The Birth of the Pill: How Four Crusaders Reinvented Sex and Launched a Revolution (36 page)

The statistical measures mattered to the scientists and would no doubt matter to the FDA, but to those working in Rio Piedras and Humacao, there were other signs that convinced them the drug was proving effective and popular. Anne Merrill, a laboratory worker for the Worcester Foundation who spent time in Puerto Rico, told an interviewer she was excited by the early results: “I would see these young women with many, many children, although I wouldn’t know they were young women until I looked at their records. Some of them looked like what I would think of as great-grandmotherly type, you know? All wizened up and gaunt. . . . I’d look at the records and the woman would be thirty-four, you know, with ten children.”

She continued:

To see these women after they’d been on for a year. . . . You know, to get them through one year, without having a baby . . . and here they were hale and hearty! But the exciting thing was that, for instance, some lost their babies in a flood, and they decided they wanted another baby and they just stopped the pills. And then we started seeing
the babies that were arriving
, and they’d be fine.

Merrill said there was “this terror” among the scientists that only girls or only boys would be born to women who had taken the pill, that the hormones might in some way alter the sex of their babies, or, worse, that the babies might be born with deformities. There was great relief, she said, as the social workers kept track of the babies born and found that they were healthy and that boys and girls appeared to be arriving in roughly equal numbers.

Such anecdotal evidence did not prove the drug’s safety, of course, but it gave the doctors and researchers in Puerto Rico increasing confidence that they were doing the right thing.

Back in the Chicago suburb of Skokie, Jack Searle and his fellow executives faced a dilemma. The pill was sure to be controversial. It was largely untested and firmly opposed by the Catholic Church. At the same time, it represented a potential goldmine to the company that marketed it first. Here was a medicine women would take more often than aspirin or penicillin, a pill they would take every day, possibly for years, in sickness and in health. If it worked, if it won approval, if it didn’t make women sick, and if it became popular or at least socially acceptable, millions of women all over the world might each consume 240 tablets a year at a price of about fifty cents a pill. The numbers were mind-boggling. It would easily be the biggest product Searle had ever brought to market. Best of all, they had paid almost nothing for it up to this point, because Katharine McCormick had carried most of the costs of research and development.

Searle faced difficult questions: What were the rules for testing a pill for healthy people? How far did a company have to go to prove the safety of such a product? Was one year of testing enough to measure long-term effects? Five? Ten?

Pincus urged Jack Searle not to get bogged down. In the end, there was no way to answer such questions because no one had ever done anything like this. There were risks with any drug, but the rewards for this drug in particular were like no other. This was a drug that had a chance to make money, change lives, change the culture, and combat massive world problems such as hunger, poverty, and overcrowding. Pincus made one more important argument: Childbirth was dangerous, too, especially for women who were sick, weak, or starving. There was no way to measure how many lives might be saved by a reliable contraceptive, but even without a measure, that had to be factored into analysis of the drug’s risks. Years later, the same argument would be made on behalf of legalizing abortion.

Jack Searle and others within the company had been to the slums of Puerto Rico. They knew that Pincus was right. They knew that it was nearly impossible to quantify the potential benefits of this pill.

Searle’s director of clinical research, I. C. Winter—or Icy Winter, as everyone at Searle called him—told the story of a couple he knew that had three “extra children” because the wife hated to get out of her warm bed on cold winter nights to
fetch her diaphragm from the bathroom
.

“You know,” Winter said, “those are the realities.”

Pincus—who was a shareholder in G. D. Searle & Co. as well as a contract employee—was so confident that he urged Jack Searle to consider buying one of the companies that manufactured the main ingredients for the pill. If the drug became the blockbuster that Pincus thought it might be, G. D. Searle would sharply boost its profits by
taking control of the supply chain
.

Within months of Pincus’s recommendation, Searle made its first-ever corporate acquisition, taking over Root Chemicals Inc. of Puerto Rico along with its Mexican subsidiary, Productos Esteroides. In a speech to shareholders, Searle said the acquisition would provide an economical source of the raw materials needed to make
some of its new hormone products
. He didn’t say which ones.

Jack Searle had good reason to move fast. Pincus and Searle had decided to use the compound norethynodrel, which had been patented by Searle’s own scientist, Frank Colton. Meanwhile, one of Searle’s competitors, Parke-Davis, was exploring the possibility of using the other compound Pincus had considered, norethindrone, which had been produced by Djerassi and Syntex.
Djerassi urged Parke-Davis to fight
, but Parke-Davis and Searle had business ties and didn’t want to go to war. Pincus’s pill, in Parke-Davis’s view, was “
small potatoes
.”

Other competitors might have jumped in. Everyone in the industry knew what Pincus and Searle were up to. The question wasn’t whether other companies had the capacity to make a similar drug; the question was whether other companies had the nerve.

“We were a company with an absolutely impeccable reputation,” said James S. Irwin, Searle’s top marketing executive at the time. But with birth control, he added, “We were going into
absolutely unexplored ground
in terms of public opinion.”

In the end, Jack Searle concluded that the potential rewards outweighed the risks. But he did hedge his bet in one important way. Instead of seeking approval from the FDA for a birth-control pill, the company applied for the approval of Enovid as a treatment for menstrual disorders. “There has been speculation,” Jack Searle told the company’s stockholders, “that the drug may have use in the
field of physiological birth control
.”

Searle’s application to the FDA in 1957 made no mention of contraception. Amenorrhea, dysmenorrhea, and menorrhagia: these were the menstrual problems Enovid was said to combat. The company also claimed that its new drug would be used to treat infertility because, even though the number of cases was small, tests showed that women resting their ovaries for several months were more likely to become pregnant when they stopped taking the drug. It was the “Rock Rebound” again. FDA officials could read between the lines, of course. They could also read in the mainstream press that Pincus and Searle were studying the effects of Enovid as a contraceptive. For the time being, though, it didn’t matter. Inspectors couldn’t reject the drug as a contraceptive because Searle wasn’t asking for approval as a contraceptive. The only question was whether it worked safely and effectively in treating menstrual disorders.

If the FDA approved the pill for menstrual disorders, Enovid would be legal and available by prescription at every doctor’s office in the country. That would make it much easier for Pincus to find gynecologists willing to prescribe it for their patients, and if some of those patients were perhaps not exactly suffering from menstrual disorders but in need of an effective form of contraceptive, that would be all right with Pincus. The world would begin to learn what Enovid could do.

TWENTY-EIGHT

“
Believed to Have Magical Powers
”

O
N JUNE 10, 1957,
after taking two months to review the application filed by G. D. Searle & Co., the FDA approved the sale of Enovid for infertility and menstrual irregularities. At about the same time, the drug was approved for the same uses in England under the brand name Enavid.

Pincus and the team at Searle were ecstatic, as were Sanger and McCormick. Searle began advertising the drug in medical journals with a picture of a West African fertility doll and this legend: “Believed to have magical powers, these objects are carried by young women of the tribe when they desire to become pregnant.” Hoping to avoid controversy, at least for the time being, Searle advertised the drug as a boon to infertile women. Enovid, they said, would help women regulate their cycles. Once they achieved better control of those cycles, the company promised, they would have a greater chance of becoming pregnant.

That was the official line. Let women discover Enovid; let them see that it was safe. Let doctors prescribe it. Let everyone discover that it worked—as a regulator of menstruation and, oh, by the way, as a contraceptive, too. As the word spread from woman to woman, doctor to doctor, Searle would quietly make the necessary preparations to market the drug as the world’s first scientific birth-control pill.

Pincus couldn’t wait. In June, he went to Sweden and boasted in a widely reported speech that he had developed “an almost 100 percent effective pill for preventing pregnancy.” Rock, still uneasy about incurring the wrath of the Catholic Church, hurriedly sent him a telegram.
“
SUGGEST BUTTONING UP
,” it read
.

Pincus did not button up. Instead, he gave an interview to the science writer Albert Q. Maisel for an article that appeared in the August issue of
Ladies’ Home Journal
, which had a circulation of more than four million, making it the most popular women’s magazine in the world and one of the most popular magazines of any kind. Maisel offered readers a detailed account of the “
brilliant and painstaking work
” Pincus and his team were doing to develop what the three-page article referred to as “the new hormone preparation . . . for widespread and long-term use as a method of controlling fertility.”

Officials at G. D. Searle were furious. Six months earlier, Searle had sponsored a symposium for some of the nation’s leading reproductive scientists and gynecologists, hoping to educate them about Enovid and win their support for the drug. The company had promised that the material presented at the symposium would not be released to the public. Now, scientists who had attended the meeting wrote to Searle, asking how details from the meeting had made it into print—and into
Ladies’ Home Journal
, of all places. I. C. Winter wrote to the scientists in apology, saying the Searle company had neither instigated the article
nor cooperated with the author
. But Winter knew who had. Goody Pincus and the writer Maisel were old friends. In fact, not long after the article appeared in
Ladies’ Home Journal
, Pincus would put Maisel on the Worcester Foundation payroll to help with publicity.

Pincus had done it again. Just as he had twenty years earlier at Harvard, when a
Collier’s
article had helped sink his academic career, he had used the mainstream press instead of a scientific journal to inform the world about his thrilling, frightening, utterly unfinished work. This time, though, the stakes were even higher. G. D. Searle and Katharine McCormick had spent hundreds of thousands of dollars backing the birth-control pill, and Searle had recently received FDA approval to sell it. It didn’t matter that the approval was not for a birth-control pill but for a pill to regulate menstrual disorders; what mattered was that Enovid did the work of a birth-control pill and it was now legal. Searle officials were deeply worried that there might be a backlash against the company, and that such a backlash could lead to a boycott of Searle products and a drop in the company’s stock price.

Searle proceeded cautiously. Beginning in July 1957, the company offered Enovid
only to doctors on the West Coast
. The company advertised the pill for the regulation of menstruation, but salesmen made no secret of its other benefit. Federal law regulated the behavior of drug companies, but not that of doctors. Once a drug was approved for any purpose, physicians were free to prescribe it liberally (medical professionals refer to those other purposes as the “off-label uses”).