Associations between pharmaceutical industry payments to physicians and prescription of PARP inhibitors in the United States.

PURPOSE: To evaluate the association between industry payments to physicians related to poly (ADP-ribose) polymerase inhibitors (PARPis) and physicians' prescribing behaviors for PARPis. METHODS: This panel-data analysis used the publicly accessible Open Payments Database and Medicare Part D database between 2017 and 2021. All physicians who reported >10 claims for either olaparib, rucaparib, or niraparib were included in this study. Non-research payments for the PARPis to the physicians from the PARPi manufacturers were extracted from the Open Payments Database. Associations between the physicians' receipt of payments and likelihood of prescribing PARPis were assessed with logistic generalized estimating equations (GEEs). Dose-response associations between the number of payments and prescription volumes and Medicare expenditures were evaluated with linear GEEs. RESULTS: Of the 1686 eligible physician prescribers, 68.7% received one or more non-research payments related to any of the three PARPis from the manufacturers between 2017 and 2021. Median annual payments per physician were $57 for olaparib, $39 for rucaparib, and $62 for niraparib. Receipt of payments for each PARPi was associated with higher odds of prescribing olaparib (odds ratio [OR]: 1.30 [95% CI: 1.14-1.48], p < 0.001), rucaparib (OR: 2.07 [95% CI: 1.58-2.72], p < 0.001), and niraparib (OR: 1.49 [95% CI: 1.22-1.81], p < 0.001). Dose-response effects were observed between the number of annual payments and the number of prescriptions and/or Medicare expenditures for olaparib and rucaparib. CONCLUSION: Non-research payments to physician prescribers of PARP inhibitors from the manufacturers were significantly associated with increased prescriptions and Medicare expenditures for olaparib and rucaparib in the United States.

Characteristics of Japanese physician influencers on Twitter during the COVID-19 pandemic and fact-checking their tweets on COVID-19-related drugs.

BACKGROUND: During the coronavirus disease-2019 (COVID-19) pandemic, segments of the public relied on social media platforms such as Twitter for medical information shared by medical personnel. Although physicians are likely to disseminate more accurate information on Twitter than non-medical individuals, it cannot be taken for granted. As such, tweets written by physicians in Japan should also be scrutinized for accuracy. PURPOSE: The purpose of this study was to create a profile of the most popular physician influencers on Twitter in Japan, and to do a fact-check of their tweets regarding COVID-19-related drugs. DESIGN: This is a retrospective observational study. METHODS: We purchased Twitter data for Japan for the initial 9 months of the COVID-19 pandemic (from January 2020 to September 2020), and extracted tweets with keywords related to COVID-19 at a sampling rate of 3%. The most popular physicians were identified and selected consecutively by searching for the top 1000 accounts using Twitter's search function. These top accounts were considered influencers and their tweets and retweets concerning COVID-19-related drugs were fact-checked against scientific literature. RESULTS: We identified 21 physician influencers with real names: most were male in their 40s and 50s working at private medical facilities. The contents of their tweets were mainly sourced from scientific publications that were current at that time. The fact-check revealed that only one of 50 tweets was not correct while the others had no identifiable inaccuracies. CONCLUSIONS: Except for one tweet, tweets written and retweeted by Japanese physician influencers concerning the COVID-19-related drugs contained predominantly accurate information.

Cross-sectional analysis of financial relationships between board certified allergists and the pharmaceutical industry in Japan.

BACKGROUND: Financial interactions between pharmaceutical companies and physicians lead to conflicts of interest. This study examines the extent and trends of non-research payments made by pharmaceutical companies to board-certified allergists in Japan between 2016 and 2020. METHODS: A retrospective analysis of disclosed payment data from pharmaceutical companies affiliated with the Japanese Pharmaceutical Manufacturers Association was conducted. The study focused on non-research payments for lecturing, consulting, and manuscript drafting made to board-certified allergists from 2016 to 2020. We performed descriptive analyses on payment data. Trends were analyzed using generalized estimating equation models. RESULTS: Of the 3,943 board-certified allergists, 2,398 (60.8%) received non-research payments totaling $43.4 million over five years. Lecturing fees comprised 85.7% ($37.2 million) of the total payment amounts. For allergists who received at least one payment, the median amount per allergist was $3,106 (interquartile range: $966 - $12,124), in contrast to a mean of $18,092 (standard deviation: $49,233) over the five-year span. The top 1% and 10% of these allergists accounted for 20.8% and 68.8% of all non-research payments, respectively. The annual payment amounts significantly increased by 7.2% annual increase (95% CI: 4.4 - 10.0%, p < 0.001) each year until 2019, but saw a significant decrease in 2020 amid the COVID-19 pandemic. CONCLUSION: The majority of allergists received non-research payments, with a notable concentration among a small group. Payments increased annually until the pandemic's onset, which coincided with a substantial decrease. Further research is needed to explore the implications of these financial interactions on clinical practice and patient care in Japan.

Research and Nonresearch Industry Payments to Nephrologists in the United States between 2014 and 2021.

SIGNIFICANCE STATEMENT: Concerns about the financial relationships between nephrologists and the health care industry have been reported in the United States over the past decade. However, since the 2014 launch of the federal transparency database, Open Payments, few documents have explored the whole picture of research and nonresearch payments to US nephrologists from industry sources. In this study, the authors found that 87% of nephrologists have received nonresearch payments, and the aggregate amount of these payments has been increasing since 2014. Only 12% of nephrologists received research payments; these recipients were disproportionately male. In addition, the top 5% of nephrologists receiving nonresearch funds received 81% of all such payments. Nonresearch payments were larger among male nephrologists than among female nephrologists and increased by 8% annually among male nephrologists between 2014 and 2019. BACKGROUND: Financial relationships between nephrologists and the health care industry have been a concern in the United States over the past decade. METHODS: To evaluate industry payments to nephrologists, we conducted a cross-sectional study examining nonresearch and research payments to all US nephrologists registered in the National Plan and Provider Enumeration System between 2014 and 2021, using the Open Payments database. Payment data were descriptively analyzed on the basis of monetary value, and payment trends were evaluated by using a generalized estimating equations model. RESULTS: From 2014 through 2021, 10,463 of 12,059 nephrologists (87%) received at least one payment from the US health care industry, totaling $778 million. The proportion of nephrologists who did not receive nonresearch payments varied each year, ranging from 38% to 51%. Nonresearch payments comprised 22% ($168 million) of overall industry payments in monetary value but 87% in the number of payments. Among those receiving payments, the median per-physician 8-year aggregated payment values were $999 in nonresearch payments and $102,329 in associated research payments. Male nephrologists were more likely than female nephrologists to receive research payments, but the per-physician amount did not differ. However, nonresearch payments were three times larger for male nephrologists and increased by 8% annually between 2014 and 2019 among male nephrologists but remained stable among female nephrologists. The top 5% of nephrologists receiving nonresearch payments received 81% of all such payments. CONCLUSIONS: Between 2014 and 2021, 87% of US nephrologists received at least one payment from the health care industry. Notably, nonresearch payments to nephrologists have been increasing since the Open Payments database's 2014 launch. Male nephrologists were more likely than female nephrologists to receive research payments.

A Nine-Year Investigation of Industry Research and Nonresearch Payments to Emergency Physicians in the United States Between 2014 and 2022.

BACKGROUND: Financial relationships between physicians and the health care industry are common in the United States. Yet, there are limited data on payments to emergency physicians since the 2014 launch of the Open Payments Database. OBJECTIVES: To analyze the trends and characteristics of industry payments to U.S. emergency physicians from 2014 to 2022. METHODS: This retrospective study used the Open Payments Database to examine all general and research payments to all active emergency physicians. Descriptive statistics and generalized estimating equations were employed. RESULTS: Between 2014 and 2022, 50.1% (33,021) of emergency physicians received $640.1 million in payments. Of these, 50.1% received general payments, and 1.2% received research payments. General payments constituted 18.7% ($119.7 million) of the overall industry payments. Median general and research payments were $149 ($49-$401) and $72,083 ($13,903-$370,142), respectively. Compared with other specialties, fewer emergency physicians received general payments, and the amounts were lower. The top 1% of emergency physicians received 80.5% of the general payments. No significant trends in payment amounts were observed from 2014 to 2019, but there was a significant decrease in both types of payments in 2020 due to the COVID-19 pandemic. CONCLUSIONS: The majority of emergency physicians received payments from the health care industry, although these payments were typically minimal compared with other specialties. Payment trends remained consistent from 2014 to 2019, with a notable decrease in 2020 due to the pandemic.

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.

Evaluation of non-research payments from pharmaceutical companies to urologists in Japan between 2016 and 2019.

OBJECTIVE: To evaluate the magnitude and trends in personal payments from pharmaceutical companies to urologists in Japan. METHODS: This cross-sectional study examined the personal payments made to urologists by the major pharmaceutical companies in Japan between 2016 and 2019. Descriptive analyses were performed on the payment data. All urologists board-certified by the Japanese Urological Association as of March 2022 were included in this study. Trends in personal payments were assessed using the population-averaged generalized estimating equations with panel data of per-physician personal payments. RESULTS: Among 7016 active board-certified urologists, 4962 (70.7%) accepted 53,070 payments totaling $36,424,239 for reimbursement of lecturing, writing, and consulting compensations from 66 pharmaceutical companies between 2016 and 2019. The median payments per urologist receiving payments were $1714 [interquartile range(IQR): $700-$4583] in payment amounts and 4.0 (IQR: 2.0-10.0) in the number of payments. Only 1%, 5%, 10%, and 25% of top-paid urologists accepted 36.2%, 64.8%, 75.8%, and 90.1% of overall payments respectively. The payments per urologist and the number of payment contracts had annually increased over this period by 4.1% (95% CI: 2.3%-6.0%, p < 0.001) and 2.4% (95% CI: 1.2%-3.7%, p < 0.001), but there was no significant change in the number of urologists receiving payments, with a relative average annual change of 0.7% (95% CI: -0.15%-1.6%, p = 0.10) between 2016 and 2019. CONCLUSION: Most urologists received personal payments for lecturing, consulting, and writing compensations from pharmaceutical companies in Japan. The payments from pharmaceutical companies had been increasing over the 4-year period. These payments were substantially concentrated on a small number of urologists.

A single-center retrospective comparative analysis of urinary continence in robotic prostatectomy with a combination of umbilical ligament preservation and Hood technique.

OBJECTIVES: Data available on the effect of the recently developed Hood technique and its modified iterations in robot-assisted radical prostatectomy on postoperative urinary continence are insufficient. We evaluated the time to achieve urinary continence with the modified Hood technique compared with the standard or umbilical ligament preservation robot-assisted radical prostatectomy. METHODS: This retrospective analysis examines patient records for those who underwent robot-assisted radical prostatectomy at the Jyoban Hospital of Tokiwa Foundation in Fukushima, Japan, from 2017 to 2021. The main outcome was to determine significant differences in the time taken to achieve urinary continence among the three procedure types. We employed the Kaplan-Meier survival analysis to estimate the time to achieve urinary continence in the three procedure types of robot-assisted radical prostatectomy. Additionally, we used a Cox regression hazard model to evaluate the association between the time to achieve urinary continence and the procedure types. RESULTS: We considered 196 patients in this study. The estimated rates of achieving urinary continence at 6 months following standard, umbilical ligament preservation, and modified Hood technique robot-assisted radical prostatectomy were 77.6%, 89.5%, and 100%, respectively. The multivariable Cox hazard regression model showed that patients who underwent the modified Hood technique were significantly more likely to achieve urinary continence than those who underwent the standard robot-assisted radical prostatectomy. CONCLUSIONS: The modified Hood technique achieved better urinary continence outcomes, with all patients with the procedure achieving urinary continence at 6 months. Further randomized controlled trials are required to validate this finding.

Japan's valsartan clinical trials shambles; time for fundamental changes.

Japan's Diovan® /valsartan 'scandal' has received sensational coverage in the nation's media since 2012. Publication of fraudulent research and their subsequent retraction boosted and then curtailed the use of what was a useful therapeutic drug. Some authors of the papers resigned, others disputed the retractions and resorted to legal counsel to protect themselves. One individual, an undeclared Novartis employee involved in the research, was arrested. A complex and virtually unwinnable case was brought against him and Novartis, claiming that data alteration amounted to false advertising, but lengthy criminal court cases resulted in the case failing. Unfortunately, key elements, including conflicts of interest, pharmaceutical company interference in trials of its product, and the role of the institutions involved, have been effectively ignored. The incident also emphasised the fact that Japan's unique society and approach to science does not conform well to international standards. Although the supposed impropriety caused the appearance of a new Clinical Trials Act in 2018, the law has been criticized for being ineffectual and simply increasing clinical trial bureaucracy. This article examines the 'scandal' and identifies where changes must be made to clinical research and the roles of the various stakeholders in Japan to increase public trust in clinical trials and biomedical publications.

Financial Relationships Between Pharmaceutical Companies and Rheumatologists in Japan Between 2016 and 2019.

BACKGROUNDS: Given the increasing number of novel and expensive drugs for rheumatoid diseases, the financial relationships between pharmaceutical companies and rheumatologists could be prevalent and substantial. However, little was known about the information in Japan. METHODS: Using payment data publicly disclosed by 92 major pharmaceutical companies, we evaluated the financial relationships between pharmaceutical companies and rheumatologists who were board certified by the Japan College of Rheumatology between 2016 and 2019. The trends in payments were estimated by the generalized estimating equations with 4-year payment data. Differences in payments between general and leading rheumatologists including the board members, clinical practice guideline authors, and medical journal editors were assessed. RESULTS: Of the board-certified rheumatologists, 70.7% (3563 of 5038) received a total of $55,246,485 in personal payments for lecturing, writing, and consulting from 79 pharmaceutical companies between 2016 and 2019. The median payments per rheumatologist receiving payments were $3447 (interquartile range, $1124-$11,974) in payment amounts. There were increasing trends in the payments per rheumatologist and the number of rheumatologists with payments, with average yearly change rates of 5.9% (95% confidence interval, 3.9%-7.9%; p < 0.001) and 1.2% (95% CI, 0.3%-2.0%; p = 0.008). The leading rheumatologists such as the society board members, clinical practice guideline authors, and medical journal editors received much more payments than other rheumatologists. CONCLUSION: Most rheumatologists increasingly received personal payments for lecturing, consulting, and writing reimbursements from pharmaceutical companies in Japan. These payments were significantly concentrated on rheumatologists in authoritative and influential positions.

Telepathology in intraoperative frozen section consultation of breast cancer sentinel node biopsy in Fukushima, Japan following the 2011 triple disaster: diagnostic accuracy and required time during the early implementation phase.

In breast cancer surgery, some medical facilities lack the necessary resources to conduct sentinel lymph node biopsy and its intraoperative frozen section consultation. In the coastal rural area of Fukushima, Japan, which has suffered from physician undersupply following the 2011 triple disaster of earthquake, tsunami and nuclear disaster, we explored the feasibility of telepathology by evaluating the diagnostic accuracy in remote intraoperative frozen section consultation of sentinel lymph node biopsy and its required time. Although examination time has room for improvement, telepathology can be one possible solution in resource-limited areas.

Evaluation of financial relationships between Japanese certified pediatric hematologist/oncologists and pharmaceutical companies: a cross-sectional analysis of personal payments from pharmaceutical companies between 2016 and 2019.

This cross-sectional study evaluated the magnitude of personal payments made by pharmaceutical companies to pediatric hematologist-oncologists (PHOs) board-certified by the Japanese Society of Pediatric Hematology/Oncology (JSPHO), using publicly disclosed data. Among all 307 PHOs, 215 (70.0%) PHOs received $916 703 personal payments from 54 pharmaceutical companies between 2016 and 2019 in total. Median four-year payments per PHO was $1440 (interquartile range, $523-$4015). Payments per PHO significantly increased during the study period, by 23.8% (95% confidence interval: 15.3%-32.8%, P < 0.001) annually. Furthermore, leading PHOs, including university professors, society board members, and clinical practice guideline authors, received far larger personal payments from the companies.

Nature and Trends in Personal Payments Made to the Respiratory Physicians by Pharmaceutical Companies in Japan between 2016 and 2019.

BACKGROUND: Financial relationships between healthcare professionals and pharmaceutical companies have historically caused conflicts of interest and unduly influenced patient care. However, little was known about such relationship and its effect in clinical practice among specialists in respiratory medicine. METHODS: Based on the retrospective analysis of payment data made available by all 92 pharmaceutical companies in Japan, this study evaluated the magnitude and trend of financial relationships between all board-certified Japanese respiratory specialists and pharmaceutical companies between 2016 and 2019. Magnitude and prevalence of payments for specialists were analyzed descriptively. The payment trends were assessed using the generalized estimating equations for the payment per specialist and the number of specialists with payments. RESULTS: Among all 7,114 respiratory specialists certified as of August 2021, 4,413 (62.0%) received a total of USD 53,547,391 and 74,195 counts from 72 (78.3%) pharmaceutical companies between 2016 and 2019. The median (interquartile range) 4-year combined payment values per specialist were USD 2,210 (USD 715-8,178). At maximum, one specialist received USD 495,332 personal payments over the 4 years. Both payments per specialist and number of specialists with payments significantly increased during the 4-year period, with 7.8% (95% CI: 5.5-9.8; p < 0.001) in payments and 1.5% (95% CI: 0.61-2.4; p = 0.001) in number of specialists with payments, respectively. CONCLUSION: The majority of respiratory specialists had increasingly received more personal payments from pharmaceutical companies for the reimbursement of lecturing, consulting, and writing between 2016 and 2019. These increasing financial relationships with pharmaceutical companies might cause conflicts of interest among respiratory physicians.

Pharmaceutical company payments to authors of the Japanese Clinical Practice Guidelines for Hepatitis C treatment.

BACKGROUND & AIMS: Promotional activities of pharmaceutical companies (Pharma) relating to newly marketed direct-acting antivirals (DAAs) may have targeted the authors of the Japanese Clinical Practice Guidelines (CPGs) for Hepatitis C. This study aimed to assess payments made by Pharma to the CPG authors and the financial conflicts of interest (FCOIs) reported by those authors. METHODS: We analyzed payments reported by Pharma to the CPG authors as well as the COI as published by the JSH, using publicly available data for 2016 and 2017. RESULTS: A total of 35 of 78 Pharma-reported payments of $613,973 in 2016, while 40 of 73 Pharma declared payments of $524,674 in 2017, with six companies failing to report. Payments by Pharma manufacturing DAAs accounted for 53.7% of the total (55.7% and 51.6% in 2016 and 2017 respectively). All 17 authors received payments from Pharma which totalled $1,138,647. The mean and median payments per author were $66,979 (standard deviation (SD): $64,875) and $46,033 (interquartile range [IQR]: $29,796 - $34,428) for 2016 and 2017 combined. CONCLUSIONS: Financial relationship between Pharma and the Hepatitis C CPG authors, which was unclear owing to the guideline regulation, was clarified. The authors had the strongest ties to the Pharma which manufactures DAAs in 2016 and 2017.

Financial conflicts of interest between pharmaceutical companies and the authors of urology clinical practice guidelines in Japan.

INTRODUCTION AND HYPOTHESIS: In Japan, the authors of urology clinical practice guidelines (UCPG) used in patient-centered care are often targeted by pharmaceutical companies with financial payments. However, the financial relationship between UCPG authors and pharmaceutical companies remains unclear. This study aimed to determine the characteristics of industry payments to physicians that may influence recommendations in UCPG and to assess the transparency of payment disclosure. METHODS: We considered 193 UCPG authors receiving payments from 79 companies between 2016 and 2017 and the 13 UCPG published by the Japanese Urological Association between 2015 and 2018. We determined 2-year combined mean and median payments to authors, total company payments, and associations between author attributes and payment values using multivariate negative binomial regression. Also, we assessed the extent of the financial disclosure policies among the 13 UCPG. RESULTS: Overall, 171 (88.6%) authors received payments with a combined value of $6,169,333. Median and mean payments were $7147 (interquartile range, $1512-$44,807) and $31,965 (standard deviation, $51,684), respectively. University professors working on multiple UCPG with new drug approvals were associated with higher payments. Twelve (92.3%) UCPG failed to disclose financial conflicts. CONCLUSIONS: While it remains unclear whether financial entanglements improperly influence the contents of UCPG, most Japanese authors received substantial payments from pharmaceutical companies with little or no disclosure. Because insufficient transparency in disclosure of these financial entanglements may compromise the integrity of UCPG, more rigorous regulation and greater disclosure of financial conflicts of interest are needed.