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News from the National Academies
Date: May 28, 1996
Contacts: Dan Quinn, Media Relations Associate
Molly Galvin, Media Relations Associate
Bill Kearney, Media Relations Assistant
(202) 334-2138; Internet <news@nas.edu>

EMBARGOED: NOT FOR PUBLIC RELEASE BEFORE 11 A.M. EDT TUESDAY, MAY 28
NEW 'CONTRACEPTIVE REVOLUTION' REQUIRED
TO ADDRESS UNMET NEEDS

WASHINGTON -- Despite a dramatic need and promising advances in science, no new contraceptives will reach the market soon without stronger support and creative collaborations among government, industry, private insurers, and the general public, says a new report* from a committee of the Institute of Medicine (IOM). The report says that as many as 228 million women worldwide still lack effective contraceptive protection, and new methods are needed if that number is to be significantly reduced.

The committee examined the science base for contraceptive research and determined that there are exciting possibilities for the development of new methods -- but only if industry and government commit to the necessary basic and applied research, and manufacturers are convinced that the demand for them outweighs the risks of investing large amounts of capital and time. The report says routine coverage of a full range of contraceptive options by private insurers and public-sector providers could help create the kind of market demand that manufacturers need to decide whether to commit to developing new products. The report also reiterates the recommendation of a 1990 IOM report that called on Congress to enact a federal product liability statute to protect manufacturers from excessive punitive damage awards.

Societal, legal, regulatory, and financial pressures have all but stalled efforts to develop new contraceptives, resulting in few breakthroughs since oral contraceptives and intrauterine devices led the "contraceptive revolution" of the early 1960s. Most development activity has focused on modifying existing hormonally based methods rather than on creating truly innovative new techniques.

"We know from the high rate of unintended pregnancies and abortions that our current array of contraceptive choices is simply not adequate for many people in the United States and worldwide," said committee chair Allan Rosenfield, professor of public health and of obstetrics and gynecology, and dean, Columbia University School of Public Health, New York City. "The design of new contraceptives will have to take into account the rising rates of sexually transmitted diseases. The costs to society of unintended pregnancy and sexually transmitted disease are tremendous, especially when you consider the cost-effectiveness of preventing them using contraceptive methods."

A WOMAN-CENTERED AGENDA

The committee called for a "woman-centered agenda" in the development of new contraceptives. Research priorities should be weighted toward the overall reproductive health and general well-being of women, the primary users of contraception, in areas where their contraceptive requirements are still unmet. These requirements include improved options for women, specifically methods that act as chemical or physical barriers to conception and to transmission of sexually transmitted diseases, including HIV; once-a-month methods that induce menstruation, targeted at different points in the menstrual cycle; and contraceptives to expand the choices available to men.

Because successful conception relies on many different, highly specific biological events, there is a rich array of targets for contraceptive research -- especially given recent advances in molecular and cellular research. The report says that highest priority should be given to methods that impair the function of specific genes found to be essential for conception, rather than to methods like oral contraceptives that act systemically. The committee also expressed support for continued research in immunocontraception, especially for methods that would offer protection against certain sexually transmitted diseases as well as pregnancy.

Partly because of powerful political and social pressures against "menses inducers," particularly postimplantation methods, there is no product available today that was explicitly designed to prevent or interrupt pregnancy in women exposed to unprotected sex. Such pressures prompted the French company that created one such product, RU 486, to abandon plans to market the product in the United States. The report predicts that, ultimately, it may take partnerships between smaller firms and non-profit organizations dedicated to women's reproductive health to bring these controversial products to market since large pharmaceutical companies may be reluctant to do so.

ELIMINATING OBSTACLES

Nearly 60 percent of all pregnancies in the United States are unintended; either mistimed or not wanted at all. Slightly less than half of these occur after contraception either has failed, or was used improperly. An estimated one-third of all pregnancies worldwide end in abortion. If just the unwanted births were prevented, the global rate of population growth would drop by 19 percent. And studies have shown that the addition of a single major method to a family planning program can account for significant increase in the prevalence of contraceptive use, even in places where several options are available.

In addition to the benefits to the woman or her partner in preventing an unwanted pregnancy, the savings from new contraceptives will be reaped primarily by those who now pay the bill for unintended pregnancies -- the public sector, through Medicaid and various social programs, and third-party payers such as health management organizations and private insurance carriers. Yet despite the powerful cost-reducing benefits of contraception, many health insurance plans and health maintenance organizations offer very limited coverage, which acts as a constraint on demand. Broader provision of third-party coverage by government and private health insurers could improve the level of demand and the size of the market for contraceptives here and abroad.

Industry also wants legal assurance that investing in new contraceptives is a sound business decision. The report calls for a federal product liability statute protecting contraceptive manufacturers from some liability once they had satisfied the rigors of Food and Drug Administration approval. The committee also stressed the need for "user-friendly" packaging and labeling information that would do a better job of guiding consumers and providers in proper and appropriate contraceptive use.

In the United States the most popular forms of reversible contraception for women are hormonally based oral, injectable, and implant contraceptives. Although these methods are considered safe and pose few health risks, they do have side effects that frequently result in their discontinuation or misuse. Intrauterine devices (IUD) still suffer from the negative impact that endures as a result of publicity generated by the infections and deaths attributable to one brand of IUD in the 1970s. Rather than simply continue efforts to improve the existing methods, the report argues for emphasis on innovative contraceptive methods for the future. No single new contraceptive will be fully effective, free of side effects, and adequate for all users under all conditions, but the spectrum of possibilities and the populations served expand with each new product introduced into the market.

The report was sponsored by the Contraceptive Research and Development Program, the National Institute for Child Health and Human Development of the National Institutes of Health, the Rockefeller Foundation, the Andrew W. Mellon Foundation, and the U.S. Agency for International Development. A committee roster follows. The Institute of Medicine is a private, non-profit organization that provides health policy advice under a congressional charter granted to the National Academy of Sciences.

*Pre-publication copies of Contraceptive Research and Development: Looking to the Future are available from the National Academy Press at the mailing address in the letterhead; tel. (202) 334-3313 or 1-800-624-6242. The cost of the report is $45.00 (prepaid) plus shipping charges of $4.00 for the first copy and $.50 for each additional copy. Reporters may obtain copies from the Office of News and Public Information at the letterhead address (contacts listed above).
# # #

[Internet availability: This news release is available on the World Wide Web at <http.//www.nas.edu>]
      INSTITUTE OF MEDICINE
      Division of Health Sciences Policy

      Committee on Contraceptive Research and Development

      Allan Rosenfield, M.D., F.A.C.O.G. (1) (chair)
      Dean and Professor of Public Health and of Obstetrics and Gynecology
      Columbia University School of Public Health
      New York City

      Hedia Belhadj-El Ghouayel, M.D.
      Technical Officer
      Reproductive Health Branch
      United Nations Population Fund
      New York City

      Donald D. Brown, M.D. (2)
      Director
      Department of Embryology
      Carnegie Institute of Washington
      Baltimore

      Nancy L. Buc, Esq.
      Partner
      Buc and Beardsley
      Washington, D.C.

      Peter F. Carpenter, Ph.D., M.B.A.
      Visiting Scholar
      Center for Biomedical Ethics
      Stanford University
      Palo Alto, Calif.

      Willard Cates Jr., M.D., M.P.H.
      Corporate Director of Medical Affairs
      Family Health International
      Research Triangle Park, N.C.

      Rebecca J. Cook, J.D., J.S.D.
      Associate Professor
      Faculty of Law
      University of Toronto

      Horacio B. Croxatto, M.D.
      Director
      Instituto Chilena de Medicina Reproductiva
      Santiago, Chile

      Richard H. Douglas, Ph.D.
      Vice President of Corporate Development
      Genzyme Corp.
      Cambridge, Mass.

      Michael J.K. Harper, Ph.D., Sc.D., M.B.A.
      Professor of Obstetrics and Gynecology
      Eastern Virginia Medical School
      Arlington, Va.

      Donald Patrick McDonnell, Ph.D.
      Associate Professor of Pharmacology
      Duke University Medical Center
      Durham, N.C.

      David C. Mowery, Ph.D.
      Professor of Business and Public Policy
      Walter A. Haas School of Business
      University of California
      Berkeley

      Judy Norsigian
      Co-director
      Boston Women's Health Book Collective
      Somerville, Mass.

      Sandra Panem, Ph.D.
      President
      Vector Fund Management
      Deerfield, Ill.

      Bennett M. Shapiro, M.D.
      Executive Vice President
      Worldwide Basic Research
      Merck Research Laboratories
      Rahway, N.J.

      Wylie Vale, Ph.D.(2)
      Professor
      The Clayton Foundation Laboratories for Peptide Biology
      The Salk Institute
      La Jolla, Calif.

      Bai-ge Zhao, M.D.
      Director
      Shanghai Institute of Planned Parenthood Research
      New York City


      INSTITUTE OF MEDICINE STAFF

      Polly F. Harrison, Ph.D.
      Senior Study Director

      Valerie A. Setlow, Ph.D.
      Division Director

      (1) Member, Institute of Medicine
      (2) Member, National Academy of Sciences