Healthy Skepticism Library item: 2017
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Seaman B.
The Pill and I: 40 Years On, the Relationship Remains Wary
The New York Times 2000 Jun 25
Full text:
I am not a scientist. I’m not a doctor. I’ve never been on the Pill.
But the Pill and I have been going steady for 40 years, and I seem to have collected information about it that other old-timers either don’t know or won’t tell.
The Pill was a brainchild of Margaret Sanger, the founder of Planned Parenthood, popularizer of the diaphragm and an indomitable fighter for women’s rights. Surviving jail, ridicule and decades of harassment, she, more than anyone, made birth control respectable. In about 1950, when she was about 88, Ms. Sanger was introduced to Gregory Pincus, a reproductive scientist from Massachusetts.
She raised approximately $150,000 — mainly from her friend Katherine McCormick, an heiress to a farm-machinery fortune — to get Pincus started on research toward a universal contraceptive.
Twenty years earlier, animal researchers established that hormones could prevent ovulation in rabbits and other species.
However, scientists (outside Nazi Germany) deemed it unethical to try such experiments on humans, since the physiology of female reproduction depends on a delicate, imperfectly understood feedback system. Within this system any hormonal interference may change the patient’s entire metabolism.
At first, Pincus was understandably wary of estrogen, as it was already understood to increase cancer risks. His dream was to create a progestin-only contraceptive, and that is what he intended to test in his historic 1956 Puerto Rican clinical trials, in which hundreds of mostly impoverished Puerto Rican women were given the newly developed pill experimentally.
But there is a problem with progestin-only contraceptives: they produce irregular and unpredictable spotting, or conversely, a complete absence of menstruation. Cycles range from a few days to many months, a condition aptly called menstrual chaos. Pincus, after wavering, eventually put estrogen back into the pill that was being tested.
How much Pincus wavered is evident in his papers, which are now available at the Library of Congress. They comprise approximately 44,000 items, filling 213 containers on 85.2 feet of shelf space. They reveal an awesome scientific and entrepreneurial brinkmanship, and make one wonder why Pincus didn’t burn the evidence.
Late in the study, for example, the Food and Drug Administration informed Pincus that he would need a control group. When the recruiter at the Family Planning Association in RÃo Piedras, P.R., could get no volunteers, Pincus instructed her to falsely relabel the “dropout folders” — which listed the women who had dropped out of the trials — as controls. This made the records especially confusing because it wasn’t until May 1959 that the formula, with the final amount of estrogen officially added to the progestin, was fabricated and shipped to the trial participants. Thus, the so-called control group was not only a dropout group, but it was a dropout group from a different pill.
The female medical students and nurses at the University of San Juan were fearful of the study and refused to participate.
According to a doctor who corresponded with Pincus, the medical students were punished with lower grades. The letters don’t say what happened to the nurses.
Still, when the Pincus pill was introduced, under the brand name Enovid, women embraced it as a marvel, for after the word no it was the most effective and convenient reversible contraceptive ever devised. It also held alluring health benefits, particularly the relief of painful menstruation.
Beneath the surface, however, Enovid was a chemical swamp, for, amid sworn assurances of safety, it began its commercial life as a massive overdose. Only after millions of women had taken Enovid — and thousands had died or had been disabled by blood clots — was it discovered that the amount of hormones in the Pill was 10 times what is needed for contraception.
Around this time, consumer protests against the excesses of some reproductive technologies began. One example was La Leche League, which in 1956 advocated breast-feeding as a better alternative to infant formula. Women dissatisfied with the anesthetized experience of hospital childbirth (shaved, humiliated and stuck in stirrups was how they described it) turned to natural childbirth techniques. The perception shared by many of these dissidents was that doctors were taking decisions out of women’s hands under the pretext of giving them more freedom.
These protests occurred under the radar of most of the medical and scientific press. It was only in the ghetto of the women’s magazines that reporters were expected — or allowed — to include the voices and the experiences of mere patients. In the early 60’s, I wrote for Brides magazine and the Ladies’ Home Journal, whose editor, Peter Wyden, believed that the Pill enjoyed a mantle of diplomatic immunity.
In 1967, Wyden recommended me for an advanced science writing fellowship at the Columbia University Journalism School.
He advised me to become expert in distinguishing ersatz studies from good stuff. Though he didn’t reveal it at the time, Wyden was grooming me to write my first book, “The Doctors’ Case Against the Pill.” He published it in 1969. Through a friend, the Washington public relations executive John Hoving, he got a copy to the drug industry’s principal foe in the Senate, the Wisconsin Democrat Gaylord Nelson.
Nelson was sufficiently convinced to plan hearings around the book.
A highlight of the hearings, which began in January 1970 and continued until early March, was the persistent interruptions by members of the D.C. Women’s Liberation, led by a young Barnard graduate, Alice Wolfson. With much of the international press — including TV cameras — watching, the Wolfson women repeatedly (until dragged away by guards) called out questions like “Why isn’t there a Pill for men?” and “Why are 10 million women being used as guinea pigs?”
Surveys during the hearings confirmed that only a minority of women were warned by their prescribing doctors about the Pill’s side effects.
Defenders of the Pill floated the rumor that Nelson and I wanted to ban it. We had no such intention; we just wanted women to have the information to make their own decisions.
At the hearings’ end, the F.D.A. commissioner at the time, Charles Edwards, submitted a 600-word document, “What You Should Know About Birth Control Pills,” describing the risks, side effects and contraindications of oral contraceptives.
In response, however, to pressure from professional, industrial and government interests, the agency submitted a 100-word revision that mentioned only one complication, blood clots.
Outraged, the protesters staged a noisy sit-in at the office of Robert Finch, secretary of health, education and welfare.
On March 30, Secretary Finch, Commissioner Edwards and Surgeon General Jesse Steinfeld met with five of the protesters and me. The outcome was a compromise, wherein the longer versions were sent to doctors to distribute. Most of these landed in “circular files” (wastebaskets), although Planned Parenthood did give them out.
In any case, the 100-word warning on the package, which flagged serious danger signals like coughing up blood or swelling in the legs, was effective in reducing the death rate from Pill-associated blood clots.
The right of the F.D.A. to require patient information was also established.
Ms. Wolfson and her colleagues had trained in the civil rights, student and antiwar movements.
Their Senate action became the Boston Tea Party of women’s health. In 1975, the National Women’s Health Network was officially cofounded by Ms. Wolfson, Belita Cowan, Dr. Mary Howell, Dr. Phyllis Chesler and me. It became the central switchboard for the hundreds — and then thousands — of activist and self-help groups then dealing with women’s health rights and body issues.
Of all the witnesses whose Senate testimony was interrupted by the protests, only one, Dr. Philip Corfman of the National Institutes of Health, paused to confirm the legitimacy of the shouted questions. And it was Dr. Corfman who, in the late 80’s, finally prevailed on manufacturers to withdraw all brands of oral contraceptive containing more than 50 micrograms of estrogen.
This year, on its 40th birthday, the Pill is well regarded and popular, but less than the universal contraceptive Margaret Sanger envisioned. By the 90’s, 80 percent of all American women born since 1945 had tried the Pill, but sterilization, including vasectomy, had become the No. 1 choice of married folk, while barrier methods that protect against sexually transmitted diseases — especially condoms — have gained favor among the not necessarily monogamous. Indeed, men have quietly increased their participation in birth control.
If my daughters had wanted to go on the Pill, I might have cried. Now, if my granddaughters should choose it, I guess I can live with that.
But even as the Pill gets safer, some troubling questions remain. The jury, in my opinion, is still out on the relationship of the Pill to breast cancer, infertility and high blood pressure, and we are only beginning to learn about some of its toxic interactions with other common drugs, like some antidepressants.
Then too there are always uncertainties about newer products, like the third-generation progestins (desogestrel is one example), which may be raising the risk of blood clots, according to reports from Europe and New Zealand. Even at the very lowest doses, any hormonal contraceptive is, in some sense, tampering with nature, and is bound to cause some . . . dislocations.
I still frequently think about those women of an earlier generation who took the first Pill — unaware of their part in a still unfolding experiment — and died for love.
I also think about the Tuskegee experiment on black men with syphilis, for which President Clinton apologized. Perhaps the families of those who died from Enovid deserve the same.
