The National Institutes of Health has suspended enrollment in a huge clinical trial on the health benefits of moderate drinking while officials review whether its employees inappropriately solicited funding from the alcohol industry.
Five liquor and beer companies are providing about $67 million of the $100 million cost of the 10-year study. In March, The New York Times reported that scientists and officials with the N.I.H.’s National Institute on Alcohol Abuse and Alcoholism met with alcohol industry groups on several occasions in 2013 and 2014 to discuss funding.
During the meetings, scientists suggested the research might reflect favorably on moderate drinking, while institute officials pressed the groups for support, according to documents obtained by The Times.
The lead investigator on the trial, Dr. Kenneth J. Mukamal, an associate professor of medicine at Harvard Medical School, described his role in the meetings as educational. Critics said the presentations compromised the objectivity of the trial and may have violated federal funding rules.
The N.I.H. stopped enrollment at all trial clinical sites on May 10, a spokesman said, but a public statement was issued only Thursday.
Beth Israel Deaconess Medical Center, where the trial is based, issued a statement that said the hospital “has strong policies in place to ensure the scientific and ethical integrity of any research involving our investigators,” and that the protocol of the alcohol trial “underwent thorough evaluation” by its own Institutional Review Board as well as an independent review committee and an independent data safety monitoring board.
“When the N.I.H. undertook its review, we also initiated a full review of the study to further ensure it reflects our rigorous standards, and we have not found any reason to believe that it does not adhere to our institutional requirements,” its statement said.
On Wednesday, Senator Charles E. Grassley, Republican of Iowa and chairman of the Senate Judiciary Committee, wrote to the director of the N.I.H., Dr. Francis Collins, asking about the findings of its investigation into “this potential conflict of interest” and whether the fund-raising efforts violated federal law.
He asked Dr. Collins to respond to several questions by May 30, including:
* “Are the scientists leading the study the same people who conducted the fund-raising efforts?”
* “If the fund-raising efforts did violate federal policy, what will be done with the ongoing clinical trial?”
* How does the alcohol institute “plan to ensure scientific integrity and independence of the trial, in the face of such widespread public controversy?”
The N.I.H. is conducting two investigations. Its Office of Management Assessment is examining whether “any process or conduct irregularities occurred with grants associated” with the moderate drinking trial, while the advisory committee to the director is reviewing the scientific merits of the trial.
N.I.H. policy prohibits employees from soliciting donations of funds or other resources to support research. Instead, a separate foundation is tasked with outreach to private donors.
Results of the investigations are expected in June.
The study, which had already begun, is the first large, long-term, randomized clinical trial to test the hypothesis that moderate drinking prevents heart attacks and strokes, as well as Type 2 diabetes and cognitive decline.
The investigators aim to recruit 7,800 men and women at 16 sites around the world, instructing half to abstain from alcohol and half to have a single serving of alcohol of their choice every day. The health of the participants would be tracked for six years on average.