--Pre-1986: Women were not routinely included in clinical trials. There was an assumption that results of research on men could be extrapolated to women.
--1986: The NIH established a policy requiring the inclusion of women in clinical research.
--1990: A GAO audit identified that women were still not adequately represented in clinical trials. Why? The policy was vague, inconsistently applied and poorly communicated.
--1992: Another GAO audit found that while women were included in trials, they were underrepresented. (Oops..must have been another misinterpretation.)
--2000: A GAO audit revealed that although women were included and adequately represented, studies were not adequately designed to permit analysis by sex.
--2001: A GAO audit of the FDA showed that 30 percent of studies failed to fulfill requirements for outcome data by sex. Clinical significance? Eight of 10 drugs withdrawn from the market caused more adverse effects in women.
--2001: The Institute of Medicine published Exploring the Biological Contribution to Human Health: Does Sex Matter?
Yes, Virginia...sex matters. But, it is 2010 and women are still under-represented and comprise only 39 percent of the participants in Phase 1 trials, the phase that assesses the safety, tolerability, and dosing of a drug.
Not outraged yet? What if you knew that:
--During the height of the H1N1 vaccine shortage, researchers identified that women could be immunized with a lower dose of the vaccine and get adequate protection since we have a more pronounced immune response. Great news, right? Regulators were informed, but said they were too busy to consider this information in the vaccination guidelines.
--Prominent researchers were recently discouraged from submitting any new grant proposals to the NIH for research on sex differences of mental health disorders.