Eve's Rib, Part 2

The Groundbreaking Guide to Women's Health
by Marianne J. Legato, MD, FACP

(Page 2 of 2)

Why Have Researchers Studied Only Men?

Like every other scientist trained in a top-rank medical center, I was taught, and had accepted, that the results of research done in males were applicable to both sexes. In anatomy laboratory, none of my instructors thought it important to point out whether our cadaver was male or female, except when we studied the reproductive organs. I didn't even entertain the idea that there might be significant differences between the two beyond the reproductive system. In a revealing monograph, the National Academy of Sciences' Institute of Medicine calculated that fully two-thirds of all diseases that affect both men and women have been studied exclusively in men. As a result, the models not only of how humans function normally but also of how they experience illness are essentially male. This assumption that men and women are so alike that it's not important to study women directly has dominated the way scientists do biomedical research and the way doctors practice medicine. Until very recently, everything about American health care, from research protocols to public health policies, reflected an intellectual mistake of astounding proportions, one that undoubtedly has affected the health and the lives of many women over the years.

How in the world did this happen? The answer is complicated. It is not simply that men, who have traditionally dominated the worlds of academic medicine and scientific research, didn't care about women or thought they were unimportant. In fact, many of the dictates that restricted medical research to males were the result of an effort to protect women - particularly premenopausal women, whose reproductive abilities were of primary concern - from the risks of experimentation. (Scientists seldom if ever worried about a young man's reproductive potential: society still measures men principally by what they achieve, and women by their ability to conceive and bear children.) Researchers know that damage done to a fetus conceived during a clinical trial is not only an ethical issue; it can have potentially disastrous legal and economic implications if the child is born malformed.

This philosophy of protectionism, by the way, was reinforced by the publicizing of Nazi atrocities during the Nuremberg trials, particularly the Doctors' Trial, which detailed the experiments done on concentration camp inmates (including children) in the name of medical science. That exploitation was not exclusively the work of fringe elements in the medical profession. One of the doctors, Paul Rostock, was the dean of the University of Berlin School of Medicine and chief of its department of surgery. Before the war, he had been an internationally respected member of the scientific research community, but now it was clear that even the "best" doctors were capable of exploiting the defenseless and the vulnerable in the name of medical progress.

The Nazis were not unique: events in the United States reinforced the need for protection of vulnerable populations. In 1963 a physician-researcher injected cancer cells into elderly patients at the Jewish Chronic Disease Hospital in New York, in some cases without the consent of the physicians responsible for their care, and in other cases over the objections of doctors who pointed out that the patients were incapable of understanding what was going to happen to them. In 1932 in the Tuskegee Syphilis Study, doctors withheld treatment for syphilis for years in four hundred black men, so that doctors could observe the natural course of the untreated illness, even though it was known that penicillin cured the disease. This famous example of the abuse of unprotected research subjects took place well before the Nuremberg trials.

Concern for pregnant women (or young women who might become pregnant during the course of a drug trial) as subjects of medical research was fueled by two disasters. In the 1940s and 1950s, diethylstilbestrol (DES) was a popular drug used in pregnant women to prevent miscarriage (in spite of excellent evidence from well-done studies that it really had no ability to do so). In the 1970s it became apparent that many daughters born of those mothers were suffering from a rare form of vaginal cancer. A second drug, thalidomide, an antinausea treatment approved for use in 1958, produced devastating deformities in children born to women who used it while they were pregnant. These tragedies were a major reason that Congress in 1962 passed protectionist legislation (the Kefauver-Harris amendments and the National Research Act), which created a commission to develop guidelines for research in human subjects. Careful principles were developed and encoded in the policies and procedures of the National Institutes of Health.

Another reason that only males were used in clinical studies was scarcity of research dollars. The cyclic variations in women's hormonal levels made it necessary to include many more of them in any protocol in order to achieve significant and reliable information. Researchers viewed men as a more homogeneous and stable population and were reluctant to spend extra time and money to study females.

Today all of this is changing. Scientists know that in most cases the benefits of including women in clinical trials and research studies far outweigh the drawbacks; they know more about how to include women in studies without putting them at risk; and they are beginning to understand the importance of the information. They have arrived at this position via a couple of routes: tragedies like the thalidomide disaster; the increased influence and effectiveness of the feminist movement; and revolutionary improvements in medical technology. A societal event also greatly influenced the change.

How World War II Changed American Medicine

Exploring the factors that have shaped modern medical science and women's place in it could be a life's work, but the historical event that is widely accepted as playing a pivotal role in the process is World War II. The workforce changed during the war, and women took on all kinds of jobs that were once the exclusive province of men. These changes took place not only in factories and offices but in the medical profession as well. For the first time in history, women were admitted to surgical and orthopedic training programs and rose to high positions in teaching hospitals. When the war ended, they were often sent back to specialties like obstetrics and pediatrics, where "women belonged," but they never returned to prewar roles and attitudes.

The war also profoundly increased the power of physicians. Before the war, physicians, armed with little more than laudanum, whiskey, and leeches, were unable to do more in the face of disease than cultivate the clinical skills that made the best of them superb diagnosticians, with a precise knowledge of how a disease, once contracted, played out its natural course. Their primary function was to predict a patient's fate: "On the tenth day of this pneumonia, the patient will either die, or her fever will break and she will recover." But under the pressures of the battlefield, physicians refined and used the first antibiotics to combat infection. They perfected the new discipline of plastic surgery (begun by John Converse, private practitioner and faculty of NYU College of Medicine, on the battlefields of France during World War I) and discovered that a virus was the cause of the hepatitis that they inadvertently spread when transfusing wounded soldiers with contaminated blood. They learned how to treat shock and to safely anesthetize patients during long surgical procedures.

By the end of the war, Americans had developed an almost religious respect for the power of science. In 1944 scientists in the U.S. Public Health Service led Congress to pass the Public Health Service Act, which greatly expanded federal funding for medical research. Between 1955 and 1968, under the direction of James A. Shannon, the National Institutes of Health expanded significantly. By the 1960s, the United States led the world in medical and technological advances.

Copyright © 2002 by Marianne J. Legato, M.D.

About the Author

Marianne J. Legato, MD, FACP, is a professor of clinical medicine at Columbia University, where she founded and heads the Partnership for Gender-Specific Medicine. One of the world's foremost experts on gender medicine and winner of many awards for her work, she is the author of The Female Heart, What Women Need to Know, and Eve's Rib.