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One-third of oncologist authors fail to disclose industry payments
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A substantial portion of oncologists working on published clinical trials that led to FDA approvals failed to fully disclose payments from trial sponsors, according to a research letter published in JAMA Oncology.
Of the oncologist authors included in the study, 76.5% received at least one industry payment, and 32% failed to fully disclose their received payments.
“Financial disclosures are important for the reasons of transparency and trust between physicians and other stakeholders, such as patients,” Cole Wayant, DO, PhD, researcher at Oklahoma State University, told HemOnc Today. “Disclosing conflicts of interest helps readers interpret the findings of a research study, especially given the fact that drug companies finance their own drug trials.”
Wayant and colleagues identified publications related to oncology drugs approved between January 2016 and August 2017.
Using the Open Payments Database, the researchers identified all industry payments to oncologist authors that occurred during the conduct of a trial — from trial registration to publication — from the trial sponsor. Researchers then cross-referenced these data with the disclosure statements included in the published trials.
“Trials that underpin FDA approvals are important because the newly approved drugs have been shown to be very expensive and have variable efficacy,” Wayant said. “Patients and physicians deserve trials free from bias to ensure evidence-based oncology care.”
Wayant and colleagues categorized payments as general (ie, personal payments, speaking fees, travel reimbursement), research (ie, fees for enrolling patients and study coordination), associated research (ie, grants) and ownership (ie, stock).
The analysis included data on 344 oncologist authors from 43 published trials.
Exclusion criteria included non-U.S.-based doctors, nonphysicians and nononcologists.
Overall, 76.5% (n = 263) received at least one industry payment. Thirty-two percent of the study population did not fully disclose payments from the trial sponsor.
The median value of general payments to the study authors was $2,828 (interquartile range [IQR], 0-19,628) and median associated research payment was $164,644 (IQR, 0-551,926).
Researchers found lower median disclosed vs. undisclosed values for general payments ($1,170 vs. $3,783) and associated research ($81,591 vs. $292,273).
“We know that pharmaceutical companies sponsor trials of their own drugs. That’s not a surprise,” Wayant said in a press release. “But, what is a surprise, and what warrants concern, is that this funding is often not disclosed in the publication of clinical trials that form the basis of FDA approvals and clinical practice guidelines.”
The journals with the most frequent publications from oncologist authors included The Lancet Oncology (n = 115), The New England Journal of Medicine (n = 100) and The Lancet (n = 70).
NEJM (46%) and The Lancet (37.1%) had the highest proportion of oncologist authors with undisclosed payments. In addition, authors who published in NEJM failed to disclose 45% ($34,426,582 of $75,701,366) of payments. The Lancet authors failed to disclosure 49% ($22,519,822 of $46,534,132) of received payments. These two journals represented the highest percentages of undisclosed dollars received compared with The Lancet Haematology, The Lancet Oncology, Journal of Clinical Oncology and JAMA Oncology.
“For individual clinical trials — like those that underpin FDA drug approvals — the only oversight comes from the journals,” Wayant told HemOnc Today. “The Open Payments Database catalogues all payments to U.S. physicians by pharmaceutical companies and has oversight from CMS. However, there is no ‘cross-talk’ between journals and the Open Payments Database. That is, journals have a policy for disclosure of conflicts of interest but do not seem to use Open Payments Database to ensure their policies are enforced.”
Results also showed one-quarter of oncologist authors did not receive any payments, implying withholding from receiving industry payment is possible while conducting a clinical trial.
“Personally, I believe one of the more effective ways to ensure accurate disclosures is to have journals reference Open Payments Database for each U.S. physician author,” Wayant said. “Journal staff or editors may oversee this process. What’s clear is that asking authors to self-disclose is ineffective, and that undisclosed conflicts of interest exist in the published oncology literature.”
The study limitations included the 20 months span of the study and the fact that most of the study population worked on novel drugs or in novel indications, limiting the generality to all oncologist authors. – by Cassie Homer
For more information:
Cole Wayant, DO, PhD, can be reached at Oklahoma State University Center for Health Sciences, 1111 W. 17th St., Tulsa, OK; email: cole.wayant@okstate.edu.
Disclosures: The authors report no relevant financial disclosures.
Perspective
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This is a concerning study that suggests widespread failure to disclose financial ties from drug makers to authors of clinical trials. We aren’t talking just about research payments, which is money paid from drug makers to universities to run trials. We are also talking about general or personal payments, which is money transferred from companies to physician pockets.
I happen to think research payments are necessary and useful and represent collaboration between the industry and universities. However, personal payments seem to lack justification altogether.
In this study, the mean personal payment was $18,000, which is not a trivial sum. Moreover, undisclosed mean person payments were $16,000. I work with medical students. Not a single one has given me $16,000 for my ‘collaboration.’ I do it because that is part of my job. And part of the job of trialists is to run trials. They do not need these extra ‘consulting’ payments.
Further, we have to be honest in medicine. There are so many things we could do to curb the widespread and corrosive impact of the industry on the analysis, dissemination, spin and interpretation of clinical research, including divesture of CME and recusal of conflicted faculty from writing editorials, independent guidelines, etc. We do nearly none of that.
The tool we principally employ is disclosure. Disclosure is a dull, dispassionate tool that perhaps does little more than permit the study of this topic. Here, the authors show we don’t even do that well. Moreover, we showed a few years ago, many conference presenters flash their disclosure faster than the ability of humans to read. In other words, we pay token efforts to the one tool we employ. This study furthers that idea. My take away is: this is not good.
Reference:
Boothby A, et al. JAMA Oncology. 2016;doi:10.1001/jamaoncol.2016.2706.
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