Major Study of Drinking Will Be Shut Down
Posted June 15, 2018 6:02 p.m. EDT
The extensive 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 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 healthy diet.
As it turned out, much of the money for the study came from the alcohol industry. Earlier this year, The New York Times reported that officials at the National Institute on Alcohol and Alcohol Abuse, 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 stopped altogether. Shortly afterward, Collins agreed.
While the advisory group was not asked to determine whether NIH officials violated federal policy, investigators did find that 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 J. 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 the Foundation for the NIH, which has the authority to seek donations for government studies, was given permission to raise private funding for the trial.
Investigators also found that officials at the alcohol institute “hid facts” from other staff and from the foundation.
Dr. Michael Siegel, a professor of community health sciences 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. “The NIH research portfolio should not be up to the highest corporate bidder.”
Officials at the alcohol institute lobbied beer and liquor companies to help fund 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 investigation into whether that policy had been violated.
He also asked a working group of his advisory committee to review the scientific merits of the government trial. That study, called MACH, was already underway, but enrollment of volunteers was suspended May 10.
Anheuser Busch InBev, one of the five industry sponsors, pulled its $15 million in funding from the study last week, saying the controversy had undermined the trial’s credibility.
The international study, a 10-year-long randomized clinical trial that aimed to recruit 7,800 participants at 16 sites around the world, is the kind of ambitious, broad-reaching scientific project that few agencies other than the NIH could attempt.
Carried out under the auspices of the alcohol institute and led by Mukamal, the study was to examine the effects of alcohol on adults 50 and older who were at high risk for heart disease. Half were to be asked to consume a single serving of alcohol of their choice every day, while the other half were to abstain.
The goal was to follow the two groups for six years on average to see if moderate drinkers have fewer heart attacks and strokes, and lower odds of death and diabetes.
But NIH investigators Friday were extremely critical of the trial’s design, suggesting that the investigators’ interactions with the alcohol industry “appear to intentionally bias the framing of the scientific premise in the direction of demonstrating a beneficial health effect of moderate alcohol consumption.”
A review by two NIH officials concluded the number of participants and the follow-up time were insufficient to assess important adverse outcomes of daily alcohol consumption, particularly its relationship to cancer.
“Thus the trial could show benefits while missing the harms,” said the investigators’ report.
The trial also did not include heart failure as a primary endpoint, and alcohol consumption is associated with a higher risk of heart failure, the investigators said. Outside experts also have criticized the design of the study.
Though the goal was to recruit an equal number of male and female participants, for example, Mukamal has acknowledged the study would not be large enough to detect gender differences unless they were pronounced.
Women metabolize alcohol more slowly than men, and studies have shown that women are more susceptible than men to the toxic effects of alcohol on the liver at any dose. Heart disease also manifests differently in women, experts say.
The investigators also planned to exclude any participants whose health might be compromised by light drinking, including people with a history of substance abuse, mental health problems, liver or kidney problems, certain cancers or family histories of cancer, as well as people who have never consumed alcohol.
The exclusions were meant to protect volunteers, but they would have altered the results of the trial and minimized the potential harms, particularly to older adults, noted Dr. Richard Saitz, chairman of the community health sciences department at Boston University School of Public Health.
Many of the researchers selected to run clinical trial centers in the United States and abroad also enjoy close ties to alcohol beverage companies, receiving research funding from industry groups like the Alcoholic Beverage Medical Research Foundation and the International Life Sciences Institute.
“Industry influence on the NIH research agenda should be avoided. It’s very important that NIH make research decisions independently,” said Dr. Adriane Fugh-Berman, a professor of pharmacology at Georgetown University.
“NIH should focus on studying what industry does not want to study.”