Clinical Practice Guidelines (CPGs) play significant roles in most medical fields. However, little is known about the extent of financial Conflicts of Interest (FCOIs) related to pharmaceutical companies (Pharma) selling dermatology prescription products and dermatology CPG authors in Japan. The aims of this study were to elucidate the characteristics and distribution of payments from Pharma to dermatology CPG authors in Japan, and to evaluate the extent of transparency and accuracy in their FCOI disclosures. We analyzed the records of 296 authors from 32 dermatology CPGs published by the Japanese Dermatological Association from the beginning of 2015 to the end of 2018. Using the payment data reported by 79 Pharma between 2016-2017 in Japan, we investigated the characteristics of the CPG authors and the payments from the Pharma to them. Furthermore, we evaluated the transparency and accuracy of the FCOI disclosures of the individual CPG authors. Of the 296

Prognostication of invasive ampullary adenocarcinomas (AACs) and their stratification into appropriate management categories have been highly challenging owing to a lack of well-established predictive parameters. In colorectal cancers, recent studies have shown that tumor budding confers a worse prognosis and correlates significantly with nodal metastasis and recurrence; however, this has not been evaluated in AAC. To investigate the prevalence, significance, and clinical correlations of tumor budding in AAC, 244 surgically resected, stringently defined, invasive AAC were analyzed for tumor budding—defined as the presence of more than or equal to 5 isolated single cancer cells or clusters composed of fewer than 5 cancer cells per field measuring 0.785 mm2 using a 20 × objective lens in the stroma of the invasive front. The extent of the budding was then further classified as “high” if there were greater than or equal to 3 budding foci and as “low” if there were <3 budding foci or no budding focus. One hundred ninety-four AACs (80%) were found to be high-budding and 50 (20%) were low-budding. When the clinicopathologic features and survival of the 2 groups were compared, the AACs with high-budding had larger invasion size (19 mm vs. 13 mm; P<0.001), an unrecognizable/absent pre-invasive component (57% vs. 82%; P<0.005), infiltrative growth (51% vs. 2%; P<0.001), nonintestinal-type histology (72% vs. 46%; P<0.001), worse differentiation (58% vs. 10%; P<0.001), more lymphatic (74% vs. 10%; P<0.001), and perineural invasion (28% vs. 2%; P<0.001); more lymph node metastasis (44% vs. 17%; P<0.001), higher T-stage (T3 and T4) (42% vs. 10%; P<0.001), and more aggressive behavior (mean survival: 50 mo vs. 32 mo; 3-year and 5-year survival rates: 93% vs. 41% and 68% vs. 24%, respectively; P<0.001). Furthermore, using a multivariable Cox regression model, tumor budding was found to be an independent predictor of survival (P = 0.01), which impacts prognosis (hazard ratio: 2.6) even more than T-stage and lymph node metastasis (hazard ratio: 1.9 and 1.8, respectively). In conclusion, tumor budding is frequently encountered in AAC. High-budding is a strong independent predictor of overall survival, with a prognostic correlation stronger than the 2 established parameters: T-stage and lymph node metastasis. Therefore, budding should be incorporated into surgical pathology reports for AAC.

ObjectiveThis study investigated payments made by pharmaceutical companies to oncology specialists in Japan, what the payments were for and whether the receipt of such payments contravened any conflict of interest (COI) regulations.Design, setting and participantsPayment data to physicians, as reported by all pharmaceutical companies belonging to the Japan Pharmaceutical Manufacturers Association, were retrospectively extracted for 2016. Of the named individual recipients of payments, all certified oncologists were identified, using certification data from the Japanese Society of Medical Oncology (JSMO). The individual specialisations of each of the oncologists was also identified.OutcomePayments to individual cancer specialists and what they were for were identified. Factors associated with receipt of higher value payments and payment flows to specialties were determined. Companies selling oncology drugs with annual sales of ≥5 billion yen (£33.9 million, €40.2 million and $46.0 million) (high revenue-generating drugs) were identified.ResultsIn total, 59 companies made at least one payment to oncologists. Of the 1080 oncology specialists identified, 763 (70.6%) received at least one payment, while 317 received no payment. Of the 763, some 142 (13.1%) receiving at least 1 million yen (£6,800, €8,000 and $9200) accounted for 71.5% of the total. After adjustment of covariates, working for university hospitals and cancer hospitals and male gender were key factors associated with larger monetary payments. Payments preferentially targeted on cancer specialties using high revenue-generating drugs. The JSMO has its own COI policy for its members, but the policy did not mention any specific guidelines for certified oncology specialists.ConclusionFinancial relationships were identified and quantified between pharmaceutical companies and oncology specialists, but the extent and worth varied significantly. Given the frequency and amounts of money involved in such linkages, it would be beneficial for specific COI regulations to be developed and policed for oncologists.

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This cross-sectional study evaluates the payment type and distribution from pharmaceutical companies, as well as policy transparency for conflict of interest disclosures among clinical practice guideline authors in Japan.