Evaluation of financial conflicts of interest and quality of evidence in Japanese gastroenterology clinical practice guidelines.

BACKGROUND: Clinical practice guidelines assist healthcare professionals in providing evidence-based care. However, pharmaceutical companies' financial interests often influence guideline content. This study aimed to elucidate the magnitude of financial ties among Japanese gastroenterology guideline authors and the pharmaceutical industry. METHODS: Using pharmaceutical company disclosed payment data, we evaluated financial conflicts of interest (COI) among Japanese Society of Gastroenterology guideline authors between 2016 and 2021. Additionally, we assessed the evidence quality supporting guideline recommendations and associations with financial COI. Finally, we evaluated author COI management during guideline development against global standards. RESULTS: Overall, 88.2% (231/262) of guideline authors received a median of $12 968 (interquartile range [IQR]: $1839-$70 374) in payments between 2016 and 2019 for lectures, writings, and consulting. Chairpersons received significantly higher payments (median: $86 444 [IQR: $15 455-$165 679]). Notably, 41 (15.6%) authors had undeclared payments exceeding declaration requirements. Low or very low-quality evidence supported 41.0% of recommendations. There was a negative association between the median 4-year payment per author and the proportion of recommendations based on low-quality evidence (odds ratio: 0.966 [95% confidence interval [95% CI]: 0.945-0.987], P = 0.002) and positive association with moderate-quality evidence (odds ratio: 1.018 [95% CI: 1.011-1.025], P < 0.001). Still, the Japanese Society of Gastroenterology guideline development process remains less transparent, with insufficient COI policies relative to global standards. CONCLUSION: There were extensive financial COI between pharmaceutical companies and guideline authors, and more than 40% of recommendations were based on low-quality evidence. More rigorous and transparent COI policies for guideline development adhering to global standards are warranted.

Interactions with the pharmaceutical industry and the practice, knowledge and beliefs of medical oncologists and clinical haematologists: a systematic review.

BACKGROUND: No previous review has assessed the extent and effect of industry interactions on medical oncologists and haematologists specifically. METHODS: A systematic review investigated interactions with the pharmaceutical industry and how these might affect the clinical practice, knowledge and beliefs of cancer physicians. MEDLINE, Embase, PsycINFO and Web of Science Core Collection databases were searched from inception to February 2021. RESULTS: Twenty-nine cross-sectional and two cohort studies met the inclusion criteria. These were classified into three categories of investigation: (1) extent of exposure to industry for cancer physicians as whole (n = 11); (2) financial ties among influential cancer physicians specifically (n = 11) and (3) associations between industry exposure and prescribing (n = 9). Cancer physicians frequently receive payments from or maintain financial ties with industry, at a prevalence of up to 63% in the United States (US) and 70.6% in Japan. Among influential clinicians, 86% of US and 78% of Japanese oncology guidelines authors receive payments. Payments were associated with either a neutral or negative influence on the quality of prescribing practice. Limited evidence suggests oncologists believe education by industry could lead to unconscious bias. CONCLUSIONS: There is substantial evidence of frequent relationships between cancer physicians and the pharmaceutical industry in a range of high-income countries. More research is needed on clinical implications for patients and better management of these relationships. REGISTRATION: PROSPERO identification number CRD42020143353.

The Big Pharma: a indústria bilionária farmacêutica na berlinda

Em entrevista a Lucas Mendes, a médica e professora da Harvar Medical School, Marcia Angell diz que a indústria farmacêutica não inventa nada de novo, abusa de patentes e transforma a medicina em produto descartável em nome da ganância obsessiva.

Mapping conflict of interests: scoping review.

OBJECTIVE: To identify all known ties between the medical product industry and the healthcare ecosystem. DESIGN: Scoping review. METHODS: From initial literature searches and expert input, a map was created to show the network of medical product industry ties across parties and activities in the healthcare ecosystem. Through a scoping review, the ties were then verified, cataloged, and characterized, with data abstracted on types of industry ties (financial, non-financial), applicable policies for conflict of interests, and publicly available data sources. MAIN OUTCOME MEASURES: Presence and types of medical product industry ties to activities and parties, presence of policies for conflict of interests, and publicly available data. RESULTS: A map derived through synthesis of 538 articles from 37 countries shows an extensive network of medical product industry ties to activities and parties in the healthcare ecosystem. Key activities include research, healthcare education, guideline development, formulary selection, and clinical care. Parties include non-profit entities, the healthcare profession, the market supply chain, and government. The medical product industry has direct ties to all parties and some activities through multiple pathways; direct ties extend through interrelationships among parties and activities. The most frequently identified parties were within the healthcare profession, with individual professionals described in 422 (78%) of the included studies. More than half (303, 56%) of the publications documented medical product industry ties to research, with clinical care (156, 29%), health professional education (145, 27%), guideline development (33, 6%), and formulary selection (8, 1%) appearing less often. Policies for conflict of interests exist for some financial and a few non-financial ties; publicly available data sources seldom describe or quantify these ties. CONCLUSIONS: An extensive network of medical product industry ties to activities and parties exists in the healthcare ecosystem. Policies for conflict of interests and publicly available data are lacking, suggesting that enhanced oversight and transparency are needed to protect patient care from commercial influence and to ensure public trust.

French pediatricians' views on industry-sponsored clinical trials: Toward stronger research on ethics?

INTRODUCTION: There is a crucial need to perform clinical trials in pediatrics due to an increased prescription rate of unapproved drugs. Since pediatricians are the gatekeepers of clinical trials, the primary objective of the current study was to evaluate, for the first time in France, pediatricians' views on performing clinical trials. The second objective was to identify the factors that influence their perceptions. MATERIAL AND METHODS: In 2017, pediatricians who were members of the French Pediatric Society completed an online survey comprising 27 questions. Fisher's exact test was performed to evaluate possible correlations between pediatrician characteristics (age, sex, parenthood, professional experience, status, type of practice, previous participation in clinical trials, ethics education) and personal views on clinical trials. A value of P≤0.001 was considered statistically significant. RESULTS: Overall, 207 pediatricians completed the questionnaire. Almost all participants (96.6%) were in favor of performing clinical trials. Pediatricians with teaching experience at university hospitals were more reluctant to propose children's participation in clinical trials for fear of increasing parental stress (P<0.001), or the occurrence of serious adverse reactions (P<0.001). Pediatricians with coordinator or investigator experience considered that one of the ethical drifts in pediatric clinical trials is the risk of child exploitation (P<0.001). CONCLUSION: Our findings suggest a favorable position of pediatricians concerning clinical trials, despite numerous concerns. Another outcome is the need to create an educational system of research in ethics in France dedicated to pediatricians in order to guarantee good clinical practice in research.

Pharmaceutical company payments to authors of the Japanese guidelines for the management of hypertension.

ABSTRACT: Antihypertensive drugs have been of significant interest to the pharmaceutical industry due to increasing sales opportunities in a global market. The financial relationships between pharmaceutical companies and the Japanese Society of Hypertension (JSH) have a possible influence on clinical practices in Japan. This study examined the distribution of pharmaceutical payments made to the authors of the revised Guidelines for the Management of Hypertension (JSH2019) and the transparency of the Conflict of Interest disclosure that each author made.We retrospectively obtained publicly available data regarding payments made by Japanese pharmaceutical companies to all authors of the JSH2019 in 2016. We also collected data on individual financial disclosure of JSH2019 authors to investigate whether their self-reported financial relationship with companies were compliant to the financial disclosure policy of JSH2019.The total and mean payment values reported by pharmaceutical companies were $4,246,436 and $21,447, respectively. Of the 198 authors, 171 (86.4%) authors received at least 1 payment. Of 74 authors required to disclose their conflict of interest (COI) the authors, one-third failed to follow the COI policy covering the clinical guidelines.Major pharmaceutical companies selling antihypertensive drug products in the Japanese market had a significant financial connection with the JSH2019 authors. Financial relationships between pharmaceutical companies and authors or Japanese medical societies are raising significant concerns about the credibility of clinical guidelines and the potentially biases and undue influences that they may cause, especially with respect to adverse prescription patterns.