The National Institutes of Health (NIH) in Bethesda, Maryland, is launching an investigation into whether NIH officials improperly urged the alcohol industry to help fund a 10-year, $100 million study on the health benefits of moderate drinking. The agency will also review the scientific merits of the study, which was pitched by a Harvard University researcher who is now its leader.
The agency is responding to an article published last week in The New York Times that described how companies came to fund the study, launched in January by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). It will enroll 7800 participants over age 50 in several countries who will either abstain from drinking or consume one alcoholic beverage of their choice daily for 6 years.
Although epidemiological studies have suggested that moderate drinking can lower a person’s risk of heart attack or stroke, that possibility has not been studied in a randomized trial with a control group. Funding for the study from Anheuser Busch InBev, Pernod Ricard, and three other beverage companies is being channeled through the Foundation for the NIH (FNIH), a congressionally chartered nonprofit organization in Bethesda, the Times reports.
The newspaper described emails, other documents, and interviews indicating that two NIAAA officials met with alcohol industry executives in late 2013 and early 2014 to urge them to support the study, with one noting that it probably would not happen otherwise. That appears to violate a policy prohibiting employees from soliciting contributions to NIH.
The Times also suggested the scientific review of the study was biased to favor a specific investigator. Kenneth Mukamal, a cardiovascular disease researcher at Harvard Medical School and the Beth Israel Deaconess Medical Center in Boston, and another academic researcher gave presentations at the same meetings on the proposed study. Mukamal was later selected as its principal investigator. (The Times and Wired had raised questions last year about the objectivity of the study, given that it is being funded by the alcohol industry.)
In a statement yesterday, NIH Director Francis Collins said he supports “the scientific goals” of the study and asserted that NIH followed its standard peer-review process. He also noted that NIH signed a September 2016 memorandum with FNIH limiting communications between NIH officials and industry sponsors about the study. However, he is “concerned … about information” in the Times article about “what may have happened prior to FNIH’s engagement to obtain funding for the study.” He said that “NIH will be looking into this matter” and will also have an advisory committee review the science of the study. Although NIH staff “routinely” discuss possible collaborations with outside scientists and other groups, agency policy bars “soliciting donations of funds,” Collins noted.
“There are concerns that, perhaps before that [the FNIH memorandum] was all worked out, there may have been some inappropriate discussions that went on between people working at NIH unbeknown to me and the beverage industry,” Collins told reporters yesterday, according to The Washington Post.