Wanted: women in medical trials
courtesy of slate.com
Men and women can experience different reactions to the same medicines. As a result, the Food and Drug Administration (FDA) enforces restrictions which prevent women from participating in drug trials. Specifically, in cardiovascular (CDV) trials, there are obstacles which make it more difficult for women to participate. Consequently, the number of men participating in medical trials is disproportional to the number of women who participate.
In 1982, the FDA released a new version of the General Considerations for the Clinical Evaluation of Drugs. This document heavily restricted the participation of women in clinical trials because of the potential complications drug companies feared could arise from unexpected pregnancies.
There are typically five phases in selecting human test subjects for clinical trials. At the start of phase one and through phase two, the document states that “women of childbearing potential should be excluded.” Once the researchers have reached phase three, they are allowed to include women of childbearing potential, but only if the drug was first tested on a pregnant animal.
Courtesy of drugwatch.com
Researchers feared that they could test an unknowingly pregnant woman and the effect on the fetus could be fatal. Thus, the guidelines made clear that doctors must examine the baby whose mother participated in a clinical trial once they are born to see if the drug caused any unintended effects.
In 1993, the FDA revised their 1982 document and released the Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs. This new set of regulations changed the process to include more women in clinical trials. Along with these new guidelines, the FDA encourages female participation so any laboratory data will include the drug’s side effects for both genders.
With the release of this document, the FDA believes that women can participate in drug trials without first testing the drug on an animal. A new protocol now includes checking for pregnancy as well as implementing measures to prevent pregnancy during the trial.
Like the FDA, The National Institute of Health (NIH), is an organization that sponsors clinical trials and aims to discover scientific evidence to improve health policy and standard of care. In 1993, the NIH released a document called the NIH Revitalization Act of 1993, then revised in 2001. This document discusses NIH policies in regards to the inclusion of women and minorities in clinical trials. The NIH now prefers to have a large and diverse group of test subjects to discover if a drug affects one group of individuals differently than the wider population.
Courtesy of atvb.ahajournals.org
Women were previously excluded from CDV trials, which is the number one cause of death in the United States, according to the NIH. The number of women who participate in single-sex CDV clinical trials has significantly increased, according to atvb.ahajournals.org. However, in mixed-gender CDV trials, women are still under-represented.
Both the NIH and FDA released documents on how to handle the inclusion of women in clinical trials. However, there is still not a minimum number for how many women are required to participate in a mixed gender trial.
Many Sacred Heart Greenwich Upper School teachers were unaware of this issue.
– Shantel Guzman, Staff Writer
Featured Image courtesy of Slate.com.
