In June 2018, the National Institutes of Health (NIH) shut down a $100 million clinical trial comparing drinkers and non-drinkers after reports that NIH officials had solicited funding from the alcohol industry.
The study’s goal was to provide clarity on whether alcohol was the factor that causes moderate alcohol drinkers to outlive abstainers. A conclusion linking alcohol consumption to longer lifespans would have been a major boost to the industry, particularly if that conclusion came from a seemingly independent study.
The 7,800-person randomized trial was flawed from the start, however. Although NIH prohibits employees from suggesting donations intended to support activities, both the scientists behind the research as well as an NIH official repeatedly discussed their proposed study with and sought funding from alcohol manufacturers. One 2014 presentation to liquor company executives argued that “a definitive clinical trial represents a unique opportunity to show that moderate alcohol consumption is safe and lowers risk of common diseases.” As a result of these meetings, five major industry players—Anheuser Busch InBev, Heineken, Diageo, Pernod Ricard, and Carlsberg—poured $67.7 million into the trial. This funding was not disclosed on the online clinical trials registry that enrolls patients.
Such contact and funding is troubling because it can introduce bias into studies. As nutrition professor Marion Nestle has noted, “research shows that industry-sponsored research almost invariably favors the interests of the industry sponsor, even when investigators believe they are immune from such influence.” NIH officials involved with planning the study hid facts from their colleagues, and the principal investigator consistently denied contact with the industry, telling a reporter in 2017 “we have had literally no contact with anyone in the alcohol industry in the planning of this.” In fact, these meetings allowed the industry to examine the study’s design and to view investigators “on board” with the project, among other details.
In March 2018, after news broke about the extent to which the scientists had courted industry, NIH suspended the study and undertook internal investigations. A working group determined that “The early and frequent 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’s June 2018 report recommended the trial’s termination, and NIH director Francis Collins promptly ended the study’s funding. By the time the trial closed, the project had spent more than $15 million.
At a December 2018 Advisory Committee to the Director meeting, an NIH official noted in a presentation on the alcohol study that “this represents a critical moment” and outlined steps the agency had taken to improve research integrity and transparency since June. The presentation directed officials as to proper conduct with outside partners and argued that “it is paramount that NIH promote a culture of impartiality and responsibility within the program community regarding acceptable levels of interaction.” Promoting this culture is indeed key. When industry-biased science is allowed to adopt a façade of independence, it can mislead the public into making decisions that negatively affect their health.