The National Institutes of Health has ordered a halt to a $100 million, 10-year study of moderate drinking that’s being funded in large part by the alcoholic beverage industry.
Thursday morning’s announcement by NIH Director Francis Collins reflects the seriousness of allegations that surfaced in news reports in recent months, including a story in March in the New York Times that described two scientists and a federal health official pitching the idea for the study to liquor company executives at a 2014 gathering in Palm Beach, Fla.
The alcohol industry agreed to fund the research via a private foundation that supports NIH. The goal of the study, which involves 7,000 individuals, is to assess whether moderate drinking — a single drink a day — has a health benefit. Some research has suggested such a benefit, but the conclusion remains controversial, and the U.S. dietary guidelines recommend that people who do not drink alcohol should not start.
The Moderate Alcohol and Cardiovascular (MACH) trial is based at Harvard’s Beth Israel Deaconess Medical Center, a grantee of the National Institute on Alcohol Abuse and Alcoholism. Two reviews of the clinical trial are underway at NIH. The first, by the Office of Management Assessment, will look at any possible irregularities in the grant process. The second, by an advisory committee to Collins, will examine the scientific merit of the study.
“NIH has requested that the grantee, Beth Israel Deaconess Medical Center, pause all study activities until the reviews are completed,” NIH said in a brief announcement that gave no further details on the reasons for the pause. NIH said Thursday that the reviews are expected to be concluded in June.
Beth Israel has policies to ensure the scientific and ethical integrity of research, medical center spokeswoman Jennifer Kritz said in a statement soon after NIH revealed its decision. Kritz added that Beth Israel has conducted its own review of the MACH trial “and we have not found any reason to believe that it does not adhere to our institutional requirements.”
Collins testified in a Senate subcommittee hearing Thursday and revealed that enrollments in the moderate drinking study had ceased a week ago.
“This particular study was set up in such a way that the funding is largely coming from the beverage industry and there is evidence that NIH employees assisted in recruiting those funds for this study in a way that would violate our usual policies,” Collins said.
He said the controversy has “caused considerable pain and stress upon the people involved” and said NIH will make a decision about “whether the study is, in fact, still worth pursuing.”