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Big Booze helped plan $100 million NIH study on alcohol–here’s how they’ve also tried to influence journalists

Kevin Lomangino is the managing editor of HealthNewsReview.org. He tweets as @KLomangino.

Like a St. Patrick’s Day hangover, news of federal researchers courting liquor company executives for funding leaves a bad taste in the mouth of many who care about the quality and independence of science at the National Institutes of Health.

The New York Times reported yesterday that the lead researchers on a $100 million study of the effects of moderate alcohol consumption had extensive discussions with the alcohol industry prior to securing their sponsorship. Those discussions–during which researchers told industry representatives they had “a strong reason to suspect” that moderate alcohol consumption is beneficial–included specifics about how the trial would be planned and conducted, according to the Times, which reviewed e-mails and travel vouchers obtained via a Freedom of Information Act request. The researchers had previously denied discussing the planning of the study with anyone in the alcohol industry.

Wired Magazine also raised questions about the role of beverage companies in the planning of the study in October, 2017.

The new revelations are pertinent to journalists who may be or will be covering the study and its eventual findings — as well as news consumers who will be reading about the study.  The alcohol industry is not just interested in funding research that will help promote its products; it’s also funding journalism organizations whose members will be reporting on this research.

‘Not public health research — it’s marketing’

Here are the key excerpts from the Times describing the NIH’s discussions with industry executives:

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.”

The deeply reported story includes input from Lorraine Gunzerath, PhD, a retired NIH official who helped arrange the industry sponsorship. She acknowledges that alcohol industry representatives “would have said no” if they didn’t like the research team being proposed to run the trial. Moreover, the NIH took steps to ensure that investigators acceptable to industry — including Kenneth Mukamal, MD, who had published extensively on the potential benefits of moderate alcohol consumption — were selected to receive the grant money.

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.

A ‘troubling’ and ‘disturbing’ approach

Arthur Caplan, PhD, a professor of bioethics at New York University, described the Times report to me as “very disturbing.”

“The message has been going out that the Foundation for the NIH [a private entity that raises money for the agency] puts a firewall between sponsors and who to fund and what to fund,” he said. “But the suggestion here is that funders were lured in by the promise of favorable results, and the routing of the funding to particular investigators. That can’t be. The NIH’s reputation depends on independence — that’s where its trustworthiness comes from.”

Caplan said that in his view, it isn’t necessarily a problem to include industry in the mix of funders for important public health research. However, he said that such funding partnerships have to include “an ironclad policy” and “can’t deviate from gold standard practices to minimize conflict of interest.” Pointing to the NIH’s recent termination of an agreement with the National Football League to conduct concussion research, Caplan said it appeared that the federal agency was having problems maintaining those gold standard policies in its industry relationships.

“It looks like the funders have been trying either to get hoped-for results or to handpick the people to carry out the work, and that’s just not consistent with what’s necessary for independent peer-reviewed science,” Caplan said. “It’s very troubling.”

Big Booze also funding journalism

We’ve been following this story since last summer, when we learned that the alcohol industry wasn’t just funding research on moderate drinking — it was also funding journalism in a possible attempt to sway public opinion.

Our publisher, Gary Schwitzer, wrote that the Foundation for Advancing Alcohol Responsibility, founded by distillers, funded two all-expenses-paid training sessions for journalists hosted by the Poynter Institute. The Foundation CEO, Ralph Blackman, spoke to journalists at one of the meetings, another instance where a necessary firewall — this time between funders and the journalists attending the workshop — wasn’t strong enough to withstand industry pressure.

The Poynter Institute revised its ethics policy following our criticism.

But Carl Elliott, MD, PhD, a bioethicist at the University of Minnesota, said the Poynter Institute’s policies still don’t go far enough. He said their emphasis on disclosure of relevant industry conflicts isn’t sufficient to prevent those conflicts from introducing bias.

“The answer is to say no,” he said. “Journalists shouldn’t take money and gifts from organizations they will be covering. This is not a hard ethical dilemma. Does any journalist really think that they’re getting free meals and travel money and conference expenses because the booze industry has a deep interest in their education? For that matter, why would the Beer Institute have any interest in funding a study that doesn’t promote the interests of companies that make beer?”

Daniel Goldberg, JD, PhD, an ethicist at the University of Colorado, Denver, agreed that emphasis on disclosure in these situations may ultimately distract from more important issues.

“It is not good enough to argue that disclosure of these relationships is sufficient, and we proceed at our peril when we spend all of our time and energy debating whether the disclosure was appropriate,” Goldberg said.

“Relationships with regulated industries have the significant probability of altering the professional behavior of scientists, research teams, and health professionals. We have excellent evidence for this, both experimental and natural. Moreover, industrial efforts to purchase credibility by partnering with respected scientists is part of an older historical script, one intimately connected to the manufacture of doubt.”

Connecting the dots: Industry, research, journalism

It’s not too difficult to connect the dots between the alcohol industry’s funding of medical research and its funding of journalists who might report on that research.

After all, if you’re going to invest $100 million in a study, wouldn’t it make sense to cultivate sympathetic journalists to help put a nice shine on the results?

“That’s a real danger,” said Caplan, who noted that industry is always on the lookout for opportunities to broadcast good news about its products. He said that sometimes industry really does contribute to advances that merit the positive coverage they receive. But industry also has a tendency to spin negative results to its advantage.

“You have to aware that the goal of industry is the make money and the way you make money is put out messages that are favorable,” he said.

What does this mean for journalists? Caplan emphasized three points for any reporter who may cover this story, either while the study is ongoing or when the results are eventually reported.

  1. “Pay attention to who wrote the news release.” This is a prime opportunity for a sponsor to introduce spin, and these public relations documents should be written solely by the NIH without input from the alcohol industry. “I would be nervous about any press release that was written jointly with industry,” he said.
  2. “Wait until the results are published in a peer-reviewed journal; don’t report from a  press conference.” The peer-reviewed study will include details that investigators and sponsors will likely gloss over in any press conference about the research.
  3. “Start lining up the critics right now.” Many public health researchers believe that the design of the current study doesn’t adequately account for the harms of alcohol, such as the potential to slide into alcoholism or the long-term risk of cancer that may be increased by regular alcohol consumption.

Says Caplan: “A lot of people would be thrilled to hear that moderate drinking is good for you because they want an excuse to justify their habit. You need to hear those balancing voices who say this may not be as good as it sounds.”

Addendum 3/21/18: The New York Times is reporting that the NIH is now investigating “whether health officials violated federal policy against soliciting donations when they met with alcohol companies to discuss funding a study of the benefits of moderate drinking.”  In addition, the NIH director “will ask outside experts who are part of a standing advisory committee to review the design and scientific methodology of the 10-year government trial, which is already underway.”

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Barry Clark

March 21, 2018 at 9:56 am

Imagine that alcohol was not available as booze and a pharma company submitted it to the FDA as a heart medication. The FDA would not approve it. There are plenty of safer alternatives: low-dose aspirin, generic Plavix, triflusal (if the FDA ever approves it), statins, many foods high in antioxidants, etc.

There is also the HDL cholesterol claim, which the booze industry clings to for dear life. Here is what the Mayo Clinic says about HDL, “High-density lipoprotein (HDL) is known as the “good” cholesterol because it helps remove other forms of cholesterol from your bloodstream.” But raising HDL through healthy eating or certain medications is one thing. Raising it by drinking alcohol is an entirely different matter. Animal studies do not confirm that alcohol lowers other cholesterol (LDL and VLDL). If a person has a cholesterol problem not solved by healthy eating, taking a statin or other medication is the logical approach, not drinking alcohol.