Corrupt NIAAA "Healthy Drinking" Trial Suspended

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In a short-term victory for public health and transparency, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) has suspended its controversial MACH15 trial. The trial, designed to fish for evidence of the health benefits of "moderate" drinking, received $67 million in funding from Big Alcohol, rendering it suspect from the outset. Now, under pressure from watchdog groups and congress, National Institutes of Health (NIH) Director Francis Collins stopped enrollment in the study and ordered official reviews of NIAAA's process.

As the Washington Post reports, Collins told congress that "this particular study was set up in such a way that the funding is largely coming from the beverage industry and there is evidence that NIH employees assisted in recruiting those funds for this study in a way that would violate our usual policies." The NIH had rejected similar funding offers from pharma companies this past April, Collins noted.

Pressure from civic groups, spearheaded by Public Citizen and strongly supported by Alcohol Justice, brought the funding issue to the forefront of public debate. The issues at NIAAA, however, run deeper than an ill-conceived study. The proverbial "revolving door" has seen NIAAA Director George Koob go from alcohol industry research groups to public health. In the process, he promised to end government support of research into harmful marketing practices despite findings of major significance to the health promotion community. In addition, he had direct contact with alcohol industry representatives, reassuring them the institute would back away from research that cast Big Alcohol in a bad light.

Despite the suspension and review of the study, Public Citizen believes more needs to be done. In a statement, Dr. Michael Carome, director of Public Citizen's Health Research Group, said, "The institute cannot function effectively without independence from the alcohol industry and must support science-based inquiry into industry practices without fear of industry retaliation." He calls for the removal of Dr. Koob, and a full investigation from the inspector general of the Department of Health and Human Services, which oversees NIH. Still, he tells the <em>Post</em>, halting the study "is a small step towards restoring [NIH's] reputation."

"Suspending the study is not the same as ending it," said Carson Benowitz-Fredericks, Research Manager at Alcohol Justice. "If NIH decides its hands are clean, they can start it right back up. We need to move now to make sure NIH remembers its mission, dumps the dirty money, and refuses to be a marketing tool for Big Alcohol."

TAKE ACTION to tell your representatives to end the corrupt NIAAA study.

READ MORE about how the study is rigged to benefit Big Alcohol.

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How Corruption and Cash Led to NIAAA's "Healthy Drinking" Study

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National Institutes of Health Must Shut It Down Now

Alcohol Justice is calling for an immediate end to a rigged study on alcohol and health. The Moderate Alcohol and Cardiovascular Health Trial (abbreviated MACH15 by its lead investigators) seeks to evaluate the health-promoting effects of alcohol use. It is largely funded with industry money, staffed with industry-approved researchers, and causing government public health watchdogs to turn its back on vital research in the name of appeasing Big Alcohol.

"Healthy drinking" is already a boon to Big Alcohol. Even the slightest hints that alcohol could have a positive effect on health elicit fawning write-ups. These come despite the tenuous nature of the findings. A government-sponsored study reinforcing these findings would be an industry goldmine. Through ready allies at the National Institute of Alcohol Abuse and Alcoholism (NIAAA), the industry may get just that.

NIAAA senior staff, led by demonstrated friend-of-AB-Inbev Dr. George Koob, explicitly solicited over $67 million in funding from the alcohol industry, according to an expose in the March 17, 2018, New York Times. Moreover, follow-up reporting from STAT traced how NIAAA sought to aggressively suppress lines of research that might threaten industry profits.

The NIAAA-led Moderate Alcohol and Cardiovascular Health Trial, abbreviated MACH15 by its investigators, is now recruiting. The study seeks to assess the long-term health benefits of "moderate" drinking in 7,800 participants across 4 sites in the U.S., Netherlands, and Nigeria. Each participant will be randomized to either have 1 drink of alcohol per day or abstain from alcohol, for six years.

There are interesting questions that could come from this trial, including: what are the health risks of such low levels of drinking? Do people asked to regularly drink alcohol have any tendency to increase their consumption? Decrease it? The research team, led by Dr. Kenneth Mukamal of Beth Israel Deaconess Medical Center, are not asking those questions. Instead, they are only asking two: how can we prove that alcohol protects against cardiovascular events, and how can we prove that alcohol protects against diabetes?

"There are a lot of great questions about long-term, low-level exposure," said Carson Benowitz-Fredericks, MSPH, Research Manager for Alcohol Justice. "We know it’s carcinogenic at any dose, and that it becomes massively toxic at high doses. But this is so narrow in scope, it makes it seems like they could be fishing for a result."

Both the Times report and the study protocols show that the researchers have zero interest in many of the established harms of alcohol use. They are only looking at three outcomes: cardiovascular disease, pre-diabetes, and/or cognitive decline. In fact, the six-year window of the study makes detection of slow-developing conditions, ncluding cancers and gastrointestinal issues, less likely, even if the trial was set up to monitor those outcomes.

These limitations may not be an oversight, but rather the result of deliberate planning. Dr. Lorraine Gunzerrath, a retired senior adviser to NIAAA, told the times that Dr. Mukamal "already believed that moderate alcohol is a good thing." In fact, having published dozens of papers extolling the benefits of alcohol, his professional reputation depends on it. Speaking to Vox, Dr. Marion Nestle of New York University noted, "If want to know if moderate drinking is good for you, bad for you, or indifferent, you design a study to do that. If you want to prove moderate drinking is good for you, you design a study like [the NIH study]."

In fact, a line in the protocols authored by Dr. Mukamal specifies that the drinks taken by recipients in the drink-a-day group represent "a clinical scenario in which a moderate amount of alcohol is ‘recommended’ by a clinician for potential health benefits."

"No doctor in his right mind would prescribe alcohol for any condition," said Bruce Lee Livingston, Executive Director/CEO of Alcohol Justice, "given that the heart is not the only organ in your body."

This alone is a good reason why he should not be heading up a study with such profound importance to industry. However, Dr. Mukamal had already approached the alcohol industry on behalf of NIAAA with what amounted to a promise to find those results. The study would provide "a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases," according to a slide that Dr. Mukamal prepared for a series of meetings with the alcohol industry in 2013 and 2014, as reported by the Times. Another slide declared that when asking if alcohol reduces cardiovascular mortality, "we have strong reason to suspect so."

Also speaking to the Times, Dr. Michael Siegel of Boston University noted the study "is not public health research—it’s marketing."

Alongside his efforts to lure Big Alcohol with the prospects of commercially lucrative findings MACH15, Dr. Mukamal gave industry representatives the proposed protocols and the list of potential investigators. This, in effect, allowed the industry to pre-approve every piece of the study before agreeing to fund it. Ceding such privileges to industry funders violates a core tenet of NIH funding: that employees cannot solicit donations, because doing so effectively lets anyone with money dictate the public health agenda.

"The double-dealing here is a betrayal of the public trust," said Livingston. "NIAAA should work for those hurt by alcohol use, not pump up its own standing with the industry."

As Dr. Gunzerrath acknowledges, Dr. Mukamal did not approach the industry of his own accord. The idea to solicit funding from Big Alcohol originated in the highest office of NIAAA, as did the the promise that the trial would be led by an applicant like Dr. Mukamal. Dr. Koob, the director of NIAAA, went further. Not only did he provide assurances to industry about who would conduct "healthy drinking" research, he actively directed resources away from research that might hurt industry bottom lines.

In 2015, Dr. Siegel had been collaborating with Dr. David Jernigan of Johns Hopkins University on a NIAAA-funded study assessing the impacts of alcohol advertising on underage drinking. The two researchers were asked to come to the NIAAA offices to speak about the study. According to STAT, Dr. Koob told the two scientists, "I don’t f***ing care!" about the project’s findings. He then swore not to fund such investigations in the future.

One Dr. Koob and NIAAA leadership’s active efforts to woo industry dollars came to light, STAT obtained NIAAA emails showing that the director had already made the same vow to alcohol industry groups. In a late 2014 email exchange with Dr. Samir Zakhari, a leading executive at the Distilled Spirits Council, Dr. Koob disavowed the study and promised, "This will NOT happen again." At that point, Dr. Mukamal was already making presentations to eager industry representatives.

A follow-up STAT report shows that Dr. Koob made good on his threats to cut off alcohol marketing research studies. Dr. Jernigan had a 2015 grant proposal to NIAAA rejected despite the fact that it received high marks from scientific reviewers. Meanwhile, Dr. Koob told Diane Riibe of the U.S. Alcohol Policy Alliance that NIAAA would not fund "anything on taxes or anything on advertising." While he allowed studies funded under prior leadership to continue under his appointment, the only new grant was actually an extension to a longitudinal study on drinking behaviors in which advertising exposure was only a small part.

"The most generous read is that NIAAA leadership were way too invested in this single research angle," said Mr. Benowitz-Fredericks. "But when you're guiding health policy, you can't have tunnel vision like that. When you do, you can't see the people dying around you."

To end this failure of vision, Alcohol Justice calls upon the National Institutes of Health to immediately suspend MACH15 and return the funds to the industry. It needs to make sure none of its institutes solicit directly from industry funders. And it needs to reassure the public that it is concerned first and foremost with the health of the public.

TAKE ACTION to get NIH to end this biased and corrupt study now.

READ MORE about NIAAA leadership’s cozy relationship to Big Alcohol.

READ MORE about how this study will be used by industry to undermine public health.

READ MORE about Dr. Siegel’s investigations into the NIAAA scandal.

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