A major, National Institutes of Health (NIH) study on the health effects of moderate drinking is being largely funded by companies which make and sell alcohol, according to a March 19 New York Times report. The article raises questions about the scientific integrity of the Moderate Alcohol and Cardiovascular Health Trial, based on the funding being provided by companies which could benefit from the 10-year, $100 million study
Most of the cost is being covered by Anheuser Busch InBev, Heineken and other alcohol companies, along with donations to a private foundation that raises money for the National Institutes of Health.
The Times said statements by NIH officials that they never discussed the planning of the study with alcohol industry representatives were contradicted by emails and travel vouchers the newspaper obtained under the Freedom of Information Act.
According to the Times, “the documents and interviews show that the institute waged a vigorous campaign to court the alcohol industry, paying for scientists to travel to meetings with executives, where they gave talks strongly suggesting that the study’s results would endorse moderate drinking as healthy.
The alcohol study is being supervised by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), one of 27 centers under the N.I.H.
An NIAAA official who has since retired said she made pitches to industry executives to provide financial support for the study. The meetings in late 2013 and early 2014 included a luncheon at the Beer Institute convention in Philadelphia, and two meetings at the Washington headquarters of the Distilled Spirits Council, a liquor industry trade group.
At presentations in 2013 and 2014, attended by liquor industry stakeholders, Kenneth J. Mukamal, M.D., an associate professor of medicine at Harvard Medical School and now the lead investigator of the study, and John Krystal, M.D., a Yale University neuroscientist, said a long-term randomized controlled trial is needed to clarify issues related to the benefits of moderate daily drinking.
“A definitive clinical trial represents a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases,” said one slide in the scientists’ presentation at The Breakers. “That level of evidence is necessary if alcohol is to be recommended as part of a healthy diet.”
According to the Times, the fund-raising may have violated N.I.H. policy, which prohibits employees from soliciting or suggesting donations, funds or other resources intended to support activities. At the least, the campaign is bound to raise more questions about the independence of the investigators and the scientific integrity of the huge trial.
The presentations gave the alcohol industry an opportunity to preview the trial design and vet the investigators. The scientist leading the meetings was eventually chosen to head the huge clinical trial, the Times points out.
The industry was also given details about the study, including a list of clinical sites and investigators who were “already on board,” the size and length of the trial, approximate number of participants, and the fact that they could choose any beverage.
Michael Siegel, M.D., a professor of community health sciences at Boston University School of Public Health, told the Times the study “is not public health research — it’s marketing. This must have seemed like a dream come true for industry. Of course they would pay for it,” he said. “They’re admitting the trial is designed to provide a justification for moderate drinking. That’s not objective science.”
Art Caplan, the director of medical ethics at the NYU School of Medicine, said the role of the industry should be disclosed when the results eventually are disseminated to the public. “People will react differently if it says the study is ‘sponsored by NIH’ or ‘sponsored by Anheuser-Busch,’” he told the Times. Laypeople could use any finding supporting alcohol’s health benefits as a reason to drink excessively, Caplan said.
Asked about the meetings, Mukamal did not deny he had participated, but said the slides did not convey the full complexity of his presentation. Mukamal had told the Times last year that he had had “literally no contact with anyone in the alcohol industry in the planning of this.”
In January, Dr. Mukamal and his colleagues started recruiting volunteers ages 50 and older who are at high risk for heart disease; eventually there will be 7,800 participants at 16 sites worldwide. Half will agree to abstain from alcohol. The rest, including both men and women, will have one serving of alcohol a day.