January 21, 2023

Drug Develoment for Women's Reproductive and Overall Health

Development of new pharmaceutical drug treatments entails basic scientific discovery which is usually conducted in research intensive universities and scientific institutions and then translational studies to determine what discoveries will be useful potential drugs followed by clinical trials and scale up manufacturing strategies.  These steps take time and money and cannot be short circuited. Basic discovery science in the US in reproductive biology is superb and is providing many break-throughs in the understanding of reproductive processes and diseases of the reproductive tracts as well as in greater knowledge regarding the molecular physiology of gestation and parturition. However, this fundamental basic science is vastly underfunded.  The important step of bringing new advances to the clinic which involves translational science and necessary clinical trials in reproductive development and biology is also underfunded as well.  This situation causes two critical roadblocks to the expansion of therapies for men and women with infertility, and reproductive diseases and conditions as well as approaches to ensure healthy pregnancy outcomes for mothers and infants.

Recently Bloomberg (1) reported that of the almost $200 billion spent by pharmaceutical companies only 1% is allocated to women’s health. They cited a report by McKinney and Company (2) that presented this fact in more detail. That report stated that the pharmaceutical companies spent $198 billion on drug development.  Women’s health exclusive of women’s oncological disease was allocated 1% of the $198 billion. 4% of that was allocated to women’s cancers. These percentages included all diseases that affect women of all ages but in looking at the data closely it is apparent that reproductive health concerns receive a very small portion of the 1% allocated for women’s health.  The drug development includes studies to develop novel approaches to treatments as well as clinical phase studies. Women’s health overall is unique as all cells have sex chromosomes and the differences in having XX rather than XY cells impacts disease progression and symptoms. Women do not respond to drugs in the same way as men.  Thoughtful scientists have been pointing this our for many years (3).  It is also true that women’s health is intrinsically tied to reproductive health.  Ovulation, pregnancy and birth and menopause are extremely important aspects of women’s health with big impacts on well-being. We still do not have definitive treatments for disease conditions of women’s reproductive tract such a uterine fibroids and endometriosis. Nor do we have a good approach to chronic pelvic pain. Thus facts plus the obvious truth that women are slightly over 50% of the population provides overwhelming evidence that 1% of $198 billion is far too little investment drug treatment development for women. At a time when maternal mortality in the US is embarrassingly high this is more than a scandal.  There are a perhaps six large pharmaceutical companies world-wide that are increasing their women’s health products and they are apparently expanding their interest. Nevertheless, their actions only increase the amount allocated to women’s health to 2%.  It has been stated by some in the industry that women’s health, especially reproductive health has been neglected is due to the complexity of the conditions affecting women which makes pharmaceutical and venture capital companies reluctant to pour resources into new drug development. However, newer technologies such as RNAseq, the ability to establish organoids, and the ability to query large genetic and protein databases will allow scientists to overcome the complexities holding drug development back. Women contribute a tremendously to making things run- in the home, in professions, in labor, in government, in the military. In short, in all aspects of society.  It would seem to be cost effective to ensure all women have all their health needs met.