NIH Shuts Down Controversial Alcohol Study, Citing Improper Ties To Alcohol Industry
NIH finds staff “intentionally biased the framing of the scientific premise” and sought funding from Big Alcohol
The US National Institutes of Health (NIH) has terminated a controversial study examining whether consuming small amounts of alcohol every day could improve health. An investigation at the NIH concluded that the $100 million trial had been tainted by funding appeals to the alcohol industry, and its credibility compromised by frequent and early interactions between alcohol industry executives, scientists and government officials.
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 Collins, according to The Hill.
New York Times revelations trigger NIH actions
The Moderate Alcohol and Cardiovascular Health (M.A.C.H.) Trial was designed to follow over 7,000 people for years. Half of the study’s participants would be instructed to abstain from alcohol, while the other half would be told to have a drink every day. The study was largely being funded by major alcohol producers, through a nonprofit foundation linked to the NIH.
Earlier this year, a New York Times investigation revealed that officials at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the NIH, had solicited funding from the alcohol industry, a violation of federal policy. These revelations prompted the NIH to shut down enrollment in the trial and commence its own investigation.
The results of that investigation were released in a report. It found that several NIAAA employees “hid facts” from other colleagues, and that there appeared to be an effort to deliberately bias the study towards alcohol industry interest. The advisory panel conducting the investigation recommended that the trial be stopped altogether.
The early and frequent 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,” said the advisory committee’s report, according to The New York Times.
Alcohol industry officials offered input into the design of the trial, the investigators found.
The lead researcher for the trial, Dr. Kenneth J. Mukamal, discussed the methods with alcohol producers by email in August 2014, responding to questions raised by Diageo, Anheuser Busch InBev, and Big Alcohol front groups like the Distilled Spirits Council (DISCUS).
Another very clear line is if that interaction involves a manipulation of what the research plan is going to be to achieve a certain outcome that would be beneficial to the donors. And that was clearly happening in these discussions as well,” said Francis Collins, director of the NIH, according to NPR.
Flawed from the outset
The advisory panel conducting the investigation was extremely critical of the M.A.C.H. trial’s design, suggesting that the researchers’ interactions with the alcohol industry “appear to intentionally bias the framing of the scientific premise in the direction of demonstrating a beneficial health effect of moderate alcohol consumption.”
Two NIH experts reviewed the trial’s design and concluded that both the number of participants and the follow-up time were insufficient to assess important adverse outcomes of daily alcohol consumption, particularly its relationship to cancer.
Thus the trial could show benefits while missing the harms,” said the investigators’ report.
Furthermore, the trial omitted heart failure as a primary endpoint, and alcohol consumption is associated with a higher risk of heart failure, the investigators said.
Other experts have also expressed criticism and concern about the design of the study, for example that the trial was set to exclude any participants whose health might be compromised by low dose alcohol consumption, for instance in people with a history of substance use disorders, mental health problems, liver or kidney problems, certain cancers or family histories of cancer, as well as people who have never consumed alcohol.
These exclusions would have altered the results of the trial and minimized the potential harms, particularly to older adults, noted Dr. Richard Saitz, chair of the community health sciences department at Boston University School of Public Health.
Speaking at #alcoholpolicy 18 today on #mach15 “moderate” #alcohol study. #NIH investigating ethics. Funds from industry. Won’t imform total mortality or cancer. Results will not be generalizeable (>25 exclusions) but you can sure they will be generalized https://t.co/oweHVMasz4
— Dr. Richard Saitz (@UnhealthyAlcDrg) April 12, 2018