WASHINGTON – U.S. Sen. Chuck Grassley of Iowa received a letter from Dr. Francis S. Collins, the director of the National Institutes of Health (NIH), the primary federal government agency responsible for medical and public health research. The letter is in response to an August 27, 2018 inquiry from Grassley seeking more information about an NIH study on the long-term effects of daily alcohol consumption that was reportedly in large part funded by alcohol companies. Grassley released the following statement.
“I appreciate that Dr. Collins addressed my concerns regarding the MACH Trial with the seriousness the situation warrants. Transparency and accountability are critical in maintaining public trust in the federal government. The questionable activities related to this study were alarming to me and all taxpayers and should have never happened in the first place. NIH’s timely response and willingness to hold responsible parties accountable is what taxpayers expect and deserve from their federal government. I look forward to receiving additional information on the NIH’s actions to correct this issue in December.”
According to the most recent letter, NIH expects to spend a total of $4 million on the study, including close-out costs. A release issued by NIH in June noted that the National Institute on Alcohol Abuse and Alcoholism (NIAAA) could have spent $20 million on the MACH Trial over 10 years if the flawed study had continued. In addition, NIH’s response stated that three individuals associated with the study “are no longer employed at NIH or anywhere within the Department of Health and Human Services.”
Grassley sent an original inquiry into this study on May 16, 2018 and Dr. Collins responded on July 17, 2018 to inform Grassley that the study had been discontinued. Grassley’s statement on the study’s discontinuation is available here.
Full text of the letter is available here and below.
The Honorable Charles E. Grassley
Chairman, Committee on the Judiciary
United States Senate
Washington, D.C. 20510
Dear Mr. Chairman:
Thank you for your August 27, 2018 letter about the Moderate Alcohol and Cardiovascular Health (MACH) Trial. As you know, I directed the National Institutes of Health (NIH) Office of Management Assessment (OMA) to conduct a review of the MACH Trial to identify any indication of misconduct by NIH employees or irregularities in the process of grant development and funding mechanisms for the study. I also engaged NIH’s Advisory Committee to the Director (ACD) to review concerns with the study and, after receiving their recommendations, I directed that the study be terminated. Thank you also for recognizing the value of the steps already taken to address this situation and for your additional questions about our activities.
The MACH Trial will end formally on January 31, 2019, following completion of an orderly closeout, which is underway. The total amount of NIH funds expected to be spent on the trial, including closeout, is $4 million. This represents funding provided in Fiscal Year (FY) 2016 and FY 2017. No additional funding has been provided.
OMA has completed its review and issued a report, which was provided to the NIH Office of Human Resources (NHR) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) management for appropriate disciplinary action. As a result, three individuals are no longer employed at NIH or anywhere within the Department of Health and Human Services. While NIH has a longstanding commitment to keep administrative personnel action information confidential, we certainly understand the concerns that you have raised.
The integrity of the NIH grants administrative process, peer review, and the quality of NIH-supported research must always be above reproach. I am determined to make sure that violations of policies are not happening in other parts of the agency. Some of the additional actions NIH has initiated include:
NIH will report on these activities at the ACD’s December meeting, which will include public discussion. We will provide more information to you at that time.
Thank you for sharing your concern about this matter. NIH remains committed to safeguarding the public’s trust in federally supported research.
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