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Mike Leavitt

The heart study beats on

Email|Print|Single Page| Text size + By Mike Leavitt
November 27, 2007

SIXTY YEARS ago, Americans smoked, drank, and ate too much of the wrong things - then died of heart disease and stroke at higher and higher rates. The town of Framingham turned things around with the help of researchers backed by the National Institutes of Health. The Framingham Heart Study exceeded expectations and changed the way many Americans live. As Framingham residents gather to celebrate their success on Thursday, the study is once again leading researchers into a new era of more personalized, genetically based healthcare.

The study began in September 1948, when 5,000 Framingham residents volunteered to let researchers study their lifestyles and track their health histories over the coming years.

In time, Framingham researchers had invented the term "risk factors" to describe the links they found between, for example, cardiovascular disease and smoking, high blood pressure, and elevated cholesterol. These risk factors eventually became household words, and since the mid-1960s the death rate from cardiovascular disease has declined more than 60 percent.

The study is still going strong, entering its 60th year and taking on its third generation of participants. More than 14,000 Framingham-area residents have taken part, with about 9,000 participating now.

All living participants have been invited to Thursday's event. With the study's current sponsor the National Heart, Lung and Blood Institute of the National Institutes of Health as well as others involved in the study, which is carried out by Boston University's School of Medicine, we will celebrate the study's historic success.We will also look to the future because the Framingham Heart Study is once again at the forefront of medical research.

Last month, Framingham became one of several research projects in which participants' clinical records have been paired with their genetic data to help researchers learn more about the associations between genetic factors and health.

Results of new genetic research have begun appearing in medical journals. But we have only just begun to understand the part that genetics play in health.

We need extensive and reliable clinical information from large numbers of people if we are to understand the genetic role and use it effectively. The data from the Framingham Study is unusually rich and deep. It promises to make a significant contribution to a future in which genetic medicine helps us predict, prevent, preempt, and cure disease.

In addition, the Framingham data has been made available to qualified researchers all over the world, in order to accelerate discovery. This release of information has been done not only with the usual stripping of personal identifiers, to ensure patient privacy, but also with the full participation and informed consent that has always marked the Framingham study.

In the years ahead, the availability of electronic health data will allow researchers to draw useful information from millions of patient encounters. This observational data, stripped of identifiers, should enable us to detect patterns and establish linkages, just as the Framingham study did - and continues to do.

But while Framingham was limited to learning from its research participants, broad-scale health information technology should let us learn from daily clinical practice all over the country. It will enable us to identify much more quickly which drugs or treatments are most effective, which may be ineffective or undesirable, and for whom. We should also then be able to target therapies much more precisely for patients.

Significant challenges remain. We need to protect the security and privacy of patient information. And we need common standards and nomenclatures to enable us to aggregate data from thousands of different settings and draw meaningful conclusions. In many of these areas, Framingham will have developed helpful approaches.

Doctors have always learned from their patients. But seldom has this been more dramatically or systematically illustrated than in Framingham. We are looking toward further advances in personalized healthcare that are much more effective for each patient, because of new genetic data to steer treatments, because of the information capacities of health IT, and because of much better use of experience and evidence in healthcare.

This is a hopeful future that will take years to achieve, as well as new levels of collaboration in our medical research and healthcare delivery sectors. It will take, so to speak, a nation of Framinghams.

The straightforward research roots of the Framingham Heart Study, the respect and care of its researchers, and the spirit of ownership and altruism among the Framingham participants provide us a solid example to follow in the way forward.

Mike Leavitt is the US secretary of health and human services.

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