Drinking Study Canceled Due To Bias Concerns

The director of the nation’s top health research agency has pulled the plug on a study of alcohol’s health effects. The research was supposed to track 7,800 people who were assigned to take either a drink a day, or totally abstain, for several years. NIH Director Francis S. Collins said the results of the 10-year, $100 million study would not be trusted after determining that officials had irrevocably compromised the research by soliciting over $60 million from beer and liquor companies.

The study was based at Beth Israel Deaconess Medical Center in Boston. Dr. Collins halted the study in March after the New York Times reported that the scientists conducting the study had aggressively sought industry funding for the trials, routing the donations through the institutes’ nongovernmental foundation. The Times used documents and travel records obtained through Freedom of Information Act requests to bolster its claims.

Staff from the N.I.H.’s National Institute on Alcohol Abuse and Alcoholism shared details of the trial with liquor and beer manufacturers. An internal investigation prepared for Dr. Collins found that the staff who met with five liquor companies did not follow existing rules that required them to report such contacts. Kenneth J. Mukamal, the lead investigator of the trial, was found to have been in close, frequent contact with beer and liquor executives while designing the study, although he has repeatedly denied communicating with the alcohol industry while planning the trial.

The N.I.H. report contains other disturbing examples of coordination between scientists and the alcohol industry on the study. In June 2013, institute staff drew up a business plan making the case for the industry’s financial support of the study. Beer and liquor companies offered their own suggestions for carrying out the trial. The investigation also found that the scientists who designed the trial acknowledged in 2016 that the study was focused on benefits and “not powered to identify negative health effects.”

Dr. Collins accepted his advisers’ recommendation to terminate the trial. Enrollment began in February, and 105 people had signed up in the United States, Europe and Africa before the termination. In a statement issued after the study’s cancelation, Dr. Mukamal said he and his colleagues “stand fully and forcefully behind the scientific integrity” of the trial.

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