Friday, May. 02, 1969

The Pros and Cons of the Pill

SINCE oral contraceptives were introduced for general prescription in 1961, at least 10 million U.S. women have taken them; about 7,000,000 are using them now. Despite the natural assumption that such popularity must be deserved, the Pill has provoked an almost equally strong countercurrent of opposition and denunciation. Anti-Pill crusaders demand that it be taken off the market, claiming that it is killing scores if not hundreds of American women every year, maiming ten times as many and making others infertile. More than a hundred lawsuits are pending against manufacturers.

The Ladies' Home Journal is editorially allergic to the Pill, and has published articles under such titles as "The Terrible Trouble with the Birth-Control Pills." McCall's has printed a review of dropouts, called "Why They Quit the Pill." Columnist Drew Pearson reported in his more than 600 subscribing newspapers that "at least 10% of all adverse-reaction reports are fatalities and that one-third of the recent reports on one specific pill involve death."

Two Synthetics. Such impassioned distortions only becloud the truth about the Pill, which is difficult enough to establish. From the most recent technical reports, however, these conclusions emerge: 1) the Pill is the most effective contraceptive yet devised; 2) like any other potent drug, it sometimes produces side effects that may be crippling or fatal to a minute proportion of users; 3) while the risks of such side effects appear to have been wildly exaggerated, there are some women for whom the Pill should never be prescribed.

The Pill on the U.S. market today contains two synthetic chemical components, one resembling the natural female hormone estrogen, the other a progestin that resembles progesterone, which women secrete chiefly during pregnancy. Some are combinations in which both the estrogen and the progestin are taken for 21 days a month; others are "sequentials," in which the estrogen alone is taken for 14 to 16 days, and estrogen with progestin for five or six.

The most recent assessments of the Pill were given last month to the American Association of Planned Parenthood Physicians and the American College of Physicians. No two of the assembled experts agreed completely on the relative advantages and risks of the Pill, or in defining the patients for whom they would prescribe or proscribe it. Nevertheless, they reached a reasonable consensus on the most important and potentially dangerous side effects.

sb BLOOD AND CLOTS. Hormone components of the Pill appear to "rev up" the chain reaction of yet other hormones that regulate blood pressure. Columbia University's Dr. John H. Laragh has seen 20 women whose blood pressure skyrocketed while they were on the Pill; presumably they were unusually sensitive to the hormonal effect. Women with kidney disease are especially susceptible. A related mechanism, said Laragh, explains some complaints of "feeling bloated" and gaining weight, usually during the first three or four months that a woman is taking the Pill; some of the hormones involved cause retention of salt and water.

The estrogen component of the Pill is known to increase the coagulability of blood and therefore the risk of clot formation. British researchers have shown that women under 40 risk a clotting problem that is seven to nine times greater than the minuscule risk among nonpregnant women of the same age not on the Pill. Clots may form in either superficial or deep veins of the legs (thrombophlebitis), and may travel to the lungs, causing pulmonary embolism, which carries a high death rate. Or they may form in the brain, causing strokes. There are also a few cases in which a myriad minute clots have blocked circulation in the heart and in intestinal arteries.

These dangers must be set against the greater hazards of pregnancy. For three weeks after a normal pregnancy and delivery, the risks of thromboembolism (including pulmonary embolism) are greatly increased, and even during pregnancy may be slightly increased. Northwestern University's Dr. David Danforth calculated for the College of Physicians that there are .55 cases of thromboembolism per 1,000 women a year among Pill takers compared with .74 per 1,000 during pregnancy and three to ten cases per 1,000 after delivery. Clotting problems aside, pregnancy carries other risks, including fatal complications associated with high blood pressure and kidney disorders. And unwanted pregnancy involves the risk of illegal, septic abortion, which is notoriously hazardous to life. Nonetheless, a one-to-one comparison of the risks of the Pill and those of pregnancy would be invalid. That is largely because a woman who chooses not to use the Pill has other alternatives for avoiding pregnancy--such as the diaphragm, foam, the intrauterine device or her husband's condom.

sb BRAIN AND EYES. High blood pressure increases the risk of strokes of both major kinds--the thromboembolic, caused by traveling clots, and the hemorrhagic, in which a blood vessel bursts. Strokes are uncommon among women under 40, but several neurologists say they have seen as many as ten cases in a year among women on the Pill, where they used to see only one or two before the Pill. Both the increased blood pressure and the estrogen's effect on the clotting mechanism may be responsible. There are a few authenticated cases of severely impaired vision, even to the extent of blindness, as the result of clotting in the minute retinal arteries.

Because migraine headaches result from dilation of small arteries near the surface of the skull, they might be related to the Pill's effects on blood vessels. Thus some physicians never prescribe the Pill for a woman who has any history of migraine, and stop it promptly if a woman with no such history complains of migraine while on it. Others counter that this could rule out 5% or more of the female population.

sb METABOLISM. Estrogens, but not progesterone, have long been known to influence the metabolism of fats--to the point where they have been given to men in the hope of lowering their blood-cholesterol levels and protecting them against heart attacks. In fact, says the University of Miami's Dr. William N. Spellacy, their effect on cholesterol is still debatable; they seem to increase the proportion of big, "flabby" fat molecules circulating in the blood. The most consistent finding, said Spellacy, is that increased estrogen levels cause increased blood levels of triglycerides, the complex, fat-containing molecules involved in atherosclerosis and heart disease. But, Spellacy emphasized, there is as yet no evidence linking the Pill with these diseases in women.

The Pill's effect on insulin and carbohydrate (sugar and starch) metabolism is somewhat clearer. In many women, the blood-sugar level goes up, and with it the level of circulating insulin. There is no reason to believe that the Pill causes diabetes, but it may, in some cases, accelerate the onset of the disease. Then again, so does pregnancy.

sb LIVER. If a woman has had pregnancies marked by either jaundice or pruritus (diffuse itching), she should not go on the Pill, suggests Dr. Robert A. Hartley of Baltimore. Both these conditions result from impaired liver function, and the Pill is likely to reproduce the effects of pregnancy. Some gynecologists, however, believe the Pill is safe if the woman has had infectious hepatitis and has fully recovered from her jaundice.

sb FERTILITY. In the early days of enthusiasm for the Pill, the word was that, far from interfering with fertility, it seemed to enhance it. Women who had just stopped taking the Pill seemed more likely to become pregnant within a couple of months. This is not true, certainly not for all women, says Dr. Alan F. Guttmacher, president of the Planned Parenthood Federation of America. Some who have taken it for two years or more, then stopped because they wanted a baby, have failed to menstruate and ovulate, and therefore to conceive, for as long as 18 months. Guttmacher prefers not to prescribe the Pill for a young woman with irregular menstruation, or no periods at all, who has not completed her family.

sb CANCER. The claim was once made that while estrogens may cause cancer, as they do in many laboratory animals, the Pill seemed actually to afford some protection against breast cancer. More cautious now, the experts claim no protective effect, but assert unequivocally that they have seen no case of breast cancer that might have been caused by the Pill. Still, to stay on the safe side, they will not prescribe it for any woman who has cancer or any suspicious change in a breast.

The greatest controversy today concerns cancer of the cervix. Again the trouble is insufficient data. What is indisputable is that many, if not most, women on the Pill undergo cellular changes in the cervical region. The question is whether these are precancerous. Two researchers, Drs. Milliard Dubrow and Myron R. Melamed, conducted a three-year study of almost 35,000 women at Manhattan Planned Parenthood clinics. Their report has not been published, and may never be, because technical reviews of the study suggest that it was badly designed. But bits and pieces of the findings have been carefully leaked to the press by anti-Pill crusaders. The essence: among women on the Pill, Dubrow and Melamed found twice as many cases of cell changes as among women using diaphragms. They call these changes "carcinoma in situ" (literally "cancer in place," as distinct from cancer that has spread). This condition is also known as "carcinoma, stage zero," and as a "precancerous condition," although it does not always lead to cancer. What is not clear is whether these women had any greater incidence of cell abnormalities than did other women who did not use diaphragms (some physicians consider the diaphragm to be a protective factor).

Second Generation. Not even the most enthusiastic supporters of the Pill in its present form believe that it is the ideal contraceptive. In addition to its side effects, it has the disadvantage of requiring close calendar watching. Researchers are working strenuously to produce a morning-after pill, a one-a-month pill or a once-a-year injection to achieve the same result with greater certainty and less fuss. What may well be the second generation of oral contraceptives is already undergoing extensive tests.

In Manhattan, at city-owned Metropolitan Hospital, Dr. Elizabeth B. Connell has had more than 1,000 women, some for as long as four years, taking a pill consisting only of chloramadinone, a progestin, every day of the year. Side effects seem to be fewer and less severe than those from pills containing estrogens, and the number of unwanted pregnancies has been negligible. The remarkable thing about these pills is that most women taking them still ovulate regularly, and so are theoretically exposed to conception. For reasons unknown, conception does not occur.

A similar progestin is being tested by the Upjohn Co. in a novel form. Upjohn technicians have made vaginal rings of Silastic (silicone rubber) impregnated with medroxyprogesterone (Provera). The rings are of the same spring-reinforced design as the ring of a diaphragm, but there is no cap. The woman inserts the ring five days after the beginning of a menstrual period, removes it after 21 days, and throws it away. She should menstruate within two days, and start the 28-day cycle again with a new ring five days later.

As for the Pill in its present forms, as sensible an opinion as any was expressed at last week's meeting of the College of Physicians by Dr. Ann Lawrence, a hormone specialist at the University of Chicago. She would not, she said, prescribe it for women with a family history of breast or cervical cancer, or the likelihood of clotting or circulatory problems, or diabetes. "I am one of what I would call the concerned physicians, simply pleading that the drug be used with a certain circumspection," said Dr. Lawrence. "But I wouldn't even try to deny that the Pill has been -L- boon to millions of women." For all but the most fanatical opponents or proponents of the Pill, Dr. Lawrence's attitude seems the soundest of all.

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