The alcohol industry agreed to fund the research via a private foundation that supports NIH.
The goal of the study, which would enroll 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 Health (MACH) trial is based at Harvard’s Beth Israel Deaconess Medical Center, a grantee of the National Institute on Alcohol Abuse and Alcoholism. [Update: As of May 10, when Collins ordered the halt, the study had enrolled 105 people in the U.S., Europe and Africa, according to Beth Israel.]
Collins has ordered two reviews of the study. The first, by the Office of Management Assessment, will “determine if any process or conduct irregularities occurred with grants associated with the MACH Trial,” according to NIH. The second review, 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.”
The statement went on: “Of course, we share the NIH’s commitment to ensuring that this trial meets the highest scientific and ethical standards. We continue to cooperate fully with their review of the trial, and at the NIH’s direction the study has been paused at all sites until this matter is resolved.”
“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.”
The controversy over the alcohol study reflects a bigger dilemma facing NIH, one that Collins addressed Thursday in his testimony. NIH has sought partnerships with industry using the private foundation as an intermediary. But as Collins noted Thursday, that can carry a reputational risk for NIH, because the research might be seen as compromised by industry interests.
Such concerns led Collins in April to reject plans to use funds from the pharmaceutical industry for research on opioid addiction and the quest to find non-narcotic pain treatments. He said Thursday that elements of the partnership, such as data sharing, will go on, but there will be no cash contribution from the pharmaceutical industry. He noted that major lawsuits have been filed against pharmaceutical companies in connection with the opioid epidemic.
Sen. Patty Murray (D-Wash.) asked whether what happened at NIAAA with the alcohol study might have happened at other institutes in the sprawling NIH operation. Collins answered, “I'm very concerned this might be the tip of a larger iceberg,” adding that his investigators are looking for other examples at NIH.
The advocacy group Public Citizen has criticized the NIH review of the alcohol study, saying it should be handled by the inspector general of the Department of Health and Human Services. Collins “is basically investigating himself,” said Michael Carome, director of Public Citizen’s Health Research Group.
Carome added that the funding of the alcohol study damaged NIH’s reputation, and the halting of the study “is a small step toward restoring that reputation.”