When Health Studies Started Including Women

It wasn’t that long ago.
It wasn’t until the 1980s that women were typically included in medical studies. In 1993, the National Institute for Health Revitalization Act was passed, which required the inclusion of men and women in any clinical research the NIH did.
According to NIH, “During the 1970s, few women worked in either medicine or science, and many women believed that women’s health needs were a low priority in the scientific and medical fields.” The picture slowly changed, partly because of the use of an insufficiently tested drug, thalidomide, a sedative never used in the United States, but, in pregnant women in Europe and Canada, it caused seriously deformed children.
In 1990, the Government Accountability Office investigated NIH’s inclusion of women in studies. They reported, “the policy had been poorly communicated and inconsistently applied.” Finally, in 1991, “Dr. Bernadine Healy became the first female NIH Director and launched the Women’s Health Initiative, a set of clinical trials and an observational study that together enrolled over 150,000 postmenopausal women over 15 years. The trials were designed to test the effects of postmenopausal hormone therapy, diet modification, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer.”
That’s the background. If you want to read more, go to the website, https://orwh.od.nih.gov/toolkit/recruitment/history
Now, the personal story. I was one of those 150,000 women who joined the original study on hormone therapy. That study’s results meant women were no longer prescribed hormones after menopause.
After the study was completed, those who participated were contacted from time to time, sometimes asking us to respond to questions about our health. Usually, that was once a year. In addition, we were asked if we wanted to take part in additional studies. The WHI developed a program called Women’s Health Initiative Strong & Healthy, or WHISH for short. WHISH educates and encourages us in how to be healthy. Brightly colored pamphlets talk about fall prevention, balance, exercises to add strength and flexibility, and healthy eating. At one time, they sent me a device to wear that would count my steps. My goal was 10,000 steps a day. I’ve changed that over the years, but it has served as a constant reminder to keep moving. You can get information at the website, whish.org.
One of the studies I agreed to take part in is called COSMOS, or Cocoa Supplement and Multivitamin Outcomes Study. Brigham and Women’s Hospital, part of the Harvard Medical School, is conducting the study in partnership with many other medical institutions across the country. The subject population was US women 65 and older and men 60 years and older free of cardiovascular disease and no cancer diagnosis in the last two years.
The purpose of the study, from the consent form which I signed in 2014 is, “to find out whether taking daily, dietary supplements of cocoa extract and/or a standard common multivitamin reduces the risk of developing heart disease, stroke, cancer, and death.” While I can’t find the quote now, some material also refers to finding out if the above supplement helps cognition skills.
I will finish taking the pills at the end of February, two days from now. In the intervening years, I’ve been tested. Each January, I’ve had a 45-minute telephone interview. They always gave me ten everyday words at the beginning, then asked me to repeat the words. The person questioning me then went on to other tests, but a few times came back to those original ten words to see how many of them I remembered.
I also had an online appointment with different questions for about an hour. For example, they’d show maybe five little alien-type figures in a certain pattern for 15 seconds and then ask me to show them in the same pattern.
I’ve always wanted to know how I did compared to other participants and to myself, over the years. I’m not sure I ever will know, but I should find out soon if I was taking a placebo or not. Eventually, I will know what researchers learned from the study, and whether this product will make a difference in the lives of older people or not.
Women’s History Month is March. I’ve been involved with WHI for about 30 years. When I started, my daughter-in-law said, “Thank you.” All the information gathered has already made a difference in the lives of many. I think that will continue. What a difference since the early 70s!





