The Pills

The directions to doctors say that the pills are offered to treat many menstrual disorders: "habitual or threatened abortion," and to "establish conditions conducive to pregnancy" in many cases of infertility. All this is true. But the pills do more: used on a precise schedule, they prevent conception, without intolerable side effects, and, beginning this week, at moderate cost. "Oral contraception," says a doctor in the Journal of the American Medical Association, "has become an accomplished fact." As an accomplished fact, its potentials are vast. In the U.S., oral contraception could, for many people, supplant more awkward, older methods. In the world, the pill could eventually keep the population growth manageable. In the field of morals, it is raising new storms of controversy.

The pills are Enovid, trade name of Chicago's G. D. Searle & Co. for norethynodrel, and Norlutin, trade name of Detroit's Parke, Davis & Co. for norethindrone (also called norethisterone).* These two chemicals, both extracted from the root of the barbasco (Mexican yam), are as alike as tweedledum and tweedledee. They are almost but not quite the same chemically as a natural female hormone that controls much of the menstrual cycle and helps to prevent ovulation--release of an egg from the ovary to the Fallopian tube, where a sperm can fertilize it.

Rebound Effect. Emphasis on the contraceptive powers of the progestins (as chemists call the semisynthetic cousins of progesterone, the natural hormone) is an ironic accident. Ten years ago, Dr. Gregory Pincus, 57, the Einstein-maned research chief at Worcester Foundation for Experimental Biology, was studying problems of overfertility and underfertility, using laboratory animals. What he learned led him to turn to Boston's Dr. John Rock for help. Rock, then professor of gynecology at Harvard, gave progesterone to women who seemingly could not conceive. They took the pills for 20 days of each monthly cycle. The hormone suppressed ovulation. But when Dr. Rock stopped treatment after about four months, there was a "rebound" effect: several of the women ovulated, became fully fertile, and conceived.

Natural progesterone is too costly and must be given in such massive doses as to be unsuited for wide use. Then Pincus and colleagues found that norethynodrel worked better and in far smaller doses. Pincus and Rock teamed with Puerto Rico's Dr. Edris Rice-Wray in a big-scale test of the drug as a contraceptive among San Juan slum dwellers. While "on the pills" only 16 out of 838 women in four study areas became pregnant and all 16 had skipped their pills occasionally. Equally important, among the 174 women who dropped out of the test because they had decided it was time to have another baby, conception occurred promptly.

Cutting the Price. Searle got norethynodrel on the market as Enovid (pronounced enovid) in 1957 as a prescription item for threatened abortion and menstrual disorders. Last May the Food and Drug Administration authorized Searle to offer Enovid for what promptly became its most popular use. Enovid proved to have remarkably few undesirable side effects: in her first month or two on the pills, a woman may be nauseated, and may gain weight. The main trouble with Enovid, as with all progestins, was cost. The pills were priced to retail at 50-c- or 55-c- each, and one a day for 20 days meant $10 or $11 a month. Last week Searle cut its price by 30%, which should bring the retail price down to $7 or $8. Parke, Davis followed suit. And Searle promptly cut this a further 50% by convincing the FDA that five milligrams will inhibit ovulation just as well as ten, making the net cost to the consumer $3.50 to $4 a month.

Volume sales and competition may lead to a further modest price cut. Mexico-based Syntex Corp. plans to market norethindrone in direct competition with Searle; Raritan, N.J.'s Ortho Pharmaceutical Corp. will soon market the same drug (bought from Syntex) as Norlutin, and many pharmaceutical houses have similar products in the research stage.

Yet hormones may not be the ultimate contraceptive. A possibility, though still remote, is a means of immunizing either a man or a woman so that sperm and ova will never unite but one will react against the other like an antibody. Dr. Albert Tyler, 54, professor of embryology at California Institute of Technology, has succeeded in preventing conception this way in such creatures as sea urchins, mice, rabbits and cattle, but not yet in the human species. His brother, Dr. Edward Tyler, 47, working at U.C.L.A., is also testing a third contraceptive principle--an oral drug (its name and maker are still secret) to work in men by suppressing the production of sperm. So far, the pills have been shown to reduce the sperm count drastically but not completely. And there is no evidence as to whether the few remaining sperm are hardy enough to sire normal offspring.

Since all hormonelike drugs are as powerful as TNT in the ways they affect much of the body's chemistry, it will be years before doctors can be positive that any pill is safe enough* for long-continued contraception. (Progestins appear safe for promoting fertility, as they are taken far only a short time.) And overshadowing everything is the moral question. Roman Catholics object to "birth control" except by the rhythm method. Dr. Rock, a Catholic himself, says the progestins should be accepted by Rome as a "licit" variant of the rhythm method. The Vatican has not yet defined its position on the pills.

* Searle sells Enovid as a contraceptive but advertises only its other uses. Parke, Davis coyly avoids mentioning Norlutin's contraceptive use, even in professional leaflets, but doctors do not need to be told about it.

* Reports that Enovid not only is free of cancer risk, but actually protects against it are premature and based on faulty statistics. The American Cancer Society this week awarded Dr. Pincus a $58,000 grant to start a study on this.

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