Women are disregarded in studies for drugs or even cure, of infection or HIV or AIDS

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Although women make up about half of HIV cases worldwide, they remain largely excluded from clinical trials testing drugs, vaccines and potential cures for the virus or AIDS, research confirms. In an analysis spanning several decades that included work done in 2012, the researchers found that women typically make up about 11 percent of trial participants looking for solutions to the HIV / AIDS epidemics. Likewise, drug studies were only about 19 percent women and only 38 percent of subjects in the vaccine trial were women.
"Based on previous studies in other areas of health, it was not surprising, but perhaps disappointing, given that almost half of people living with HIV are women," said study author Dr. Mirjam Curno, who did the analysis while working as editor-in-chief of The Journal of the International AIDS Society, he said by email.
Research in areas such as heart disease, cancer and depression has also had historically low female participation, as well as advanced human trials testing experimental drugs, note Curno and colleagues in the Journal of Acquired Immune Deficiency Syndromes. While it may make sense to have fewer women in studies focused on diseases that disproportionately affect men, the survey results may ignore specific genders, harms or benefits when the proportion of men and women in the study is extremely different from what happens in the real world, said the senior study author Dr. Shirin Heidari by email. That's because, even when the disease is the same, women can have different symptoms than men and respond in unique ways to the treatments being tested. "Failing to systematically study gender and gender differences in health research leads to less evidence-based medicine for one sex or another," said Heidari, who is chairman of the gender policy committee for the European Association of Science Editors. Analysis of gender disparities in HIV trials included more than 500 studies published in prominent medical journals over several decades. A limitation of the analysis is that, by relying on published work, it cannot capture any differences in the gender composition of more recent essays that have not yet been completed, the authors acknowledge. It is possible that at least some studies in the analysis were not done to favor men, but ended up enrolling fewer female participants due to obstacles that can disproportionately affect women, such as lack of child or elderly care or limited transportation or the time to participate, noted Mary Foulkes, a biostatistics researcher at George Washington University in Washington, DC An unanswered question by the analysis is why eligible women may have decided not to participate, Foulkes, who was not involved in the study, said by email. Sometimes, the criteria for enrollment in the trial can be too restrictive to enroll enough women, for example, prohibiting pregnant women, breastfeeding women or women of childbearing age. In the past, eligibility criteria have excluded a large number of women, even in HIV tests designed to study female patients, noted Dr. Monica Gandhi, HIV specialist at the University of California, San Francisco. Under-representation of women in HIV tests may mean that the findings are of limited use in the treatment of female patients, said Gandhi, who was not involved in the study, via email. "When I care for an HIV-infected woman in my clinic, I don't know if this new and exciting treatment or strategy applies specifically to her if the study doesn't include enough people in this or that study that look like her," said Gandhi. SOURCE: bit.ly/1JKDP44 Acquired Immunodeficiency Syndromes Diary, online September 8, 2015 (Reuters Health) -By Lisa Rapaport
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