With all the talk about personalized medicine, one would think that clinical drug trials would address the differences between the sexes. Unfortunately, that’s not always the case.
Before a drug is introduced to the U.S. market, it will have gone through extensive human testing to ensure that it is effective, adheres to claims made by its maker, and is safe.
As a reporter, I covered the Federal Drug Administration for MedShadow, an online nonprofit that educates the public about the side effects of medicine (often not discovered before being approved for the public).
I was surprised and somewhat disenchanted to learn the following four things about the drug trial process that affect women and children.
#1: Men and Women Aren’t Equal
Isn’t it logical that a drug designed to be taken by both men and women should include trials that enroll a representative sample of female participants? But this doesn't always happen.
Women and children haven’t always been represented in the clinical trials that led to the approval of the drugs they are prescribed, especially for drugs prescribed off-label.
Off-label means that, once a drug is approved, licensed physicians may prescribe it for a condition, or for a patient, not indicated on the label — meaning that it hasn’t been FDA-tested for that particular condition or group of patients.
#2: The FDA Doesn't Always Study How Women’s Bodies React to Drugs
In 1977, the FDA issued guidelines recommending that pregnant women and women who could become pregnant should be excluded from large-scale clinical trials, such as Phase III studies.
Ironically, that guideline was a response to the diethylstilbestrol (DES) tragedy, where an unproven drug was given to millions of pregnant women from the 1950s to the 1970s.
It caused cancer and infertility issues in the children, and we are discovering that the grandchildren are affected too. (For more information on that, go to DESAction.org
That tragedy should have stimulated more equality.