Penny le Couteur & Jay Burreson (37 page)

A patent for each compound was granted. The legal question of whether one molecule that the body changes to another constituted an infringement of patent law was never examined.

Pincus tried both molecules for the suppression of ovulation in rabbits at the Worcester Foundation. The only side effect was no baby rabbits. Rock then started cautious testing of norethynodrel, now given the name Enovid, with his patients. The fiction that he was still investigating infertility and menstrual irregularities was maintained, not without some degree of truth. His patients were still seeking help for this problem, and he was, for all intents and purposes, doing the same experiments as before—blocking ovulation for a few months to make use of the increase in fertility that seemed to occur, at least for some women, after this treatment. He was, however, using artificial progestins, administered orally and at lower doses than synthetic progesterone. The rebound effect seemed to be no different. Careful monitoring of his patients showed that Enovid was 100 percent effective in preventing ovulation.

What was needed now was field trials, which took place in Puerto Rico. In recent years critics have denounced the “Puerto Rico experiment” for its supposed exploitation of poor, uneducated, and uninformed women. But Puerto Rico was well ahead of Massachusetts in terms of enlightenment on birth control. Although it had a predominantly Catholic population, in 1937—thirty-five years before Massachusetts—Puerto Rico amended its laws so that the distribution of birth control supplies was no longer illegal. Family planning clinics, known as “pre-maternity” clinics, existed, and doctors at Puerto Rico's medical school as well as public health officials and nurses supported the idea of field testing an oral contraceptive.

The women selected for the study were carefully screened and meticulously monitored throughout. They may have been poor and uneducated, but they were also pragmatic and practical. These women may not have understood the intricacies of the female hormonal cycle, but they did comprehend the perils of having more children. For a thirty-six-year-old mother of thirteen, eking out a living in a two-room shack on a subsistence farm, the possible side effects of a birth control pill would seem a lot safer than a further unwanted pregnancy. There was no shortage of volunteers in Puerto Rico in 1956; nor would there be for further studies done in Haiti and Mexico City.

More than two thousand women participated in the trials in these three countries. Among them the failure-to-prevent-pregnancy rate was around 1 percent, compared with a failure rate among other forms of contraception of anywhere from 30 to 40 percent. The clinical trials of oral contraception were a success; the concept, proposed by two older women who had seen much of the hardship and misery of unfettered fertility, was workable. Ironically, if these trials had occurred in Massachusetts, even informing the subjects about the aim of the tests would have been illegal.

In 1957 the drug Enovid was given limited approval by the Food and Drug Administration as a treatment for menstrual irregularities. The forces of tradition and authority still prevailed; though the pill's contraceptive properties were definitely known, it was believed that women would be unlikely to take a daily contraceptive pill and that the relatively high cost (about ten dollars monthly) would be a deterrent. Yet two years after the FDA's approval, half a million women were taking Enovid for their “menstrual irregularities.”

G. D. Searle finally applied for the approval of Enovid as an oral contraceptive and formally obtained it in May 1960. By 1965 nearly four million American women were “on the pill,” and twenty years later it was estimated that as many as eighty million women worldwide were taking advantage of the molecule made possible by Marker's experiments with a Mexican yam.

The ten-milligram dose used during field trials (another point of present-day criticism of the Puerto Rican tests) was soon reduced to five milligrams, then to two milligrams and later to even less. Combining the synthetic progestin with a small percentage of estrogen was found to decrease side effects (weight gain, nausea, breakthrough bleeding, and mood swings). By 1965 Syntex's molecule, norethindrone, through its licensees Parke-Davis and Ortho, a division of Johnson & Johnson, had the major share of the contraceptive market.

Why was a birth control pill not developed for men? Both Margaret Sanger—whose mother died of consumption at fifty after having eleven children and a number of miscarriages—and Katherine McCormick played crucial roles in the development of the pill. Both believed that women should have contraceptive control. It is doubtful they would have supported research for a male pill. If the early pioneers of oral contraceptives had synthesized a molecule to be taken by men, would the criticism now be that “male chemists developed a method allowing men to have contraceptive control”? Probably.

The difficulty with oral contraception for men lies in biology. Norethindrone (and the other artificial progestins) only mimic what natural progesterone tells the body to do—that is, to stop ovulating. Men do not have a hormonal cycle. Preventing, on a temporary basis, the daily production of millions of sperm is much more difficult than preventing the development of a once-a-month egg.

Still, a number of different molecules are being investigated for possible birth control pills for men, in response to a perceived need to share the responsibility for contraception more equally between genders. One non-hormonal approach involves the molecule gossypol, the toxic polyphenol extracted from cottonseed oil that we mentioned in Chapter 7.

In the 1970s tests in China showed gossypol to be effective in suppressing sperm production, but uncertainty about the reversibility of the process and depleted levels of potassium leading to heartbeat irregularity were problems. Recent tests in both China and Brazil, using lower doses of gossypol (10 to 12.5 mg daily), have indicated that these side effects can be controlled. Wider testing is planned for this molecule.

 

 

Whatever happens in the future with new and better methods of birth control, it seems unlikely that another contraceptive molecule could change society to quite the same extent as the pill. This molecule has not gained universal acceptance; issues of morality, family values, possible health problems, long-term effects, and other related concerns are still matters for debate. But there can be little doubt that the major change brought about by the pill—a woman's control of her own fertility—led to a social revolution. In the last forty years, in countries where norethindrone and similar molecules became widely available, the birth rate has dropped, and women have gained more education and have entered the workforce in unprecedented numbers: in politics, in business, and in trade women are no longer an exception.

Norethindrone was more than just a fertility-controlling medication. Its introduction signaled the beginning of an awareness, not only of fertility and contraception, but of openness and opportunity, allowing women to speak out (and do something about) subjects that had been taboo for centuries—breast cancer, family violence, incest. The changes in attitudes in just forty years are astounding. With the option of having babies and raising families, women now govern countries, fly jet fighters, perform heart surgery, run marathons, become astronauts, direct companies, and sail the world.

12. MOLECULES OF WITCHCRAFT

F
ROM THE MIDDLE of the fourteenth until the late eighteenth century, a group of molecules contributed to the doom of hundreds of thousands of people. It can never be known exactly how many, in almost every country in Europe during these centuries, were burned at the stake, hanged, or tortured as witches. Estimates range from forty thousand to millions. Though accused witches included men, women, and children, aristocrats, peasants, and clergy, mostly the fingers were pointed at women—often poor and elderly women. Many reasons have been advanced for why women became the main victims of the waves of hysteria and delusion that threatened whole populations for hundreds of years. We speculate that certain molecules, while not wholly responsible for the centuries of persecution, played a substantial role in this discrimination.

Belief in sorcery and magic has always been part of human society, long before witch-hunts began at the end of the Middle Ages. Stone Age carvings of female figures were supposedly venerated for their magical powers of fertility. Legends of all ancient civilizations abound in the supernatural: deities that take on animal form, monsters, goddesses who cast spells, enchanters, specters, goblins, ghosts, fearsome creatures who were half animal and half man, spirit-beings, and gods who lived in the sky, in forests, in lakes, in the ocean, and underground. Pre-Christian Europe, a world full of magic and superstition, was no exception.

As Christianity spread throughout Europe, many old pagan symbols and festivals were incorporated into the rituals and celebrations of the Church. We still celebrate as Halloween the great Celtic festival of the dead, marking the beginning of winter on October 31, although November 1, All Saints' Day, was the Church's attempt to divert attention away from the pagan festivities. Christmas Eve was originally the Roman feast day of Saturnalia. Christmas trees and many other symbols (holly, ivy, candles) that we now associate with Christmas are pagan in origin.

Before 1350 witchcraft was regarded as the practice of sorcery, a method of trying to control nature in one's own interest. Using charms in the belief that they could protect crops or people, casting spells to influence or provide, and invoking spirits were commonplace. In most parts of Europe sorcery was an accepted part of life, and witchcraft was regarded as a crime only if harm resulted. Victims of
maleficium,
or evil-doing by means of the occult, could seek legal recourse from a witch, but if they were unable to prove their case, they themselves became liable for a penalty and trial costs. By this method idle accusations were discouraged. Rarely were witches put to death. Witchcraft was neither an organized religion nor an organized opposition to religion. It was not even organized. It was just part of folklore.

But around the middle of the fourteenth century a new attitude toward witchcraft became apparent. Christianity was not opposed to magic, provided it was sanctioned by the Church and known as a miracle. But magic conducted outside the Church was considered the work of Satan. Witches were in league with the devil. The Inquisition, a court of the Roman Catholic Church originally established around 1233 to deal with heretics—mainly in southern France—expanded its mandate to deal with witchcraft. Some authorities have suggested that once heretics had been virtually eliminated, the Inquisition, needing new victims, set its sights on sorcery. The number of potential witches throughout Europe was large; the potential source of income for the inquisitors, who shared with local authorities the confiscated properties and assets of the condemned, would also have been great. Soon witches were being convicted not for performing evil deeds but for supposedly entering into a pact with the devil.

This crime was considered so horrendous that, by the mid-fifteenth century, ordinary rules of law no longer applied to trials of witches. An accusation alone was treated as evidence. Torture was not only allowed, it was used routinely; a confession without torture was seen as unreliable—a view that seems strange today.

The deeds attributed to witches—orgiastic rituals, sex with demons, flying on broomsticks, child murdering, baby eating—were, for the most part, beyond rationality but were still fervently believed. About 90 percent of accused witches were women, and their accusers were just as likely also to be women as men. Whether so-called witch-hunts revealed an underlying paranoia aimed at women and female sexuality is still being argued. Wherever a natural disaster struck—a flood, a drought, a crop failure—no lack of witnesses would attest that some poor woman, or more likely women, had been seen cavorting with demons at a sabbat (or witches' gathering) or flying around the countryside with a familiar (a malevolent spirit in animal form, such as a cat) at their side.