NIH halts alcohol study involving Johns Hopkins and other researchers

The National Institutes of Health has halted funding of a highly criticized $100 million study involving Johns Hopkins researchers that looked at whether one drink of alcohol a day can decrease the risk of heart disease and diabetes because the lead researcher and some agency employees were too cozy with the industry.

An investigation by an NIH working group also found that employees from its National Institute of Alcohol Abuse and Alcoholism were in such frequent communication with lead researcher Dr. Kenneth Mukamal of Beth Israel Deaconess Medical Center in Boston and the industry that it undermined the scientific integrity of the study.

According to a report outlining findings of the investigation, the researchers and NIH employees also “biased the framing of the scientific premise in the direction of demonstrating a beneficial health effect of moderate alcohol consumption.”

Johns Hopkins Medicine was one of 16 institutions participating in The Moderate Alcohol and Cardiovascular Health Trial, or MACH15. The research was being done through the Johns Hopkins ProHealth Clinical Research Center on Gwynn Oak Avenue in Baltimore.

Wake Forest Baptist Medical Center and the University of Copenhagen were among the other institutes participating in the 10-year international trial.

“We are disappointed that the study will not move forward,” Johns Hopkins officials said in a statement. “The study cancellation reflects the importance of funding transparency and the need for objective, unbiased analysis of all study results.”

Officials with Beth Israel said in a statement that they are reviewing the findings.

“Principal Investigator Dr. Kenneth Mukamal is an experienced researcher who has led dozens of important studies over his career,” the statement said. “We take the working group’s findings very seriously and will review the report carefully.”

Mukamal said in a statement that he was deeply disappointed in the NIH decision and called the MACH15 study of “vital scientific importance.”

“Every design consideration was carefully and deliberately vetted with no input or direction whatsoever from private sponsors, who have had no contact regarding MACH15 with any study staff member since the trial began,” he said. “The protocol has been reviewed and approved by three external scientific panels and by ten institutional review boards.”

Problems with the trial were raised in an investigation by The New York Times in March which outlined concerns about the alcohol industry’s influence. The story accused NIH employees of waging a vigorous campaign to court the alcohol industry, including giving talks strongly suggesting that the study's results would endorse moderate drinking as healthy.

The 10-year government trial was being funded mostly by Anheuser-Busch InBev, Heineken and other alcohol companies through donations to a private foundation that raises money for the National Institutes of Health.

The NIH investigation found the foundation did nothing wrong.

The study had attracted 105 participants and spent $4 million before it was suspended. Johns Hopkins had been soliciting participants in Baltimore. The trial will be closed out over the next few months.

NIH will take personnel action against the employees who violated procedures but said it could not be specific.

Johns Hopkins officials have said the institution has policies against interacting with industry and other parties that may pose a financial conflict of interest in research. The policies are intended to safeguard public trust and comply with government regulations. They noted that the money for the alcohol study came directly from National Institute on Alcohol Abuse and Alcoholism and that the study design was highly vetted.

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