Prior to the 1970s, medical research (and medical have to address all three of these areas simultaneously. I would have to educate researchers, inspire medical students, and serve my patients in a new, more enlightened way. My Sex and Gender Women’s Health Collaborative has given me momentum to do exactly that, through fellowships, lectures, programs, meetings, and research.
In this chapter, I’ll reveal the many ways in which the current medical establishment isn’t set up to support women’s bodies and how our flawed belief that women’s bodies are equivalent to men’s has negatively impacted women’s outcomes at every level of care. We’ll explore how, in every setting, from pharmaceutical laboratories to hospitals to physicians’ offices, the male-centric model of medicine is ubiquitous and nearly unquestioned—and how understanding the impacts of this male “norm” can mean the difference between life and death for women across America.
The Evolution of Male-Centric Medicine
Prior to the 1970s, medical research (and medical practice in general) was nowhere near as closely regulated as it is now. Today, every federally supported study and drug trial must be approved and monitored by an institutional review board to ensure that the study is ethical, presents minimal risks to participants, and is structured in accordance with solid scientific practices.
Fifty years ago, however, the world of medical research looked very different. It was essentially the Wild West of medicine. Every new drug was seen as likely to be beneficial and safe, and pharmaceuticals were tested and distributed with very little regulation. Clinical trials did not require approval by a review board; nor were they subject to oversight by any neutral party.
This carefree approach changed drastically after numerous unforeseen consequences from new drugs and research impacted the health of tens of thousands of people. One example of this was the drug thalidomide. An anticonvulsive also marketed as a sleep aid and as a nausea reliever for pregnant women, thalidomide was available over the counter in Germany, and by prescription elsewhere. At first deemed safe and effective for all users, it was eventually determined to cause severe congenital malformations in fetuses—but not before vast numbers of pregnant women had innocently consumed it. Over 10,000 babies were born with missing or malformed limbs; damaged hearts, eyes, or digestive organs; and other major physical handicaps. Many survived only hours or days after birth. This tragedy, which affected families across Europe, Canada, and America, prompted an international investigation into drug research and human testing practices. The eventual outcome of this (and many other concurrent investigations) was the creation of the first “informed consent” laws for pharmaceutical trials in humans.
It wasn’t until 1974 that protection for research subjects was written into law. The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, tasked with developing guidelines for medical research involving human subjects and regulating the use of human experimentation in medicine. Under this set of guidelines, pregnant women and women of childbearing age were considered “protected” subjects, and (unsurprisingly, given what had happened with thalidomide) many researchers opted to exclude them from their experiments altogether to exclude them from their experiments altogether rather than jump through the hoops necessary to include them in a safe manner.
At the same time, as medical research evolved and became more regulated, researchers noticed that monthly female hormonal fluctuations created hard-to-account-for variables in their trials. Since expensive and time-consuming testing would be required to know where each woman was in her menstrual cycle at every point in the research timeline, many scientists opted to omit women altogether—both in human trials and in the initial phase of lab testing using animals.
Don’t get me wrong: I am beyond grateful for the regulations and guidelines that keep women and babies safe from the potential complications of medical trials. No one should have to suffer in order to create a new drug or medical therapy—especially not mothers and their children. However, creating a “protected” status for premenopausal women has had the unforeseen effect of making the majority of medical research male centric. In an effort to protect women from the hazards of clinical trials, we have endangered them in another way.
The pervasive belief that women’s bodies and systems are essentially the same as men’s made this male-centric approach seem like a no-brainer in the beginning—but now that we know the difference, it’s obvious that excluding half the population from clinical trials and drug-safety testing is not only a bad idea but a dangerous one.
Our current medical system favors male centrism at every level—from research planning, to funding and human trials, to implementation in hospital and outpatient settings. In order to show the scope of this issue, I’ve broken it down to demonstrate how all these various pieces come together to create a male-dominant, male-centric medical model.
- Inception: Every research study starts with an idea. For a research study to be approved, it needs to go through a series of institutional board reviews. Researchers need to prove that this study is not only valid from a medical point of view but can be conducted with minimal harm to people and animals. Because women of childbearing age were considered “protected” subjects under the National Research Act, and to some degree still are, this necessitates that female subjects undergo pregnancy testing, which on a large scale can be both expensiveand time-consuming, and that female test subjects be educated on the risks of becoming pregnant during the study. Therefore, committees are more likely to approve research projects focused on male subjects or to suggest that a similar approach using male subjects be considered. In fact, a 2011 assessment of federally funded randomized clinical trials found that only 37 percent of participants were women. More, 64 percent of the studies examined “did not specify their results by sex and did not explain why the influence of sex in their findings was ignored.”1
- Funding: All research needs funding. Funds can be obtained from a variety of sources, including institutions like hospitals, healthcare groups, and universities; government agencies; foundations like the American Heart Association or the American Cancer Society; and industry or private donors. Because enrolling women in research trials necessitates extra costs, funding is more likely to be obtained for more “streamlined” male-model studies. Also, depending on their own donor demographic, some agencies are simply more likely to choose studies that benefit men.
- Publication: Once a research study is complete, it needs to be published in a medical journal to be disseminated. It needs to go through journal editors, then peer reviews to be published. This is a place where both explicit and implicit male bias can occur; consciously or not, journal editors tend to choose studies whose outcomes are important and interesting to them, and (at the time of this writing) most journal editors are male.
- Education: After the research is published, it will be used to educate doctors, nurses, and other medical professionals and inform patient-care decisions. However, the information in these studies is almost always presented as applicable to both men and women, regardless of what percentage (if any) of the study subjects were female, and regardless of whether sex was considered a “variable” in the research findings.
As you can see, from start to finish, our whole medical research process is based on a male paradigm. And time and time again, women have paradigm. And time and time again, women have worse outcomes in areas of high public health significance.
The good news is, because there are so many steps in the research process, there are lots of places along the way to make change—but to create a landslide effect, we need to work in all of these areas simultaneously, as well as in the areas of drug research and development and medical education.
Katherine A. Liu and Natalie A. Dipietro Mager, “Women’s Involvement in Clinical Trials: Historical Perspective and Future Implications,” Pharmacy Practice (Granada) 14, no. 1 (2016): 708. doi: 10.18549/PharmPract.2016.01.708.