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BU dissolves Framingham Heart Study spin-off

By David J. Craig

BU announced recently that it will no longer pursue an agreement with Framingham Genomic Medicine, Inc., a venture capital company the University helped launch last year, to analyze data from the long-running Framingham Heart Study for commercial users.

Citing concerns about needing to make Framingham Genomic's analyses "available in a timely manner to the scientific community as a whole," Aram Chobanian, dean and provost of the BU School of Medicine, and Claude Lenfant, director of the National Institutes of Health's National Heart, Lung, and Blood Institute (NHLBI), informed participants of the federally financed Framingham Heart Study, in a letter mailed December 26, that the company will not proceed.

Aram Chobanian. Photo by Vernon Doucette

"The success of the Framingham Heart Study over the past half-century has been based on mutual trust and an abiding commitment to the pursuit of medical and scientific knowledge," Chobanian and Lenfant wrote. They added that "new and complex issues for which there is little precedent" were involved in setting up a for-profit company that would utilize data collected in a publicly funded study.

Framingham Genomic had intended to use state-of-the-art bioinformatics tools, in conjunction with genetic maps, to analyze the study's collection of genetic, clinical, and behavioral data to enable pharmaceutical companies and research laboratories to correlate health problems with specific human genes. The company had raised $21 million in private investment for that purpose.

The heart study, which has spawned several landmark discoveries, such as the link between hypertension and heart disease, was begun in 1948 and has been administered by BU since 1970. Its database contains detailed medical records of 10,000 Framingham residents. The NHLBI has spent more than $40 million to fund the study.

Framingham Genomic had promised that the study's raw data would continue to be available essentially free to academics, while for-profit companies would pay for access to the company's analyses.

BU, which was to hold a 20 percent stake in the company, and the NHLBI had been negotiating details regarding ownership of the enhanced data and privacy protections for patients with Framingham Genomic executives for the past several months. As well, the NHLBI needed to approve the company's business plan.

But company representatives failed to reach an agreement with BU and NHLBI officials, according to Chobanian. One sticking point involved the length of time the new, enhanced data would remain proprietary, he says.

"No definite length of time was determined," says Chobanian, "but it became clear that the [analyzed] data would have to be returned to the original public database fairly quickly, which would reduce the overall value of the new database."

Among other factors leading to BU's decision not to enter an agreement with the company, Chobanian says, were "concerns raised by a few participants of the study about a private company coming in and profiting from the study."

BU and the NHLBI will explore more traditional funding sources, such as grants, contracts, and donations, for implementing the high-tech data analysis that was the objective of Framingham Genomic, according to Chobanian. But without the investment of venture capitalists, he says, it will take much longer.

Chobanian says that "only a modest amount of money" had been spent to launch Framingham Genomic. The remainder of the venture capital raised will be returned to investors.

George Annas, an SPH professor of health law and a medical ethicist, says the inability of Framingham Genomic to come to an agreement with BU and NHLBI might discourage other for-profit companies from trying to refine databases resulting from NIH-funded research.

"I thought the project sounded like a good idea, and I was very supportive of it," Annas says. "Frankly, I thought the ethical issues would be the tough part to work out. And it sounded like [Framingham Genomic] had the ethics pretty well addressed."

17 January 2001
Boston University
Office of University Relations