The National Institutes of Health (NIH) is ending funding for the Moderate Alcohol and Cardiovascular Health Trial (MACH15) trial following concerns about the study design, which the agency said “cast doubt on its ultimate credibility.”
The study is sponsored by Beth Israel Deaconess Medical Center, and as of May 10, 2018, at which time the trial was suspended, had enrolled 105 participants.
According to the NIH statement, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) was slated to provide $20m in funding, of which $4m has been spent.
Private donations from funders including Anheuser-Busch InBev, Carlsberg Breweries A/S, Diageo plc, Heineken, and Pernod Ricard USA LLC total $67.7m, of which $11.8m has been spent.
In a statement from Beth Israel Deaconess Medical Center (BIDMC), spokesperson Jennifer Kritz said: “BIDMC is deeply committed to ensuring the scientific and ethical integrity of any research study involving our investigators, and we appreciate the working group’s review.”
“Principal Investigator Dr. Kenneth Mukamal is an experienced researcher who has led dozens of important studies over his career. We take the working group’s findings very seriously and will review the report carefully,” Kritz told us.
Other study collaborators include the Harvard School of Public Health, Wake Forest University Health Sciences, and the research organization Julius Center.
The decision to end funding was based on findings from the NIH Advisory Committee to the Director (ACD). Two reviews were conducted following internal concerns raised by NIAAA and FNIH leadership, as well as reports in the media.
Per the ACD report: “Several members of NIAAA staff kept key facts hidden from other institute staff members and the FNIH. The nature of the engagement with industry representatives calls into question the impartiality of the process and thus, casts doubt that the scientific knowledge gained from the study would be actionable or believable.”
The working group found “significant process irregularities in the development of the funding opportunities for the MACH funding awards undermined the integrity of the research process,” according to the NIH statement on the matter.
The initial report from the NIH Office of Management Assessment (OMA) determined that “a small number of NIAAA employees violated NIH policies in soliciting gift funding and circumvented standard operating procedures designed to ensure a fair competition for NIH funding.”
According to the NIH, NIAAA employees committed the policy violations prior to the involvement of the Foundation for the National Institutes of Health (FNIH), which the review found “conducted its role appropriately.”
NIH said it will take “appropriate personnel actions,” but is not providing any additional comment on specific personnel matters.
“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. We take very seriously any violations of these standards,” said NIH Director Francis S. Collins, MD, PhD, in the statement.
The ACD has presented several recommendations, including termination of the MACH trial and an examination of “additional measures to prevent NIH staff from soliciting external funding to support programs.”