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N.I.H. Keeps enrollment in a study of drinking now under control



The National Institutes of Health have suspended enrollment in a large clinical study on the health benefits of moderate alcohol consumption, while officials are reviewing whether their employees have falsely requested funds from the alcohol industry.

Five liquor and beer companies provide around $ 67 million of the $ 100 million cost of the 10-year study. In March, the New York Times reported that scientists and officials from the National Institute on Alcohol Abuse and Alcoholism at the NIH met with alcohol industry groups several times in 2013 and 2014 to discuss financing.

Scientists Suggested During Meeting Research results may have a positive impact on modest drinking, while institute officials have been pushing the groups to support, according to documents received by The Times.

The principal investigator of the study, dr. Kenneth J. Mukamal, associate professor of medicine at Harvard Medical School, described his role in the sessions as educational. Critics said the presentations compromised the objectivity of the study and possibly violated federal funding rules.

The N.I.H. Enrollment at all clinical trial sites was halted on May 10, a spokesperson said, but a public statement was released on Thursday.

The Beth Israel Deaconess Medical Center, where the trial is being conducted, made a statement that the hospital has "strong guidelines in place to ensure the scientific and ethical integrity of any research involving our examiners," and that Alcohol Attempt Protocol "was thoroughly evaluated by its own Institutional Review Board and Independent Review Committee and Independent Data Security Inspectorate."

"When the NIH conducted this review, we also launched a comprehensive review of the study to ensure that it meets our strict standards, and we have found no reason to believe that it does not meet our institutional requirements, "the statement said.

On Wednesday, Senator Charles E. Grassley, Republican of Iowa and Chairman of the Board wrote Judiciary Committee of the Senate, to the Direk of the NIH, Francis Collins, and asked for the results of his investigation into "this potential conflict of interest" and whether the fundraising efforts violated federal law.

He asked Dr. Collins to answer several questions by May 30, including:

* "Are the scientists conducting the study the same people who did the fundraising efforts?"

* "If the fundraising efforts violate federal policy, what will happen to the ongoing clinical trial?"

* How does the alcohol institute plan "the scientific integrity and independence of the trial, given such widespread public controversy?"

The N.I.H. carries out two investigations. The Office of Management Assessment examines whether "any processes or irregularities associated with grants are associated with moderate alcohol consumption," while the director's advisory committee reviews the scientific merits of the study.

N.I.H. Policies prohibit employees from soliciting donations of funds or other resources to support the research. Instead, a separate foundation is mandated to contact private donors.

The results of the investigations are expected in June.

The study, which has already begun, is the first large-scale, long-term, randomized clinical trial 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 locations around the world, half of abstaining from alcohol and half having a single serving of alcohol of their choice every day. The health of the participants should be tracked for an average of six years.


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