Data that helps the health of women
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:
- The landmark 2002 study showing combined hormone therapy (estrogen plus progesterone) was associated with an increased risk of breast cancer, as well as increase in coronary disease, stroke and blood clots. Most of these adverse effects dissipated when the women stopped taking these hormones but the increase in breast cancer and breast cancer mortality persisted over at least 10 years post-trial.
- In 2004, the estrogen-only supplementation trial stopped with WHI researchers showing estrogen-only actually increased risk of stroke while offering no protection for heart disease. The possible reduction in breast cancer seen during the trial became statistically significant in the post-trial era.
- While this finding runs counter to the epidemiologic data, a more careful analyses by Dr. Ross Prentice and presented at the San Antonio Breast Cancer Conference in 2019 as well as biologic evidence from others suggest that timing of estrogen use is key.
- In 2005, the diet modification trial ended showing the low-fat diet did not significantly reduce risk of breast cancer, colorectal cancer or heart disease but longer term follow-up suggests these changes led to lower breast cancer mortality.
- After about 7 years, the calcium and vitamin D trial showed a modest increase in hip bone density and a non-significant reduction in hip fracture but no cancer risk reduction during the trial. Information from post-trial follow-up is anticipated shortly and of particular interest for colorectal cancer.
Biospecimens extend the science
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. Join the next WHI Webinar, March 17, 2021.
“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.”
A big return on investment
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.“