A study released today, Monday March 3, reports on the findings that despite a landmark law passed in 1993 requiring government-funded medical research to adequately represent women, the “fairer sex” is still being too-often ignored. This is even more so when the health issues are unique to women. The new findings were released today at a national summit on women’s health, held in Boston.
The author of the report, Dr. Paula Johnson, reports that some progress has been made in the last 20 years, but also says it is not enough by any stretch. Women are more often included in clinical trials today says Johnson, Executive Director of the Connors Center for Women’s Health at Brigham & Women’s Hospital, Boston. However she adds there are still “enormous gaps” in the process of medical research as relating to women.
Several reasons are thought to be responsible for the gap. There are legitimate concerns, such as protecting women of childbearing age (and, potentially, fetuses) from trials regarding new and unknown substances. This is prudent when possible long-term effects are unknown. However another reason often given is women’s changing hormones—that hormonal differences exist between women of the same age, and that throughout a life a single woman’s hormones change. This indeed makes the problem more complex, but the Society for Women’s Health Research points out this is all the more reason why more women need to be studied.
Many studies either do not include women and assume people taking the drug after its release will react in the same way as the people in the study (all men), or, more frequently, a small number of women is included and results are given for the entire group. These results are misleading. If numbers do not at least approach a 50/50 split, and worse, women are vastly underrepresented, outcomes cannot be said to be clear across the board. Further, manufacturers are not presently required to show separate results for men and women. If 10 women in a study of 50 people (40 being men) all have a side-effect of high blood pressure, for instance, the study only need report that 20 percent of participants experienced that side effect. Medical research results still therefore essentially ignore women, misleading the public and being downright dangerous. This is what Dr. Johnson is trying to highlight.
Another reason behind less women being included in studies is financial. Since the law was passed in 1993 the amounts allocated are thought not to have increased proportionate to how many women now need to be included. However, instead of reducing the numbers of male participants, some women have been added on to existing studies. Further, women make up only about 5 percent of top academia at U.S. medical schools, so the research is still being driven almost entirely by men. Dr. Eve Higginbotham from the University of Pennsylvania’s Perelman School of Medicine is vice dean for diversity and inclusion. She says that women are still struggling to get to the top-tier of academic medicine. She notes that bias exists and it definitely “comes down to the people…doing the studies.”
Dr. Lynn Gordon of UCLA’s David Geffen School of Medicine points out that even when researchers are reluctant to include women in studies involving new drugs, women can be followed to discover and track which conditions they have, develop over their lifetimes and so on. This information, when pooled, can paint a more accurate picture of women’s health. More importantly than this, however, Gordon feels studies involving chemical trials should be obligated to have a disclaimer when enough women have not been included, so that even if the reason was because of hormonal imbalances or any such thing, women can at least be informed before taking something that has essentially not been tested on them.
Many of the researchers find this trend egregious. There are particular instances where results can be fatal. For instance, more women die of heart disease in the United States than men each year, but clinical trial subjects are still over 66 percent male. Further, plaque on the heart is dispersed quite differently on the surface of women’s and men’s hearts, by gender. Testing is built around men, though, and the male-centered test actually does not “see” the plaque on a woman’s heart as successfully, essentially because it is designed to see plaque dispersed across a male heart. To compound all this, less than one-third of the trials involving women report their findings by gender. Doing the arithmetic while considering one-third of test subjects are women, and one-third of the findings are reported by gender, result efficacy is greatly diminished. This costs lives.
When more women are at the top of the academic medical-research ladder, their health will no longer be ignored, but advocates point out government should still be mandating clearer and more stringent policies. These should include true reporting of results by gender, and should require specific ratios within studies, where medically relevant and possible. The 1993 law required better representation of women and minorities in medical research. It should be noted that the report released today touched only on progress, or lack of, with regards to the inclusion of women.
By Julie Mahfood