Following significant backlash from researchers, federal officials announced on Thursday that they would reinstate financial support for the Women’s Health Initiative, which stands as one of the largest and most prolonged studies into women’s health in history.
The insights gained from the W.H.I. and its randomized trials have transformed medical practices, influencing clinical guidelines and helping to avert numerous cases of cardiovascular disease and breast cancer.
“These studies are vital to enhancing our understanding of women’s health,” stated Emily G. Hilliard, a representative for the Department of Health and Human Services.
“We are in the process of fully reinstating funding for these crucial research initiatives,” she remarked. The National Institutes of Health is “deeply dedicated to advancing public health through thorough, top-tier research, and we are taking prompt measures to ensure these studies continue.”
Starting in the 1990s, a time when women were scarcely involved in clinical studies, the W.H.I. enlisted over 160,000 participants nationwide. It is still monitoring approximately 42,000 women, gathering data on cardiovascular health, aging, as well as issues like frailty, eyesight deterioration, and mental well-being.
Researchers aim to utilize this information to gain insights into maintaining mobility and cognitive abilities, detect cancer at earlier stages, and evaluate the risk of various diseases.
The H.H.S. had communicated to the research team leaders that contracts for the W.H.I.’s regional centers would be terminated in September, although the clinical coordinating center at the Fred Hutch Cancer Center in Seattle would continue to receive funding until at least January 2026. By early Thursday evening, investigators had yet to be notified about the restoration of grants.
Senator Patty Murray, a Democrat from Washington, remarked that discontinuing the trial would be “a catastrophic setback for women’s health research.”
Not only did the initiative result in significant progress in women’s health, but “it has also laid the groundwork for a new generation of researchers focused on women’s health, an area that has historically been neglected and underfunded,” Ms. Murray added.
The W.H.I. encompassed several randomized controlled trials and has led to over 2,000 published research papers. It is perhaps most recognized for its hormone replacement therapy study, which was unexpectedly stopped in 2002 after findings indicated that older women taking a combination of estrogen and progestin faced a minor yet significant rise in breast cancer risk.
Until that point, hormone replacement therapy was commonly thought to provide protection against cardiovascular disease. However, the trial discovered that while the hormone mix decreased colorectal cancer and hip fractures, it elevated the risk of heart attacks, strokes, and blood clots.
Dr. JoAnn Manson, a principal investigator of the study and professor at Harvard Medical School and Brigham and Women’s Hospital, described the funding cut announcement as “devastating.”
The initial decision to reduce funding was puzzling to her, especially given statements made by Robert F. Kennedy Jr., the health secretary, highlighting the need to lower chronic diseases in the U.S.
“The W.H.I. exemplifies the scientific achievement of research in chronic disease prevention,” Dr. Manson remarked.
Research has indicated that insights from the hormone study have resulted in substantial reductions in healthcare expenditures — approximately $35 billion between 2003 and 2012, due to the prevention of cancer and cardiovascular disease cases. For every dollar spent on the W.H.I., a savings of $140 was realized.
One randomized trial conducted by the W.H.I. examined the effects of a low-fat diet rich in fruits and vegetables. While the initial results showed a decrease only in ovarian cancer, long-term follow-ups revealed that the diet also lowered breast cancer mortality rates.
Another examination of calcium and vitamin D supplements showed only modest benefits in maintaining bone mass and preventing hip fractures in older women, but did not safeguard against other fractures or colorectal cancer.
These findings have shaped medical guidelines, which currently do not advocate routine supplementation for all women.
Participants in the initiative are now aged between 78 and 108 years, and some researchers acknowledge that there is a case for concluding the trial. Nonetheless, carefully planned procedures are typically followed when closing such a wide-ranging and vast study.
“There’s still so much knowledge we need to acquire,” said Garnet Anderson, senior vice president and head of the public health sciences division at Fred Hutch Cancer Center, and a principal investigator of the initiative.
“No one has thoroughly researched the health requirements of 13,000 women aged over 90: How can they maintain a long and healthy life?” she expressed. “We would be keen to discover the secrets to successful aging.”
The study was launched in the 1990s due to a lack of information and research focusing on women’s health and insufficient data to inform clinical recommendations, according to Marian Neuhouser, who leads the cancer prevention program at Fred Hutch and serves as chair of the W.H.I. steering committee.
“Women make up half the population,” Dr. Neuhouser stated, “but they have historically been underrepresented in research. Most studies focused primarily on men, and the findings were improperly inferred for women.”
