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Published On January 15, 2014

CLINICAL RESEARCH

In Framingham, Deep Cuts

Sharply pared budgets could kill the Framingham Heart Study—after 50 years of astonishing research breakthroughs.

In 1948 the Framingham Heart Study began monitoring the health of 5,209 people in one Massachusetts town, and the addition of second and third generations swelled those numbers to almost 15,000. The observations and data FHS has produced are credited with helping reverse an epidemic of heart disease and ushering in an era of preventive care. More recent work has probed for links between genetic variations and everything from blood pressure and cholesterol levels to heart attacks and stroke, as Proto reported in “One Town’s Treasure” (Winter 2008).

The pace of those discoveries is likely to slow now that the hallmark clinical exams that Framingham investigators conducted on participants every two years for the past 65 years will cease. As a result of the federal government’s automatic spending cuts, the National Heart, Lung, and Blood Institute (NHLBI) cut Framingham’s 2013 operating budget by 40%, or $4 million. In addition, when FHS’s contract expires in 2015, it is slated to be renewed for only two or three years.

Framingham investigators will continue to follow participants, but in lieu of physical exams, it will survey participants’ health status by phone or letter and mine Medicare hospital records and death certificates for clinical data. Physicals had been “the lifeblood of the study,” says Philip Wolf, who joined FHS in 1967 as a stroke researcher and recently stepped down as its principal investigator. “We measure participants’ coronary calcium levels and vascular stiffness to predict disease, we do MRI scans of the brain, and we were going to start measuring the microbiome. You can’t do those tests by e-mail or get such data from a death certificate.”

Still, forcing Framingham to adapt to a different research structure won’t harm its scientific value, suggests Michael Lauer, director of the division of cardiovascular sciences at NHLBI. “We’ve paused exams a number of times before in other epidemiological studies and it hasn’t jeopardized their scientific value,” he says.

There is concern among FHS investigators that this change is part of a larger trend that could make the personal interactions of its epidemiological model obsolete. The NIH is spending $100 million on the Big Data to Knowledge project, for example, to figure out how to collect research to draw conclusions from the analysis of huge pools of data. “This gives us an opportunity to make epidemiological studies bigger and better by collecting even more detailed genomic, epigenetic or metabolomic data,” says Lauer. But Wolf argues against moving too quickly. “Before closing down prospective epidemiological studies, we should see whether Big Data can reach the same conclusions our studies can.”

FHS has operated under the auspices of Boston University since 1971, and the study is now working through the university’s development office to raise money from private sources. “There is no intention for the study to end,” says Lauer. “Our goal is to figure out how to strengthen all the epidemiology studies that NHLBI supports, and we have no choice but to do it less expensively.”