The Birth of the Pill: How Four Crusaders Reinvented Sex and Launched a Revolution (42 page)

Sanger, not satisfied, followed up with a personal letter to Kennedy in which she tried to pin him down. She urged him to forget India and show leadership closer to home by speaking out against a Massachusetts law that limited women’s access to contraception. “
You are young
,” she wrote. “You come from a splendid, well cared for family, and it would be a great honor to you to raise your voice on behalf of the families of your church against this outrageous legislation.” There is no record of Kennedy ever having responded.

Meanwhile, Pincus asked McCormick to approve a three-year budget for ongoing work on Enovid, including more safety tests. Whether or not the FDA approved the pill for contraception, much work remained to be done. In addition to his research on the pill, Pincus also wanted to conduct further experiments on a biological contraceptive for men.
He had begun testing progestins on men
in 1957, but he found that the hormones reduced the libidos and potency of his subjects, most of whom had been patients at the Worcester State Hospital. He thought it might be worth trying again with lower doses, and McCormick was encouraging him to do so. She also wanted him to see if Enovid would remain effective at lower doses. At ten dollars a month, it was simply too expensive, and she was eager to bring down the cost. At the same time, however, she did not intend to fund Pincus’s research indefinitely.
She had already committed $152,000
to Pincus ($1.2 million in today’s dollars) for the first part of 1960, and she wanted to see what the FDA would decide on Enovid before giving him more.

While the FDA continued to process responses in its poll of physicians, the Family Planning Association of England was quietly testing the birth-control drug in London and Devon. The
doctors leading those experiments
concluded that the pill, while highly effective, produced too many side effects to be used by the general public.

In his Palm Sunday homily in 1960, Pope John XXIII reminded Catholics yet again where the Church stood on birth control as he urged parents to have many children. “
Don’t be afraid of the number
of your sons and daughters,” he said. “On the contrary, ask Divine Providence for them so that you can rear and educate them . . . to the glory of your fatherland here on earth and of that one in heaven.” At the same time,
leaders in the Vatican were growing concerned
that other Christian churches were abandoning the ban on contraception, including the Anglican, Lutheran, and Calvinist communions, bodies whose general theology were not far removed from Catholic thought. Leading
theologians like Reinhold Niebuhr
, Karl Barth, and Emil Brunner were calling for a relaxation of the ban on contraception. Day by day, the Catholic Church was growing more isolated.

By the time of the pope’s exhortation, four months had passed since John Rock’s meeting with Pasquale DeFelice. The FDA still had not reached a decision. If the agency refused to grant Searle the right to sell Enovid for birth control, Rock wrote in April, “
I am prepared to go to war
with them.”

By early May, the results were in from the FDA’s survey of doctors. Of the sixty-one physicians responding to the agency’s questionnaire, twenty-six recommended that the FDA approve Enovid for birth control; fourteen said they did not have enough experience with the pill to reach any conclusion; and twenty-one said they believed the FDA should deny its approval.

It was hardly an overwhelming show of support.

At least two of the doctors
voting for denial cited religious beliefs. Some said they believed the drug was too expensive at fifty cents a dose, and others insisted that more testing should be required to prove the drug’s long-term safety.

In an internal FDA memo, the agency’s medical director, William H. Kessenich, acknowledged that the evidence on safety was thin. Most women had used the drug for no more than three or four months, and none of the women had used it for more than three years. “Only 66 patients have continued medication for 24 cycles or more,” he wrote.

Kessenich also noted that the FDA’s decision was likely to raise “
possible objections from some quarters
,” an obvious reference to the Catholic Church.

But he also had to consider the agency’s mandate. The FDA’s job was to establish whether a drug worked. If it worked and there were no obvious indications that it caused harm, the agency had to approve. Even the doctors who urged the FDA to reject Enovid as contraception admitted that there were no signs of serious side effects “
as far as they could tell
.”

That left the agency in a difficult spot. The bureaucrats at the FDA couldn’t reject the pill on religious, political, or moral grounds. They couldn’t say it didn’t work. Nor could they say it caused harm. Uncertainty swirled around any new product. The only thing that was different about this one was that it happened to be associated with sex. For the FDA to reject the birth-control pill, it would have to have a solid scientific reason, and so far none had emerged.

On April 7, 1960, the phone on I. C. Winter’s desk at Searle corporate headquarters rang.

Winter answered, and Pasquale DeFelice greeted him.

DeFelice gave him the news
. In reviewing Searle’s data, the FDA found no serious threat of side effects and no evident threat to overall patient health. What’s more, there was no disputing that the drug worked effectively in preventing pregnancy. DeFelice said the agency had agreed to approve Enovid as an oral contraceptive.

There was only one caveat: The FDA wanted patients to limit their use of Enovid to two years in case the drug caused long-term side effects that had not come to light during the limited clinical trials. Those trials would continue, and if Searle wanted approval of the same pill at lower doses, they would have to reapply and provide additional scientific data.

The men discussed a few other matters. Searle would need to make minor changes in the text of its manual for doctors, and it would need to submit all of its labeling and advertising to the FDA before Enovid went on sale. But those were routine pieces of business. Searle officials
wrote and mailed a memo the same day
agreeing to every one of the FDA’s conditions.

Just like that, it was done.

On May 9, 1960, the FDA issued its announcement, and newspapers across the country spread the news.

“
U.S. APPROVES PILL FOR BIRTH CONTROL
,” read the headline in the
New York Times
. The article, only 136 words long, appeared on page seventy-five of the Tuesday, May 10, edition. “
Approval was based on the question of safety
,” associate FDA commissioner John L. Harvey said in his official announcement. “We had no choice as to the morality that might be involved.”

In the days ahead, dozens of other newspapers around the country carried the story. In most cities and towns, it did not make front-page news; newspapers were edited mostly by men and few anticipated the impact this development would soon have. The Associated Press account, which was the most widely published, began this way: “The federal government for the first time has approved a pill as safe for birth control.” An official from Searle told the AP that the pill’s function was “to
interfere with the production of the ova
in the same way nature does after a woman becomes pregnant.” It was just the beginning of the company’s work to put women at ease by stressing how the pill imitated nature. Soon John Rock would present the same argument to officials at the Vatican.

For Pincus, there was no time to celebrate.
His daughter remembered no reaction
from her father to the news. His personal and professional letters offer not the least hint that this was a momentous occasion. For him, the FDA’s announcement on May 9 was not a finish line but a turn in the course. He made plans to return to Puerto Rico to expand testing of the smaller doses of his pill. If they worked, as he thought they probably would, the smaller doses might accomplish two important goals: reducing side effects and bringing down prices—and those two results in turn would help make the pill more popular.

Pincus might have had more reason to celebrate if he had maintained a financial stake in the development of Enovid. But he had never pursued a patent for his pill. Perhaps he had second thoughts about his decision now that it was reaching the market, but if he did, those concerns never materialized in his letters or in the minutes of his meetings with the Worcester Foundation’s board of directors. Neither did any of his relatives or friends ever hear him complain about a missed opportunity to become wealthy. Through the years as the pill was in development, officials at Planned Parenthood and the Worcester Foundation had raised questions about patent rights. They had recognized, wisely, that if Pincus succeeded in making a birth-control pill and getting it approved, the pill had the potential to generate millions of dollars in profit. But all along, Pincus had discouraged such discussion. As far as he was concerned, he had not invented anything. His view was that his idea—like that of Jonas Salk and so many other scientists—had been built on the ideas and contributions of countless others. The pill was nothing new, according to this line of logic; it was merely nature refined and an extension of the body’s own functions.

Salk had been widely quoted for his response after releasing his polio vaccine when Edward R. Murrow had asked him, “Who owns the patent on this vaccine?”

“
Well, the people, I would say
,” Salk had answered. “There is no patent. Could you patent the sun?”

Pincus had almost certainly heard Salk’s magnanimous response, and in the years ahead when the pill became enormously profitable, he would make similar comments, suggesting that there had really been nothing for him to patent. “
Do not forget
that we have never even made a pill at the foundation,” he said. “All we did was to perfect the formula.”

That was only partially true, of course. In reality, Pincus knew all along that Searle had developed the compound at the heart of Enovid. He also knew that other companies were working on copies of the pill and that each compound was slightly different. He might have tried to file his own patent once he perfected the mix of estrogen and progesterone in the pill, but such a move would have been difficult given how closely he’d been working with Searle. Pincus made the decision early in his career that science mattered more than money. He needed enough money to operate the Worcester Foundation and pay his associates, and he was aggressive about getting that money, but he never showed strong interest in the profit-making prospects of the work he and his fellow scientists did. In many ways he remained a purist, the same romantic spirit who, as a young man, had written sappy love poems and dreamed of making the world a better place.