The Birth of the Pill: How Four Crusaders Reinvented Sex and Launched a Revolution (41 page)

John Rock was angry, too. How could the FDA hand a decision as important as this to a kid? What qualified
him
to judge? Hadn’t he, the legendary Dr. Rock, already given Enovid his stamp of approval?

On a bitterly cold day in December 1959, Rock, along with I. C. Winter and another Searle official, traveled to Washington, D.C., where they intended to confront DeFelice. The FDA inspector’s office was located in a temporary wooden building that had been constructed during World War I. The lobby was freezing and there were no chairs. Rock and the men from Searle stood for ninety minutes while DeFelice kept them waiting.

To DeFelice, Rock was a legend, “
the light of the obstetrical world
,” he said. “Anything he said had to be listened to.”

But while he respected Rock as much if not more than any doctor, that didn’t mean DeFelice was prepared to cave in to him—even when Rock spoke to him in a manner clearly intended to intimidate. Asked to explain his decision on Enovid, DeFelice said that he had to be more careful than he would with other drugs because healthy women would be taking it for extended periods of time. What if it turned out to cause cancer?

“I don’t know how much
training you’ve had in female cancer
, young man,” Rock said, “but I’ve had considerable.”

DeFelice acknowledged that he lacked Rock’s experience, but he noted that no one, not even Rock, had enough experience with Enovid to fully understand what it might do to women’s bodies.

Rock fired back, shifting the argument away from personal health to the bigger issue of population control: “If your garage is on fire,” he told DeFelice, “you do not wait to see if your bucket has a hole in it before trying to throw water on the blaze.”

But DeFelice was not buying it and would not be cowed. He was a safety inspector, after all, not a firefighter. His job was to avert catastrophes, not to stop them from spreading. He said he wanted more data. He suggested, among other things, that Searle do additional lab tests to see if their drug caused blood clotting. Given that Enovid created pseudo-pregnancies in women and pregnant women tended to get more blood clots than other women, the
question seemed reasonable and important
to DeFelice.

When the meeting ended, Rock was still angry but Searle officials were humbled. They had little choice except to do what they’d been told. As for DeFelice, he remained an admirer of John Rock’s. “
I’ve only met about three doctors
in my entire life who I would trust with anything,” he said years later. “Rock was one of them. He still is.”

While Searle went back to work to collect more data, DeFelice did more than wait. In an unusual though not unprecedented move for an FDA inspector, he launched a small research project of his own. DeFelice knew that thousands—and possibly even hundreds of thousands—of women were already using Enovid for birth control. He also knew that some of those women had found a way to get around the fact that their prescriptions were good only for three or four months. Many of them, when their initial prescriptions expired, simply made appointments to see new doctors and get new prescriptions. Such behavior might have been risky for the patients, but for DeFelice it presented an opportunity. Thousands of doctors across the country were gaining experience with Enovid—more every day. It was safe to assume that most of the prescribing doctors knew exactly which patients were taking the pill for birth control and how long they’d been taking it. If the doctors were doing their jobs well, they were probably gathering a great deal of information about the effects of this new medication. If side effects or health hazards had arisen in any significant numbers, the doctors likely would have heard about them. So DeFelice decided to contact some of those doctors and see what he could learn. He sent a questionnaire to
sixty-one obstetrician-gynecologists
at some of the leading medical schools in the United States, asking them a series of questions about their experiences with Enovid. Were the side effects serious enough to proscribe use of the product? Was long-term fertility affected? Were there any signs of cancer risk? Premature menopause? Were there any abnormalities among children born to women who used the medicine? And finally, he asked: Do you think Enovid or another product like it ought to be made available for contraceptive purposes?

If the doctors prescribing the drug considered it safe, DeFelice would be more inclined to approve. If they didn’t, if they thought the side effects were too severe, he would be inclined to reject.

Perhaps to prove to Searle that he was objective, DeFelice included Rock and Pincus (despite the fact that Pincus was not a physician)
among his sixty-one experts
, even though DeFelice already knew what both of them were going to say.

One of the doctors to whom DeFelice wrote was Edward Tyler, a
former joke writer for Groucho Marx
, who by 1959 was running the Planned Parenthood birth-control clinic in Los Angeles. Tyler had been conducting his own trials in Los Angeles, giving Enovid and a similar drug being developed by Parke-Davis to hundreds of patients. Outside of Puerto Rico, no one on earth had more experience administering birth-control pills than Dr. Tyler. His opinion meant a great deal to DeFelice, in part because Tyler, unlike Rock and Pincus, had no stake in the decision. He was not a consultant to Searle and he had not helped Pincus with the clinical trials in Puerto Rico.

Edward Tyler was administering the pill widely in his Los Angeles office, but he had reservations about its use. Too many of his patients, he said, experienced weight gain, fluid retention, and abnormal bleeding. At a 1958 meeting of the American Medical Association, Tyler had reported that more than two-thirds of his patients who had tried the pill had given it up, mostly because of the side effects. In his follow-up exams with women, Tyler detected symptoms of early menopause in two women. Most patients regained a normal menstrual rhythm after two months off the hormones, he reported, but he still feared that the pill might cause permanent change in the women’s uteruses. He was also worried that female newborns of pregnant women who had been treated with the pill “not uncommonly” had
adhesions of the labia and hypertrophy of the clitoris
.

In 1958, Searle had invited Tyler and other doctors familiar with the new birth-control compounds to a meeting at the company’s headquarters in Skokie. At that time, Tyler had expressed serious doubts about the wisdom of putting Enovid on the market. Now, in the early part of 1960, he would have a critical vote. FDA officials, after reading his written responses to their questionnaire, requested a personal interview.

Tyler still had concerns about the new oral contraception, but he also had a broader perspective. He was, after all, the head of one of Planned Parenthood’s largest clinics. He knew what Margaret Sanger had first come to know back in the early part of the twentieth century: that the physical and emotional toll of nausea and bloating were nothing compared to the physical and emotional toll of an unwanted pregnancy, and that even the long-term risk of cancer might pale compared to the dangers of pregnancy or abortion for some women. The birth-control pill was still unproven, and it was far from perfect, but it was incredibly effective when it came to preventing pregnancy. That had to be weighed in his decision.

Tyler directly addressed the question that DeFelice had identified as so critical. How should the agency assess risk for a medication not designed to cure disease or relieve pain? As long as condoms and IUDs were an option, did it make sense for women to take such a chance?

If the FDA had assigned a woman to evaluate the pill in 1959, the agency’s approach might have been different. A female investigator might have asked different questions. She might have surveyed patients instead of doctors, for example. But Tyler may have been the next best thing. He had seen firsthand the pill’s effects—the good and the bad, the comfort and the pain. He was also clever enough to do some simple calculations. Diaphragms, condoms, and IUDs did not cause nausea or other side effects, but they did cause pregnancy because they had such high failure rates, and pregnancy came with its own long list of serious side effects, including preeclampsia, diabetes, hypertension, and heart attack. To analyze the risks of the birth-control pill effectively, one had to factor in the complications for women
not
using it.

After weighing all those factors, Tyler concluded that unwanted pregnancies would do more harm than the pill. He urged the FDA to approve it.

THIRTY-THREE

The Climax

I
T HAD BEEN
almost ten years since Gregory Pincus met Margaret Sanger on a winter night in an apartment high above Manhattan. Their chances of success at the time had seemed remote—almost ridiculously so. Sanger had been searching so long for her magic pill that even such a determined woman as she must have doubted at times whether she would succeed. Pincus had been a fringe player with nothing to lose. But there had been something durable and determined in each of them that kept them going through the years and the setbacks. Now, one way or another, their quest would come to an end. If the FDA rejected their application, there was no telling if they would get another chance. A Catholic might soon be in the White House. The FDA might tighten the rules surrounding drug approvals. G. D. Searle might get cold feet. Katharine McCormick might move on to another cause, or die and leave her money to others. Anything could happen.

And so Sanger and Pincus waited, and while they did, thalidomide began to reach customers in the United States. Richardson-Merrell, Inc., had already distributed more than two and a half million doses of its new sleeping pill—known by its trade name, Kevadon—to doctors across the country. Officials at the company hoped to get twenty thousand patients started on Kevadon and use the data from their experience in support of their pending application for federal approval. This drug trial would be one of the biggest in American history, much bigger than the trial for the birth-control pill. Richardson-Merrell was confident it would win FDA approval and thalidomide would soon be as popular in the United States as it was in Europe.

While Sanger and Pincus waited, Hugh Hefner opened the first Playboy Club, a so-called Disneyland for adults, where the famous Bunnies strolled in their electric-blue and kelly-green costumes, each breast looking to Norman Mailer “like the big bullet on the front bumper of a Cadillac,” with little white tails bouncing on the ends of their bottoms. Within two years, the clubs would have
three hundred thousand members
.

In February 1960, while the FDA continued to review the application for Enovid,
results of a Gallup poll showed
nearly three out of four people believed birth control should be made available to anyone who wanted it.

Two months later, Leo Koch, a biology professor at the University of Illinois, was fired after writing a letter to the campus newspaper proposing a new approach to sex. “With modern contraceptives and medical advice readily available at the nearest drugstore, or at least from a family physician,” he said, “there is no valid reason that sexual intercourse should not be condoned among those sufficiently mature to engage in it without social consequences and without violating their own codes of morality and ethics.” His firing set off
massive protests on campus
, but the university refused to rehire him.

At the same time, an organization of respected judges, lawyers, and law professors in the United States known as the American Law Institute worked on one of the most ambitious projects in American legal history: an attempt to reform the nation’s criminal codes, which varied from state to state and in many cases were so poorly written and organized that it was difficult to say what they meant or how they should be enforced. The judges and lawyers created a Model Penal Code that recommended to legislatures around the country how they might improve and standardize their own codes. One recommendation: Abortions should be legal when the pregnancy resulted from rape or when the baby was likely to be severely disabled.

It was part of a trend. The federal Comstock law and the “little Comstock laws” imposed by state governments were falling away. For most of American history, society and the law had seen womanhood and motherhood as virtually one and the same. Now, finally, that was changing, just as Margaret Sanger had always thought it would.

Still, she and Pincus waited. In those early days of 1960, Sanger wrote a letter to the
New York Times
criticizing President Eisenhower for knuckling under the pressure of the Catholic Church in refusing to support the Draper report. “Today our United States Government needs to listen to the voice of a majority of its voters,” she wrote. “
Birth control and contraceptive practices
are a medically recognized part of current ethical healing.” On the same morning Sanger’s letter appeared, Senator Kennedy appeared on NBC’s
Meet the Press
, where he was asked what he would do as a Catholic and as president if India asked for help from the U.S. government in controlling its population. It was yet another indication that Sanger’s crusade was not so radical anymore. Once, it would have been unimaginable for a presidential candidate to be asked his views on birth control. Kennedy diplomatically answered that by putting such a controversial request to Congress “you’d get
neither birth control nor foreign aid
.” The better approach, he said, would be to increase general economic assistance to India and let leaders of that country decide how best to spend it.