The federal government, along with scientists from Yale and Harvard, are asking wine, beer and spirits organizations to fund most of a landmark clinical study on the health effects of moderate alcohol consumption.

According to documents provided to Wine Industry Insight, the National Institute of Alcohol Abuse and Alcoholism (part of the National Institutes of Health) plans to spend $2 million to $3 million on a six-year, multinational clinical trial that it estimates will cost $6 million to $9 million per year to complete.

The NIH Foundation is seeking outside funding which includes asking beer, spirits, wine, insurance and drug companies to come up with $24 million to $36 million towards an estimated $36 million to $54 million total cost.

Spirits: Hot On The Idea, Beer: Warm, Wine: Cool

Sources said that the Distilled Spirits Council of the United States (DISCUS) is among the early supporters of the study with beer being “very interested.” The same sources familiar with the process says wine industry interest has been “cool.”

The Wine Institute had not responded to WII’s query about this by publication deadline.

“Study To End All Studies” Aims To End Alcohol/Health Ambiguities

“This issue [moderate alcohol consumption and health] has floated around for decades, but there have never been the sort of clinical trials that are needed in order to make official recommendations on moderate drinking, “ said the informed source. “Those trials are vital but very expensive. This is the study that should be able to end the ambiguity once and for all. This is the study to end all studies.”

Study Would Provide Physician Recommendation For Patients

The source said that physicians have “besieged” government agencies to provide an official statement on moderate consumption because they need to know what to recommend.

DISCUS Taking The Program Seriously

“While there are risks in every new endeavor, this study will be a landmark piece of research that should legitimize moderate consumption,” said a member of the DISCUS board of directors, speaking off the record to Wine Industry Insight.

The source added that the only risk involved is that some new negative information might be uncovered. “The evidence is overwhelming that moderate consumers live longer,” the source said. “The risk of discovering negative information is very small given the decades and billions that the government has spent trying to prove the French Paradox wrong.”

The source said that the DISCUS board was scheduled to take up the issue during its Feb. 27 meeting.

Looking For Equal Contributions From Wine, Beer and Spirits

The effort to raise funds has asked for $1 million per year each from wine, beer and spirits.

The fundraising has been compared to the $30 million that the National Football League granted to the NIH Foundation in 2012 for head injury and concussion research.

NIAAA Participant Was Top Author On Moderate Drinking Recommendations For U.S. Dietary Guidelines

The NIAAA’s chief proponent for the new proposed study is Lorraine Gunzerath, (Ph.D, MBA) who is Senior Policy Advisor, Office of the NIAAA Director. She was the chief author of a pivotal study assessing the health effects of moderate alcohol consumption. The study was conducted as part of the 2006 update of the National Dietary Guidelines.

Yale & Harvard Profs Prominent In Their Fields

The prime movers from the university research sector are John H. Krystal, MD, of the Yale University School of Medicine and Kenneth J. Mukamal, MD, MPH, MA of the
Harvard University Medical School.

John H. Krystal, MD

Dr. Krystal serves as the Robert L. McNeil, Jr. Professor Translational Research Chair, Department of Psychiatry, and Chief of Psychiatry, Yale-New Haven Hospital.

He also serves as Director: NIAAA Center for the Translational Neuroscience of Alcoholism; Director, Clinical Neuroscience Division, VA National Center for PTSD; Director, VA Alcohol Research Center; Medical Director, Schizophrenia Biological Research Center, DVA.

The following comes from Dr. Krystal’s online biography: Dr. Krystal is a leading expert in the areas of alcoholism, schizophrenia, and post-traumatic stress disorders. His work links psychopharmacology, neuroimaging, and molecular genetics to study the neurobiology and to develop novel treatments for these disorders.
He is a member of the Institute of Medicine of the National Academy of Sciences. He also serves in a variety of advisory and review capacities for NIAAA, NIMH, Wellcome Trust, Brain and Behavior Research Foundation, and the Karolinska Institutet.

He previously served on the National Alcohol Abuse and Alcoholism Advisory Council (NIAAA), the Department of Defense Psychological Health Advisory Committee, the NIMH Board of Scientific Counselors (chair, 2005-2007), and American College of Neuropsychopharmacology (president, 2012).

Dr. Krystal also edits the journal, Biological Psychiatry (impact factor: 9.247).

Kenneth J. Mukamal, MD, MPH, MA

Dr. Mukamal, is an Associate Professor of Medicine and General Internist at Beth Israel Deaconess Medical Center.

The following comes from Dr. Mukamal’s online biography: Dr. Mukamal’s primary research interests are investigating the role of dietary and lifestyle factors – particularly alcohol consumption – on the incidence and prognosis of cardiovascular and neurovascular disease and its risk factors. As a general internist and clinical investigator, his research has incorporated ongoing epidemiological studies, utilized hospital-based clinical data, and interventional studies. The outcomes of this research have been broad-based and include diverse health effects of alcohol ranging from novel cardiovascular risk factors and subclinical vascular disease to falls and suicide. Recent work in collaboration with Murray Mittleman of BIDMC’s Cardiovascular Division and Eric Rimm of the Harvard School of Public Health seeks to examine novel biomarkers in important candidate pathways leading to cardiovascular disease and diabetes in large, ongoing cohort studies.

Between them, the two have authored more than 650 scientific papers, articles and reviews.