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1.
PLoS One ; 15(10): e0239610, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33048952

RESUMO

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 CPGs authors, 269 authors (90.6%) received at least one payment from the Pharma. The total monetary value of payments for the 2-year period was $7,128,762. The median and mean monetary value of payments from the Pharma reporting were $10,281 (interquartile range $2,796 -$34,962) and $26,600 (standard deviation $40,950) for the two years combined. Of the 26 CPG authors who disclosed FCOIs due to the monies received from Pharma, only the atopic dermatitis CPG authors and the acne vulgaris CPG authors published their potential FCOIs. In Japan, most dermatology CPG authors received financial payments from Pharma. The transparency of the CPGs, as reported by the CPG authors, was inadequate, and a more rigorous framework of reporting and monitoring FCOI disclosure is required to improve the accuracy and transparency with relation to possible Conflicts of Interest.


Assuntos
Conflito de Interesses/economia , Dermatologia/economia , Revelação , Indústria Farmacêutica/economia , Guias de Prática Clínica como Assunto , Autoria , Dermatologia/ética , Revelação/ética , Indústria Farmacêutica/ética , Feminino , Apoio Financeiro/ética , Humanos , Japão , Masculino , Preparações Farmacêuticas/economia , Sociedades Médicas/economia , Sociedades Médicas/ética
4.
PLoS One ; 15(9): e0239118, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32946474

RESUMO

INTRODUCTION: In 2012, bedaquiline became the first new treatment from a novel class to be approved for tuberculosis in nearly five decades and is now a core component of the standard of care for multidrug-resistant tuberculosis. In addition to the originator pharmaceutical company, Janssen, a range of governmental and non-profit entities have contributed to the development of bedaquiline. MATERIALS AND METHODS: We identified various avenues of public investments in the development of bedaquiline: direct funding of clinical trials and a donation programme, tax credits and deductions, and revenues resulting from the priority review voucher (PRV) awarded to the originator. Data on investments were gathered through contact with study leads and/or funders; for non-responses, published average costs were substituted. The originator company's expenses were estimated by similar methods. Tax credits and deductions were calculated based on estimated originator trial costs and donation expenses. The value of the PRV was estimated by application of a published model. RESULTS: Public contributions through clinical trials funding were estimated at US$109-252 million, tax credits at US$22-36 million, tax deductions at US$8-27 million, administration of a donation programme at US$5 million, PRV revenues at US$300-400 million. Total public investments were US$455-747 million and originator investments were US$90-240 million (if capitalized and risk-adjusted, US$647-1,201 million and US$292-772 million, respectively). CONCLUSIONS: Estimating the investments in the development of a medicine can inform discussions regarding fair pricing and future drug development. We estimated that total public investments exceeded the originator's by a factor of 1.6-5.1.


Assuntos
Antituberculosos/economia , Diarilquinolinas/economia , Desenvolvimento de Medicamentos/economia , Financiamento Governamental/economia , Organizações sem Fins Lucrativos/economia , Antituberculosos/uso terapêutico , Ensaios Clínicos como Assunto/economia , Diarilquinolinas/uso terapêutico , Custos de Medicamentos , Indústria Farmacêutica/economia , Humanos , Tuberculose Resistente a Múltiplos Medicamentos/tratamento farmacológico
10.
Pharmazie ; 75(8): 407-410, 2020 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-32758342

RESUMO

New drugs against the in COVID-19 pandemic are urgently needed. Gilead Science's remdesivir has been introduced to China through special approval procedures, and was directly conducting the Phase III clinical trial. As expected, the marketing authorization process was completed soon. The drug brought hope to patients as well as business opportunities to companies. However, we must pay attention to the patent competition, generic drug competition and other unfair competition that remdesivir may face in China. China also needs to strengthen the innovation ability and international cooperation ability of local pharmaceutical companies by taking advantages of the opportunity to introduce remdesivir.


Assuntos
Monofosfato de Adenosina/análogos & derivados , Alanina/análogos & derivados , Antivirais/administração & dosagem , Infecções por Coronavirus/tratamento farmacológico , Pneumonia Viral/tratamento farmacológico , Monofosfato de Adenosina/administração & dosagem , Monofosfato de Adenosina/economia , Alanina/administração & dosagem , Alanina/economia , Antivirais/economia , China , Ensaios Clínicos como Assunto , Infecções por Coronavirus/epidemiologia , Aprovação de Drogas , Indústria Farmacêutica/economia , Medicamentos Genéricos/administração & dosagem , Medicamentos Genéricos/economia , Competição Econômica , Humanos , Pandemias , Pneumonia Viral/epidemiologia
14.
Am Heart J ; 227: 107-110, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32730906

RESUMO

We extended an earlier analysis of the gross revenue, payments, and net revenues of pharmaceutical manufacturers to include data from 2017 through 2019. In the period of 2017 to 2019, we found that gross revenue increased by 6.8% per annum, and payments from manufacturers increased by 13.5% annually, whereas net revenues for the same manufacturers increased by only 2.9% annually. By 2019, these same firms made payments of 67.4% of net revenue, or $141.4 billion, to generate $209.9 billion in net sales. We observed that list price increases and payments have been growing disproportionally to manufacturer net income despite widespread public concern about rising outpatient prescription drug prices.


Assuntos
Comércio/economia , Indústria Farmacêutica/economia , Fatores de Tempo , Estados Unidos
15.
Proc Natl Acad Sci U S A ; 117(24): 13386-13392, 2020 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-32487730

RESUMO

Clinical research should conform to high standards of ethical and scientific integrity, given that human lives are at stake. However, economic incentives can generate conflicts of interest for investigators, who may be inclined to withhold unfavorable results or even tamper with data in order to achieve desired outcomes. To shed light on the integrity of clinical trial results, this paper systematically analyzes the distribution of P values of primary outcomes for phase II and phase III drug trials reported to the ClinicalTrials.gov registry. First, we detect no bunching of results just above the classical 5% threshold for statistical significance. Second, a density-discontinuity test reveals an upward jump at the 5% threshold for phase III results by small industry sponsors. Third, we document a larger fraction of significant results in phase III compared to phase II. Linking trials across phases, we find that early favorable results increase the likelihood of continuing into the next phase. Once we take into account this selective continuation, we can explain almost completely the excess of significant results in phase III for trials conducted by large industry sponsors. For small industry sponsors, instead, part of the excess remains unexplained.


Assuntos
Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/normas , Relatório de Pesquisa/normas , Pesquisa Biomédica/economia , Ensaios Clínicos como Assunto/estatística & dados numéricos , Desenvolvimento de Medicamentos/economia , Desenvolvimento de Medicamentos/organização & administração , Indústria Farmacêutica/economia , Humanos , Sistema de Registros , Apoio à Pesquisa como Assunto
17.
PLoS One ; 15(6): e0234463, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32525965

RESUMO

The affordability of pharmaceuticals has been a major challenge in US health care. Generic substitution has been proposed as an important tool to reduce the costs, yet little is known how the prices of more expensive brand-name drugs would be affected by an increased utilization of generics. We aimed to examine the trend of overall utilization and the total costs of brand-name oral contraceptive pills (OCPs), the most widely used form of contraception, and its association with the pharmaceutical market concentration among the OCPs. Data from the Medical Expenditure Panel Survey (MEPS) 2011-2014, a nationally representative survey of healthcare utilization, were extracted on the utilization of generic and brand-name OCPs. A multiple logit regression analysis was conducted to assess the trend in utilization of brand-name OCPs over time. Total costs, including the costs to the payers and consumers, were synthesized. The Herfindahl-Hirschman Index (HHI), an index describing market concentration, was constructed, and a multiple regression analysis was conducted to evaluate the association between the brand-name OCP prices and the market share of individual brand-name drugs. The odds of utilizing brand-name drugs decreased steadily in 2012, 2013, and 2014 compared to 2012 (AOR 0.87, 0.73, 0.55, respectively, p<0.05) controlling for patient mix. Despite significant decline in total utilization, there was a 90% increase in the price of brand-name OCPs, resulting an 18% increase in revenue from 2011 to 2014 for the industry. During this time, pharmaceutical market concentration for OCPs increased (HHI increased from 1105 in 2011 to 2415 in 2014). Each percentage point increase in the market share by a brand-name OCPs was associated with a $3.12 increase in its price. Market mechanisms matter. Practitioners and policy makers need to take market mechanisms into account in order to realize the benefits of generic substitutions.


Assuntos
Anticoncepcionais Orais Combinados/economia , Custos de Medicamentos/tendências , Indústria Farmacêutica/tendências , Uso de Medicamentos/tendências , Gastos em Saúde/tendências , Adulto , Anticoncepção/economia , Anticoncepção/métodos , Anticoncepção/estatística & dados numéricos , Anticoncepção/tendências , Comportamento Contraceptivo/estatística & dados numéricos , Custos de Medicamentos/estatística & dados numéricos , Indústria Farmacêutica/economia , Indústria Farmacêutica/estatística & dados numéricos , Uso de Medicamentos/economia , Uso de Medicamentos/estatística & dados numéricos , Medicamentos Genéricos/economia , Competição Econômica/estatística & dados numéricos , Competição Econômica/tendências , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Custos de Cuidados de Saúde/tendências , Gastos em Saúde/estatística & dados numéricos , Humanos , Inquéritos e Questionários/estatística & dados numéricos , Estados Unidos , Adulto Jovem
18.
PLoS One ; 15(6): e0233601, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32497063

RESUMO

Financing by patent pledge is an important way for small- and medium-sized pharmaceutical enterprises to address financing problems. In this study, eight indexes are analyzed considering both the pledge patent value and pledger credit value. And a prediction model for the patent pledge financing amount for pharmaceutical enterprises is constructed for the first time using the analytic hierarchy process and the fuzzy comprehensive evaluation method. Three levels of financing amount are concluded through the prediction model and prediction results corresponding with the financing amount are displayed. This model was designed to help small- and medium-sized pharmaceutical enterprises get access to financing through patent pledge to relieve their financial stress. At the same time, it provides guides for pledgees and policymakers to improve the efficiency and quality of patent pledge. This work is reliable and valid in that it constructs this prediction model based on systematical data from official data sources.


Assuntos
Indústria Farmacêutica/economia , Financiamento da Assistência à Saúde , Tecnologia Farmacêutica/economia , China , Previsões/métodos , Humanos , Modelos Teóricos
19.
PLoS One ; 15(6): e0235021, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32579571

RESUMO

BACKGROUND: Many patient organisations collaborate with drug companies, resulting in concerns about commercial agendas influencing patient advocacy. We contribute to an international body of knowledge on patient organisation-industry relations by considering payments reported in the industry's centralised 'collaboration database' in Sweden. We also investigate possible commercial motives behind the funding by assessing its association with drug commercialisation. METHODS: Our primary data source were 1,337 payment reports from 2014-2018. After extraction and coding, we analysed the data descriptively, calculating the number, value and distribution of payments for various units of analysis, e.g. individual companies, diseases and payment goals. The association between drug commercialisation and patient organisation funding was assessed by, first, the concordance between leading companies marketing drugs in specific diseases and their funding of corresponding patient organisations and, second, the correlation between new drugs in broader condition areas and payments to corresponding patient organisations. RESULTS: 46 companies reported paying €6,449.224 (median €2,411; IQR €1,024-4,569) to 77 patient organisations, but ten companies provided 67% of the funding. Small payments dominated, many of which covered costs of events organised by patient organisations. An association existed between drug commercialisation and industry funding. Companies supported patient organisations in diseases linked to their drug portfolios, with the top 3 condition areas in terms of funding-cancer; endocrine, nutritional and metabolic disorders; and infectious and parasitic disorders-accounting for 63% of new drugs and 56% of the funding. CONCLUSION: This study reveals close and widespread ties between patient organisations and drug companies. A relatively few number of companies dominated the funding landscape by supporting patient organisations in disease areas linked to their drug portfolios. This commercially motivated funding may contribute to inequalities in resource and influence between patient organisations. The association between drug commercialisation and industry funding is also worrying because of the therapeutic uncertainty of many new drugs. Our analysis benefited from the existence of a centralised database of payments-which should be adopted by other countries too-but databases should be downloadable in an analysable format to permit efficient and independent analysis.


Assuntos
Indústria Farmacêutica/economia , Apoio Financeiro , Defesa do Paciente/economia , Preparações Farmacêuticas/economia , Conflito de Interesses , Estudos Transversais , Custos de Medicamentos , Humanos , Marketing/economia , Organizações/economia , Organizações/ética , Defesa do Paciente/ética , Suécia
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