NIH ends $100 million alcohol trial after funding controversy

The nation’s premier medical research institution announced Friday it would discontinue a landmark, nearly $100 million alcohol study meant to critically evaluate the benefits or drawbacks of long-term moderate drinking.

The decision by the National Institutes of Health to cease research came after a damning report by internal investigators at the institution that employees acted inappropriately in collaborating with certain researchers and donors, particularly from the alcohol and liquor industry.

“NIH has strong policies that detail the standards of conduct for NIH employees, including prohibiting the solicitation of gifts and promoting fairness in grant competitions,” NIH Director Francis S. Collins said in a statement. “We take very seriously any violations of these standards.”

The trial — the Moderate Alcohol and Cardiovascular Risk study (MACH) — was expected to be a gold standard in understanding the relationship between alcohol and heart health. In research centers in the U.S., Spain, Nigeria and the Netherlands, an estimated 7,800 participants would be assigned to either consume one serving of alcohol every day or none and watched for new risks of cardiovascular disease or diabetes.

The National Institute of Alcohol Abuse and Alcoholism, part of the NIH, has already spent $4 million of an expected $20 million, on the now-defunct project.

Private donations to the Foundations for the National Institutes of Health amounted to $67.7 million, donated by alcohol companies Anheuser-Busch InBev, Carlsberg Breweries A/S, Diageo plc, Heineken, and Pernod Ricard USA LLC.

At least $11.8 million has been spent, the NIH said in a statement.

On Saturday, Anheuser-Busch InBev pulled its funding.

“It’s no question that it’s a great concern that resources have been expended on something that ultimately we feel was so compromised that it would never lead to anything that’s actionable,” said Lawrence Tabak, NIH principal director, in a conference call with reporters. “By terminating the study now, we minimize the loss of resources but acknowledge that significant resources have been spent.”

An investigation and report by the Advisory Committee to the Director cleared responsibility from the Foundation for the National Institutes of Health, which collects private donations for research, but called into question the actions of NIAAA employees in their interaction with researchers designing the study and the alcohol companies committing funds.

The charges are that “a small number” of NIAAA employees helped specific researchers get to the head of the line of having their proposal funded and then also helped to solicit those funds from the alcohol industry.

“In this case, it’s really obvious because the staff themselves crossed the line because they were keeping it secret,” Dr. Tabak said.

The charges leveled by the ACD report are that senior members of NIAAA and independent researchers — including the eventual principal investigator of the study, Dr. Kenneth J. Mukamal at the Beth Israel Deaconness Medical Center in Boston — were in talks with alcohol industry representatives about funding a potential study. They kept these conversations secret from other NIAAA staff members and violated NIH’s code of ethics.

The New York Times reported in March that NIAAA staff, in violation of NIH policy, accepted flights to alcohol industry events, then lobbied company representatives to fund a study that would likely be favorable to alcohol consumption as part of a healthy American diet.

The NIH said in a statement that it will take appropriate personnel actions, but cannot comment on specific personal matters.

“It is clear from our review that the individuals involved in this kept pertinent and important information from folks who are most qualified to very rapidly say there are process issues here,” Dr. Tabak said.

NIAAA Director George Koob said in a statement that he is “grateful” for the ACD report and that it has “has brought to light significant concerns about the study and its ultimate credibility.”

Mr. Koob joined the institute after the problematic interactions between staff and industry, but was also accused of killing research seen as not favorable to alcohol companies, STATnews reported.

STATnews reported in April that the NIAAA in 2015 rejected a study on alcohol advertising methods towards those underage and that Mr. Koob personally shot down any prospect for such a study to take place, also emailing alcohol industry representatives that they were safe from such criticism.

Mr. Koob told STATnews at the time that he rejected the research for not being of the highest scientific quality.

The MACH study began enrolling participants in February, reaching 105, but was suspended May 10 over growing concern about the legitimacy of the project, study design and efficacy, and new information on improper conduct by employees within the NIAAA.

The NIH said in a statement that it will end the study over the next few months with an “orderly closeout.”

Dr. Tabak said the NIH will reexamine studies coming out of the different institutes that also receive private funding to make sure they are not in violation as the NIAAA was.

“We’re going through the necessary additional steps, working with all the institutes and centers to ensure that things are how they should be,” he said. “The hope is that this is an extraordinary, albeit very sad, event. But we have to look, we can’t just assume that it’s not.”

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