The National Institutes of Health is facing mounting criticism and questions amid a series of reports outlining what appears to be an all-too-cozy relationship with the alcohol industry.

Central to the concerns are how the federal research agency schmoozed industry executives into donating tens of millions of dollars for a study assessing the potential health benefits of daily drinking. Researchers and NIH officials pitched the study by strongly suggesting that it would end up endorsing moderate drinking as part of a healthy lifestyle, documents and interviews showed.

Amid that wooing, other researchers claimed for the first time Monday that they were scolded by agency officials for collecting data that appeared critical of the alcohol industry. They also suggest that the agency spiked a similarly critical research proposal, despite that it was highly ranked by scientific peers who evaluate proposals for funding purposes.

In a statement last month, NIH Director Francis Collins said that the “NIH will be looking into this matter.” He also told reporters that “there are concerns that... there may have been some inappropriate discussions that went on between people working at NIH unbeknown to me and the beverage industry,” according to The Washington Post.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA), which is at the center of the controversy, did not immediately respond to a request for comment from Ars.

Tipsy track record

One of the first sips of scandal dates back to last July when The New York Times reported on the study looking at potential benefits of booze, dubbed the Moderate Alcohol and Cardiovascular Health Trial (MACH). The $100 million-dollar, 10-year study is now underway and will ultimately enroll 7,800 participants aged 50 or over at 16 sites worldwide. Half of the participants will abstain from hooch, while the rest will imbibe one serving a day. Scientists will track participants for an average of six years, looking at risks of heart attacks, strokes, diabetes, and death.

The Times article noted that $67.7 million for the study came—indirectly—from five of the world’s largest alcoholic beverage companies, including Anheuser-Busch InBev, Diageo, Pernod Ricard, Heineken, and Carlsberg. The companies pledged the money for the study through a foundation that raises funds for NIH research. Many of the researchers at the receiving end of those funds already had close personal ties and/or financial links to the alcohol industry, the Times article noted. That includes NIAAA Director George Koob, who, for years prior, served on an industry advisory board that also provided him with tens of thousands of dollars in research funding.

Koob was dismissive of any conflicts of interest at the time, however, telling the Times: “This study could completely backfire on the alcoholic beverage industry, and they’re going to have to live with it. The money from the Foundation for the NIH has no strings attached.”

But the links and the funding didn’t sit well among the research community, who are all too aware that industry-sponsored research often ends up favoring the interests of industry. Many also noted weaknesses in the study's design, including the short duration, limiting “moderate” drinking to one drink rather than the more common two, and lumping men and women’s health assessments together. In a subsequent story in Wired from October, researchers again expressed concern, with alcohol researcher Jürgen Rehm of Toronto’s Centre for Addiction and Mental Health telling the magazine that "the way this is set up, it smells."

The Wired article also noted that Koob and NIAAA Director of Global Alcohol Research Margaret (Peggy) Murray both appeared in a promotional video for Anheuser-Busch InBev, one of the MACH funders, as the NIAAA was setting up for the trial. The video was about company-sponsored research.

Over a drink

The situation looked even more ethically dubious after a follow-up report in The New York Times published March 17 of this year. Based on emails and travel vouchers obtained through a Freedom of Information Act request, as well as interviews, the Times reported that the NIAAA “waged a vigorous campaign” to pursue industry funding in 2013 and 2014. This involved having scientists schmooze with industry executives at meetings and lunches, allowing executives to preview the trial design and vet researchers who strongly suggested the study would end in their favor.

Kenneth Mukamal, of Harvard Medical School and now lead investigator of the MACH trial, along with John Krystal, a Yale University neuroscientist, forcefully pitched the trial as being able to dispel concerns about moderate, daily drinking. And their pitch was followed up with NIAAA officials who urged them to financially support the study.

“A definitive clinical trial represents a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases,” one of the scientists’ slides read. “That level of evidence is necessary if alcohol is to be recommended as part of a healthy diet.”

“We have strong reason to suspect so,” another slide read, referring to the previous research linking moderate alcohol to reduced risks of cardiovascular disease.

The Times concluded that its efforts may have violated NIH policies, which prevent employees from soliciting funds, donations, or other resources to support NIH activities. The NIH is now investigating whether that was the case. NIH Director Francis Collins noted in his response to the latest Times report that the NIH signed a memorandum in 2016 with the foundation, which would limit contact between NIH officials and industry sponsors. But he expressed concern about what went on before that memorandum was in place.

For his part, Koob raised his voice during an interview for the latest Times article, insisting that the industry sponsorship was not an issue and that the study was set up appropriately.

Bottoms up

On Monday, Stat reported another troubling wrinkle to the story: while the NIAAA was ironing out its industry-sponsored study on alcohol’s potential benefits, it was finishing off research that might appear hostile to the industry.

Alcohol researchers David Jernigan of Johns Hopkins University and Michael Siegel of Boston University told the news outlet that they were summoned to a meeting at the NIH, in Bethesda, Maryland, with Director Koob in 2015. The meeting was regarding their NIH-funded work assessing the links between alcohol industry advertising and underage drinking. The pair received roughly $600,000 a year between 2011 and 2014 to fund work that resulted in 27 publications in respectable, peer-reviewed journals. One of those, published in 2014, found a “robust relationship” between brand-specific alcohol TV commercials and consumption of those branded alcohols by teenagers.

The findings did not sit well with Koob, who allegedly leapt screaming from his chair during his meeting with Jernigan and Siegel. After hearing a summary of their research findings, the pair said he hotly yelled “I don’t f***ing care!” He also indicated that such research would not be funded in the future.

Koob was true to his word, apparently. The pair submitted another grant application later in 2015, proposing to study whether alcohol brands’ use of social media influences underage drinking. The proposal scored “in the exceptional range” among scientific-grant reviewers, according to the evaluation shared by Siegel. The scientists recommended the proposal for funding. But a secondary review, led by Koob, denied the project funding without explanation.

According to emails obtained by Stat through a public records request, Koob had rushed to reassure industry about Siegel and Jernigan’s work—months prior to their tense meeting at the NIH. In an email dated July 30, 2014, Koob wrote to Samir Zakhari, senior vice president for science at the Distilled Spirits Council of the United States, the lobbying group for alcoholic beverage producers.

Koob, who took over the role of NIAAA director in January 2014, wrote:

Sam: For the record. This will NOT happen again. It was funded over three years ago under a PA [project announcement] that does not exist anymore. I will NOT be funding this kind of work under my tenure. Best wishes George.”

Zakhari, who joined the lobbying group after retiring from two decades of work at the NIAA, responded two hours later, writing:

Thanks, George.

I am 100% sure that you will spend research money on real science. You have several people in the division of epidemiology who push to fund this kind of research out of shear [sic] ignorance or because they are sympathetic. This kind of research not only wastes precious research dollars but also damages NIAAA’s stature within the NIH community. Best regards,

Sam

In a statement to Stat, Koob said that his email to Zakhari was “to convey that I had no intention of supporting research that was not of the highest scientific quality. NIAAA funds a vast amount of research on underage drinking, which is among the Institute’s top research priorities.”