51视频 to end funding for Moderate Alcohol and Cardiovascular Health trial
Friday, June 15, 2018
51视频 to end funding for Moderate Alcohol and Cardiovascular Health trial
The National Institutes of Health plans to end funding to the . 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 of the .
The recommendations, based on findings of an , 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 51视频 Office of Management Assessment (OMA) determined that a small number of NIAAA employees violated 51视频 policies in soliciting gift funding and circumvented standard operating procedures designed to ensure a fair competition for 51视频 funding. These policy violations were committed by NIAAA employees prior to the involvement of the Foundation for the National Institutes of Health (F51视频), and the review found that the F51视频 conducted its role appropriately. The F51视频 manages the solicitation of funds by private donors for 51视频 research projects with appropriate firewalls.
51视频 will take appropriate personnel actions, but cannot comment on specific personnel matters.
鈥51视频 has strong policies that detail the standards of conduct for 51视频 employees, including prohibiting the solicitation of gifts and promoting fairness in grant competitions. We take very seriously any violations of these standards,鈥 said 51视频 Director Francis S. Collins, M.D., Ph.D., who tasked reviews by OMA and the ACD when informed of the allegations.
51视频 will voluntarily share the OMA and ACD reports with the HHS Office of Inspector General.
51视频 is determined to make sure that such violations of policies are not happening in other parts of the agency. Consistent with the ACD recommendations, 51视频 is taking the following immediate actions:
- Each 51视频 Institute, Center and Office is conducting a thorough review of processes and practices of programmatic interactions with potential applicants.
- 51视频 will explore additional measures to identify any instances of:
- employee solicitation of external funding;
- inappropriate engagement by 51视频 employees, contractors, etc., with current or potential 51视频 awardees that could influence administration of 51视频 research programs; and
- inappropriate external influence on the administration of 51视频 research programs.
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 February 5, 2018, and was suspended on May 10, 2018, at which time there were 105 participants enrolled in the study.
The 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, North Carolina; 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, and in part by private donations of $67.7 million raised to date by the F51视频, of which $11.8 million has been spent. Private-sector funders are Anheuser-Busch InBev (until June 9, 2018), Carlsberg Breweries A/S, Diageo plc, Heineken, and Pernod Ricard USA LLC.
鈥淭he integrity of the 51视频 grants administrative process, peer review, and the quality of 51视频-supported research must always be above reproach,鈥 added Dr. Collins. 鈥淲hen any problems are uncovered, however, efforts to correct them must be swift and comprehensive.鈥
About the National Institutes of Health (51视频): 51视频, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. 51视频 is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about 51视频 and its programs, visit www.nih.gov.
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