By: Bharat Kirthivasan, Co-Copy Editor [Content-Focused]
Most people would prefer that a research paper be mandated to disclose its source of funds. For example, if a publication effusively supports a certain drug, we want to know if its parent company is footing the bill. Transparency allows research to be viewed in light of its inherent biases and brooks an objective examination of its conclusions.
Or does it? What about our biases? I have never read a research paper without noting the authors’ names, affiliations, and funding sources, and these details affect my first impression of the research. Knowing that a paper comes from a prestigious university or that it’s published in a high-impact journal makes us less skeptical—our burden is shared by the editors and peer-reviewers of said journal. Simply put, they wouldn’t publish it if it weren’t good.
But this does not allow for high-quality research and analysis. The veracity of an experimental conclusion is independent of who the scientists are and who funds them. It is human nature to shudder at the thought of a pharmaceutical company nudging its research toward a favorable conclusion, and it is likely that people get hurt as a result of such flaws in studies. But a blanket distrust of research that is funded by pharmaceutical industries stands to harm more people.
While such prejudice would be expected of the general public, physicians aren’t immune to it either. Kesselheim et al. (2012) asked board-certified internists to judge the abstracts of clinical trials involving three fictitious drugs.1,2 The internists were randomly told that the trial in question was of low, medium, or high methodological rigor. Each trial report also included one of three disclosures of financial support: a pharmaceutical company, the National Institutes of Health (NIH), or none. About 54% of the surveyed physicians responded, and the results indicated that their willingness to prescribe a drug increased with the methodological rigor of the study. Furthermore, the physicians were half as likely to prescribe a drug if a pharmaceutical company, as opposed to the NIH, was purported to have funded the research. In fact, the knowledge that a trial was industry-funded adversely affected the internists’ opinion of its methodological rigor. The authors concluded:
“Physicians discriminate among trials of varying degrees of rigor, but industry sponsorship negatively influences their perception of methodologic quality and reduces their willingness to believe and act on trial findings, independently of the trial’s quality.” 1,2
To be fair, a pharmaceutical industry does stand to gain from research favoring its product. In fact, Lexchin et al. (2003) reported that an industry-funded article was about four times more likely to favor its sponsor than an article with other sponsors.3 Als-Nielsen et al. (2003) reported similar odds.4 There are two reasons for such a skew in studies conducted honestly: (1) biased interpretation of experimental results and (2) publication bias—studies showing positive results are more likely to be published. Either way, the skepticism of industry-sponsored research isn’t unfounded.
Nor is it inappropriate, say Dr. Keyhani and Dr. Korenstein.5 In a perfect world, clinicians would pore over methodologies and appraise clinical trials accurately. In reality, most clinicians only read the abstracts.6 Also, physicians without training in the methodology of clinical trials would find it difficult to identify errors of method and judgment that escaped peer-review.
The total spending on clinical trials of investigational drugs and devices in the U.S. reached $35 billion in 2008, of which industry funding accounted for nearly $32 billion (90%).7 A physician’s opinion of industry-funded clinical research, flawed or otherwise, has a lot of influence. Dr. Kesselheim explains,
“While there is good reason to be extra vigilant about industry-funded research, if physicians are reluctant to trust all such research, this could hinder the translation of even high-quality industry-funded research into practice. Strategies such as greater transparency and independent review of trial data could be pursued to try to change such attitudes among physicians” 1,2
- Kesselheim AS et al. A randomized study of how physicians interpret research funding disclosures. N Engl J Med. 2012; 367(12):1119-27
- Can disclosure hurt the translation of research? World Pharma News. 2012. Available at http://www.worldpharmanews.com/research/2212-can-disclosure-hurt-the-translation-of-research. Accessed March 10, 2013.
- Lexchin J et al. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326:1167
- Als-Nielsen B et al. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA. 2003; 290(7):921-8
- Keyhani S. and Korenstein D. Physician skepticism about industry-funded clinical trials. The Medical Professionalism Blog, ABIM Foundation. 2012. Available at http://blog.abimfoundation.org/physician-skepticism-about-industry-funded-clinical-trials/. Accessed March 10, 2013
- Hopewell S, Eisinga A, and Clarke M. Better reporting of randomized trials in biomedical journal and conference abstracts. J Inf Sci. 2008; 34(2). 162-173
- Getz. KA. Sizing up the clinical research market. Applied Clinical Trials Online. 2010. Available at http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/CRO%2FSponsor/Sizing-Up-the-Clinical-Research-Market/ArticleStandard/Article/detail/660749. Accessed March 10, 2013