[Congressional Record Volume 161, Number 130 (Thursday, September 10, 2015)]
[Senate]
[Pages S6602-S6603]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




RECOGNIZING THE 25TH ANNIVERSARY OF NIH'S OFFICE OF RESEARCH ON WOMEN'S 
                                 HEALTH

  Ms. MIKULSKI. Mr. President, I rise today to commemorate the 25th 
anniversary of the NIH's Office of Research on Women's Health, which 
was established on September 10, 1990, to end gender bias in medical 
research.
  It is hard to believe that 25 years ago, women were not included in 
protocols at the NIH. Faux science said that our reproductive systems 
got in the way or that we had ``raging hormones.''
  I was here 25 years ago, as a young Senator representing the great 
State of Maryland. I remember this big ``landmark'' study coming out. 
It showed that aspirin could help prevent heart attacks and save lives. 
Everyone was so excited. A relatively cheap and widely available 
medication that could improve cardiovascular health--this was a huge 
discovery.
  But then we looked closer at the study, and what did we find? We 
found that the study tested the effects of aspirin on more than 22,000 
men, but zero women. Zero women. This big, landmark study enrolled only 
men. How could that be? So we took a closer look, and we found that 
this study--and the exclusion of women from clinical trials--was not an 
aberration. We found that prior to 1989 clinical trials of new drugs 
were routinely conducted predominantly on men, even though women 
consume approximately 80 percent of pharmaceuticals in the United 
States and make up half the population. To add fuel to the fire, a 1992 
report by the U.S. General Accounting Office found that less than half 
of prescription drugs on the market had been analyzed for gender-
related response differences.
  So what we had was a system where medical research was done based on 
male-only clinical trials, which led to the development of diagnoses, 
preventive measures, and treatments that were commonly used in women, 
despite never having been studied on women. As you might imagine, this 
didn't sit well with the women in Congress. It certainly didn't sit 
well with me.
  At that time--in 1990--a lot was going on. George Bush the elder was 
in the White House. The gulf war was about to begin. The Hubble Space 
Telescope had just been launched. We didn't have a confirmed NIH 
Director, and the Human Genome Project had just begun.
  There was a lot going on in the world. But the women of Congress knew 
that we had a real problem to solve. At the time, the Congressional 
Caucus for Women's Issues was comprised of myself and then-
Representatives Pat Schroeder, Olympia Snowe, Connie Morella, and many 
others. On Aug. 22, 1990, Pat, Olympia, Connie, and I sent a landmark 
letter to the Acting Director of NIH, Dr. William Raub, requesting a 
public meeting to discuss how best to improve Federal research on 
women's health. We wanted all the key health people there: all 12 NIH 
Institute Directors, then-HHS Secretary Louis Sullivan, then-Surgeon 
General Antonia Novello, and the beloved Dr. Ruth Kirschstein.
  Let me speak a moment about Dr. Ruth Kirschstein, a woman who 
provided direction and leadership to NIH through much of the second 
half of the 20th century. She was a daughter of immigrant parents. She 
weathered disgraceful prejudice and stereotyping of women and Jews. But 
that didn't stop her. Thanks to hard work and perseverance, she went on 
to become a key player in the development of the polio vaccine, the 
first woman Director of a major Institute at NIH, and a lifelong 
champion of the importance of basic biomedical research and training 
programs that provided opportunity to all talented students. The 
contributions made by Dr. Ruth Kirschstein to the NIH, to women's 
health, and to better health for all are invaluable.
  But back to September 1990. On Sept. 10, 1990, the women of Congress 
got our meeting. We drove out to the NIH's Bethesda campus--Connie 
Morella, Olympia Snowe, Pat Schroeder, and Barb all showed up. So did 
Time magazine and the TV cameras.
  And what do you know. President Bush announced Dr. Bernadine Healy as 
the first female Director of the NIH. Dr. Healy was a friend, a 
colleague, and an adviser. She was a gifted physician and a brilliant 
researcher and administrator. She was also a very special advocate for 
women. She was deeply committed to the advancement of women in science 
and biomedical research.
  It is hard to believe that meeting at NIH happened 25 years ago 
today. And it marked the official establishment of the NIH's Office of 
Research on Women's Health.
  The NIH Office of Research on Women's Health was established to do 
three things: ensure that women are included in NIH-funded clinical 
research; set research priorities to address gaps in scientific 
knowledge; and promote biomedical research careers for women.
  Under Dr. Healy, the NIH's Office of Research on Women's Health 
really came alive. She appointed Dr. Vivian Pinn as its first Director. 
And today the Office works in partnership with NIH's Institutes and 
Centers to ensure that women's health research is part of the 
scientific framework at NIH and throughout the scientific community. I 
am so proud of what they have accomplished over the past 25 years.
  Thanks to the Office of Research on Women's Health, the Women's 
Health

[[Page S6603]]

Initiative was conducted. I remember when Dr. Healy came to me with the 
idea for this study. She needed money to get a study underway looking 
at post-menopausal hormone therapy. I was so proud to work on the 
Appropriations Committee to get Dr. Healy and NIH the money they 
needed. I worked hand-in-hand with Senators Kennedy, Harkin, and 
Specter.
  The Women's Health Initiative had groundbreaking findings that led to 
big changes in hormone replacement treatment protocols. As a result, we 
have seen significant reductions in breast cancer rates. We have 
reduced the incidence of breast cancer by 10,000 to 15,000 cases per 
year. Just think, this study alone--the brainchild of Dr. Healy--has 
helped save 375,000 lives over the past 25 years.
  But the Office of Research on Women's Health has done so much more. 
Today, more than half of participants in NIH-funded clinical trials are 
women. The office worked with the National Cancer Institute to develop 
a vaccine that prevents the transmission of Human Papilloma Virus, HPV, 
resulting in fewer cervical cancer cases. The office worked with the 
National Institute of Allergy and Infectious Diseases on a landmark 
study which showed that giving the drug AZT to certain HIV-infected 
women reduced risk of mother-to-child transmission of HIV by two-
thirds. The office has supported major advances in knowledge about 
genetic risk for breast cancer and discovery of BRCA1 and BRCA2 genetic 
risk markers. The office codirects the NIH Working Group on Women in 
Biomedical Careers, which develops and evaluates policies to promote 
recruitment, retention, and sustained advancement of women scientists.
  We have come so far over the past 25 years, but we still have a long 
way to go. There remain striking gender differences in many diseases 
and conditions, including autoimmune diseases, cancer, cardiovascular 
diseases, depression and brain disorders, Alzheimer's disease, 
diabetes, and addictive disorders. We still don't have enough 
information on the involvement of women in clinical research and 
trials. We still don't have reliable data on how drugs currently on the 
market affect women differently than men. And still to this day, women 
are often prescribed dosages devised for men's average weights and 
metabolisms.
  As you can see, there remains work to be done. But that doesn't mean 
we can't take a moment to commemorate how far we have come over the 
past quarter century. I am immensely proud of the work done by the 
NIH's Office of Research on Women's Health and all those who have 
worked day-in and day-out to end gender bias in medical research, 
including Dr. Ruth Kirschstein, Dr. Bernadine Healy, Dr. Vivian Pinn, 
and Dr. Janine Clayton, current Director of the office. I very much 
look forward to what the next 25 years will bring. Thank you.

                          ____________________