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6.
BMJ ; 368: l6925, 2020 01 22.
Artículo en Inglés | MEDLINE | ID: mdl-31969320

RESUMEN

OBJECTIVE: To investigate pharmaceutical or medical device industry funding of patient groups. DESIGN: Systematic review with meta-analysis. DATA SOURCES: Ovid Medline, Embase, Web of Science, Scopus, and Google Scholar from inception to January 2018; reference lists of eligible studies and experts in the field. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Observational studies including cross sectional, cohort, case-control, interrupted time series, and before-after studies of patient groups reporting at least one of the following outcomes: prevalence of industry funding; proportion of industry funded patient groups that disclosed information about this funding; and association between industry funding and organisational positions on health and policy issues. Studies were included irrespective of language or publication type. REVIEW METHODS: Reviewers carried out duplicate independent data extraction and assessment of study quality. An amended version of the checklist for prevalence studies developed by the Joanna Briggs Institute was used to assess study quality. A DerSimonian-Laird estimate of single proportions with Freeman-Tukey arcsine transformation was used for meta-analyses of prevalence. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to assess the quality of the evidence for each outcome. RESULTS: 26 cross sectional studies met the inclusion criteria. Of these, 15 studies estimated the prevalence of industry funding, which ranged from 20% (12/61) to 83% (86/104). Among patient organisations that received industry funding, 27% (175/642; 95% confidence interval 24% to 31%) disclosed this information on their websites. In submissions to consultations, two studies showed very different disclosure rates (0% and 91%), which appeared to reflect differences in the relevant government agency's disclosure requirements. Prevalence estimates of organisational policies that govern corporate sponsorship ranged from 2% (2/125) to 64% (175/274). Four studies analysed the relationship between industry funding and organisational positions on a range of highly controversial issues. Industry funded groups generally supported sponsors' interests. CONCLUSION: In general, industry funding of patient groups seems to be common, with prevalence estimates ranging from 20% to 83%. Few patient groups have policies that govern corporate sponsorship. Transparency about corporate funding is also inadequate. Among the few studies that examined associations between industry funding and organisational positions, industry funded groups tended to have positions favourable to the sponsor. Patient groups have an important role in advocacy, education, and research, therefore strategies are needed to prevent biases that could favour the interests of sponsors above those of the public. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017079265.


Asunto(s)
Organizaciones del Consumidor/economía , Industria Farmacéutica/economía , Administración Financiera/legislación & jurisprudencia , Organizaciones del Consumidor/ética , Organizaciones del Consumidor/legislación & jurisprudencia , Revelación/ética , Revelación/legislación & jurisprudencia , Industria Farmacéutica/ética , Administración Financiera/ética , Estudios Observacionales como Asunto , Política Organizacional
9.
Expert Rev Pharmacoecon Outcomes Res ; 19(6): 749-753, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31825682

RESUMEN

Background: Agreements between payers and pharmaceutical/medical device companies are widely implemented to address financial and clinical uncertainties. We analyzed the main characteristics of these agreements in Israel from 2011-2018.Research design and methods: We reviewed all agreements implemented during the study period. Information regarding the type of agreement, therapeutic indications, its time frame and the total budget involved are presented.Results: A total of 56 agreements were signed since 2011, of which 53 (95%) were financial-based and 50 (89%) referred to pharmaceuticals. The annual number of agreements increased from one in 2011 to 21 in 2018. The main therapeutic areas covered were: oncology (41%), hepatitis C (16%), neurology (11%), respiratory (9%), and cardiovascular (7%). The proportion of the annual budget allocated subject to these agreements increased accordingly from 3% in 2011 to 73% in 2018. The majority (63%) of the agreements were signed for 5 years, 9% were shorter-term and 20% have no time-limit. In 14 (44%) of the financial-based agreements implemented through 2017, the actual utilization exceeded the pre-specified threshold and the companies reimbursed the health-plans accordingly.Conclusions: The number of agreements and the allocated budget subject to these agreements increased substantially in recent years. Most agreements are financial-based that, in many cases, shifted the short-term financial risk from health-plans to the industry.


Asunto(s)
Industria Farmacéutica/organización & administración , Accesibilidad a los Servicios de Salud/economía , Programas Nacionales de Salud/organización & administración , Prorrateo de Riesgo Financiero/organización & administración , Presupuestos , Industria Farmacéutica/economía , Servicios de Salud/economía , Humanos , Israel , Programas Nacionales de Salud/economía , Mecanismo de Reembolso/economía , Prorrateo de Riesgo Financiero/economía , Incertidumbre
10.
BMJ ; 367: l6694, 2019 12 12.
Artículo en Inglés | MEDLINE | ID: mdl-31831471

RESUMEN

OBJECTIVE: To understand and report on the nature of patient group interactions with the pharmaceutical industry from the perspective of patient group representatives by exploring the range of attitudes towards pharmaceutical industry sponsorship and how, why, and when interactions occur. DESIGN: Empirical qualitative interview study informed by ethics theory. SETTING: Australian patient groups. PARTICIPANTS: 27 participants from 23 Australian patient groups that represented diverse levels of financial engagement with the pharmaceutical industry. Groups were focused on general health consumer issues or disease specific topics, and had regional or national jurisdictions. ANALYSIS: Analytic techniques were informed by grounded theory. Interview transcripts were coded into data driven categories. Findings were organised into new conceptual categories to describe and explain the data, and were supported by quotes. RESULTS: A range of attitudes towards pharmaceutical industry sponsorship were identified that are presented as four different types of relationship between patient groups and the pharmaceutical industry. The dominant relationship type was of a successful business partnership, and participants described close working relationships with industry personnel. These participants acknowledged a potential for adverse industry influence, but expressed confidence in existing strategies for avoiding industry influence. Other participants described unsatisfactory or undeveloped relationships, and some participants (all from general health consumer groups) presented their groups' missions as incompatible with the pharmaceutical industry because of fundamentally opposing interests. Participants reported that interactions between their patient group and pharmaceutical companies were more common when companies had new drugs of potential interest to group members. Patient groups that accepted industry funding engaged in exchanges of "assets" with companies. Groups received money, information, and advice in exchange for providing companies with marketing, relationship building opportunities with key opinion leaders, coordinated lobbying with companies about drug access and subsidy, assisting companies with clinical trial recruitment, and enhancing company credibility. CONCLUSIONS: An understanding of the range of views patient groups have about pharmaceutical company sponsorship will be useful for groups that seek to identify and manage any ethical concerns about these relationships. Patient groups that receive pharmaceutical industry money should anticipate they might be asked for specific assets in return. Selective industry funding of groups where active product marketing opportunities exist might skew the patient group sector's activity towards pharmaceutical industry interests and allow industry to exert proxy influence over advocacy and subsequent health policy.


Asunto(s)
Conflicto de Intereses , Industria Farmacéutica/economía , Política de Salud , Mercadeo/ética , Defensa del Paciente/ética , Investigación Cualitativa , Australia , Humanos
11.
Expert Rev Pharmacoecon Outcomes Res ; 19(6): 685-692, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31847613

RESUMEN

Introduction: Governments need to do far more to help curb the emergence and transmission of antibiotic resistance and help protect the efficacy of any new antibiotics that come to the market. Industry is an important stakeholder that must be brought on-board such efforts given its influence on the direction and scale of antibiotic sales. Financial incentives supporting industry R&D of novel antibiotics should structurally remove the drivers of superfluous sales and encourage access to newer antibiotics where infections are otherwise resistant to treatment. Indeed, the use of public money provides an important opportunity to prioritize these public health goals within market structures such that we both adequately reward industry for their efforts and prolong antibiotic efficacy for as long as possible.Areas covered: This work discusses possible financial 'pull' incentives that fully delink the reward paid to the developer from unit sales, examining their primary advantages and limitations.Expert opinion: Pharmaceutical companies need to be rewarded generously for their efforts to develop new, badly needed antibiotics. But the current marketplace does not provide a sustained financial lure and its reliance on unit-sales for profitability jeopardizes the efficacy of antibiotics both new and old. Fully delinked models can make antibiotic R&D more financially appealing and create a market environment that is far less threatening to public health.


Asunto(s)
Antibacterianos/farmacología , Industria Farmacéutica/economía , Farmacorresistencia Bacteriana , Antibacterianos/economía , Comercio/economía , Desarrollo de Medicamentos/economía , Humanos , Salud Pública/economía , Apoyo a la Investigación como Asunto/economía
13.
BMJ ; 367: l6015, 2019 Nov 05.
Artículo en Inglés | MEDLINE | ID: mdl-31690553

RESUMEN

OBJECTIVE: To evaluate the association between gifts from pharmaceutical companies to French general practitioners (GPs) and their drug prescribing patterns. DESIGN: Retrospective study using data from two French databases (National Health Data System, managed by the French National Health Insurance system, and Transparency in Healthcare). SETTING: Primary care, France. PARTICIPANTS: 41 257 GPs who in 2016 worked exclusively in the private sector and had at least five registered patients. The GPs were divided into six groups according to the monetary value of the received gifts reported by pharmaceutical, medical device, and other health related companies in the Transparency in Healthcare database. MAIN OUTCOME MEASURES: The main outcome measures were the amount reimbursed by the French National Health Insurance for drug prescriptions per visit (to the practice or at home) and 11 drug prescription efficiency indicators used by the National Health Insurance to calculate the performance related financial incentives of the doctors. Doctor and patient characteristics were used as adjustment variables. The significance threshold was 0.001 for statistical analyses. RESULTS: The amount reimbursed by the National Health Insurance for drug prescriptions per visit was lower in the GP group with no gifts reported in the Transparency in Healthcare database in 2016 and since its launch in 2013 (no gift group) compared with the GP groups with at least one gift in 2016 (-€5.33 (99.9% confidence interval -€6.99 to -€3.66) compared with the GP group with gifts valued at €1000 or more reported in 2016) (P<0.001). The no gift group also more frequently prescribed generic antibiotics (2.17%, 1.47% to 2.88% compared with the ≥€1000 group), antihypertensives (4.24%, 3.72% to 4.77% compared with the ≥€1000 group), and statins (12.14%, 11.03% to 13.26% compared with the ≥€1000 group) than GPs with at least one gift between 2013 and 2016 (P<0.001). The no gift group also prescribed fewer benzodiazepines for more than 12 weeks (-0.68%, -1.13% to -0.23% compared with the €240-€999 group) and vasodilators (-0.15%, -0.28% to -0.03% compared with the ≥€1000 group) than GPs with gifts valued at €240 or more reported in 2016, and more angiotensin converting enzyme (ACE) inhibitors compared with all ACE and sartan prescriptions (1.67%, 0.62% to 2.71%) compared with GPs with gifts valued at €1000 or more reported in 2016 (P<0.001). Differences were not significant for the prescription of aspirin and generic antidepressants and generic proton pump inhibitors. CONCLUSION: The findings suggest that French GPs who do not receive gifts from pharmaceutical companies have better drug prescription efficiency indicators and less costly drug prescriptions than GPs who receive gifts. This observational study is susceptible to residual confounding and therefore no causal relation can be concluded. TRIAL REGISTRATION: OSF register OSF.IO/8M3QR.


Asunto(s)
Industria Farmacéutica/economía , Prescripciones de Medicamentos/estadística & datos numéricos , Médicos Generales/estadística & datos numéricos , Donaciones , Pautas de la Práctica en Medicina/estadística & datos numéricos , Adolescente , Adulto , Anciano , Bases de Datos Factuales/estadística & datos numéricos , Industria Farmacéutica/estadística & datos numéricos , Prescripciones de Medicamentos/economía , Medicamentos Genéricos/economía , Femenino , Francia , Médicos Generales/economía , Humanos , Reembolso de Seguro de Salud/economía , Reembolso de Seguro de Salud/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Programas Nacionales de Salud/economía , Programas Nacionales de Salud/estadística & datos numéricos , Pautas de la Práctica en Medicina/economía , Medicamentos bajo Prescripción/economía , Estudios Retrospectivos , Adulto Joven
16.
Nat Commun ; 10(1): 4314, 2019 09 20.
Artículo en Inglés | MEDLINE | ID: mdl-31541096

RESUMEN

Healthcare industry players make payments to medical providers for non-research expenses. While these payments may pose conflicts of interest, their relationship with overall healthcare costs remains largely unknown. In this study, we linked Open Payments data on providers' industry payments with Medicare data on healthcare costs. We investigated 374,766 providers' industry payments and healthcare costs. We demonstrate that providers receiving higher amounts of industry payments tend to bill higher drug and medical costs. Specifically, we find that a 10% increase in industry payments is associated with 1.3% higher medical and 1.8% higher drug costs. For a typical provider, for example, a 10% or $25 increase in annual industry payments would be associated with approximately $1,100 higher medical costs and $100 higher drug costs. Furthermore, the association between payments and healthcare costs varies markedly across states and correlates with political leaning, being stronger in more conservative states.


Asunto(s)
Conflicto de Intereses , Costos y Análisis de Costo , Costos de la Atención en Salud , Personal de Salud/economía , Prestación de Atención de Salud/economía , Costos de los Medicamentos , Industria Farmacéutica/economía , Ética Médica , Gastos en Salud , Servicios de Salud/economía , Humanos , Medicare , Modelos Teóricos , Salud Pública/economía , Estados Unidos
17.
J Leg Med ; 39(2): 151-167, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31503532

RESUMEN

U.S. consumers pay high drug prices. Brand-name drug companies claim that these prices are justified by pathbreaking research and development. But, sometimes the prices result from anticompetitive conduct. This article offers three case studies of how such behavior can increase price based on wakefulness drug Provigil, the allergic-reaction-treating EpiPen, and infection-treating Daraprim. The article contends that behavior that makes no sense other than by harming a competitor, that undercuts a regulatory regime, or that involves collusive conduct should not be protected. In targeting this behavior, antitrust scrutiny promises to lower drug prices.


Asunto(s)
Costos de los Medicamentos/ética , Costos de los Medicamentos/legislación & jurisprudencia , Honorarios Farmacéuticos/ética , Honorarios Farmacéuticos/legislación & jurisprudencia , Modafinilo/economía , Pirimetamina/economía , Leyes Antitrust , Industria Farmacéutica/economía , Industria Farmacéutica/ética , Industria Farmacéutica/legislación & jurisprudencia , Competencia Económica , Humanos , Estados Unidos
20.
JAMA ; 322(5): 422-429, 2019 08 06.
Artículo en Inglés | MEDLINE | ID: mdl-31386135

RESUMEN

Importance: Although independent charity patient assistance programs improve patient access to costly prescription drugs, recent federal investigations have raised questions about their potential to increase pharmaceutical spending and to violate the federal Anti-Kickback Statute. Little is known about the design of the programs, patient eligibility, or drug coverage. Objective: To examine the eligibility criteria of the independent charity patient assistance programs and the drugs covered by them. Design, Setting, and Participants: Descriptive cross-sectional study of the 6 largest independent charities offering patient assistance programs for patients including, but not limited to, Medicare beneficiaries in 2018. These charities offered 274 different disease-specific patient assistance programs. Drugs were identified for subgroup analysis that had any use reported on the Medicare Part D spending dashboard and any off-patent brand-name drugs that incurred more than $10 000 in Medicare spending per beneficiary in 2016. Exposures: Support by independent charity patient assistance programs. Main Outcomes and Measures: The primary outcomes were the characteristics of patient assistance programs, including assistance type, insurance coverage (vs uninsured), and income eligibility. The secondary outcomes were the cost of the drugs covered by the patient assistance programs and the coverage of expensive off-patent brand-name drugs vs substitutable generic drugs. Results: Among the 6 independent charity foundations included in the analysis, their total revenue in 2017 ranged from $24 million to $532 million, and expenditures on patient assistance programs ranged from $24 million to $353 million, representing on average, 86% of their revenue. Of the 274 patient assistance programs offered by these organizations, 168 (61%) provided only co-payment assistance, and the most common therapeutic area covered was cancer or cancer treatment-related symptoms (113 patient assistance programs; 41%). A total of 267 programs (97%) required insurance coverage as an eligibility criterion (ie, excluded uninsured patients). The most common income eligibility limit was 500% of the federal poverty level. The median annual cost of the drugs per beneficiary covered by the programs was $1157 (interquartile range, $247-$5609) compared with $367 (interquartile range, $100-$1500) for the noncovered drugs. Off-patent brand-name drugs (cost: >$10 000) were covered by a mean of 3.1 (SD, 2.0) patient assistance programs, whereas their generic equivalents were covered by a mean of 1.2 (SD, 1.0) patient assistance programs. Conclusions and Relevance: In 2018, among 274 patient assistance programs operated by the 6 independent charity foundations, the majority did not provide coverage for uninsured patients. Medications that were covered by the patient assistance programs were generally more expensive than those that were not covered.


Asunto(s)
Organizaciones de Beneficencia/economía , Determinación de la Elegibilidad , Renta , Pacientes no Asegurados , Medicamentos bajo Prescripción/economía , Organizaciones de Beneficencia/legislación & jurisprudencia , Estudios Transversales , Costos de los Medicamentos , Industria Farmacéutica/economía , Gastos en Salud , Humanos , Cobertura del Seguro , Asistencia Médica/economía , Medicare Part D , Estados Unidos
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