The National Institutes of Health plans to end funding to the Moderate Alcohol and Cardiovascular Health Trial, the agency announced last week. The decision is based on concerns about the study design that led to questions about its credibility. This includes whether the study would address other significant consequences of moderate alcohol intake, such as cancer.
NIH’s National Institute of Alcohol Abuse and Alcoholism funding for the MACH trial will end within the next few months. The decision to end funding follows recommendations of the Advisory Committee to the Director.
The recommendations, based on findings of an ACD working group, also said that significant process irregularities in the development of the funding for the MACH funding awards undermined the integrity of the research process.
In addition, a preliminary report from the NIH Office of Management Assessment found that some NIAAA employees violated NIH policies by going around procedures designed to ensure a fair competition for NIH funding.
NIH will take appropriate personnel actions, but can’t comment on specific personnel matters, said NIH Director Francis S. Collins, M.D.
“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,” said Collins. “We take very seriously any violations of these standards.”
NIH is determined whether such violations of policies are taking place in other parts of the agency by taking the following actions:
- Each NIH institute, center, and the office is conducting a review of processes and practices of program interactions with potential applicants.
- NIH will explore additional measures to identify any cases of:
- Employee solicitation of external funding.
- Inappropriate engagement by NIH employees or contractors with current or potential NIH awardees could influence the administration of NIH research programs.
- Inappropriate external influence on the administration of NIH research programs.
The MACH study was designed as a randomized clinical trial to determine the effects of one serving of alcohol, about 15 grams, daily compared to drinking no alcohol, on the rate of new cases of cardiovascular disease and the rate of new cases of diabetes among participants. The study was launched because some epidemiological studies have shown that moderate alcohol consumption has health benefits by reducing the risk for coronary artery disease, type 2 diabetes, and rheumatoid arthritis. The study was going to enroll 7,800 participants. After a planning phase, it began enrollment on February 5, and was suspended on May 10, at which time there were 105 participants enrolled in the study.
“The integrity of the NIH grants administrative process, peer review, and the quality of NIH-supported research must always be above reproach,” said Collins. “When any problems are uncovered, however, efforts to correct them must be swift and comprehensive.”