August 24, 2018 — The National Institutes of Health announced in June it plans to end funding to the Moderate Alcohol and Cardiovascular Health (MACH) trial. The decision is based on concerns about the study design that cast doubt on its ultimate credibility. This includes whether the study would effectively address other significant consequences of moderate alcohol intake, such as cancer.
National Institute of Alcohol Abuse and Alcoholism (NIAAA) funding for the MACH trial will end within the next few months following completion of an orderly closeout. The decision to end funding is informed by recommendations of the Advisory Committee to the Director (ACD).
The MACH study was designed as a multicenter, randomized clinical trial to determine the effects of one serving of alcohol (approximately 15 grams) daily, compared to no alcohol intake, on the rate of new cases of cardiovascular disease and the rate of new cases of diabetes among participants free of diabetes at baseline. The study was launched because some epidemiological studies have shown that moderate alcohol consumption has health benefits by reducing risk for coronary artery disease, type 2 diabetes and rheumatoid arthritis. A multi-site randomized trial often is the best way to establish the evidence base about the benefits versus the risks of an intervention like moderate alcohol intake. The study aimed to enroll 7,800 participants. After a planning phase, it began enrollment on Feb. 5, 2018, and was suspended on May 10, 2018, at which time there were 105 participants enrolled in the study.
The recommendations, based on findings of an ACD working group, also noted that significant process irregularities in the development of the funding opportunities for the MACH funding awards undermined the integrity of the research process. Additionally, a preliminary report from the NIH Office of Management Assessment (OMA) determined that a small number of NIAAA employees violated NIH policies in soliciting gift funding and circumvented standard operating procedures designed to ensure a fair competition for NIH funding. These policy violations were committed by NIAAA employees prior to the involvement of the Foundation for the National Institutes of Health (FNIH), and the review found that the FNIH conducted its role appropriately. The FNIH manages the solicitation of funds by private donors for NIH research projects with appropriate firewalls.
NIH will take appropriate personnel actions, but cannot comment on specific personnel matters.
“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,” said NIH Director Francis S. Collins, M.D., Ph.D., who tasked reviews by OMA and the ACD when informed of the allegations.
NIH will voluntarily share the OMA and ACD reports with the HHS Office of Inspector General.
NIH is determined to make sure that such violations of policies are not happening in other parts of the agency. Consistent with the ACD recommendations, NIH is taking the following immediate actions:
- Each NIH institute, center and office is conducting a thorough review of processes and practices of programmatic interactions with potential applicants;
- NIH will explore additional measures to identify any instances of:
- Employee solicitation of external funding;
- Inappropriate engagement by NIH employees, contractors, etc., with current or potential NIH awardees that could influence administration of NIH research programs; and
- Inappropriate external influence on the administration of NIH research programs.
The MACH trial is led by Beth Israel Deaconess Medical Center, Boston. Collaborators are:
- The Center for Bioethics and Research, Nigeria;
- Harvard School of Public Health, Boston;
- IDIBAPS, Spain;
- Johns Hopkins University, Baltimore;
- University of Copenhagen, Denmark;
- Wake Forest University Health Sciences, Winston-Salem, N.C.; and
- Julius Center, Netherlands.
The trial is funded in part by NIAAA, which expected to commit $20 million to the overall project over 10 years, of which $4 million has been spent. It is also funded in part by private donations of $67.7 million raised to date by the FNIH, of which $11.8 million has been spent.
“The integrity of the NIH grants administrative process, peer review, and the quality of NIH-supported research must always be above reproach,” added Collins. “When any problems are uncovered, however, efforts to correct them must be swift and comprehensive.”
For more information: www.nih.gov