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2.
PLoS One ; 18(6): e0286339, 2023.
Article in English | MEDLINE | ID: covidwho-20242307

ABSTRACT

BACKGROUND: A national survey we conducted in 2008 showed that many Japanese physicians interacted with and received gifts from pharmaceutical representatives (PRs) and had a positive attitude toward relationships with PRs. The revised promotion code of the Japan Pharmaceutical Manufacturers Association in 2019 prohibited the provision of non-educational promotional aids including sticky notes, mouse pads, and calendars. During the COVID-19 pandemic in 2020, face-to-face meetings were socially restricted. This study assessed the extent of current Japanese physicians' involvement in pharmaceutical promotional activities and their attitudes toward relationships with PRs and to ascertain any changes between 2008 and 2021. We also examined the factors that predicted positive attitudes toward gifts from PRs. METHODS: From January to March 2021, we conducted a national mail survey of Japanese physicians in seven specialties: internal medicine, surgery, orthopedics, pediatrics, obstetrics-gynecology, psychiatry, and ophthalmology. RESULTS: There were 1636 participants and the response rate was 63.2%. Most physicians met face-to-face with PRs (78.8%), whereas only a minority received meals outside the workplace (4.5%). PRs were thought to have an important role in continuing medical education (66.1%) and to provide accurate information about new drugs (74.2%). Opinions were divided on the appropriateness of gifts from PRs. Most thought that stationery and meals provided by the industry did not affect prescribing behavior (89.7% and 75.8%, respectively). Factors that predicted a positive attitude toward gifts from PRs were male, orthopedic specialty vs. internal medicine, more interactions with PRs, a positive attitude toward informational value, and no rules banning meetings with PRs. CONCLUSION: Involvement in pharmaceutical promotional activities is still common among practicing physicians in Japan, although the extent of the involvement had declined. Rules banning meetings with PRs appear to continue being effective at limiting a physician's involvement with promotional activities and their critical attitudes toward gifts from PRs.


Subject(s)
Drug Industry , Interprofessional Relations , Physicians , Child , Female , Humans , Male , Attitude of Health Personnel , East Asian People , Gift Giving , Practice Patterns, Physicians'
3.
BMJ Open ; 13(5): e065719, 2023 05 26.
Article in English | MEDLINE | ID: covidwho-20241385

ABSTRACT

OBJECTIVES: To understand how and why Australian cancer physicians interact with the pharmaceutical industry. DESIGN: Qualitative study using semistructured interviews, performed by a medical oncologist. Thematic analysis using a combination of deductive and inductive codes. SETTING: Given the evidence on industry influences on clinical practice and the importance to the market of oncology drugs, we sought to better understand cancer physicians' experiences. Practising consultant medical oncologists and clinical haematologists from four Australian states were interviewed over Zoom. PARTICIPANTS: 16 cancer physicians were interviewed between November 2021 and March 2022, from 37 invited (response rate 43%). Most were medical oncologists (n=12 of 16, 75%) and male (n=9 of 16, 56%). OUTCOME MEASURES: The analysis of all interviews was based on grounded theory. Transcripts were coded and then codes formed into themes with supporting quotes. The themes were then placed into categories, used to describe the broad areas into which the themes could be grouped. RESULTS: Six themes were identified that fell within two broad categories: cancer physicians' views and experiences of interactions and management of these interactions. Views and experiences included: the transactional nature of relationships, risks of research dependence, ethical challenges and varied attitudes based on interaction type. Management themes included: lack of useful guidance and reduced interactions during the COVID-19 pandemic. These led to an overarching seventh theme, on the desire for a 'middle road'. Cancer physicians identified the transactional nature of industry relationships and felt uncomfortable with several types of interactions, including those with sales representatives. Most wanted less contact with industry, and the forced separation that occurred with the COVID-19 pandemic was generally welcome. CONCLUSIONS: Cancer physicians may have difficulty balancing the perceived need to interact with industry in modern cancer care while maintaining distance to minimise conflicts of interest. Further research is needed to assess management strategies in this area.


Subject(s)
Drug Industry , Medical Oncology , Physicians , Humans , Male , Attitude of Health Personnel , Australia , Conflict of Interest , COVID-19 , Neoplasms , Pandemics , Qualitative Research , Female
4.
Ther Deliv ; 12(11): 757-774, 2021 11.
Article in English | MEDLINE | ID: covidwho-2319895
6.
Ther Deliv ; 11(9): 541-546, 2020 09.
Article in English | MEDLINE | ID: covidwho-2319552

ABSTRACT

The present industry update covers the period 1-31 May 2020, with information sourced from company press releases, regulatory and patent agencies as well as scientific literature.


Subject(s)
Drug Delivery Systems/trends , Viral Vaccines , COVID-19 Vaccines , Clinical Trials as Topic , Coronavirus Infections/prevention & control , Device Approval , Drug Industry , Humans , Nanostructures , Viral Vaccines/administration & dosage , Viral Vaccines/pharmacokinetics , Viral Vaccines/supply & distribution
7.
Ther Deliv ; 13(3): 141-156, 2022 03.
Article in English | MEDLINE | ID: covidwho-2319897
8.
Am J Manag Care ; 27(8): e251-e253, 2021 08 01.
Article in English | MEDLINE | ID: covidwho-2296537

ABSTRACT

After years of anticipation about Amazon's rumored entry into pharmacy, Amazon Pharmacy launched in November 2020. What is yet to be understood is whether this new Amazon offering is a true market disruption capable of upending the pharmacy industry. This commentary describes the epic rise of Amazon from bookseller to retail giant, leading to its entry into the retail pharmacy space. Amazon Pharmacy's business model is described and its potential for industry disruption discussed.


Subject(s)
Pharmaceutical Services , Pharmacies , Pharmacy , Commerce , Drug Industry , Humans
9.
Nat Rev Drug Discov ; 22(4): 260, 2023 04.
Article in English | MEDLINE | ID: covidwho-2305063

Subject(s)
Commerce , Drug Industry , Humans
10.
Biotechnol Prog ; 39(2): e3321, 2023 03.
Article in English | MEDLINE | ID: covidwho-2296459

ABSTRACT

The COVID-19 pandemic has placed unprecedented pressure on biopharmaceutical companies to develop efficacious preventative and therapeutic treatments, which is unlikely to abate in the coming years. The importance of fast progress to clinical evaluation for treatments, which tackle unmet medical needs puts strain on traditional product development timelines, which can take years from start to finish. Although previous work has been successful in reducing phase 1 timelines for recombinant antibodies, through utilization of the latest technological advances and acceptance of greater business risk or costs, substantially faster development is likely achievable without increased risk to patients during initial clinical evaluation. To optimize lessons learned from the pandemic and maximize multi-stakeholder (i.e., patients, clinicians, companies, regulatory agencies) benefit, we conducted an industry wide benchmarking survey in September/October 2021. The aims of this survey were to: (i) benchmark current technical practices of key process and product development activities related to manufacturing of therapeutic proteins, (ii) understand the impact of changes implemented in COVID-19 accelerated Ab programs, and whether any such changes can be retained as part of sustainable long-term business practices and (iii) understand whether any accelerative action(s) taken have (negatively) impacted the wider development process. This article provides an in-depth analysis of this data, ultimately highlighting an industry perspective of how biopharmaceutical companies can sustainably adopt new approaches to therapeutic protein development and production.


Subject(s)
Biological Products , COVID-19 , Humans , Drug Industry , Biological Products/therapeutic use , Pandemics/prevention & control , Workflow
11.
Regen Med ; 16(1): 1-8, 2021 01.
Article in English | MEDLINE | ID: covidwho-2263872

ABSTRACT

Latest developments in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from nonacademic institutions in September 2020.


Subject(s)
Regenerative Medicine , Stem Cell Research , Drug Industry
13.
J Clin Psychopharmacol ; 42(6): 518-522, 2022.
Article in English | MEDLINE | ID: covidwho-2260473

ABSTRACT

BACKGROUND: Current psychiatric drug discovery and development has not produced very effective medications in the past few decades. Conventional wisdom provides reasons for failure that do not address major structural obstacles to true innovation for psychiatric drugs. METHOD: Narrative review based on analysis of the scientific literature augmented by personal experience in academic clinical research as well as in the pharmaceutical industry. RESULTS: The largest obstacles to drug discovery and development are the biological invalidity of most DSM diagnoses, the economic incentives to produce short-term symptomatic treatments with blockbuster profit potential, and very low thresholds set by the FDA for ending drug discovery due to toxicity. Since these larger structural socio-economic obstacles to drug development will be difficult to change, a new proposal is made for a parallel non-profit drug discovery paradigm, to be funded by governments, akin to the development of vaccines for the Covid-19 pandemic. The key public health implications are highlighted in the example of developing new drugs for Alzheimer dementia, and the potential utility of an anti-tau agent like lithium, currently ignored in drug development in favor of much more expensive and questionably effective amyloid-reducing agents. CONCLUSIONS: Given the key structural problems of psychiatric drug discovery and development, a parallel non-profit drug discovery paradigm is needed to meet all public health needs, as well as to reinvigorate truly innovative and transformative research.


Subject(s)
COVID-19 Vaccines , COVID-19 , Humans , Drug Discovery , Drug Industry , Drug Development
15.
Nat Rev Drug Discov ; 22(3): 235-250, 2023 03.
Article in English | MEDLINE | ID: covidwho-2278945

ABSTRACT

The pharmaceutical industry and its global regulators have routinely used frequentist statistical methods, such as null hypothesis significance testing and p values, for evaluation and approval of new treatments. The clinical drug development process, however, with its accumulation of data over time, can be well suited for the use of Bayesian statistical approaches that explicitly incorporate existing data into clinical trial design, analysis and decision-making. Such approaches, if used appropriately, have the potential to substantially reduce the time and cost of bringing innovative medicines to patients, as well as to reduce the exposure of patients in clinical trials to ineffective or unsafe treatment regimens. Nevertheless, despite advances in Bayesian methodology, the availability of the necessary computational power and growing amounts of relevant existing data that could be used, Bayesian methods remain underused in the clinical development and regulatory review of new therapies. Here, we highlight the value of Bayesian methods in drug development, discuss barriers to their application and recommend approaches to address them. Our aim is to engage stakeholders in the process of considering when the use of existing data is appropriate and how Bayesian methods can be implemented more routinely as an effective tool for doing so.


Subject(s)
Drug Industry , Research Design , Humans , Bayes Theorem
16.
Pharm Pat Anal ; 11(6): 225-231, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-2267539

ABSTRACT

Compulsory licensing (CL) is a mechanism made by the government to provide balance between the monopoly right holders and the third person with public interest by ensuring the ease availability of the patented products at reasonable rate. This paper discusses the background criteria for getting CL in India as per the Indian Patent Act, 1970 starting from the concepts outlined in the Trade-Related Aspects of Intellectual Property Rights agreement. We reviewed the case studies for the accepted and rejected CL in India. We also discuss important CL cases that were permitted internationally, including the present COVID pandemic CL. Finally, we provide our analytical perspectives regarding the pros and cons of CL.


Subject(s)
COVID-19 , Humans , India , Drug Industry
18.
Health Econ ; 32(5): 1019-1039, 2023 05.
Article in English | MEDLINE | ID: covidwho-2219712

ABSTRACT

Do movies reduce stigma, increasing healthcare product choices offered by firms? We provide causal evidence on this question in the context of Indian pharmaceutical markets. For unpacking these effects, we use an exogenous shock to the market due to the release of a Bollywood blockbuster movie - My Name is Khan (MNIK) where the protagonist, superstar Shahrukh Khan, suffers from Asperger's Syndrome (AS). Using a difference-in-differences design, we find a positive and statistically significant effect of MNIK (between 14% and 22% increase in variety sold and prescribed) on product differentiation and choices in the market for antipsychotic medicines used to clinically treat AS. Results are consistent using alternative controls, a placebo treatment-based test and with a variety of other robustness checks. Our findings document likely for the first-time, supply side responses to edutainment and suggests potential associated welfare effects in healthcare markets characterized by sticky demand. Implications for global health and public policy given worldwide concerns around a mental wellness epidemic with Covid-19 are discussed.


Subject(s)
COVID-19 , Motion Pictures , Humans , Drug Industry
19.
Medicine (Baltimore) ; 102(4): e32776, 2023 Jan 27.
Article in English | MEDLINE | ID: covidwho-2222899

ABSTRACT

This cross-sectional analysis aimed to assess the extent of conflicts of interest among the Japanese government coronavirus disease 2019 (COVID-19) advisory board members and elucidate the accuracy of conflicts of interest (COI) disclosure and management strategies. Using the payment data from all 79 pharmaceutical companies in Japan between 2017 and 2019 and direct research grants from the Japanese government between 2019 and 2020, we evaluated the extent of financial and non-financial COI among all 20 Japanese government COVID-19 advisory board members. The Ethic Committee of the Medical Governance Research Institute approved this study. Japanese government COVID-19 advisory board members were predominantly male (75.0%) and physicians (50.0%). Between 2019 and 2020, 2 members (10.0%) received a total of $819,244 in government research funding. Another 5 members (25.0%) received $532,127 in payments, including $276,722 in personal fees, from 31 pharmaceutical companies between 2017 and 2019. The average value of the pharmaceutical payments was $9155 (standard deviation: $12,975). Furthermore, neither the Ministry of Health, Labor, and Welfare nor the Japanese Cabinet Secretariat disclosed financial or non-financial COI with industry. Additionally, the government had no policies for managing COI among advisory board members. This study found that the Japanese government COVID-19 advisory board had financial and non-financial COI with pharmaceutical companies and the government. Furthermore, personal communication received as part of this research indicated that there were no rigorous COI management strategies for the COVID-19 advisory board members. Any government must ensure the independence of scientific advisory boards by implementing more rigorous and transparent management strategies that require the declaration and public disclosure of all COI.


Subject(s)
Advisory Committees , COVID-19 , Conflict of Interest , Government , Female , Humans , Male , COVID-19/epidemiology , Cross-Sectional Studies , Disclosure , Japan/epidemiology , Drug Industry
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