NIH Disbands Alcohol Clinical Trial Because of Scientific and Ethical Breaches

In a decision that I applaud, NIH Director Dr. Francis Collins announced yesterday that based on the recommendation of his Advisory Committee after an extensive investigation, he is discontinuing the MACH15 (Moderate Alcohol and Cardiovascular Health) clinical trial of moderate alcohol consumption (see original news reportshere andhere).In itsreport, the NIH Advisory Committee to the Director concluded as follows:" To understand the context that led NIAAA to embark on the MACH trial, the ACD WG considered the nature and extent of interactions among NIAAA staff, select extramural investigators, and industry representatives before FNIH received approval to secure funding to support the trial. There was early and frequent engagement among these parties which appear to be an attempt to persuade industry to support the project. 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. "" There were sustained interactions between the eventual principal investigator of the MACH trial and members of the NIAAA leadership prior to and during the development of FOAs for planning and main grants to fund the program. These interactions appear to have provided the eventual principal investigator with a competitive advantage not av...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - Category: Addiction Source Type: blogs