There were early warning signs that could not be ignored, however, for another blockbuster hormone drug created and marketed only to women: the contraceptive pill. In under a decade since the FDA approved it, Searle’s Enovid had become an enormous success. Ten million women were regular users in the U.S. and another four million in another twenty countries. Searle liked to crow that one of every four married women in America was on the Pill.1
The Pill was undoubtedly a medical breakthrough that had empowered women to take charge of their reproductive options through a simple once-a-day tablet. In its first couple of years, physicians dispensed it as if there were no more side effects than aspirin. Searle’s advertisements boasted, “It has been studied more thoroughly and for a longer continuous time in the same persons and in more women than any other drug.”2
When patient complaints started trickling in of headaches, bloating, nausea, and breast tenderness, doctors were mostly dismissive, believing that women’s bodies had to adjust to the pseudopregnancy stage the Pill induced. Through the mid-1960s, however, the number of reported side effects grew. It prompted the FDA to appoint an all-male panel of nine physicians to study whether the Pill made blood clots more likely, the adverse effect that raised the most concern, since it was potentially fatal. They found 272 reports of Enovid users who developed blood clots; thirty patients had died. The panel recommended that Searle add a warning to its label about the possibility of blood clots for those most at risk, women over thirty-five. Under intense pushback from Searle, the FDA overruled its committee, claiming the doctors had made a mathematical error in calculating the death rate from blood clots and the real risk for those on the Pill was “not statistically significant.”3 In 1966, in another concession to Searle’s lobbying, the FDA lifted its forty-eight-month limit for how long a woman should stay on the Pill; there was now no time limit.4
From 1966 through 1969, the FDA documented another 1,034 instances of serious adverse effects, including 118 deaths, mostly from blood clots, but also a few from strokes and complications from hepatitis.5 The FDA could not determine if the fatal illnesses resulted from the contraceptive or were merely a coincidence. By the late 1960s, the prescription package insert sent to pharmacists was a tiny booklet of three thousand words and five complex scientific tables that listed more than fifty side effects, including some potentially fatal ones.
Questions about the Pill’s safety did not affect its commercial success. A five-year study concluded that 80 percent of women who stopped taking it did so because they were bothered by side effects such as bloating, cramping, and water retention, not because of fears about whether it might make them seriously ill. The market for the contraceptive kept expanding because so many more new patients between the ages of fifteen and forty-four replaced those who had discontinued it.6 The number taking the Pill grew on average about half a million annually.
Patients never saw the prescription package inserts. Those only went to druggists and physicians who requested them. Most doctors dispensed the Pill with a generic “call me if something unusual occurs” assurance. There was a widespread sentiment among physicians that if patients received too much information about possible side effects, many “wouldn’t understand it” or “it would scare the hell out of them.”7 In subsequent Senate hearings, Kansas senator Bob Dole questioned if telling women about the health risks might cause such anxiety they might end up “taking two pills… a tranquilizer and then the regular Pill.”8
The University of Kentucky’s Dr. David Clark believed the reason most of his colleagues were hesitant to criticize the Pill was that it had “diplomatic immunity.” Its backers considered it as critical in everything from controlling overpopulation to ending poverty to reducing the divorce rate to improving sex lives by eliminating the fear of unwanted pregnancies, and emancipating women by giving them full and simplified control of their reproductive rights.9 Peter Wyden, the editor of Ladies’ Home Journal, rejected any critical stories about the oral contraceptive since he did not believe the magazine’s readers wanted bad news.10 Medical researchers at a 1965 World Health Organization conference were so worried about overpopulation that in the final report they omitted mentioning any of the Pill’s side effects.11
The only information most women got was what they picked up in the “About the Pill” booklets that pharma companies printed by the tens of thousands. Those were distributed at Planned Parenthood, women’s health clinics, hospitals, and private medical practices. No more than a few dozen pages each, they were reassuring in emphasizing that side effects were almost always minor and temporary. Searle ignored several FDA warnings and kept crossing the line between physician education and overzealous promotion. In its most widely distributed booklet, “A Prescription for Family Planning—The Story of Enovid,” Searle totally ignored the most recent and disturbing adverse effects among its millions of consumers.12 I 13
The first cracks in the benign view of the Pill appeared slowly. “The Terrible Trouble with the Birth-Control Pill: Should You Stop Taking Them Immediately?” in the July 1967 Ladies’ Home Journal was the first time millions read about the accumulating questions concerning long-term safety. It focused on new evidence of blood clot risks and a possible cervical cancer connection. Prominent medical journal editorials slammed the article for “sensationalism… half-truths… and quoting authorities out of context.”14
A 1968 British study concluded that women on the Pill had a ninefold chance of developing blood clots, and they were seven times more likely to be fatal. The results received only passing coverage in the mainstream media.15 The Pill’s advocates dismissed the findings, contending that the risk, three deaths per 100,000 patients, was small when compared to the chances of death from other serious illnesses that women sometimes got during pregnancy.16
“A woman who takes oral contraceptives,” said Dr. Malcolm Potts, Planned Parenthood’s first medical director, “has more chance of being alive one year later than her sisters who choose to have a baby.” The risk of death during childbirth was fifteen times greater than the risk of dying from the blood clots identified in the British study.17
The tide of public opinion, especially for those on the Pill, turned in 1969. Since the contraceptive was considered such an emancipating scientific advance for women, it seemed only fair that female critics expose the dangers to a wide audience. Barbara Seaman, a respected medical writer, published The Doctors’ Case Against the Pill.18 The bold tagline on the jacket gave all the preview necessary of the contents: “More than 100 medical specialists report how love with the pill can cripple and kill.”19 Her interviews with doctors and researchers resulted in some extraordinary warnings that the “public… and scientific scandal” of “pretending the Pill is safe” was at the precipice of a tsunami of cancer in those who had been using it for several years.20
Jane Brody, the New York Times medicine and biology reporter, followed Seaman the following year with an extensive front-page story that set the tone for much of the subsequent national press. In addition to accumulating accounts of patients with depression or loss of libido, Brody noted the Pill had been linked to “a long list of serious illnesses, among them blood clots, strokes, sight-threatening eye disease, sterility, seizures, diabetes-like upsets in sugar tolerance and even cancer.” Most alarming was her inclusion of “two unpublished, highly controversial studies” by a New York gynecologist and researchers from Sloan Kettering Institute and the University of Chicago. In reviewing the records of 35,000 Planned Parenthood clients, the New York duo concluded that women on the Pill were twice as likely as diaphragm users to develop cancerlike changes in the cervix (carcinoma in situ). The Chicago researcher found the same risk was six times more likely for women over thirty-five.21
The question Brody posed is what millions of women in America were soon asking: “Is the woman who takes the Pill risking her life for the surety and convenience of this method of contraception?”22
In the spring and summer of 1969, on the heels of Brody’s piece, the media was consumed with the dangers posed by the Pill. Dr. Roy Hertz, the chief of the National Institutes of Health’s endocrine cancer research, predicted in a Newsweek cover story titled “The Pill and Cancer” that the Pill would cause a breast cancer crisis in a few years.23 The warning from the National Conference on Breast Cancer that May was that if studies showed the Pill caused cancer in animals, then those studies applied to women: “The world stands on the threshold of a pill-caused cancer epidemic that will dwarf the thalidomide birth-deformity tragedy.”24 A leading Stanford pharmacologist, Sumner Kalman, said that “eight million women in this country alone now serve as guinea pigs.”25 Endocrinologists told reporters that since the Pill worked through the pituitary gland, it was “unrealistic to think that long-range effects will not be inevitable.”26 A New York gynecologist who treated more than fifty wives of physicians told the Ladies’ Home Journal in another cover story that “not one of them is still on the Pill.”27 II 28
All the doomsday coverage set off warning lights for government regulators. Louis Hellman, the chair of the FDA’s Obstetrics and Gynecology Advisory Panel, had by 1969 changed from an avid proponent to publicly advising caution about the unknown effects of long-term use of “powerful synthetic hormones.” Philip Corfman, the doctor in charge of the NIH’s contraceptive research, admitted he would not prescribe the Pill in private practice unless a woman had no other option.29 By June 1969, a medical malpractice insurance company in California was the first to require its sixteen thousand doctors to obtain signed disclosure forms from patients before prescribing the Pill.30
Not everyone was upset with the growing litany of side effects and serious illnesses. The author has learned that at least one pharmaceutical firm that did not have a contraceptive product in the market considered the Pill a “gateway drug” by which they could sell half a dozen of their own brands to mitigate the Pill’s side effects. There were diuretics for bloating, antinausea and indigestion remedies, blood thinners to counter clotting, tranquilizers and benzos to reduce agitation or irritability, thyroid supplements or amphetamines to overcome fatigue, and antibiotics to treat the increased number of yeast infections. One Medicine Avenue antibiotic ad run made a direct pitch for the business of treating the contraceptive’s side effects: “If she’s on the Pill, she may need this tablet.”31
The media and public focus, however, was not concerned about whether some drug firms had a mercenary strategy to take advantage of the Pill’s woes. Instead, by the fall of 1969 the spotlight was on the FDA and questions about why it had not done a better job of alerting the public to the accumulating dangers. The British government had instituted stronger label warnings the previous year. When the FDA issued its second report on the Pill that September, it proved tone-deaf. Despite admitting a “small number” of women died annually from the medication, the benefits-to-risk ratio was high enough to keep its classification as a safe drug.32
The pressure was on the FDA to do something dramatic to make up for what seemed its laissez-faire oversight. Congressional and consumer advocacy critics agreed that Commissioner Herbert Ley bore the responsibility for the agency’s failure to be more proactive. The last straw turned out not to be about the Pill but rather an announcement by the agency on November 10 that it had failed in two years to recall any of the two hundred fixed-dose antibiotics and cold remedies it had targeted for removal. Pharma firms had tied up the FDA in litigation, but that was lost mostly in news coverage that added to the agency’s seeming incompetence under Ley.33
In early December, Ley was ousted, along with the agency’s next two ranking officials, the deputy commissioner and the chief of compliance. The Nixon administration, less than a year in power, decided to change more than just the top few jobs. The secretary of HEW announced an overhaul of the 4,200-person agency. The FDA’s Bureau of Science, Medicine and Compliance, which consumer advocates like Ralph Nader had excoriated for being too chummy with pharma, was disbanded and replaced with two streamlined departments. The entire agency was moved up in the HEW hierarchy, giving it expanded federal powers. Finally, a new commissioner was selected: Charles Edwards, a general surgeon who balanced a leadership role at the AMA with a part-time teaching post at Georgetown University Hospital. Edwards was also a vice president at the management consulting firm Booz Allen Hamilton.
With a reputation as a “hard-nosed, no nonsense decision-maker,” Edwards viewed the disarray as an opportunity.34 He knew that as the FDA’s powers got redefined, it would sometimes gain new authority and occasionally lose it. The previous year the FDA had lost its jurisdiction over illegal drugs to the Justice Department’s newly formed Bureau of Narcotics and Dangerous Drugs. But it had also received expanded control over medicated feeds and animal drugs. The FDA had just gotten the green light from the Public Health Service to administer sanitation programs for shellfish, milk, and food services, and to the extent necessary for preventing poisoning or accidents at interstate travel facilities. The FDA also was in charge of antibiotic levels in milk, eggs, and food plants. However, Food Safety and Inspection Service was tasked with testing for antibiotic levels in poultry and meat.35 The Environmental Protection Agency was given the oversight of antibiotic residues left on the outside of food plants, including fruits and vegetables.36
Edwards turned out to be good at bureaucratic chess. He got the right for the FDA to regulate biologics—serums, seasonal (antigenic) vaccines, and some blood products—taking them away from the NIH. After successfully getting Congress to double the FDA budget, Edwards established the National Center for Toxicological Research, dedicated to examining the biological effects of chemicals in the environment. The most important new power in a few years would be the Medical Device Amendments, by which the FDA got oversight of both the safety and efficacy of medical instruments and diagnostic products.37
On the other hand, Edwards could not prevail in every skirmish. The FDA lost to the Environmental Protection Agency the right to set tolerance limits for pesticides. The NIH’s Division of Biologics Standards took the authority over the importation and distribution of foreign blood products. Nonmedical consumer goods such as home appliances and toys, as well as household chemicals, went to the newly created Consumer Product Safety Commission. Microwaves, however, went to the FDA because they emitted low levels of radiation. The biggest blow would be when HEW and Congress blocked the agency from setting standards and regulating vitamins, minerals, and supplements.38
As the power tug-of-war played out, Edwards knew that he had assumed control at a time when Congress intended to take the agency to task for the uproar over the Pill. Senator Gaylord Nelson—who had succeeded Kefauver as the Senate’s crusader fighting abuses by big business—had pharma in his sights since 1967 with his Competitive Problems in the Drug Industry probe. Nelson thought that the FDA should be held responsible for their “abject failure” to protect American women from the health dangers of the Pill.39 That was the focus of his investigation in January 1970. The following two months of public hearings riveted much of the country. Nearly 90 percent of all women between the ages of twenty-one and forty-five followed the hearings.
Nelson began with eight doctors and researchers (all men) specializing in birth control.40 The first witness on January 14 was Hugh Davis, a Johns Hopkins professor of gynecology and the chief of its Contraceptive Clinic. Not only might the Pill cause breast cancer, he testified, but by the time a woman or her physician discovered a lump, it would have been there for many years.
The FDA’s chief of the cell biology division, Dr. Marvin Legator, followed Davis by warning the subcommittee that the Pill made cellular and genetic changes that could lead to cancers or even inheritable mutations. It was difficult to identify those changes as they were indistinguishable from the ones caused by some other illnesses. As a result, Legator concluded, the Pill posed a more dangerous crisis than thalidomide.41
Dr. Herbert Ratner, a leading physician and author, was not able to hide his disdain for the extent to which women were at risk for unknown perils from the Pill. “The scientist in the laboratory has never had it so good.… [w]omen make superb guinea pigs—they don’t cost anything. They clean their own ‘cages,’ feed themselves, pay for their own Pills and remunerate the clinical observer.” 42
The disclosures about blood clots and possible breast cancer and heart disease were not news to medical researchers. The Senate hearings were, however, the first time most women heard about them. All the facts and figures about risk versus benefits paled in insignificance when NIH scientist Roy Hertz testified to the committee that “estrogen is to cancer what fertilizer is to the wheat crop.”43 Women were stunned and infuriated. Two thirds of women in a Gallup poll said their physicians had never given them a single warning about any possible dangers.44 Why had their doctors been silent?
Commissioner Edwards knew the FDA had to do something fast. Four days after the hearings got under way the agency sent a letter to the country’s 381,000 doctors, urging them to advise their patients of the Pill’s potential serious side effects.45 Critics thought it too little too late. Edwards stumbled a couple of weeks later when he told a reporter that subject to different advice from their doctors, women “should continue to take” the Pill. At a contentious meeting with an activist group, D.C. Women’s Liberation, members shouted questions at him about why there were not more women in authority at the FDA and why the agency had not pushed pharma to develop a male pill. Edwards stormed out before it finished.46 III 47
The pharma industry tried reversing the damning Senate narrative. It spread a rumor that Nelson’s hearings were a prelude to the government banning the Pill and turning back the clock on women’s reproductive rights.48 A series of rebuttal witnesses went on the offensive before Nelson’s subcommittee, accusing the investigation of creating “unwarranted and dangerous alarm… [and] panic.”49 They repeated a few key themes: the Pill was more effective than IUDs and diaphragms; no other form of birth control fully gave women the ability to plan their lives free of unwanted pregnancies; and the risks of death from blood clots caused by the Pill were statistically less than the number of women who died during childbirth or car accidents.50 Other witnesses did not address whether the Pill was safe but instead emphasized its overriding social benefit.
Most women who followed the hearings were not interested in broad policy issues about curbing overpopulation. They were concerned about the degree to which pharma had put millions of them at risk by downplaying side effect reports for a decade. Was the Pill unsafe? A poll taken just two weeks after the Nelson inquiry had gotten under way showed that a sizable number of women answered yes: 18 percent with prescriptions had stopped taking it and another 23 percent were giving it “serious consideration.”51 At family planning clinics where it was dispensed to women too poor to otherwise afford it, upward of 30 percent stopped. After a month of public testimony, obstetricians and family clinics noted “a run on diaphragms.”52 Jane Brody reported in The New York Times that a check of pharmacies around New York confirmed a “significant increase in the sales of contraceptive foams, jellies and creams and condoms, and a definite falling off in sales of oral contraceptives.”53
When a New York obstetrician later testified before the subcommittee, he castigated the panel for creating “dozens of unwanted pregnancies.”54 By March, the hearings’ two-month point, Dr. Phyllis Piotrow, the director for the Population Crisis Committee, scolded the senators for “scaring [women] to death.” Because so many were abandoning oral contraceptives, Piotrow predicted 100,000 unwanted “Nelson babies” by the end of the year.55
The warning of 100,000 unwanted “Nelson babies” proved wildly off target. A year later, even large, inner-city family clinics reported unwanted births in the hundreds, not in the tens of thousands. A lot of women had switched to different methods but they had not abandoned contraceptives. The biggest beneficiary of the fright over the Pill was not another drug, but rather a medical device, a uniquely designed IUD called the Dalkon Shield. Johns Hopkins’s Hugh Davis had introduced it in 1969. By the time of the Nelson hearings it had sold 600,000 units.56 That was the year A. H. Robins—the maker of ChapStick, Robitussin, and Dimetapp—bought the rights from Davis and marketed it as a “safe alternative” to the Pill. (Davis, who had excoriated the Pill when he was the leadoff witness before the Senate, was later condemned by colleagues for not disclosing his financial conflict of interest.)57 IV 58
In the wake of Nelson’s hearings there was a sharp drop in public confidence for the FDA, particularly among women. Eight years earlier with the thalidomide disaster, the FDA had been hailed for not approving a drug that left a trail of horrible birth defects in Europe.59 The FDA emerged as the culprit from the Nelson hearings. Not only had it approved Enovid in 1960, the first of a radically new class of medications, but it had done so without any data about its long-term safety. Worse was its repeated failure to do anything as adverse effect reports poured in. While many expected the drug companies to bury bad news about their products, it was disturbing to see that pharma had so thoroughly outwitted and outmaneuvered the FDA regulators.
Many women wondered that if the government watchdog had failed them on something as fundamental as birth control, what else might it have missed about the many other drugs on the market? One not very good answer came a few months after the Nelson hearings. Researchers linked diethylstilbestrol (DES), the first synthetic estrogen that had been dispensed since 1940 to women to prevent pregnancy complications, to a forty times greater risk of developing a rare vaginal cancer (clear-cell adenocarcinoma). Upward of 10 million women had used the more than one hundred DES-based drugs while pregnant. The FDA hurriedly sent letters to the nation’s doctors directing they stop prescribing them. Researchers later concluded that DES was also responsible for birth deformities and even reproductive problems and increased instances of cancer in the daughters of women who had used it.60 V 61
Commissioner Edwards decided bold action was needed to restore public confidence. Citing a 1966 law requiring accurate labeling, he ordered that a message highlighting the Pill’s major health risks be added to prescription inserts and distributed to patients. Edwards faced a torrent of opposition from physicians who thought that infringed on their autonomy to advise patients. Planned Parenthood rallied against it claiming that the Pill’s dangers were greatly outweighed by its benefits and the insert might scare away patients. The pro-Pill lobby, led by the American Medical Association and the Pharmaceutical Manufacturers Association, got Edwards to slash his warning from six hundred words to one hundred. Still, the final version cautioned about possible blood clots. Pharma and the AMA were relentless, however, and forced another last-minute compromise. Instead of mandating the insert be in every package of oral contraceptives, the FDA allowed doctors to merely tell their patients about it.62 Edwards, and activists like author Barbara Seaman, were justifiably concerned that many of the inserts to doctors would “land in ‘circular files’ (wastebaskets).” They were right. Physicians distributed only four million FDA warning inserts to ten million patients between 1970 and 1975.63
Edwards was so incensed at the labeling fiasco that he ordered two birth control pills off the market for safety and quality concerns. Intended to show pharma that he would not be bullied, it was not very effective. Both companies were bit players with tiny sales.64 A backup plan for showcasing the FDA’s new aggressiveness had nothing to do with oral contraceptives. Edwards recalled nine of the country’s best-selling mouthwashes, all of which had been advertised to “combat cold symptoms [and] destroy bacteria.” The FDA announced they “were ineffective for preventative or therapeutic claims.” Two of the nine, Betadine Mouthwash Gargle and Isodine, were Purdue Frederick products.65 Large pharma firms, with fat profit margins earned from their top selling prescription drugs, paid little attention to the removal of the mouthwashes from the nation’s drugstores.66 Edwards followed up in November with a broader recall of several hundred prescription and over-the-counter drugs that the FDA judged “either ineffective or hazardous.”67
Small drug firms with limited product lines, such as the Sackler-owned Purdue, took a short-term revenue hit from the FDA enforcement (one of Purdue’s antiseptic solutions was also included in the November recall).68 The overall industry, though, was unfazed by the FDA’s actions. The sheer number of recalled drugs, reprinted in their entirety on full pages of the country’s leading newspapers, seemed impressive to the lay public. Pharma, however, knew the medications were mostly unimportant. There was not a blockbuster on the list, not a single one in the top one hundred best-selling prescription drugs.69
As far as the industry was concerned, it had won the key battle, keeping most of the health risks about their oral contraceptives away from the women who took them. The next few years, however, showed that it was a Pyrrhic victory. There was a far more important battleground for the bottom line of the companies. Sales of birth control pills plummeted for five years before stabilizing. And the FDA responded with more stringent animal toxicology trials for oral contraceptives. The troubles over the Pill attracted attorneys specializing in consumer class action litigation (aggregated suits consolidating the claims of thousands of plaintiffs were only possible after a 1966 change in Federal Civil Procedure rules).70
The regulators, lawyers, and sinking sales meant that drug companies had little incentive to spend money for research and development for innovative new methods of birth control. The entire field went into hiatus at most pharmaceutical laboratories for the next two decades. Schering, for instance, had invested substantially during the 1960s into an injectable drug designed to provide three months of contraceptive protection. It shelved that work after the firestorm produced by the Nelson hearings. The same happened with collaborative 1960s research between Wyeth and the nonprofit Population Council on subdermal implants. That would have been useful for women who did not always remember to take a daily pill. That research was also halted after the Senate inquiry.VI71
Eventually, the NIH prevailed on pharma to stop manufacturing any Pill that had more than 50 micrograms of estrogen. By then, clinicians estimated that 80 percent of all American women born after 1945 had at least tried the Pill. Pharma companies started searching for a “new generation pill” that might work with even less estrogen. Fifteen years later, following studies that showed adding low levels of progesterone reduced the odds for ovarian cancer, drug companies started mixing the two hormones.
“Only after millions of women had taken Enovid,” Barbara Seaman later wrote, “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 was needed.”72 VII 73
I. Gynecologists, the same specialty responsible for dispensing most estrogen medications, wrote many of the oral contraceptive prescriptions. Menopause and birth control drugs consisted of different amounts of the same hormones. For contraception, it was estrogen and progesterone, while it was estrogen alone for the early menopause drugs. The “change of life” meds later added progesterone. They were designed so the Pill’s estrogen suppressed a woman’s natural production of hormones, while those aimed at menopause added to the body’s declining levels. In terms of risk, however, there was no difference.
II. To Arthur Sackler’s credit, his Medical Tribune was one of the first to report in 1966 that clinical testing of a new contraceptive pill on 340 women “had been halted because of evidence of cancer in test animals (dogs) receiving the product.” At the time, many doctors summarily dismissed results in animal studies by contending they did not apply to women. It took another three years before the alarm about whether the Pill caused cancer became mainstream. Sackler, of course, was always more than willing to undermine the business of pharmaceutical firms that were not his clients. McAdams had no drug firm selling an oral contraceptive.
III. Alice Wolfson, a Barnard graduate, founded D.C. Women’s Liberation. Five years later, she was one of the cofounders of the nonprofit National Women’s Health Network. By then, 1975, there were some 1,200 women’s advocacy groups focused on women’s health care rights.
IV. At its peak, 3.5 million women in eighty countries, most formerly on oral contraceptives, relied on the Dalkon Shield. The first reports of blood poisoning, pelvic infections, and gynecological complications came to the FDA at the end of 1970. After four deaths were linked to the Dalkon Shield in 1974, Robins suspended sales. Two hundred thousand women eventually sued, forcing Robins into bankruptcy (American Home Products bought the company for a fraction of its pre-Dalkon value). Searle recalled its popular copper-7 IUD. An unintended benefit from the Dalkon Shield disaster was that, as it had in the past, it forced bipartisan Congressional action. The Medical Device Amendments to the 1938 Food, Drug, and Cosmetic Act gave the FDA authority over the approval and safety of medical devices.
V. The perception that male-dominated medical and pharmaceutical industries shortchanged women was one of the reasons for the enormous success of a 1967 book, Our Bodies, Ourselves. Published by the Boston Women’s Health Book Collective, organized the previous year by a dozen young feminists, it helped women become educated consumers about their own health. The book sold more than four million copies.
VI. Pharma took more than twenty years to restart its work on the suspended 1960s research. Wyeth got FDA approval for Norplant, the first subdermal implant, in 1990. The FDA approved Schering’s injectable contraceptive, Depostat, in 1992. The 1990s also marked the introduction of hormonal skin patch and vaginal ring. In some instances, the new ways of delivering hormones did not come without risks for the patients’ health and the drug firms’ bottom line. Fifty thousand women sued Wyeth over Norplant, contending the implant resulted in infections and debilitating fatigue; they settled for $100 million.
VII. On the fortieth anniversary of the sale of Searle’s first Pill, Enovid, Barbara Seaman wrote in The New York Times: “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.”