Medicines prices in International (Geary-Khamis) Dollar. The comparison between regulated and deregulated markets.

BACKGROUND: Affordability of medicines is key for effective healthcare. Thus, we compared medicine prices using International Dollar (I$), which allows confronting the values of different currencies. Besides, we intended to verify if pharmaceutical market deregulation leads to lower medicines prices. MATERIALS AND METHODS: We conducted the study between December 2019 and September 2022 collecting data from 21 countries. From the preliminary sampling of 30 medicines, we selected 10 brand names (5 Rx and 5 OTC brands) for the analysis. In each country, we collected price information from 3 pharmacies and then converted them to the I$ using the rates published by the International Monetary Fund. RESULTS: There were differences between regulated and deregulated markets in prices presented in I$. For instance, Aspirin C® (10 soluble pills) was on average I$ 5.41 in Finland (regulated market) and I$ 13.25 in Brazil. The most expensive Xarelto® 20 x 28 pills (I$ 538.40) was in Romania, which in the case of other medicines, was in the group of cheaper countries. There was no statistical significance in price comparison between regulated and deregulated markets. In some cases, however, regulated markets offered lower prices of the same medicine than deregulated markets. CONCLUSION: The analysis revealed differences in I$ prices between countries. Pharmaceutical market regulation does not mean higher prices of medicines. There is a need for affordable medicines. Hence, decision-makers should work on the medicines prices and adjust them to the local economies. I$ could be important in creating pharmaceuticals prices, and the conducted study should encourage other researchers to present their results using this currency.

Cross-sectional analysis of pharmaceutical industry payments to authors of clinical practice guidelines for bipolar disorder and major depressive disorder in Japan.

OBJECTIVE: Clinical practice guidelines (CPGs) are essential for standardising patient care based on evidence-based medicine. However, the presence of financial conflicts of interest (COIs) among CPG authors can undermine their credibility. This study aimed to examine the extent and size of COIs among authors of psychiatry CPGs in Japan. METHODS: This cross-sectional analysis of disclosed payments from pharmaceutical companies assesses the prevalence and magnitude of personal payments for lecturing, consulting and writing to CPGs for bipolar disorder and major depressive disorder in Japan between 2016 and 2020. RESULTS: This study found that 93.3% of authors received payments over a 5-year period, with total payments exceeding US$4 million. The median payment per author was US$51 403 (IQR: US$9982-US$111 567), with a notable concentration of payments among a small number of authors, including the CPG chairperson. Despite these extensive financial relationships, only a fraction of authors disclosed their COIs in the CPGs. These large amounts of personal payments were made by pharmaceutical companies manufacturing new antidepressants and sleeping aids listed in the CPGs. CONCLUSIONS: This study found that more than 93% of authors of CPGs for major depressive disorder and bipolar disorder in Japan received considerable amounts of personal payments from the pharmaceutical industry. The findings highlight deviations from international COI management standards and suggest a need for more stringent COI policies for psychiatry CPGs in Japan.

Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis.

We aim to characterize industry-funded trials that have posted the informed consent forms (ICFs), and to assess whether the role played by industry as 'sponsor' or 'collaborator' could impact several relevant variables. A cross-sectional study was conducted on ClinicalTrials.gov on all industry-funded trials registered on or before 25 February 2023. We registered types of intervention, current recruitment status, design, enrollment, and countries involved. For trials with special interest to potential participants and investigators and/or clinicians an analysis of the role played by industry as 'sponsor' or 'collaborator' was performed. Of 116,281 industry-funded trials registered, 741 (0.6%) had posted ICFs. Most of these trials were categorized as 'completed' (n = 408) or 'terminated' (n = 107). The review of a sample of 359 trials showed that most were on drugs and/or biologics (59%), were randomized (51%), conducted exclusively in the USA (72%), and had posted results (79%), protocols (92%), and statistical analysis plans (SAPs) (89%). Trials in which industry participated as 'collaborator' were significantly more likely to post ICFs when trials were in the 'active, not recruiting' phase (OR 4.70, 99.71% CI 1.59-13.9, p < 0.001) than industry-sponsored trials. This was also the case when assessing drugs/biologics (OR 2.64, 99.71% CI 1.25-5.58, p < 0.001). Conversely, companies acting as 'sponsors' were significantly more likely to post ICFs with trials assessing devices, radiation interventions and/or diagnostic tests (OR 0.37, 99.71% CI 0.17-0.79, p < 0.001) than when participating as 'collaborators'. While industry-funded trials rarely post ICFs, when they do, they are highly compliant with transparency requirements. Regulations and ethics codes should consider requiring posting of protocols, SAPs, and ICFs for all clinical trials, regardless the type of sponsor.

Patient-Level Savings on Generic Drugs Through the Mark Cuban Cost Plus Drug Company.

This economic evaluation estimates the out-of-pocket cost savings patients could achieve if generic drugs were purchased directly from the Mark Cuban Cost Plus Drug Company rather than using their health insurance.

Trends in financial payments from industry to US cancer centers, 2014-2021.

BACKGROUND: Industry payments to US cancer centers are poorly understood. METHODS: US National Cancer Institute (NCI)-designated comprehensive cancer centers were identified (n = 51). Industry payments to NCI-designated comprehensive cancer centers from 2014 to 2021 were obtained from Open Payments and National Institutes of Health (NIH) grant funding from NIH Research Portfolio Online Reporting Tools (RePORT). Given our focus on cancer centers, we measured the subset of industry payments related to cancer drugs specifically and the subset of NIH funding from the NCI. RESULTS: Despite a pandemic-related decline in 2020-2021, cancer-related industry payments to NCI-designated comprehensive cancer centers increased from $482 million in 2014 to $972 million in 2021. Over the same period, NCI research grant funding increased from $2 481  million to $2 724  million. The large majority of nonresearch payments were royalties and licensing payments. CONCLUSION: Industry payments to NCI-designated comprehensive cancer centers increased substantially more than NCI funding in recent years but were also more variable. These trends raise concerns regarding the influence and instability of industry payments.

Quantifying Industry Spending on Promotional Events Using Open Payments Data.

Importance: Sponsorship of promotional events for health professionals is a key facet of marketing campaigns for pharmaceuticals and medical devices; however, there appears to be limited transparency regarding the scope and scale of this spending. Objective: To develop a novel method for describing the scope and quantifying the spending by US pharmaceutical and medical companies on industry-sponsored promotional events for particular products. Design and Setting: This was a cross-sectional study using records from the Centers for Medicare & Medicaid's Open Payments database on payments made to prescribing clinicians from January 1 to December 21, 2022. Main Outcomes and Measures: An event-centric approach was used to define sponsored events as groupings of payment records with matching variables. Events were characterized by value (coffee, lunch, dinner, or banquet) and number of attendees (small vs large). To test the method, the number of and total spending for each type of event across professional groups were calculated and used to identify the top 10 products related to dinner events. To validate the method, we extracted all event details advertised on the websites of 4 state-level nurse practitioner associations that regularly hosted industry-sponsored dinner events during 2022 and compared these with events identified in the Open Payments database. Results: A total of 1 154 806 events sponsored by pharmaceutical and medical device companies were identified for 2022. Of these, 1 151 351 (99.7%) had fewer than 20 attendees, and 922 214 (80.0%) were considered to be a lunch ($10-$30 per person). Seven companies sponsored 16 031 dinners for the top 10 products. Of the 227 sponsored in-person dinner events hosted by the 4 state-level nurse practitioner associations, 168 (74.0%) matched events constructed from the Open Payments dataset. Conclusions and Relevance: These findings indicate that an event-centric analysis of Open Payments data is a valid method to understand the scope and quantify spending by pharmaceutical and medical device companies on industry-sponsored promotional events attended by prescribers. Expanding and enforcing the reporting requirements to cover all payments to all registered health professionals would improve the accuracy of estimates of the true extent of all sponsored events and their impact on clinical practice.

Costs of Drug Development and Research and Development Intensity in the US, 2000-2018.

Importance: Understanding the cost of drug development can help inform the development of policies to reduce costs, encourage innovation, and improve patient access to drugs. Objective: To estimate the cost of drug development by therapeutic class and trends in pharmaceutical research and development (R&D) intensity over time. Design, Setting, and Participants: In this economic evaluation study, an analytical model of drug development constructed using public and proprietary sources that collectively cover data from 2000 to 2018 was used to estimate the cost of bringing a drug to market, overall and for specific therapeutic classes. The analysis for the study was completed in October 2020. Main Outcomes and Measures: Three measures of development cost from nonclinical through postmarketing stages were estimated: mean out-of-pocket cost or cash outlay, mean expected cost, and mean expected capitalized cost. Pharmaceutical R&D intensity, defined as the ratio of R&D spending to total sales, from 2008 to 2019, based on the time frame for available data, was also analyzed. Results: The estimated mean cost of developing a new drug was approximately $172.7 million (2018 dollars) (range, $72.5 million for genitourinary to $297.2 million for pain and anesthesia), inclusive of postmarketing studies. The cost increased to $515.8 million when cost of failures was included. When the costs of failures and capital were included, the mean expected capitalized cost of drug development increased to $879.3 million (range, $378.7 million for anti-infectives to $1756.2 million for pain and anesthesia); results varied widely by therapeutic class. The pharmaceutical industry as a whole experienced a decline of 15.6% in sales but increased R&D intensity from 11.9% to 17.7% from 2008 to 2019. By contrast, R&D intensity of large pharmaceutical companies increased from 16.6% to 19.3%, whereas sales increased by 10.0% (from $380.0 to $418.0 billion) over the same 2008 to 2019 period, even though the cost of drug development remained relatively stable or may have even decreased. Conclusions and Relevance: In this economic evaluation of new drug development costs, even though the cost of drug development appears to have remained stable, R&D intensity of large pharmaceutical companies remained relatively unchanged, despite substantial growth in revenues during this period. These findings can inform the design of drug-related policies and their potential impacts on innovation and competition.

Industry Payments to Physicians Endorsing Drugs and Devices on a Social Media Platform.

This study evaluates adherence to industry and professional standards among physicians endorsing drugs and devices on a social media platform.

Pharmaceutical company payments to NHS trusts.

Overview of: Ozieranski P, Saghy E, Mulinari S. Pharmaceutical industry payments to NHS trusts in England: a four-year analysis of the Disclosure UK database. PLoS One 2023;18:e0290022.

Drug Promotions Between Ethics, Regulations, and Financial Interests.

BACKGROUND: The promotion of the latest medicines produced by the pharmaceutical industry is an important issue both from an ethical point of view (the level of accessibility, the way research is carried out) and from the point of view of marketing and especially from the lobbying issues raised. AREAS OF UNCERTAINTY: The ethical dilemmas raised by the promotion of new drugs revolve between the need to discover new molecules important for treating a wide range of diseases and the need to establish a battery of ethical rules, absolutely necessary for regulations in the field to be compliant with all ethical principles. DATA SOURCES: A literature search was conducted through PubMed, MEDLINE, Plus, Scopus, and Web of Science (2015-2023) using combinations of keywords, including drugs, medical publicity, and pharma marketing plus ethical dilemma. ETHICS AND THERAPEUTIC ADVANCES: The promotion of medicines is governed by advertising laws and regulations in many countries, including at EU level, based on the need for countries to ensure that the promotion and advertising of medicines is truthful, based on information understood by consumers. The ethical analysis of the issues raised is more necessary and complex as the channels used for promotion are more accessible to the population, and the information, easier to obtain, can be the cause of increased self-medication and overeating. Large amounts of money invested in the development of new molecules, but also the risk of scientific fraud through manipulation of data during clinical trials, selective or biased publication of information can have repercussions on the health of the population. CONCLUSIONS: The development of new pharmaceutical molecules is necessary to intervene and treat as many conditions as possible, but marketing must not neglect the observance of ethical principles. The promotion of medicines should be the attribute especially of the medical staff, which should also be a mandatory part of the mechanism for approving the marketing methods and means used by the pharmaceutical companies.

Trends in Industry-Sponsored Research Payments to Physician Principal Investigators.

This cohort study investigates trends in total and per-physician industry-sponsored research payments to physician principal investigators from 2015 to 2022.

The cost of influence: How gifts to physicians shape prescriptions and drug costs.

This paper investigates the influence of gifts - monetary and in-kind payments - from drug firms to US physicians on prescription behavior and drug costs. Using causal models and machine learning, we estimate physicians' heterogeneous responses to payments on antidiabetic prescriptions. We find that payments lead to increased prescription of brand drugs, resulting in a cost rise of $23 per dollar value of transfer received. Paid physicians show higher responses when they treat higher proportions of patients receiving a government-funded low-income subsidy that lowers out-of-pocket drug costs. We estimate that introducing a national gift ban would reduce diabetes drug costs by 2%.

How Labor Costs Affect Innovation Output in Pharmaceutical Companies: Evidence from China.

Existing literature generally suggests that rising labor costs lead to the substitution of capital for labor, prompting firms to save on labor costs through technological upgrades. However, as a typical human capital-intensive industry, the pharmaceutical sector finds it challenging to replace labor with capital through the introduction of advanced equipment. Therefore, compared to other industries, the pharmaceutical sector faces greater adverse impacts. Research on how pharmaceutical R&D behavior is influenced by labor costs is scarce. This paper analyzes the triple effects of rising labor costs on corporate innovation from the perspectives of human capital, physical capital, and financial capital. Based on empirical research using data from Chinese listed companies, we found that an increase in labor costs promotes innovation output in the pharmaceutical sector, but this effect is more pronounced in other sectors. Financing constraints play a negative role on corporate innovation in the pharmaceutical sector, while it is not significant in the other sectors. Factor substitution play a positive effect on corporate innovation in the other sectors, which is invalid in the pharmaceutical sector. This research contributes to a deeper understanding of the unique mechanisms by which labor costs impact innovation activities in the pharmaceutical industry.