Results for ' Pharmaceutical Safety'

988 found
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  1.  10
    Pharmaceutical and medical device safety: a study in public and private regulation.Sonia Macleod - 2019 - Chicago, Illinois: Hart Publishing. Edited by Sweta Chakraborty.
    This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory (...)
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  2.  28
    Pharmaceutical Knowledge Governance: A Human Rights Perspective.Trudo Lemmens - 2013 - Journal of Law, Medicine and Ethics 41 (1):163-184.
    Industry control over the production and distribution of pharmaceutical safety and efficacy data has become a serious public health and health care funding concern. Various recent scandals, several involving the use of flawed representations of scientific data in the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes why this is a human rights concern and what difference a human rights analysis can make. The paper first identifies the challenges associated with (...)
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  3.  18
    Participants’ awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey.Gerardo González-Saldivar, René Rodríguez-Gutiérrez, Jose Luis Viramontes-Madrid, Alejandro Salcido-Montenegro, Neri Alejandro Álvarez-Villalobos, Victoria González-Nava & José Gerardo González-González - 2019 - BMC Medical Ethics 20 (1):2.
    The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials on ethical, safety, and protection topics. A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT as well as non-participants (...)
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  4. Pharmaceutical risk communication: sources of uncertainty and legal tools of uncertainty management.Barbara Osimani - 2010 - Health Risk and Society 12 (5):453-69.
    Risk communication has been generally categorized as a warning act, which is performed in order to prevent or minimize risk. On the other side, risk analysis has also underscored the role played by information in reducing uncertainty about risk. In both approaches the safety aspects related to the protection of the right to health are on focus. However, it seems that there are cases where a risk cannot possibly be avoided or uncertainty reduced, this is for instance valid for (...)
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  5.  23
    Pharmaceutical Ethics and Grassroots Activism in the United States: A Social History Perspective.Sharon Batt, Judy Butler, Olivia Shannon & Adriane Fugh-Berman - 2020 - Journal of Bioethical Inquiry 17 (1):49-60.
    Women’s health activists laid the groundwork for passage of the law that created the U.S. Food and Drug Administration in 1906. The pharmaceutical and food industries fought regulatory reforms then and continue to do so now. We examine public health activism in the Progressive Era, the postwar era and the present day. The women’s health movement began in the 1960s, and criticized both the pharmaceutical industry and the medical establishment. In the 1990s, patient advocacy groups began accepting industry (...)
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  6.  28
    Understanding Pharmaceutical Research Manipulation in the Context of Accounting Manipulation.Abigail Brown - 2013 - Journal of Law, Medicine and Ethics 41 (3):611-619.
    Good decision-making requires reliable information. In medicine, relevant information comes from clinical trials and other forms of scientific research. In business, one source is in corporate annual financial statements. As for-profit, publicly traded companies whose business is discovering, manufacturing, and marketing drugs, pharmaceutical companies sit at the nexus of these two fields. Determining the safety and efficacy of a pharmaceutical product and determining the profitability of a complex enterprise are similarly difficult tasks: each is fraught with deeply (...)
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  7.  21
    Pharmaceuticals, Political Money, and Public Policy: A Theoretical and Empirical Agenda.Paul D. Jorgensen - 2013 - Journal of Law, Medicine and Ethics 41 (3):561-570.
    The point, for the 946,326th time is that people get elected to office by currying the favor of powerful interest groups. They don’t get elected for their excellence as political philosophers.Congress has consistently failed to solve some serious problems with the cost, effectiveness, and safety of pharmaceuticals. In part, this failure results from the pharmaceutical industry convincing legislators to define policy problems in ways that protect industry profits. By targeting campaign contributions to influential legislators and by providing them (...)
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  8.  17
    Pharmaceutical Knowledge Governance: A Human Rights Perspective.Trudo Lemmens - 2013 - Journal of Law, Medicine and Ethics 41 (1):163-184.
    In recent years, the development process of pharmaceuticals, medical devices, and related products and the overall market of these products have become increasingly global. This paper discusses the need for better governance of one aspect of this market: the production, distribution, and use of pharmaceutical knowledge. Various controversies, some of which will be described in this paper, highlight how industry control over pharmaceutical data production has resulted in very serious threats to public health. Different practices and regulatory fields (...)
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  9.  60
    Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs.Donald W. Light, Joel Lexchin & Jonathan J. Darrow - 2013 - Journal of Law, Medicine and Ethics 41 (3):590-600.
    Over the past 35 years, patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the (...)
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  10.  88
    Direct-to-Consumer Advertising of Pharmaceuticals as a Matter of Corporate Social Responsibility?Pepijn K. C. van de Pol & Frank G. A. de Bakker - 2010 - Journal of Business Ethics 94 (2):211-224.
    Direct-to-consumer advertising (DTCA) of prescription drugs has been a heavily contested issue over the past decade, touching on several issues of responsibility facing the pharmaceutical industry. Much research has been conducted on DTCA, but hardly any studies have discussed this topic from a corporate social responsibility (CSR) perspective. In this article, we use several elements of CSR, emphasising consumer autonomy and safety, to analyse differences in DTCA practices within two different policy contexts, the United States of America and (...)
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  11.  16
    Curbing Misconduct in the Pharmaceutical Industry: Insights from Behavioral Ethics and the Behavioral Approach to Law.Yuval Feldman, Rebecca Gauthier & Troy Schuler - 2013 - Journal of Law, Medicine and Ethics 41 (3):620-628.
    To sell a new drug, pharmaceutical companies must discover a compound, run clinical trials to test its efficacy and safety, get it approved by regulatory bodies, produce the drug, and market it. As this process brings the drug through so many hands, there are risks of many kinds of corruption. The pharmaceutical industry has recently gone from being one of the most admired industries to being described by the majority of Americans as “dishonest, unethical, and more concerned (...)
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  12.  37
    Institutional Corruption and the Pharmaceutical Policy.Marc A. Rodwin - 2013 - Journal of Law, Medicine and Ethics 41 (3):544-552.
    Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of (...)
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  13.  34
    Placebogenic Potential is no Reason to Favour Pharmaceutical Advertising.Paul Biegler - 2014 - Journal of Business Ethics 123 (1):145-155.
    Advertisements for pharmaceuticals may promote placebo responses by generating an expectation of therapeutic success. Some cite this as reason to favour Direct to Consumer Advertising of Prescription Pharmaceuticals (DTCA). Against this, I show placebo responses to emanate from beliefs rendered unjustified by the influence of a conditioning process. I argue that drug safety and efficacy are material properties and that unjustified beliefs in these domains entail costs to autonomy that outweigh any prudential gains attending a placebo response. I conclude (...)
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  14.  21
    Formulating an Ethics of Pharmaceutical Disinvestment.Jessica Pace, Tracey-Lea Laba, Marie-Paul Nisingizwe & Wendy Lipworth - 2020 - Journal of Bioethical Inquiry 17 (1):75-86.
    There is growing interest among pharmaceutical policymakers in how to “disinvest” from subsidized medicines. This is due to both the rapidly rising costs of healthcare and the increasing use of accelerated and conditional reimbursement pathways which mean that medicines are being subsidized on the basis of less robust evidence of safety and efficacy. It is crucial that disinvestment decisions are morally sound and socially legitimate, but there is currently no framework to facilitate this. We therefore reviewed the bioethics (...)
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  15.  3
    Direct-to-Consumer Advertising of Pharmaceuticals as a Matter of Corporate Social Responsibility?Pepijn Pol & Frank Bakker - 2010 - Journal of Business Ethics 94 (2):211-224.
    Direct-to-consumer advertising (DTCA) of prescription drugs has been a heavily contested issue over the past decade, touching on several issues of responsibility facing the pharmaceutical industry. Much research has been conducted on DTCA, but hardly any studies have discussed this topic from a corporate social responsibility (CSR) perspective. In this article, we use several elements of CSR, emphasising consumer autonomy and safety, to analyse differences in DTCA practices within two different policy contexts, the United States of America and (...)
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  16.  68
    Ban the Sunset? Nonpropositional Content and Regulation of Pharmaceutical Advertising.Paul Biegler & Patrick Vargas - 2013 - American Journal of Bioethics 13 (5):3-13.
    The risk that direct-to-consumer advertising of prescription pharmaceuticals (DTCA) may increase inappropriate medicine use is well recognized. The U.S. Food and Drug Administration addresses this concern by subjecting DTCA content to strict scrutiny. Its strictures are, however, heavily focused on the explicit claims made in commercials, what we term their “propositional content.” Yet research in social psychology suggests advertising employs techniques to influence viewers via nonpropositional content, for example, images and music. We argue that one such technique, evaluative conditioning, is (...)
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  17.  53
    The Law and Ethics of the Pharmaceutical Industry.Maurice Nelson Graham Dukes - 2005 - Elsevier.
    As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and criminal - succeeds in guiding (and where neccessary contraining) it. The (...)
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  18.  36
    Five Un‐Easy Pieces of Pharmaceutical Policy Reform.Marc A. Rodwin - 2013 - Journal of Law, Medicine and Ethics 41 (3):581-589.
    Improper dependencies slant policy over a drug's life span, biasing the development of new drugs, the testing and marketing approval for new drugs, and the monitoring of patient safety after drugs are marketed. This article examines five ways in which the public improperly depends on pharmaceutical firms that compromise the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials to test (...)
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  19.  47
    A quantitative safety assessment model for transgenic protein products produced in agricultural crops.John A. Howard & Kirby C. Donnelly - 2004 - Journal of Agricultural and Environmental Ethics 17 (6):545-558.
    Transgenic plants are now being used to develop pharmaceutical and industrial products in addition to their use in crop improvement. Using confinement requirements, these transgenic plants are grown and processed under conditions that prevent intermixing with commodity crops. Regulatory agencies in the United States have provided guidance of zero tolerance of these new industrial crops with commodity crops. While this is a worthy goal, it is theoretically unattainable. In spite of the best containment practices, there is a potential risk (...)
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  20.  90
    Scientific Evidence and the Law: An Objective Bayesian Formalisation of the Precautionary Principle in Pharmaceutical Regulation.Barbara Osimani - 2011 - Journal of Philosophy, Science and Law 11:1-24.
    The paper considers the legal tools that have been developed in German pharmaceutical regulation as a result of the precautionary attitude inaugurated by the Contergan decision. These tools are the notion of “well-founded suspicion”, which attenuates the requirements for safety intervention by relaxing the requirement of a proved causal connection between danger and source, and the introduction of the reversal of proof burden in liability norms. The paper focuses on the first and proposes seeing the precautionary principle as (...)
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  21. Safety perspectives of medicinal products.Rishi Kumar, Nishith Keserwani & Parveen Kumar Goyal - 2024 - In Faraat Ali & Leo M. L. Nollet (eds.), Global regulations of medicinal, pharmaceutical, and food products. Boca Raton: CRC Press.
     
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  22.  30
    Prescription Drug Labeling and “Over‐Warning”: The Disturbing Case of Diana Levine and Wyeth Pharmaceutical.Ronald J. Adams - 2010 - Business and Society Review 115 (2):231-248.
    ABSTRACTIn April of 2000, Diana Levine went to a clinic in Vermont suffering from a migraine headache. She was given the drug Demerol for the migraine symptoms and Phenergan for nausea. Complications with the administration of Phenergan ultimately resulted in Ms. Levine contracting gangrene, necessitating the amputation of her right arm. Ms. Levine sued the drug maker, Wyeth Pharmaceutical, in state court and prevailed. The lower court's decision was appealed by Wyeth to the state supreme court where the ruling (...)
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  23.  38
    Filling in the Gaps: Priming and the Ethics of Pharmaceutical Advertising.Paul Biegler - 2015 - Kennedy Institute of Ethics Journal 25 (2):193-230.
    A prime is a cue that makes associated concepts, behaviors, and goals more psychologically accessible to people, influencing their responses in subsequent related environments. I build a case that Direct to Consumer Advertising of Prescription Pharmaceuticals (DTCA) operates as a prime that causes some viewers to prefer and pursue the advertised drug. Drawing on literature from social psychology I show that people subject to priming are mostly unaware of its influence and liable to misattribute the reasons for their primed actions. (...)
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  24.  44
    The politics and bio-ethics of regulatory trust: case-studies of pharmaceuticals. [REVIEW]John Abraham - 2008 - Medicine, Health Care and Philosophy 11 (4):415-426.
    Drawing on case studies from the modern era of pharmaceutical regulation in the UK, US and Europe, I examine how the extent and distribution of trust between regulators, the pharmaceutical industry, and the medical profession about drug testing and monitoring influences knowledge and regulatory judgements about the efficacy and safety of prescription drugs. Introducing the concepts of ‘acquiescent’ and ‘investigative’ norms of regulatory trust, I demonstrate how investigative norms of regulatory trust—which deter pharmaceutical companies from assuming (...)
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  25.  38
    Just a Spoonful of Sugar: Drug Safety for Pediatric Populations.Barbara A. Noah - 2009 - Journal of Law, Medicine and Ethics 37 (2):280-291.
    Children deserve optimal medical care. Although prescription drugs play a prominent and essential role in pediatric health care delivery, health care providers often must make prescribing decisions for their young patients based on imperfect or absent safety and efficacy data for pediatric populations. Until relatively recently, the Food and Drug Administration made surprisingly little effort to improve the quality or quantity of clinical research data for this patient group. Despite recent agency efforts to improve the situation, only one-third of (...)
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  26.  9
    Distributing the Benefit of the Doubt: Scientists, Regulators, and Drug Safety.John Abraham - 1994 - Science, Technology and Human Values 19 (4):493-522.
    This article examines how scientists and regulators distribute the benefit of the doubt about drug safety under conditions of scientific uncertainty. The focus of the empirical research is the regulatory controversy over the hepatorenal toxicity of benoxaprofen in the United Kingdom and the United States. By scrutinizing the technical coherence of the arguments put forward by industrial and government scientists, it is concluded that these scientists are willing to award the commercial interests of the pharmaceutical industry an enormous (...)
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  27.  38
    Recent Developments in Health Law: FDA and Drug Safety: New Tufts Study Challenges Critics of the Prescription Drug User Fee Act.Rochelle Lee - 2006 - Journal of Law, Medicine and Ethics 34 (1):131-134.
    In the wake of several highly publicized lawsuits over drugs recalled for safety – most notably, Vioxx and Paxil – the Food and Drug Administration and the pharmaceutical industry have faced increasingly intense public scrutiny over the drug testing and approval process. Critics blame the FDA's shorter pre-market approval process that has resulted from the enactment of the Prescription Drug User Fee Act, which effected, among other changes, an increased number of reviewers, a higher review load for each (...)
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  28.  4
    Positive risk balance: a comprehensive framework to ensure vehicle safety.Florian Raisch, Ludwig Drees, Felix Fahrenkrog & Nina Kauffmann - 2022 - Ethics and Information Technology 24 (1).
    The introduction of automated vehicles promises an increase in traffic safety. Prior to its launch proof of the anticipated reduction in the sense of a positive risk balance compared with human driving performance is required from various stakeholders such as the European Union Commission, the German Ethic Commission, and the ISO TR 4804. To meet this requirement and to generate acceptance by the public and the regulatory authorities, a qualitative Risk- Benefit framework has been defined. This framework is based (...)
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  29. Introduction, challenges, and safety issues of food regulation.Leo M. L. Nollet - 2024 - In Faraat Ali & Leo M. L. Nollet (eds.), Global regulations of medicinal, pharmaceutical, and food products. Boca Raton: CRC Press.
     
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  30. Is regulatory innovation fit for purpose? A case study of adaptive regulation for advanced biotherapeutics.Giovanni De Grandis - 2022 - Regulation and Governance 16.
    The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article investigates (...)
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  31.  35
    Dogs for Life: Beagles, Drugs, and Capital in the Twentieth Century.Brad Bolman - 2022 - Journal of the History of Biology 55 (1):147-179.
    This article tracks the transformation of beagle dogs from a common breed in mid-twentieth century American laboratories to the de jure standard in global toxicological research by the turn of the twenty-first. The breed was dispersed widely due to the expanding use of dogs in pharmacology in the 1950s and a worldwide crisis around pharmaceutical safety following the thalidomide scandal of the 1960s. Nevertheless, debates continued for decades over the beagle’s value as a model of carcinogenicity, even as (...)
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  32.  90
    Pharmacological cognitive enhancement : how neuroscientific research could advance ethical debate.Hannah Maslen, Nadira Faulmüller & Julian Savulescu - unknown
    There are numerous ways people can improve their cognitive capacities: good nutrition and regular exercise can produce long-term improvements across many cognitive domains, whilst commonplace stimulants such as coffee temporarily boost levels of alertness and concentration. Effects like these have been well-documented in the medical literature and they raise few ethical issues. More recently, however, clinical research has shown that the off-label use of some pharmaceuticals can, under certain conditions, have modest cognition-improving effects. Substances such as methylphenidate and modafinil can (...)
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  33.  6
    Continuous Reproductive Surveillance.Michael R. Ulrich & Leah R. Fowler - 2023 - Journal of Law, Medicine and Ethics 51 (3):570-574.
    The Dobbs opinion emphasizes that the state’s interest in the fetus extends to “all stages of development.” This essay briefly explores whether state legislators, agencies, and courts could use the “all stages of development” language to expand reproductive surveillance by using novel developments in consumer health technologies to augment those efforts.
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  34.  37
    Ethical considerations in the testing of biopharmaceuticals for adventitious agents.Richard S. Woodward - 1995 - Science and Engineering Ethics 1 (3):273-282.
    Safety testing of biological pharmaceuticals is often carried out by contract testing laboratories which perform these tests on behalf of the drug’s developer. These laboratories are confronted with a number of ethical issues related to selling their services, maintaining confidentiality, and the handling of results. This paper outlines these issues, and, by way of illustration, discusses how one such laboratory addresses them.
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  35.  12
    A China business primer: ethics, culture, and relationships.Michael A. Santoro - 2021 - New York, NY: Routledge. Edited by Robert Shanklin.
    The COVID-19 pandemic underscored longstanding fissures in China's business relationships with the West. If the West is going to develop a relationship of mutual trust, and improve business relations with China in the coming decades, it is imperative to understand how to engage with Chinese thinking on ethics in business-this book explains how. Policy-makers, businesspeople and business-ethicists have trouble communicating about issues in ethics, policy and business across the China-West divide. This book shows how to overcome the us-versus-them mindset plaguing (...)
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  36. The Paroxetine 352 Bipolar Study Revisited: Deconstruction of Corporate and Academic Misconduct.Leemon McHenry & Jay D. Amsterdam - 2019 - Journal of Scientific Practice and Integrity 1 (1):1-12.
    Medical ghostwriting is the practice in which pharmaceutical companies engage an outside writer to draft a manuscript submitted for publication in the names of “honorary authors,” typically academic key opinion leaders. Using newly-posted documents from paroxetine litigation, we show how the use of ghostwriters and key opinion leaders contributed to the publication of a medical journal article containing manipulated outcome data to favor the proprietary medication. The article was ghostwritten and managed by SmithKline Beecham, now GlaxoSmithKline (GSK) and Scientific (...)
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  37.  36
    Research ethics and public trust in vaccines: the case of COVID-19 challenge trials.Nir Eyal - 2024 - Journal of Medical Ethics 50 (4):278-284.
    Despite their clearly demonstrated safety and effectiveness, approved vaccines against COVID-19 are commonly mistrusted. Nations should find and implement effective ways to boost vaccine confidence. But the implications for ethical vaccine development are less straightforward than some have assumed. Opponents of COVID-19 vaccine challenge trials, in particular, made speculative or empirically implausible warnings on this matter, some of which, if applied consistently, would have ruled out most COVID-19 vaccine trials and many non-pharmaceutical responses.
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  38.  26
    Phase IV research: innovation in need of ethics.G. J. M. W. van Thiel & J. J. M. van Delden - 2008 - Journal of Medical Ethics 34 (6):415-416.
    Worries about safety of approved drugs have pushed post registration research to become the fastest growing drug research phase. Until recently, phase IV studies were mainly conducted for marketing purposes and run much like a phase III trial—at institutions with experienced investigators and a list of inclusion and exclusion criteria. Innovative phase IV studies involve ordinary physicians in research naïve communities. This brings ethical issues familiar to medical research into clinical practice. As a consequence, individual physicians are challenged to (...)
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  39.  45
    The value and pitfalls of speculation about science and technology in bioethics: the case of cognitive enhancement.Eric Racine, Tristana Martin Rubio, Jennifer Chandler, Cynthia Forlini & Jayne Lucke - 2014 - Medicine, Health Care and Philosophy 17 (3):325-337.
    In the debate on the ethics of the non-medical use of pharmaceuticals for cognitive performance enhancement in healthy individuals there is a clear division between those who view “cognitive enhancement” as ethically unproblematic and those who see such practices as fraught with ethical problems. Yet another, more subtle issue, relates to the relevance and quality of the contribution of scholarly bioethics to this debate. More specifically, how have various forms of speculation, anticipatory ethics, and methods to predict scientific trends and (...)
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  40.  53
    Filling the information void: Using public registries as a tool in nanotechnologies regulation. [REVIEW]Diana M. Bowman & Karinne Ludlow - 2009 - Journal of Bioethical Inquiry 6 (1):25-36.
    Based on the experiences of two high profile voluntary data collection programs for engineered nanomaterials, this article considers the merit of an international online registry for scientific data on engineered nanomaterials and environmental, health and safety (EHS) data. Drawing on the earlier experiences from the pharmaceutical industry, the article considers whether a registry of nanomaterials at the international level is practical or indeed desirable, and if so, whether such an initiative—based on the current state of play—should be voluntary (...)
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  41.  15
    Leopards in the Temple: Restoring Scientific Integrity to the Commercialized Research Scene.Trudo Lemmens - 2004 - Journal of Law, Medicine and Ethics 32 (4):641-657.
    Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this is repeated over and over again; finally it can be calculated in advance, and it becomes part of the ceremony.–Franz KaflaFor more than two decades, significant controversies have been brewing over the efficacy and safety of Selective Serotonin Reuptake Inhibitors and other treatments for depression, and also over the expansion of their use for the treatment of a variety of other conditions. These (...)
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  42.  7
    Introduction to the Special Section on Psychedelics Research and Treatment.Dominic Sisti - 2024 - Perspectives in Biology and Medicine 67 (1):114-116.
    In lieu of an abstract, here is a brief excerpt of the content:Introduction to the Special Section on Psychedelics Research and TreatmentDominic SistiAgainst a backdrop of post-pandemic malaise, diseases of despair, and a fragmented mental health care system, psychedelics have enjoyed a resurgence of interest as powerful psychotherapeutic agents and as catalysts of personal growth. The true power of these substances—some of which are considered sacramental by Indigenous peoples—has been shrouded for half a century by cultural mythology, political propaganda, and (...)
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  43.  10
    Governing the Globalization of Public Health.Allyn L. Taylor - 2004 - Journal of Law, Medicine and Ethics 32 (3):500-508.
    The number and the scale of transboundary public health concerns are increasing. Infectious and non-communicable diseases, international trade in tobacco, alcohol, and other dangerous products as well as the control of the safety of health services, pharmaceuticals, and food are merely a few examples of contemporary transnationalization of health concerns. The rapid development and diffusion of scientific and technological developments across national borders are creating new realms of international health concern, such as aspects of biomedical science, including human reproductive (...)
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  44.  19
    Neuroenhancing public health.David Shaw - 2014 - Journal of Medical Ethics 40 (6):389-391.
    One of the most fascinating issues in the emerging field of neuroethics is pharmaceutical cognitive enhancement. The three main ethical concerns around CE were identified in a Nature commentary in 2008 as safety, coercion and fairness; debate has largely focused on the potential to help those who are cognitively disabled, and on the issue of ‘cosmetic neurology’, where people enhance not because of a medical need, but because they want to. However, the potential for CE to improve public (...)
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  45. Vacuna del VPH: elementos conceptuales ginecológicos, éticos y bioéticos.Gilberto A. Gamboa-Bernal, Jairo Echeverry-Raad & Carlos Alberto Gómez-Fajardo - 2021 - Bioethics 2 (7):106-116.
    Based on the most recent metanalysis on the efficacy and safety of the human papilloma virus (HPV) vaccine, thevicissitudes in the gynecological, ethical, and bioethical fields are explored. A review of the bibliography on thesubject is made. As one of the justifications for the vaccine is the prevention of endocervical cancer, viable alter-natives for its early detection and treatment are shown and discussed. Some ethical limitations that this vaccinehas shown are analyzed. It is concluded that there is a need (...)
     
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  46.  14
    Equipoise, standard of care and consent: responding to the authorisation of new COVID-19 treatments in randomised controlled trials.Soren Holm, Jonathan Lewis & Rafael Dal-Ré - 2023 - Journal of Medical Ethics 49 (7):465-470.
    In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of molnupiravir, a novel antiviral medicine (...)
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  47.  41
    Developing U.S. Oversight Strategies for Nanobiotechnology: Learning from Past Oversight Experiences.Jordan Paradise, Susan M. Wolf, Jennifer Kuzma, Aliya Kuzhabekova, Alison W. Tisdale, Efrosini Kokkoli & Gurumurthy Ramachandran - 2009 - Journal of Law, Medicine and Ethics 37 (4):688-705.
    The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration , Environmental Protection Agency , Department of Agriculture , Occupational Safety and Health Administration , and National Institutes of Health . All can learn from assessment of the successes and failures of past oversight efforts aimed (...)
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  48.  11
    Governing the Globalization of Public Health.Allyn L. Taylor - 2004 - Journal of Law, Medicine and Ethics 32 (3):500-508.
    The number and the scale of transboundary public health concerns are increasing. Infectious and non-communicable diseases, international trade in tobacco, alcohol, and other dangerous products as well as the control of the safety of health services, pharmaceuticals, and food are merely a few examples of contemporary transnationalization of health concerns. The rapid development and diffusion of scientific and technological developments across national borders are creating new realms of international health concern, such as aspects of biomedical science, including human reproductive (...)
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  49.  32
    Update on unethical use of placebos in randomised trials.Karin B. Michels & Kenneth J. Rothman - 2003 - Bioethics 17 (2):188–204.
    The most recent (Fifth) revision of the Declaration of Helsinki, adopted in October 2000 by the World Medical Association (WMA), reinforces the longstanding prohibition against offering placebo instead of effective therapy. The WMA left no doubt that if a beneficial treatment for a condition has already been recognised, it is unethical to offer placebo in place of such treatment to anyone in a study of the same condition. We have previously drawn attention to the discrepancy between the spirit of the (...)
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  50. Towards a Smart Population: A Public Health Framework for Cognitive Enhancement.Jayne Lucke & Brad Partridge - 2012 - Neuroethics 6 (2):419-427.
    This paper presents a novel view of the concept of cognitive enhancement by taking a population health perspective. We propose four main modifiable healthy lifestyle factors for optimal cognitive functioning across the population for which there is evidence of safety and efficacy. These include i) promoting adequate sleep, ii) increasing physical activity, iii) encouraging a healthy diet, including minimising consumption of stimulants, alcohol and other drugs including nicotine, iv) and promoting good mental health. We argue that it is not (...)
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