The Gender Gap in Medical Trials: What to Know

When you examine medical research — or place your trust in health care providers who delve into this research on your behalf — you trust that experts have taken every step necessary to control for variables that might affect the results. Unfortunately, while many studies are trustworthy, some researchers neglect to account for factors that can have a huge impact on outcomes. This, in turn, may affect the health of countless patients. Often, those who bear the brunt of the damage are female, thanks to an enduring gender gap in medical trials.

Researchers from the University of Chicago and the University of California, Berkeley have shined a light on this huge problem by examining data published in a variety of medical journals. During this effort, they uncovered gender gaps in several medications that had previously been approved by the Food and Drug Administration.

The study was sparked by adverse effects from taking the common sleep medicine Ambien. The researcher’s lead author explained, “The standard dose [of Ambien] produced much higher blood concentrations and longer drug elimination times in women than men.”

This discovery represents just one of many examples of how sex differences impact medical treatments, and, all too often, cause women to suffer. Based on this research, it’s increasingly clear that, when prescribed the same doses as men, women experience far more adverse side effects.

Meanwhile, their failure to be properly included in trials may reduce the efficacy of drugs and other treatments. In some cases, this problem also leads to unacceptable delays in diagnosis.

What Causes Sex Differences in Treatments?

Previously, many medical experts have theorized that women simply have a “lower threshold for reporting adverse drug effects.” Increasingly, however, it’s becoming evident that the cause actually lies with metabolic processes. From body fat composition to intestinal enzymatic activity, a variety of sex-dependent differences can influence how the body handles various medications.

Why Have Women Been Excluded From Medical Trials?

Many studies neglect to analyze results based on the participants’ sex. Vineet Aurora of the University of Chicago’s Pritzker School of Medicine suspects that this may still be a problem simply because male investigators have long been overrepresented.

Many of these researchers still assume that there are no significant differences between how medications play out in male and female patients, even when a wealth of evidence suggests otherwise. This belief has its basis in common practices from the 70s and 80s.

As Regine Douthard, MD, MPH of the Office of Research on Women’s Health explains, “Many clinical trials ran under an unspoken assumption that the only difference between women and men was their sexual and reproductive organ. Women were, in essence, considered small men.”

Another concern that has prevented women from being included in important clinical trials? Fears of harm to the potential fetus for participants of childbearing age. In fact, in 1977, the Food and Drug Administration (FDA) explicitly instated a policy of banning women from trials due to birth defects caused by drugs from previous studies. While this policy was rescinded in 1993, the effects have lingered, with women still underrepresented to this day and the gender gap in medical trials persisting.

How Does a Lack of Female Representation Impact Treatment?

As highlighted above, Ambien represents one of the most common complaints regarding the medical research gender gap. Additional examples abound, with new issues coming to light all the time. These include:

• Underdiagnosis of heart disease. Cholesterol plaque presents differently in the arteries of men and women, resulting in underdiagnosis among female patients. Treatments for women also tend to be less aggressive than those targeted at their male counterparts.
• Alzheimer’s disease. The lifetime risk of developing Alzheimer’s is far higher for women than for men, and yet, studies on the disease and its treatment protocol have rarely bothered to take sex differences into account. Recent research suggests that the hormonal changes associated with menopause may have a greater impact than previously assumed.
• Glioblastoma therapies. While gender differences in treatment are typically thought of as problematic for female patients, the reverse can sometimes prove true. With glioblastoma, for example, current therapies are far more effective for women than they are for men. As such, a report in the journal Science Translational Medicine suggests that future treatments will need to be tailored based on sex-based differences.

Regardless of the condition or treatment, a lack of female representation in studies will ultimately have a negative impact. As the Texas Heart Institute’s regenerative medicine expert Doris Taylor explains, “Women’s response to an injury, to something foreign, to even any kind of inflammatory response that occurs involves a completely different chemical pathway than what occurs in men.”

Change Is on the Horizon

With so much at stake, it can be easy to feel discouraged about the state of gender within the medical and pharmaceutical industries.

The good news? Change is afoot. The National Institute of Health (NIH), for example, has mandated that sex be considered a key biological variable in all studies it funds. This will be true not only for studies involving human subjects, but also, in research involving lab animals.

In recent years, women have been included in the research process to a greater extent. Recent data suggests that they now make up 49 percent of research participants. While a great deal of progress is needed to ensure equitable research practices in the future, achievements thus far suggest that the vision of a closed gender gap is far from unrealistic in the healthcare sector.

Seeking Justice With a D.C. Medical Malpractice Lawyer

The gender gap in medical trials is just one of many alarming issues at play in the healthcare industry. Negligence is also a huge concern. If this has caused you to suffer, you owe it to yourself to seek justice with help from a D.C. medical malpractice lawyer. Our team at Regan Zambri Long PLLC can help, so reach out today to get started.