Alcohol industry officials had input into the design of the trial, the investigators found.
The government trial was intended to settle an age-old question about alcohol and diet: Does a daily cocktail or beer really protect against heart attacks and stroke?
To find out, the National Institutes of Health (NIH) gave scientists $100 million to fund a global study comparing people who drink with those who don’t. Its conclusions could have enshrined alcohol as part of a healthful diet.
As it turned out, much of the money for the study came from the alcohol industry. This year, The New York Times reported that officials at the National Institute on Alcohol Abuse and Alcoholism, part of the NIH, had solicited that funding from alcohol manufacturers, a violation of federal policy.
On Friday, an advisory panel to Dr. Francis Collins, director of the NIH, recommended that the trial be halted. Collins agreed.
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While the advisory group was not asked to determine whether NIH officials violated federal policy, investigators did find there “was frequent email correspondence” among the staff of the alcohol institute, outside scientists and alcohol-industry representatives.
Alcohol-industry officials had input into the design of the trial, the investigators found.
The lead investigator, Dr. Kenneth Mukamal, an associate professor of medicine at Harvard Medical School, discussed the methods with alcohol groups by email in August 2014, responding to questions raised by Diageo, Anheuser Busch InBev and trade groups like the Distilled Spirits Council.
In December 2014, he participated in a conference call discussing the research with a dozen representatives of alcohol companies, the investigators said. “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,” said the advisory committee’s report.
The contacts by staff with industry officials and others took place before permission to raise private trial funding was given to the Foundation for the NIH, which has the authority to seek donations for government studies. Investigators also found officials at the alcohol institute “hid facts” from other staff and from the foundation.
Dr. Michael Siegel, a professor at Boston University and an early critic of the alcohol study, applauded the NIH for discontinuing the research. “This ensures that NIH’s research agenda will be determined by scientific merit, not corporate marketing priorities,” he said.
In a statement, Mukamal denied any wrongdoing and said he and his colleagues “stand fully and forcefully behind the scientific integrity” of the trial.
Officials at the alcohol institute lobbied beer and liquor companies to help pay for the $100 million trial, The Times reported in March. Scientists were flown to industry meetings where they described the proposed trial and suggested that the results would support moderate drinking.
NIH policy prohibits employees from soliciting, suggesting or requesting donations, funds or other resources to support the institutes’ activities. After The Times revealed the industry’s financial interests in the study, Collins ordered an internal probe into whether that policy had been violated.