90-day birth control drug tests out safe The 90-day injectable birth control drug got another boost late last month when a medical researcher said that depomedroxyprogesterone acetate (DMPA) "appears to be a safe, effective contraceptive agent that exceeds the oral contraceptives in pregnancy prevention." Speaking to a symposium on population research at the American Association for the Advancement of Science's annual meeting in New York City, Dr. L. Charles Powell, M.D., of the University of Texas medical branch, Galveston, reported the results of clinical trials conducted with the still somewhat experimental drug. DMPA is distributed on a limited basis under the trademark Depo-Provera by Upjohn Co., Kalamazoo, Mich., but only for treatment of uterine cancer. Powell's study involved 1123 patients receiving 150 mg of the drug every three months for about one year. In this group, says Powell, only two pregnancies were directly attributable to failure of the drug, well under 1%. Mortality among test group members was in the same range as the pregnancy rate with only four deaths, and these were unrelated to the drug administration. (Two died from gunshot wounds, one from liver failure precipitated by heroin addiction, and one from subacute bacterial endocarditis.) Spacing the injection of DMPA every 90 days is apparently critical, according to Powell. Two patients conceived after only 107 days from their last injection, indicating that fertility returns quickly after discontinuing drug administration. In fact, says Powell, infertility effects are generally reversible within six months. Of the 159 infants born after discontinuation of DMPA, notes Powell, only two showed major abnormalities, one
with congenital dislocation of the hips and the other a cleft palate. This incidence rate is the same as that for former oral contraceptive users and that for the general population before the introduction of oral contraceptives. Physiological findings were generally normal among the test subjects, with the exception of some cervical cytological changes. But Powell points out that the rate of cytological changes or carcinoma in situ is less than that reported for the oral contraceptives. DMPA was first investigated for contraceptive use by its inventor, Upjohn, in 1963. The company filed a New Drug Application in 1968 requesting that the compound be allowed for contraception. In September 1974 the Food & Drug Administration was ready to approve DMPA for marketing for this use, but objections about the drug's safety from Rep. L. H. Fountain (D.-N.C.) in October stalled the action. FDA still is reviewing its data pending a final decision. Fountain's objections grew from an investigation of FDA advisory committee operations by the House Intergovernmental Relations Subcommittee, which he chairs. Looking over the data that FDA had used to approve DepoProvera, the subcommittee determined that the incidence of cervical cancer associated with use of the drug might be as much as four to five times higher than that indicated by previous clinical studies (including Powell's). The House subcommittee questioned some of the statistical methods used to analyze data in the clinical trials. Although the committee agreed that Depo-Provera has significant benefits over oral contraceptives, it believed that the potential risks associated with the drug, based on the evidence it had seen, outweighed the benefits. Thus, in a letter to Health, Education & Welfare Secretary Caspar W. Weinberger, chairman Fountain urged that approval of Depo-Provera be held up. D
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WRITE OR PHONE COLLECT
Education St. Leo program trains industrial chemists This May, St. Leo College of St. Leo, Fla., will graduate the first class of three students from a new training program in industrial chemistry. These graduates will have spent their past two academic years in the possibly trend-setting program called EPIC (Education of Prospective Industrial Chemists). Although the graduates will be equipped academically to pursue graduate study in chemistry, they have elected to begin industrial careers after graduation. Dr. John J. Kolfenbach, coordinator of the EPIC program, says that most curricula in chemistry ignore disciplines other than chemistry that are necessary in industry. Conventional
curricula usually are aimed at further graduate study. Kolfenbach and his associates, Miguel Zepeda and Ralph Pendexter, have designed the EPIC program to correct this situation. The emphasis in the program is on product development. According to Kolfenbach, this emphasis includes an understanding of the relations between composition and properties of materials and is heavily dependent upon analysis of quality requirements needed to meet end-use applications for products. Profitability considerations are included in the program. Basic and applied chemistry, engineering, and economic^ also are involved, as is the ability to communicate with all kinds
chattem chemicals DEPT. CEN, 1715 W. 38th ST., CHATTANOOGA, TENN. 37409 PHONE 615/821-4571
Feb. 17, 1975 C&EN
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