Financial Conflicts of Interest: Payment at the Expense of Patients?

This provocative editorial proposes four steps that can be immediately implemented to reduce the impact of financial conflicts of interest in oncology without stifling collaboration.

An urgent call to raise the bar in oncology.

Important breakthroughs in medical treatments have improved outcomes for patients suffering from several types of cancer. However, many oncological treatments approved by regulatory agencies are of low value and do not contribute significantly to cancer mortality reduction, but lead to unrealistic patient expectations and push even affluent societies to unsustainable health care costs. Several factors that contribute to approvals of low-value oncology treatments are addressed, including issues with clinical trials, bias in reporting, regulatory agency shortcomings and drug pricing. With the COVID-19 pandemic enforcing the elimination of low-value interventions in all fields of medicine, efforts should urgently be made by all involved in cancer care to select only high-value and sustainable interventions. Transformation of medical education, improvement in clinical trial design, quality, conduct and reporting, strict adherence to scientific norms by regulatory agencies and use of value-based scales can all contribute to raising the bar for oncology drug approvals and influence drug pricing and availability.

The Ethical Imperative of Equity in Oncology: Lessons Learned From 2020 and a Path Forward.

The COVID-19 pandemic and the simultaneous increased focus on structural racism and racial/ethnic disparities across the United States have shed light on glaring inequities in U.S. health care, both in oncology and more generally. In this article, we describe how, through the lens of fundamental ethical principles, an ethical imperative exists for the oncology community to overcome these inequities in cancer care, research, and the oncology workforce. We first explain why this is an ethical imperative, centering the discussion on lessons learned during 2020. We continue by describing ongoing equity-focused efforts by ASCO and other related professional medical organizations. We end with a call to action-all members of the oncology community have an ethical responsibility to take steps to address inequities in their clinical and academic work-and with guidance to practicing oncologists looking to optimize equity in their research and clinical practice.

Discrepancies between author- and industry-reported disclosures of financial relationships at an annual gynecologic oncology research meeting.

OBJECTIVE: Trillions of dollars pass to physicians from industry-related businesses annually, leading to many opportunities for financial conflicts of interest. The Open Payments Database (OPD) was created to ensure transparency. We describe the industry relationships as reported in the OPD for presenters at the 2019 Society of Gynecologic Oncology (SGO) Annual Meeting and evaluate concordance between author disclosures of their financial interests and information provided by the OPD. METHODS: This is an observational, cross-sectional study. Disclosure data were collected from authors with oral and featured abstract presentations in the 2019 SGO annual conference. These disclosures were compared to data available for each author in the 2018 OPD, which included the amount and nature of industry payments. RESULTS: We examined the disclosures of 301 authors who met inclusion criteria. Of 161 authors who had disclosure statements on their presentations,147 reported "no disclosures," and 14 disclosed industry relationships. The remaining 140 did not list any disclosure information. Sixty percent (184/301) of authors had industry relationships in the 2018 OPD, including 173 of 287 (60.3%) of authors who either reported no disclosures or did not have disclosure data available in their presentations. These transactions totaled over 43 million USD from 122 different companies, with most payments (46%) categorized as "Research or Associated Research." Accurate disclosure reporting was associated with receiving higher payments or research payments, and being a presenting author. CONCLUSIONS: Most authors at the SGO annual conference did not correctly disclose their industry relationships when compared with their entries in the OPD.

Care in the time of coronavirus: Ethical considerations in head and neck oncology.

As COVID-19 continues to challenge the practice of head and neck oncology, clinicians are forced to make new decisions in the setting of the pandemic that impact the safety of their patients, their institutions, and themselves. The difficulty inherent in these decisions is compounded by potentially serious ramifications to the welfare of patients and health-care staff, amid a scarcity of data on which to base informed choices. This paper explores the risks of COVID-19 incurred while striving to uphold the standard of care in head and neck oncology. The ethical problems are assessed from the perspective of the patient with cancer, health-care provider, and other patients within the health-care system. While no single management algorithm for head and neck cancer can be universally implemented, a detailed examination of these issues is necessary to formulate ethically sound treatment strategies.

Challenges of international oncology trial collaboration-a call to action.

International collaboration in oncology trials has the potential to enhance clinical trial activity by expediting the recruitment of large patient populations, testing treatments in diverse populations and facilitating the study of rare tumours or specific molecular subtypes. However, a number of challenges continue to hinder the efficient and productive conduct of both commercial and non-commercial international clinical trials. These challenges include complex and burdensome regulatory requirements, the high cost of conducting trials, and logistical challenges associated with ethics review, drug supply and biospecimen collection and management. We propose solutions to promote oncology trial collaboration, such as regulatory reform, harmonisation of trial initiation and management processes and greater recognition and funding of academic (non-commercial) clinical trials. It is only through coordinated effort and leadership from researchers, regulators and those responsible for health systems that the full potential of international trial collaboration can be realised.

Financial conflicts of interest of clinicians making submissions to the pan-Canadian Oncology Drug Review: a descriptive study.

OBJECTIVES: This study examines financial conflict of interest (FCOI) of clinicians who made submissions to the pan-Canadian Oncology Drug Review (pCODR), the arm of the Canadian Agency for Drugs and Technology in Health that recommends whether oncology drug indications should be publicly funded. Final reports from pCODR published between October 2016 and February 2019 were examined. DESIGN: Descriptive study. DATA SOURCES: Website of pCODR. INTERVENTIONS: None. PRIMARY AND SECONDARY OUTCOMES: The primary outcome is the number of submissions declaring FCOI. Secondary outcomes are the number of times where clinicians agreed and disagreed with preliminary recommendation from pCODR and the association between the distribution of individual clinicians' FCOI and pCODR's funding recommendations. RESULTS: There were 46 drug indication reports from pCODR. Clinicians made 261 submissions. Clinicians declared they received payments from companies 323 times and named 38 different companies making those payments a total of 500 times. Financial conflicts with drug companies were declared in 176 (66.3%) of all submissions. In 21 (45.7%) of the 46 drug indications, 50% or more of the clinicians had a conflict with the company making the drug. Clinicians commented on 37 preliminary recommendations. In all 25 where pCODR recommended funding or conditional funding, the clinicians either agreed or agreed in part. pCODR recommended that the drug indication not be funded 12 times and 9 times clinicians disagreed with that recommendation. The distribution of clinician responses was statistically significantly different depending on whether pCODR recommended funding/conditional funding or do not fund p<0.0001 (Fisher exact test). The distribution of clinicians' FCOI differed depending on whether the recommendation was fund/conditional fund or do not fund p=0.027 (Fisher exact test). CONCLUSION: Financial conflicts with pharmaceutical companies are widespread among experts making submissions to the pCODR.

Recruitment and Trial-Finding Apps-Time for Rules of the Road.

The problem of insufficient recruitment to clinical oncology trials is well known. Some stakeholders view mobile apps as a solution with the potential to make recruitment more efficient, lower trial costs, support patient-centeredness, and accelerate treatment advances. Recruitment and trial-finding apps seek to disrupt the traditional approach to recruitment in several ways, including aggregating information about ongoing trials and presenting it in a user-friendly format, curating information to tailor search results to prospective participants' interests, facilitating direct contact between prospective participants and trial sites, and, in at least one case, analyzing individuals' tumor samples and medical records to provide tailored recommendations both for approved treatments and clinical trials. Although recruitment and trial-finding apps respond to a real need, they raise ethical concerns. Here, we outline six domains of ethical concern: review of recruitment materials, privacy and confidentiality, constrained choice and conflicts of interest, therapeutic misbranding, payment for accessing research-related information, and disruptions to care and research. We offer several suggestions and encourage additional dialogue to improve the ethical acceptability of these apps because, as third parties increasingly promise to revolutionize clinical trial recruitment by connecting patients and investigators via recruitment and trial-finding apps, we need some rules of the road.

Evaluating the Strength of the Association Between Industry Payments and Prescribing Practices in Oncology.

BACKGROUND: Financial relationships between physicians and the pharmaceutical industry are common, but factors that may determine whether such relationships result in physician practice changes are unknown. MATERIALS AND METHODS: We evaluated physician use of orally administered cancer drugs for four cancers: prostate (abiraterone, enzalutamide), renal cell (axitinib, everolimus, pazopanib, sorafenib, sunitinib), lung (afatinib, erlotinib), and chronic myeloid leukemia (CML; dasatinib, imatinib, nilotinib). Separate physician cohorts were defined for each cancer type by prescribing history. The primary exposure was the number of calendar years during 2013-2015 in which a physician received payments from the manufacturer of one of the studied drugs; the outcome was relative prescribing of that drug in 2015, compared with the other drugs for that cancer. We evaluated whether practice setting at a National Cancer Institute (NCI)-designated Comprehensive Cancer Center, receipt of payments for purposes other than education or research (compensation payments), maximum annual dollar value received, and institutional conflict-of-interest policies were associated with the strength of the payment-prescribing association. We used modified Poisson regression to control confounding by other physician characteristics. RESULTS: Physicians who received payments for a drug in all 3 years had increased prescribing of that drug (compared with 0 years), for renal cell (relative risk [RR] 1.81, 95% confidence interval [CI] 1.58-2.07), CML (RR 1.22, 95% CI 1.08-1.39), and lung (RR 1.69, 95% CI 1.58-1.82), but not prostate (RR 0.97, 95% CI 0.93-1.02). Physicians who received compensation payments or >$100 annually had increased prescribing compared with those who did not, but NCI setting and institutional conflict-of-interest policies were not consistently associated with the direction of prescribing change. CONCLUSION: The association between industry payments and cancer drug prescribing was greatest among physicians who received payments consistently (within each calendar year). Receipt of payments for compensation purposes, such as for consulting or travel, and higher dollar value of payments were also associated with increased prescribing. IMPLICATIONS FOR PRACTICE: Financial payments from pharmaceutical companies are common among oncologists. It is known from prior work that oncologists tend to prescribe more of the drugs made by companies that have given them money. By combining records of industry gifts with prescribing records, this study identifies the consistency of payments over time, the dollar value of payments, and payments for compensation as factors that may strengthen the association between receiving payments and increased prescribing of that company's drug.

Biospecimens, Research Consent, and Distinguishing Cell Line Research.

Newly revised regulations for human research affecting translational oncology will become effective in January 2019. A substantial component of the debate leading to this revision was how to regulate biospecimen research; specifically, whether all biospecimens should be considered inherently "identifiable," thereby necessitating informed consent for use in research. The famous cases seminal to this discussion involve cancer cell lines, but the unique features of this kind of biospecimen research were largely missing from the regulatory deliberation. However, special aspects of cell line research-at the stages of procurement, generation, evolution, and sharing-alter how society should balance participant interests against the goals of research. Recommendations are offered to cancer researchers and policymakers going forward to enable ethically appropriate regulation of biospecimen research across its diverse spectrum.

Personalised medicine in paediatric oncology: Ethical practice outside the clinical trial framework?

Modern paediatric oncology practice has rapidly evolved from a fatal condition at diagnosis in the 1940s to modern survival rates of over 80%. With the advent of the 'omics' era and modern diagnostics platforms, we can now determine many of the molecular driving mechanisms of malignancy. Current molecular diagnostics trials PRISM and AIM/MNP, open in Australia, allow accurate diagnosis and determination of the molecular drivers of many cancers leading to new targeted opportunities for treatment. Unfortunately, clinical trial support, development and drug access for children has lagged behind. This is leaving clinicians and their institutions with increasingly difficult medical and ethical decisions, further complicating an already demanding profession.

Application of the rapid ethical assessment approach to enhance the ethical conduct of longitudinal population based female cancer research in an urban setting in Ethiopia.

BACKGROUND: Rapid Ethical Assessment (REA) is an approach used to design context tailored consent process for voluntary participation of participants in research including human subjects. There is, however, limited evidence on the design of ethical assessment in studies targeting cancer patients in Ethiopia. REA was conducted to explore factors that influence the informed consent process among female cancer patients recruited for longitudinal research from Addis Ababa Population-based Cancer Registry. METHODS: Qualitative study employing rapid ethnographic approach was conducted from May-July, 2017, at the Tikur Anbessa Specialized Referral Hospital. In-depth and key informants' interviews were conducted among purposively selected 16 participants. Regular de-briefings among the study team helped to identify emerging themes and ensure saturation. Interviews and debriefings were tape recorded in Amharic, and transcribed and translated to English. Coding of the transcripts was facilitated by use of NVivo software. Thematic analysis was employed to respond to the initial questions and interpret findings. RESULTS: Perceived barriers to voluntary study participation included lack of reporting back study results of previous studies, the decision making status of women, hopelessness or fatigue in the patients, shyness of the women, data collectors approach to the patient, and patient's time constraints. Most of the patients preferred oral over written consent and face-to-face interview over telephone interview. Provision of detail information about the study, using short and understandable tool, competent, compassionate and respectful enumerators of the same gender were suggested to assure participation. Due to the perceived severity, the use of the term "cancer" was associated with fear and anxiety. Alternatively, uses of phrases like "breast or cervical illness/disease" were suggested during patient interviews. CONCLUSIONS: Voluntary participation is not straight forward but affected by different factors. Using competent, compassionate and respectful enumerators, short and precise questioning tools to limit the time of the interview could improve voluntary participation. Moreover, careful consideration of the patients and families concept of the disease such as wording and information has to be taken into account. This assessment helped in improving the consent process of the ongoing project on breast and cervical cancer patients.

Balancing the Economics and Ethics of Personalised Oncology.

The cost of personalised medicine in oncology is increasing. The varied and contrasting priorities of the pharmaceutical industry, local and national governments, international medical community, and patients need to be reviewed and balanced. In addition to the economic and political standpoints on this issue, the ethical considerations from physicians' viewpoints need to be considered to optimise cancer patients' care. In this paper we discuss the way research and development (R&D) of these drugs is carried out and reimbursed, and how this needs to change. We describe frameworks assessing the value of these treatments which been developed. Physicians need to develop their knowledge and understanding of these issues to best meet their dual responsibilities of advocating for their patients and promoting public health.

Conflict of interest among Italian medical oncologists: a national survey.

OBJECTIVES: To assess Italian medical oncologists' opinion on the implications of conflict of interest (COI) on medical education, care and research, and to evaluate their direct financial relationships. DESIGN: National cross-sectional survey conducted between March and April 2017 among Italian oncologists. SETTING: Online survey sponsored by the Italian College of Medical Oncology Chiefs through its website. PARTICIPANTS: Italian oncologists who filled out an anonymous questionnaire including 19 items and individual and working characteristics. MAIN OUTCOME MEASURE: The proportion of medical oncologists perceiving COI as an outstanding issue and those receiving direct payments from industry. RESULTS: There were 321 respondents, representing 13% of Italian tenured medical oncologists. Overall, 62% declared direct payments from the pharmaceutical industry in the last 3 years. Sixty-eight per cent felt the majority of Italian oncologists have a COI with industry, but 59% suppose this is not greater than that of other specialties. Eighty-two per cent consider that most oncology education is supported by industry. More than 75% believe that current allocation of industry budget on marketing and promotion rather than research and development is unfair, but 75% consider it appropriate to receive travel and lodging hospitality from industry. A median net profit margin of €5000 per patient enrolled in an industry trial was considered appropriate for the employee institution. Sixty per cent agree to receive a personal fee for patients enrolled in industry trials, but 79% state this should be reported in the informed consent. Over 90% believe that scientific societies should publish a financial report of industry support. Finally, 79% disagree to being a coauthor of an article written by a medical writer when no substantial scientific contribution is made. CONCLUSIONS: Among Italian oncologists COI is perceived as an important issue influencing costs, education, care and science. A more rigorous policy on COI should be implemented.