NIH study of moderate drinking comes up dry
The National Institutes of Health has canceled a mammoth study of moderate drinking, after determining that officials had irrevocably compromised the research by soliciting $66 million from beer and liquor companies to underwrite the effort.
NIH Director Francis Collins said the results of the 10-year, $100 million study would not be trusted because of the secretive way in which staff at an institute under NIH met with major liquor companies, talked to them about the trial’s design and convinced them to pick up most of the tab for it.
“Many people who have seen this working-group report were frankly shocked to see so many lines crossed,” he said, calling the staff interaction with the alcohol industry “far out of bounds.”
Collins ordered the examination of what was originally planned as a study of more than 7,800 people around the globe after The New York Times reported in March that officials had sought the industry funding and routed their donations through the institutes’ nongovernmental foundation.
In May, NIH suspended enrollment of participants in the research, which was already underway when the newspaper published its story.
The findings released last week address the scientific merit of the study.
The review found that the staff who met with five liquor companies did not follow existing rules that required them to report such contacts.
In a statement, NIH said that “a small number” of employees at the National Institute of Alcohol Abuse and Alcoholism violated policies and that “appropriate personnel actions” would be taken, without specifying what that would entail. The report includes a lengthy appendix with emails between staff and industry representatives.
But NIH officials also identified flaws in the scientific design of the Moderate Alcohol and Cardiovascular Health trial, which they think might skew the results to highlight benefits while minimizing harms, such as alcohol consumption’s relationship with cancer and heart problems.
The study was based at Beth Israel Deaconess Medical Center in Boston. Enrollment began in February, and 105 people were signed up in the United States, Europe and Africa when Collins halted the study.
The report has six recommendations, which were unanimously approved last week by an advisory board and adopted by Collins.
They include terminating the trial, making sure NIH staff are not providing any industry representatives with secrets about trials that would give them an advantage, and examining if additional measures need to be taken to prevent NIH staff from soliciting funding from other industries in unethical ways.
A second inquiry, not yet finished, is examining the issue of possible industry influence on NIH-funded research overall.