Though the influence of industry funding on research outcomes has long been a subject of concern for IRBs, it is unusual to find a “smoking gun” strongly linking an undisclosed funding source to biased research outcomes, says Marion Nestle, PhD, MPH, an author and professor in the department of nutrition and food studies at New York University in New York City.
A recently published study,1 which found that the sugar lobby secretly funded studies in the 1960s that apparently “cherry picked” data to downplay the role of sugar in coronary heart disease (CHD), has the documentation and granular detail to meet the smoking gun test, she noted in a commentary2 accompanying the study.
“From a deep dive into archival documents from the 1950s and 1960s, they have produced compelling evidence that a sugar trade association not only paid for, but also initiated and influenced, research expressly to exonerate sugar as a major risk factor for CHD,” Nestle wrote in the commentary. “Although studies at that time indicated a relationship between high-sugar diets and CHD risk, the Sugar Association preferred scientists and policymakers to focus on the role of dietary fat and cholesterol. The association paid the equivalent of more than $48,000 in today’s dollars to three nutrition professors — at Harvard, no less — to publish a research review that would refute evidence linking sugars to CHD.”
The historical investigation documents the influence of the industry on the results of a subsequent study, suggesting the authors at the time knew what they were being paid to produce.
“The investigators knew what the funder expected, and produced it,” Nestle wrote. “Whether they did this deliberately, unconsciously, or because they genuinely believed saturated fat to be the greater threat is unknown. But science is not supposed to work this way. The documents make this review seem more about public relations than science.”
The study serves as more than a historical cautionary tale, as Nestle cites current efforts of industry to influence research findings as reported by journalists.3,4 IRB Advisor asked Nestle to discuss the issue, and her answers are as follows:
IRB Advisor: You mention that industry attempts to influence research are not ancient industry, but are indeed ongoing. Do more rigorous requirements for disclosure for conflict of interest make it much less likely that something as blatant as this historical example could occur today?
Nestle: The disclosure requirements help, but there is considerable evidence that they are not always adhered to. In any case, disclosure is necessary but not sufficient for addressing real conflicts of interest, particularly because the influence of industry funding on investigators is usually unconscious, unintentional, and unrecognized.
IRB Advisor: You have certainly written a lot of books on the food industry. Were you surprised at the degree of sophistication the sugar industry seems to have put into spinning the research findings in the 1960s?
Nestle: No. The big surprise was the documentation. That is hard to come by. We suspect that corporations funding research do so for a purpose and want to ensure that their purpose is achieved, but finding documentation for corporate involvement is rare. We now know from recent examples in which reporters obtained emails that funding sources attempt to manipulate investigators, and the example in 1967 suggests that these kinds of relationships have gone on for a long time.
IRB Advisor: There has been some debate about the influence of big pharma on research and actually some pushback that industry has been unfairly vilified. Do you think there is just too much conflict of interest for an industry to be involved in research that could translate to lost profits?
Nestle: I have just reviewed the literature on drug industry funding of research and can say that this topic has been studied extensively for more than 40 years. Drug industry-funded research comes out with results that favor the benefits and lack of harm of the sponsor’s patented, branded drug. The purposes and lack of controls in that research have also been well-documented. Experts concerned about the conflicts of interest in this research — and the potential harm to patients — believe that this research is unethical and deserves intense criticism.
REFERENCES
- Kearns CE, Schmidt LA, Glantz SA. Sugar industry and coronary heart disease research: a historical analysis of internal industry documents [published online September 12, 2016]. JAMA Intern Med doi:10.1001/jamainternmed.2016.5394.
- Nestle, M. Food Industry Funding of Nutrition Research: The Relevance of History for Current Debates: Invited Commentary. JAMA Intern Med September 12, 2016 doi:10.1001/jamainternmed.2016.5400.
- O’Connor A. Coca-Cola funds scientists who shift blame for obesity away from bad diets. New York Times, August 9, 2015.
http://nyti.ms/1f2lI1J. - Choi CAP. Exclusive: how candy makers shape nutrition science. Associated Press, The Big Story, June 2, 2016. http://apne.ws/1UhbJmR.
Though the influence of industry funding on research outcomes has long been a subject of concern for IRBs, it is unusual to find a “smoking gun” strongly linking an undisclosed funding source to biased research outcomes.
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