Congress now has a second chance to act on the Research for All Act, which would bring gender equality to essential aspects of medical research.
Elements of the legislation range from basic NIH research requiring inclusion and separate analysis of male and female animals, tissues and cells, to the FDA conducting expedited drug approvals that are sufficient to determine safety and effectiveness for both men and women. The goal: to improve health outcomes for both men and women by more precisely ensuring the proper indication and dosage of approved medicines.
Although efforts to increase the participation of women in clinical trials have been ongoing for years, the Research for All Act would ensure that when drugs are approved by the FDA through an expedited pathway, specific sub-group analysis confirms safety and effectiveness for women.
Originally introduced last June, the Research for All Act was reintroduced by U.S. Rep. Jim Cooper (D-Tenn.) and U.S. Rep. Cynthia Lummis (R-Wy.) in late April to replace the current law, which they say that does not require researchers to study female animals when conducting basic medical research and puts women at risk for missed opportunities with incorrect diagnoses and misinformed treatments.
“Mad Men may be ending soon, but medical research is still stuck in the ‘60s,” said Cooper. “Women deserve good medicine just as men do. This is a fairness issue, as some medicines work different in the female metabolism, and for Congress to ignore the disparity has shocked some members.”
Women comprise slightly more than half the U.S. population, yet for cardiovascular disease, the leading killer of both men and women in the U.S., only one third of patients in cardiac clinical trials are women, Cooper said. He also emphasized that women metabolize drugs differently and pointed to one example in which that was ignored by researchers, when they determined the dosage of insomnia medication Ambien. The recommended dose was double what it should have been for women and has since been revised to a smaller dose.
Dozens of healthcare organizations, women’s groups and academic institutions, including the American Heart Association, the National Women’s Health Network and Vanderbilt University Medical Center, have expressed support for this legislation.
“Even when studies do include women, 70% fail to report outcomes by sex,” stated the 15-member Patient, Consumer and Public Health Coalition in its support for the Research for All Act. “Insufficient inclusion in clinical trials, failure to conduct appropriate subgroup analysis and lack of publicly available information puts women at risk when they use FDA-approved diagnostics and treatments.”
Cooper’s bill would alleviate such disparities, as it also promotes men’s health. He cited a recent diabetes drug study that suggested the medication may lower women’s risk of heart failure but increase men’s risk.
Earlier this year, the FDA implemented “Drug Trials Snapshots,” which provides consumers with safety and efficacy information about newly approved drugs and who participated in the clinical trials by sex, race and age. However, critics maintain it lacks inclusion of subgroups, particularly minorities and the elderly, in all phases of clinical trials, as Snapshot is focused primarily on phase III trials.
“The FDA needs to get more involved, and the proposed legislation is a good first step,” said Londa Schiebinger, professor of the history of science at Stanford University who has written extensively about gender and science. “The failure by pharmaceutical companies to routinely use female cells, tissues and animals can lead to greater health risks for women.”
She said there is quiet resistance from those who question whether including more females in animal studies will increase preclinical costs. But the legislation, she said, would remove a bias from science that, in the long run, will cost less and save lives.
“Unfortunately, most preclinical biomedical research has been conducted with inadequate consideration for sex, which needs to change,” said Schiebinger, adding that it is one of the most underappreciated differences in biomedical research.
Cooper said he is hopeful the legislation will be approved either later this year or in 2016 with bipartisan support.
He acknowledged a “whispering campaign” within Congress that clinical trials could become more expensive and they should move slowly on the issue, which could stretch out final Congressional action.
“Big pharmaceutical companies may not be enthusiastic, as they have shunted aside these research concerns for decades and have excuses for not doing it, but that may change,” said Cooper. “There will be bipartisan support for this bill, as Republicans will be open to attracting the female electorate and many Democrats who have sided with women’s issues will continue to push for it.”
“After all, we are just making people aware of these medical research discrepancies and want to work for greater fairness,” he said. “This bill is more of a nudge than a hammer.”
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