The Birth of the Pill: How Four Crusaders Reinvented Sex and Launched a Revolution (40 page)

On July 23, 1959—two days after Grove Press won permission to publish
Lady Chatterley’s Lover
—G. D. Searle made it official and asked the FDA to approve Enovid for birth control. At the time, no one could have recognized that these two small ripples presaged a tidal wave that would sweep away the nation’s culture of restraint.

Though the number of women enrolled in clinical trials for the pill remained relatively small, Searle submitted the biggest new-drug application in American history at that time, with twenty volumes of data. The application included details from Pap smears, biopsies, temperature readings, and much more. Results for each woman in the study were provided, as well as summaries of all the data presented as both raw statistics and in a dizzying array of charts. This was the moment Pincus, Rock, and others like Rice-Wray and Chang had been working toward, and they put everything they had on the table.

In 1959, the United States possessed one of the most stringent new-drug approval processes in the world. Drugs were originally sold and prepared by apothecaries and pharmacists, and regulation was nearly impossible. By the 1800s, some countries, including the United States, established pharmacopoeias to impose quality standards for medications. These national certification boards did not pay attention to safety or efficacy, but they did address issues of honesty in advertising and purity of ingredients. When con artists began peddling pills that promised to cure cancer, syphilis, diabetes, and more, governments began to enforce more stringent rules. In the United States, the first set of meaningful laws was passed in 1902 after twelve children in St. Louis died from a diphtheria vaccine that had been contaminated with tetanus. The St. Louis health department had made the vaccine. In response, a drug laboratory was created within the Department of Agriculture. That lab would eventually become the Food and Drug Administration.

Still, the U.S. government had little power to protect customers from bad drugs until 1938, when Congress passed the Food, Drug, and Cosmetic Act. For the first time, new drugs had to be approved for safety by the FDA and labeled with directions for safe use.

More than 6,000 new drug applications flooded the FDA in the decade that followed, and another 4,200 came in between 1950 and 1959. The FDA approved more than two-thirds of all applications over the course of the decade. But in all those years and all those applications, the agency had never approved anything like Enovid.

THIRTY-TWO

“A Whole New Bag of Beans”

P
INCUS AND ROCK
still weren’t sure their pill would be safe for women to take for years on end. In fact, even as the FDA began reviewing the field trial data, the scientist and the physician continued experimenting with lower doses to see if the pill would remain effective. In an acknowledgment that their team did not yet have all the data they would have liked concerning long-term health effects, Searle asked the FDA to approve Enovid for no more than two years of use per patient.

In 1959, the FDA had only four full-time physicians and four part-timers assigned to investigate the 369 new drug applications submitted that year. Those seven investigators were under such extreme pressure to keep up with applications that they had little time to conduct their own research
or maintain their professional education
. In addition to new drug applications and complaints about misleading advertising, the same investigators also handled supplemental applications such as the one Searle had submitted for Enovid.

The Enovid application wound up on the desk of one of the part-timers, Pasquale DeFelice, a thirty-four-year-old obstetrician-gynecologist who was still completing his residency at Georgetown Medical Center. DeFelice, a native of Connecticut, was not only Catholic, he was a young man on his way to becoming the
father of ten children
.

The future of the pill was in his hands.

It was a strange moment for DeFelice. He was neither a career bureaucrat nor an experienced doctor. Yet he had in his power now the chance to review the work of far more experienced medical men and make a decision on the merits of their findings that would dramatically alter the world of medicine.

Even though he was Catholic and would go on to have a large family of his own, DeFelice disagreed with the Church’s ban on birth control. He thought the pope had erred in taking such a firm line on contraception. But those were only his personal views. When it came to his job at the FDA, his faith and personal opinions were irrelevant. The only thing that mattered, he said, was whether the medication was safe and effective. In the case of Enovid, he had the sense that safety and effectiveness mattered even more than usual, because if the pill were approved, as he said, “
everybody and her sister would be taking it
.”

As he sifted through the evidence and weighed the consequences of his action, DeFelice did not come under outside pressure, as far as the records of his work and his subsequent interviews indicate. No one in the White House or Congress weighed in publicly or tried to influence his decision behind the scenes. On the contrary, most officials in government seemed happy to avoid this particular controversy. No one in the Catholic Church made any effort to lobby for the application to be squashed and no one at Planned Parenthood pulled strings to try to help it get approved. In 1959, it was still possible for a bureaucratic process with huge social, economic, and religious stakes to come off without outside interference.

But that was about to change.

In the late 1950s, John D. Rockefeller began lobbying the U.S. government to make family planning part of its foreign aid work. In 1959, a presidential committee on military assistance programs headed by General William H. Draper backed Rockefeller’s plea, recommending that foreign countries receiving military aid from the United States be encouraged to undertake birth-control programs. When Eisenhower appointed Draper, he thought he was getting a conservative committee leader. After all, Draper was an investment banker and a former economic advisor to the postwar commander in chief of U.S. forces in Europe. But it turned out the general had a radical streak and wasn’t afraid to toss grenades. After World War II, he had become concerned with population growth. He feared that Japan would soon have more people than it could feed. Much to the president’s surprise, he argued in his report that America needed to get directly involved in international family planning so that developing countries would not be vulnerable to “
communist political and economic domination
.” America’s Catholic bishops immediately issued a statement of opposition, complaining that federal funds should never be used to promote contraception. On the presidential campaign trail, John Kennedy issued a statement backing the bishops and opposing American aid for family planning. His rivals for the Democratic nomination attacked, accusing Kennedy of attempting to impose his religious values on a pluralistic nation.

Eventually, Eisenhower distanced himself from the report, saying, perhaps disingenuously, that the U.S. government ought not to interfere with the internal affairs of foreign countries—even though the U.S. government did so all the time. “
I cannot imagine anything more emphatically
a subject that is not a proper political or governmental activity or function or responsibility,” the president said at a news conference. Later, Eisenhower would change his mind and advocate federal support for family planning, but the first round in a battle over the government’s role in birth control—a battle that would continue throughout the twentieth century and well into the twenty-first—went to the opposition. Congress rejected the Draper report.

Searle officials had hoped that DeFelice might rubber-stamp Enovid. The drug had already been approved, after all. They were merely asking for permission to prescribe it for another purpose. But as days turned to weeks and weeks to months, their hopes faded. DeFelice took his job too seriously to rubber-stamp anything. After three years at the agency, he found some of its conduct worrisome. If a company submitted an application for water to treat arthritis, he complained, the water stood a fair chance of winning approval because it did no harm and investigators
couldn’t prove that it
didn’t
help arthritis
. When ridiculous but difficult-to-reject applications of that variety crossed his desk, DeFelice sometimes requested extensions in the approval process. It was one of the few tools he had at his disposal to squeeze more information out of the companies pitching new drugs. By taking more time and insisting the company provide additional information, he hoped to find flaws in the application or, on the other hand, gain confidence that the drugs deserved his approval. Now, even though Searle had filed the most voluminous application in the history of American medicine with its petition for Enovid, DeFelice was determined to be meticulous in his review.

“When a New Drug Application came in for the birth-control pills,” he told the writer Loretta McLaughlin, “it was, needless to say, revolutionary for that indication! It was a whole new bag of beans. Everything else up to that time was a drug to treat a condition. Here, suddenly, was a pill to be used to treat a healthy person and for long-term use.” It was also likely to garner more attention than most if approved. The FDA, he said, could ill afford to make the wrong decision. The agency, he said, “had to come out of the licensing absolutely clean. . . .
We were in no hurry
to put the FDA stamp of approval on it.”

After keeping the drug company waiting for more than two months, in late September DeFelice sent Searle officials a letter saying he needed yet more time. Too many questions remained, he wrote. DeFelice looked beyond the number of menstrual cycles Searle provided and bore down on the number of actual women tested. For example, how did the company know their pill was safe for twenty-four months when only 130 women in the trials had taken the drug for a year or more? Wasn’t it possible the drug might trigger premature menopause if used for long durations? What about cancer, he asked, or the impact on other glands, or the long-term effect on future pregnancies?

He wrote: “We seriously question the validity of the use of a progestational agent . . . for the inhibition of ovulation, a normal body function, when there are so many unanswered questions concerning the potential for harm. This is especially true in view of the lack of advantage over other presently available contraceptive agents.”

DeFelice had hit on the key issue. The pill treated a normal biological process as if it were a disease, and that made it unlike any other drug he could think of. The bar for approval had to be higher than usual. Why should women take something even the slightest bit risky when they were not sick and when condoms and IUDs offered safe if not exactly elegant alternatives? The application, he said, was “
incomplete and inadequate
.”

Officials at Searle were furious.

The FDA had already approved the pill for the inhibition of ovulation. Why didn’t the questions arise then, during the New Drug Approval process? The inhibition of ovulation was not a new claim, one Searle official wrote back in an angry rebuttal to DeFelice; inhibition of ovulation was the “inherent action of the drug . . .
clearly outlined in our N.D.A.
” The letter went on to say that Pincus and Rock had found “no single case” of premature menopause, cancer, or trouble with future pregnancies. What cause did DeFelice have for raising those concerns?