Failure to Disclose Conflict of Interest in Article Published in JAMA on Detection of Cancer-Related Genes

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To the Editor I write to take full responsibility for failing to report appropriate conflict of interest disclosures in articles published in JAMA and the JAMA Network journals between 2015 and 2018, including “Mutation Detection in Patients With Advanced Cancer by Universal Sequencing of Cancer-Related Genes in Tumor and Normal DNA vs Guideline-Based Germline Testing,” published in the September 5, 2017, issue of JAMA.¹ In that article, I had reported nothing to disclose. In the interest of full disclosure, I now report the following financial interests and activities that I had been involved in from 2013 to the present, regardless of potential relevance:

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... Professional associations can take a leadership role in setting cultural expectations in a discipline [12,14]. Associations have an important responsibility to address harassment and other exclusionary behaviors in the first place because these occur at conferences [80,81]. Another reason is because societies administer awards and honors in the discipline and can either incentivize abusive behaviors by failing to include them in the evaluation process or actively discourage and penalize the full spectrum of misconduct by wielding effective codes of conduct. ...
... The inadequacies of FCOI disclosure in CREATE-X was not an isolated case. Such disclosure issues have been problematic many times in the past [42][43][44]80]. Consequently, it may well be necessary to consider more robust future measures to correct inappropriate FCOI disclosure practices. ...
The spread of misinformation and disinformation related to science and technology has impeded public and policy efforts to mitigate threats such as COVID-19 and anthropogenic climate change. In the digital age, such so-called fake science can propagate faster and capture the public imagination to a greater extent than accurate science. Therefore, ensuring the most reliable science reaches and is accepted by audiences now entails understanding the origins of fake science so that effective measures can be operationalized to recognize misinformation and inhibit its spread. In this chapter, we review the potential weaknesses of science publishing and assessment as an origin of misinformation; the interplay between science, the media, and society; and the limitations of literacy as an inoculation against misinformation; and we offer guidance on the most effective ways to frame science to engage non-expert audiences. We conclude by offering avenues for future science communication research.
... 10,11 The news circulated widely in the press and social media, opening questions not simply about one person's practice in filling out disclosure forms but also about the overall quality and integrity of cancer research and medical journals worldwide. Baselga revisited his previous disclosure practices, apologized, 11,12 and resigned from his post at Memorial Sloane Kettering, but somehow that did not seem to be quite enough. Something, the public demanded, had to be done, which supports the International Committee of Medical Journal Editors (ICMJE) position that perceptions of COIs are as important to consider as actual conflicts. ...
Purpose: Confusion exists around the nature and best practices for authors in biomedical fields seeking to disclose conflicts of interest (COIs) and other information that can produce bias. Guidelines often provide principles for action and to avoid granularity that can limit their general usefulness. Journal editors must also interpret various guidelines to produce and enhance their own disclosure and COI policies. We discussion COIs and present heuristics that can enhance disclosure practices by individual authors and inform policy and practice among medical journal editors. Methods: The authors reviewed the biomedical literature and drew on professional and academic experience to develop examples and a suggested matrix for decision making. Findings: Most COI commentary centers on financial relationships. Disagreement still exists about the nature and impact of various forms of COI, making critical reasoning essential when making and interpreting disclosures. Journal editors, authors, critics, and other experts express varying opinions about best practices regarding COIs. Policy decisions should be balanced and reasonable. Narrative context may help readers understand the meaning and relevance of disclosures and COIs. Implications: A balance of personal responsibility and critical thinking can enhance disclosure practices as well as confidence in the medical literature. Using a heuristic to think through possible areas of conflict can help authors provide more complete disclosure information. Providing narrative context can ease the burden of peer reviewers, editors, and readers trying to understand disclosures.
... For example, JAMA and the JAMA Network journals recently published Letters of explanation with Corrections regarding articles in 5 journals to correct and clarify the originally published incomplete or inaccurate COI disclosure statements of authors. 39,40 In addition, academic medical centers and other organizations have increased efforts to encourage 24 and promote transparent reporting of financial interests and other COI disclosures, such as by posting faculty COI information on institutional websites. Botkin 41 has suggested that institutional COI policies should be strengthened, such as by considering the intentional or negligent failure to disclose significant financial relationships relevant to the conduct of research to be a form of research reporting misconduct. ...
It is imperative to properly manage financial conflicts of interest (FCOI) in clinical trials. Non-profit or other third-party organizations obviously should be considered potential FCOI. This chapter discusses this under-recognized type of FCOI based on the Capecitabine for Residual Cancer as Adjuvant Therapy (CREATE-X) trial conducted targeting high-risk breast cancer patients in Japan and Korea. We also present issues of insufficient individual-level FCOI disclosure and health insurance fraud in the CREATE-X trial and the underlying structure of the profit-first doctrine of pharmaceutical companies.
To the Editor The recent investigation¹ of a prominent researcher for nondisclosure of significant conflicts of interest (COIs) has resurfaced the debate about COIs. In an Editorial, Dr Bauchner and colleagues² discussed the responsibilities of authors, institutions, and editors in ensuring accurate, detailed, complete, and transparent disclosure of COIs. A financial relationship with a company may not be relevant and hence not constitute a conflict. However, “relevance” is subjective and to remove any ambiguity, the editorialists encouraged authors to provide complete and broad disclosure, thereby allowing readers to decide whether reported COIs are important in their interpretation of an article.
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Importance Guidelines for cancer genetic testing based on family history may miss clinically actionable genetic changes with established implications for cancer screening or prevention. Objective To determine the proportion and potential clinical implications of inherited variants detected using simultaneous sequencing of the tumor and normal tissue (“tumor-normal sequencing”) compared with genetic test results based on current guidelines. Design, Setting, and Participants From January 2014 until May 2016 at Memorial Sloan Kettering Cancer Center, 10 336 patients consented to tumor DNA sequencing. Since May 2015, 1040 of these patients with advanced cancer were referred by their oncologists for germline analysis of 76 cancer predisposition genes. Patients with clinically actionable inherited mutations whose genetic test results would not have been predicted by published decision rules were identified. Follow-up for potential clinical implications of mutation detection was through May 2017. Exposure Tumor and germline sequencing compared with the predicted yield of targeted germline sequencing based on clinical guidelines. Main Outcomes and Measures Proportion of clinically actionable germline mutations detected by universal tumor-normal sequencing that would not have been detected by guideline-directed testing. Results Of 1040 patients, the median age was 58 years (interquartile range, 50.5-66 years), 65.3% were male, and 81.3% had stage IV disease at the time of genomic analysis, with prostate, renal, pancreatic, breast, and colon cancer as the most common diagnoses. Of the 1040 patients, 182 (17.5%; 95% CI, 15.3%-19.9%) had clinically actionable mutations conferring cancer susceptibility, including 149 with moderate- to high-penetrance mutations; 101 patients tested (9.7%; 95% CI, 8.1%-11.7%) would not have had these mutations detected using clinical guidelines, including 65 with moderate- to high-penetrance mutations. Frequency of inherited mutations was related to case mix, stage, and founder mutations. Germline findings led to discussion or initiation of change to targeted therapy in 38 patients tested (3.7%) and predictive testing in the families of 13 individuals (1.3%), including 6 for whom genetic evaluation would not have been initiated by guideline-based testing. Conclusions and Relevance In this referral population with selected advanced cancers, universal sequencing of a broad panel of cancer-related genes in paired germline and tumor DNA samples was associated with increased detection of individuals with potentially clinically significant heritable mutations over the predicted yield of targeted germline testing based on current clinical guidelines. Knowledge of these additional mutations can help guide therapeutic and preventive interventions, but whether all of these interventions would improve outcomes for patients with cancer or their family members requires further study. Trial Registration Identifier: NCT01775072