Alcohol Study Cancelled Due To Concerns Over Science, Industry Manipulation

The National Institutes of Health (NIH) has pulled the plug on a controversial alcohol study, which was designed to evaluate whether moderate alcohol consumption may be part of a healthy diet. 

In a press release issued on June 15, the agency announced an end to the $100 million study, after it was revealed that it was secretly funded, in part, by alcoholic beverage companies, which may taint the results. It was also revealed that some NIH officials hid certain facts from other staff members.

If completed, the research may have assessed the side effects of moderate drinking on cardiovascular disease and diabetes. It was a multicenter, randomized clinical trial led by researchers from Beth Israel Deaconess Medical Center.

The NIH’s National Institute of Alcohol Abuse and Alcoholism (NIAAA) was to provide $20 million over 10 years to fund the research, but the Foundation of the NIH had also raised $67.7 million in private donations. It was recently revealed that those donors included Anheuser-Busch, Carlsberg Breweries, Heineken and other alcoholic beverage companies.

The study began enrolling participants in February, with a goal of 7,800 subjects. However, NIH’s Advisory Committee recommended ending the study after only a 105 participants were enrolled, when the committee discovered early and frequent contact between NIAA staff and industry representatives.

The committee expressed concerns about the credibility of the study, suggesting that the industry funding may have played a role in the selection of a lead researcher who had written favorably about alcohol consumption in the past.

“Given how the trial was being funded, and the existing research of the lead principal investigator (PI) to which the awards were directed to, any outcome of this existing trial will point back to the initial questions and concerns raised by the process abnormalities, given that the lead PI had previously published on the benefits of moderate alcohol consumption,” the committee wrote in its recommendations (PDF).

The NIH also noted that a preliminary report from the NIH Office of Management Assessment (OMA) found that some NIAAA employees violated a number of policies, such as soliciting gift funding and not abiding by standard operating procedures in ensuring fair competition for NIH funding. Investigators also found that some had discussed the study several times with alcohol beverage industry representatives.

“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,” NIH Director Francis S. Collins said in the press release. “We take very seriously any violations of these standards.”

The NIH indicates that it will take “appropriate personnel actions” but cannot publicly state what those actions will be. The institute will also conduct a thorough review of policies and practices and attempt to identify any other instances of similar violations, the press release indicated.