Controversial Trial of Alcohol’s ‘Benefits’ for Preventing CVD Halted by NIH

The National Institutes of Health (NIH) in the United States has pulled the plug on a large, randomized clinical trial that might once and for all have answered the question of whether moderate alcohol consumption helps or harms the heart.

The decision comes following reports that NIH employees, as well as the principal investigator for the study, had directly sought funding from the alcohol industry amid hints that the research might ultimately deliver favorable results for beer, wine, and spirits companies.

“NIH has strong policies that detail the standards of conduct for NIH employees, including prohibiting the solicitation of gifts and promoting fairness in grant competitions. We take very seriously any violations of these standards,” the agency’s director, Francis S. Collins, MD, PhD, said in an NIH press release.

After years of discussion, the Moderate Alcohol and Cardiovascular Health (MACH) trial launched February 5, 2018, with the aim of enrolling 7,800 participants. The plan was to randomize subjects at high cardiovascular risk to one serving of alcohol (approximately 15 g) daily or to no alcohol intake over a 5-year period. The primary aim of the trial was to compare rates of new cardiovascular disease and new diabetes between study groups, with additional analyses looking at the incidence of cancer and any other health consequences believed to be related to alcohol intake.

At the time the trial was halted on May 10, 2018, 105 participants had been enrolled.

The anticipated cost of the MACH trial was $100 million. According to the NIH, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) was expected to commit $20 million to the overall project over 10 years, of which $4 million has been spent. Private donations of $67.7 million had been raised by donations to the Foundation for the National Institutes of Health (FNIH), which manages the solicitation of funds by private donors for NIH research projects. FNIH donors for MACH included major alcohol corporations Anheuser-Busch InBev, Carlsberg Breweries A/S, Diageo plc, Heineken, and Pernod Ricard USA LLC. $11.8 million of private funding has been spent. 

Reporting by the New York Times earlier this year described a meeting between liquor company representatives, an NIAA official), and a prominent Harvard professor of medicine—Kenneth J. Mukamal, MD—who was later appointed lead investigator of the study. According to the Times, a slide presentation by Mukamal to alcohol execs at that meeting stated: “A definitive clinical trial represents a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases.” It continued: “That level of evidence is necessary if alcohol is to be recommended as part of a healthy diet.”

In addition, the liquor industry representatives were allowed to offer input on aspects of trial design and methods.

Last week, the Advisory Committee to the Director (ACD) of the NIH, tasked with reviewing the trial, issued a report, concluding, “There was early and frequent engagement among these parties which appear to be an attempt to persuade industry to support the project. Several members of NIAAA staff kept key facts hidden from other institute staff members and the FNIH. The nature of the 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.”

The ACD pointed to “sustained interactions” between NIAAA leadership and Mukamal that gave him a competitive advantage over other prospective trial leaders. It also condemned interactions between NIAAA staff and the liquor industry that appeared “to intentionally bias the framing of the scientific premise in the direction of demonstrating a beneficial health effect of moderate alcohol consumption.”