Major women's health study paid big dividends

May 5, 2014 by Barbara Bronson Gray, Healthday Reporter
Major women's health study paid big dividends
Scientists say HRT research has returned $140 for every $1 spent on the $260 million trial.

(HealthDay)— A comprehensive look at the decade-old "estrogen study"—the U.S. government-sponsored trial that turned the tables on assumptions about hormone replacement therapy—suggests there can be a billion-dollar upside to the millions spent on research.

The research, published May 6 in the Annals of Internal Medicine, shows the public has received a high return on its tax-funded investment in the Women's Health Initiative (WHI).

"Everything we do in medicine comes with a level of uncertainty," said Dr. Scott Ramsey, the study's lead author and director of the Hutchinson Institute for Cancer Outcomes Research, in Seattle. "The question is whether it's worth the investment in research to be sure we're not making a mistake."

The results of his research, he said, showed that, even though the WHI cost $260 million, the net economic return was $37 billion, or $140 for every dollar spent on the trial.

"Even if we only focus on medical care costs, the study saved $27 billion, a huge savings and, I think, quite a conservative estimate because we didn't assume all the decline in was due to the study," said Ramsey.

Before the WHI study, almost 6 million menopausal American women took a pill called combined , which paired the hormones estrogen and progestin, to reduce hot flashes and cut their risk of and the bone-thinning disease osteoporosis.

But the WHI's Estrogen Plus Progestin clinical trial, a huge, randomized and controlled trial, which is considered the gold standard for research, produced shocking results. Rather than cutting the risk of serious disease, combined hormone-replacement therapy (HRT) actually increased the chances women would develop cardiovascular disease, blood clots and breast cancer, according to the evidence produced by the study. The trial was stopped in 2002, after investigators found that the associated risks of HRT outweighed the benefits.

As a result of the $260 million research, funded by the U.S. National Institutes of Health, many physicians stopped prescribing combined hormone therapy. Hormone use among menopausal women decreased almost immediately by about 50 percent and continued to decline by 5 percent to 10 percent each year, according to the researchers.

In the years following the drastic drop in hormone use, the number of cases of breast cancer, cardiovascular disease and blood clots declined significantly.

The latest research shows that 10 years after the WHI study was widely disseminated, there were 126,000 fewer cases of , 76,000 fewer cases of cardiovascular disease, and 80,000 fewer cases of (in larger veins or lungs) than there were before the drop in HRT use.

On the other hand, the study also shows that hormone therapy may have played a role in preventing bone problems and colon cancer: The researchers found that there were 263,000 more fractures associated with bone weakening and 15,000 more cases of colorectal cancer after HRT use decreased.

For the new study, the research team used a statistical "disease-simulation model" that looked at HRT use after the WHI study was published and compared that with the expected use of hormone replacement therapy had the study not been done (if physicians had continued prescribing the pills as they had been doing). They then analyzed cost and health issues.

To understand the impact of the study on health finance, they gathered all the costs of treatments, side effects and loss of life, and subtracted those numbers from the cost of the study itself. Data was gathered up to 2012.

Comprehensive studies like the WHI are necessary to fully understand the unintended consequences of some medications, procedures and surgeries, Ramsey noted.

"This is a classic example of the potential long-term impact of drugs. We're lucky this study happened. There was controversy within the National Institutes of Health [the study's funders]; some people were really opposed to it. There is a role for big science, big studies like this, when there are big questions," he added.

Many people don't think of research as an investment, or they consider it to be something like choosing a Silicon Valley start-up to support, said Dr. Michael Lauer, who wrote an editorial accompanying the research and is director of the division of cardiovascular sciences at the U.S. National Heart, Lung, and Blood Institute. But with limited federal funds, decisions about what to support can be a roll of the dice, he explained.

"Can we go too far demanding return on investment? Like any good investor, it's important for us to develop a diverse portfolio," Lauer said. "But this paper shows that investment has paid off very nicely."

Despite the success of the WHI and the demand to fund complex studies, Lauer isn't optimistic that $260 million trials will continue to be funded in today's economic climate. His hope is that advances in technology will make it easier to do large-scale clinical trials at lower cost, perhaps tapping vast amounts of Medicare data, he suggested.

Lauer said the study also taught medicine and science a lesson. "The study reminds us of the need to show humility when approaching scientific questions, and the need to do things right and rigorously."

Explore further: For women with hysterectomies, estrogen may be a lifesaver after all

More information: Learn more about hormone replacement therapy from the U.S. National Library of Medicine.

Related Stories

For women with hysterectomies, estrogen may be a lifesaver after all

July 18, 2013
The widespread rejection of estrogen therapy after the 2002 Women's Health Initiative (WHI) study has most likely led to almost 50,000 unnecessary deaths over the last 10 years among women aged 50 to 69 who have had a hysterectomy, ...

Women should still be concerned about hormone replacement therapy, researchers say

December 21, 2011
McMaster University researchers have found consistent evidence that use of hormone replacement therapy (HRT) is associated with breast cancer globally. This study comes at a time when more women are again asking for this ...

Estrogen plus progestin use linked with increased breast cancer incidence and mortality

March 29, 2013
Estrogen plus progestin use is linked with increased breast cancer incidence. In addition, prognosis is similar for both users and nonusers of combined hormone therapy, suggesting that mortality from breast cancer may be ...

Menopausal hormone therapy and breast cancer risk

March 15, 2012
In the past decade, results from large prospective cohort studies and the Women's Health Initiative (WHI) randomized placebo-controlled hormone therapy trials have substantially changed thoughts about how estrogen alone and ...

Recommended for you

Who uses phone apps to track sleep habits? Mostly the healthy and wealthy in US

January 16, 2018
The profile of most Americans who use popular mobile phone apps that track sleep habits is that they are relatively affluent, claim to eat well, and say they are in good health, even if some of them tend to smoke.

Improvements in mortality rates are slowed by rise in obesity in the United States

January 15, 2018
With countless medical advances and efforts to curb smoking, one might expect that life expectancy in the United States would improve. Yet according to recent studies, there's been a reduction in the rate of improvement in ...

Teens likely to crave junk food after watching TV ads

January 15, 2018
Teenagers who watch more than three hours of commercial TV a day are more likely to eat hundreds of extra junk food snacks, according to a report by Cancer Research UK.

Can muesli help against arthritis?

January 15, 2018
It is well known that healthy eating increases a general sense of wellbeing. Researchers at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) have now discovered that a fibre-rich diet can have a positive influence ...

Your dishwasher is not as sterile as you think

January 13, 2018
(HealthDay)—Your dishwasher may get those plates spotless, but it is also probably teeming with bacteria and fungus, a new study suggests.

Study reveals what sleep talkers have to say

January 12, 2018
A team of researchers with members from several institutions in France has conducted a study regarding sleep talking and has found that most sleep talking is not only negative in nature, but involves a large amount of swearing. ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.