DGE Diageo Plc

By Thomas M. Burton 

The National Institutes of Health terminated a study into the benefits and risks of moderate drinking, concluding that the agency's staff had improperly interacted with the alcoholic-beverage companies to get funding.

NIH Director Francis S. Collins said his agency's dealings with the alcoholic-beverage industry were early and frequent and that he plans to investigate to ensure that the handling of this one study was unique and not representative of the agency's work overall.

Anheuser-Busch InBev SA, Heineken Holding NV, Diageo PLC, Pernod Ricard USA LLC and other alcohol companies had agreed to pay for most of the $100 million study through donations to a private foundation that raises money for the NIH. The NIH's National Institute on Alcohol Abuse and Alcoholism oversaw the study and planned to contribute funds to the research.

In a meeting Friday of an advisory board to Dr. Collins, Lawrence A. Tabak, NIH principal deputy director, said an outside report on the study that was commissioned by the NIH concludes that NIAAA officials "appear to have intentionally biased the framing of the scientific premise" of the study in the direction of focusing on possible benefits of alcohol.

The report said that email correspondence involving NIAAA staff, outside researchers and the alcohol industry "appear to be an attempt to persuade industry to provide funding" for the study.

Also at the meeting, NIAAA director George Koob said, "I'm disappointed in what transpired. I think the trial is irrevocably damaged." He said he also concluded that "we did not see a truly open competition" in selecting the outside investigators to conduct the alcohol research.

Dr. Collins testified before a Senate committee last month that the funding source, along with NIH employees' soliciting of funds for the research, "would violate our usual policies." The issue has "caused considerable pain and stress upon the people involved," and the NIH would make a decision about whether the study still should be conducted, he said.

The main grantee under the research is Beth Israel Deaconess Medical Center in Boston, which has said it has policies in place to ensure the scientific and medical validity of the research.

An article in the New York Times in March described two scientists, as well as a federal health official, pitching the study to liquor company executives in 2014 in a gathering in Palm Beach, Fla. Dr. Kenneth J. Mukamal, associate professor of medicine at Harvard Medical School and the study's lead investigator, and Dr. John Krystal, a Yale University neuroscientist, said in their presentation that a randomized clinical trial could clarify the possible benefits of moderate drinking.

Dr. Mukamal didn't respond immediately to a request for comment.

Dr. Krystal said the risks and benefits of alcohol use have been "hotly contested" based on complex epidemiologic data.

"We have long needed a prospective, randomized, controlled trial to enable us to make sense of the epidemiologic data," he said in an email. The study, he said, "will be the first definitive test" of the notion that alcohol has health benefits.

NIH officials said they have already spent $4 million on the study.

Write to Thomas M. Burton at tom.burton@wsj.com

(END) Dow Jones Newswires

June 15, 2018 14:32 ET (18:32 GMT)

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