Tenth grade Social Studies class. My first term paper. Typed on a Remington Select with bottles of White Out and typewriter correction tape by my side. The topic: The Equal Rights Amendment (ERA).
In case you haven't read it lately, the language in the ERA simply states:
Section 1: Equality of rights under the law shall not be denied or abridged by the United States or by any state on account of sex.
Section 2. The Congress shall have the power to enforce, by appropriate legislation, the provisions of this article.
The Amendment was originally introduced in 1923. In 1972, it finally passed in both the House and Senate but sits dormant, and is not part of the U.S. Constitution since it has only been ratified in 35 of the necessary 38 states.
As you might expect, I took the position 30-plus years ago that the Amendment should be passed. And, I still do. Not because women still need equal due process rights; the 14th Amendment takes care of that. Not because women still need equal opportunity for employment and compensation; the Civil Rights Act of 1964 and the Equal Pay Act (1963), theoretically at least, afford these protections.
The ERA needs to be passed so that women finally have an equal opportunity to achieve and maintain their health.
Two weeks ago, the Institute of Medicine published a report: Women's Health Research: Progress, Pitfalls, and Promise. This report was commissioned by Health and Human Services to examine the status of women's health research over the last 20 years and to determine how effectively findings have been put into practice. The report's findings highlight that, indeed, there has been progress, particularly in the treatment of women with heart disease, breast and cervical cancer. There is a longer list of conditions for which progress has not been made.
Among the findings that I want to call attention to because, frankly, they are appalling, are those regarding the inclusion of women in clinical trials. Here is a brief synopsis; comments in parentheses are my editorial comments. What are blogs for, anyway?
--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.)
--1993: The FDA issued new guidelines for requiring inclusion of women in clinical trials and required gender specific analysis of the data.
--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. Does this make sense since science can’t yet explain why depression is twice as common in women, alcoholism is twice as common in men, eating disorders are three times more common is girls and autism is four times more common in boys? Nope. What are they thinking?
--Male mice, rats, and rodents are even preferentially used over females in basic clinical research!
What will it take to make women's health a priority in clinical research? We have Federal laws, NIH policies, FDA guidelines, four separate Federal agencies with an "Office of Women's Health," and repeated GAO audits, but the status of women's health research is abysmal for a nation that spends almost $3 trillion on health care. We've come a long way baby, but not far enough, and we may need a 28th amendment to the Constitution to finally have equal rights to a healthy life.
What can you do? Whether you are male of female:
Read the report. Educate yourself on sex-based differences. Advocate for yourself. Men are from Mars, women are from Venus, and sex matters, damn it!
*"Sexx Matters" is the creative brainchild of the Society for Women's Health Research...an organization that works tirelessly to promote and advocate for sex-based differences research.