Sponsor Influences on the Quality and Independence of Health Research Proceedings of a Workshop (2023) / Chapter Skim
Currently Skimming:
3 Example of Funder Influence on Health Research
3 Example of Funder Influence on Health Research
Pages 11-38
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 11... ...
Adrian Hernandez, vice dean for clinical research at the Duke University School of Medicine, shared his perspective on the multiple entities that can influence research results. Laura Schmidt, professor of health policy in the UCSF School of Medicine, addressed industry funding bias in nutrition science.
|
From page 12... ...
They are not intended to reflect a consensus among workshop participants. PROTECTING PUBLIC HEALTH IN THE FACE OF CORPORATE DISINFORMATION1 David Michaels noted that it is now standard operating procedure for corporations to create and disseminate disinformation by hiring "product defense" experts to manufacture scientific uncertainty about potential harms caused by their products or activities.
|
From page 13... ...
"Yet they also funded these groups that said we do not know enough, there is a lot of controversy, so let us not do anything," he said. Product Defense Firms: A Growing Industry Michaels called this new disinformation industry the "Enronization of science" -- phony companies producing paperwork and documents that claim something without any evidence to support it.
|
From page 14... ...
moved to classify diesel engine exhaust as carcinogenic to humans, Michaels explained that the industry hired product defense firms to conduct a disinformation campaign designed to confuse the public and regulators. It relied on legislation designed by the tobacco industry that required any studies done or paid for by the federal government to release their raw data to anyone who wanted to reanalyze the data.
|
From page 15... ...
government not to label products containing talc as potentially carcinogenic," said Michaels. These documents outlined how product defense firms would create a reasonable doubt in the minds of NTP's Board of Scientific Counselors, which was considering categorizing "asbestiform talc" as a human carcinogen and non-asbestiform talc as reasonably anticipated to be a human carcinogen, and cause more confusion over the link between talcum powder use and ovarian cancer.
|
From page 16... ...
"We have got to build the scientific evidence base from research produced by independent, unconflicted scientists," he said, citing the Health Effects Institute (HEI) ,4 a public-private partnership the supports research on the health effects of air pollution, where the funding is balanced between EPA and the automobile industry, as a positive example of how utilizing industry funding can balance biases.
|
From page 17... ...
As for which funders might influence results the most, Hernandez named the life sciences industries, government agencies, contract research organizations, data aggregators, research technology companies, and social networks. When he was vice dean for overseeing clinical research and research integrity, he saw examples of each of these at play.
|
From page 18... ...
The company is aiming for the trial to generate positive results and has plans for scaling the technology with a series of funding rounds and perhaps a public stock offering. The questions, said Hernandez, are whether the company might influence the results, what the quality of the data will be, and if the data will be available in an open-access venue.
|
From page 19... ...
Most COIs are manageable if the conflict compliance program is implemented and maintained effectively, and the entire process must be conducted and overseen with complete confidence. To address potential implicit bias, Hernandez said it is important to ensure awareness of associational or intellectual interests, that future gain may be important, and that the intellectual interest or agenda can drive different decisions on study design and how the investigators report their results (Benjamin et al., 2021)
|
From page 20... ...
The other aspect is to make sure people understand where other players have influence, such as through in-kind support, and ensure it is disclosed. INDUSTRY FUNDING BIAS IN NUTRITION SCIENCE ON ULTRAPROCESSED FOODS6 When Schmidt began to explore the nutrition science field, she was surprised at how common it is to accept industry funding.
|
From page 21... ...
FIGURE 3-2 Industry sponsors of ultraprocessed food research. 21 SOURCE: Presented by Laura Schmidt on December 15, 2022 (Oxfam International, 2013)
|
From page 22... ...
. One reason nutrition science and ultraprocessed food research may be a special case in terms of COI is that historically, most nutrition research is industry funded.
|
From page 23... ...
. For example, the International Life Sciences Institute, which Schmidt said is a well-researched front group for food and beverage industry interests, TABLE 3-1 Industry Sponsors of Nutrition Science Organizations and Scientific Journals Professional Organization Sponsored Journals Selected Corporate Sponsors American Society Journal of Nutrition Danone of Nutrition American Journal of General Mills Clinical Nutrition Mars Advances in Nutrition Mondelez Current Developments in Nestle Nutrition The Sugar Association Academy of Journal of the Academy of Abbott Nutrition and Nutrition & Dietetics National Confectioners Dietetics Association Quaker Wyman's of Maine General Mills The Obesity Obesity Nova Nordisk Society Lilly Pacira Biosciences SOURCE: Derived from Schmidt presentation slide 17.
|
From page 24... ...
• Applying more scrutiny to COIs in ultraprocessed food research given the health harms associated with them. • Earmarking revenue earned from soda and fat taxes to fund inde pendent research on ultraprocessed foods.
|
From page 25... ...
Nothing was wrong with the unexciting paper, but after publishing it, McKee was told that Ragnar Rylander, Swedish environmental health scholar, had undisclosed links to the tobacco industry. "He denied it, and a very lengthy correspondence followed.
|
From page 26... ...
According to 1996 testimony from a former Philip Morris employee, "All in all, it seemed as if there was an inner company within Philip Morris that conducted at least some of its investigations behind the scenes on a strict need-to-know basis. Interestingly, many if not all these activities appeared to be related in one way or another to these sensitive topics of smoking and health." When McKee and his colleagues gained access to the tobacco industry documents, they found over 800 studies on sidestream smoke -- the smoke from the lighted end of a burning tobacco product -- conducted between 1981 and 1989.
|
From page 27... ...
He noted the distinction in meta-research between funding for research and financial COIs that represent money or other financial gain for being an expert. Dunn also reiterated statements by previous speakers that influence happens when studies are funded, designed, and reported and that sponsor influence can also happen in systematic reviews, guidelines, what the media products, and what the public consumes.
|
From page 28... ...
Dunn explained that disclosure is not enough; even with perfect disclosure practices, the reader is left with having to decide whether to ignore it, minimize it, be wary of the results, or trust the research more because they can assume that the authors must be experts to have access to industry funding. He argued for better and more accessible records of sponsorship and financial COIs among the people who produce and report on research.
|
From page 29... ...
On the other hand, he added, it may be possible to develop natural language processing methods and tools to automatically extract and compare information to support meta-research studies investigating factors that might indicate bias. These include comparing design factors in protocols and registrations, such as changes in primary outcomes or the choice of comparators or identifying missing links between registrations and the articles reporting their results (Bashir et al., 2019; Liu et al., 2022; Surian et al., 2021)
|
From page 30... ...
However, he added, a public health turnaround may be happening in the United States, and it is likely connected to a decline in longer-term trends in consumption of sugar-sweetened beverages, which peaked around 1998, thanks to changes in social norms related to research findings around the negative health impacts. He noted that diabetes prevalence has been following the longer-term trends in that consumption, with a delay of approximately 15 years.
|
From page 31... ...
The relative risk with respect to finding that the industry had funded a study showing no association, when compared to independently funded studies, was 32.7, similar to what Bero found when she measured the effects of tobacco industry funding on study outcomes. "We concluded that this industry appears to be manipulating the contemporary scientific process to create controversy and advance their business interests at the expense of the public's health," said Schillinger.
|
From page 32... ...
Intellectually motivated biases are as important as financial conflicts of interest." Schillinger argued that treating intellectual and financial COIs as equal is dangerous and seems calculated to undermine the work of independent clinician investigators whose primary obligation is the health of their patients and communities. Accusing investigators concerned about industry influence of intellectual COIs goes back to the 1970s and 1980s and was a strategy of the tobacco industry, he explained (Brandt, 2012)
|
From page 33... ...
The second flaw was that the ILSI-funded review stated that the funding sources for the Dietary Guidelines for Americans were unclear, so it questioned their editorial independence and gave it a poor score. This assessment was curious because the review's appendix acknowledged that the guidelines were developed with federal funding and the advisory committee members were vetted thoroughly for COIs per federal advisory committee rules.
|
From page 34... ...
• The beverage industry has demonstrated its ability to manipulate the scientific process to shape what is considered scientific "fact" or scientifically "controversial." • Scientific -- and policy making -- communities must continue to be vigilant, in defense of pursuing truth for public health, about the effects of financial COIs. • Many prestigious journals require expert reviews by biostatisti cians.
|
From page 35... ...
" he asked. McKinney pointed out that clinical research is expensive, and the federal government has not provided enough funds to counterbalance industry funding of clinical trials.
|
From page 36... ...
"The talks today clearly illustrated these biases related to industry funding," she said. Bero asked Dunn if an automated tool to identify bias and assess risk of bias in an individual study would include funding source and investigator COI.
|
From page 37... ...
He explained that in his area of nutrition research, he can correctly presuppose the direction of an outcome and whether the study is about health risks from carbohydrates, fats, red meat, or other factors based on the title of a paper and the name of a senior author. McKee said that he has seen a great deal of this during the COVID-19 pandemic, where the authors of systematic reviews had a particular view on how serious the virus was that came out strongly in their papers.
|
From page 38... ...
Bero noted that journalist Jeanne Lenzer keeps a long list of researchers without financial COIs for which researchers can apply to be included.12 12 Available at https://jeannelenzer.com/list-independent-experts (accessed February 2, 2023)
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.