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After canceling an ethically dubious trial, NIH sticks with a muddled message on booze

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Mary Chris Jaklevic is a reporter-editor at HealthNewsReview.org. She tweets as @mcjaklevic.

After a public outcry, the National Institutes of Health recently halted an industry-funded trial to find out whether moderate alcohol consumption promotes heart health.

But its advice to the public on drinking remains problematic.

Last week a link to the agency’s Rethinking Drinking website was sent to HealthNewsReview.org’s general email as part of a seasonal media promotion, according to a consulting firm acting on NIH’s behalf.

The website, created in 2009, offers “research-based” tools to help people who already drink decide whether they should cut back.

What caught our attention was this sentence on the home page: “Drinking can be beneficial or harmful, depending on your age and health status, and, of course, how much you drink.”

There was also this from its Q&A:

Isn’t drinking good for the heart?

For some people, the answer can be “yes,” depending on the amount. Regular light to moderate drinking can lower the risk for coronary heart disease, mainly among middle-aged and older adults (other factors also cut the risk, including a healthy diet and weight, exercise, and not smoking). Heavy drinking can actually increase blood pressure and damage the heart.

It’s curious that the agency is stating that drinking can help the heart, when the point of the aborted trial was to find out whether that’s actually the case. If we already know the answer, why try to launch an expensive clinical trial?

Others we reached out to asked the same question.

“Why would the agency invest so much time and tens of millions of dollars to conduct such a study if we already knew the answer?” said Michael A. Carome, M.D., director of health research at the watchdog group Public Citizen, via email.

Association studies don’t prove a benefit

The heart benefit theory has long been put forth by the alcohol industry, bolstered by observational data that showed people who drink moderately tend to have less heart disease.

Those studies may have swayed some physicians and consumers to believe a benefit exists, but they are not definitive.

It’s worth noting that the suggestion that there’s a health benefit doesn’t align with messaging of other major health organizations. For example, the U.S. government’s Dietary Guidelines recommend against people starting to drink “for any reason.”

Some doctors disagreed with the “benefit” wording.

Richard Saitz, MD, chair of community health sciences at Boston University’s School of Public Health, said the mention of a cardiovascular benefit “really effects the clarity of the message” that drinking even what are considered moderate amounts causes known harms, including various cancers. He said it might lead some people to drink slightly more than they otherwise might.

“In my opinion it would be better if (the statements) weren’t there,” Saitz said. “It would be better if it said something like, we don’t know, or it’s uncertain, or there’s disagreement in the public health and research community about whether there’s any benefit.”

Recent data cast doubt

Recent studies — including an analysis published in the Lancet of nearly 600,000 people in high-income countries — have cast doubts on the existence of health benefits from alcohol.

Cardiologist and HealthNewsReview.org contributor Christopher Labos, MD, said via email: “I think the messaging here doesn’t really acknowledge how shaky the evidence base really is.”

Labos said “increased risk of cancer and the added calories and sugar you get from alcohol would likely outweigh” any possible cardiovascular benefit, and he’s skeptical that a cardiovascular benefit in fact does exist.

“I can’t see my way to saying alcohol can be healthy,” another HealthNewsReview.org contributor, addiction specialist Michael Bierer, MD, said in email. “I’m fine with my patients (adults) making an informed decision to drink below ‘recommended’ levels, especially if they are able to voice the risk: ‘I like the taste/effect enough to bear the risk of this carcinogen.'”

A cautionary tale: estrogen therapy

Saitz noted that estrogen therapy was widely prescribed by doctors for decades based on data that showed women who had the therapy had fewer heart attacks, but a randomized clinical trial found it actually put them at higher risk of heart disease, breast cancer, and other disease. In that case, experts think women who took estrogen tended to have higher incomes and healthier lifestyles overall.

A similar situation could be true with some of the alcohol studies. For example, people who abstain might have health problems that preclude them from drinking, known as the “sick quitter” effect. That means people who do drink at moderate levels tend to be healthier by comparison.

As the New York Times reported, NIH scientists wooed alcohol manufacturers to back a randomized clinical trial they said could provide definitive proof that “moderate alcohol consumption is safe and lowers risk of common diseases” and offer the “level of evidence (that) is necessary if alcohol is to be recommended as part of a healthy diet.”

What constitutes balance?

The Rethinking Drinking materials were co-written by psychiatrist Mark Willenbring, MD, who at the time was the director of Division of Treatment and Recovery Research in the NIH’s National Institute on Alcohol Abuse and Alcoholism (NIAAA).

In an interview with HealthNewsReview.org, Willenbring called the evidence “really quite strong on that (cardiovascular benefit) if you look at the overall literature, especially for middle-aged men. With any scientific findings there are skeptics, especially with something like this.”

Willenbring said he doesn’t think suggesting a benefit would encourage drinking. “I think people who drink too much don’t need a rationalization like that,” he said.

He said a heart benefit was mentioned as “an attempt to be balanced about it and not to err on the side of caution with the idea that you’re going to be discouraging a bad habit. To me those things always ring hollow. Rethinking Drinking, I think, has credibility because it’s so balanced.”

But Michael Siegel, MD, a professor in community health sciences at Boston University, who has received NIH funding for research on alcohol advertising, didn’t buy that.

“Making up a piece of information that’s not scientifically justified is not balanced,” Siegel said. “It’s misleading at the very least.”

“This is exactly what the alcohol industry wants the NIAAA to do and say,” he added.

Editor’s note: After this post was published, a spokesperson with the the NIAAA sent this response:

“The Rethinking Drinking website, which was originally produced in 2009, was based on epidemiological studies showing associations between moderate alcohol consumption and reduced risk for certain diseases, e.g. cardiovascular disease, ischemic stroke, etc.; however, the results of more recent epidemiological research, including numerous meta-analyses, have been mixed. NIAAA is reviewing its resources to ensure that they reflect the current state of the science on the health effects of alcohol.”

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