Drug Promotions Between Ethics, Regulations, and Financial Interests.

BACKGROUND: The promotion of the latest medicines produced by the pharmaceutical industry is an important issue both from an ethical point of view (the level of accessibility, the way research is carried out) and from the point of view of marketing and especially from the lobbying issues raised. AREAS OF UNCERTAINTY: The ethical dilemmas raised by the promotion of new drugs revolve between the need to discover new molecules important for treating a wide range of diseases and the need to establish a battery of ethical rules, absolutely necessary for regulations in the field to be compliant with all ethical principles. DATA SOURCES: A literature search was conducted through PubMed, MEDLINE, Plus, Scopus, and Web of Science (2015-2023) using combinations of keywords, including drugs, medical publicity, and pharma marketing plus ethical dilemma. ETHICS AND THERAPEUTIC ADVANCES: The promotion of medicines is governed by advertising laws and regulations in many countries, including at EU level, based on the need for countries to ensure that the promotion and advertising of medicines is truthful, based on information understood by consumers. The ethical analysis of the issues raised is more necessary and complex as the channels used for promotion are more accessible to the population, and the information, easier to obtain, can be the cause of increased self-medication and overeating. Large amounts of money invested in the development of new molecules, but also the risk of scientific fraud through manipulation of data during clinical trials, selective or biased publication of information can have repercussions on the health of the population. CONCLUSIONS: The development of new pharmaceutical molecules is necessary to intervene and treat as many conditions as possible, but marketing must not neglect the observance of ethical principles. The promotion of medicines should be the attribute especially of the medical staff, which should also be a mandatory part of the mechanism for approving the marketing methods and means used by the pharmaceutical companies.

Industry Payments to US Physicians by Specialty and Product Type.

This study examines the distribution of payments within and across specialties and the medical products associated with the largest total payments.

Understanding Financial Relationships Between Orthopedic Surgeons and Industry for Research.

OBJECTIVE: This study sought to understand trends in industry payments for research awarded to orthopedic surgeons. MATERIALS AND METHODS: The Centers for Medicare & Medicaid Services Open Payments database was queried for the years 2016 to 2021 for industry payments for research. Financial analyses were performed to understand temporal trends and differences by orthopedic subspecialty and principal investigator characteristics such as sex. The threshold for statistical significance was set at .05. RESULTS: A total of 2014 orthopedic surgeons were identified, among whom 542 adult reconstruction (27%) and 460 sports medicine (23%) surgeons were major beneficiaries. Seventy-one female orthopedic surgeons comprised the minority (4%). Total research payments awarded during the study period aggregated to $266,633,592, with adult reconstruction ($88,819,047; 33%) and sports medicine ($57,949,822; 22%) receiving the highest amounts. Total research payments awarded trended upward yearly except for a decline in 2020 that subsequently rebounded (P<.001). Median annual research payment per orthopedic surgeon was $13,375. Median total industry payments per orthopedic surgeon differed between specialties (P <.001), with the highest amounts for adult reconstruction ($44,063) and sports medicine ($34,567) and the lowest amounts for hand ($12,052) and foot and ankle ($19,233). Median total payments did not differ significantly when stratified by sex (P=.276) and region (P=.906). Specialties in which the respective top three companies offered the majority of the research funding were musculoskeletal oncology (90%), pediatric orthopedics (66%), and shoulder and elbow (64%). CONCLUSION: These results can be used as a primer for orthopedic surgeons seeking to leverage industry relationships to fund translational research. [Orthopedics. 2024;47(3):172-178.].

Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices.

This study reviewed public comments for all Medicare National Coverage Determinations between June 2019 and 2022 on select pulmonary and cardiac devices to determine whether financial conflicts of interest were disclosed.

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.

Association of Financial Conflicts of Interest With Academic Productivity Among Junior Faculty in Hematology and Oncology

INTRODUCTION: Financial conflicts of interest (COIs) represent a common and complex issue in hematology and oncology. However, little is known about the timing of when COIs begin to develop during a career trajectory. We evaluated self-reported COIs for junior faculty members at top cancer centers to determine how these financial relationships correlated with measures of academic career productivity. METHODS: We analyzed data from 230 assistant professors at 10 academic cancer centers. Financial COIs were identified from the CMS Open Payments (Sunshine Act dollars) database. Self-reported COIs were obtained from American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH) disclosures, and from disclosures in recent publications. Number of publications and h-index (defined as the largest number of publications [h] such that h publications each have at least h citations) were used as measures of academic productivity. Scatter plots and Spearman correlation coefficients were used to assess the relationship between COIs or Sunshine Act dollars with number of publications and h-index. Linear regression modeling was used to analyze the relationships between COIs or Sunshine Act dollars with number of publications and h-index, adjusting for years of experience since completing fellowship (YSF). RESULTS: A total of 46% of junior faculty had at least 1 COI. Number of COIs reported to ASCO/ASH was positively correlated with total Sunshine Act dollars (Spearman correlation, 0.53; P <.01). The number of COIs and the number of Sunshine Act dollars increased with years in practice (Spearman correlation, 0.38 and 0.25, respectively; P <.01 for both). COIs and Sunshine Act dollars correlated with h-index (Spearman correlation, 0.41 and 0.37, respectively; both P <.01). After adjusting for YSF, linear regression demonstrated that log-transformed h-index and number of publications were associated with Sunshine Act dollars (both P <.01) and COIs (ASCO/ASH) (both P = .01). CONCLUSIONS: Financial COIs increased with number of YSF. Measures of academic productivity were positively correlated with COIs (ASCO/ASH) and Sunshine Act dollars. These data suggest that the cultivation of industry relationships is associated with the early academic productivity of junior faculty.

A Guide to Industry Payments and an Algorithm for Their Management.

BACKGROUND: The Open Payments database was created to increase transparency of industry payment relationships within medicine. The current literature often examines only 1 year of the database. In this study, the authors use 5 years of data to show trends among industry payments to plastic surgeons from 2014 to 2018. In addition, the authors lay out the basics of conflict-of-interest reporting for the new plastic surgeon. Finally, the authors suggest an algorithm for the responsible management of industry relationships. METHODS: This study analyzed nonresearch payments made to plastic surgeons from January 1, 2014, to December 31, 2018. Descriptive statistics were calculated using R Statistical Software and visualized using Tableau. RESULTS: A total of 304,663 payments totaling $140,889,747 were made to 8148 plastic surgeons; 41 percent ($58.28 million) was paid to 50 plastic surgeons in the form of royalty or license payments. With royalties excluded, average and median payments were $276 and $25. The average yearly total per physician was $2028. Of the 14 payment categories, 95 percent of the total amount paid was attributable payments in one of six categories. Seven hundred thirty companies reported payments to plastic surgeons from 2014 to 2018; 15 companies (2 percent) were responsible for 80 percent ($66.34 million) of the total sum paid. Allergan was responsible for $24.45 million (29.6 percent) of this amount. CONCLUSIONS: Although discussions on the proper management of industry relationships continue to evolve, the data in this study illustrate the importance of managing industry relationships. The simple guidelines suggested create a basis for managing industry relationships in the career of the everyday plastic surgeon.

Industry Payments to Plastic Surgeons, 2013 to 2018: Who's Getting Paid?

BACKGROUND: The Physician Payments Sunshine Act of 2010 mandated that all industry payments to physicians be publicly disclosed. To date, industry support of plastic surgeons has not been longitudinally characterized. The authors seek to evaluate payment trends from 2013 to 2018 and characteristics across plastic surgeon recipients of industry payments. METHODS: The authors cross-referenced those in the 2019 American Society of Plastic Surgeons member database with Centers for Medicare & Medicaid Services Open Payments database physician profile identification number indicating industry funds received within the study period. We categorized surgeons by years since American Board of Plastic Surgery certification, practice region, and academic affiliation. RESULTS: A sum of $89,436,100 (247,614 payments) was received by 3855 plastic surgeons. The top 1 percent of earners (n = 39) by dollar amount received 52 percent of industry dollars to plastic surgeons; of these, nine (23 percent) were academic. Overall, 428 surgeons (11 percent) were academic and received comparable dollar amounts from industry as their nonacademic counterparts. Neither geographic location nor years of experience were independent predictors of payments received. The majority of individual transactions were for food and beverage, whereas the majority of industry dollars were typically for royalties or license. CONCLUSIONS: Over half of all industry dollars transferred went to just 1 percent of American Society of Plastic Surgeons members receiving payments between 2013 and 2018. Considerable heterogeneity exists when accounting for payment subcategories.

Association between Industry Payments and Published Position on Use of Devices for the Treatment of Lower Urinary Tract Symptoms.

OBJECTIVE: To determine the impact of industry payments to authors of opinion articles on the Urolift and Rezum devices. We also examined the extent to which authors omitted acknowledgements of financial conflicts-of-interest. METHODS: We searched Google Scholar for all articles that cite either of the respective pivotal trials for these devices. 2 blinded urologists coded the articles as favorable or neutral. A separate blinded researcher recorded industry payments from the manufacturers using the Open Payments Program database. RESULTS: We identified 29 articles written by 27 unique authors from an initial screening list of 235 articles. Of these articles, 15 (52%) were coded as positive and 14 (48%) were coded as neutral. 20 (74%) authors have accepted payments from the manufacturer of the device. Since 2014, these authors have collectively received $270,000 from NeoTract and $314,000 from Boston Scientific. Of the 20 authors with payments, 9 (45%) received more than $10,000 from either manufacturer. Of authors with payments, 65% (13/20) contributed to only positive articles. Authors who received payments had more than 4 times the number of article contributions than did authors without payments (42 vs 10). Authors of at least one favorable article were more likely to have received payments from the device manufacturers than authors of neutral articles (P = .014, Chi-squared test). Most (80%, 16/20) authors with payments did not report a relevant conflict-of-interest within any of their articles. CONCLUSION: These data suggest a relationship between payments from a manufacturer and positive published position on that company's device. There may be a critical lack of published editorial pieces by authors without financial conflicts of interest.

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.

Conflicts of interest in oncology expanded access studies.

Expanded access is a treatment use of investigational drugs, biologicals or medical devices outside of clinical trials. The purpose of our study was to assess self-reported conflicts of interest (COIs) in oncology expanded access studies. One hundred fifty-eight oncology expanded access studies published from 2013 through 2020 were included. The pharmaceutical industry funded either completely or in part 94 studies (59.49%). The authors disclosed mostly financial COIs, while the number of the reported nonfinancial conflicts was relatively small (3528 and 57 COIs, respectively). The number of articles in which at least one author had a financial COI was 118 (74.68%). The most common financial COI types included advisory board membership/consulting (1471 COIs; 41.7%), followed by honoraria (570 COIs; 16.16%) and research funding (441 COIs; 12.5%). Logistic regression was performed to identify predictors of disclosing financial COIs and positive study's conclusions. On univariate analysis, financial COIs were more likely to occur in studies with at least one center located in the United States (odds ratio [OR], 5.62; 95% confidence interval [CI], 1.57-35.98; P = .02). We also found that positive conclusions about the studied treatments were less likely in studies without industry funding (OR, 0.26; CI, 0.08-0.77; P = .01). Most of the research on COIs in oncology performed to date focused on other types of studies, especially clinical trials. To our knowledge, our study is the first to evaluate COIs in oncology expanded access studies.

Association between industry payments and prescriptions of long-acting insulin: An observational study with propensity score matching.

BACKGROUND: The rapidly increased spending on insulin is a major public health issue in the United States. Industry marketing might be one of the upstream determinants of physicians' prescription of long-acting insulin-the most commonly used and costly type of insulin, but the evidence is lacking. We therefore aimed to investigate the association between industry payments to physicians and subsequent prescriptions of long-acting insulin. METHODS AND FINDINGS: Using the databases of Open Payments and Medicare Part D, we examined the association between the receipt of industry payments for long-acting insulin in 2016 and (1) the number of claims; (2) the costs paid for all claims; and (3) the costs per claim of long-acting insulin in 2017. We also examined the association between the receipt of payments and the change in these outcomes from 2016 to 2017. We employed propensity score matching to adjust for the physician-level characteristics (sex, years in practice, specialty, and medical school attended). Among 145,587 eligible physicians treating Medicare beneficiaries, 51,851 physicians received industry payments for long-acting insulin worth $22.3 million. In the propensity score-matched analysis including 102,590 physicians, we found that physicians who received the payments prescribed a higher number of claims (adjusted difference, 57.8; 95% CI, 55.8 to 59.7), higher costs for total claims (adjusted difference, +$22,111; 95% CI, $21,387 to $22,836), and higher costs per claim (adjusted difference, +$71.1; 95% CI, $69.0 to $73.2) of long-acting insulin, compared with physicians who did not receive the payments. The association was also found for changes in these outcomes from 2016 to 2017. Limitations to our study include limited generalizability, confounding, and possible reverse causation. CONCLUSIONS: Industry marketing payments to physicians for long-acting insulin were associated with the physicians' prescriptions and costs of long-acting insulin in the subsequent year. Future research is needed to assess whether policy interventions on physician-industry financial relationships will help to ensure appropriate prescriptions and limit overall costs of this essential drug for diabetes care.

[Actuality of conflicts of interests in medicine. From financial interests to the run for scientific publication]. / Actualité des conflits d'intérêts en médecine. Des intérêts financiers à la course à la publication scientifique.

Clinical practice and medical research can expose to several situations with risks of conflicts of interests. Such situations can induce attenuations of their primary professional interest in favor of, so-called, secondary interests, and leading to bias in their judgement and actions. In this area, if financial conflicts of interests are consistent and frequently dominant, intellectual conflicts of interests have to be analyzed and considered, like those amplified and even induced by the current tremendous competition for scientific publication. In this article, after a contextual review of conflicts of interests in medicine, we will document and discuss more specifically those frequently induced by leaks of financial interests and those linked by evolutions of the current scientific expansion and competition.

Assessment of self-reported financial conflicts of interest in vascular surgery studies.

OBJECTIVE/BACKGROUND: With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COIs). This study aims to determine the accuracy of reporting of COIs among studies in major vascular surgery journals. METHODS: A literature search identified all comparative studies published from January 2018 through December 2018 from three major United States vascular surgery journals (Journal of Vascular Surgery, Vascular and Endovascular Surgery, and Annals of Vascular Surgery). Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior. RESULTS: A total of 239 studies (1642 authors) were identified. Two hundred twenty-one studies (92%) and 669 authors (63%) received undisclosed payments when utilizing a cut-off payment amount of $250. In 2018, 10,778 payments (totaling $22,174,578) were made by 145 companies. Food and beverage payments were the most commonly reported transaction (42%), but accounted for only 3% of total reported monetary values. Authors who accurately disclosed payments received significantly higher median general payments compared with authors who did not accurately disclose payments ($56,581 [interquartile range, $2441-$100,551] vs $2361 [interquartile range, $525-$9,699]; P < .001). When stratifying by dollar-amount discrepancy, the proportions of authors receiving undisclosed payments decreased with increasing payment thresholds. Multivariate analysis demonstrated that first and senior authors were both significantly more likely to have undisclosed payments (odds ratio, 2.0; 95% confidence interval, 1.1-3.6 and odds ratio, 2.9; 95% confidence interval, 1.6-5.2, respectively). CONCLUSIONS: There is a significant discordance between self-reported COI in vascular surgery studies compared with payments received in the Centers for Medicare and Medicaid Services Open Payments database. This study highlights the need for increased efforts to both improve definitions of what constitutes a relevant COI and encourage a standardized reporting process for vascular surgery studies.