“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 aggressively 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 Friday 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 (NIAAA) 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 (MACH) trial, which they thought 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 had signed up in the United States, Europe and Africa when Collins halted the study.
The report has six recommendations, which were unanimously approved Friday by an advisory board and adopted by Collins. They include terminating the trial, making sure NIH staff are not providing any industry representatives with secret information 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 completed, is examining the wider issue of possible industry influence on NIH-funded research overall.
The Times used documents and travel records obtained through Freedom of Information Act requests to show that former NIAAA acting director Kenneth R. Warren and others pitched the idea of such a study in meetings with the alcoholic-beverage industry in 2013 and 2014.
Anheuser-Busch InBev, Heineken and other industry giants agreed to jointly pay over $60 million, although Anheuser-Busch InBev recently withdrew its $15.4 million contribution. Of the $20 million that NIAAA expected to commit, $4 million had already been spent. Of the $67.7 million raised from private donations — nearly all from the alcohol industry — $11.8 million had already been spent.
Any unobligated funds will be returned, NIH officials said Friday.
NIH, the government’s major funder for biomedical research around the world, doles out more $30 billion annually. The NIAAA is one of 27 institutes and centers that comprise NIH.
When Collins announced the two inquiries in March, he noted that the study was intended to help settle the persistent public health question of whether a daily drink benefits the cardiovascular system, as some less rigorous studies have suggested.
And George F. Koob, current director of the NIAAA, initially said that industry sponsorship of the research would not compromise the study. He told the Times that the foundation’s participation in the funding plan created a “firewall” that would prevent donors from interfering with the research. Most of the meetings occurred before he took over in January 2014.
On Friday, however, Koob called the trial “irrevocably damaged.”
The advocacy group Public Citizen welcomed the trial’s termination but called for an outside investigation of what went wrong.
“They can’t be investigating themselves,” said Michael Carome, the group’s health research director. Given unanswered questions about what other NIH officials were aware of how the study funding was being solicited, he said the inspector general of the Department of Health and Human Services should launch an inquiry.
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