Payments to the authors of Clinical Practice Guidelines for Breast Cancer 2022
We identified 149 JBCS2022 authors. Of them, 115 (77.2%) received at least one personal payment from pharmaceutical companies totaling $3,828,455 between 2016 and 2020 (Table 1). The average and median payment amounts per author were $25,772 (SD: $58,197) and $2,761 (IQR: $322‒$15,828) over the five years, respectively. The large gap between mean and median payments per author indicates that only the small number of authors received substantial amounts personal payments. The maximum payments per author were $317,291 received by the Epidemiology and Prevention Subcommittee chairperson. The JBCS2022 chairperson and vice-chairperson received $246,936 (4th highest) and $216,744 (5th highest) over the five years.
As for the payment category, payments for lecturing were the largest $3.0 million (79.6% of overall payments) and most frequent 3710 (79.4%) payment categories (Table 2). Of all authors, 74.8% authors received one or more payments for lectures from pharmaceutical companies, while 38.8% authors received payments for consulting and drafting fees over five years.
Payment trends between 2016 and 2020
Table 1 shows the annual trends in personal payment to the JBCS2022 authors between 2016 and 2019. The total annual payments per JBCS2022 authors between 2016 and 2019 increased from $588,054 in 2016 to $967,802 in 2019 (Table 1). The median annual payments per author ranged from $261 in 2016 to $967,802 and $521 in 2019. A slight decline in the total payment to $781,312 (19.3% decrease from the previous year) was observed in 2020. More than 50% of the JBCS2022 authors received personal payments from pharmaceutical companies each year between 2016 and 2020. However, the proportion of authors receiving more than $10,000 ranged from 16 authors (10.7%) in 2016 to 23 authors (15.4%) in 2020.
Undeclared and under-declared financial conflicts of interest
Our analysis illuminated that 31 (20.8%) authors disclosed financial COIs with companies for at least COI category. Of 31 authors disclosing their COIs, 25 (80.6%) declared financial COIs for receiving lecturing and consulting payments.
Of a total of $11,119,367 payments for lecturing, consulting, and writing made to the authors between 2019 and 2020, $4,372,931 (39.3%) payments exceeded the declaration threshold set by the JSBC (Figure 1), while the remaining 60.7% ($6.7 million) were less than the declaration thresholds. Of the payments exceeding the thresholds, 86.4% ($3.8 million) were correctly declared by 16 authors. However, nine authors received undeclared payments summing $594,615, with median payments of $6,109 per author.
Payments by types of guideline committees
Table 3 represents the payments to the authors by the types of guideline committees. The prevalence of authors' self-declared FCOIs was more than 50% only for the General Guidelines Committee and the Pharmacotherapy Subcommittee. However, subgroup analysis by types of guideline committee showed that 88.9% of the members authors of the General Guideline Committee received at least one payment, with the highest median payment of $114,153 (IQR: $2,944 – $216,744). All authors of the Pharmacotherapy Subcommittee and Surgical Therapy Subcommittee received personal payments, with median payments of $38,075 (IQR: $16,443 – $79,571) and $13,453 (IQR: $2,944 – $27,230), respectively. Authors of the Radiotherapy Subcommittee and Systematic Review Committee received the lowest payment amounts with a median of $900 (IQR: $0–$1,360) and $477 (IQR: $0–$1,584), respectively. There were committee chairpersons receiving more than $100,000 in five-year payments in four JBCS2022 subcommittees.
Payments by companies
Among the 45 pharmaceutical companies making one or more payments to the JBCS2022 authors, the top five and ten companies occupied 65.3% and 87.8% of the total payments (Table 2). Chugai Pharmaceutical Co., Ltd., made the largest amounts of personal payments, accounting for $795,542 (20.8% of all overall payments) over the five years in monetary value, followed by AstraZeneca ($490,994, 12.8%), Pfizer Japan Inc ($490,164, 12.8%), Eisai Ltd. ($390,538, 10.2%), and Eli Lilly Japan K.,K. ($330,878, 8.6%). Furthermore, Chugai Pharmaceutical made payments to the highest number of authors (75 authors, 50.3%), followed by Eisai Ltd. (64 authors, 43.0%) and AstraZeneca (60 authors, 40.3%).
Table 4 shows the drugs of the top five companies granted new approval and/or additional indications for breast cancer between 2010 and 2022. Chugai Pharmaceutical Co., Ltd. had five breast cancer granted new and/or additional indications between 2010 and 2022, including trastuzumab (Herceptin), bevacizumab (Avastin), pertuzumab (Perjeta), trastuzumab emtansine (Kadcyla), and atezolizumab (Tecentriq). AstraZeneca manufactured fulvestrant (Faslodex) and goserelin acetate (Zoladex), both for the treatment of hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.(REF https://ascopost.com/News/58264). Pfizer Japan Inc., and Eli Lilly Japan K.,K., manufacture CDK4/6 inhibitors, palbociclib (Ibrance approved in 2017) and abemaciclib (Vezenio approved in 2018), respectively.