After just 4 months, the National Institute of Alcohol Abuse and Alcoholism (NIAAA) is ending funding for the Moderate Alcohol and Cardiovascular Health (MACH) trial, citing concerns about the study design.
The MACH study was designed as a multicenter randomized trial to determine the effects of 1 serving of alcohol (approximately 15 g) a day compared with no alcohol intake on the rate of new cases of cardiovascular disease and new cases of diabetes among participants free of diabetes at baseline. The study was launched because some epidemiologic research had shown that moderate alcohol consumption had health benefits by reducing risk for coronary artery disease, type 2 diabetes, and rheumatoid arthritis.
The study began enrollment in February 2018 and was suspended on May 10. The NIAAA expected to commit $20 million to the project over 10 years, of which $4 million has been spent; remaining funding came from private donations of $67.7 million, of which $11.8 million has been spent.
The “orderly closeout” is based on recommendations from the advisory committee to the director working group, which found “significant process irregularities in the development of funding opportunities for the MACH funding awards undermined the integrity of the research process.” Additionally, a preliminary report from the National Institutes of Health (NIH) Office of Management Assessment determined that a small number of NIAAA employees violated NIH policies in soliciting gift funding and circumvented standard operating procedures.