Nestorone implants, transdermal delivery systems for women, and immunocontraception for men. Exploring cultural differences Vivian Brache, of PROFAMILIA, also has been associated with the ICCR since 1974. “Our research has benefited our clinic and our clients. We helped to develop products, such as the copper IUD and Norplant, with the dedication and effort of the women who participated in the clinical trials.” Brache’s research at the Santo Domingo clinic has helped explain the relationships between hormonal dosage, effectiveness, and bleeding patterns. Some hormonal combinations lead to excessive bleeding, while others produce no bleeding at all. Anna Glasier, from the University of Edinburgh in Scotland, joined the ICCR in 1996. Glasier described the “double value of collaborating with other members of the ICCR and with the CBR staff. We do quite a lot of research in our clinic in Edinburgh. The Population Council and the ICCR clearly have developed new methods; others do research but rarely make something available right away. The ICCR provides me with an opportunity to be involved with other researchers who have an academic interest in contraception.” Glasier has been testing MENT on hypogonadal men. “It is refreshing after years of working with methods for women to be doing something that holds real promise for men,” she says. Recognizing the importance of brainstorming The type of contraceptive research undertaken by the ICCR has relevance to women in all countries, Fraser says. “The participation of our research center in studies of this type helps to make other members of the Australian Family Planning Movement, the gynecological community, and pharmaceutical companies aware of research going on all over the world.” Fraser will host the October 2000 meeting of the ICCR in Australia. Takeshi Maruo, of Kobe University School of Medicine in Japan, joined the ICCR in 1991 to learn more about modern contraceptives from the global viewpoint. He had previously been a research fellow at CBR from 1977 to 1979. “The kind of research undertaken by the ICCR is particularly important for Japanese women,” Maruo says, “because they unfortunately have not been exposed to modern contraceptives, except barrier methods, until now.” It will take some time for methods that are newly approved in Japan, such as oral contraceptive pills and the copper IUD, to be accepted by Japanese women, Maruo says.
Maruo helped open a family planning outpatient clinic in a satellite private hospital in Kobe City where collaborative contraceptive studies could be conducted. The doctor in charge received support from the Population Council for first-hand training in family planning provision at Fraser’s Sydney Family Planning Center. Maruo’s clinic has actively participated in clinical studies with Mirena®, a medicated intrauterine system, and vaginal rings as part of the ICCR’s work. Maruo was recently appointed medical organizer for a 50-center clinical study of Mirena in Japan. He has also edited a recently published monograph in Japanese covering all modern contraceptives. Providing choices for men "Many European men wish to contribute to family planning but have few choices," Nieschlag says. "The volunteers in our clinical trials are motivated to contribute to the development of a male contraceptive; some participate because their wives have had problems using contraceptive methods." Future directions Public-sector contraceptive development will be needed in the future, he says, to work in specialized areas of research, such as male methods and ways (microbicides, for example) to prevent the spread of sexually transmitted infections. The Council is working to make affordable reproductive health products, Johansson says, adding that large American pharmaceutical companies have shown little interest in contraceptive development. “Public-sector organizations like the Council, along with a new breed of smaller companies that realize the potential of the reproductive health market, are taking the lead now.” (return to Momentum home page)
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