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Corporate Funding Concerns Shut Down Medical School Prof’s Study

Harvard Medical School Quadrangle
Lead investigator Kenneth J. Mukamal is an associate professor at the Medical School.
A Harvard Medical School professor’s study was terminated Friday after the National Institutes of Health found an inappropriate relationship between researchers and alcohol industry representatives.

The NIH report found “early and frequent engagement” between liquor companies, researchers, and employees of the National Institute of Alcohol Abuse and Alcoholism, which “calls into question the impartiality of the process.”

“Interactions among several NIAAA staff and industry representatives appear to intentionally bias the framing of the scientific premise in the direction of demonstrating a beneficial health effect of moderate alcohol consumption,” the report stated.

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Heavily redacted emails included in the report show that researchers extensively contacted alcohol executives and frequently promised positive results in an attempt to secure funding for their project. In one, a researcher referred to the the study staff as “team health benefits of drinking.”

Officially titled the Moderate Alcohol and Cardiovascular Health trial, or MACH 15, the study was led by Kenneth J. Mukamal, an associate professor at the Medical School.

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In an emailed statement, Mukamal wrote that he believes its design was appropriate.

“As investigators, we stand fully and forcefully behind the scientific integrity of the MACH15 trial protocol and team,” he wrote. “We are deeply disappointed that issues raised have led to a recommendation to end the trial.”

“We strongly believe that MACH15 has a critically important scientific premise, rigorous design, and highly-qualified team and represents the best and perhaps only opportunity ever to gain clear answers to these important questions,” Mukamal wrote.

Mukamal based the study at Beth Israel Deaconess Medical Center, where he is a doctor. Jennifer Kritz, a Beth Israel spokesperson, wrote in an email that the hospital takes the NIH’s decision “very seriously” and “will review the report carefully.”

The termination comes after the NIH suspended enrollment in the study last month as it conducted its investigations, prompted by media reports about the researchers’ meetings with alcohol company representatives.

Researchers initially wanted to enroll about 7,800 study participants, who would be randomly assigned to either drink once a day or not at all for six years, according to the MACH 15 study website.

Mukamal and his colleagues pitched the study to alcohol industry groups at high-end hotels, telling them the study “represents a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases,” the New York Times reported in March.

The NIH’s Advisory Committee to the Director published the results of that investigation, Friday. It detailed interactions between industry groups and study organizers, which lasted between September 2013 and February 2015.

The NIH report also identified methodological flaws in the study, such as the study having “not enough patients and not enough follow-up time” to assess both the harms and benefits of alcohol use.

Michael B. Siegel, a professor at the Boston University School of Public Health, wrote in an email that he agreed with the NIH’s decision because the report “reveals numerous serious scientific and ethical breaches that fatally compromise the integrity of the research.”

“The problem is that the principal investigator in this case was not transparent and hid the fact that he was soliciting money from the industry and essentially promising them positive results,” Siegel added.

—Staff writer Luke W. Vrotsos can be reached at luke.vrotsos@thecrimson.com.

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