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Comparative Effectiveness Research: What a Difference an X Should Make

June 22nd, 2009

comparative-effectiveness-research-what-a-difference-an-x-should-make

With all the chatter and perhaps now “ twitter” about health care reform, one area has gotten a lot of attention and it is an issue that is near and dear to the Society for Women’s Health Research—that is comparative effectiveness research (CER).

Since it is accepted knowledge that women and minorities were not, and are still not, to the degree they should be, included in clinical trials, there is much we are learning and still do not know about sex and ethnic differences in terms of prevention, diagnosis and treatment. My concern with CER, therefore, is how differences in effectiveness and treatment will be determined. Several genetic, hormonal, environmental factors influence health and disease in particularly different ways in women and men. Because of that, CER must study both men AND women and analyze fully any sex based difference in disease prevalence, treatment options and procedures. Those decisions must correlate to real world experiences.

In January, I sent a letter to Senator Tom Harkin that outlines the Society’s concerns and offers suggestions and recommendations.

CER decisions must be clinically relevant to decisions made by health care professionals and patients and that to achieve this, patients must be provided a voice in the health care decision-making and determination process.

The research results must avoid creating unintended access barriers, coverage denials, or arbitrary dollar thresholds that can arise through centralized cost effectiveness determinations. By focusing on gaps in clinical knowledge the research findings may improve the quality and ultimately, the value of health care.

I am encouraged that most recently there has been attention to this issue and that many of the concerns raised by the Society and other groups are being discussed and in some pieces of legislation are addressed. However, the devil is always in the details and there are several legislative proposals out there and it is not clear which one or which parts will prevail and when and by whom these decisions will ultimately be made.

As an organization whose mission is to improve the health of all women through advocacy, research and education, we will keep a watchful eye on this and other issues that may have negative consequences for women in this health care reform debate.

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