It started in 1992 with over $600 million worth of National Institutes of Health funding, 40 research centers, 161,000-plus study participants and big plans. Nearly 30 years later, the Women’s Health Initiative is still going strong with over 60,000 actively involved participants — some centenarians — and an economic return estimated at over $37 billion.
Launched by the first (and lone) female NIH director, Dr. Bernadine Healy, the WHI was designed to study the effects of specific prevention strategies on major causes of death and disability in women after menopause. Ambitious, comprehensive, and collaborative, the WHI’s goal was to fill the large gaps in our public health knowledge about women, specifically with regard to heart disease, cancer, and osteoporosis. Trials were designed to answer key questions: Did the use of hormone replacement, supplements like calcium and vitamin D and a low-fat diet with veggies, fruits and grains help or hinder?
Men had been participants in clinical trials since their inception in 1747, but willing women weren’t actively recruited in many trials until around 1993. As Dr. Lesley Tinker, a WHI investigator with Fred Hutchinson Cancer Research Center, reiterated in an interview, the WHI needed women to be ”part of the answer.”
They were then, and remain so today, with a $72 million extension of the WHI grant from the NIH’s National Heart, Lung, and Blood Institute. Fred Hutch houses the WHI’s clinical coordinating center, which handles collection, management and analysis of the WHI data. Dr. Garnet Anderson, director of Public Health Sciences division, is the principal investigator. This new funding will support the WHI’s coordinating center through the end of 2028.
“The WHI has been remarkably productive in pursuing a broad range of scientific questions important to women,” said Anderson. “With the completion of the first trials, the NIH recognized how incredibly valuable this effort is, not just for what we learned with the original trials but what has yet to be learned through our ongoing long-term follow-up and through our hundreds of ancillary studies. We are thrilled with this new extension and are so appreciative of the participants’ contributions to this great effort and the continued support of our terrific staff.”
Participants are equally enthusiastic about the longstanding study.
“WHI is very important to me,” wrote Ruth, a 25-year participant, via the study’s newly revamped website. “It gives me a sense of participation and of contributing to the health of women.”
Today, the 40 research centers have been streamlined to four regional centers; the initial set of clinical trials and the single observational study have been supplemented by hundreds of ancillary studies that tap into the WHI’s vast data and biorepositories. The longer the follow-up of the women, the more knowledge is gained — and gleaned. Learn more about the WHI through their new monthly webinars.
So far, WHI data has been used in over 2,000 scientific papers and the WHI continues to provide solid, evidenced-based advice to help women maintain better health and quality of life as they age. A few of WHI’s key findings over the decades include:
Data from the WHI biorepository is also being used in several large NCI-funded collaborations aimed at paving the way for precision medicine and improving health equity. Drs. Riki Peters, Amanda Phipps and others at the Hutch, for instance, are currently using WHI’s tumor specimens to do everything from create better polygenic risk scores to assess T-cell response in colorectal cancers.
Over 550 ancillary studies have been approved by the WHI; nearly half have been funded. This latest extension will allow for additional ancillary studies and support the WHI’s ongoing research.
“WHI is currently supporting two newer randomized trials,” Anderson said. “One is on physical activity in older women [the WHISH trial], led locally by Dr. Charles Kooperberg, and another is on multi-vitamins and cocoa extract supplements [COSMOS]. There are also several large-scale observational studies including one looking at sleep [WHISPER] and its relationship to cardiovascular disease, cancer and cognitive function. Two of my colleagues, Drs. Bette Caan and Electra Paskett, and I also lead a study on cancer survivorship [LILAC], looking at the challenges and issues that cancer survivors face in their older years. Our women, our participants, are between 72 and 103, and we are interested in the unique challenges they face.”
WHI participants stay informed through an annual newsletter — a monthly webinar has been recently added, as well — and many continue to send in photographs and notes of appreciation for the program. Listen to the most recent WHI Webinar.
“I’m a very healthy 76-year-young woman that started with WHI in the very beginning,” wrote Deena, another 25-year participant. “I am over-the-top happy that the findings of WHI, which will help … millions of other women make decisions regarding their health, findings that were unavailable to me and my generation.”
The WHI studies haven’t just changed women’s health, they’ve saved untold suffering and billions of dollars in medical costs.
An economic analysis of the benefits of just one study, WHI’s hormone replacement trial, showed the drop in use of combined hormone therapy resulted in a net economic return of over $37 billion, with 76,000 fewer cases of cardiovascular disease and 126,000 fewer breast cancer cases.
“When the 2002 study of estrogen plus progestin came out, many women quickly responded to this new information,” Anderson said. “Combined hormone use reduced by 50 percent within a year and breast cancer rates went down for the first time in history. The cost of that trial was around $212 million. It was an expensive enterprise for sure but it was clearly a good one. We estimated it provided nearly 150-fold return on investment with the savings in medical care costs that ensued.”
The Hutch’s WHI center and its many investigators will continue to coordinate and analyze data from trials and ancillary studies. Tinker said the COSMOS cocoa study ended its intervention in December 2020 with results expected by late 2021.
The LILAC cohort, designed to study aging issues in WHI cancer survivors, will run for another four years. The new funding will allow an in-person follow up visit in a subset of study participants, some of whom are in their 100s.
Out of the 161,000 women originally enrolled in the WHI’s longstanding observational trial, more than 60,000 are still alive and continue to provide regular health updates.
“WHI participants are hungry for reliable information and we want to be a trustworthy source,” Anderson said. “We also want to give them the opportunity to be more engaged in this research.”
A large celebratory meeting planned for May of last year was cancelled due to COVID-19, Anderson said.
“To reach our participants now, many of whom have been isolated for months, we have launched a monthly webinar series, featuring NIH leaders, WHI investigators, staff and participants,” she added. “The study participants who helped with this effort were delighted to get involved.”
For them, WHI is a gift that keeps giving back.
“I’ve learned so much from the WHI about exercise and diet and nutrition,” said Shirley Brooks-Jones, 84, in WHI’s first February webinar. “A lot of people have no idea that this research has been going on for so long. I’m very, very grateful to have had the opportunity to be part of it — and really appreciate the continuing efforts. I hope they’ll continue with the excellent work they’ve been doing.“
Diane Mapes is a staff writer at Fred Hutchinson Cancer Research Center. She has written extensively about health issues for NBC News, TODAY, CNN, MSN, Seattle Magazine and other publications. A breast cancer survivor, she blogs at doublewhammied.com and tweets @double_whammied. Email her at firstname.lastname@example.org.