Financial Conflict of Interest and Academic Influence Among Experts Speaking on Behalf of the Pharmaceutical Industry at the US Food and Drug Administration's Oncologic Drugs Advisory Committee Meetings

Lammers, Austin; Edmiston, Jonathan; Kaestner, Victoria; Prasad, Vinay

doi:10.1016/j.mayocp.2017.04.014

Cited by 10 publications

(7 citation statements)

References 8 publications

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“…Lammers et al 16 reviewed 35 ODAC meetings between 2011 and 2015 and found that 35 out of 38 experts (US healthcare professional with an MD degree) who spoke at these meetings had received industry payments with a mean income of $39 316. In addition, this study found a strong correlation among these expert's payments and their degree of academic success.…”

Section: Discussionmentioning

confidence: 99%

Characteristics and conflicts of interests of public speakers at the Psychopharmacologic Drug and Advisory Committee meetings regarding psychiatric drugs

Roberts

Jellison

Wayant

et al. 2020

BMJ EBM

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The Psychopharmacologic Drug Advisory Committee (PDAC) is one of 33 advisory committees of the Food and Drug Administration (FDA). During committee meetings, an open public hearing takes place where speakers provide testimonies about the drug in question and are asked, not required, to disclose any conflicts of interests (COIs) before speaking. These speakers may present with COIs which include, but are not limited to, reimbursement for travel and lodging by the pharmaceutical company to attend the meeting; previous or current payments for consulting from the pharmaceutical company and compensation as a paid investigator in previously conducted clinical trials for the drug under review. Our study aimed to investigate the characteristics and COIs of public speakers at PDAC meetings of the FDA. We evaluated 145 public speakers at FDA committee meetings over a 10-year period. We found a total of 52 public speakers disclosed a COI with travel and lodging being the most prominent. Among these speakers, 82.4% provided a positive testimony regarding the psychiatric drug in question. Speakers who had the condition in question were not more likely to provide a positive statement than those who did not. Our results showed that disclosing a COI was associated with increased odds of public speakers providing a favourable testimony for the recommendation of psychiatric drugs. The implications of these findings are concerning since COIs have the potential to skew public speaker’s testimonies and persuade committee members to recommend a drug through emotionally charged tactics.

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Section: Discussionmentioning

confidence: 99%

Characteristics and conflicts of interests of public speakers at the Psychopharmacologic Drug and Advisory Committee meetings regarding psychiatric drugs

Roberts

Jellison

Wayant

et al. 2020

BMJ EBM

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“…In the research area, they are increasingly involved in primary research, evidence synthesis, as well as clinical and public health guideline development . In the regulatory field, patient representatives serve as voting members in United States (US) Food and Drug Administration (FDA) drug advisory committees, as well as invited speakers . In Canada, patient groups participate in drug reviews and voice their position on drug funding decisions .…”

Section: Introductionmentioning

confidence: 99%

“…5 In the regulatory field, patient representatives serve as voting members in United States (US) Food and Drug Administration (FDA) drug advisory committees, 6 as well as invited speakers. 7 In Canada, patient groups participate in drug reviews and voice their position on drug funding decisions. 8 This increased interest in patients' and health consumers' engagement is further reflected in the emergence of programmes that support patient and public participation in the above activities such as INVOLVE 9 and the FDA Patient Representative Program℠.…”

Section: Introductionmentioning

confidence: 99%

Financial relationships between patient and consumer representatives and the health industry: A systematic review

Khabsa

Semaan

El‐Harakeh

et al. 2019

Health Expectations

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Background Patients and consumers are increasingly engaged in health policymaking, research and drug regulation. Having financial relationships with the health industry creates situations of conflicts of interest (COI) and might compromise their meaningful and unbiased participation. Objective To synthesize available evidence on the financial relationships between the health industry and patient and consumer representatives and their organizations. Methods We systematically searched MEDLINE and EMBASE. We selected studies and abstracted data in duplicate and independently. We reported on outcomes related to financial relationships of individuals with, and/or funding of organizations by the health industry. Results We identified a total of 14 510 unique citations, of which 24 reports of 23 studies were eligible. Three studies (13%) addressed the financial relationship of patient and consumer representatives with the health industry. Of these, two examined the proportion of public speakers in drug regulatory processes who have financial relationships; the proportions in the two studies were 25% and 19% respectively. Twenty studies (87%) addressed funding of patient and consumer organizations. The median proportion of organizations that reported funding from the health industry was 62% (IQR: 34%‐69%) in questionnaire surveys, and 75% (IQR: 58%‐85%) in surveys of their websites. Among organizations for which there was evidence of industry funding, a median proportion of 29% (IQR: 27%‐44%) acknowledged on their websites receiving that funding. Conclusion Financial relationships between the health industry and patient and consumer representatives and their organizations are common and may not be disclosed. Stricter regulation on disclosure and management is needed.

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“…Consensus such as this may provide a useful mechanism to synthesize available evidence together with expert opinion. However, the data may only reflect a snapshot in a rapid moving area; besides, the agreement among experts does not mean surety, because experts can be influenced by data, individual experiences, momentum, practice setting, the peers' sentiments, financial conflicts of interest, trials they conducted, among other scenarios (6).…”

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confidence: 99%

National Consensus on Non-metastatic Castration-Resistant Prostate Cancer: more than just a snapshot

2021

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The landscape of castration-resistant prostate cancer (CRPC) has dramatically improved in the last few years. Still, it remains a very heterogeneous clinical setting. It ranges from patients with good performance status having an asymptomatic PSA elevation after hormone blockage failure with previous hormone-sensitive prostate cancer to those with a rapidly progressing disease and a dismal prognosis. Non-metastatic castration-resistant prostate cancer (nmCRPC-M0) is a transient stage that affects almost 10% of prostate cancer patients, with up to 60% progressing to the metastatic disease within 5 years (1). Recently 3 new androgen receptor blockers have been approved in Brazil by ANVISA for nmCRPC based on their level 1 pivotal studies-Spartan (apalutamide); Prosper (enzalutamide) and Aramis (darolutamide). These studies showed a remarkably similar result albeit targeting patients with slightly different characteristics (Table-1). Overall, the pooled analysis of the data revealed a significantly increased overall survival and improved progression-free survival due to these new agents compared with placebo. In the current edition of the IBJU, Maluf et al. describe a national consensus of experts on nmCRPC, aiming to provide data on diverse topics such as diagnosis, patient selection, management of comorbidities, treatment efficacy, side effects due to the "inexistence of a national guideline for this clinical scenario" (2). It was not stated on the paper which criteria was used for selecting the Specialists nor which Medical Societies (if any) promoted the consensus; and, there was no disclaimer of how the consensus was supported. The article brings a good review of the literature to hold up the expert's opinions. While every effort is expected from groups of experts to provide the best knowledge to diagnostic and treatments according to the most up-to-date data and international recommendations, one must not lose sight of the significant gaps and controversies that might coexist regarding clinically meaningful endpoints, financial toxicity, overtreatment, pharmacoeconomic and polypharmacy for this type of cancer patients, especially in a country as large and heterogeneous as Brazil, which may provide all available resources in one area but may lack significant basic means in several others. Thus, several important points deserve consideration. The consensus is somehow outdated; although the authors do mention data from the Aramis study, darolutamide was not included in the experts' questions and responses because it was only approved in Brazil by December 2019. The panel agreed to answer questions on the assumption of the existence of an ideal clinical scenario based on the best evidence available. Yet it was unable to reach consensus in any of the questions EDITORIAL COMMENT

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Financial Conflict of Interest and Academic Influence Among Experts Speaking on Behalf of the Pharmaceutical Industry at the US Food and Drug Administration's Oncologic Drugs Advisory Committee Meetings

Cited by 10 publications

References 8 publications

Characteristics and conflicts of interests of public speakers at the Psychopharmacologic Drug and Advisory Committee meetings regarding psychiatric drugs

Characteristics and conflicts of interests of public speakers at the Psychopharmacologic Drug and Advisory Committee meetings regarding psychiatric drugs

Financial relationships between patient and consumer representatives and the health industry: A systematic review

National Consensus on Non-metastatic Castration-Resistant Prostate Cancer: more than just a snapshot

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