10/25/2025
Safe and effective for who???
Double blind studies for half the population.
Don’t get me started on pregnant women and babies being given drugs that were never tested on them.
Thank God my family and I chose a different path.
Until 1993, there was no FDA requirement that women be included in clinical trials for new drugs. In fact, the FDA had explicitly discouraged the participation of women of childbearing potential in early-stage drug trials after the thalidomide tragedy of the early 1960s (when the drug caused severe birth defects).
Here’s a brief timeline for context:
• 1977: The FDA issued guidance excluding most women of childbearing potential* from early clinical drug trials* to protect potential pregnancies.
• 1980s: This policy led to widespread underrepresentation of women in biomedical research — even in studies on conditions that affect men and women differently.
• 1993: The FDA reversed this policy and issued a new guideline, “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” requiring that:
• Women be included in clinical trials, and
• Data be analyzed for s*x-based differences in drug safety and efficacy.
That shift was largely driven by advocacy and research from the National Institutes of Health (NIH), the Office of Research on Women’s Health, and public pressure to recognize s*x as a biological variable in medicine.
Here’s what changed after the 1993 FDA policy shift — and why it mattered so much:
1. Women were formally required to be included in drug trials
Before 1993, women (especially of childbearing age) were often excluded from studies entirely. After the rule change, the FDA required that:
• Women be included in all phases of clinical drug development (not just later stages).
• Researchers analyze data by s*x to identify any differences in how drugs affect men and women.
This was the beginning of “s*x-based analysis” in clinical research — something we take for granted today.
2. Recognition of biological and hormonal differences
Post-1993 research began revealing major differences in how men and women metabolize drugs, experience side effects, and respond to treatment. For example:
• Sleep medications like Ambien (zolpidem) were later found to stay in women’s systems longer — leading the FDA in 2013 to recommend cutting the women’s dose in half.
• Cardiovascular drugs, pain medications, and antidepressants all showed varying effects depending on s*x and hormone levels.
This meant dosages, safety warnings, and efficacy data could finally be tailored more accurately.
3. Establishment of the NIH Office of Research on Women’s Health
Also in 1993, the NIH Revitalization Act was passed, mandating the inclusion of women and minorities in federally funded research. This led to major oversight reforms and the creation of specific offices to track compliance and promote women’s health research.
4. Gradual cultural and scientific shift
Even though the rule changed in 1993, progress was slow. It took decades for full compliance and for journals, regulators, and research funders to start demanding s*x-disaggregated data.
Today, both the FDA and NIH require s*x as a biological variable to be considered in study design, analysis, and reporting.
5. The long-term impact
• We now know that women experience adverse drug reactions nearly twice as often as men, often because early safety data came from male-dominant studies.
• Including women has improved drug safety, understanding of autoimmune diseases, cardiovascular health, and mental health outcomes — all areas where s*x differences are significant.
