U.S. wooed alcohol industry for study

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 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 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 NIH, 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 NIH, 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 NIH. The lead investigator and NIH officials have said they never discussed the planning of the study with the industry. But a different picture emerges from emails and travel vouchers obtained by 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 NIAAA 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.

Dr. Kenneth Mukamal, an associate professor of medicine at Harvard Medical School and 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 fundraising may have violated NIH policy, which prohibits employees from soliciting or suggesting donations, funds or other resources intended to support activities. The campaign is bound to raise more questions about the independence of the investigators and the scientific integrity of the trial.

The presentations gave the alcohol industry an opportunity to preview the trial design and vet the investigators.