NIH Director Francis Collins on Tuesday said he has assigned a group of advisers to look into whether an agency employee acted inappropriately in seeking funding for research on the health effects of moderate alcohol consumption.
Background: NYT highlights link between alcohol industry and NIH research
The announcement comes after a New York Times article published Saturday stated that an NIH official and two outside researchers, including one who later became the lead researcher on the new NIH study, asked liquor companies to help pay for the research.
According to the Times, emails and travel vouchers obtained through a Freedom of Information Act request show the researchers presented the research idea at meetings with beverage-industry executives and an industry trade group in three cities in 2013 and 2014. In addition, the Times reports that a senior adviser at the National Institute on Alcohol Abuse and Alcoholism also asked industry stakeholders for funding, saying the research could not be completed without the industry's financial support.
According to the Times, five alcoholic beverage manufacturers—Anheuser-Busch InBev, Carlsberg, Diageo, Heineken, and Pernod Ricard—are funding a majority of the $100 million study through the Foundation for the National Institutes of Health. According to NIH's website, the foundation is an independent nonprofit that creates public-private partnerships and raises private funds "in support of [NIH's] mission."
Collins says advisers will look into the study
Collins on Tuesday said the study aims to determine whether daily moderate drinking can benefit cardiovascular health, as some research has suggested. According to the Times, the study "is the first large, long-term randomized clinical trial to test the hypothesis that moderate drinking prevents heart attacks and strokes, and perhaps also Type 2 diabetes and cognitive decline." Researchers hope to recruit 7,800 women and men from 16 different sites worldwide. Half of the participants would be asked to abstain from alcohol, while have would be asked to have a single serving of alcohol a day of the type of their choosing. The study would track participants' health for six years on average.
Collins said although the study is worthwhile, "The controversy … is how the study came about."
Collins said NIH in 2016 signed a memorandum with the Foundation for the National Institutes of Health "that limits NIH-donor communications in the moderate drinking study." He said the memo serves as "a very well-written firewall" that bars NIH from using outside donations to "design or influence the way the study is carried out."
However, Collins said, "There are concerns that, perhaps before that 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." He explained, "While NIH officials and scientists routinely discuss and present information on proposed collaborations with outside scientists and other members of the public, NIH policy prohibits employees from soliciting donations of funds or other resources to the NIH or any of its components."
To address the concerns, Collins said an advisory group will examine "whether any of our employees committed an impropriety" and review the study's design. "We shall see what that turns up," Collins said, adding, "I am taking this very seriously" (Goldstein, Washington Post, 3/20; Rabin, New York Times, 3/20).
Just updated: Your cheat sheets for understanding health care's legal landscape
To help you keep up with the ever-changing regulatory environment, we recently updated our cheat sheets on some of the most important—and complicated—legal landmarks to include a brand new one-pager on the new tax law.
Check out the cheat sheets now for everything you need to know about MACRA, the Affordable Care Act, antitrust laws, fraud and abuse prevention measures, HIPAA, and the two-midnight rule.