The Pill on Trial

Few subjects are more likely to attract widespread TV and press coverage than an investigation of the dangers of the Pill, now used by 9,000,000 women in the U.S. alone. In full awareness of that fact, Wisconsin's Senator Gaylord Nelson used his monopoly subcommittee last week to conduct a highly publicized investigation of the oral contraceptive that at times seemed more like a trial than an empirical examination of the available medical evidence.

The subcommittee's announced intent, according to Nelson, was to "explore the question whether users of birth control pills are being adequately informed concerning the Pill's known health hazards." The fact is, they are not--either by the Pill's proponents or by its crusading critics. And as Nelson pointed out: "It is important that women be informed about all aspects of use of the Pill so that they are able to make an intelligent, personal decision about its use."

Fallopian Fallacy. But when Nelson lined up his witnesses, adamant critics outnumbered defenders by seven to one. Most conspicuously missing from the roster was Harvard's Dr. John Rock, co-developer of the Pill, a conscientious Roman Catholic and a thoughtful advocate of research to reduce the Pill's admitted and harmful side effects.

Nelson chose as his lead-off witness Dr. Hugh J. Davis, an assistant professor of obstetrics and gynecology at Johns Hopkins University. Since 1962 Davis has specialized in intrauterine devices (lUDs) and he is one of the inventors of a ring device not yet on the market. Davis argued that "breast cancers have been induced in at least five different species of animals by treatment with the same synthetic hormones being marketed in the oral contraceptives. Every important agent which has a carcinogenic [cancer-causing] effect in humans has been shown to cause cancer in animals. There is no reason," Davis insisted, "to presume that the single exception will turn out to be the oral contraceptives." Neither Nelson nor the only other Senator present, New Hampshire's Thomas J. Mclntyre, caught Davis up on what might be called a Fallopian fallacy: while it is correct to say that everything known to cause cancer in man also causes cancer in animals, the converse is not true.

There is as yet no conclusive evidence that the Pill causes cancer, although it may eventually be shown to do so--just as cigarette smoking was prevalent for 50 years before its link to lung cancer was established. Researchers are testing the Pill's hormones on animals which are expected to provide answers much sooner than they could be derived from studying human patients. This research prompted Dr. Roy Hertz of Rockefeller University to comment: "The ultimate outcome of this race between dogs, monkeys and women can be anticipated by informed observers only with the greatest apprehension." Harvard's Dr. Robert W. Kistner, the only pro-Pill witness called, testified that the supposedly "precancerous" cervical cell changes detected in women on the Pill are the same as those occurring spontaneously in women who are pregnant --and even in newborn babies. But Kistner also declared that in endometriosis (a painful overgrowth of the lining of the womb), one of the two hormones in the Pill "may have marked protective effects" against the development of cancer.

Clots and Cramps. Although the hearing droned on for two days, with further testimony scheduled for two more weeks, there was little chance that any new medical evidence on the safety of the Pill would be presented.* For example, the Pill's opponents claimed that its annual toll among British users is 30 deaths per million. Even if this figure is confirmed for Britain and the U.S.--which has not yet happened --there will be no way of knowing how many of those women would have died from complications of pregnancy, childbirth or illegal abortion if they had not taken the Pill. And although medical scientists still have much to learn about the effects of the Pill in its various forms, some facts now seem clear.

Because the Pill consists of two powerful hormones, it is likely to have more side effects than most other drugs. The immediate effects of which women complain most frequently are weight gain, breast tenderness and changes in sex drive (both increase and decrease). These symptoms usually subside within three months. Far more significant is what the Pill can do to the blood-clotting mechanism. Its use can cause clot formation in a leg vein (thrombophlebitis or phlebothrombosis), signaled by painful cramps. This condition may be temporarily incapacitating but is not immediately dangerous. A far greater hazard is that such a clot may be dislodged, then travel through the right side of the heart to the lungs and cause pulmonary embolism--a frequently fatal condition. Equally dangerous is obstruction of one of the brain's arteries by a clot--the commonest form of stroke, with a high risk of incapacity or death.

In some cases the Pill raises an unstable blood pressure so abruptly and severely as to cause a blowout in a brain artery--the hemorrhagic type of stroke. Another vascular disturbance is the migraine headache, which results from dilation of peripheral arteries in the head. Any woman who has ever had migraines is likely to find that they strike more often and more severely after she goes on the Pill. Others may suffer their first, alarming and hideously painful migraine when taking the Pill. Among other "contraindications," as doctors call them, are diabetes, liver disease, breast cancer and possibly rheumatoid arthritis. Serious allegations against the Pill which cannot yet be proved or disproved are that it may cause genetic changes, or damage the fetus, as does thalidomide.

Bad Medicine. Of all the reported side effects, the one of deepest concern to young women who have not had all the children they want, is that after they stop taking it their fertility may be reduced. Pro-Pill parenthood planners share this concern. There is indeed a definite suppression of fertility in some women who fail to menstruate or ovulate for a year or two after dropping the Pill. But the true incidence of Pill-induced infertility cannot yet be measured, Kistner points out, because if a woman has never had a child before going on the Pill and does not conceive afterward, she may be among the 10% to 15% of women who are naturally infertile. Even after having borne one child, Kistner said, 7% to 8% of women cannot conceive again.

The most glaring defect in discussion of the Pill has been the slight attention, if any, given to the failure of too many U.S. doctors to study their patients before prescribing it. When a woman aged 15 to 45 asks a physician for the Pill, she is almost invariably handed a prescription that is often, in practice, refillable indefinitely. This is bad medicine. A conscientious doctor will ask the woman, if he does not already know, whether she has had any blood tests, and whether they showed anything unusual about her blood sugar or clotting. Has she had high blood pressure or migraine headaches? If her mother is not still living, the cause of her death and the age at which she died are relevant. If alive, does her mother have high blood pressure, phlebitis or severe headaches?

Then the doctor can quickly decide whether the Pill carries an unacceptable risk for this particular patient. If it does, he is ethically obliged to refuse her the prescription and to suggest some other contraceptive such as a diaphragm or IUD. If all U.S. doctors followed these rules they could avert many, perhaps a majority, of the severe and fatal Pill reactions now being reported.

Two other measures now under consideration could reduce the harmful effects still further. British research, cited repeatedly at Nelson's hearings, suggests that the risk of clotting is somewhat greater with the sequential pills. It is also directly related to the amount of estrogen in either type of Pill, and is markedly increased if the estrogen component is more than 50 micrograms (less than two millionths of an ounce). Britain has already officially discouraged the dispensing of pills with any higher estrogen content. By this reasoning, women in the U.S. would find themselves limited to seven out of the 20 oral contraceptives now on the market. The "one-every-day" Pill containing no estrogen should virtually eliminate clotting risks, though it will still require intensive study of other side effects. As, in fact, do all potent drugs.

-Two types are approved for general prescription: 1) 21 daily combination pills containing synthetic equivalents of the hormones progesterone and estrogen, with the latter in a microscopic dose; 2) sequential pills, which provide tablets of an estrogen alone for 14 to 16 days, followed by five to seven combination tablets. A third variety, the "one-everyday" pill of progestin (progesterone equivalent) only, is being tested but is not yet licensed for U.S. prescription.

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