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Matthew S. McCoy

Bio: Matthew S. McCoy is an academic researcher from University of Pennsylvania. The author has contributed to research in topics: Medicine & Patient advocacy. The author has an hindex of 10, co-authored 25 publications receiving 426 citations. Previous affiliations of Matthew S. McCoy include Leonard Davis Institute of Health Economics.

Papers
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Journal ArticleDOI
11 Sep 2020-Science
TL;DR: The Fair Priority Model offers a practical way to fulfill pledges to distribute vaccines fairly and equitably once effective coronavirus disease 2019 (COVID-19) vaccines are developed and will be scarce.
Abstract: The Fair Priority Model offers a practical way to fulfill pledges to distribute vaccine fairly and equitably

226 citations

Journal ArticleDOI
TL;DR: In this examination of 104 large patient-advocacy organizations, 83% receive financial support from drug, device, and biotechnology companies, and industry executives often serve on governing boards.
Abstract: In this examination of 104 large patient-advocacy organizations, 83% receive financial support from drug, device, and biotechnology companies, and industry executives often serve on governing boards. The authors recommend more transparency about industry involvement.

116 citations

Journal ArticleDOI
05 Jan 2021-BMJ
TL;DR: In this paper, the Fair Priority Model (FPM) is proposed for the fair and efficient distribution of covid-19 vaccines, which is based on ethical principles better than Covax's proposal of proportional allocation based on population.
Abstract: International collaboration is key for the fair and efficient distribution of covid-19 vaccines. Lisa Herzog and colleagues’ Fair Priority Model, with its focus on allocating vaccine based on limiting covid-19 harms, realises ethical principles better than Covax’s proposal of proportional allocation based on population

59 citations

Journal ArticleDOI
02 May 2017-JAMA
TL;DR: Labeling certain COI as merely “potential” or “perceived” diminishes their seriousness and obscures the ethical rationale for trying to limit COI in medical practice and research.
Abstract: During the Institute of Medicine’s 2013 workshop on conflict of interest (COI) and medical innovation, a presentation from PhRMA, the pharmaceutical industry association, delineated 5 types of potential conflict in medical research and the likelihood of each resulting in a true conflict.1 Even though these sorts of distinctions between potential or perceived COI on one hand and true or actual COI on the other have become commonplace,2,3 they are misguided. Not only is the notion of a potential COI conceptually confused, labeling certain COI as merely “potential” or “perceived” diminishes their seriousness and obscures the ethical rationale for trying to limit COI in medical practice and research.

51 citations

Journal ArticleDOI
TL;DR: The Standards are assessed and it is found that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place.
Abstract: Biomedical research funding bodies across Europe and North America increasingly encourage-and, in some cases, require-investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what 'good' or 'successful' public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement.

45 citations


Cited by
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Journal ArticleDOI
TL;DR: The authors in this article reviewed potential challenges to success in each of these dimensions and discussed policy implications. But having licensed vaccines is not enough to achieve global control of COVID-19: they also need to be produced at scale, priced affordably, allocated globally so that they are available where needed, and widely deployed in local communities.

782 citations

Journal ArticleDOI
TL;DR: Numerous frameworks for supporting, evaluating and reporting patient and public involvement in research exist and are diverse and theoretically heterogeneous.
Abstract: © 2019 The Authors Health Expectations published by John Wiley & Sons Ltd Background: Numerous frameworks for supporting, evaluating and reporting patient and public involvement in research exist. The literature is diverse and theoretically heterogeneous. Objectives: To identify and synthesize published frameworks, consider whether and how these have been used, and apply design principles to improve usability. Search strategy: Keyword search of six databases; hand search of eight journals; ancestry and snowball search; requests to experts. Inclusion criteria: Published, systematic approaches (frameworks) designed to support, evaluate or report on patient or public involvement in health-related research. Data extraction and synthesis: Data were extracted on provenance; collaborators and sponsors; theoretical basis; lay input; intended user(s) and use(s); topics covered; examples of use; critiques; and updates. We used the Canadian Centre for Excellence on Partnerships with Patients and Public (CEPPP) evaluation tool and hermeneutic methodology to grade and synthesize the frameworks. In five co-design workshops, we tested evidence-based resources based on the review findings. Results: Our final data set consisted of 65 frameworks, most of which scored highly on the CEPPP tool. They had different provenances, intended purposes, strengths and limitations. We grouped them into five categories: power-focused; priority-setting; study-focused; report-focused; and partnership-focused. Frameworks were used mainly by the groups who developed them. The empirical component of our study generated a structured format and evidence-based facilitator notes for a “build your own framework” co-design workshop. Conclusion: The plethora of frameworks combined with evidence of limited transferability suggests that a single, off-the-shelf framework may be less useful than a menu of evidence-based resources which stakeholders can use to co-design their own frameworks.

334 citations

Journal Article
TL;DR: The Institute of Medicine’s Conflict of Interest in Medical Research, Education, and Practice makes an important contribution to the continuing debate about financial conflicts of interest in medicine and makes 16 recommendations for reforming medicine, some of which would require radical changes.
Abstract: Concerns about the potentially corrupting influence of private industry on medical research, education, and practice have been growing since the 1970s, when the U.S. Congress passed the first anti-kickback law applying to medicine. Since then, Congress has banned self-referrals in medicine, enacted laws that regulate the commercialization of publicly funded biomedical research, and held hearings on conflicts of interest in biomedicine. Government agencies have issued policies concerning disclosure of financial interests in research, professional associations have published guidelines pertaining to financial relationships with industry, and scientific journals have developed conflict of interest policies. The Institute of Medicine (IOM)’s Conflict of Interest in Medical Research, Education, and Practice makes an important contribution to the continuing debate about financial conflicts of interest in medicine. This report reviews empirical studies, analytic essays, regulations, and guidance documents concerning conflicts of interest in medical research and makes recommendations for researchers, educators, physicians, institutions, corporations, and government agencies. The report consists of nine chapters as well as appendices that examine particular topics in greater depth, such as the relevance of psychological research on subconscious biases to conflict of interest policies, and a comparative analysis of conflicts of interest in nonmedical professions. To draft this report, the IOM assembled experts from various fields including medicine, public health, law, health policy, ethics, philosophy, and economics. The authors acknowledge that collaboration with industry is a double-edged sword: Collaboration can produce important benefits, but it can compromise the integrity of professional judgment and erode the public’s trust in medicine. In crafting their recommendations, the authors strike a balance between protecting medical research, education, and practice from the harmful effects of industry collaboration and avoiding unnecessary administrative burdens that could undermine the benefits of collaboration. They make judicious use of empirical evidence to support their conclusions and recommendations. When evidence was lacking, the authors developed arguments based on their own experience and judgment as well as different approaches found in the literature. The IOM report makes 16 recommendations for reforming medicine, some of which would require radical changes. For example, the report recommends that all academic medical centers, teaching hospitals, and training sites prohibit faculty, students, residents, and fellows from accepting gifts from pharmaceutical, biotechnology, or medical device companies, except in some circumstances, and not allow drug and medical sales representatives to have access to faculty, except by invitation in specified situations. The IOM report also recommends that academic medical centers, hospitals, and training sites develop a new system of funding continuing medical education that is free from industry influence; that research institutions prohibit investigators from conducting research with human subjects if they have a significant financial interest related to a product that would be affected by the research, except when the investigator’s participation is essential for conducting the research; and that physicians in private practice refrain from accepting items of value from pharmaceutical, biotechnology, or medical device companies. The report also contains a conceptual framework that provides a foundation for policy recommendations. This includes a definition of conflict of interest (“a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest”) and criteria for assessing conflict of interest policies, such as proportionality (does the policy focus on the most important conflicts and is the policy practical?), transparency (is the policy understandable to those to whom it applies?), accountability (does the policy have enforcement procedures?), and fairness (does the policy apply equally to all relevant people in similar situations?). The authors also discuss problems with interpreting and applying the notion of an apparent conflict of interest. This comprehensive and insightful report will undoubtedly have considerable influence over research, scholarship, and policy development for years to come. It is highly recommended reading for physicians, medical researchers, and medical educators.

267 citations

Journal ArticleDOI
01 Jan 2019-JAMA
TL;DR: 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) is reviewed.
Abstract: 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.

213 citations