“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.”