The National Institutes of Health has terminated a controversial $100-million study on the health effects of daily drinking that was largely funded by the alcohol industry. The announcement comes after internal NIH investigations found evidence of scientific bias, policy violations, and inappropriate engagement with industry representatives.
The findings—announced by the NIH on Friday, June 15—largely support recent investigations by the press that suggested NIH officials and the study’s lead researchers had inappropriately wooed industry and pitched the study as “necessary if alcohol is to be recommended as part of a healthy diet.”
Five of the world’s largest alcoholic beverage companies, namely Anheuser-Busch InBev, Diageo, Pernod Ricard, Heineken, and Carlsberg, subsequently agreed to pitch in $67.7 million for the study. Those funds would be provided indirectly through a nongovernmental foundation that raises funds for the NIH.
“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 Collins said in a statement. “We take very seriously any violations of these standards.”
The study, the Moderate Alcohol and Cardiovascular Health (MACH) trial, had begun enrollment February 5, 2018 and intended to take in 7,800 participants at 16 sites worldwide. Researchers were to assess over a 10-year period whether a single serving (approximately 15 grams) of alcohol each day could provide health benefits, such as lowering rates of cardiovascular disease, compared with no alcohol consumption.
But on May 10, the NIH halted enrollment pending the results of the internal investigations, conducted by the Advisory Committee to the Director (ACD) and the NIH Office of Management Assessment (OMA). The investigations were conducted at the behest of Collins after he learned of the media’s findings.
In the ACD’s draft report (PDF), investigators looked at the early interactions between staff at the NIH’s National Institute on Alcohol Abuse and Alcoholism (NIAAA), the MACH researchers, and alcohol industry representatives:
There was early and frequent engagement among these parties which appear to be an attempt to persuade industry to support the project. Several members of NIAAA staff kept key facts hidden from other institute staff members and the FNIH. The nature of the engagement with industry representatives calls into question the impartiality of the process and thus, casts doubt that the scientific knowledge gained from the study would be actionable or believable.
In addition to inappropriately pursuing funding, the cozy relationships also led to questions about the trial’s design.
Interactions among several NIAAA staff and industry representatives appear to intentionally bias the framing of the scientific premise in the direction of demonstrating a beneficial health effect of moderate alcohol consumption. Independent review of the trial plan raised concerns that there are insufficient patients and not enough follow-up time to allow for meaningful assessment of cancer endpoints. The composite primary endpoint does not include heart failure. Thus, the trial could show benefits while missing harms.
Overall, the ACD called for MACH to be terminated and for the NIH to take additional steps to prevent such issues from arising elsewhere at the NIH.
Similarly, the preliminary report by the OMA suggested that a small number of NIAA staff may have violated federal rules, which prohibit NIH employees from soliciting funds or donations to support NIH’s activities. The OMA also found evidence that the staff circumvented standard operating procedures to ensure fair competition for NIH funding.
Before the investigations’ findings were revealed, NIAAA Director George Koob had drawn scrutiny for his role in the study’s setup as well as his long-standing ties to the alcohol industry. In heated exchanges with reporters, Koob defended MACH, forcefully insisting that it was set up appropriately and that industry sponsorship was not an issue. Other academic researchers, meanwhile, had accused Koob of berating them and nixing research projects that were seen as hostile to the industry.
In today’s announcement, the NIH noted that it “will take appropriate personnel actions, but cannot comment on specific personnel matters.”
The NIH plans on an orderly closeout of MACH within the next few months. So far, $15.8 million of the planned $100 million has been spent on the trial. Of that, $11.8 million came from industry, and $4 million was provided by the NIAAA. Last week, beer giant Anheuser-Busch InBev said in a letter that it was withdrawing its funding pledge, which would have totaled $15.4 million.
