A recently published study1 linking secret funding by the sugar industry to bias in research studies published in the 1960s is less a historical curiosity than a clear warning to IRBs to remain vigilant about conflicts of interest.
“The purpose of IRBs is to protect patients and human subjects in research. Industry-sponsored research deserves more than the usual level of scrutiny to ensure that subjects are not at risk,” 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.
Though the influence of industry funding on research outcomes has long been a subject of concern for IRBs, it is exceedingly rare to find such a “smoking gun” linking an undisclosed funding source to skewed research outcomes, says Nestle, who wrote a commentary accompanying the study. (For more information, see related story in this issue.)
“I think the public and policymakers need to view any industry-funded research that could be averse to the industry’s bottom line with extreme skepticism,” says Stanton A. Glantz, PhD, co-author of the study and professor at the Phillip R. Lee Institute for Health Policy Studies at the University of California, San Francisco. “There is a difference between work that is funded by the NIH or the American Heart Association. It is being supported by organizations that have a fundamental interest in getting the answer correct. [Industry] has a fundamental interest in maximizing profits.”
Glantz and colleagues analyzed historical documents and reports by the Sugar Research Foundation (SRF) — now the Sugar Association — related to publication of articles in the 1960s in the New England Journal of Medicine. Like other medical journals at the time, the prestigious publication did not have stringent disclosure and conflict of interest policies. Though full disclosure is now a given for research enterprises and journal publications, IRBs should not become complacent just because it is more difficult for industry to secretly fund research under current requirements.
“It’s harder now, but the whole disclosure issue really relies on people to be honest,” Glantz says. “Medical journals today almost uniformly require disclosure of who funded the study, and many require disclosure of any active involvement the funding agency had in preparing in the manuscript. Some journals even require disclosure of any other interests you have that could be viewed as a conflict.”
Pay for Play?
The investigators essentially found that the SRF paid researchers at Harvard to do a literature review that ultimately minimized the role of sugar as a risk factor for coronary heart disease (CHD). By all appearances, the study fulfilled the expectations of a predetermined conclusion. For example, in correspondence with the SRF, the Harvard researchers explained a delay in completing the review paper due to the need to “rework a section in rebuttal” every time research raised concerns about sugar consumption and public health, the authors report.
“The SRF set the review’s objective, contributed articles for inclusion, and received drafts,” the authors found. “The SRF’s funding and role was not disclosed. Together with other recent analyses of sugar industry documents, our findings suggest the industry-sponsored a research program in the 1960s and 1970s that successfully cast doubt about the hazards of sucrose while promoting fat as the dietary culprit in CHD.”
In response to the investigative report, the Sugar Association posted a comment on its website that stated in part, “We acknowledge that the Sugar Research Foundation should have exercised greater transparency in all of its research activities, however, when the studies in question were published, funding disclosures and transparency standards were not the norm they are today. Beyond this, it is challenging for us to comment on events that allegedly occurred 60 years ago, and on documents we have never seen. Generally speaking, it is not only unfortunate but a disservice that industry-funded research is branded as tainted. What is often missing from the dialogue is that industry-funded research has been informative in addressing key issues.”
Glantz found the defense somewhat disingenuous, as practices like that of the sugar group in the 1960s ultimately led to the disclosure reforms in place today.
“What they did for a journal paper in the ‘60s was a clear violation of current ethics,” he says. “The reason we have heard comments like, ‘well, they didn’t break the rules’ is because there weren’t any rules. The reason we now have all of these rules is because back in the ‘60s there was this expectation that forthright, honest people would disclose this information. So while they didn’t break any rules, the reason we have the rules that they didn’t break is that there were a lot of people misbehaving the way they did.”
The Sugar Association accused the researchers of trying to “reframe historical occurrences to conveniently align with the currently trending anti-sugar narrative, particularly when the last several decades of research have concluded that sugar does not have a unique role in heart disease.”
The investigators concede in the paper that “the contribution of dietary sugars to CHD is still debated,” but also note that the sugar industry “steadfastly denies that there is a relationship between added sugar consumption” and heart disease.
“All you have to do is look at the Sugar Association’s website to see how active they are,” says Cristin E. Kearns, DDS, MBA, the lead author of the paper and a professor at the Phillip R. Lee Institute for Health Policy Studies. “They submit comments on anything to do with sugar and health going on at the federal level. So they are actively out trying to shape the debates.”
The historical findings about undisclosed industry funding of research in the 1960s could well apply to other groups as well.
“The sugar industry was not the only active trade group back during that time,” Kearns says. “That’s one of the limitations of our study — we only looked at this one. Certainly, other food industries, including the corn and wheat industries, all had an interest in this debate going back that far. It’s important to look at those industries as well.”
The trend of funding favorable research is certainly not limited to the food industry, as similar patterns are seen for a wide variety of groups trying to protect and expand their market share for a particular commodity, Glantz adds.
“It’s beyond dispute,” he says. “The petrol, chemical, and coal industries do it around global warming. Pharma often tries to shade the results of the work they fund. It is a broad problem. That’s why you see this consistent pattern in areas related to public health and public policy. Businesses support and promote work that supports their political, economic, and ideological positons, which may or may not have anything to do with public health.”
- 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.