Assessing the impact of the Physician Payments Sunshine Act on pharmaceutical companies' payments to physicians.

Enacted in 2010 as part of the Affordable Care Act, the Physician Payments Sunshine Act (PPSA) mandates transparency in financial interactions between pharmaceutical companies and healthcare providers. This study investigates the PPSA's effectiveness and its impact on industry payments to physicians. Utilizing ProPublica and Open Payments databases, a difference-in-difference analysis was conducted across ten states. Results reveal a significant reduction in pharmaceutical companies' meal-related payments post-PPSA, impacting both the total payment amount and the number of unique physicians reached. Conversely, travel payments showed no significant impact in the primary analysis. However, subsequent analyses revealed nuanced reductions in the number of unique physicians reached, highlighting a more intricate relationship wherein pharmaceutical companies likely adjusted their financial interaction strategies with physicians differently across states. State-level variations in meals further underscore the complexity of PPSA's influence. This pioneering research contributes valuable empirical evidence, addressing gaps in prior studies and emphasizing the ongoing need for policy assessment to guide industry-physician relationships.

Opposed to Pain: Antikamnia Chemical Company.

The Antikamnia (AK) Chemical Company founded in 1890, which eventually was renamed The Antikamnia Remedy Company in 1819, was an important medicine company that thrived prior to passage of the 1906 Food and Drug act using smart worldwide marketing. As dangerous as the AK products were, success continued after 1906 by pursuing methods to flout regulations and stick to the marketing methods and legal maneuvering that kept AK sales strong. This article describes the tumultuous history of one of the most successful drug companies between 1890 and well into the 1920s.

Complexin vitromodels positioned for impact to drug testing in pharma: a review.

Recent years have seen the creation and popularization of various complexin vitromodels (CIVMs), such as organoids and organs-on-chip, as a technology with the potential to reduce animal usage in pharma while also enhancing our ability to create safe and efficacious drugs for patients. Public awareness of CIVMs has increased, in part, due to the recent passage of the FDA Modernization Act 2.0. This visibility is expected to spur deeper investment in and adoption of such models. Thus, end-users and model developers alike require a framework to both understand the readiness of current models to enter the drug development process, and to assess upcoming models for the same. This review presents such a framework for model selection based on comparative -omics data (which we term model-omics), and metrics for qualification of specific test assays that a model may support that we term context-of-use (COU) assays. We surveyed existing healthy tissue models and assays for ten drug development-critical organs of the body, and provide evaluations of readiness and suggestions for improving model-omics and COU assays for each. In whole, this review comes from a pharma perspective, and seeks to provide an evaluation of where CIVMs are poised for maximum impact in the drug development process, and a roadmap for realizing that potential.

[The metamorphoses of denationalization of 1993. Report-I. The market fight for medications import].

In the history of the Russian pharmaceutical market the year of 1993 became the year of formation of rules of market relations and changing under them of market landscape. The significant segment of state-centralized purchases moved under responsibility of regional authorities and their health care authorities. At that, powers of three former state organizations being occupied with purchases of imported medications were distributed between new state companies of Ministry of Health and commercial organizations and firms that entered pharmaceutical market. This diversity rather soon gave rise to competitive fight for budget funds and experiments of Government with market regulation. The traces of these clashes and attempts to make market regulated can be found in Ministry of Health archives and journal publications. The Report I reveals circumstances of entrance of Ministry of Health into market relationships and its acquisition of market player identity.

The role of metaphor in the corporate political strategies of health harming industries: Comparing the concept of balance in the gambling and opioid industry discourses.

Scholars have identified notable similarities between the political strategies employed by health-harming industries. This includes similarities in the narratives employed by industry actors seeking to oppose public health regulations that threaten their commercial interests. This study seeks to examine the use of a specific concept - the balance metaphor - in the policy discourses of two health-harming industries. Namely, the pharmaceutical industry implicated in the prescription opioid crisis in the US, and the UK gambling industry, whose products and practices are associated with a serious, but largely neglected, series of harms. We first review research on metaphors, demonstrating how this provides additional theoretically-informed concepts with which to understand how industry discourse circumscribes the terrain of policy debates in ways amenable to commercial interests. Building from these insights, we conducted a rhetorical analysis, examining how the concept of balance is employed by different actors in distinct contexts to shape understandings of the social and policy problems associated with gambling and opioid products and to promote industry-favourable regulatory responses to these. This brings a micro-level of analysis to supplement previous meso- and macro-level scholarship in this space. We use our findings to argue that the depoliticization of the policy process and objectivization of the policy space - in ways that obscure its contingent and political nature - through discourses of balance is itself an arch political act. Examining the metaphors used in policy debates and their functions provides important insights that can be used to inform the construction of counter-narratives to industry-favourable discourses, including the creative use of novel metaphors in the service of public health goals.

Non-research payments to board-certified cardiologists from pharmaceutical industry in Japan from 2016 to 2019: a retrospective analysis.

OBJECTIVES: To evaluate the extent and trends of personal payments from pharmaceutical companies to cardiologists board-certified by the Japanese Circulation Society. DESIGN: A retrospective analysis study using data from a publicly available database. SETTING: The study focused on payments to cardiologists in Japan. PARTICIPANTS: All 15 048 cardiologists who were board-certified by the Japanese Circulation Society as of 2021. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the extent of personal payments to cardiologists in 2016-19. Secondary outcomes included the analysis of trends in these payments over the same period. RESULTS: Of all 15 048 board-certified cardiologists, 9858 (65.5%) received personal payments totaling $112 934 503 entailing 165 013 transactions in 2016-19. The median payment per cardiologist was $2947 (IQR, $1022-$8787), with a mean of $11 456 (SD, $35 876). The Gini Index was 0.840, indicating a high concentration of payments to a small number of cardiologists. The top 1%, 5% and 10% of cardiologists received 31.6%, 59.4% and 73.5% of all payments, respectively. There were no significant trends in the number of cardiologists receiving payments or number of payments per cardiologist during the study period. CONCLUSIONS: More than 65% of Japanese cardiologists received personal payments from pharmaceutical companies over the 4-year study period. Although the payment amount was relatively small for the majority of cardiologists, a small number of cardiologists received the vast majority of the payments.

Ethical and Practical Considerations for an Agreement to Ensure Equitable Vaccine Access Comment on "More Pain, More Gain! The Delivery of COVID-19 Vaccines and the Pharmaceutical Industry's Role in Widening the Access Gap".

This paper discusses the potential of an international agreement to ensure equitable vaccine distribution, addressing the failures witnessed during the COVID-19 pandemic. COVAX was unable to prevent vaccine monopolization and unequal distribution, which led to significant disparities in vaccination rates and avoidable deaths. Any future agreement on equitable vaccine distribution must address ethical and practical issues to ensure global health equity and access. The proposed agreement should recognize healthcare as a human right and consider vaccines beyond mere commodities, emphasizing the social responsibility of pharmaceutical companies to prioritize affordability, availability, and accessibility, particularly for low-income countries (LICs). Voluntary licensing agreements are suggested as a means to enhance access to essential medicines. The paper also outlines the necessity of international cooperation, with robust compliance mechanisms, to effectively enforce such an agreement and mitigate future health crises.

Profits First, Health Second: The Pharmaceutical Industry and the Global South Comment on "More Pain, More Gain! The Delivery of COVID-19 Vaccines and the Pharmaceutical Industry's Role in Widening the Access Gap".

The pharmaceutical industry has a long history of prioritizing the research and sale of medicines that will yield the largest amount of revenue and placing the health of people second. This gap is especially prevalent in countries of the Global South. This article first explores the dichotomy in research between the Global North and the Global South and then looks at examples of how access to key medicines used in diseases such as HIV, oncology and hepatitis C is limited in the latter group of countries. The role of pharmaceutical companies during the COVID-19 pandemic prompted negotiations for a pandemic accord that would ensure more equity in both research and access when the next pandemic comes. However, efforts by a combination of the pharmaceutical industry and some high-income countries (HICs) are creating serious obstacles to achieving the goal of an accord that would place health over profits.

Evaluation of the strategies opioid manufacturers used to recruit health professionals and encourage overprescribing: an analysis of industry documents.

BACKGROUND: More than 263,000 individuals died due to prescription opioid misuse between 1999 and 2020. Between 2013 and 2015 alone, pharmaceutical companies spent over $39 million to market opioids to over 67,000 prescribers. However, there is still limited information about differences in provider responses to promotions for medications. In this study we investigated and evaluated strategies used by opioid manufacturers to encourage overprescribing, specifically focusing on oncology. METHODS: We conducted a retrospective review of opioid industry documents released in litigation between 1999 and 2021. We began with a preliminary search for business plans in a subset of collections that identified key terms and phrases. These search terms were then used to narrow the investigation, which ultimately focused on Insys Therapeutics, and how they targeted oncology providers as well as patients with cancer pain. RESULTS: We found that, overall, Insys sought to market to institutions with fewer resources, to less experienced and high-volume providers, and directly to cancer patients, with the goal of encouraging increased opioid prescribing and use. CONCLUSIONS: Our research revealed gaps in provider training that may make some providers more susceptible to pharmaceutical marketing. Developing and promoting continuing education courses for providers that are free from conflicts of interest, particularly at smaller institutions, may be one step towards reducing opioid overprescribing and its associated harms.

Phase IV Drug Trials With a Canadian Site: A Comparison of Industry-Funded and Non-Industry-Funded Trials.

Recent regulatory reforms have favored expedited drug marketing and increased reliance on Phase IV clinical trials for safety and efficacy assurance. This study, utilizing ClinicalTrials.gov, assesses the characteristics of Phase IV trials, with at least one site in Canada, examining those funded by industry sponsors and those lacking industry funding. Additionally, it compares the publication status of industry-funded and non-industry-funded trials through a manual review of the medical literature. Between 2000 and 2022, 864 Phase IV trials were completed, with 480 (55.6%) receiving industry funding and 384 (44.4%) funded solely by non-industry sources. Industry-funded clinical trials were larger (mean 204 enrollees versus 70), more likely to be international (57.7% versus 9.6%) and reported results more promptly (1.21 years after completion versus 1.85 years), yet both types shared similar designs, outcomes, and completion times. Publication rates were 81.8% for industry-funded and 65.8% for non-industry-funded trials. The ClinicalTrials. gov registry displayed 48 inaccuracies in publication associations, raising concerns about its accuracy. Our findings underscore the existing institutional limitations in ensuring comprehensive reporting and publication of Phase IV trial results funded by both industry and non-industry sources.

Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical Applications.

Stress testing (also known as forced degradation) of pharmaceutical drug substances and products is a critical part of the drug development process, providing insight into the degradation pathways of drug substances and drug products. This information is used to support the development of stability-indicating methods (SIMs) capable of detecting pharmaceutically relevant degradation products that might potentially be observed during manufacturing, long-term storage, distribution, and use. Assessing mass balance of stressed samples is a key aspect of developing SIMs and is a regulatory expectation. However, the approaches to measure, calculate, and interpret mass balance can vary among different pharmaceutical companies. Such disparities also pose difficulties for health authorities when reviewing mass balance assessments, which may result in the potential delay of drug application approvals. The authors have gathered input from 10 pharma companies to map out a practical review of science-based approaches and technical details to assess and interpret mass balance results. Key concepts of mass balance are introduced, various mass balance calculations are demonstrated, and recommendations on how to investigate poor mass balance results are presented using real-world case studies. Herein we provide a single source reference on the topic of mass balance in pharmaceutical forced degradation for small molecule drug substances and drug products in support of regulatory submissions with the goal of facilitating a shared understanding among pharmaceutical scientists and health authorities.

Detection of Pharmaceutical Personal Protective Equipment in Video Stream.

Pharmaceutical manufacturing is a complex process, where each stage requires a high level of safety and sterility. Personal Protective Equipment (PPE) is used for this purpose. Despite all the measures of control, human factor (improper PPE wearing) causes numerous losses for human health and material property. This research proposes solid computer vision system for ensuring safety in pharmaceutical laboratories. For this we have tested wide range of state-of-the-art object detection methods. Composing previously obtained results in this sphere with our own approach to this problem, we have reached the high accuracy (mAP@0.5) ranging from 0.77 up to 0.98 in detecting all the elements of common set of PPE used in pharmaceutical laboratories. Our system is the step towards safe medicine producing.

Reusable vs Single Use: what Are the Device Trade-Offs in Improving Sustainability.

As autoinjector requirements become increasingly diverse and pharma companies look for quicker routes to market, with lower costs and improved sustainability, there is an increasing trend towards devices with a reusable element. The flexibility in reusable elements can be beneficial for pharma companies with access to these platforms, allowing a relatively rapid transition between different drug combinations. However, it can also lead to devices designed to cover a wide range of requirements which are over designed for their actual more limited end use. The challenge of creating both a cost and sustainability optimised platform device is significantly harder than if developing a single use device with a specific purpose in mind. This paper looks at the range of reusable products on the market, examining some of the assertions around the cost and sustainability benefits of these devices as well as where there are trade-offs relative to current single use format devices.

Examining media's coverage of COVID-19 vaccines and social media sentiments on vaccine manufacturers' stock prices.

Introduction: The COVID-19 pandemic caused a widespread public health and financial crisis. The rapid vaccine development generated extensive discussions in both mainstream and social media, sparking optimism in the global financial markets. This study aims to explore the key themes from mainstream media's coverage of COVID-19 vaccines on Facebook and examine how public interactions and responses on Facebook to mainstream media's posts are associated with daily stock prices and trade volume of major vaccine manufacturers. Methods: We obtained mainstream media's coverage of COVID-19 vaccines and major vaccine manufacturers on Facebook from CrowdTangle, a public insights tool owned and operated by Facebook, as well as the corresponding trade volume and daily closing prices from January 2020 to December 2021. Structural topic modelling was used to analyze social media posts while regression analysis was conducted to determine the impact of Facebook reactions on stock prices and trade volume. Results: 10 diverse topics ranging from vaccine trials and their politicization (note: check that we use American spelling throughout), to stock market discussions were found to evolve over the pandemic. Although Facebook reactions were not consistently associated with vaccine manufacturers' stock prices, 'Haha' and 'Angry' reactions showed the strongest association with stock price fluctuations. In comparison, social media reactions had little observable impact on trading volume. Discussion: Topics generated reflect both actual events during vaccine development as well as its political and economic impact. The topics generated in this study reflect both the actual events surrounding vaccine development and its broader political and economic impact. While we anticipated a stronger correlation, our findings suggest a limited relationship between emotional reactions on Facebook and vaccine manufacturers' stock prices and trading volume. We also discussed potential technical enhancements for future studies, including the integration of large language models.

Research on the impact of technology mergers and acquisitions on corporate performance: an empirical analysis based on China's pharmaceutical industry.

There is intense competition among pharmaceutical companies with the rapid growth of the global pharmaceutical industry. In recent years, China has continuously increased the reform of the medical system. Technology mergers and acquisitions (M&A) in China's pharmaceutical industry have emerged in this complex policy and economic background. This paper conducts an empirical study from the dual perspectives of financial performance and innovation performance, based on unbalanced panel data of Chinese listed pharmaceutical firms from 2012 to 2022. The impact of technology M&A on firm performance is analyzed in terms of the heterogeneity of firm characteristics. Meanwhile, the relationship between R&D investment in technology M&A and firm performance is examined. The results show that technology M&A can promote the performance of pharmaceutical companies, and R&D investment has a mediating effect on the impact of technology M&A on corporate performance. Based on the above findings, this study enriches the relevant literature on technology M&A in the pharmaceutical industry, provides warnings and suggestions for pharmaceutical companies to improve corporate performance through technology M&A, and provides reference materials for future policy formulation.

NK model simulation study of intelligent manufacturing transformation path selection in pharmaceutical manufacturing enterprises.

Under the wave of Industry 4.0, traditional pharmaceutical manufacturing enterprises are in urgent need of intelligent manufacturing transformation and upgrading, and exploring the optimal realization path of intelligent manufacturing transformation can help accelerate the transformation process of pharmaceutical manufacturing enterprises. This paper uses grounded theory research methods to conduct a multi-case study to summarize six influencing factors of the intelligent manufacturing transformation of Chinese pharmaceutical manufacturing enterprises; and then analyzes the correlation between the intelligent manufacturing influencing factors based on the DEMATEL method and the NK model, and identifies the key influencing factors according to this, and then draws the fitness landscape map of the intelligent manufacturing transformation, and finally arrives at the optimal path selection of the intelligent manufacturing transformation of pharmaceutical manufacturing enterprises. The study enriches and extends the research paradigm of intelligent manufacturing transformation, and provides lessons for pharmaceutical manufacturing enterprises to realize intelligent manufacturing transformation and upgrading.