Thursday, November 30, 2023

Why is the National Academies Appointing Alcohol-Industry Funded Researchers to Serve on Panel to Review the Health Effects of Alcohol?

I have always thought of the National Academies (full name is the National Academies of Sciences, Engineering, and Medicine [NASEM]) as being a highly reputable, impartial entity that objectively reviews scientific issues by appointing panelists who do not have conflicts of interest with industry that could create the appearance of bias. The National Academies has a detailed policy that disallows panel members who have a conflict of interest by virtue of funding by industries whose interests could be affected by the results of the panel review.

Well, that view of the National Academies has just flown out the window. Why? Because they have recently appointed to their newly formed expert committee to review the health effects of alcohol two scientists who were principal investigators in a research grant funded by the alcohol industry. And this was not minor funding. It was funding to the tune of $67 million! 

According to the National Academies web site listing the members of the panel entitled "Review of Evidence on Alcohol and Health," the chair of the panel is Dr. Eric Rimm and a second member of the panel is Dr. Kenneth Mukamal. 

For background, this panel is being convened as part of a larger process to develop dietary guidelines and those guidelines will presumably address the issue of alcohol consumption. The alcohol industry is presumably hoping for a recommendation that moderate alcohol consumption be part of a healthy diet, based on its view that there could be some cardiovascular benefits of moderate alcohol use.

The Rest of the Story

The last person one could possibly want on this panel is someone who lobbied the alcohol industry to provide funding for a clinical trial of the health benefits of alcohol use for which he would likely serve as the principal investigator and was awarded that funding. Well, that person - Dr. Kenneth Mukamal - was indeed appointed to the panel.   

In 2017, the New York Times reported that: "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, said 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 principal investigator of the study, which was called "MACH" (Moderate Alcohol and Cardiovascular Health), was Dr. Kenneth Mukamal from the Harvard Medical School. According to an article in the Harvard Crimson (and supported by numerous other articles as well as by an NIH review committee), "Mukamal and his colleagues pitched the study to alcohol industry groups at high-end hotels, telling them the study “represents a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases,” the New York Times reported in March."

At a meeting with alcohol industry representatives in February 2014, Dr. Mukamal pitched the idea of a clinical trial of the benefits of drinking in an effort to solicit alcohol industry funding for the trial. In his presentation, Dr. Mukamal included a slide entitled "The Ultimate Goal." It was a newspaper headline from a Boston Globe article that stated "Mediterranean diet shows key benefits." Presumably, Dr. Mukamal was trying to convince the alcohol industry that this trial would allow the industry to reap the rewards from similar newspaper articles reporting the benefits of a diet that includes moderate alcohol consumption. In another slide, entitled "The Bottom Line," the presentation again explains that the primary purpose for the study is to "convince clinicians, patients, and policymakers that alcohol consumption in moderation is safe and a healthy part of diet..."

Later, in November 2014, Dr. Mukamal wrote an email to NIAAA stating: "I think that our chances with brewers and distillers would only go up with buy-in from other sources, including wine, if we can find any." Clearly, Dr. Mukamal was part of an effort, in collaboration with NIAAA, to seek alcohol industry funding that would support his role in the clinical trial.

Eventually, the alcohol industry contributed $67 million to which NIAAA added $33 million and the $100 million MACH trial was initiated under the leadership of Dr. Mukamal. However, the NIH halted the trial in June 2018 after an NIH review committee report concluded that:

"To understand the context that led NIAAA to embark on the MACH trial, the ACD WG considered the nature and extent of interactions among NIAAA staff, select extramural investigators, and industry representatives before FNIH received approval to secure funding to support the trial. There was early and frequent engagement among these parties which appear to be an attempt to persuade industry to support the project. Several members of NIAAA staff kept key facts hidden from other institute staff members and the FNIH. The nature of the engagement with industry representatives calls into question the impartiality of the process and thus, casts doubt that the scientific knowledge gained from the study would be actionable or believable. There were sustained interactions between the eventual principal investigator of the MACH trial and members of the NIAAA leadership prior to and during the development of FOAs for planning and main grants to fund the program. These interactions appear to have provided the eventual principal investigator with a competitive advantage not available to other applicants, and effectively steered funding to this investigator. Interactions among several NIAAA staff and industry representatives appear to intentionally bias the framing of the scientific premise in the direction of demonstrating a beneficial health effect of moderate alcohol consumption."

To make matters worse, Dr. Mukamal appears to have lied in publicly denying that he solicited funding from the alcohol industry. According to a New York Times article: "Dr. Mukamal, who has published dozens of papers on the health benefits of alcohol consumption, said he was not aware that alcohol companies were supporting the trial financially. “This isn’t anything other than a good old-fashioned N.I.H. trial,” he said. “We have had literally no contact with anyone in the alcohol industry in the planning of this.”"

Thus, not only does Dr. Mukamal have a severe conflict of interest by virtue of having colluded with NIAAA to secretly solicit and obtain alcohol company funding and by having been awarded that alcohol industry funding, but he also appears to have lied about it.

In conclusion, there is no doubt that Dr. Mukamal should be removed from the National Academies panel in order to preserve the integrity of both the panel and of the National Academies itself.

Although Dr. Rimm was not involved in the solicitation of funding, he did serve as a principal investigator of the MACH trial. Thus, he has been funded by the alcohol industry and this conflict of interest should disqualify him from participating in, much less chairing the panel. 

Dr. Rimm should be removed from the National Academies panel in order to preserve the integrity of both the panel and of the National Academies itself.

The final blow, and perhaps the biggest reason to exclude both Dr. Mukamal and Dr. Rimm from the panel, is that neither has been forthright about this conflict of interest in papers they have published subsequent to the trial. For example, in this 2020 paper of which both Dr. Mukamal and Dr. Rimm are co-authors, there is no visible disclosure that they had conducted research funded by the alcohol industry. In a section of the paper entitled "Author Relationship with Industry," two of the co-authors disclose their relationships, but Dr. Mukamal and Rimm do not. In fact, the section ends by stating: "All other authors have reported that they have no relationships relevant to the contents of this paper to disclose." However, one of the facts presented in the paper is that wine has high anti-inflammatory potential!

Furthermore, in an article that appears in this month's issue of the European Journal of Epidemiology, both Dr. Mukamal and Dr. Rimm are co-authors and neither discloses their prior research that was funded by the alcohol industry. The conflict of interest section states only that: "We declare that we have no conflicts of interest." Here, there isn't even a remote argument that the conflict of interest is not relevant to the topic of the study because the article is specifically about the health effects of moderate alcohol consumption! This conflict of interest of both investigators should have been disclosed in the paper.

It would be interesting to know whether Dr. Mukamal and Dr. Rimm disclosed their having received alcohol industry funding in the disclosure they submitted for the National Academies panel. Unfortunately, these disclosures are not made public by the National Academies.