ACD Working Group for Review of the Moderate Alcohol and Cardiovascular Health Trial
Background
NIH has entered into a variety of highly successful public-private partnerships (PPPs) through which seemingly intractable and highly significant biomedical research problems have been addressed. For example, the Accelerating Medicines Partnership (AMP) has been an enormously successful PPP between the NIH, U.S. Food and Drug Administration, 12 biopharmaceutical and life science companies, and 13 non-profit organizations. AMP is working to transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets for therapeutics in Alzheimer's disease, autoimmune disease (lupus and rheumatoid arthritis), type-2 diabetes, and Parkinson's disease. The Foundation for the National Institutes of Health (FNIH) has been a key partner in such PPPs. They procure funding on behalf of defined NIH activities and manage the partnerships with public and private institutions in support of the NIH mission.
Several epidemiological and basic science studies have suggested that moderate drinking can be beneficial to health by reducing risk for coronary artery disease, type 2 diabetes, and rheumatoid arthritis, among other diseases and conditions. However, these studies used different protocols and are difficult to compare. The National Institute of Alcohol Abuse and Alcoholism (NIAAA) was encouraged to launch a multi-site, multiyear clinical study to clarify the health impact of moderate alcohol consumption via a "Significant Item" from the Joint Explanatory Statement on the Consolidated Appropriations Act of 2015. As a result, NIAAA issued a funding opportunity (PAR-16-363) for a multi-site randomized trial of health effects of moderate drinking, which was launched in 2016. FNIH was engaged to help support the efforts.
The scientific goals of such a multi-site, randomized clinical trial — to establish an evidence base and provide clear guidelines on the benefits versus the risks of moderate alcohol intake — are worthwhile. The NIH and the FNIH have mechanisms in place designed to protect the integrity of the science supported by donations through the FNIH. For example, NIH completed a Memorandum of Understanding in September 2016 with the FNIH that limits NIH-donor communication in the moderate drinking study. NIH is deeply concerned, however, about reports in the media of what may have happened prior to FNIH's engagement to obtain funding for this trial.
The NIH director assembled a working group of his ACD for an independent review of the scientific planning and administration of the Moderate Alcohol and Cardiovascular Health (MACH) trial, which was funded in response to the funding opportunity PAR-16-363.
Charge
This ACD working group members, external to NIH, together with the working group chair, will review the merit and soundness of the scientific planning phases, the administrative approaches used to conduct peer review and ultimately select the trial for support, and oversight of the study since its inception, including records on the development of the funding opportunity, the grant application, peer review results, and other materials as appropriate.
Structure
Subcommittee members are selected by the NIH Director. Meetings will be held by teleconference. The working group will report their recommendations to the ACD, with a target reporting date of the June 14-15, 2018 ACD meeting.
Reports
- Moderate Alcohol and Cardiovascular Health (MACH) Trial ACD Working Group Report* (PDF – 3.1MB)
- December 13, 2018 – NIH Responses and Follow-up to ACD Working Group Report
*The 508 corrected version is in process.