Re-posted from the Ladibug substack
I’m sure you’ve often seen harrowing headlines about the dire state of women’s health - “women spend 25% more of their time in poorer health than men”, “the women’s health gap equates to 75 million years of life lost due to poor health or early death” or my personal favourite “male baldness received 5x more funding than endometriosis” but have you ever actually wondered why is it, do women tend to have worse health outcomes?
It is because women have been poorly represented in clinical trials, which in turn means we have a shortage of data on how drugs affect women. Let me explain.
Before drugs (and their recommended doses) are sold on the market, they have to go through clinical trials. Historically, women have been excluded from clinical trials because of the biological ‘complexity’ of our hormonal cycle and the fear of harming reproductive health. But in 1977, the FDA solidified this issue by excluding women of reproductive potential from Phase 1 and Phase 2 trials. This was in response to a 1962 tragedy, where a medication used for morning sickness killed or caused birth defects in more than 10,000 babies in Australia and Europe. However, this policy was interpreted broadly, to pretty much exclude nearly ALL premenopausal women, not just women in reproductive years.
It wasn’t until 1993 that the U.S. Congress passed a law requiring the inclusion of women in clinical research. However, decades of underrepresentation had already caused significant harm. Diagnostic criteria and medication dosages for common conditions had been developed largely without considering women. This oversight led to a range of issues—for example, women taking digoxin, a medication for heart failure, faced a 23% higher risk of death. Similarly, women using Ambien, a common sleep aid, experienced severe morning drowsiness because they metabolize the drug more slowly than men.
While improvements have been made, as of 2019, women still only accounted for 40% of participants in clinical trials for three diseases that affect them more (cancer, cardiovascular disease and psychiatric disorders). The data vacuum in women’s health remains, undoubtedly, the largest obstacle in advancing women’s health. And this is why it is difficult to decipher what over the counter products actually work, because there is not enough data to substantiate its effectiveness.
However, this data shortage has not gone unnoticed and meaningful improvements have been made in recent years. It is important to continue making progress towards a more inclusive and accurate medical science!