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Conclusions of the International Medical Advisory Panel (IMAP) on DMPA at its meeting on 14th October 1980.
London, England, IPPF, . 4 p.The International Planned Parenthood Federation (IPPF) supplies 400,000 3-monthly injections of depot medroxyprogesterone acetate (DMPA) each year; this use is estimated to prevent between 30 to 100 deaths per year. Up to 10 million women have used the drug at some time, and more than 1 million and a quarter use it currently. DMPA is registered as a therapeutic agent in cancer treatment in nearly all countries and as a contraceptive agent in over 80 developed and developing countries. The supply of DMPA has never kept pace with the demand in developing countries. Present information fails to indicate that DMPA causes endometrial cancer. It is too early to know if it will always prevent it. Both the WHO and the Biometrics and Epidemiological Methodology Advisory Committee of the U.S. Food and Drug Administration found no evidence of an increased risk of disease of the uterine cervix in women on DMPA. No evidence of increased breast cancer has been found in humans on DMPA. Investigations conducted in Chile, Egypt, Iraq, and Thailand have found that DMPA may increase both milk production and the duration of lactation. The question of possible consequences of the transfer of the steroid to the breast-feeding infant has yet to be resolved. The only clinical metabolic effect attributed to DMPA is weight gain.
Re: Depo Provera: a critical analysis, Stephen Minkin, Women & Health, Vol. 5:49-69, Summer, 1980 [letter]
Women and Health. 1980 Winter; 5(4):85-7.The readers of "Women and Health" and the American public deserve to hear the other side of the argument in regard to Depo Provera. This physician, who has been responsible for the operation of a large family planning program in northern Thailand for 17 years, has been personally responsible for the administration of over a million injections of Depo Provera to almost 100,000 women, for a total usage of over 240,000 woman years. Many of these women have used this method for 10 years or longer. Surveillance of all family planning patients goes on continuously, with particular emphasis on the users and former users of depomedroxyprogesterone acetate (DMPA), the active component in Depo Provera. A large and unbiased component of this surveillance is the Chian Mai component of the worldwide, multicentered, 5-year case control World Health Organization study of homronal steroid contraception. At McCormick Hospital in Chiang Mai, clinic records have been maintained on every family planning acceptor since the program began in 1963, and every DMPA acceptor since the start of this method in 1965. The research shows the following: a method failure rate on the average of only 1 unintended pregnancy in every 142 women using the DMPA 3-month injection method for a full year; a good return to fertility rate with the outcomes of pregnancies and deliveries being normal; and a rate of congenital anomalies not significantly different from that observed in former pill or IUD users or in non-contracepting mothers. There has been no increase in endometritis, endometrial cancer, inhibition of milk supply of nursing mothers, or detectable harm to the infants of mothers receiving DMPA injections. The alleged "marked increase in breast and cervical cancer rates in Chiang Mai, Thailand," as indicated by Minkin in his testimony before the Congressional Committee on September 9, 1980, is a misinterpretation of a WHO report and is contrary to fact. There has been no indication that women on DMPA or their nursing infants suffer an increased incidence of infections or cancers of any kind.
Activities of the Special Program of Research, Training and Development in Human Reproduction, World Health Organization in the field of long acting contraceptives.
In: Bangladesh Fertility Research Program. Workshop on Injectable Contraceptives: Noristerat, Dacca, Bangladesh, April 25, 1980. [Dacca, Bangladesh, BFRP, 1980]. 70-80.Following a brief introduction to the World Health Organization (WHO) Special Program of Research, Development and Research Training in Human Reproduction, established in 1972, focus is on what has been achieved thus far with long-acting injectable fertility regulating agents based on steroidal hormones and possessing a duration of action of at least 1 month. Over the last 20-year period, several estrogen-progestin combinations have been developed as monthly injectable contraceptives. The Special Program has initiated a series of clinical pharmacological studies aimed at developing new and improved estrogen progestin injectable formulations. 1 preparation, composed of norethisterone enanthate (50 mg) plus 5 mg of estradiol valerate, has shown promise in preliminary clinical studies. 3 progestogen only preparations with a duration of action of several months have been tested clinically: clormadinone acetate, depo-medroxyprogesterone acetate and norethisterone-enanthate. The 1st clinical trials utilizing the heptanoic acid ester of norethisterone raised considerable hopes, for no pregnancies were observed in 70 highly fertile women given the drug every 90 days. In a WHO trial preliminary data on Depo-Provera (DMPA) bleeding irregularities were responsible for the discontinuation of 9.3 subjects/100 women-years; prolonged amenorrhea accounted for the termination of 11.5 subjects/100 women years. There are several ongoing studies to evaluate the effects of the injectables on users. Norethisterone enanthate, although not possessing the same degree of effectiveness as DMPA, when adminstered every 3 months, remains an attractive injectable because of its lower incidence of amenorrhea.
A preliminary pharmacokinetic and pharmacodynamic evaluation of depot-medroxyprogesterone acetate and norethisterone oenanthate.
Fertility and Sterility. 1980 Aug; 34(2):131-9.2 populations attending WHO centers, one in Sweden and one in India, participated in a comparative, pilot trial of 2 increasingly popular injectable progestin-only female contraceptives, Depo-Provera and Norigest. The purpose of the study was to assess the pharmacokinetic and pharmacodynamic properties of the 2 formulations (depot medroxyprogesterone acetate and norethisterone enanthate). Differences were found between Swedish women and Indian women in their reactions to the 2 drugs: 1) Norigest was detectable in blood samples a significantly shorter time after injection of the agent in Indian women than in Swedish women; this difference was not apparent with Depo-Provera. 2) Although there was no difference at the 2 centers in the time of ovulation return for subjects receiving Norigest, 0 of 4 Swedish women ovulated more than 156 days after Depo-Provera injection, whereas all 4 Indian women ovulated within 73 days of Depo-Provera injection; in the Swedish women, the levels of medroxyprogesterone were undetectable at time of return to ovulation, whereas Indian women had levels of .6 ng/ml when ovulation resumed. 3) In both cultures, Depo-Provera users had significantly more episodes of bleeding and spotting than Norigest users. This preliminary report emphasizes the variety of responses possible to injection of different contraceptive progestins among various populations and points to the need for further culturally comparative studies.
New Scientist. 1980 Sep 25; 87(1220):945-6.Women in Bangladesh are under pressure to participate in a mass program that uses injectable contraceptives. The reason is that the big aid donors, particularly the World Bank, are pressuring Bangladesh to show quick results in its family planning program. In many areas of Bangladesh, the women who are sterilized or on injectables receive 6 kg of wheat a month, plus oil, powdered milk, and fish meal. These incentives are taken from the United Nations World Food Program. United States law bars the United States Agency for International Development (USAID) from supplying Depo-Provera because it has been banned in the United States as it causes cancer in animals. As there are no restrictions preventing United Nations agencies from supplying potentially dangerous drugs, the United Nations Fund for Population Activities provides Depo-Provera to Bangladesh. 1/3 of the women suffer unacceptable side effects from the Depo-Provera, particularly irregular menstruation. 5% have serious bleeding. With Depo-Provera, women cannot stop and permit the side effects to go away; they have the unexpected problems for the 3-month duration of the shots.
PEOPLE. 1980; 7(2):22.Recent studies have not turned up any negative findings on Depo Provera, the controversial injectable contraceptive which is currently banned in the U.S. 2 large studies, in the U.S. and England, found no increased risk of breast cancer in Depo Provera users. A 3rd study, in fact, found a decrease in the incidence of breast cancer in postmenopausal users of Depo Provera. Doubt has been cast on the earlier studies with female beagles which found breast cancer increased through association with Depo Provera. Further studies have also shown no increased risk of endometrial cancer in Depo Provera users. The International Federation for Family Health has issued a report advising the use of Depo Provera. It is an especially useful contraceptive for developing countries because 1 injection gives 3 months' protection and cannot be wrongly used.