Dataset Information

Show us the money: lessons in transparency from state pharmaceutical marketing disclosure laws.

ABSTRACT:

Objective

To assess legislation requiring drug companies to report gifts to providers, and to evaluate the information obtained.

Data sources

Data included legislation in Vermont, Minnesota, Maine, Massachusetts, West Virginia, and the District of Columbia, and company disclosure data from Vermont.

Study design

We evaluated the strengths and weaknesses of state legislation. We also analyzed 4 years of company disclosures from Vermont, assessing the value and distribution of industry-provider exchanges and identifying emerging trends in companies' practices.

Data collection methods

State legislation is publically available. We obtained Vermont's data through requests to the state's Attorney General's office.

Principal findings

Of the state laws, only Vermont's yielded robust, publically available data. These data show gifting was dominated by a few major corporations, and <2 percent of Vermont's prescribers received 69 percent of gifts and payments. Companies were especially generous to specialists in psychiatry, endocrinology/diabetes/metabolism, internal medicine, and neurology. Companies increasingly used loopholes in the law to avoid public scrutiny.

Conclusions

Disclosure laws are an important first step in bringing greater transparency to physician-industry relationships. But flaws and weaknesses limit the states' ability to render physician-industry exchanges fully transparent. Future efforts should build on these lessons to render physician-industry relationships fully transparent.

SUBMITTER: Chimonas S

PROVIDER: S-EPMC2813439 | biostudies-literature | 2010 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Show us the money: lessons in transparency from state pharmaceutical marketing disclosure laws.

Chimonas Susan S Rozario Natassia M NM Rothman David J DJ

Health services research 20091013 1

<h4>Objective</h4>To assess legislation requiring drug companies to report gifts to providers, and to evaluate the information obtained.<h4>Data sources</h4>Data included legislation in Vermont, Minnesota, Maine, Massachusetts, West Virginia, and the District of Columbia, and company disclosure data from Vermont.<h4>Study design</h4>We evaluated the strengths and weaknesses of state legislation. We also analyzed 4 years of company disclosures from Vermont, assessing the value and distribution of ...[more]

PMID: 19840133

Similar Datasets

Project description:ObjectivesTo investigate German physicians' attitudes towards and experiences with voluntary disclosure of payments by pharmaceutical companies in a public database and their impact on future decisions for or against disclosure.DesignA national cross-sectional survey conducted in 2018 among physicians who voluntarily disclosed at least one payment in the German transparency regulation.SettingRetrospective paper-pencil questionnaire about attitudes towards and experiences with voluntary payment disclosures in the first (2015) and second (2016) years of the German transparency regulation.ParticipantsGerman physicians who disclosed either in the first year only, the second year only, or in both years of the transparency regulation.Primary outcomes(1) The probability to disclose in 2016, predicted by physicians' experience of reactions from others in 2015, descriptive norms and attitudes towards transparency; (2) Frequency and (3) Content of reactions from others in 2015 compared with 2016.ResultsData of 234 respondents were analysed (n=42, 45 and 147 physicians who disclosed in 2015, 2016 or both years, respectively). The probability to disclose in 2016 was not predicted by perceived reactions, norms or attitudes towards transparency (p>0.01). Most participants reported not to have received any reactions by patients (190/234, 81%), colleagues (128/234, 55%) or the private environment (153/234, 65%). Neither frequency nor content of reactions differed between the first and second years (scale 1-5; frequency: Mdn 2015,2016 = 1.33 vs 1.00, r b=-0.17, p>0.01; content: Mdn 2015,2016 = 3.00 vs 3.00, r b=0.19, p>0.01). However, media reporting, fear of reputational damage and a feeling of being defamed were mentioned as reasons for non-disclosure.ConclusionsWhile confirmatory analyses did not provide significant results, descriptive analyses showed that participants who voluntarily disclose payments mainly do not experience any reactions towards their disclosures but report fears about losing their reputation due to disclosures.

Project description:BackgroundWeak governance over public sector pharmaceutical policy and practice limits access to essential medicines, inflates pharmaceutical prices, and wastes scarce health system resources. Pharmaceutical systems are technically complex and involve extensive interactions between the private and public sectors. For members of public sector pharmaceutical committees, relationships with the private sector can result in conflicts of interest, which may introduce commercial biases into decision-making, potentially compromising public health objectives and health system sustainability. We conducted a descriptive, qualitative study of conflict of interest policies and practices in the public pharmaceutical sector in ten countries in the World Health Organization (WHO) South-East Asia Region (SEAR) (Bangladesh, Bhutan, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand, and Timor-Leste) between September 2020 and March 2021.ResultsWe identified 45 policy and regulatory documents and triangulated documentary data with 21 expert interviews. Key informants articulated very different governance priorities and conflict of interest concerns depending on the features of their country's pharmaceutical industry, market size, and national economic objectives related to the domestic pharmaceutical industry. Public sector pharmaceutical policies and regulations consistently contained provisions for pharmaceutical committee members to disclose relevant interests, but contained little detail about what should be declared, when, and how often, nor whether disclosures are evaluated and by whom. Processes for preventing or managing conflicts of interest were less well developed than those for disclosure except for a few key procurement processes. Where processes for managing conflicts of interest were specified, the dominant strategy was to recuse committee members with a conflict of interest from relevant work. Policies rarely specified that committee members should divest or otherwise be free from conflicts of interest.ConclusionsRobust processes for conflict of interest prevention and management could ensure the integrity of decision-making and build public trust in pharmaceutical processes to achieve public health objectives. Upstream approaches including supportive legislative frameworks, the creation of oversight bodies, and strengthening regulatory institutions can also contribute to building cultures of transparency, accountability, and trust.

Project description:BackgroundWithin the rapidly evolving healthcare landscape in Japan, digital marketing innovations are transforming pharmaceutical and medical device marketing. This study explores the emergence of new business models in the digital marketing, highlighting a transition from traditional methods to more dynamic, data-driven strategies.MethodsInsighTCROSS® is a business model that qualitatively and quantitatively examines three steps based on stratified persona images: (1) verifying the effectiveness of product marketing promotions, (2) identifying competitors from the users' perspective, and (3) developing marketing strategies to counter competition. To demonstrate the effectiveness of this model, a case study was conducted focusing on the current anticoagulant drugs, including apixaban, dabigatran, edoxaban, rivaroxaban, and warfarin.ResultsRivaroxaban, the only drug prescribed for the prevention of thrombus and embolism formation in patients with peripheral artery disease after lower limb revascularization, garnered the most interest from interventional cardiologists performing peripheral vascular interventions, as determined by InsighTCROSS® factor analysis, confirming that the manufacturer's marketing activities have effectively penetrated the market. A survey conducted between 20 September 2023 and 3 October 2023, among members of a cardiology website, identified edoxaban as the market leader with a 39.1% share, followed by apixaban (32.7%) and rivaroxaban (16.8%). The main competitor of edoxaban was warfarin, whereas that of rivaroxaban was apixaban. Decision tree analysis was conducted using InsighTCROSS®, highlighting the strengths and weaknesses of each anticoagulant, providing strategic approaches to exploit competitive weaknesses. For edoxaban, increased use was driven by elderly and poorly adherent patients; for apixaban, high-volume percutaneous coronary intervention centers; and for rivaroxaban, the influence of medical representative detailing. It is recommended to avoid markets where these drugs have a strong presence and to focus marketing activities on leveraging their specific strengths.ConclusionThe findings suggest that digital marketing enhances product visibility and patient engagement, providing valuable insights into market behavior and consumer preferences.

Project description:BackgroundPharmaceuticals are an integral component of health care systems worldwide, thus, regulatory weaknesses in governance of the pharmaceutical system negatively impact health outcomes especially in developing countries 1. Nigeria is one of a number of countries whose pharmaceutical system has been impacted by corruption and has struggled to curtail the production and trafficking of substandard drugs. In 2001, the National Agency for Food and Drug Administration and Control (NAFDAC) underwent an organizational restructuring resulting in reforms to reduce counterfeit drugs and better regulate pharmaceuticals 2. Despite these changes, there is still room for improvement. This study assessed the perceived level of transparency and potential vulnerability to corruption that exists in four essential areas of Nigeria's pharmaceutical sector: registration, procurement, inspection (divided into inspection of ports and of establishments), and distribution.MethodsStandardized questionnaires were adapted from the World Health Organization assessment tool and used in semi-structured interviews with key stakeholders in the public and private pharmaceutical system. The responses to the questions were tallied and converted to scores on a numerical scale where lower scores suggested greater vulnerability to corruption and higher scores suggested lower vulnerability.ResultsThe overall score for Nigeria's pharmaceutical system was 7.4 out of 10, indicating a system that is marginally vulnerable to corruption. The weakest links were the areas of drug registration and inspection of ports. Analysis of the qualitative results revealed that the perceived level of corruption did not always match the qualitative evidence.ConclusionDespite the many reported reforms instituted by NAFDAC, the study findings suggest that facets of the pharmaceutical system in Nigeria remain fairly vulnerable to corruption. The most glaring deficiency seems to be the absence of conflict of interest guidelines which, if present and consistently administered, limit the promulgation of corrupt practices. Other major contributing factors are the inconsistency in documentation of procedures, lack of public availability of such documentation, and inadequacies in monitoring and evaluation. What is most critical from this study is the identification of areas that still remain permeable to corruption and, perhaps, where more appropriate checks and balances are needed from the Nigerian government and the international community.

Project description:OBJECTIVES:To analyse the section of Disclosure UK that pertains to healthcare professionals (HCPs) in order to provide insight into the database's structure and content and suggest ways to improve its transparency. DESIGN AND PARTICIPANTS:Cohort study of drug companies and HCPs in the 2015 and 2016 versions of Disclosure UK. RESULTS:Companies report transfers of value (ToVs) to named HCPs or, where an HCP declines to consent, in aggregate. Only a limited number of variables describe the recipient HCP and the ToV, precluding refined analyses. In 2015, 107 companies reported 54 910 ToVs worth ?50 967 728. In 2016, 109 companies reported ToVs but spending decreased by 7.3%. The spending was concentrated: the top 10 spenders reported about 50% of the total value, with consultancy-related payments comprising over 70%, and the rest being costs for events. In 2015, 55.5% (30 478) of ToVs worth ?24 428 619 (47.9%) were disclosed at the individual HCP level, increasing to 64.5% (32 407) and ?28 145 091 (59.2%) in 2016. Despite increased individual-level disclosure in 2016, the median number of ToVs reported by each company at the individual level was only 57.7%, with 25% of companies reporting less than 38.6%. We found little agreement (62%-48% in 2015 and 46%-30% in 2016) between HCP consent rates that we calculated based on information in the database and those provided by companies. CONCLUSIONS:Key deficiencies in Disclosure UK include: insufficient information on payments and recipients, a relatively low HCP consent rate for individual-level disclosure, differences in consent rates across companies and payment types, and reporting ambiguities or inconsistencies. We employ these findings to develop recommendations for improving transparency, including an easily interpretable consent rate statistic that allows for comparison across years, firms and countries. If deficiencies remain unresolved, the UK should consider introducing legislation requiring mandatory disclosure to allow for adequate tracking of industry payments.

Dataset Information

Show us the money: lessons in transparency from state pharmaceutical marketing disclosure laws.

Objective

Data sources

Study design

Data collection methods

Principal findings

Conclusions

Publications

Show us the money: lessons in transparency from state pharmaceutical marketing disclosure laws.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets