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$100m alcohol study is cancelled amid pro-industry “bias”

BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k2689 (Published 19 June 2018) Cite this as: BMJ 2018;361:k2689
  1. Owen Dyer
  1. Montreal

The US National Institutes of Health (NIH) has cancelled its $100m (£76m; €87m) prospective study into the health effects of moderate drinking, after an internal investigation found that government scientists seeking to win alcohol industry funding for the research had told executives that the study could offer the “level of evidence necessary if alcohol is to be recommended as part of a healthy diet.”

The NIH investigation report concluded, “Interactions among several NIAAA [National Institute on Alcohol Abuse and Alcoholism] 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.”1

The Moderate Alcohol and Cardiovascular Health (MACH 15) trial was due to recruit 7800 participants and randomly assign them to moderate drinking (one drink a day) or no drinking. It was run by the NIAAA, an NIH agency.

But the ambitious scale brought a heavy reliance on industry funding, and the NIH investigation found “early and frequent engagement” between officials and the alcohol industry that seemed 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.”

These conversations were reported by the New York Times in March, sparking congressional hearings and causing the trial’s recruitment to be frozen at only 105 participants.

NIAAA officials told industry representatives that MACH 15 “represents a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases,” particularly heart disease, the New York Times reported.2

Appearing before Congress in April the NIH’s director, Francis Collins, said, “We are looking into this in a very aggressive way,” and he announced the investigation that has now substantiated the newspaper’s claims.

The investigation also looked at allegations raised in April by the website Stat against the NIAAA’s director, George Koob, who was accused of shutting down research into the effects of alcohol advertising after he arrived at the agency in 2014.34

At one point, Stat reported, he yelled, “I don’t fucking care” at Boston University researchers who were presenting the findings of NIAAA funded advertising research, and he told them that the agency would do no more such research under his direction.

Collins told Congress in April that the NIH investigation was “looking at the whole spectrum, going back to before Dr Koob came when there were questions about how this interaction with the beverage industry happened, going right up to the present.”

The report found that the NIAAA’s policy focus had shifted since Koob’s arrival, with no new research commissioned into alcohol advertising, although support continued for ongoing research. It is still not clear where that finding leaves him, as the report says, “It is not unusual for Institute research portfolios to evolve over time.”

Koob arrived at the NIAAA after problematic MACH 15 meetings. He said that he agreed with the decision to stop the study, calling it “irrevocably damaged.”

Last week the study’s biggest industry sponsor, Anheuser-Busch, which makes Budweiser beer, withdrew its $15m funding commitment, writing to the NIH that, “unfortunately, recent questions raised around the study could undermine its lasting credibility, which is why we have decided to end our funding.”

The NIH report found that the trial’s design favoured short term cardiovascular endpoints. “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,” it said. “The composite primary endpoint does not include heart failure. Thus, the trial could show benefits while missing harms.”

The investigation also found that “sustained interactions between the eventual principal investigator of the MACH trial and members of the NIAAA leadership . . . appear to have provided the eventual principal investigator with a competitive advantage not available to other applicants, and effectively steered funding to this investigator.”

The MACH trial’s principal investigator, Kenneth Mukamal of Beth Israel Deaconess Medical Center, issued a response saying that he and rest of the research team were “deeply disappointed” by the trial’s closure. “We stand fully and forcefully behind the scientific integrity” of the study, he said. “Every design consideration was carefully and deliberately vetted with no input or direction whatsoever from private sponsors.”

Collins remarked, “This is a matter of the greatest seriousness,” adding that the NIH is launching a general review to seek out even “subtle examples of cosy relationships” with industry that could compromise research.

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