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NIH shuts down controversial drink-a-day alcohol study
The National Institutes of Health (NIH), part of the US government’s Department of Health and Human Services, is to end funding for a study to explore if there are any health benefits associated with moderate drinking after “concerns about the study design” cast doubt on its “ultimate credibility”.
The government-funded medical research agency said its decision to end the Moderate Alcohol and Cardiovascular Health (MACH) trial was prompted by concerns about the design of the study and also whether it would address other “significant consequences of moderate alcohol intake” such as cancer.
The move was taken following recommendations of the Advisory Committee to the Director, with funding from the National Institute of Alcohol Abuse and Alcoholism (NIAAA) due to end “within the next few months”.
The investigation by the advisory committee found “significant process irregularities” in the attraction of funding while a preliminary report conducted by the NIH Office of Management Assessment (OMA) found that a small number of NIAAA workers violated NIH policy by “soliciting gift funding”.
NIH director Francis S. Collins, M.D., Ph.D commented: “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.
“The integrity of the NIH grants administrative process, peer review, and the quality of NIH-supported research must always be above reproach. When any problems are uncovered, however, efforts to correct them must be swift and comprehensive”.
The ten-year long clinical study, announced last year and which began enrolment on 5 February this year, had the backing of five global drinks companies including Diageo, Pernod Ricard, Heineken, Carlsberg and AB InBev.
According to the New York Times, the combined total donated by the drinks companies came to around $66 million, of which AB InBev contributed $15.4 million. Earlier this month, AB InBev pulled funding for the study, stating that “recent questions raised around the study could undermine its lasting credibility”.
The MACH study aimed to enrol 7,800 participants aged over 50 from across the world and who were all at high risk of heart disease and monitor them for an average period of six years. Half of the group were to be asked to abstain from alcohol while the other half would have a single serving of alcohol every day.
A single serving is defined as 12 ounces of beer, five ounces of wine or 1.5 ounces of distilled spirits.
Enrolment was suspended on 10 May at which time there were 105 participants enrolled in the study. This followed an exposé in the New York Times, which reported that reported that N.I.H. officials and scientists solicited funds from alcohol groups by “strongly suggesting that the study’s results would endorse moderate drinking as healthy”.
The trial was part funding by the NIAAA, which had committed US$20 million to the project over a 10-year period, with $4 million already spent. Private donations raised by the Foundation for the National Institutes of Health (FNIH) totalled $67.7m of which $11.8m has already been spent.