Author Affiliations Article Information
JAMA Intern Med. Published online December 18, 2023. doi:10.1001/jamainternmed.2023.6962
Corporations have been developing tactics to undermine independent science for decades.1 In the 1950s, on learning of the damaging effects of tobacco on health, the tobacco industry used campaigns of criticism to defend their products and the substantial revenue they were generating. Corporations could effectively cast doubt over any unfavorable findings by creating industry-funded counterevidence (original studies and reviews), supporting researchers to write criticisms, and providing a venue for publication in industry-sponsored journals. These tactics and others extended beyond the tobacco industry: pharmaceutical, lead, vinyl chloride, and silicosis-generating industries have all used similar approaches to protect profits.2 Recently, we have observed some of the same tactics used by the spinal cord stimulator industry.
In the past 3 years, several independent studies have questioned the safety and efficacy of spinal cord stimulation to manage pain. Our 2023 Cochrane review,3 an earlier review by O’Connell and colleagues,4 and key articles published in JAMA5,6 and JAMA Neurology7 from industry-independent teams found evidence of no benefit on pain and risk of harms. Authors funded by the spinal cord stimulator industry were swift to respond. We located 18 critiques of the Cochrane reviews and JAMA Network articles, all written by industry-funded authors. Herein, we share our experiences, as a recent subject of these critiques (A.C.T.) and as a researcher of commercial interests in research (L.A.B.), and reflect on how the critiques illustrate broader issues in the way corporations continue to influence science and health.
Control the Discourse
Industry-funded critics of independent studies often do not follow the usual route of scientific discourse. Rather than respond to the journal where the original study was published, critics frequently publish in journals where they are the editors and can control the discourse (15 of 18 letters criticizing the independent studies cited in this article appeared in journals with industry-affiliated editors). The journal can then choose to paywall the subsequent response from the independent authors, giving critics the last word. Critics of our Cochrane review3 claiming errors published a 1400-word open access critique in their own journal. We were then allowed 700 words to respond, and that response was paywalled (though we did have the option to pay an open access fee for $4612). The Cochrane review by O’Connell and colleagues4 attracted a 4000-word critique in a journal where the senior author was editor in chief. In both cases, critics were industry funded and chose to avoid accepted Cochrane channels, where conflicts must be declared.
Attack the Credibility of Independent Scientists
Another industry strategy to undermine science is to attack the credibility of the researchers rather than the research. We and other independent researchers of spinal cord stimulation have been accused of being incompetent, naive, or ourselves conflicted. Dhruva and colleagues7 were accused of conflict due to affiliation with an insurance company that would not benefit directly from the outcome of their study. The credibility of our review team was attacked because one of the authors of our Cochrane review3 had authored books on harms in health care. Critics may attack an author team’s professional expertise. These tactics distract readers by implying that all authors have conflicts of some kind and that only experts in interventional pain management can conduct rigorous research.
Emphasize “Real-World Studies” Over Rigorous Trials
Both Cochrane reviews3,4 were criticized for excluding studies that did not meet their published, prespecified inclusion criteria. Critics suggested that efficacy and safety have already been established, so the focus of research should be on “real-world studies” rather than on placebo-controlled trials. In this context, a real-world study is an unblinded study that compares different patterns of stimulation in people who already have a stimulator implanted, or one that compares spinal cord stimulation with other care options such as spinal surgery. Although well-designed unblinded studies can inform practice, these study designs are at risk of performance bias and, in the absence of evidence of efficacy, could be comparing 2 or more harmful treatments. Until efficacy is established through rigorous trials, the real-world studies promoted by critics are likely to be more misleading than informative, hence their exclusion from the Cochrane reviews.
Critique Parts of the Research but Not the Whole
The trial by Hara and colleagues,5 published in JAMA, was, to our knowledge, the first placebo-controlled trial of spinal cord stimulation from a team without financial conflicts. It successfully blinded patients, surgeons, investigators, and the trial statistician. The trial found no benefit of spinal cord stimulation on pain and disability outcomes in people with radicular pain. Industry-funded critics attempted to invalidate the findings by claiming the stimulation settings used during the intervention periods were incorrect. The trial was also criticized for preventing patients from controlling their own stimulator settings (to preserve patient blinding). However, Hara and colleagues used the stimulation settings recommended by the manufacturer, and their 6-month follow-up study6 has since shown no benefit of allowing patients to control their own stimulation settings. Of the 8 letters we located criticizing the trial, all focused on the stimulation settings, and none acknowledged the robust methods used to reduce risk of selection, performance, attrition, and reporting bias.
Fund Research and Scientists
Corporations influencing the design, conduct, and publication of studies to favor an industry-sponsored intervention is widely documented.1 By flooding the scientific literature with studies that favor their products, corporate interests appear to be proscience while distracting from unfavorable research. Critiques may cite industry-led studies as counterevidence. For example, most of the critiques of the trial by Hara and colleagues5 exclusively cited research from industry-funded authors.
Conflate Regulatory Approval With Efficacy and Safety
Critics claim that because the US Food and Drug Administration has approved use of spinal cord stimulators, and they have been widely used for decades, there is already evidence for efficacy and safety. This is not the case. Provision 510(k) requires that new medical devices need only be “substantially equivalent” to a product already on the market, even if the earlier product is itself untested.8 When the active device may be no more effective than placebo, the new device could have little to no effect and still enter the market.
Conclusions
The responses to recent research on spinal cord stimulation illustrate how corporations continue to undermine independent science. We have focused on tactics used in the academic literature; independent scientists are also at risk of industry-led attacks in the media, lawsuits, and attempts to have them expelled or sanctioned by their institutions. One solution would be to eliminate financial conflicts from research: the scientific community simply stops accepting funding or publishing work from industry-funded researchers (eg, BMJ, Cochrane, other journals that have prohibited publication of industry-funded research). Without a venue for publication, those with financial interests would lose their ability to launch critical campaigns in the literature. Solutions should extend further than journal policies. Academic institutions could commit to defending targeted individuals publicly (eg, through a focused communications strategy) and, if necessary, provide legal support in more serious cases. To maintain independence, professional organizations should not accept industry funding and should have strict policies to actively manage financial conflicts of their members. At a minimum, readers should recognize that attacks on independent science are often sustained and repetitive industry tactics to protect profits and should discount these criticisms.
Article Information
Corresponding Author: Adrian C. Traeger, PhD, School of Public Health, The University of Sydney, Level 10N, King George V Building, Royal Prince Alfred Hospital (C39), PO Box M179, Missenden Road NSW 2050, Australia (adrian.traeger@sydney.edu.au).
Published Online: December 18, 2023. doi:10.1001/jamainternmed.2023.6962
Conflict of Interest Disclosures: Dr Bero is Senior Research Integrity Editor for Cochrane, for which the University of Colorado receives remuneration outside the submitted work. No other disclosures were reported.
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