Pharmaceutical company payments to Japanese breast cancer practice guideline authors

Anju Murayama , Kenichi Higuchi , Keerthana R. Byreddy , Kugo Hinari , Yuki Senoo

Clinical and Translational Discovery ›› 2024, Vol. 4 ›› Issue (3) : e304

PDF
Clinical and Translational Discovery ›› 2024, Vol. 4 ›› Issue (3) : e304 DOI: 10.1002/ctd2.304
RESEARCH ARTICLE

Pharmaceutical company payments to Japanese breast cancer practice guideline authors

Author information +
History +
PDF

Abstract

Background: The creation of breast cancer practice guidelines requires proper management of financial relationships with drug companies, as they can introduce conflicts of interest (COIs) among guideline authors. However, little is known about the specific landscape and fraction of financial interactions between the authors of the Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer, edition 2022 (JBCS2022) and drug companies.

Methods: Using payment data publicly disclosed by major drug companies in Japan, this study analysed the personal payments made to the authors of JBCS2022 between 2016 and 2020. We performed descriptive analyses on the payment data.

Results: Of the 149 JBCS2022 authors, 115 (77.2%) received at least one personal payment totaling $3 828 455 from drug companies between 2016 and 2020. The average and median payment amounts per author were $25 772 (standard deviation: $58 197) and $2761 (interquartile range: $322‒$15 828), respectively. The total annual payments per JBCS2022 authors between 2016 and 2019 increased from $588 054 in 2016 to $967 802 in 2019. The JBCS2022 chairperson and vice-chairperson received $246 936 (fourth highest) and $216 744 (fifth highest) over the 5 years. More than 60% of personal payments to the JBCS2022 authors were not declared by the authors as they were below the declaration threshold set by the Japanese Breast Cancer Society. However, nine authors undeclared personal payments summing $594 615 even though these payments were higher than the thresholds.

Conclusion: This study demonstrated that the majority of the breast cancer guideline authors received personal payments from drug companies in Japan. Furthermore, the majority of payments were not declared because of the less transparent COI policy.

Keywords

clinical practice guideline / conflicts of interest / ethics / evidence-based medicine / health policy / pharmaceutical companies

Cite this article

Download citation ▾
Anju Murayama, Kenichi Higuchi, Keerthana R. Byreddy, Kugo Hinari, Yuki Senoo. Pharmaceutical company payments to Japanese breast cancer practice guideline authors. Clinical and Translational Discovery, 2024, 4(3): e304 DOI:10.1002/ctd2.304

登录浏览全文

4963

注册一个新账户 忘记密码

References

[1]

SchunemannHJ, Al-Ansary LA, ForlandF, et al. Guidelines International Network: principles for disclosure of interests and management of conflicts in guidelines. Ann Intern Med. 2015;163(7):548-553.

[2]

Institute of Medicine. Clinical Practice Guidelines We Can Trust. The National Academies Press; 2011:290.

[3]

MurayamaA, Kamamoto S, MurataN, et al. Evaluation of financial conflicts of interest and quality of evidence in Japanese gastroenterology clinical practice guidelines. J Gastroenterol Hepatol. 2023;38(4):565-573.

[4]

MamadaH, Murayama A, KamamotoS, et al. Evaluation of financial and nonfinancial conflicts of interest and quality of evidence underlying psoriatic arthritis clinical practice guidelines: analysis of personal payments from pharmaceutical companies and authors' self-citation rate in Japan and the United States. Arthritis Care Res (Hoboken). 2023;75(6):1278-1286.

[5]

MurayamaA, YamadaK, YoshidaM, et al. Evaluation of conflicts of interest among participants of the Japanese Nephrology Clinical Practice Guideline. Clin J Am Soc Nephrol. 2022;17(6):819-826.

[6]

HashimotoT, Murayama A, MamadaH, SaitoH, Tanimoto T, OzakiA. Evaluation of financial conflicts of interest and drug statements in the coronavirus disease 2019 clinical practice guideline in Japan. Clin Microbiol Infect. 2022;28(3):460-462.

[7]

MurayamaA, KidaF, OzakiA, Saito H, SawanoT, TanimotoT. Financial and intellectual conflicts of interest among Japanese Clinical Practice Guidelines authors for allergic rhinitis. Otolaryngol Head Neck Surg. 2022;166(5):869-876.

[8]

KidaF, Murayama A, SaitoH, OzakiA, Shimada Y, TanimotoT. Pharmaceutical company payments to authors of the Japanese Clinical Practice Guidelines for hepatitis C treatment. Liver Int. 2021;41(3):464-469.

[9]

HaradaK, OzakiA, SaitoH, et al. Financial payments made by pharmaceutical companies to the authors of Japanese hematology clinical practice guidelines between 2016 and 2017. Health Policy. 2021;125(3):320-326.

[10]

KamamotoS, Murayama A, KusumiE, et al. 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. Pediatr Blood Cancer. 2022;69(10):e29891.

[11]

MoynihanR, LaiA, JarvisH, et al. Undisclosed financial ties between guideline writers and pharmaceutical companies: a cross-sectional study across 10 disease categories. BMJ Open. 2019;9(2):e025864.

[12]

TabatabavakiliS, KhanR, ScaffidiMA, Gimpaya N, LightfootD, GroverSC. Financial conflicts of interest in Clinical Practice Guidelines: a systematic review. Mayo Clin Proc Innov Qual Outcomes. 2021;5(2):466-475.

[13]

MurayamaA, Miyazawa K, KamamotoS, et al. Financial conflicts of interest in Japanese obstetrics and gynaecology clinical practice guidelines. Clin Transl Discov. 2024;4(1):e273.

[14]

SteinbrookR. Guidance for guidelines. N Engl J Med. 2007;356(4):331-333.

[15]

LenzerJ, Hoffman JR, FurbergCD, IoannidisJP, Guideline Panel Review Working Group. Ensuring the integrity of clinical practice guidelines: a tool for protecting patients. Br Med J. 2013;347:f5535.

[16]

BremsJH, DavisAE, ClaytonEW. Analysis of conflict of interest policies among organizations producing clinical practice guidelines. PLoS One. 2021;16(4):e0249267.

[17]

Ngo-MetzgerQ, MoyerV, GrossmanD, et al. Conflicts of interest in clinical guidelines: update of U.S. Preventive Services Task Force Policies and Procedures. Am J Prev Med. 2018;54(1S1):S70-S80.

[18]

NorrisSL, HolmerHK, BurdaBU, Ogden LA, FuR. Conflict of interest policies for organizations producing a large number of clinical practice guidelines. PLoS One. 2012;7(5):e37413.

[19]

SongCV, YipCH, Mohd TaibNA, et al. Association between adherence to Clinical Practice Guidelines for adjuvant therapy for breast cancer and survival in a resource-limited setting. JCO Glob Oncol. 2022;8:e2100314.

[20]

AhlawatA, Narayanaswami P. Financial relationships between neurologists and industry: the 2015 Open Payments database. Neurology. 2019;92(21):1006-1013.

[21]

MesséSR, SmithEE, GetchiusTSD, Gronseth GS. American Academy of neurology replies to Jeanne Lenzer. Br Med J. 2013;347:f5324.

[22]

ArnoldM, MorganE, RumgayH, et al. Current and future burden of breast cancer: global statistics for 2020 and 2040. Breast. 2022;66:15-23.

[23]

Cancer Information Service NCC, Japan (National Cancer Registry, Ministry of Health, Labour and Welfare). Cancer Statistics in Japan 2023. Ministry of Health, Labour and Welfare. Updated October 19, 2023. Accessed November 11, 2023.

[24]

McGaleP, TaylorC, CorreaC, et al. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet. 2014;383(9935):2127-2135.

[25]

MomohAO, AhmedR, KelleyBP, et al. A systematic review of complications of implant-based breast reconstruction with prereconstruction and postreconstruction radiotherapy. Ann Surg Oncol. 2014;21(1):118-124.

[26]

Early Breast Cancer Trialists' Collaborative Group. Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005;365(9472):1687-1717.

[27]

TaylorC, McGaleP, ProbertJ, et al. Breast cancer mortality in 500 000 women with early invasive breast cancer diagnosed in England, 1993–2015: population based observational cohort study. Br Med J. 2023;381:e074684.

[28]

HoriM, Matsuda T, ShibataA, et al. Cancer incidence and incidence rates in Japan in 2009: a study of 32 population-based cancer registries for the Monitoring of Cancer Incidence in Japan (MCIJ) project. Jpn J Clin Oncol. 2015;45(9):884-891.

[29]

YoshimuraA, ItoH, NishinoY, et al. Recent improvement in the long-term survival of breast cancer patients by age and stage in Japan. J Epidemiol. 2018;28(10):420-427.

[30]

MitchellAP, WinnAN, LundJL, Dusetzina SB. Evaluating the strength of the association between industry payments and prescribing practices in oncology. Oncologist. 2019;24(5):632-639.

[31]

MitchellAP, Dusetzina SB, Mishra MezaA, TrivediNU, BachPB, WinnAN. Pharmaceutical industry payments and delivery of non-recommended and low value cancer drugs: population based cohort study. Br Med J. 2023;383:e075512.

[32]

MitchellAP, WinnAN, DusetzinaSB. Pharmaceutical industry payments and oncologists' selection of targeted cancer therapies in Medicare beneficiaries. JAMA Intern Med. 2018;178(6):854-856.

[33]

MurayamaA, Marshall DC. Associations between pharmaceutical industry payments to physicians and prescription of PARP inhibitors in the United States. Gynecol Oncol. 2024;181:83-90.

[34]

TarrasES, Marshall DC, RosenzweigK, KorensteinD, Chimonas S. Trends in industry payments to medical oncologists in the United States since the inception of the open payments program, 2014 to 2019. JAMA Oncol. 2021;7(3):440-444.

[35]

RahmanMW, Trivedi NU, BachPB, MitchellAP. Increasing financial payments from industry to medical oncologists in the United States, 2014–2017. J Natl Compr Canc Netw. 2021;20(13):1-9.

[36]

MitchellAP, Mishra Meza A, TrivediNU, BachPB, GonenM. Physician payments from pharmaceutical companies related to cancer drugs. Oncologist. 2022;27(10):857-863.

[37]

SaitoH, OzakiA, SawanoT, Shimada Y, TanimotoT. Evaluation of pharmaceutical company payments and conflict of interest disclosures among oncology clinical practice guideline authors in Japan. JAMA Netw Open. 2019;2(4):e192834.

[38]

Japan Pharmaceutical Manufacturers Association. Regarding the Transparency Guideline for the Relation Between Corporate Activities and Medical Institutions. Accessed March 4, 2022.

[39]

Japanese Breast Cancer Society. Japanese Breast Cancer Society Clinical Practice Guidelines for Breast Cancer 2022. Japanese Breast Cancer Society. Accessed September 20, 2023.

[40]

Medical Governance Research Institute. Yen For Docs. Online database. 2024. Updated December 23, 2023. Accessed March 6, 2024.

[41]

MurayamaA. Financial conflicts of interest among the authors of the clinical practice guidelines for rheumatoid arthritis in Japan. Cureus. 2023;15(10):e46650.

[42]

MurayamaA. Financial conflicts of interest among authors of clinical practice guidelines for diabetes mellitus in Japan. J Diabetes. 2024;16(4):e13533.

[43]

Pharmaceuticals and Medical Devices Agency. List of Approved Products. Pharmaceutical and Medical Devices Agency. Accessed February 24, 2022.

[44]

MurayamaA, ShinN, HiguchiK, Kohli I, KugoH, SenooY. Financial conflicts of interest between infectious diseases clinical practice guideline authors and the pharmaceutical industry in Japan. Infect Dis (Lond). 2024;56(4):330-334.

[45]

MurayamaA, Kamamoto S, ShigetaH, et al. Undisclosed financial conflicts of interest with pharmaceutical companies among the authors of the Esophageal Cancer Practice Guidelines 2017 by the Japan Esophageal Society. Dis Esophagus. 2022;35(10):doac056.

[46]

YamamotoK, Murayama A, OzakiA, SaitoH, SawanoT, TanimotoT. Financial conflicts of interest between pharmaceutical companies and the authors of urology clinical practice guidelines in Japan. Int Urogynecol J. 2021;32(2):443-451.

[47]

MurayamaA, OzakiA, SaitoH, et al. Pharmaceutical company payments to dermatology Clinical Practice Guideline authors in Japan. PLoS One. 2020;15(10):e0239610.

[48]

MurayamaA, AizawaM, ByreddyKR, Higuchi K, SenooY. Conflicts of interest among cardiology clinical practice guideline authors in Japan. J Am Heart Assoc. 2024;13(8):e034506.

[49]

ElderK, TurnerKA, CosgroveL, et al. Reporting of financial conflicts of interest by Canadian clinical practice guideline producers: a descriptive study. CMAJ. 2020;192(23):E617-E625.

[50]

CombsT, TritzD, IvyH, von Borstel D, HornJ, VassarM. Financial conflicts of interest among authors of clinical practice guidelines for routine screening mammography. J Am Coll Radiol. 2019;16(11):1598-1603.

[51]

IrwigMS, KyinnM, ShefaMC. Financial conflicts of interest among authors of endocrine society clinical practice guidelines. J Clin Endocrinol Metab. 2018;103(12):4333-4338.

[52]

CombsTR, ScottJ, JorskiA, Heavener T, VassarM. Evaluation of industry relationships among authors of clinical practice guidelines in gastroenterology. JAMA Intern Med. 2018;178(12):1711-1712.

[53]

CampsallP, Colizza K, StrausS, StelfoxHT. Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry: a cross-sectional study. PLoS Med. 2016;13(5):e1002029.

[54]

TibauA, BedardPL, SrikanthanA, et al. Author financial conflicts of interest, industry funding, and clinical practice guidelines for anticancer drugs. J Clin Oncol. 2015;33(1):100-106.

[55]

NorrisSL, HolmerHK, OgdenLA, Burda BU, FuR. Conflicts of interest among authors of clinical practice guidelines for glycemic control in type 2 diabetes mellitus. PLoS One. 2013;8(10):e75284.

[56]

DesaiAP, Chengappa M, GoRS, PoonachaTK. Financial conflicts of interest among National Comprehensive Cancer Network clinical practice guideline panelists in 2019. Cancer. 2020;126(16):3742-3749.

[57]

MitchellAP, BaschEM, DusetzinaSB. Financial relationships with industry among national comprehensive cancer network guideline authors. JAMA Oncol. 2016;2(12):1628-1631.

[58]

MurayamaA, MamadaH, ShigetaH, et al. Financial relationships between pharmaceutical companies and rheumatologists in Japan between 2016 and 2019. J Clin Rheumatol. 2023;29(3):118-125.

[59]

KamamotoS, OzakiA, MurayamaA. Assessment of financial relationships between otorhinolaryngologists and pharmaceutical companies in Japan between 2016 and 2019. Cureus. 2023;15(8):e43633.

[60]

NejstgaardCH, BeroL, HrobjartssonA, et al. Association between conflicts of interest and favourable recommendations in clinical guidelines, advisory committee reports, opinion pieces, and narrative reviews: systematic review. Br Med J. 2020;371:m4234.

[61]

EichackerPQ, Natanson C, DannerRL. Surviving sepsis—practice guidelines, marketing campaigns, and Eli Lilly. N Engl J Med. 2006;355(16):1640-1642.

[62]

DellingerRP, CarletJM, MasurH, et al. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004;32(3):858-873.

[63]

MurayamaA, Higuchi K, SenooY. Pharmaceutical industry payments to professional medical societies in Japan. J Gen Intern Med. 2024.

[64]

MurayamaA, Higuchi K, SenooY. Financial relationships between pharmaceutical companies and internal medicine societies. JAMA Netw Open. 2024;7(4):e244777.

[65]

MurayamaA, SaitoH, TanimotoT, Ozaki A. Financial conflicts of interest between pharmaceutical companies and executive board members of internal medicine subspecialty societies in Japan between 2016 and 2020. J Eval Clin Pract. 2023;29(6):883-886.

[66]

MorcianoC, BaseviV, FaralliC, Hilton Boon M, TononS, TaruscioD. Policies on conflicts of interest in health care guideline development: a cross-sectional analysis. PLoS One. 2016;11(11):e0166485.

[67]

SanthakumarS, AdashiEY. The Physician Payment Sunshine Act: testing the value of transparency. JAMA. 2015;313(1):23-24.

[68]

FudmanD, Feuerstein JD. The call for greater transparency in conflicts of interest. JAMA Netw Open. 2018;1(8):e186342.

[69]

MathewA, ClaseCM. Conflicts of interest and the trustworthiness of clinical practice guidelines. Clin J Am Soc Nephrol. 2022;17(6):771-773.

[70]

SchmidP, AdamsS, RugoHS, et al. Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer. N Engl J Med. 2018;379(22):2108-2121.

[71]

EmensLA, AdamsS, BarriosCH, et al. First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis. Ann Oncol. 2021;32(8):983-993.

[72]

MilesD, Gligorov J, AndréF, et al. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. Ann Oncol. 2021;32(8):994-1004.

[73]

Genentech. Genentech Provides Update on Tecentriq U.S. Indication for PD-L1-Positive, Metastatic Triple-Negative Breast Cancer. Genentech. Accessed December 4, 2023.

[74]

de MouraA, Vuagnat P, RenoufB, et al. Atezolizumab and paclitaxel as first line therapy in advanced triple-negative breast cancer patients included in the French early access program. Sci Rep. 2023;13(1):13427.

[75]

MillerK, WangM, GralowJ, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007;357(26):2666-2676.

[76]

MillerKD, ChapLI, HolmesFA, et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol. 2005;23(4):792-799.

[77]

MilesDW, ChanA, DirixLY, et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2010;28(20):3239-3247.

[78]

MartinM, RocheH, PinterT, et al. Motesanib, or open-label bevacizumab, in combination with paclitaxel, as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol. 2011;12(4):369-376.

[79]

RobertNJ, Diéras V, GlaspyJ, et al. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol. 2011;29(10):1252-1260.

[80]

BrufskyAM, Hurvitz S, PerezE, et al. RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2011;29(32):4286-4293.

[81]

von MinckwitzG, Puglisi F, CortesJ, et al. Bevacizumab plus chemotherapy versus chemotherapy alone as second-line treatment for patients with HER2-negative locally recurrent or metastatic breast cancer after first-line treatment with bevacizumab plus chemotherapy (TANIA): an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1269-1278.

[82]

SasichLD, Sukkari SR. The US FDAs withdrawal of the breast cancer indication for Avastin (bevacizumab). Saudi Pharm J. 2012;20(4):381-385.

[83]

OzakiA, SaitoH, SenooY, et al. Overview and transparency of non-research payments to healthcare organizations and healthcare professionals from pharmaceutical companies in Japan: analysis of payment data in 2016. Health Policy. 2020;124(7):727-735.

[84]

MulinariS, Ozieranski P. Capitalizing on transparency: commercial surveillance and pharmaceutical marketing after the Physician Sunshine Act. Big Data Soc. 2022;9(1):20539517211069631.

[85]

MurayamaA, Kamamoto S, SaitoH, et al. Characteristics and distribution of scholarship donations from pharmaceutical companies to Japanese Healthcare Institutions in 2017: a cross-sectional analysis. Int J Health Policy Manag. 2023;12(1):7621.

[86]

OzieranskiP, SaitoH, RickardE, Mulinari S, OzakiA. International comparison of pharmaceutical industry payment disclosures in the UK and Japan: implications for self-regulation, public regulation, and transparency. Global Health. 2023;19(1):14.

RIGHTS & PERMISSIONS

2024 The Author(s). Clinical and Translational Discovery published by John Wiley & Sons Australia, Ltd on behalf of Shanghai Institute of Clinical Bioinformatics.

AI Summary AI Mindmap
PDF

201

Accesses

0

Citation

Detail

Sections
Recommended

AI思维导图

/