Medical Research Must Not Ignore Women
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Sponsor: The Breast Cancer Site
There's no one-size-fits-all approach to disease and treatment. Studies must distinguish between male and female subjects!
Today, the vast majority of medical research is done on men, with women compromising only one-third of test subjects1.
The cause and rationale behind this is a long and complex one. In 1977, the FDA recommended that women of childbearing age essentially be excluded from clinical trials after medical disasters like the Thalidomide tragedy and synthetic estrogen known as DES, which led to malignancies in reproductive organs2. Women's bodies also go through considerably more change then men's in the forms of menstruation, pregnancy, and menopause which can complicate research data sets3.
But for those women who are willing to participate in medical research studies, all of the above facts are reasons why men and women must be separated when it comes to medical research4.
Symptoms of medical complications, such as heart attacks, are experienced differently in men and women. A general unfamiliarity of women's symptoms when they don't match men's has cost countless lives in the form of misdiagnosis5. Women also absorb and react to medicine differently than men which can lead to complications and side-effects unanticipated by male-dominated drug trials6.
Clearly, something needs to be done. Women's health needs cannot be ignored any longer. While there is wisdom in the decision to limit women's participation in studies to protect the unborn7, those women who do choose to participate in studies should not have their results scrutinized under the same standards as men. Quite simply, male and female bodies are different, and medical data should treat them as such.
Sign below and ask the FDA Center for Drug Evaluation and Research to require studies to separate their results by male and female for the entire research process rather than lumping them together and to draw separate recommendations for the safe use of medicine for men and women.
- Mary Horrigan Connors Center for WomenÂ’s Health & Gender Biology at Brigham and Women's Hospital (2014), "Sex-Specific Medical Research Why Women's Health Can't Wait."
- "Office on Women's Health (1 April 2019), Policy of inclusion of women in clinical trials."
- Science Direct, Elsevier B.V. (2021), "Menopause."
- Anita Holdcroft, Journal of the Royal Society of Medicine (January 2007), "Gender bias in research: how does it affect evidence based medicine?"
- Jonathan C Reiter Law Firm (7 June 2020), "Women More Likely Than Men to Suffer Misdiagnosis, According to Studies."
- The Pharmaceutical Journal (28 May 2020), "Why we need to talk about sex and clinical trials."
- American College of Obstetricians and Gynecologists (September 2007), "Ethical Considerations for Including Women as Research Participants."
The Petition:
To the Director of the FDA Center for Drug Evaluation and Research,
I am writing to you today to express my concern after discovering that the FDA does not require medical research and drug trials to separate their findings by the sex of their participants. To get better data on the way women respond to specific drugs and treatment, this must change.
As you are no doubt aware, women and men do not always display the same signs, symptoms, or reactions to treatment. Symptoms of medical complications, such as heart attacks, are experienced differently in men and women. A general unfamiliarity of women's symptoms when they don't match men's has cost countless lives in the form of misdiagnosis. Women also absorb and react to medicine differently than men which can lead to complications and side-effects unanticipated by male-dominated drug trials.
I understand that in 1977, the FDA recommended that women of childbearing age essentially be excluded from clinical trials after medical disasters like the Thalidomide tragedy and synthetic estrogen known as DES, which led to malignancies in reproductive organs. I also realize that women's bodies also go through considerably more change then men's in the forms of menstruation, pregnancy, and menopause which can complicate research data sets.
While there is wisdom in the decision to limit women's participation in studies to protect the unborn, those women who do choose to participate in studies should not have their results scrutinized under the same standards as men. Quite simply, male and female bodies are different, and medical data should treat them as such.
Women need to benefit from medical trials by having researchers separate their data by sex. Please, change your policies to require studies to separate their results by male and female for the entire research process rather than lumping them together and to draw separate recommendations for the safe use of medicine for men and women.
Sincerely,
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