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  1. 1
    077765

    FDA gives final approval to Depo amid concerns over safety, cost and coercion.

    WASHINGTON MEMO. 1992 Nov 12; (17):2-3.

    In October 1992, the US Food and Drug Administration (FDA) approved Depo-Provera for contraceptive use thus increasing the number of available contraceptives to women. Yet USAID has distributed it through its family planning programs in developing countries for many years. It has been available in the US since 1969 for noncontraceptive purposes such as endometrial cancer treatment. More than >30 million women around the world have used it to prevent conception. Today about 9 million women in 90 countries use it. A reason FDA did not approve Depo-Provera is that some studies revealed a link between it and breast tumors and cervical cancer in animals. More recent research conducted by WHO shows no connection with cervical cancer or ovarian cancer. In fact, it demonstrates Depo-Provera may protect against endometrial cancer. Yet it does indicate an insignificant increased risk of breast cancer in younger women. Some research suggests Depo-Provera may decrease bone density leading to osteoporosis and may increase the risk of having a low birth weight infant if the child is conceived before an injection. Evidence exists that it may lead to longer delays in becoming pregnant than other forms of contraception. Still 70% do conceive within 12 months after the last injection. Each Depo-Provera injection delivers a progestin in a water-based solution over 12 weeks resulting in suppressed ovulation. Its failure rate is <.5%/year, so Depo-Provera is one of the most effective reversible contraceptive available. The most common side effects are menstrual changes and weight gain (5-15 lbs.). Some contraindications include pregnancy, heart or liver disease, and breast cancer. As of November 1992, the FDA had not announced the cost or whether there would be a reduced price for family planning and public health clinics. Women's health and rights advocates plan on monitoring introduction of Depo-Provera to make sure that women have received comprehensive information and were not coerced to use it.
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  2. 2
    010601

    Depo-Provera debate revs up at FDA.

    Sun M

    Science. 1982 Jul 30; 217(4558):424-8.

    The record of the U.S. Food and Drug Administration's (USFDA) actions regarding Depo-Provera, a medroxyprogesterone acetate, as an injectable contraceptive and the international implications are reviewed. In September 1982 a special panel of scientists began deliberations to recommend whether Depo-Provera should be approved for use as an injectable contraceptive. The U.S. Agency for International Development (USAID) has been asked by developing countries to furnish the drug but will not export drugs that are not approved by USFDA. More than 80 countries have approved the drug. Advocates for USFDA approval include the Upjohn Company (manufacturer of the drug), World Health Organization, International Planned Parenthood Federation, Population Crisis Committee, and the American College of Obstetrics and Gynecology. The opposition includes the Health Research Group affiliated with Ralph Nader, the National Women's Health Network, and several right-to-life groups. Hesitation by USFDA is related to laboratory animal studies which suggest that Depo-Provera is a potential human carcinogen. Upjohn conducted a 7 year study with 16 beagles and a 10 year study with Rhesus monkeys; both of the test animals developed more tumors than the controls. Questions were raised about using the animals since the response of these two species to the drug and the human response are not necessarily comparable. Limited approval has been recommended twice by expert advisory committees in 1974 and 1975, but USFDA refused both times. It is suspected that Korea, Taiwan, Egypt, Jordan, and Yemen reversed their approval as a result of the latest USFDA rejection. This final decision will have major economic and social implications and will assume international importance.
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  3. 3
    004713

    Reversal of tubal ligation in AID-funded population programs.

    Labbok MH; Wiley AT

    In: Phillips JM, ed. Microsurgery in gynecology, 2. Downey, California, American Association of Gynecologic Laparoscopists, 1981. 224-6.

    AID's Office of Population has been providing voluntary sterilization through its programs in developing countries since 1965. The demand has grown over the years. However, there is also a growing demand for both female and male reversal procedures. Usually the reasons for a reversal request are divorce and remarriage or the death of a child. To meet this increased demand, the Office of Population is sponsoring a program of research, training, and service. A 1977 workshop on reversal of sterilization, sponsored by the AID-funded Program for Applied Research on Fertility Regulation, presented the results of ongoing research. Microsurgery was highlighted as the main tool for sterilization reversal programs. A training program in microsurgery reversal techniques is in operation at Johns Hopkins University. This program is training participants from developing countries and now has 12 trained individuals with the necessary skills and equipment to establish a national reversal center. Other researchers are investigating the possibility of using uterotubal-juncture blocking devices or removable, modified Hulka clips for sterilization to facilitate a potential reversal procedure. Since the number of sterilization procedures performed far outweighs that of reversals, ease and safety of the sterilization must be the main priority. Therefore, such experimental methods are of secondary interest. While sterilization at this time must be considered permanent, microsurgery techniques have achieved reversal success rates as high as 83% in females and 95% in males.
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  4. 4
    781353

    A.I.D.'s research program to develop new and improved means of fertility control. (Statement, May 2, 1978)

    SPEIDEL JJ

    In: United States. Congress. House of Representatives. Select Committee on Population. Population and development: research in population and development: needs and capacities. Vol. 3. Hearings, May 2-4, 1978. Washington, D.C., U.S. Government Printing Office, 1978. p. 287-319

    USAID, in attempts to develop and improve means of fertility control, spent $4.8 million on new ways to control corpus luteum function and block progestational activity, $4.4 million to develop gonadotropin releasing factors, and $6 million on prostaglandins as a means of inducing the menses or terminating pregnancy in the second trimester. Studies at Johns Hopkins University developed thyrotropin releasing hormones to ensure postpartum infertility without interfering with lactation. Research to improve current forms of birth control amounts to $16.5 million. Side effects of oral contraceptives, single aperture laparoscopic sterilization, reversible male sterilization, and tissue glues for non-surgical female sterilization are some of the new techniques being funded by USAID. $19 million has been allocated to evaluate contraceptive programs in developing countries. Funds have come from DHEW, the Ford foundation, the Population Council, pharmaceutical companies, and WHO. Although improved birth control is desireable, money is best spent supplying available methods to developing countries.
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  5. 5
    753743

    An overview of research approaches to the control of male fertility.

    Perry MI; Speidel JJ; Winter JN

    In: Sciarra, J.J., Markland, C. and Speidel, J.J., eds. Control of male fertility. (Proceedings of a Workshop on the Control of Male Fertility, San Francisco, June 19-21, 1974). Hagerstown, Maryland, Harper and Row, 1975. p. 274-307

    Literature on research approaches to permanent and relatively reversible methods of male fertility control is reviewed. Sources and expenditures for research into male fertility control are noted. Permanent methods discussed include electrocautery of the vas, transcutaneous interruption of the vas, vasectomy clips, chemical occlusion of the vas, and passive immunization. Reversible methods reviewed include vasovasotomy, intravasal plugs, and vas valves. Current research into animal models, reversibility after vas occlusion, nonocclusive surgical techniques, pharmacological alteration of male reproductive function, including adrenergic blocking agents, steroidal compounds, inhibitors of gonadotropin secretion, clomiphene citrate, organosiloxanes, prostaglandins, alpha-chlorohydrin, heterocyclic agents, and alkylating agents, and delivery systems for antifertility agents is discussed. Research into semen storage and improved condoms is also reviewed. As a relatively low proportion of funds are committed to research in male fertility control, a greater investment in applied and clinical research is warranted.
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