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Enrollment for a Medical School professor’s study was “paused” earlier this month because the project is facing two federal investigations for its relationship with alcohol industry groups.
The study is sponsored by the National Institute on Alcohol Abuse and Alcoholism, part of the National Institutes of Health. The study’s principal investigator, Kenneth J. Mukamal, holds appointments at Beth Israel and Harvard Medical School, where he is an associate professor of medicine. He is also a visiting scientist at the School of Public Health.
The study originally aimed to enroll 7,800 participants, who would be randomly assigned to either have one drink a day or not drink at all for the next six years to study the effects of moderate drinking, according to the study’s website. It sought participants over the age of 50 without a family history of breast cancer.
Mukamal and his colleagues met with alcohol executives multiple times in 2013 and 2014. At one meeting, they said the study presented a “unique opportunity to show that moderate alcohol consumption is safe,” the New York Times reported in March.
The study’s funding sources include five large liquor companies, which channeled funding through the nongovernmental organization, Foundation for the NIH, according to the Times.
The NIH has since launched two reviews of the study—one by its Office of Management Assessment and the other by its Advisory Committee to the Director—and has instructed Beth Israel to “pause all study activities until the reviews are completed,” according to an NIH statement.
Mukamal declined an interview through Jennifer Kritz, a Beth Israel spokesperson, but Kritz provided a statement from the hospital about the study.
“BIDMC has strong policies in place to ensure the scientific and ethical integrity of any research study involving our investigators,” the statement read, adding that multiple boards reviewed the study before it began. “[W]e have not found any reason to believe that it does not adhere to our institutional requirements.”
Eric G. Campbell, a professor of medicine at the University of Colorado who directs the university’s center for bioethics and humanities and recently left Harvard Medical School, said much medical research would not be able to take place without industry support, but identified several “problematic” aspects of the study’s funding and design.
“The solicitation of funding from the alcohol industry appears to have preceded the review of the studies. In other words, they got the money and then went out and had people apply for those studies,” he said.
Campbell added that Mukamal’s statements in advance of the study may have predicted its results in a way that violates fundamental scientific norms.
Results from the NIH’s investigation are expected next month.
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