May 21, 2018

NIH just halted a $100M alcohol study amid questions about industry funding

Daily Briefing

    NIH Director Francis Collins on Thursday announced that the agency has halted a 10-year study into moderate alcohol consumption, after questions were raised about whether an agency employee acted inappropriately in seeking funding for the research.

    Background: NYT highlights link between alcohol industry and NIH research

    A New York Times article published in March 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 reported 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—funded 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."

    Following the article's publication, Collins explained that 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 served as "a very well-written firewall" that barred 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." Collins said an advisory group would examine "whether any [NIH] employees committed an impropriety" and review the study's design.

    NIH halts the research

    Collins on Thursday said on May 10 he ordered NIH to halt its research on moderate alcohol consumption. Specifically, NIH said it "has requested that the grantee, Beth Israel Deaconess Medical Center, pause all study activities until [certain] reviews are completed."

    According to NIH, Collins has ordered two reviews of the research:

    • One conducted by an advisory committee that will examine the research's scientific merit; and
    • One conducted by the Office of Management Assessment that will "determine if any process or conduct irregularities occurred with grants associated with the" research.

    NIH said the reviews are scheduled to be completed in June.

    According to the Washington Post's "To Your Health," Collins during a Senate committee hearing on Thursday said, "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." He added that NIH ultimately would decide "whether the study is, in fact, still worth pursuing."

    Collins also stated that similar controversial practices might have occurred in other studies sponsored by NIH. "I'm very concerned this might be the tip of a larger iceberg," he said, adding that investigators are looking into the matter.

    Reaction

    Beth Israel spokesperson Jennifer Kritz said the medical center has policies in place to ensure the ethical and scientific integrity of its research. She said Beth Israel had conducted its own review of the study and did not find "any reason to believe that it does not adhere to our institutional requirements."

    Kritz said Beth Israel "share[s] NIH's commitment to ensuring that this trial meets the highest scientific and ethical standards." She said the medical center "continue[s] to cooperate fully with [NIH's] review of the trial, and at … [NIH's] direction the study has been paused at all sites until this matter is resolved" (Achenback, "To Your Health," Washington Post, 5/18; Caryn Rabin, New York Times, 5/17; Hellmann, The Hill, 5/17).

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