Clinical Mistrials: Show Us the Women

Women make up 51 percent of the United States population, based on the 2010 Census. Yet, only 21 to 32 percent of clinical trial participants in early stages of research are women. With a 1.5 to 1.7-fold greater risk of experiencing harmful reactions to drugs, it is imperative that more demographic data from clinical trails are available about women so that they know how they will react to certain drugs.

Last week, twenty-two Democratic congressmen wrote a letter to Dr. Francis Collins, Director of the National Institutes of Health (NIH), asking that demographic information on clinical health trials be made public, including those done by pharmaceutical companies. In 1993, the NIH was mandated by Congress to require female and minority participation in Phase III clinical trials through the NIH Revitalization Act. However, most clinical studies are conducted by pharmaceutical companies, which are outside the jurisdiction of the NIH. Trials done by these pharmaceutical companies, therefore, are not required by law to provide this demographic breakdown of clinical trial participants. This congressional letter is requesting the demographic data from clinical trials performed by both the NIH and pharmaceutical companies.

The two biggest challenges faced in clinical trails are competition and cost. Compared to men, women are more likely to be ineligible for the clinical trials, as a result of hormone treatment, pregnancy or history of childbirth. Female participants in clinical trials are often associated with lower retention rates and higher costs.

Women’s health care is more expensive than men’s for a variety of reasons. First of all, maternity care is expensive. As women carry and deliver the babies, extra costs result from reproductive health care and services. Women also live longer, about five years longer than men, on average. End-of-life care is the most expensive kind of care offered, and as women are living longer than men, they are consuming more of this expensive care. Women also bear a greater disease burden than men and often have smaller bodies that are more vulnerable to injury. They also seek preventative care, visit doctors, take more medication, and use alternative therapies more frequently than men. All of these biological and social differences result in higher health care spending by women.

In 2011, the Food and Drug Administration held a conference in collaboration with the Society for Women’s Health Research. The Conference put forth several recommendations for doing a better job of including women in clinical health trails. One of these recommendations is the recruitment of more female physicians. Research has found that minority patients seek physicians of their own race, and similar patterns are seen for women seeking female physicians.

Education as a means to awareness was another recommendation. Not only do the patients need to be better educated about symptoms of disease and importance of treatment, but physicians also need to be educated in the current research and studies showing how certain drugs specifically affect women.

Only 17 percent of cardiologists are aware of the greater female mortality due to heart disease than men. This is only one example of the dearth of information physicians and patients have regarding clinical trials and drugs affecting women.

Given all of the reasons mentioned, women consume more health care services and live longer than men do. These patterns result in greater health care spending which is further exacerbated by treatment and spending required to correct health complications resulting from drugs given to patients without knowing their effect on females. With health care expenditures only continuing to increase, providing demographic data about women in clinical trials is one step the United States can take in making our health care system safer and more transparent for its consumers.

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