Friday, Apr. 07, 1967

Freedom from Fear

CONTRACEPTION

(See Cover)

"The pill" is a miraculous tablet that contains as little as one thirty-thousandth of an ounce of chemical. It costs 11-c- to manufacture; a month's supply now sells for $2.00 retail. It is little more trouble to take on schedule than a daily vitamin. Yet in a mere six years it has changed and liberated the sex and family life of a large and still growing segment of the U.S. population: eventually, it promises to do the same for much of the world.

"The pill," as oral contraceptives are now universally known, may well have as great an impact on the health of billions of people yet unborn as did the work of Pasteur in revealing the mechanism of infections, or of Lister in preventing them. For if the pill can defuse the population explosion, it will go far toward eliminating hunger, want and ignorance. So far, it has reached only a tiny fraction of the world's 700 million women of childbearing age, but its potential is clear from U.S. experience. Of the 39 million American women capable of motherhood, 7,000,000 have already taken the pills; some 5,700,000 are on them now.

Until this year, it appeared that because of their cost and the need to take them on a rigorous schedule, the pills were only for the few in advanced countries with high literacy and living standards. For those in the slums and back-lands of such nations as Brazil and Malaysia, hope seemed to lie with a much cheaper and simpler mechanical contraceptive, the intrauterine device, or IUD. Once inserted by a doctor, an IUD can be left in place and forgotten. But latest reports show that illiterate women who can't count can still take their pills on schedule. In Pakistan, Denver's Dr. John C. Cobb got dozens of them to do it, simply by starting them on the night of the new moon. In semiliterate Taiwan, where lUDs have won wide acceptance, more and more women are switching to the pills. The number of users outside the U.S. is about 5,000,000, and the figure is rising.

Hormonal Messenger. The pills were first approved for prescription use in the U.S. in June 1960. Now there are twelve varieties, divided into two main classes, but all have two principal effects. First, they regularize a woman's monthly cycle so that she has her "period" every 26 to 28 days, as nature presumably intended. To this extent, the pills are biologically normalizing. Their second major effect is to do something that nature neither intended nor foresaw, and that is to prevent the release of a fertilizable egg from the woman's ovaries during the cycle in which the pills are taken, and thus make it impossible for her to conceive.

Females of many animal species are fertile for only a short time at comparatively long intervals. The female human animal is an outstanding exception, with a fertile period of three to six days out of every 28. The cycle begins with the start of menstrual bleeding. For the first four or five days, her uterus sloughs off part of its lining (endometrium). This accomplished, her complex hormonal system sends a messenger chemical to her ovaries, telling them to ripen one of the 50,000 or more potential egg cells with which she was born. Usually, only one ovary responds, and on Day 10 or soon after, a fully formed ovum is released into the Fallopian tube. The ovum takes three or four days to work its way down the tube. If, en route, it meets a fresh and viable sperm, conception occurs, and the fertilized egg proceeds to the uterus for implantation in its wall and development into a baby. Soon after the egg is released, the automatic hormone mechanism sends another chemical messenger to the ovaries, telling them not to release any more ripe eggs--to guard against multiple or superimposed pregnancies. If there has been no fertilization, the uterus again gets ready to slough off its lining, and the cycle is repeated.

"Pincus Pills." Probably no single name will be forever linked with the pills, as is Jenner's with vaccination. The search for medically useful knowledge nowadays goes along parallel lines at many places, often with a team working at each center. But Physiologist Gregory Pincus of the Worcester Foundation for Experimental Biology and Gynecologist John Rock of Harvard University rate high among the pioneers of oral contraception. It was at Harvard, too, that Dr. Fuller Albright noted in the mid-1940s that an excess of estrogen* in the bloodstream soon after the end of menstruation somehow prevented ovulation. A few years later, Pincus and Rock were working together to find a way of helping subfertile women ovulate, and thus conceive. They first had to regularize the woman's cycle, and they hit upon a synthetic progestin chemically akin to another female sex hormone, progesterone. The progestin, taken for 20 days in mid-menstrual cycle, suppressed ovulation by simulating pregnancy. Taken off the medicine, the women had a more normal cycle, with surer ovulation. After Pincus and Rock had produced a gratifying number of conceptions, a new idea struck them: Why not use the progestin deliberately to suppress ovulation every month--in other words, as a contraceptive?

At first the drug worked well. Several days after a woman stopped taking it, she had what seemed like a normal but mild menstrual period. There were few side effects. But as the drug was further purified, Dr. Rock began to hear patients complain of too much "breakthrough bleeding" in mid-cycle. Analysis showed that the purified drug contained no detectable estrogen. Apparently estrogen, even in the most minute quantity, prevented some side effects, including unwanted bleeding. So when Chicago's G. D. Searle & Co., which had worked closely with Pincus and Rock, began making "the Pincus pills" as Enovid in 1957, the formulation contained 66 parts progestin to one part estrogen. The progestin dose has been reduced by as much as 90% in Searle's newest pills, Ovulen, but the combination principle is the same.

Other hormone investigators took a different direction, concentrating on the rediscovered, though still not fully understood, powers of estrogen. From the fifth to the 20th day of a normal woman's cycle, her estrogen level is fairly steady, except for a dip at the time of ovulation. If they could prevent this dip, the researchers reasoned, they could prevent ovulation. They felt it would be more natural to do this by providing nothing but added estrogen until the 20th day, and then giving progestin only briefly. San Antonio Researcher Dr. Joseph W. Goldzieher worked with Syntex Laboratories to develop the resulting "sequentials." Beginning with Day 5, the woman takes a white estrogen pill for 15 days, then a distinctively colored progestin (with a protective smidgen of estrogen added) for five or six days. The sequentials, like the combinations, tend to regularize the cycle, and most women who take them have an acceptably mild menstrual period.

Skipped a Day. All the pills of both types now approved by the Food and Drug Administration for U.S. prescription (see box, page 80) are as close to 100% effective as any medication ever devised for any purpose. When a woman "on the pills" has become pregnant, it has been shown in virtually every case--and suspected in the others--that she has skipped a pill or two. The failure rate is slightly higher on the sequentials, apparently because the estrogen taken early in the cycle wears off rapidly, and a single day's missed pill may spell pregnancy. The progestin combinations afford a slightly broader margin of safety.

Like all other potent medicines, the pills produce many incidental effects. Some are good, some bad. Largely because of the thalidomide disaster, which occurred soon after the pills went on the market, many women are leary of them. Says a 31-year-old Houston woman who has only two children: "I'm just not convinced that the doctors know all they need to know about the pills yet, and their possible side effects." In fact, the doctors know a great deal.

The side effect most commonly complained of is weight gain--up to 20 lbs., say some women. Yet most gynecologists believe this was caused only by early, high-dosage forms, and that today's one-milligram pills rarely provoke a gain of more than five pounds. The sequentials usually cause less weight gain than the combinations. The next most frequent complaints are nausea ("like being four months pregnant"), breast tenderness and breakthrough bleeding. These usually disappear within three months.

Despite dark fears, there is not a shred of evidence that the pills cause cancer. In fact, they may even give some protection against it. But because estrogens are believed to promote the growth of some breast and cervical cancers, the pills may not be prescribed for women who are known or suspected to have this type of disease. Similarly, there is no evidence that the pills cause blood clots that might travel to the lungs or develop in the brain. But for safety's sake, they are not prescribed for women with any history of clotting problems.

Prescribed for Acne. Some women complain that the pills cause acne. This is physiologically impossible, because acne is associated with an excess of androgens (male hormone) over estrogen. Since the pills supply estrogen, they are often prescribed for treatment of acne. Other women complain that they don't menstruate while on the pills. This is seldom true, because of the pills' regularizing effect. A Los Angeles mother says that the pill was "magic--a godsend" for her 15-year-old daughter, whose menstruation was so irregular and heavy that she suffered serious blood loss and near-shock, and needed transfusions. On the pill for six months, she now has "pink cheeks, regular periods, a good figure and has gained ten pounds." Wryly, a young woman in Miami says, "They've improved my complexion, done away with menstrual problems, eliminated worry, and I feel better physically. But they haven't straightened out my lousy love life."

It is not only the young whose complexions and dispositions benefit from the pill. Many a woman entering menopause, confident that soon she can forget about contraception, is advised to stay on the pills because they postpone many of the stigmata of age--dryness and wrinkling of the skin, sagging bosom, edginess and depression, and a reduction of vaginal secretions that may make intercourse too painful.

The most recent canard about the pills, fostered by the birth of octuplets in Mexico, is that after a woman stops taking them she is more likely to have a multiple pregnancy. This is not true.

Whatever their shortcomings, the pills are unquestionably superior to all other contraceptives. The condom, still the bestseller (almost 2 billion sold all over the world, 400 million in the U.S. last year), is unesthetic. Even more than the diaphragm, it requires interruption of a normal progression to perform an antaphrodisiac rite.

5,500 Per Lifetime. For every American woman who has rejected the pills because of conscious doubt or uncon scious fears and guilt, a dozen have accepted them. Says Dr. Richard Frank, medical chief of Chicago's Planned Parenthood clinics: "More than five million women can't be wrong about the acceptability of the pills." This impressive total, according to the 1965 National Fertility Study,* means that of all white American women using any form of contraception, 24% are on the pills. Broken down, it shows 27% pill use among Protestants, 22% among Jews, 18% among Roman Catholics. This last figure may be low because some Catholics say they use the pills for reasons other than contraception. The use rate among Negroes is only slightly lower than among whites.

For married couples whose religious beliefs interpose no moral problem, the pill is indeed a boon. Biologists have computed that under a dictum of St. Augustine, permitting "only those sexual relations which are necessary to procreation," a man could not expect to have intercourse more than 55 times in his life. But the late Alfred C. Kinsey's studies indicated that the average American has intercourse 5,500 times, leaving coitus with procreative intent at a mere 1%. Dr. S. Leon Israel of the University of Pennsylvania believes that this is ten times too high--that conception is specifically planned in no more than one incident of coitus out of a thousand. In a logical deduction, Dr. Edris Rice-Wray, who conducted the first pill tests in Puerto Rico in 1956, declares: "Ninety percent of all people are caused by accidents."/-

Four Little Indians. Typical of the woman who has had all the children she wants and dreads that "menopause baby" is an Atlanta mother of three, aged 44, who says: "I'm getting too old to start looking after another baby. I've been taking the pill for almost two years with no side effects, and it's much simpler than any other method I've tried." To the neurotics who complain that it is too difficult or too much trouble to take a pill a day, a 34-year-old mother in Oak Park, Mich., responds: "I have my hands full running after four little Indians, and if I had another I'd die. The mere thought of having an unwanted baby is enough to make me remember to take my pills."

The pill is equally helpful to the newly married who want babies at times of their choosing. Says a Detroit secretary: "Sex is especially important when you first get married, and it was so much easier not to have to worry about having a baby that first year." An Indiana teacher, 23, concurs: "When I got married I was still in college, and I wanted to be certain that I finished. Now we want to buy a home, and it's going to be possible a lot sooner if I teach. With the pill I know I can keep earning money and not worry about an accident that would ruin everything." For all these women, the pill spells freedom from fear.

Catholics & Conscience. The pill poses two grave moral problems. The first affects Roman Catholics and, for different theological reasons, the smaller number of Orthodox Jews. Not until 1930 did the Vatican modify the Augustinian rule that sex must be for procreation, when Pope Pius XI approved the rhythm method. The Vatican has banned all mechanical and chemical contraception. But Dr. Rock, an unswerving Catholic, has been arguing ever since he sired the pill that its use imitates nature--which occasionally, but only occasionally, makes a woman skip ovulation--and that it should therefore be approved by the Vatican.

Pope Paul said last October that the question of birth control was not open to doubt. But the Rev. Albert Schlitzer, head of Notre Dame's theology department, declares: "Many Catholics believe that there is still doubt, so it remains a personal choice. A good many theologians would question whether it is a matter of divine law at all. Many Catholics have already made up their minds, and will follow their decisions no matter what the Pope says in the future."

What Paul will say and even when he will say it are still the subject of speculation. In his encyclical last week (see RELIGION) the Pope said: "It is for the parents to decide, with full knowledge of the matter, on the number of their children ... In this they must follow the demands of their own conscience en lightened by God's law authentically interpreted." Dr. Rock interpreted it his way: "Oh, perfect! Parental responsibility and the supremacy of conscience--that's an excellent way to satisfy the Old Guard as well as the young." The Old Guard was unmoved. Said Msgr. William F. McManus, director of the Family Life Bureau in the Archdiocese of New York: "I see in the encyclical no substantial change in what the Vatican has said for some time in the matter of family control."

With that stand-off the matter rests, while the Pope ponders majority and minority reports from his special commission on marriage and birth control. Meanwhile, pressure for action rises from such prominent laymen as Clare Boothe Luce, who in the February McCall's equated the rhythm method's calendar watching with "checked-off love and clocked-out continence."

No less than 53% of American Catholic couples, according to the Ryder-Westoff survey, have adopted some form of birth control other than rhythm. And though some Catholic doctors will not prescribe the pill for them, many others will. In heavily Catholic Massachusetts, its use is widespread. Says Norwood Gynecologist Francis C. Mason: "Despite the doubletalk from Rome, the pill is the most acceptable method of birth regulation. Use of the pill by a large Catholic population acts to make them psychologically sound and to create a sound family relationship. I don't practice medicine as a Catholic. If a woman asks me for medical advice, I give her medical advice." With two Catholic partners, Dr. Mason shares what is probably New England's biggest group practice in obstetrics and gynecology.

"It Takes Character." The second moral problem posed by the pills relates to the unmarried. Does the convenient contraceptive promote promiscuity? In some cases, no doubt it does--as did the automobile, the drive-in movie and the motel. But the consensus among both physicians and sociologists is that a girl who is promiscuous on the pill would have been promiscuous without it. The more mature of the unmarried in the Now Generation say that, far from promoting promiscuity, the pills impose a sense of responsibility. Formerly, many a young woman rejected premarital relations specifically because of her fear of pregnancy. Now, on the pills, she has to make the decision according to her own conscience.

Availability of the pills also has an inhibiting effect on some unmarried girls. They feel that to take them regularly, calculatingly, in anticipation of a possible amorous encounter, would deprive them of a treasured "feeling of innocence" when the great moment arrived. For some of them, as for their boy friends, an essential element in a premarital fling is risk.

In the Milk. At the high school level, it is harder to separate contraception from sexual delinquency, and the lack of it from pregnancy and possible abortion. Once a teen-ager has become pregnant, has been expelled from school, and has had either a baby or an abortion, the chances are that she will soon be pregnant again. To break the pattern, Dr. Philip Sarrel recently took 90 pregnancy dropouts in New Haven, set up special classes for them and, with their parents' permission, put them on the pill or gave them IUDs. On form, he could have expected 50 pregnancies within a year and a half. Actually there was only one--and that because a girl deliberately skipped her pills. In Baltimore, a preventive pill-and-IUD program is being carried out among pubertal-age girls in "high-risk" (slum) areas.

Such problems are not exclusive with the poor. Last week, during a private lecture at a California resort for the well-to-do, a psychiatrist asked 30 assembled mothers whether they would give birth-control pills to their teen-age daughters. Only a few said no. Most were undecided. One-third said yes, definitely--and one mother announced that she was already slipping the pill into her daughter's breakfast milk.

Health on Wheels. When Searle first marketed Enovid in 1960, it cost $11 for a month's supply, automatically limiting its use. Today, with mass production, smaller doses and intense competition, the pills are cheap enough to be dispensed to hundreds of thousands of women, either at nominal cost or at no cost, through clinics operated by Planned Parenthood and some public agencies.

One of the most effective programs is a Planned Parenthood operation in Birmingham, Ala., called Health on Wheels. The brainchild of Planned Parenthood Chairman Tom Bolding, its wheels are those of a Dodge van with its own generator. Equipped with examining table and the latest medical equipment, staffed by a nurse and a doctor who volunteers for a day's duty, the van takes the back roads into remote parts of Winston and Walker counties. "Most of the women there," says Dr. Bolding, "don't have the 250 bus fare to get to a stationary clinic, and some don't have the motivation. We're taking this service to the people who need it--to the women with twelve children who don't want any more." Most of these women choose lUDs; some get a supply of pills sufficient to last them until the van's next visit.

Memory in Plastic. The pills might never have had such an impact and acceptance if research on lUDs had been pursued more vigorously. The lUD's underlying principle traces back to an old practice of Arab cameleers: putting a round, smooth stone in the womb of a female camel at the start of a long trade journey, to avoid the economic loss of having the animal get pregnant. In the 1920s, Berlin Gynecologist Ernst Grafenberg transmuted the Arabs' camel stone into a ring of surgical silk or silver, gentle enough for the human womb. But this was in pre-antibiotic days; many women developed severe infections. Except in a few foreign medical centers, the 1UD was neglected. When the pill was proving itself, several inventive Americans took up the lUDea and devised vastly improved models. Most of them are now made of plastic with a built-in "memory," so that the device can be straightened for easy insertion but will resume its desired shape in the womb.

From Dr. Jack Lippes' labs in Buffalo came a series of doubleS designs, now known as the Lippes loop, which has probably the widest acceptance both in the U.S. (150,000 users) and overseas (up to 4,000,000). Manhattan's Dr. Lazar C. Margulies devised a spiral; Brooklyn's Dr. Charles Birnberg, a bow; Kentucky's Dr. Ralph Robinson, a twin-spiral "safety coil"; and Brooklyn's Dr. Gregory Majzlin, a wire formation that looks like a bunch of paper clips. How the lUDs work is uncertain. Dr. Margulies believes that it is by speeding the ovum through the Fallopian tubes too fast for it to be fertilized, because of intensified muscle contractions.

lUDs must be inserted by a physician or highly trained nurse-technician. A non-expert can easily push one through the wall of the uterus, and the U.S. armed forces have decided not to use them, for lack of doctors skilled in this procedure. There are other drawbacks. It is difficult to fit an IUD for a woman who has never had a child, because the cervical orifice is too small. Even with women who have had children, anywhere from 10% to 15% expel the device by uterine contractions--in many cases without knowing that they have done so until they become pregnant. The IUD "failure" (meaning pregnancy) rate in the first year of use is about 3%, dropping to 2% thereafter.

"With its higher failure rate," says Dr. Alan Guttmacher, president of Planned Parenthood-World Population, "the IUD may not be good enough for your wife, but it may still be good enough for a public-health program in a developing country." And it is in just such places that the IUD is mainly being used--Taiwan, Ceylon, India and Mexico.

Elite Planning. Even in areas where poverty and population pressure are greatest, the pill is beginning to crowd the IUD. Dr. Rice-Wray, now in Mexico City, pooh-poohs the idea that poor, illiterate women cannot learn to take pills regularly: "We have some women who've been on the pills for eight years straight, and we can't get 'em off them--not even to take part in our study of a once-a-month injection."

National preferences and practices in birth control vary astonishingly, without regard to education or socioeconomic levels. The highly sophisticated Swedes are educated in contraception early, and get frequent reminders in slick magazine ads. In affluent, literate West Germany, the pills and lUDs are little used; abortions equal live births--every year, 1,000,000 of each. France forbids the importation of birth-control materials; only a few women in elite private clubs pour le planning familial enjoy their benefits; again, abortion is rampant, as it is in Italy and an endless list of other, supposedly civilized nations. In most Iron Curtain countries, abortion is discouraged but permitted, and performed quickly and safely with a Soviet-invented vacuum suction device. Dr. Guttmacher calls abortion "the most severe pandemic disease in the world today."

Latin America counts 2,000,000 pill users, a remarkably large number considering its Roman Catholic heritage and low income levels. But that is still less than 5% of the fertile women. Among the masses, baby follows baby with such deadly rapidity that Colombian women crouch on the ground to abort themselves with sharp sticks. In Chile, the victims of bungled abortions occupy 20% of the beds in maternity wards, use up 27% of the transfusion blood. The situation became so serious that four years ago, with a high death rate among women who left five to ten orphans behind, the Catholic hierarchy tacitly agreed to look the other way while the government backed family planning. About one-sixth of Chile's fertile women now have lUDs or take the pills. Next week, partly in recognition of this progress, Chile will be host to the eighth world conference of the International Planned Parenthood Federation.

At the conference, talk will turn from what present contraceptives are achieving to new methods still in the experimental stage, which it is hoped will eventually surpass the pill in simplicity and effectiveness. Among them:

sb THE MINIPILL. In what Manhattan's Dr. Elizabeth B. Connell calls "Harlem and other underdeveloped areas," carelessness in counting 20 days on and eight days off is as common as it is serious. Dr. Connell is experimenting with a one-every-day "minipill." It consists of chlormadinone acetate, a synthetic that resembles progesterone and works in much the same way, but in doses only a quarter or half as big as those in even the smallest of the usual pills. Menstrual periods arrive regularly after a few months. The unwanted pregnancy rate is less than 2%, and a woman, knowing that she has to take the pill every day of the year, can forget about counting days.

sb INJECTIONS. A progesterone derivative, the Upjohn Co.'s Depo-Provera, has had FDA approval for six years as a treatment for disorders of the lining of the uterus. Its use as a contraceptive is still limited in the U.S. to experimentation by researchers. The dose, injected into a muscle and slowly released into the system, can be adjusted so that women might need an injection only once a month, or every three or six months.

sb IMPLANTS. A year's supply, or 20 years', of contraceptive hormones, placed in a slow-release capsule no more than an inch long and the thickness of a kitchen match, is undergoing tests. Implanted in the arm or buttock, the capsule would provide long-lasting protection--or could be removed if pregnancy were desired.

sb MORNING-AFTER PILL. For the woman who has intercourse seldom or unpredictably, a one-shot birth-control pill is being developed for use the day afterward. Yale University's Dr. John McLean Morris has given large doses of one of the standard estrogens to more than 100 women for four or five days immediately after unwanted coitus--in many cases from rape or incest. There have been no pregnancies. In the absence of any short-order pregnancy test, no one knows how many there would have been without the medication, and the drug produces severe side effects (bleeding, clotting, nausea) when used this way. But the idea is so attractive that virtually all pharmaceutical manufacturers are pursuing it.

Other contraceptive techniques are farther off--but not beyond possibility. How about a drug that works the way an IUD apparently does, speeding ova through the Fallopian tubes so that they cannot be fertilized, or preventing the implantation of fertilized ova in the uterine wall? Searle's Dr. Thomas P. Carney is searching for a chemical that will serve to activate the specific muscles involved. In his research with infertile women, St. Louis' Dr. William H. Masters noticed that some had cervical mu cus so hostile to sperm that it killed them almost on contact. In normal women, during their "safe" periods, the mucus is so sticky and viscous that it tends to smother spermatozoa. So two lines of research are being followed: 1) to keep a woman's cervical mucus viscous enough to block sperm, and 2) to identify the chemical in Dr. Masters' infertile patients and then use it as a contraceptive.

A male contraceptive seems more remote. On a suggestion from Dr. Rock, who noted that sperm production is prevented by too high a temperature in the testicles, some men have immersed their scrota in water at 130DEG. Sperm reduction lasted for as long as a month, but did not become effective until at least two weeks after the treatment. The tech nique is not likely to catch on. Los Angeles' Dr. Edward T. Tyler found a male pill that knocked out the sperm after two or three weeks. Trouble was, the drug worked with prison volunteers who had no access to alcohol. Combined with even a single glass of beer, it produced severe vomiting, an intolerable rash, giddiness and stupor.

Female hormones will also suppress a man's sperm production--the present pills do this--but they lower both libido and potency, along with more dangerous side effects. Vaccinating a woman against her husband's sperm, or vaccinating him against his own, has been investigated by Dr. Tyler's biologist brother Albert, with poor results so far.

Despite the impressive progress of the past few years, Dr. Guttmacher complains: "We're still in the horse-and-buggy stage of contraception." Dr. Rock and Dr. Goldzieher have a more funda mental objection to present methods. All, they say, attack the problem from the wrong direction, trying to negate nature during most of a woman's possible average of about 400 menstrual cycles. The ideal would be to have women in fertile all their lives, except when they specifically wanted to conceive, and then switch on their fertility with a pill or a shot. If that sounds far out, so did the pills themselves, when such men as Dr. Rock began their research less than 20 years ago.

* The collective name used for convenience for at least three of the female sex hormones, now applied also to synthetic chemicals of similar molecular structure. *Made by Norman B. Ryder, director of the University of Wisconsin's Center for Demography and Ecology, and Charles F. Westoff, associate director of Princeton University's Office of Population Research, and reported to the Notre Dame Conference on Population last December. /-A play on the safety poster: "Ninety percent of accidents are caused by people."

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