It was going to be a study that could change the American diet, a huge clinical trial that might well deliver all the medical evidence needed to recommend a daily alcoholic drink as part of a healthy lifestyle.
That was how two prominent scientists and a senior federal health official pitched the project during a presentation at the luxurious Breakers Hotel in Palm Beach, Fla., in 2014. And the audience members who were being asked to help pay for the $100 million study seemed receptive: They were all liquor company executives.
The 10-year government trial is now underway, and Anheuser Busch InBev, Heineken and other alcohol companies are picking up most of the tab, through donations to a private foundation that raises money for the National Institutes of Health.
The N.I.H., a federal agency, is considered one of the world’s foremost medical research centers, investing over $30 billion of taxpayer money in biomedical research each year. The vast majority of the funding goes to scientists outside the N.I.H., which manages the grants and provides oversight.
The alcohol study is overseen by the National Institute on Alcohol Abuse and Alcoholism, one of 27 centers under the N.I.H. The lead investigator and N.I.H. officials have said repeatedly that they never discussed the planning of the study with the industry. But a different picture emerges from emails and travel vouchers obtained by The New York Times under the Freedom of Information Act, as well as from interviews with former federal officials.
The documents and interviews show that the institute waged a vigorous campaign to court the alcohol industry, paying for scientists to travel to meetings with executives, where they gave talks strongly suggesting that the study’s results would endorse moderate drinking as healthy.
An N.I.A.A.A. official, now retired, said she followed up after the presentations with appeals for money, telling industry executives the research could not be done without their support.
The meetings in late 2013 and early 2014 included a “working lunch” at the Beer Institute convention in Philadelphia, and two meetings at the Washington headquarters of the Distilled Spirits Council, a liquor industry trade group, as well as the presentation at The Breakers.
Dr. Kenneth J. Mukamal, an associate professor of medicine at Harvard Medical School and now the lead investigator of the study, and Dr. John Krystal, a Yale University neuroscientist, argued that a long-term randomized controlled trial could dispel lingering doubts about the benefits of moderate daily drinking.
“A definitive clinical trial represents a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases,” said one slide in the scientists’ presentation at The Breakers. “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,” said another slide, referring to the large number of studies suggesting that moderate alcohol may be linked to reduced risk of cardiovascular disease.
The fund-raising may have violated N.I.H. policy, which prohibits employees from soliciting or suggesting donations, funds or other resources intended to support activities. At the least, the campaign is bound to raise more questions about the independence of the investigators and the scientific integrity of the huge trial.
The presentations gave the alcohol industry an opportunity to preview the trial design and vet the investigators. Indeed, the scientist leading the meetings was eventually chosen to head the huge clinical trial.
They also made the industry privy to pertinent details, including a list of clinical sites and investigators who were “already on board,” the size and length of the trial, approximate number of participants, and the fact that they could choose any beverage. By design, no form of alcohol — wine, liquor or beer — would be called out as better than another in the trial.
Dr. Michael Siegel, a professor of community health sciences at Boston University School of Public Health who was shown slides from the scientists’ presentation at The Breakers by The Times, said the study “is not public health research — it’s marketing.”
“This must have seemed like a dream come true for industry. Of course they would pay for it,” he said. “They’re admitting the trial is designed to provide a justification for moderate drinking. That’s not objective science.”
Asked about the meetings, Dr. Mukamal did not deny he had participated, but said the slides did not convey the full complexity of his presentation.
Last year, Dr. Mukamal told The New York Times that he had had “literally no contact with anyone in the alcohol industry in the planning of this.” He defended that statement saying the presentations took place long before the N.I.H. announced the funding grant in late 2015.
The description of the trial that he gave at the meetings was just a “boilerplate,” he said.
“My job there wasn’t to raise money,” Dr. Mukamal added. “It was to educate.”
A Vexing Question
The N.I.H. awards most research funds on a competitive basis, and grant applications undergo a two-tier review of the scientific merit and public import of a project, as well as the scientific integrity.
At a cost of $100 million, the new trial aims to resolve a persistent medical conundrum. Though excessive drinking is harmful and problem drinking is on the rise in the United States, many observational studies have found that moderate drinkers outlive abstainers and have less heart disease.
These studies don’t prove that moderate drinking is the reason these people live longer, however. The new trial, called the Moderate Alcohol and Cardiovascular Health Trial (M.A.C.H.), is intended to answer that question.
In January, Dr. Mukamal and his colleagues started recruiting volunteers ages 50 and older who are at high risk for heart disease; eventually there are to be 7,800 participants at 16 sites worldwide. Half will be told to abstain from alcohol. The rest, including both men and women, will be told to have one serving of alcohol a day.
No other long-term trial has ever asked participants to drink, much less drink every day. Scientists will track the two groups for six years on average to see whether daily drinkers have fewer heart attacks and strokes, and lower odds of diabetes and death.
The research will attempt to track the risks of drinking, but critics say it may not fully capture the harms. For one thing, the study will be too short to detect an increase in cancers linked to alcohol consumption, which may take decades to develop.
In addition, two servings has long been considered moderate drinking for men. Lowering the threshold may reduce falls, car accidents and alcohol abuse among the subjects; but one drink daily also may not reflect real-life habits.
Moreover, many people whose health might be compromised by light drinking — anyone with a history of addiction, psychiatric, liver or kidney problems, certain cancers or a family history of breast cancer — will not be allowed to participate. People who have never drunk alcohol also are excluded.
“You’re picking off the people who are most likely to have the harms,” said Dr. Richard Saitz, chair of the Department of Community Health Sciences at Boston University School of Public Health, after reviewing the parameters of the study.
But if the study finds even a modest cardiovascular benefit to light drinking, he added, “You can be sure that the way it will be understood by the general public is that this applies to everybody.”
Despite its shortcomings, M.A.C.H. may well be the last word on the subject of moderate drinking, since trials like these are both expensive and logistically complicated to carry out.
Dr. Mukamal, who has published nearly a hundred scientific papers on the relationship between moderate drinking and cardiovascular disease. emphasized in an interview that he was committed to reporting the results accurately based on the data.
“If anyone has any doubt whatsoever that our intent is to provide the most accurate and precise description of our findings, they are sorely mistaken,” he said.
‘They’d Be Happy’
Private contributions for the study from the alcohol industry are being channeled through the Foundation for the N.I.H., a nongovernmental entity that raises money for N.I.H. research and manages the partnerships established to direct private donations.
In this case, the industry donors were expected to be held at “arm’s length” and not to play any role in the research or to communicate with the scientists, said Julie Wolf-Rodda, director of development for the foundation.
George Koob, the current director of the National Institute on Alcohol Abuse and Alcoholism, said the foundation constitutes an impregnable “firewall” that prevents donors from interfering with research.
In an interview, he said he was unaware of the meetings between N.I.H. officials and industry officials to rally support for the study, most of which took place before he took the helm of the institute in late January 2014. He denied that the institute had solicited funding.
Raising his voice during an interview, Dr. Koob insisted the industry’s sponsorship would not compromise the study and said that the study protocol went through several rigorous reviews. “We do things right at N.I.H.,” he said.
But his predecessor, Dr. Ken Warren, who helped organize and participated in some of the meetings as acting director of the alcohol abuse institute, acknowledged in an interview that the scientists’ presentations were meant to both “demonstrate to the industry that the study was feasible” and “to determine if they had interest in taking part” as funders.
Questions about moderate drinking and heart disease are important public health questions, Dr. Warren said, and a government trial would be more credible than research “directly funded by an entity such as the alcoholic beverage industry, which could be considered biased.”
Most of the cost of this government trial, however, is being picked up by five of the world’s largest alcoholic beverage makers — Anheuser-Busch InBev, Heineken, Diageo, Pernod Ricard and Carlsberg.
In an interview, Dr. Lorraine Gunzerath, a retired senior adviser to Dr. Warren, took credit for coming up with the idea of reaching out to the alcohol industry for funding.
Clinical trials like this one don’t fall neatly under the mission of the alcohol abuse institute, she said. “We were supposed to be preventing alcoholism, so to spend that kind of money on research for a possible good use of alcohol was something that would never fly,” she said.
But, referring to the alcohol industry, Dr. Gunzerath said, “If we had a clinical trial, and it was a positive result — which we thought it might be, you sort of think you know where it’s going — they’d be happy.”
All the N.I.H. had to do was “make a business case to the industry that it would be to their benefit, even if they couldn’t actually control the trial’s outcome,” Dr. Gunzerath said.
She arranged for the university scientists to address executives at alcohol industry meetings. “If they didn’t like the research team, they would have said no,” she said.
It was no secret at the time that Dr. Mukamal and his collaborators “already believed that moderate alcohol is a good thing,” she said. He already had published papers suggesting as much.
After the scientists’ presentations, which were provided to The Times by Dr. Gunzerath, she would speak briefly to say that “it would be nice if we could get money from the industry,” but explain that funds would have to flow through the foundation.
On Sept. 30, 2013, Dr. Gunzerath sent an email headed “URGENT! Response needed ASAP!” to Dr. Mukamal, inviting him to Philadelphia to address the annual meeting of the Worldwide Brewing Alliance, to get the brewers’ “buy in” and “extra overall funding potential as well.”
“I can make it,” Dr. Mukamal responded. “I could do any version or part or the whole day, night before or drive down that day etc. whatever works best for you.”
Dr. Gunzerath and Dr. Warren also arranged meetings between the scientists and industry representatives at the Distilled Spirits Council’s Washington headquarters on Nov. 21, 2013, and Jan. 28, 2014.
A spokesman for the Distilled Spirits Council said that after the N.I.A.A.A. approached the trade group in 2013, the council “provided them with a forum to present the initial outline of their study.”
Representatives of Anheuser-Busch InBev, Heineken and Diageo confirmed that the scientists’ presentations played a role in the companies’ decisions to underwrite the trial.
“When Heineken was invited by the N.I.H. to partially fund the N.I.A.A.A. trial for a duration of ten years, as part of our decision making process, the scientists presented the research project to us so we would have a sound understanding of the trial,” Michael Fuchs, a company spokesman, said in an email.
These days, it is not unusual for the N.I.H. to look to business to participate in public-private partnerships to fund medical research. When an N.I.H. center is seeking outside funding from the private sector, it starts by submitting a “request for collaboration” to a steering committee of the N.I.H. and the foundation based in the office of the director of the N.I.H., Dr. Francis Collins.
For the moderate drinking trial, the alcohol abuse institute signed an agreement with the foundation that said, “Under no circumstances shall N.I.A.A.A. or its representatives communicate directly with any Donor in order to raise funds for the project or to disclose to any Donor any information” about “the name and affiliation of the awardee” or “details and information relevant to the award.”
But by the time the institute submitted the request for outside funding in early 2015, its officials and outside scientists had already met with alcohol industry executives. Representatives of beer and liquor companies had already heard directly from Dr. Mukamal.
The alcohol abuse institute took an extra step to secure Dr. Mukamal’s position as top contender for the grant. While N.I.H. grants are supposed to be awarded on a competitive basis, the institute’s request for outside funding said the award would be restricted to applicants with “unique” resources and backgrounds — and specifically mentioned Dr. Mukamal, who had helped persuade the alcohol industry to fund the research.
Whether scientists studying alcohol should accept money from the industry has long been controversial. Many scientists and policymakers have publicly said that any engagement with the alcohol industry undermines the credibility of the research.
In 2016, a group representing hundreds of scientists and policymakers published a statement saying researchers should never accept direct or indirect industry funding, and that “any form of engagement with the alcohol industry may influence the independence, objectivity, integrity and credibility” of the research.
“We know that industry funding not only affects the results of studies but affects the questions that are asked, how the results are analyzed and what the answers are,” said Dr. Adriane Fugh-Berman, a professor of pharmacology at Georgetown University and director of Pharmed Out, a group that researches drug marketing.
If the health effects of moderate drinking are a priority for the N.I.H., she added, “they should fund it themselves.”