The National Institutes of Health is starting a $100-million clinical trial to test for the first time whether a drink a day really does prevent heart attacks.
It may be the most palatable advice you will ever get from a doctor: have a glass of wine, a beer or a cocktail every day, and you just might prevent a heart attack and live longer. But the mantra that moderate drinking is good for the heart has never been put to a rigorous scientific test, and new research has linked even modest alcohol consumption to increases in breast cancer and changes in the brain. That has not stopped the alcoholic beverage industry from promoting the alcohol-is-good-for-you message by supporting scientific meetings and nurturing budding researchers in the field.
Now, the National Institutes of Health is starting a $100-million clinical trial to test for the first time whether a drink a day really does prevent heart attacks. And guess who is picking up most of the tab? Five companies that are among the world’s largest alcoholic beverage manufacturers—Anheuser-Busch InBev, Heineken, Diageo, Pernod Ricard and Carlsberg—have so far pledged $67.7 million to a foundation that raises money for the National Institutes of Health, says Margaret Murray, the director of the Global Alcohol Research Program at the National Institute on Alcohol Abuse and Alcoholism, which will oversee the study. The decision to let the alcohol industry pay the bulk of the cost has raised concern among researchers who track influence-peddling in science. “Research shows that industry-sponsored research almost invariably favours the interests of the industry sponsor, even when investigators believe they are immune from such influence,” says Marion Nestle, a professor of nutrition and food studies at New York University who is the author of several books on the topic.
The international effort to study the benefits and risks of alcohol will recruit nearly 8,000 volunteers aged 50 or older at 16 sites around the world, starting at medical centres in the USA, Europe, Africa and South America. Participants will be randomly assigned to quit alcohol altogether or to drink a single alcoholic beverage of their choice every day. The trial will follow them for six years to see which group—the moderate drinkers or the abstainers—has more heart attacks, strokes and deaths. The study organisers conceded that it would be a challenge to recruit volunteers, who will not know in advance whether they will be assigned to abstain or be required to drink. Those in the drinking group will be partly reimbursed for the cost of the alcohol. George F Koob, the director of the alcohol institute, says the trial will be immune from industry influence and will be an unbiased test of whether alcohol “in moderation” protects against heart disease.
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“This study could completely backfire on the alcoholic beverage industry, and they’re going to have to live with it,” Koob says. “The money from the Foundation for the NIH has no strings attached. Whoever donates to that fund has no leverage whatsoever—no contribution to the study, no input to the study, no say whatsoever.” But Koob, like many of the researchers and academic institutions playing pivotal roles in the trial, has had close ties to the alcoholic beverage industry. Koob served from 1999 to 2003 on the medical advisory council of the Alcoholic Beverage Medical Research Foundation, now called the Foundation for Alcohol Research, an industry group that also provided him research grants of up to $40,000 a year between 1990 and 1994, says John Bowersox, a spokesman for the NIH’s alcohol institute.
Indeed, many of those involved in the study have financial links—either personally or through an institution—to alcohol industry money. Harvard, the hub of the clinical trial, has a long relationship with the alcoholic beverage industry. One of the trial’s principal investigators, Eric Rimm of the Harvard TH Chan School of Public Health, has acknowledged through various financial disclosures that he has been paid to speak at conferences sponsored by the alcohol industry and received reimbursement for travel expenses. He said it had been at least eight or nine years since those events, and he has no current relationship with the alcoholic beverage industry. The principal investigator of the new study, Kenneth J Mukamal, a Harvard associate professor of medicine and a visiting scientist at the school of public health, says he has never received funding from the industry. Mukamal, who has published dozens of papers on the health benefits of alcohol consumption, says he was not aware that alcohol companies were supporting the trial financially.
“This isn’t anything other than a good old-fashioned NIH trial,” he says. “We have had literally no contact with anyone in the alcohol industry in the planning of this.” A spokeswoman for Pernod Ricard, one of the beverage firms that has pledged money to pay for the study, says company officials signed on because they were impressed by the ambitious scale of the trial.
Scientists first floated the hypothesis that moderate alcohol consumption is good for one’s health nearly 100 years ago, when a Johns Hopkins scientist published a graph showing that modest drinkers lived longer than not only heavy drinkers, but also abstainers. Critics of the alcohol hypothesis say moderate drinking may just be something that healthy people tend to do, not something that makes people healthy.
Despite the heart-healthy hypothesis, plenty of studies have linked moderate drinking to more health problems. One study found an increased rate of atrial fibrillation among moderate drinkers. Proponents of the moderate alcohol hypothesis, on the other hand, pointed to alcohol’s anti-clotting effects and its apparent ability to raise the level of so-called good cholesterol to help explain its benefits.
The new trial defines moderate drinking as one serving a day, defined as 12 ounces of beer, 5 ounces of wine or 1.5 ounces of distilled spirits. The definition is significantly lower than what has typically been considered a moderate level of drinking for men, which has long been defined as up to two servings a day. Moderate drinking for women has been defined as one serving a day. The recruits will be men and women, all of whom either have cardiovascular disease or are at high risk for developing it. Investigators have not determined how they will verify that participants are sticking to their regimens of one drink a day or no alcohol at all. And while the investigators’ goal is to recruit an equal number of men and women, and analyse results by gender, Mukamal says the trial most likely would not be able to detect gender differences unless they are pronounced.
The lack of focus on gender differences related to alcohol consumption has drawn criticism. It is already known that women metabolise alcohol more slowly than men, and that heart disease in women is different than it is in men. Women respond differently than men to many medications because of differences in body fat, size, liver metabolism and kidney function. As currently planned, the alcohol trial “makes the assumption that men and women are the same biologically, and that’s not true,” says Anne McTiernan, a physician and researcher at Fred Hutchinson Cancer Research Center in Seattle. “This sort of thing has been a problem in some NIH studies for a long time.”
Art Caplan, the director of medical ethics at the NYU School of Medicine, says the concern is that any findings supporting the benefits of alcohol could easily be misinterpreted. “If there is some health benefit for people over 50 from one drink a day, many people will just hear that alcohol is good for you, and some will say, ‘ I can drink all the beer I want,’” he says.
Roni Caryn Rabin