Financial payments made by pharmaceutical companies to the authors of Japanese hematology clinical practice guidelines between 2016 and 2017

Financial conflicts of interest (FCOI) between pharmaceutical companies and physicians may negatively impact patient care. This is particularly relevant regarding clinical practice guidelines (CPG), where FCOI may inappropriately influence individual drugs' promotion or use. In a cross-sectional analysis of pharmaceutical company payments, we sought to elucidate the extent of FCOI between Japanese hematologists and drug promotion in CPG. Data collected from two professional medical associations and companies belonging to the Japanese Pharmaceutical Manufacturers Association included the type and amount of company payments, individual financial disclosures, and new drug or indication approvals between 2015 and 2017. Of the 74 hematologists drafting CPG, 70 (94.6 %) received at least one payment during the study period. The cumulative median (interquartile range) value of these payments was $31,553 ($11,449-$74,390). Also, during this period, 26 new drugs or indications were approved and discussed in the CPG. Among the 79 pharmaceutical companies, the 11 (13.9 %) with newly approved and discussed drugs in the CPG made median (interquartile range) payments of $210,388 ($85,141-$292,536), while the remaining 68 (86.1 %) made $0 ($0-$9607) in payments. Disclosure of these payments was inconsistent. Such discrepancies suggest an association between pharmaceutical payments and drug approvals that only greater transparency can clarify. Consequently, a comprehensive overhaul of the current framework to control FCOI that includes legal regulation may be necessary.     

Evaluating the transparency of pharmaceutical company disclosure of payments to patient organisations in the UK

Patient organisations contribute to many areas of pharmaceutical policy. In developing their organisational capacity, many turn to financial support from pharmaceutical companies, which may create conflicts of interests. However, the transparency of the industry’s self-regulatory approach to the disclosure of payments to patient organisations has evaded scrutiny. Using company reports disclosing payments to UK patient organisations in 2012–2016, we evaluate the transparency of reporting using indicators derived from industry’s European patient organisation Code. We found a large proportion of companies did not have any disclosure reports available despite many having made payments, confirmed by comparing with annual financial accounts of patient organisations registered as charities. Where disclosure reports were available, many payments were not adequately described, resulting in large portions of money being disclosed without clarity as to the payment type and purpose. We found companies were clearer regarding whether payments were financial or benefits-in-kind, but transparency was particularly inadequate as to whether it could be determined if payments were indirect or direct and restricted or unrestricted, and almost no companies mentioned the VAT status of payments. Our findings suggest that the industry’s self-regulatory approach to transparency has not been working efficiently. We suggest ways for standardising and increasing the precision of information by pharmaceutical companies and advocate for the introduction of a centralised, and easily accessible national-level payment database.     

Responsiveness to physicians' requests for information concerning drug interactions: a comparison of brand and generic companies

Research-based pharmaceutical companies maintain that there are important differences between themselves and their generic competitors. Prominent among them is an alleged greater ability to provide accurate and rapid responses to requests from physicians for information about drug products. This study evaluates pharmaceutical company behavior with regard to these issues. Two drug-drug interactions were identified, along with all of the companies in Canada marketing any of the four drugs involved. Each company received a letter describing symptoms suggestive of an interaction in a patient taking its particular product and the relevant second drug. The companies were asked if they were aware of any evidence of an interaction involving the two drugs. They were also asked to provide references regarding the interaction. Responses were received from all companies contacted except one. There were no significant differences (in the hypothesized direction) between the generic and brand companies with regard to either the accuracy or promptness of the response, or the usefulness of the references cited. On the contrary, generic firms were markedly quicker to respond than were brand manufacturers. The latter were slightly more likely to acknowledge evidence of an adverse drug interaction, and to provide useful references to relevant published research.     

The impact of the 2008/2009 financial crisis on specialist physician activity in Canada

Fee‐for‐service physicians are responsible for planning for their retirements, and there is no mandated retirement age. Changes in financial markets may influence how long they remain in practice and how much they choose to work. The 2008 crisis provides a natural experiment to analyze elasticity in physician service supply in response to dramatic financial market changes. We examined quarterly fee‐for‐service data for specialist physicians over the period from 1999/2000 to 2013/2014 in Canada. We used segmented regression to estimate changes in the number of physicians receiving payments, per‐physician service counts, and per‐physician payments following the 2008 financial crisis and explored whether patterns differed by physician age. The number of specialist physicians increased more rapidly in the period since 2008 than in earlier years, but increases were largest within the youngest age group, and we observed no evidence of delayed retirement among older physicians. Where changes in service volume and payments were observed, they occurred across all ages and not immediately following the 2008 financial crisis. We conclude that any response to the financial crisis was small compared with demographic shifts in the physician population and changes in payments per service over the same time period.     

Reverse payments,patent strength,and asymmetric information

Reverse payments (pay‐for‐delay) are payments from an originator to a generic pharmaceutical producer to settle a potential litigation. In many jurisdictions, these payments are banned. This study shows that when the parties' investments are considered and the information about the patent strength is asymmetric, reverse payments increase both the possibility of generic entry and the litigation rate—both of which increase consumer surplus and do not necessarily delay generic entry. Reverse payments typically increase consumer surplus when the asymmetry between the parties is low, the competitiveness in the market is soft, and their size is small. Results suggest that a ban per se may be suboptimal.     

The state and results of countermeasures for mental health at a certain apparel company]

We speculated that there would be more occupational stress in an apparel company than in other areas of business, because employees work long hours and under poor conditions. We investigated 66 employees of an apparel company who visited an occupational physician to consult about their mental health. There were 561 male and 387 female employees in that company. The employees who had visited an occupational physician had worked long every day under poor conditions, and they had been required to be more artistic than other employees in that company. Female employees visited occupational physicians more than males. Apparel companies, use a system of "specialty store retailer of Private-label Apparel (SPA)", and several sections make special trademark "brands". These sections compete with each other. Employees must plan, design, make patterns, and sew new dresses in a 7-day cycle. They are extremely busy and this therefore creates stress. We came to the conclusion that many apparel companies were stressful workplaces. It is important that a psychiatrist examines employees who occupational physicians have diagnosed as unhealthy. Frequent consultation with occupational physicians is as important as a psychiatrists examination. Managers must manage absence, efficiency, and written correspondence of all employees. These are useful signs of mental disorder. When employees return to work after sick leave, rehabilitation in the workplace after absence is useful. The employee should work for only two hours a day at first. Working hours are then extended gradually. The employee can then return to work easily if this rehabilitation program is followed.     

Practicing research ethics: private-sector physicians & pharmaceutical clinical trials

This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first on historical studies of physicians as investigators and then on 12 months of qualitative fieldwork in the Southwestern US, this paper analyzes the shifting, contextualized ethics that shape physicians' relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities.     

Hospital-physician collaboration: landscape of economic integration and impact on clinical integration

Context: Hospital‐physician relationships (HPRs) are an important area of academic research, given their impact on hospitals' financial success. HPRs also are at the center of several federal policy proposals such as gain sharing, bundled payments, and pay‐for‐performance (P4P). Methods: This article analyzes the HPRs that focus on the economic integration of hospitals and physicians and the goals that HPRs are designed to achieve. It then reviews the literature on the impact of HPRs on cost, quality, and clinical integration. Findings: The goals of the two parties in HPRs overlap only partly, and their primary aim is not reducing cost or improving quality. The evidence base for the impact of many models of economic integration is either weak or nonexistent, with only a few models of economic integration having robust effects. The relationship between economic and clinical integration also is weak and inconsistent. There are several possible reasons for this weak linkage and many barriers to further integration between hospitals and physicians. Conclusions: Successful HPRs may require better financial conditions for physicians, internal changes to clinical operations, application of behavioral skills to the management of HPRs, changes in how providers are paid, and systemic changes encompassing several types of integration simultaneously.     

Recent trends in expenditures on physicians' services in Canada

Analysis of Canada's restraints on the growth in volume of physicians' services can help shape the framework and direction of policy development in other countries. This paper analyzes trends in recent expenditures on physicians' services in Canada from 1982 to 1987. Growth in payments to physicians who were paid fee-for-service is broken down into three component parts in Canada nationwide and in four provinces: Ontario, Quebec, Nova Scotia and British Columbia. The three component parts are: (1) growth in the number of services billed; (2) physician service prices; and (3) the mixture of high- and low-priced services billed. Expenditure increases are disaggregated according to some major categories of medical services, both per physician and per capita. Increases in growth in physician payments were explained mainly by increases in prices, while some evidence of an increase in higher priced services per physician was found. The varying payment restraint policies across Canadian provinces were manifested in different patterns with respect to components of payment change. Higher rates of payment and volume growth were found for diagnostic/therapeutic and office medical services than for surgeries, although a few contrary patterns across provinces occurred. Interprovincial utilization growth, both per physician and per capita, was variable. This suggests that Canada's regionally administered system is neither uniform nor monolithic.     

Vulnerabilities to misinformation in online pharmaceutical marketing

Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users’ vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain.     

PRICING DISTORTIONS IN MEDICARE'S PHYSICIAN FEE SCHEDULE AND PATIENT SATISFACTION WITH CARE QUALITY AND ACCESS

Medicare adjusts its payments to physicians for geographic differences in the cost of operating a medical practice, but the method it uses is imprecise. We measure the inaccuracy in its geographic adjustment factors and categorize beneficiaries by whether they live where Medicare's formula is favorable or unfavorable to physicians. Then, using the 2001–2003 Medicare Current Beneficiary Survey, we examine whether differences in physician payment generosity, that is, whether favorable or unfavorable, influence the satisfaction ratings Medicare seniors assign to their quality of care and access to services. We find strong evidence that they do. Many beneficiaries live in payment‐unfavorable areas and receive a less satisfying quality of care and less satisfying access to services than beneficiaries who live where payments are favorable to physicians. Copyright © 2013 John Wiley & Sons, Ltd.     

Ongoing pharmaceutical reforms in France

The rapid rise in pharmaceutical costs in France has been driven by new technologies and the growing prevalence of chronic diseases as well as considerable prescribing freedom and choice of physician among patients. This has led to the introduction of a number of reforms and initiatives in an attempt to moderate expenditure whilst ensuring universal coverage and rewarding innovation. These reforms include accelerating access to and granting average European prices for new innovative drugs, delisting drugs where there are concerns over their value and instigating rebates for excessive prescribing. Alongside this, ongoing initiatives to improve the quality and efficiency of prescribing include programmes to enhance generic prescribing and dispensing as well as to reduce antibacterial and anxiolytic/hypnotic prescribing. However, there have been few publications documenting the impact of specific reforms on the overall costs and quality of care, which have been exacerbated by compartmentalization of budgets. Estimates suggest savings of over €27 million/year by decreasing antibacterial prescribing, €450 million/year by not reimbursing ineffective drugs, €670 million/year from pharmaceutical company rebates and approximately €1 billion/year from increased prescribing and dispensing of generics (year 2003–7 values). Additional savings of at least €1.5 billion/year are seen as being possible from increased use of generics such as generic proton pump inhibitors, statins (HMG-CoA reductase inhibitors) and ACE inhibitors instead of current branded products such as angiotensin II type 1 receptor antagonists (angiotensin receptor blockers [ARBs]). Delisting drugs when there are concerns about their value provides an example to other countries with currently limited demand-side measures. Other possible examples include price : volume agreements and multifaceted campaigns to enhance generic prescribing and dispensing and reduce antibacterial prescribing. Possible future initiatives could include adopting more stringent criteria for categorizing new drugs as innovative as well as further reductions in the prices of generics. Other initiatives could include further enhancement of the quality and efficiency of prescribing, including formal auditing of physician prescribing, as well as increasing efforts to monitor the risk : benefit ratio of new drugs post-launch in real-world practice.     

The impact of generic goods in the pharmaceutical industry.

This paper studies the effects of generic drugs in the pharmaceutical industry. Two firms produce two branded goods, with a different active ingredient, and the patent for one of them has expired, so that a generic alternative is in the market. This paper focuses on the case where the branded goods are perfect substitutes and where there exists a degree of differentiation between the branded and the generic goods. The study looks at whether the firm producing the branded good whose patent has expired has incentives to produce its own generic alternative too. For this purpose, the scenario where the firm producing the branded good also produces the generic drug is compared with the situation where the generic good is produced by a third firm. It is found that the firm producing the branded good has incentives to produce its generic alternative, owing to a market segmentation effect. This induces an increase in the price of the branded good produced by this firm, which in turn implies a welfare reduction.