Background
In 2004, the U.S. Department of Health and Human Services created an interagency committee to direct federal efforts to reduce underage drinking. The committee, which is called the Interagency Coordinating Committee on the Prevention of Underage Drinking (ICCPUD), is led by the Substance Abuse and Mental Health and Mental Health Services Administration (SAMHSA) and includes agencies such as the Centers for Disease Control and Prevention (CDC), the Surgeon General, and the National Institute on Alcohol Abuse and Alcoholism (NIAAA), which is part of the National Institutes of Health (NIH).
The ICCPUD recently decided to undertake a study, which it calls the Alcohol Intake and Health Study, to review the scientific evidence on the health effects of alcohol. In part, this study is intended to inform the upcoming development of the 2025 Dietary Guidelines, which will presumably make a recommendation regarding the use of alcohol as it relates to health. The current guideline (2020-2025) recommended as follows: "A healthy dietary pattern doesn’t have much room for extra added sugars, saturated fat, or sodium—or for alcoholic beverages. ... Adults of legal drinking age can choose not to drink, or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed. Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant."
After the ICCPUD had begun its review process, the alcohol industry successfully lobbied Congress to fund another study, this one to be conducted by the National Academy of Sciences, Engineering, and Medicine (NASEM), to also review the health effects of alcohol consumption with an eye towards informing the 2025 Dietary Guidelines.
The NASEM study was tainted by alcohol industry influence from the start. As I revealed this past January, NASEM selected two researchers with severe conflicts of interest with the alcohol industry to be on its review panel. These two alcohol industry-funded researchers (Dr. Kenneth Mukamal and Dr. Eric Timm) were principal investigators in a research grant funded by the alcohol industry, to the tune of $67 million, which promised in advance to produce findings showing that moderate alcohol consumption is good for one's health. The principal investigator actually courted the alcohol industry funding by essentially promising Big Alcohol positive results (meaning a positive overall effect of moderate drinking on health).
After the story of this scandal was broken by Roni Rabin of the New York Times, NASEM backtracked and removed the two conflicted researchers from the panel. However, one of the scientists they chose as a replacement (Dr. Luc Djousse) was another conflicted researcher with a history of alcohol industry funding. This scandal, too, was broken by Roni Rabin, but this time NASEM did not relent.
The Story
Three weeks ago, 25 members of Congress wrote a letter to the director of the NIAAA suggesting that it was inappropriate for ICCPUD to study the health effects of alcohol use, that this was duplicative of the work by NASEM, and questioning the appointment of four specific researchers to serve on a scientific review subcommittee to inform ICCPUD's consideration of the scientific issues around alcohol consumption and health. In addition, the letter claimed that: "ICCPUD participants have already formed an opinion and are working towards a predetermined result." Two of the researchers who the Congressmembers called out were Dr. Tim Naimi and Dr. Kevin Shield.
Ultimately, the letter asserts that the ICCPUD is not an appropriate body to be reviewing the health effects of alcohol, asking: "Is an interagency coordinating committee tasked with stopping underage drinking an appropriate venue to conduct a comprehensive review of legal adult alcohol consumption?"
The Rest of the Story
This letter is an absolutely inappropriate intrusion into the scientific workings of the federal public health agencies that are entrusted with protecting the nation's health. Congress has no business interfering with research being conducted by the National Institutes of Health, with the sole exception of impropriety in the research, such as undue financial influence by corporate interests or research misconduct.
Here, the opposite is occurring. These members of Congress are clearly intervening to protect the interests of the alcohol industry, whether intentionally or not. It certainly has the appearance of undue alcohol industry influence and there is enough evidence of wrongdoing in the degree of alcohol industry influence on the 2025 Dietary Guidelines that I believe the Inspector General of the House should conduct an investigation to determine whether the alcohol industry played any role in this unseemly and political encroachment on the ability of the NIH to conduct independent and unbiased research.
The question of whether an interagency coordinating committee tasked with stopping underage alcohol use is an appropriate venue to conduct a review of the health effects of alcohol is laughable. Are these members of Congress seriously suggesting that CDC, NIH, DHHS, NIAAA, NIDA, and SAMHSA are not the appropriate agencies to be involved in a review of the scientific evidence regarding alcohol use and health?
If, in fact, these members of Congress are successful in their attempt to intimidate these federal public health agencies into halting their scientific review of the health effects of alcohol, it would be a travesty because it would be yet another example of politics interfering with science. And the very thing that these members of Congress are purporting to try to prevent--conflict of interest--is precisely what they are introducing into the process by suggesting that NASEM is the only body that should conduct this review. The NASEM review is being conducted at the behest of the alcohol industry in the first place. That is the likely explanation for the attempt to pack the expert panel with alcohol industry-funded researchers and for the replacement of the experts whose conflicts of interest were called out with another scientist who has a conflict of interest by virtue of previous funding from Big Alcohol.
Incidentally, Dr. Tim Naimi and Dr. Kenneth Shield are unassailable in terms of their qualifications to review the health effects of alcohol and in terms of their scientific objectivity and absence of conflicts of interest.
Dr. Naimi "received his bachelor’s degree from Harvard College, his M.D. degree from the University of Massachusetts, and his M.P.H degree from the Harvard School of Public Health. He completed a combined internal medicine-pediatrics residency program at the Massachusetts General Hospital, the Epidemiologic Intelligence Officer program with the Centers for Disease Control and Prevention (CDC), and a preventive medicine residency with the CDC. Prior to his time at Boston Medical Center, Dr. Naimi worked as a clinician for the U.S. Indian Health Service, and as a senior epidemiologist with the Alcohol Team at CDC. His current research interests, for which he receives grant support from the National Institutes of Health and CDC, include binge drinking, youth drinking, health effects of low-dose ethanol, and substance use policy including the impact of alcohol control policies, cannabis policies, and opioid policies on substance use and other health outcomes. He has co-authored more than 100 published manuscripts and book chapters." Moreover, he has never received any funding from the alcohol industry so he is clear of any financial conflicts of interest that would disqualify him from being a part of the scientific review subcommittee, unlike Dr. Djousse.
Dr. Shield "is a scientist with the Institute for Mental Health Policy Research at the Centre for Addiction and Mental Health (CAMH), and an assistant professor in the epidemiology division of the Dalla Lana School of Public Health at the University of Toronto. Dr. Shield is also the head of the World Health Organization (WHO)/Pan American Health Organization (PAHO) Collaborating Centre in Addiction and Mental Health at CAMH. Dr. Shield’s multi-disciplinary public health surveillance research programs generate scientific data that inform individuals, clinicians and policymakers on how best to reduce the public health harms caused by alcohol and other drugs." He conducts research to estimate "the first- and second-hand mortality and morbidity attributable to alcohol consumption at the country and global levels," which is a perfect fit for the review subcommittee. Most importantly, he has no history of alcohol industry funding; thus, there is no financial conflict of interest as there is with Dr. Djousse.
The Congressional letter makes the error of asserting that if a researcher has previously asserted a position on a scientific issue, that represents a conflict of interest. This is a bogus argument because if true, it would mean that no scientist could ever conduct more than one study on a topic before having a conflict of interest. If such an absurd policy were adopted, the only scientists who could serve on review panels would be those who don't know a thing about the topic being discussed!
In the field of scientific ethics, the worldwide accepted consensus is that conflicts of interest occur when an investigator has financial interests (including research funding) with an entity (typically a corporate entity) whose financial status could be affected by the results of the research. Thus, funding by the alcohol industry is a clear conflict of interest. Having written a previous scientific article about a topic is not.
Ironically, despite my previous criticism of the NIAAA for its previous relationship with the alcohol industry, the Institute appears to be holding fast to scientific principles and not allowing the alcohol industry to direct its work. I praise Dr. Koob (NIAAA director) for changing the ethic in his institute and not allowing politics to interfere with science. I trust that he will ignore or dismiss this undue intrusion into the scientific working of his institute.
Note: This commentary is being submitted as a formal complaint to the Office of the Inspector General of the U.S. House of Representatives.
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