June 18, 2018

NIH just ended its controversial alcohol study after 'egregious violation' of policy

Daily Briefing

    NIH Director Francis Collins announced Friday that the department will terminate a controversial 10-year study into moderate alcohol consumption after an internal investigation revealed severe ethical and scientific problems with the study's planning and methodology.   

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    Background

    The Moderate Alcohol and Cardiovascular Health Trial was intended to track 7,800 people and determine whether a single alcoholic drink a day could help prevent heart attacks. The study was projected to cost around $100 million.

    A New York Times investigation published in March found that five alcoholic beverage manufacturers had funded a majority of the study through the Foundation for the National Institutes of Health. According to the Times, 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.

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    In response to the Times' article, Collins in May suspended the study while NIH examined the claims. At the time, researchers had enrolled 105 participants and spent $4 million, STAT News reports.

    A scathing report

    Investigators on Friday published a report of their findings that revealed "frequent email correspondence" between National Institute on Alcohol Abuse and Alcoholism (NIAAA) staff, outside scientists, and representatives of the alcohol industry. The investigators also found that officials at NIAAA "hid facts" from staff and the foundation.

    According to the report, "The early and frequent engagement with industry representatives calls into question the impartiality of the process and thus casts doubt that the scientific knowledge gained from the study would be actionable ... or ... believable."

    Specifically, the task force's report said interactions between the study's lead author, Kenneth Mukamal of Beth Israel Deaconess Medical Center, NIAAA officials, and the liquor industry, "appear to intentionally bias the framing of the scientific premise in the direction of demonstrating a beneficial health effect of moderate alcohol consumption."

    The task force also found those early interactions "effectively steered funding" to Mukamal, giving him an unfair advantage over others seeking NIH research funding, STAT News reports. According to STAT News, NIH said it would take "appropriate personnel actions," but did not specify what those actions would be.

    In addition, the task force determined that the study itself had design flaws that would enable it to "show benefits while missing harms." For instance, the report found the trial had enrolled too few patients and had allotted insufficient follow-up time.

    Reaction

    Experts praised NIH's decision to shut down the study. Michael Siegel, from Boston University, said that the decision was "the appropriate response to the egregious violation of NIH policy" by the NIAAA, which Siegel said "undermined its own scientific integrity by soliciting and accepting alcohol industry funding to study the health 'benefits' of alcohol."

    Siegel added that ending the study "will help ensure that this fiasco is never repeated."

    NIAAA Director George Koob said the study had been "irrevocably damaged," and supported the decision to shut it down.

    In response to the report, Collins said that NIH officials would examine other industry-NIH ties to be sure that the correct procedures had been followed and determine whether there were any "subtle examples of cozy relationships" that could undermine the integrity of the research.

    "I think a very flashing neon light is staff conducting activities that they are trying to hide from other staff," Collins said. "That tells you that something is being done here that everybody recognizes has crossed a line" (Begley/Joseph, STAT News, 6/15; Rabin, New York Times, 6/15; Neergaard, AP/ABC News, 6/15; Greenfieldboyce, "Shots," NPR, 6/15).

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