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Budget Woes Threaten Long-Term Heart Studies

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Science  16 Aug 2013:
Vol. 341, Issue 6147, pp. 701
DOI: 10.1126/science.341.6147.701
On hold.

The Framingham Heart Study has included clinical exams for decades (a 1952 one, below), but future ones are at risk.

TABLE SOURCE: NHLBI/P. SORLIE AND G. WEI, JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 58, 19 (2011); PHOTO CREDIT: ASSOCIATED PRESS

For more than 6 decades, thousands of residents of Framingham, Massachusetts, have reported every few years to a research clinic, where they undergo a detailed physical exam that now includes electrocardiograms, measures of lung and cognitive function, and the collection of blood and urine samples. The Framingham Heart Study (FHS) is an icon of epidemiology. Its long-term monitoring of a large group, or cohort, has yielded landmark results on everything from the link between cholesterol and heart disease to the genetic risk of stroke. But this year, those exams will be scaled back, and plans for new tests put on hold. Other cohort studies sponsored by the National Heart, Lung, and Blood Institute (NHLBI) are confronting a similar fate.

The immediate culprit is this year's across-the-board federal budget cuts known as the sequester, which trimmed 5%, or $1.55 billion, from the National Institutes of Health (NIH). To preserve investigator-initiated grants and clinical trials, NHLBI is slashing $4 million, or 40%, from the 2013 contract that supports the FHS's core operations. "We have to make cuts," explains Michael Lauer, director of the NHLBI Division of Cardiovascular Sciences. "There are other [cohort studies] that are being affected even more severely," he adds, declining to identify them because of ongoing contract negotiations.

The squeeze on cohort studies is set to continue. NHLBI has already decided to suspend exams scheduled to start 2 years from now at FHS and another study, the Multi-Ethnic Study of Atherosclerosis (MESA). Some observers say NHLBI's plans signal that the era of such large, costly long-term studies is drawing to a close.

In response to this year's cut, FHS plans to lay off 19 of 90 staffers as well as scale back clinical exams and laboratory work. Calling the exams "the lifeblood of the study," FHS principal investigator Philip Wolf of Boston University told Science that he is concerned that the study's scientific productivity will decline if investigators can no longer collect the same wealth of data. He also worries that participants will drop out of the study if not routinely brought in for exams. "We've had amazing subject retention over the decades. It obviously has to have a deleterious effect," he says.

Lauer says that NHLBI has no plans to shut FHS altogether. "We have every intention of maintaining and preserving this investment." The Framingham effort has survived money woes before, turning to private funding in 1970 when NIH slashed its budget, and its supporters say they will seek such help again now. But NHLBI's longer term plans for it and other cohort studies worry some epidemiologists.

NHLBI now spends $160 million of its $3 billion budget on epidemiology research, including cohort studies (see table). The institute began scrutinizing these studies 2 years ago, asking whether there are cheaper ways to do the research, for example, by using electronic medical records and Internet surveys of participants instead of costly in-person exams. At a June meeting of the institute's advisory council, NHLBI officials announced that the next contracts for Framingham and MESA, which start in 2015, will run for just a few years, instead of the usual 7 years. And a new working group will look for ways to make these studies more efficient "during this time of big data and small budgets," Lauer says.

Such studies can be scaled back without long-term harm, he adds. One large cohort study, Atherosclerosis Risk in Communities (ARIC), went for 10 years from 1999 to 2009 without conducting exams, yet suffered no apparent loss in participation, Lauer notes. "We've been down this road before and we've seen that it's possible to do this and support terrific science," he says.

But other epidemiologists argue that there's no substitute for in-person exams. "Some things could be done more cheaply; for others you need trained staff doing things in a standardized way," says David Couper of the University of North Carolina, Chapel Hill, one of ARIC's principal investigators. "If all you know is that someone had a heart attack, you lose a chance to better understand disease etiology and potentially new prevention strategies," says Gregory Burke of the Wake Forest School of Medicine in Winston-Salem, North Carolina, a MESA investigator.

Offering a possible model for lower-cost, large cohort research, the University of California, San Francisco (UCSF), has launched a new study called Health eHeart that aims to enroll up to a million people over the Internet and have them use technologies such as a wireless cuff linked to a smart phone to relay blood pressure data. Yet even one of its organizers, UCSF's Mark Pletcher, acknowledges that "the jury's still out on" how well such measures can substitute for in-person exams.

Bruce Psaty of the University of Washington, Seattle, a member of the working group on cohort studies, says he hopes some direct exams will be preserved in NHLBI's efforts. But in the end, he adds, Framingham's troubles are just one sign of something bigger: They are "a poster child for the larger problem of the erosion of funding for biomedical research," he says.

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