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The health and ecological harms created and spread by firms active in many unhealthy commodity industries (UCIs) have received considerable attention from the public health community. However, less focus has been paid to analysing the distribution of wealth and income – important social and economic determinants of health – by these industries. This study aimed to examine long-term trends in wealth and income distribution by publicly listed corporations active in four UCIs: fossil fuels; tobacco; ultra-processed foods; and alcohol. Quantitative analysis of a range of data was conducted for firms listed on stock exchanges in the United States (US). Wealth and income distribution metrics were analysed at the industry level, including effective corporate tax rates and shareholder value ratios. The equity ownership structures and investor location of 20 of the largest firms were also explored. Since the 1980s, US-listed firms in the examined UCIs have distributed much less of their wealth and income to governments and much more to shareholders and investors mostly based in high-income countries. The study provides evidence that firms active in UCIs create a 'double burden of maldistribution': their externalised social and ecological harms disproportionately affect disadvantaged population groups and governments in low- and middle-income countries; whilst, simultaneously, they are increasingly transferring wealth and income to a group over-represented by a small and privileged elite. The identified distributive injustice warrants increased policy attention. [ABSTRACT FROM AUTHOR]

There are various strategies to prevent and control of noise exposure in occupational settings. This study was aimed to use Shannon's entropy – PROMEHTEE hybrid model for weighing and prioritizing noise control solutions in an oil refinery. At first, the sound pressure levels were measured based on the recommended standard of ISO 9612. Next, criteria and noise control strategies were determined using the Delphi technique. In the third stage, the weights of the criteria were computed using Shannon's entropy method and in the last stage, the solutions were prioritized by the PROMEHTEE method. Based on the results of Shannon's entropy method, criteria in the order of priority included executive cost (0.2710), noise reduction efficiency (0.2531), feasibility (0.2435), safety (0.1120), possible interference with other processes (0.1107) and up-to-datedness of the methods (0.091). Also, based on the results of the PROMEHTEE method, the best solutions were construction of acoustic enclosures for people exposed to noise with a weight of 0.5476, and Modification or change of the work process with a weight of −0.6905, respectively. Therefore, the Shannon's entropy – PROMEHTEE hybrid method can be used as a credible scientific tool to select the most appropriate noise control solution in the industries. [ABSTRACT FROM AUTHOR]

The economic and social well‐being of rural, "resource‐cursed" communities can depend on the boom‐bust cycles of a single industry like oil and gas. This study used a constructivist, inductive approach to identify the challenges placed on families in one such community and the processes that strengthen family resilience. Semi‐structured interviews were conducted with 35 adult residents (30–76 years old, 19 women) from a community in Alberta, Canada, that has specialized in oil and gas extraction for 70 years and experienced its worst economic downturn while the study was underway. Results showed that many families have experienced an endless cycle of poor work–life balance and income instability throughout the economic cycle. Family life often lacked social cohesion as a consequence of demanding work schedules and economic pressures. Additional challenges were the perceived negative effects of rigid gender roles, substance abuse, family conflicts, and domestic violence. Crucial strengthening processes for family resilience were fundamental financial and living standard adaptations (e.g., living within or below one's economic means; having both spouses become earners), maintaining regular contact by having a flexible home routine, and mutually agreeing to change roles during busts (former earners take responsibility for caregiving and running of the household and vice versa). Alternatively, accepting economic volatility and its impact on normal family life processes were essential for family resilience. Findings suggest the need for clinicians to help families foster resilience in communities that depend on resource extraction industries with concurrent adaptations required by individuals, families, and socio‐political and economic systems. [ABSTRACT FROM AUTHOR]

Background: The rapidly increased spending on insulin is a major public health issue in the United States. Industry marketing might be one of the upstream determinants of physicians' prescription of long-acting insulin-the most commonly used and costly type of insulin, but the evidence is lacking. We therefore aimed to investigate the association between industry payments to physicians and subsequent prescriptions of long-acting insulin.Methods and Findings: Using the databases of Open Payments and Medicare Part D, we examined the association between the receipt of industry payments for long-acting insulin in 2016 and (1) the number of claims; (2) the costs paid for all claims; and (3) the costs per claim of long-acting insulin in 2017. We also examined the association between the receipt of payments and the change in these outcomes from 2016 to 2017. We employed propensity score matching to adjust for the physician-level characteristics (sex, years in practice, specialty, and medical school attended). Among 145,587 eligible physicians treating Medicare beneficiaries, 51,851 physicians received industry payments for long-acting insulin worth $22.3 million. In the propensity score-matched analysis including 102,590 physicians, we found that physicians who received the payments prescribed a higher number of claims (adjusted difference, 57.8; 95% CI, 55.8 to 59.7), higher costs for total claims (adjusted difference, +$22,111; 95% CI, $21,387 to $22,836), and higher costs per claim (adjusted difference, +$71.1; 95% CI, $69.0 to $73.2) of long-acting insulin, compared with physicians who did not receive the payments. The association was also found for changes in these outcomes from 2016 to 2017. Limitations to our study include limited generalizability, confounding, and possible reverse causation.Conclusions: Industry marketing payments to physicians for long-acting insulin were associated with the physicians' prescriptions and costs of long-acting insulin in the subsequent year. Future research is needed to assess whether policy interventions on physician-industry financial relationships will help to ensure appropriate prescriptions and limit overall costs of this essential drug for diabetes care. [ABSTRACT FROM AUTHOR]

Background. The current study aims to characterize and explore trends in Open Payments Database (OPD) payments reported to orthopaedic foot and ankle (F&A) surgeons. OPD payments are classified as General, Ownership, or Research. Methods. General, Ownership, and Research payments to orthopaedic F&A surgeons were characterized by total payment sum and number of transactions. The total payment was compared by category. Payments per surgeon were also assessed. Median payments for all orthopaedic F&A surgeons and the top 5% compensated were calculated and compared across the years. Medians were compared through Mann-Whitney U tests. Results. Over the period, industry paid over $39 million through 29,442 transactions to 802 orthopaedic F&A surgeons. The majority of this payment was General (64%), followed by Ownership (34%) and Research (2%). The median annual payments per orthopaedic F&A surgeon were compared to the 2014 median ($616): 2015 ($505; P = .191), 2016 ($868; P = .088), and 2017 ($336; P = .084). Over these years, the annual number of compensated orthopaedic F&A surgeons increased from 490 to 556. Averaged over 4 years, 91% of the total orthopaedic F&A payment was made to the top 5% of orthopaedic F&A surgeons. The median payment for this group increased from $177 000 (2014) to $192 000 (2017; P = .012). Conclusion. Though median payments to the top 5% of orthopaedic F&A surgeons increased, there was no overall change in median payment over four years for all compensated orthopaedic F&A surgeons. These findings shed insight into the orthopaedic F&A surgeon-industry relationship.Levels of Evidence:III, Retrospective Study. [ABSTRACT FROM AUTHOR]

Background: Financial payments from the drug industry to U.S. physicians are common. Payments may influence physicians' clinical decision making and drug prescribing.Purpose: To evaluate whether receipt of payments from the drug industry is associated with physician prescribing practices.Data Sources: MEDLINE (Ovid), Embase, the Cochrane Library, Web of Science, and EconLit were searched without language restrictions. The search had no limiting start date and concluded on 16 September 2020.Study Selection: Studies that estimated the association between receipt of industry payments (exposure) and prescribing (outcome).Data Extraction: Pairs of reviewers extracted the primary analysis or analyses from each study and evaluated risk of bias (ROB).Data Synthesis: Thirty-six studies comprising 101 analyses were included. Most studies (n = 30) identified a positive association between payments and prescribing in all analyses; the remainder (n = 6) had a mix of positive and null findings. No study had only null findings. Of 101 individual analyses, 89 identified a positive association. Payments were associated with increased prescribing of the paying company's drug, increased prescribing costs, and increased prescribing of branded drugs. Nine studies assessed and found evidence of a temporal association; 25 assessed and found evidence of a dose-response relationship.Limitation: The design was observational, 21 of 36 studies had serious ROB, and publication bias was possible.Conclusion: The association between industry payments and physician prescribing was consistent across all studies that have evaluated this association. Findings regarding a temporal association and dose-response suggest a causal relationship.Primary Funding Source: National Cancer Institute. [ABSTRACT FROM AUTHOR]

Diverse funding sources, including the government, nonprofit, and industry sectors support academic research, generally, and gambling research, specifically. This funding allows academic researchers to assess gambling-related problems in populations, evaluate tools designed to encourage responsible gambling behaviors, and develop evidence-based recommendations for gambling-related topics. Some stakeholders have raised concern about industry-funded research. These critics argue that industry funding might influence the research process. Such concerns have led to the development of research guidelines that aim to preserve academic independence. Concurrently and independently, researchers have begun to embrace 'Open Science' practices (e.g. pre-registration of research questions and hypotheses, open access to materials and data) to foster transparency and create a valid, reliable, and replicable scientific literature. We suggest that Open Science principles and practices can be integrated with existing guidelines for industry-funded research to ensure that the research process is ethical, transparent, and unbiased. In the current paper, we engage with the aforementioned issues and present a formal framework to guide industry-funded research. We outline Guidelines for Research Independence and Transparency (GRIT), which integrates Open Science practices with existing guidelines for industry-funded research. Specifically, we describe how particular Open Science practices can enhance industry-funded research, including research pre-registration, separation of confirmatory and exploratory analyses, open materials, open data availability, and open access to study manuscripts. We offer our guidelines in the context of industry-funded gambling studies, yet researchers can extend these ideas to the behavioral sciences, more generally, and to funding sources of any type. [ABSTRACT FROM AUTHOR]

Enormous progress has been made in the field of rheumatology in the past several decades, historically led by publicly funded academic innovators but in more recent times with much greater involvement of the pharmaceutical industry. This shift in resources has created a complex new model for reinvestment in the medical community in which the vast majority of private funds are redirected towards influencing the prescription behaviour of practitioners through 'key opinion leaders', with the main purpose of enhancing and perpetuating profit rather than innovation and critical thinking, and often at the expense of partnerships with scientists (that is, basic and translational researchers) and academic collaborations. This new episteme brings multiple opportunities to rethink approaches to sustaining long-term critical research in the field, ultimately maximizing the return on investment: scientific knowledge for the benefit of patients and society. Central to such strategies should be the rebalancing of academia-industry partnerships towards academic research and the involvement of 'innovation and knowledge leaders', rather than mostly key opinion leaders. [ABSTRACT FROM AUTHOR]

Purpose: The Open Payments transparency program publishes data on industry-physician payments, in part to discourage relationships considered inappropriate including gifts, meals, and speaker's bureau fees. We evaluated trends in physician-level payments to test whether implementation of Open Payments resulted in fewer industry-radiation oncologist (RO) interactions or shifted interactions toward those considered more appropriate compared with medical oncologists (MOs) and other hospital-based physicians (HBPs).Methods and Materials: We performed a retrospective, population-based cohort study of practicing US ROs versus MOs and HBPs in 2014 matched to general (nonresearch) payments between 2014 and 2018. Trends in payments were analyzed and reported by nature of payment. Values of payments to ROs from the top 10 companies were identified.Results: From 2014 to 2018, 3379 (90.3%) ROs accepted 106,930 payments totaling $40.8 million. The per-physician number and value of payments was lower in radiation oncology than in medical oncology and higher than HBPs. The proportion of ROs accepting payments increased from 61.8% in 2014 to 64.2% in 2018; the proportion of MOs accepting payments decreased from 78.7% to 77.7%; and the proportion of HBPs decreased from 40.8% to 37.5%, respectively. The annual per-physician value and number of payments accepted by ROs and MOs increased. Payments in entertainment, meals, travel and lodging, and gifts increased among ROs and remained stable or decreased among MOs and HBPs. Consulting payments increased across all groups. Top RO payors produced novel cancer therapeutics, hydrogel spacers, radiation treatment machines, and opioids.Conclusions: Industry payments to ROs have become more common since OP's inception, while becoming less common for MOs and HBPs. Payments to ROs and MOs have become more frequent and of modestly increasing value compared with other HBPs, for whom the value is decreasing. No large changes in the nature of relationships were seen in ROs. Increased engagement with financial conflicts of interest is needed in radiation oncology. [ABSTRACT FROM AUTHOR]

We analysed Open Payments programme data (https://openpaymentsdata.cms.gov) on industry‐to‐physician payments to hospitalists for the years 2014 to 2018. Payments to hospitalists increased by 106.5% from 2014 to 2018 with food and beverage (38.5%) and compensation for services other than consulting (24.3%) being the highest‐paid categories. Industry payment to hospitalists was highly skewed with top 10 hospitalists receiving more than 30% of the total payments during the study period. The most common drugs associated with payments were anticoagulant medications (apixaban and rivaroxaban). Industry seems to be spending a significant amount of money to increase awareness of medications among hospitalists. Identification of these trends and potential motives of industry spending is critical to address any potential physician bias. [ABSTRACT FROM AUTHOR]

This study uses Medicare Open Payments data to characterize trends in the prevalence and value of physicians' interactions with industry overall and by specialty between January 2014 and December 2018 after implementation of the federal Open Payments transparency program in 2013. [ABSTRACT FROM AUTHOR]

The article focuses on the decision of the U.S. District Court in the case In re Insulin Pricing Litigation on federal claims under the Racketeer Influenced and Corrupt Organizations Act (RICO). It mentions court ruled that patients who need insulin cannot seek damages from the insulin manufacturers for price inflation and insulin pricing structure and the parties involved. It also mentions antitrust and RICO standing doctrines based on proximate cause sufficiently address the policy concerns.

Background: The competition for and market dynamics of generic medicines can be understood by analyzing manufacturers' behavior. In this study, we analyzed the various types of generic atorvastatin and rosuvastatin that were introduced onto the South Korean market from 2002 to 2018 and their corresponding manufacturers. Methods: Based on publicly available data, we selected drugs containing atorvastatin and rosuvastatin as active ingredients for the analysis. We calculated the time between the date of marketing approval for the first generic and that of the remaining generics. Then, we categorized manufacturers that marketed generics into first movers and latecomers. Results: We confirmed that many manufacturers have marketed generic drugs in South Korea and that manufacturers can be categorized as first movers and latecomers. Interestingly, latecomers account for a large portion of the manufacturers of generics, and they have entered the market steadily, even after the market matured with a number of manufacturers. Additionally, the characteristics of the manufacturers were closely related to manufacturers' behaviors in the market. Conclusions: The order-of-entry effect, which is commonly observed in other markets, is marginal in the South Korean market, and this phenomenon is mainly explained by the rare price competition among generic manufacturers. [ABSTRACT FROM AUTHOR]

Manufacturing companies operate in increasingly turbulent and discontinuous environments. Uncertain projections regarding future sales, large volume fluctuations, the steady advance of new technologies, and ever-shorter product life cycles, combined at the same time with increasing product variety, demand the constant adjustment of production structures to meet the current market requirements. Uncertainty in the production area requires a continuous transformation of production structures to meet the current requirements on the market. This poses a challenge for manufacturers in the various branches of industry and creates an ever-increasing need for flexibility to find an economic balance, in times of tight budgets, between the prevailing market uncertainties and the correct arrangement of the production systems. In the following document, the applied experience is presented, extracted from the flexibility assessment tool economical flexibility measurement (ecoFLEX). It will be shown along with the practical experience gained in its application at a car-engines plant. [ABSTRACT FROM PUBLISHER]

Introduction: Health economics models are typically built in Microsoft Excel® owing to its wide familiarity, accessibility and perceived transparency. However, given the increasingly rapid and analytically complex decision-making needs of both the pharmaceutical industry and the field of health economics and outcomes research (HEOR), the demands of cost-effectiveness analyses may be better met by the programming language R.Objective: This case study provides an explicit comparison between Excel and R for contemporary cost-effectiveness analysis.Methods: We constructed duplicate cost-effectiveness models using Excel and R (with a user interface built using the Shiny package) to address a hypothetical case study typical of contemporary health technology assessment.Results: We compared R and Excel versions of the same model design to determine the advantages and limitations of the modelling platforms in terms of (i) analytical capability, (ii) data safety, (iii) building considerations, (iv) usability for technical and non-technical users and (v) model adaptability.Conclusions: The findings of this explicit comparison are used to produce recommendations for when R might be more suitable than Excel in contemporary cost-effectiveness analyses. We conclude that selection of appropriate modelling software needs to consider case-by-case modelling requirements, particularly (i) intended audience, (ii) complexity of analysis, (iii) nature and frequency of updates and (iv) anticipated model run time. [ABSTRACT FROM AUTHOR]

Keywords: alcohol; policy; delivery; COVID; online EN alcohol policy delivery COVID online 435 440 6 07/15/20 20200701 NES 200701 The COVID-19 pandemic is having an unprecedented impact on every aspect of our lives, including the way we drink alcohol. Risks associated with online alcohol sales and delivery With online sales and home delivery likely to continue to make up a considerable portion of the alcohol market in Australia for at least the next 3-6 months, it is worth considering the specific issues associated with this mode of alcohol supply. In a recent survey, one in five on-demand alcohol delivery service users reported that their motivation for using the service was because they were over the blood alcohol limit to drive, and 36% said that they would have had to stop drinking alcohol if the delivery service was not available [26]. [Extracted from the article]

Healthcare systems face challenges due to budget constraints, complex therapies, and new treatments for rare diseases. One of the most successful patient advocacy campaigns of all times was initiated by people living with HIV and AIDS in African countries. Facing industry giants, they won court cases allowing governments to ignore intellectual property rights when the price of a medicine was abnormally high. This led to the approval of the international 'Agreement on Trade Related aspects of Intellectual Property Rights', which contributed to improving the availability of AIDS treatments for millions of people. Beyond this successful patient advocacy campaign, patient organisations have an important role to play in national discussions on prices of treatments and pharmaceuticals, especially for rare diseases. This article first discusses the specificity of the pricing of orphan medicinal products, and then provides an overview of some of the important actions that can be carried out by patients' organisations. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the patterns of financial transaction between industry and urologists in the first 5 years of reporting in the Open Payments Program (OPP) by comparing transactions over time, between academic and nonacademic urologists, and by provider characteristics among academic urologists.Methods: The Center for Medicare & Medicaid Services OPP database was queried for General Payments to urologists from 2014-2018. Faculty at ACGME-accredited urology training programs were identified and characterized via publicly available websites. Industry transfers were analyzed by year, practice setting (academic vs nonacademic), provider characteristics, and AUA section. Payment nature and individual corporate contributions were also summarized.Results: A total of 12,521 urologists - representing 75% of the urology workforce in any given year - received $168 million from industry over the study period. There was no significant trend in payments by year (P = .162). Urologists received a median of $1602 over the study period, though 14% received >$10,000. Payment varied significantly by practice setting (P <.001), with nonacademic urologists receiving more but smaller payments than academic urologists. Among academic urologists, gender (P <.001), department chair status (P <.001), fellowship training (P <.001), and subspecialty (P <.001) were significantly associated with amount of payment from industry. Annual payments from industry varied significantly by AUA section.Conclusion: Reporting of physician-industry transactions has not led to a sustained decline in transactions with urologists. Significant differences in industry interaction exist between academic and nonacademic urologists, and values transferred to academic urologists varied by gender, chair status, subspecialty, and AUA section. [ABSTRACT FROM AUTHOR]

Background: Since ancient times, man has learned to use plants to obtain natural dyes, but this traditional botanical knowledge (TBK) is eroding. In the late, during, and the early 1800s, there was an increase in research related to dye species, and this allowed the development of industry and economy in rural contexts of Southern Italy. Today, dyes are mainly obtained from synthetic products, and this leads to risks for human health related to pollution. Methods: Starting from the literature, three catalogs of the dyeing species (plants, algae, fungi, and lichens) used in the Mediterranean Basin and mainly in Southern Italy have been created. Percentages of parts used and colors extracted from species have been recorded and analyzed. The plant species present in the catalogs have been verified in the territories of Southern Italy, and the data have been registered. An ethnobotanical survey was conducted, in the region of Southern Italy, to verify the erosion level of traditional botanical knowledge, linked to the ethnobotanical dyeing, over time. Results: A total of 524 species were recorded among plants, algae, fungi, and lichens, and related parts used and extracted pigments. Most uses concern the stems and leaves, and the most frequent color is yellow. From the on-field survey operations, 283 plant species have been verified. These represent 64.31% of the species reported in the flora of the dye plants produced. The results, from the ethnobotanical survey, show that only 8.6% of TBK remained in the collective memory. Conclusions: This catalog is among the largest in this sector and is the basis for studies related to the restoration of an eco-sustainable economy which would allow the development of marginal areas present throughout Southern Italy. [ABSTRACT FROM AUTHOR]

Introduction: Pharmaceutical research and development (R&D) is costly and only a minority of patients can access innovative medicines due to affordability constraints. Value-added medicines (VAMs) can offer potential benefits at significantly lower R&D costs.Areas Covered: VAMs may address different health care needs and problems, including off-label use of medicines, poor patient adherence, problems related to polypharmacy, need for home and/or personalized health care services. However, several barriers prevent societies from maximizing the benefits of incremental innovation related to VAMs. Generic manufacturers have limited budget and experience to demonstrate the value of new VAMs. Current market exclusivity options do not efficiently exclude freeridership and do not guarantee a return on investment for VAM innovators. Value propositions of VAMs are limitedly consistent with current HTA frameworks, consequently, incremental innovation is not acknowledged, nor rewarded with differential pricing by payers. Moreover, VAMs are often perceived solely as generic medicines by prescribers.Expert Opinion: Current practices may need to be reconsidered to exploit the full societal benefit of VAMs, including more efficient policies to guarantee market exclusivity for incremental innovation, acknowledgment of a fair price premium based on a specific value framework and the acceptance of low-cost evidence generation methods. [ABSTRACT FROM AUTHOR]

As U.S. policymakers consider strategies to control pharmaceutical spending, they can learn from France, which has stopped drug spending growth without slowing access to innovative medicines. France determines the comparative therapeutic value of new drugs. Insurance pays more for drugs superior to their comparator and the same or less for drugs offering modest or no improvement. Contracts require discounts for high sales volume and prohibit price increases. In addition, payers reduce prices of older drugs. Furthermore, Parliament sets an insurance pharmaceutical spending budget, and manufacturers pay clawbacks when spending exceeds the budget. France offers these lessons: setting prices based on added therapeutic value is a principled means to cap new drug prices and provides incentives for manufacturers to negotiate prices. Restricting formularies can help lower prices. Insurers can link prices and quantity to control spending and improper uses. Insurers can use global budgets to control spending and negotiate prices. Contracts can prevent manufacturers from raising prices after launch. External reference pricing can reduce price discrimination but is difficult to implement. Nations can ensure rapid access to new drugs while controlling prices. Regulation and competition are complementary strategies to control drug spending. [ABSTRACT FROM AUTHOR]

Importance: The mean cost of developing a new drug has been the subject of debate, with recent estimates ranging from $314 million to $2.8 billion.Objective: To estimate the research and development investment required to bring a new therapeutic agent to market, using publicly available data.Design and Setting: Data were analyzed on new therapeutic agents approved by the US Food and Drug Administration (FDA) between 2009 and 2018 to estimate the research and development expenditure required to bring a new medicine to market. Data were accessed from the US Securities and Exchange Commission, Drugs@FDA database, and ClinicalTrials.gov, alongside published data on clinical trial success rates.Exposures: Conduct of preclinical and clinical studies of new therapeutic agents.Main Outcomes and Measures: Median and mean research and development spending on new therapeutic agents approved by the FDA, capitalized at a real cost of capital rate (the required rate of return for an investor) of 10.5% per year, with bootstrapped CIs. All amounts were reported in 2018 US dollars.Results: The FDA approved 355 new drugs and biologics over the study period. Research and development expenditures were available for 63 (18%) products, developed by 47 different companies. After accounting for the costs of failed trials, the median capitalized research and development investment to bring a new drug to market was estimated at $985.3 million (95% CI, $683.6 million-$1228.9 million), and the mean investment was estimated at $1335.9 million (95% CI, $1042.5 million-$1637.5 million) in the base case analysis. Median estimates by therapeutic area (for areas with ≥5 drugs) ranged from $765.9 million (95% CI, $323.0 million-$1473.5 million) for nervous system agents to $2771.6 million (95% CI, $2051.8 million-$5366.2 million) for antineoplastic and immunomodulating agents. Data were mainly accessible for smaller firms, orphan drugs, products in certain therapeutic areas, first-in-class drugs, therapeutic agents that received accelerated approval, and products approved between 2014 and 2018. Results varied in sensitivity analyses using different estimates of clinical trial success rates, preclinical expenditures, and cost of capital.Conclusions and Relevance: This study provides an estimate of research and development costs for new therapeutic agents based on publicly available data. Differences from previous studies may reflect the spectrum of products analyzed, the restricted availability of data in the public domain, and differences in underlying assumptions in the cost calculations. [ABSTRACT FROM AUTHOR]

Importance: Understanding the profitability of pharmaceutical companies is essential to formulating evidence-based policies to reduce drug costs while maintaining the industry's ability to innovate and provide essential medicines.Objective: To compare the profitability of large pharmaceutical companies with other large companies.Design, Setting, and Participants: This cross-sectional study compared the annual profits of 35 large pharmaceutical companies with 357 companies in the S&P 500 Index from 2000 to 2018 using information from annual financial reports. A statistically significant differential profit margin favoring pharmaceutical companies was evidence of greater profitability.Exposures: Large pharmaceutical vs nonpharmaceutical companies.Main Outcomes and Measures: The main outcomes were revenue and 3 measures of annual profit: gross profit (revenue minus the cost of goods sold); earnings before interest, taxes, depreciation, and amortization (EBITDA; pretax profit from core business activities); and net income, also referred to as earnings (difference between all revenues and expenses). Profit measures are described as cumulative for all companies from 2000 to 2018 or annual profit as a fraction of revenue (margin).Results: From 2000 to 2018, 35 large pharmaceutical companies reported cumulative revenue of $11.5 trillion, gross profit of $8.6 trillion, EBITDA of $3.7 trillion, and net income of $1.9 trillion, while 357 S&P 500 companies reported cumulative revenue of $130.5 trillion, gross profit of $42.1 trillion, EBITDA of $22.8 trillion, and net income of $9.4 trillion. In bivariable regression models, the median annual profit margins of pharmaceutical companies were significantly greater than those of S&P 500 companies (gross profit margin: 76.5% vs 37.4%; difference, 39.1% [95% CI, 32.5%-45.7%]; P < .001; EBITDA margin: 29.4% vs 19%; difference, 10.4% [95% CI, 7.1%-13.7%]; P < .001; net income margin: 13.8% vs 7.7%; difference, 6.1% [95% CI, 2.5%-9.7%]; P < .001). The differences were smaller in regression models controlling for company size and year and when considering only companies reporting research and development expense (gross profit margin: difference, 30.5% [95% CI, 20.9%-40.1%]; P < .001; EBITDA margin: difference, 9.2% [95% CI, 5.2%-13.2%]; P < .001; net income margin: difference, 3.6% [95% CI, 0.011%-7.2%]; P = .05).Conclusions and Relevance: From 2000 to 2018, the profitability of large pharmaceutical companies was significantly greater than other large, public companies, but the difference was less pronounced when considering company size, year, or research and development expense. Data on the profitability of large pharmaceutical companies may be relevant to formulating evidence-based policies to make medicines more affordable. [ABSTRACT FROM AUTHOR]

Background: Recent studies in a number of surgical subspecialties have demonstrated that financial relationships with industry differ between men and women. This study aimed to determine if gender disparities exist in industry relationships with orthopaedic surgeons.Methods: This retrospective study utilized publicly available data from the Centers for Medicare & Medicaid Services (CMS) at OpenPayments.cms.gov. Data were extracted for payments made to orthopaedic surgeons from industry for royalties, licensing, or consulting fees from 2016 to 2017. A physician's profile was used to determine name, gender, practice location, and subspecialty. Years of experience were recorded from publicly available websites. Total number of payments and amounts were compared among men and women, subspecialties, and locations. Multivariable linear regression models were used to determine predictors of total payments and number of payments.Results: Royalties and consulting fees were paid to 3,418 individual physicians (11% of 29,996 physicians in the American Academy of Orthopaedic Surgeons [AAOS] census) and accounted for 88% of total payments. The majority of the total payment amount (99.6%) was made to men, while only 0.4% went to women. Male gender was a predictor of total number of payments (β = 5.17, p < 0.001), as were years of experience (β = 0.15 [95% confidence interval (CI): 0.10 to 0.20], p < 0.001), Mountain region (β = 2.77 [95% CI: 0.37 to 5.17], p = 0.02), and adult reconstructive subspecialty (β = 4.07 [95% CI: 1.89 to 6.25], p < 0.001). Years of experience (β = 0.046 [95% CI: 0.039 to 0.052], p < 0.001), male gender (β = 1.09 [95% CI: 0.67 to 1.51], p < 0.001), Mountain region (β = 0.35 [95% CI: 0.020 to 0.68], p = 0.04), and adult reconstructive subspecialty (β = 0.33 [95% CI: 0.030 to 0.63], p = 0.03) were associated with higher payments.Conclusions: Male gender, years of experience, Mountain region, and adult reconstructive subspecialty are independent predictors of a higher number of industry payments and payment amount. These disparities in industry payments may contribute to continued inequities in scholarship, academic rank, and leadership opportunities. [ABSTRACT FROM AUTHOR]

At the 2019 World Health Assembly, a significant new resolution was agreed by most countries to start publicly sharing information on the real net prices they pay for medicines in their health systems. The resolution also includes provisions for countries to support other transparency activities. However, an additional proposal to require pharmaceutical companies to submit information on their internal sales figures, internal research and development costs, clinical trial costs and marketing costs for each individual medicine as a condition of registration, and for governments to publish this, was not agreed. Pressure for coordinated international action to increase the transparency of medicine prices and costs has been building for some time, as confidential discounts and rebates on prices of medicines are common. We argue that while it is possible that stakeholders may benefit to some extent from greater transparency on prices, several important policy and economic issues need to be carefully considered. Such transparency, combined with widespread use of international reference pricing, might undermine companies' differential pricing strategies, which are important in fostering wider access to medicines in low- and middle-income countries in particular, noting that access to medicines issues can occur in high-income countries as well. Moreover, there is a further risk that these types of proposals will lead to price fixing, less competition and higher prices than might otherwise be the case. The lack of any commitments in the resolution to greater transparency in payer decision-making processes also risks undermining the credibility of the resolution. The resolution and further transparency measures could have the potential to undermine patient access to medicines in the developing world, lead to higher prices in some markets and compromise long-term development of new medicines for future generations. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Traditional drug payment schemes in Catalonia are generally based on the negotiation of fixed prices; however, disadvantages arise in the case of innovative therapies. Risk sharing agreements distribute potential health and economic uncertainties and high prices on access across the interested parts.Objectives: To identify, characterize and analyze current publicly available agreement reports signed by the Catalan Health Service and different pharmaceutical companies evaluating the current market access scene for new drugs in Catalonia.Methods: A database of agreements implemented between 2013 and 2018 was developed by using publicly available data. Data analysis was performed in a descriptive way, presenting summaries in datasheets.Results: A total of 7 managed entry agreements were analyzed. Two extensions regarding previous agreements were also taken into account. The main involved disease area is oncology (57%) and the most common length is 1 year, whereas the longest is 3 years.Conclusions: Managed entry agreements are gaining popularity and are viewed as positive schemes by stakeholders, payers and health services, leading to a general increase of accords during the last years. However, there are hardly any studies regarding the impact of RSA post-implementation, a field of great relevance regarding health policies. [ABSTRACT FROM AUTHOR]

We document market anticipation of merger bids and show that less anticipated bids earn significantly higher announcement returns. Subsequent bidders in the industry experience significant and positive abnormal returns around the time of initial industry bid announcements. These results suggest that announcement period returns underestimate the wealth effects of bidding. After accounting for anticipation, bidding activity is, on average, a significant wealth-creating event. Moreover, bidders pursuing public targets increase shareholder wealth and bidders in stock swaps do not lose. These results contradict conventional wisdom. Our results shed light on the correct magnitude of acquisition returns and on the transfer of information throughout an industry around the time of an economic shock. [ABSTRACT FROM PUBLISHER]

We apply structural equation models to longitudinal data on profits of firms within industries to study the persistence of abnormal returns. We obtain a two-way variance decomposition for abnormal returns: at firm vs. industry levels, and at permanent vs. transitory components. This decomposition enables us to assess the relative importance of the fundamental components of abnormal returns discussed in the literature. The method is applied to a panel of 5,000 Spanish firms observed over the period 1995–2000. We conclude that: (a) there are significant and permanent differences between profit rates at both industry and firm levels; (b) variation of abnormal returns at firm level is greater than at industry level; and (c) firm and industry levels do not differ significantly regarding rates of convergence of abnormal returns. Copyright © 2007 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: We investigated the relationship between companies' efforts to build internal (COH-INT) and external cultures of health (COH-EXT) and their stock performance.Design: We administered 2 surveys, which measure companies' programs, policies, and supports for improving the health of their employees and communities. We then compared the companies' stock performance to the Standard and Poor's (S&P) 500 Index from January 2013 through August 2017.Setting: United States.Participants: Representatives from 17 publicly traded companies who completed the COH-INT survey, of whom 14 also completed the COH-EXT.Measures: Culture of health scores were dichotomized into high versus low for both surveys. Stock price data for all companies were gathered from public sources.Analysis: We constructed 5 stock portfolios: all 17 companies, high COH-INT, low COH-INT, high COH-EXT, and low COH-EXT companies. We examined total returns for each portfolio compared to the S&P 500.Results: High COH-INT companies' stock price appreciated by 115% compared to the S&P benchmark (+69%), while low COH-INT companies appreciated only 43%. In contrast, high COH-EXT companies underperformed (+44%) when compared to the S&P 500 (+69%) and low COH-EXT companies (+89%).Conclusion: This study supports the view that employers' efforts to build an internal culture of health is a sound business strategy. More research is needed, however, to establish whether a link exists between supporting healthy community initiatives and company stock performance. [ABSTRACT FROM AUTHOR]

Spinal muscular atrophy (SMA) is the most common genetic cause of infant mortality. SMA is a spectral disorder and is categorised based on symptom onset and severity. The median life expectancy for infants with SMA presenting before 6 months of age is less than 2 years without respiratory support. To date, there is no cure for SMA. In June 2017, nusinersen was approved in Canada as the first disease-modifying drug for SMA because of its demonstrated benefits on motor function and survival in clinical trials. However, with a price tag of almost 1 million dollars for the first year of therapy, careful clinical, treatment-based and ethical consideration of the principles of (i) best interests; (ii) universality; (iii) portability; (iv) public administration; (v) accessibility; and (vi) comprehensiveness are important guideposts to ensure transparent and equitable allocation of health-care resources for nusinersen and all other future orphan drugs. [ABSTRACT FROM AUTHOR]

Importance: Manufacturers, companies, and health care professionals and organizations use an array of promotional activities to sell and increase market share of their products and services. These activities seek to shape public and clinician beliefs about laboratory testing, the benefits and harms of prescription drugs, and some disease definitions.Objective: To review the marketing of prescription drugs, disease awareness campaigns, health services, and laboratory tests and the related consequences and regulation in the United States over a 20-year period (1997-2016).Evidence: Analysis (1997-2016) of consumer advertising (Kantar Media data for spending and number of ads); professional marketing (IQVIA Institute for Human Data Science, Open Payments Data [Centers for Medicare & Medicaid Services]); regulations and legal actions of the US Food and Drug Administration (FDA), Federal Trade Commission (FTC), state attorneys general, and US Department of Justice; and searches (1975-2018) of peer-reviewed medical literature (PubMed), business journals (Business Source Ultimate), and news media (Lexis Nexis) for articles about expenditures, content, and consequences and regulation of consumer and professional medical marketing. Spending is reported in 2016 dollars.Findings: From 1997 through 2016, spending on medical marketing of drugs, disease awareness campaigns, health services, and laboratory testing increased from $17.7 to $29.9 billion. The most rapid increase was in direct-to-consumer (DTC) advertising, which increased from $2.1 billion (11.9%) of total spending in 1997 to $9.6 billion (32.0%) of total spending in 2016. DTC prescription drug advertising increased from $1.3 billion (79 000 ads) to $6 billion (4.6 million ads [including 663 000 TV commercials]), with a shift toward advertising high-cost biologics and cancer immunotherapies. Pharmaceutical companies increased DTC marketing about diseases treated by their drugs with increases in disease awareness campaigns from 44 to 401 and in spending from $177 million to $430 million. DTC advertising for health services increased from $542 million to $2.9 billion, with the largest spending increases by hospitals, dental centers, cancer centers, mental health and addiction clinics, and medical services (eg, home health). DTC spending on advertising for laboratory tests (such as genetic testing) increased from $75.4 million to $82.6 million, although the number of ads increased more substantially (from 14 100 to 255 300), reflecting an increase in less expensive electronic media advertising. Marketing to health care professionals by pharmaceutical companies accounted for most promotional spending and increased from $15.6 billion to $20.3 billion, including $5.6 billion for prescriber detailing, $13.5 billion for free samples, $979 million for direct physician payments (eg, speaking fees, meals) related to specific drugs, and $59 million for disease education. Manufacturers of FDA-approved laboratory tests paid $12.9 million to professionals in 2016. From 1997 through 2016, the number of consumer and professional drug promotional materials that companies submitted for FDA review increased from 34 182 to 97 252, while FDA violation letters for misleading drug marketing decreased from 156 to 11. Since 1997, 103 financial settlements between drug companies and federal and state governments resulted in more than $11 billion in fines for off-label or deceptive marketing practices. The FTC has acted against misleading marketing by a single for-profit cancer center.Conclusions and Relevance: Medical marketing increased substantially from 1997 through 2016, especially DTC advertising for prescription drugs and health services. Pharmaceutical marketing to health professionals accounted for most spending and remains high even with new policies to limit industry influence. Despite the increase in marketing over 20 years, regulatory oversight remains limited. [ABSTRACT FROM AUTHOR]

Differential pricing-manufacturers varying prices for on-patent pharmaceuticals across markets-can, in theory, lead to increased patient access and improved research and development (R&D) incentives compared with charging a uniform price across markets. Theoretical models of price discrimination and Ramsey pricing support differentials based inversely on price elasticities, which are plausibly related to average per capita income. However, these models do not address absolute price levels and dynamic efficiency. Value-based differential pricing theory incorporates insurance coverage and addresses static and dynamic efficiency. Limited empirical evidence indicates a weak positive relationship between prices and gross domestic product (GDP) per capita. External referencing and parallel trade undermine differential pricing. We discuss previously neglected factors that undermine differential pricing in practice. High price growth relative to GDP in the USA leads to widening differentials between the USA and other countries. Concerns over the effects of confidential rebating challenges acceptance of this approach to implementing price differentials. The growth of branded generics in low- and middle-income countries leads to complex markets with product and price differentiation. [ABSTRACT FROM AUTHOR]

Objectives: To develop and test a method for approximating generic entry of top-selling drugs.Methods: The procedure involved 1) identifying products' key patents as those with a patent term restoration extension (whenever relevant) or otherwise as the first expiring patent listed in the US Food and Drug Administration's patent register, 2) determining whether the key patent had been extended through an associated pediatric extension, 3) identifying other regulatory exclusivities associated with the drug, and 4) categorizing key patents as active ingredient (or extended) patents versus secondary patents. The accuracy and precision of the procedure's predictions were then tested against a database containing the timing of generic entry for 170 top-selling drugs that lost market exclusivity between 2000 and 2012, on the basis of Medicaid data.Results: Overall, the procedure predicted a median market exclusivity period of 12.5 years (interquartile range [IQR] 7.25-14.5) compared with the median actual period of 12.5 years (IQR 8.5-14.75 years). Among the 131 drugs (77%) with active ingredient patents, the median predicted market exclusivity was 12.25 years (IQR 7.5-14.5) compared with a median actual period of 13.0 years (IQR 10.0-14.75). Among the 38 (22%) drugs protected only by secondary patents, the median predicted market exclusivity was 16.0 years (IQR 6.75-19.5), but the median actual market exclusivity was only 8.25 years (IQR 6.25-13.5).Conclusions: The procedure approximated median actual exclusivity with reasonable accuracy and precision for drugs with active ingredient patents, but substantially overestimated exclusivity for drugs with only secondary patents. [ABSTRACT FROM AUTHOR]

The article focuses on challenges surrounding pricing of pharmaceutical industry. It mentions about impact of intersection between supply and demand on drug prices; regulation of pharmaceutical prices in Western European countries; and approach for pricing new and innovative drugs. It also mentions about the impact of economic competition on the same.

This study attempted to explain Bowman's risk-return paradox in terms of recent research in behavioral decision theory and prospect theory. The research emphasized the role of reference, or target, return levels in analyzing risky choices. For returns below target, a large majority of individuals appear to be risk seeking; for returns above target, a large majority appear to be risk averse. Using extensive COMPUSTAT-based data on U.S. firms, we consistently found a negative risk-return association for firms having returns below target levels and a positive association for firms with returns above target. These results support the basic propositions of prospect theory and are extremely robust within and across industries and for all time periods studied. [ABSTRACT FROM AUTHOR]

What happens when a simple, farming community suddenly becomes the site of a highly mechanized factory with an imported managerial force and the last word in employee comforts and production schedules is described here by the Professor of Commerce called in by a distraught management to help pick up the pieces after a bitter total strike. His observations dramatize not only the clash between two economies but ways and means by which management can make the difficult and delicate transition less painful for all concerned. [ABSTRACT FROM AUTHOR]

This study describes financial penalties levied on pharmaceutical companies for illegal activities by type of activity and dollar value between 2003 and 2016. [ABSTRACT FROM AUTHOR]

The increasing price of prescription drugs is an ongoing concern for Medicare and Medicaid, particularly for patients with chronic health conditions who are using multiple medications and patients in these programs taking high-priced brand-name specialty drugs. Shifts in benefit design, including higher deductibles and a movement away from copayments to coinsurance, have increased patient out-of-pocket costs and put pressure on program budgets. In this paper, the American College of Physicians expands on its position paper from 2016 and offers additional recommendations to decrease out-of-pocket costs for patients, enhance the government's purchasing power, and address existing policies that add costs to the health care system. [ABSTRACT FROM AUTHOR]