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 reports here and here).

In its report, 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 available to other applicants, and effectively steered funding to this investigator."

"Interactions among several NIAAA staff and industry representatives appear to intentionally bias the framing of the scientific premise in the direction of demonstrating a beneficial health effect of moderate alcohol consumption. Independent review of the trial plan raised concerns that there are insufficient patients and not enough follow-up time to allow for meaningful assessment of cancer endpoints. The composite primary endpoint does not include heart failure. Thus, the trial could show benefits while missing harms."

As a result, the Committee recommended that:

• "The MACH trial be terminated."
• "The NIH should examine additional measures to prevent NIH staff from soliciting external funding to support programs."
• "NIH Institutes, Centers, and Offices (ICOs) should ensure that program staff do not inappropriately provide non-public information, or engage in deliberations that either give the appearance of, or provide, an advantage to any single, or subset of, investigator(s)."

The Rest of the Story

I want to thank all the individuals and organizations who helped bring this to the attention of the NIH director and the DHHS Inspector General and who have been working to maintain a high level of scientific and ethical integrity at the NIAAA, especially my colleagues Dr. David Jernigan, Dr. Rich Saitz, Dr. Tim Naimi, Dr. Ziming Xuan, and Dr. David Rosenbloom here at the Boston University School of Public Health; Dr. Tom Babor at UCONN Health; Dr. Jim Sargent at Dartmouth's Geisel School of Medicine; Dr. Michael Carome and Public Citizen; Bruce Livingston and Carson Benowitz-Fredericks and Alcohol Justice; Diane Riibe and the Alcohol Policy Alliance; Dr. Thomas Hilton, former NIH science officer; Dr. Josh Sharfstein at the Johns Hopkins Bloomberg School of Public Health; Jennifer Grodsky at BU Federal Relations; Senator Edward Markey and his outstanding staff; the minority staff of the House Energy & Commerce Subcommittee on Oversight and Investigations; and Representative Lucille Roybal-Allard and her amazing staff.

And also, my sincere thanks and appreciation to the investigative reporters who helped shed sunlight (the best disinfectant, according to Justice Louis Brandeis) on what was going on behind the scenes, especially Roni Caryn Rabin at the New York Times who blew open the most important aspect of the story -- the secret meetings between NIAAA officials and alcohol industry executives in which the future principal investigator and NIAAA solicited funding from the alcohol industry. This was the revelation that led to the NIH director's investigation that ultimately led to the termination of the study.

Thanks also to Sharon Begley at STAT News; Stephanie Mencimer at Mother Jones, Miriam Shuchman (who wrote an excellent story at Wired); Ed Cara at Gizmodo; Liz Borkowski at The Pump Handle and the George Washington University School of Public Health and Health Services; Beth Mole at Ars Technica; and Shawna Williams at The Scientist.

It takes a village -- it certainly did to bring down this scientifically fraudulent and unethical research.