In The Ethics of Food, Gregory E. Pence brings together a collection of voices who share the view that the ethics of genetically modified food is among the most pressing societal questions of our time. This comprehensive collection addresses a broad range of subjects, including the meaning of food, moral analyses of vegetarianism and starvation, the safety and environmental risks of genetically modified food, issues of global food politics and the food industry, and the relationships among food, evolution, and human (...) history. (shrink)

Children who experience well-being are engaging more confidently and positively with their caregiver and peers, which helps them to profit more from available learning opportunities and support current and later life outcomes. The goodness-of-fit theory suggests that children’s well-being might be a result of the interplay between their temperament and the environment. However, there is a lack of studies that examined the association between children’s temperament and well-being in early childhood education and care, and whether this association is affected by (...) ECEC process quality. Using a multilevel random coefficient approach, this study examines the association between toddlers’ temperament and well-being in Norwegian ECEC and investigates whether process quality moderates this association. Results reveal an association between temperament and well-being. Staff-child conflict moderates the association between shyness and well-being, and between activity and well-being. Moreover, high emotional behavioral support moderates the association between activity and well-being. Extra attention should be paid by the staff to these children’s needs. (shrink)

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence (...) will be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence (...) will be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

Do pharmaceutical companies have a moral obligation to expand access to investigational drugs to patients outside the clinical trial? One reason for thinking they do not is that expanded access programs might negatively affect the clinical trial process. This potential impact creates dilemmas for practitioners who nevertheless acknowledge some moral reason for expanding access. Bioethicists have explained these reasons in terms of beneficence, compassion, or a principle of rescue, but their arguments have been limited to questions of moral permissibility, (...) leaving for future research the question of whether expanded access is morally obligatory. We take up this further question and argue that pharmaceutical companies have a moral obligation to expand access. Our defense is not based on beneficence, compassion, or rescue, but instead on a reciprocal moral expectation resulting from existing social commitments that help ensure a robust pharmaceutical practice within the broader healthcare system. Our aim is to give this obligation, along with several others, a coherent and plausible structure within the wider clinical trial process so that one might better explain the sources of the dilemmas and their possible resolutions. (shrink)

Treating physicians have key roles to play in expanded access to investigational drugs, by identifying investigational treatment options, assessing the balance of risks and potential benefits, informing their patients, and applying to the regulatory authorities. This study is the first to explore physicians’ experiences and moral views, with the aim of understanding the conditions under which doctors decide to pursue expanded access for their patients and the obstacles and facilitators they encounter in the Netherlands. In this mixed-methods study, semi-structured (...) interviews and a questionnaire were conducted with medical specialists across the country and analysed thematically. Typically, our respondents pursue expanded access in “back against the wall” situations and broadly support its classic requirements. They indicate practical hurdles related to reimbursement, the amount of time and effort required for the application, and unfamiliarity with the regulatory process. Some physicians are morally opposed to expanded access, with an appeal to safety risks, lack of evidence, and “false hope.” Some of these moral concerns and practical obstacles may be essential targets for change, if expanded access to unapproved drugs is to become available for wider groups of patients for whom standard treatment options are not—or no longer—available, on a more consistent and equal basis. (shrink)

This paper is a critique of the coercion argument against performance-enhancing drugs . According to this argument, lifting the ban on PEDs would undermine the autonomy of athletes by creating a situation where everyone must either use PEDs or not compete at the highest levels of sport. Four problems are raised for this argument and it is concluded that the argument fails. A variation on the coercion argument is also considered and rejected.

Earp, Lewis, and Hart argue the pursuit of racial justice requires a summary end to the war on drugs. In surveying the racially disparate harms of an enforcement-oriented, punitive, and ulti...

Abstract:Although the idea of intellectual property (IP) rights—proprietary rights to what one invents, writes, paints, composes or creates—is firmly embedded in Western thinking, these rights are now being challenged across the globe in a number of areas. This paper will focus on one of these challenges: government-sanctioned copying of patented drugs without permission or license of the patent owner in the name of national security, in health emergencies, or life-threatening epidemics. After discussing standard rights-based and utilitarian arguments defending intellectual (...) property we will present another model. IP is almost always a result of a long history of scientific or technological development and numbers of networks of creativity, not the act of a single person or a group of people at one moment in time. Thus thinking about and evaluating IP requires thinking about IP as shared rights. A network approach to IP challenges a traditional model of IP. It follows that the owner of those rights has some obligations to share that information or its outcomes. If that conclusion is applied to the distribution of antiretroviral drugs, what pharmaceutical companies are ethically required to do to increase access to these medicines in the developing world will have to be reanalyzed from a more systemic perspective. (shrink)

The mental illness of substance dependence or addiction is responsible for major economic, social, and personal costs. If we are to elucidate its etiology, understand its mechanisms, and eventually bring it under control, scientific investigation is essential. Research in animals and humans has enhanced our understanding of this disease through examination of genetic, neurophysiological, biochemical, and behavioral factors. But because animals cannot verbalize their subjective responses to drugs and because significant symptoms of addiction cannot be observed in non-drug-dependent humans, (...) it is not surprising that certain investigations of substance dependence have required the participation of addicted or substance-dependent humans. (shrink)

The mental illness of substance dependence or addiction is responsible for major economic, social, and personal costs. If we are to elucidate its etiology, understand its mechanisms, and eventually bring it under control, scientific investigation is essential. Research in animals and humans has enhanced our understanding of this disease through examination of genetic, neurophysiological, biochemical, and behavioral factors. But because animals cannot verbalize their subjective responses to drugs and because significant symptoms of addiction cannot be observed in non-drug-dependent humans, (...) it is not surprising that certain investigations of substance dependence have required the participation of addicted or substance-dependent humans. (shrink)

In two recent essays, Thomas Pogge addresses the question of how research and development of essential drugs should be incentivized. Essential drugs are drugs for diseases that ruin human lives. The current incentivizing scheme for such drugs is, according to Pogge, a significant causal factor in bringing about a state of affairs in which millions of people die or suffer from lack of access to essential drugs. Pogge, therefore, suggests a reform plan for how to (...) incentivize research and development of these drugs, and he is of the opinion that implementation of this plan will have a significant positive impact on the global disease burden. This paper is a critical examination of Pogge's reform plan. In the first part of the paper, Pogge's reasons for being dissatisfied with the current incentivizing scheme are spelled out. The reform plan is then presented, and in the final part of the paper, it is argued that the reform plan is flawed at a number of levels. (shrink)

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, (...) courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. (shrink)

Physicians who care for critically ill people with opioid use disorder frequently face medical, legal, and ethical questions related to the provision of life-saving medical care. We examine a complex medical case that illustrates these challenges in a person with relapsing injection drug use. We focus on a specific question: Is futility an appropriate and useful standard by which to determine provision of life-saving care to such individuals? If so, how should such determinations be made? If not, what alternative decisionmaking (...) framework exists? We determine that although futility has been historically utilized as a justification for withholding care in certain settings, it is not a useful standard to apply in cases involving people who use injection drugs for non-medical purposes. Instead, we are welladvised to explore each patient's situation in a holistic approach that includes the patient, family members, and care providers in the decision-making process. The scope of the problem illustrated demonstrates the urgent need to definitively improve outcomes in people who use injection drugs. Increasing access to high quality medication-assisted treatment and psychiatric care for individuals with opioid use disorder will help our patients achieve a sustained remission and allow us to reach this goal. (shrink)

The enduring psychiatric myth is that particular personal, interpersonal and social problems in living are manifestations of ‘mental illness’ or ‘mental disease’, which can only be addressed by ‘treatment’ with psychiatric drugs. Psychiatric drugs are used only to control ‘patient’ behaviour and do not ‘treat’ any specific pathology in the sense understood by physical medicine. Evidence that people, diagnosed with ‘serious’ forms of ‘mental illness’ can ‘recover’, without psychiatric drugs, has been marginalized by drug-focused research, much of (...) this funded by the pharmaceutical industry. The pervasive myth of psychiatric drugs dominates much of contemporary ‘mental health’ policy and practice and raises discrete ethical issues for nurses who claim to be focused on promoting or enabling the ‘mental health’ of the people in their care. (shrink)

This paper discusses so-called post-trial access to drugs for patients who participated in clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry due to the dimensions of its actual and potential market. As a consequence, the number of pharmaceutical trials has been rising. It is the largest market for pharmaceutical companies in Latin America, the 8th biggest in the world and second only to China among the so-called BRICS’s emerging countries. The demand for pharmaceutical (...) products in the country has been increasing by double digits over the last few years, reaching 20% in 2008. Not surprisingly, we are also witnessing a steady increase in the number of applications by national and international pharmaceutical companies before ethical research authorities for authorization to perform clinical trials of drugs. (shrink)

While pharmaceutical industry involvement in producing, interpreting, and regulating medical knowledge and practice is widely accepted and believed to promote medical innovation, industry-favouring biases may result in prioritizing corporate profit above public health. Using diabetes as our example, we review successive changes over forty years in screening, diagnosis, and treatment guidelines for type 2 diabetes and prediabetes, which have dramatically expanded the population prescribed diabetes drugs, generating a billion-dollar market. We argue that these guideline recommendations have emerged under pervasive (...) industry influence and persisted, despite weak evidence for their health benefits and indications of serious adverse effects associated with many of the drugs they recommend. We consider pharmaceutical industry conflicts of interest in some of the research and publications supporting these revisions, and in related standard-setting committees and oversight panels. We raise concern over the long-term impact of these multifaceted involvements. Rather than accept industry conflicts of interest as normal, needing only to be monitored and managed, we suggest challenging that normalcy, and ask: what are the real costs of tolerating such industry participation? We urge the development of a broader focus to fully understand and curtail the systemic nature of industry’s influence over medical knowledge and practice. (shrink)

BackgroundDrug user networks and community-based organizations advocate for greater, meaningful involvement of people with lived experience of drug use in research, programs and services, and policy initiatives. Community-based approaches to research provide an opportunity to engage people who use drugs in all stages of the research process. Conducting community-based participatory research with people who use drugs has its own ethical challenges that are not necessarily acknowledged or supported by institutional ethics review boards. We conducted a scoping review to (...) identify ethical issues in CBPR with people who use drugs that were documented in peer-reviewed and grey literature.MethodsThe search strategy focused on three areas; community-based research, ethical issues, and drug use. Searches of five academic databases were conducted in addition to a grey literature search, hand-searching, and consultation with organizational partners and key stakeholders. Peer reviewed literature and community reports published in English between 1985 and 2013 were included, with initial screening conducted by two reviewers.ResultsThe search strategy produced a total of 874 references. Twenty-five references met the inclusion criteria and were included in our thematic analysis. Five areas were identified as important to the ethics of CBPR with people who use drugs: 1) participant compensation, 2) drug user perspectives on CBPR, 3) peer recruitment and representation in CBPR, 4) capacity building, and 5) participation and inclusion in CBPR.ConclusionsWe critically discuss implications of the emerging research in this field and provide suggestions for future research and practice. (shrink)

Punitive policy responses to substance use and to abortion care constitute direct attacks on personal liberty and bodily autonomy. In this article, we leverage the concept of “syndemics” to anticipate how the already synergistic stigmas against people who use drugs and people who seek abortion services will be further compounded the Dobbs decision.

abstract In this paper, I first develop a neo-Aristotelian account of the virtue of magnanimity. I then apply this virtue to ethical issues that arise in sport, and argue that the magnanimous athlete will rightly use sport to foster her own moral development. I also address how the magnanimous athlete responds to the moral challenges present in sport by focusing on the issue of performance-enhancing drugs, and conclude that athletic excellence as it is conventionally understood, without moral excellence, has (...) very little value. (shrink)

The paper critically discusses a role-model argument (RMA) in favour of banning performance-enhancing drugs in sport. The argument concludes that athletes should be banned from using performance-enhancing drugs because if they are allowed to use such drugs they will encourage, or cause, youngsters who look up to them to use drugs in a way that would be harmful. In Section 2 the structure of the argument and some versions of it are presented. In Section 3 a (...) critical discussion of RMA is presented. It is argued that we should be reluctant to accept the argument as it stands for at least three reasons: (i) it rests on an unsupported empirical claim; (ii) it also makes a false empirical claim; and (iii) the normative premise of the argument is too demanding morally. Further objections to the RMA are also discussed, but argued to be beside the point. (shrink)

In crafting our paper on addressing the ethical challenges in HIV prevention research with people who inject drugs,1 we had hoped to stimulate further discussion and deliberation about the topic. We are pleased that three commentaries on our paper have begun this process.2 3 4 The commentaries rightly bring up important issues relating to community engagement and problems in translating research into practice in the fraught environments in which PWID face multiple risks. These risks include acquisition of HIV as (...) well as criminalisation, stigma and lack of access to needed healthcare, prevention and social services. We take this opportunity to respond to the excellent points raised by the commentators. All of the commentaries support our emphasis on robust community engagement with PWID and other stakeholders in designing and conducting HIV prevention research, but urge us to go farther. Wolfe highlights the difficulty of even engaging with community members in oppressive settings, where authorities severely restrict civil liberties of PWID so that even discussing issues related to drug use and enforcement may place individuals at risk. To overcome such limitations, he appropriately suggests interviewing confidentially those who have previously been detained in closed settings as part of the community engagement process. Similarly, Wolfe observes that critical issues can be overlooked with a narrow focus on study procedures if contextual factors before, during or after a study are ignored. For example, he cites the risk of overdose for study participants who have been abstinent during a study and subsequently resume injecting when the study concludes. These kinds of risks may not be obvious …. (shrink)

In crafting our paper on addressing the ethical challenges in HIV prevention research with people who inject drugs, 1 we had hoped to stimulate further discussion and deliberation about the topic. We are pleased that three commentaries on our paper have begun this process. 2 3 4 The commentaries rightly bring up important issues relating to community engagement and problems in translating research into practice in the fraught environments in which PWID face multiple risks. These risks include acquisition of (...) HIV as well as criminalisation, stigma and lack of access to needed healthcare, prevention and social services. We take this opportunity to respond to the excellent points raised by the commentators. All of the commentaries support our emphasis on robust community engagement with PWID and other stakeholders in designing and conducting HIV prevention research, but urge us to go farther. Wolfe highlights the... (shrink)

Are universities justified in trying to regulate student use of cognitive enhancing drugs? In this article I argue that they can be, but that the most appropriate kind of regulatory intervention is likely to be voluntary in nature. To be precise, I argue that universities could justifiably adopt a commitment contract system of regulation wherein students are encouraged to voluntarily commit to not using cognitive enhancing drugs. If they are found to breach that commitment, they should be penalized (...) by, for example, forfeiting a number of marks on their assessments. To defend this model of regulation, I adopt a recently-proposed evaluative framework for determining the appropriateness of enhancement in specific domains of activity, and I focus on particular existing types of cognitive enhancement drugs, not hypothetical or potential forms. In this way, my argument is tailored to the specific features of university education, and common patterns of usage among students. It is not concerned with the general ethical propriety of using cognitive enhancing drugs. (shrink)

인지 향상 약물은 안전성에 따른 위험에 대한 염려, 정의와 공정한 기회의 위협 그리고 인간 정체성과 정통성의 변화 등과 같은 윤리적 문제를 야기하고 있다. 또한 인지 향상 약물에 대한 의료 행위를 함에 있어서도 치료와 향상을 경계 짓기 위한 질병 및 정상 상태에 대한 정의가 모호하다는 한계점을 가진다. 이러한 점에서 본 논문에서는 인지 향상 약물사용을 위한 윤리적 실천 방안으로서 공동의사결정과정을 통한 자율성 존중의 강화와 선행에 근거한 위험-이익 분석 기준을 강화하는 방법을 제안하고자 한다. 구체적으로 인지향상 약물을 사용하고자 환자는 의사로부터 약물에 대한 충분한 정보를 (...) 제공받아야 하며 이를 통해 자신의 가치와 선호 따라 결정할 수 있어야 할 것이다. 또한 의사는 개별 환자의 약물 사용이 적절한지를 평가하기 위해서 동일한 약물이 다른 생명의료 중재를 위해 폭넓게 사용될 수 있으며 약물 사용의 결과 또한 다양하게 나타날 수 있다는 것을 인식하고 이를 올바르게 적용하기 위한 능력을 함양해야 할 것이다. 그리고 이에 근거하여 획일화된 기준이 아니라 개별 환자에게 적절한 위험-이익 분석 기준을 설정해야 할 것이다. 다시 말해 인지 향상 약물의 올바른 사용을 위해서는 무엇보다도 각각의 사례를 일반화시키고자 하는 것이 아니라 개별 환자의 상황에 따른 개별 단계에 초점을 맞추어 문제를 해결하고자 하는 노력이 요청된다. 또한 의사결정을 내림에 있어서도 단순히 자율성에 근거한 결정을 맹신하지 않고 환자-의사 관계의 상호성에 대한 인식을 바탕으로 개별 환자를 위한 최선의 결정을 내릴 수 있도록 하는 공동의사결정과정 체계가 구축되어야 할 것이다. (shrink)

The ethnographer has a difficult job of understanding and interpreting physical and social worlds that may be new to her. To study a society one needs an unprecedented amount of access to its peopl...

The lack of medical availability of effective pain medication is an enduring and expanding global health calamity. Despite important medical advances, pain remains severely under-treated worldwide, particularly in developing countries. This article contributes to the discussion of this global health crisis by considering international legal and institutional mechanisms to promote wider accessibility to critical narcotic drugs for pain relief.

This is a review and discussion of Ask Vest Christiansen’s book Gym Culture, Identity and Performance-Enhancing Drugs: Tracing a Typology of Steroid Use. As indicated by the title, the book...

Background In this qualitative analysis we aimed to explore addiction physicians’ perspectives on safer injection education for people who inject drugs, especially: (1) on possible means of introducing safer injection education in the medical environment, (2) on the compatibility of safer injection education with each physician’s core values and goals, and (3) on possible reasons for the ethical dilemma in safer injection education. Methods We conducted semi-structured interviews with eleven physicians practicing addiction medicine in France in clinical and harm (...) reduction settings. Results All participants were in favor of educational interventions for people who inject drugs. Nonetheless, these interventions varied from simple advice to injection supervision and they were seen as less acceptable when they concerned the practical and material aspects of injection. Some participants found that physicians practicing in clinical settings, where patients consult mostly to stop their drug use, should not practice safer injection education. On the contrary, other participants claimed that safer injection education was essential in all settings and was not a choice but rather a duty for addiction physicians. The ethical dilemma of such intervention when delivered by medical staff was viewed as a complex phenomenon, related to the representations of intravenous drug use and to societal expectations from physicians. Conclusion Physicians’ views on safer injection education for people who inject drugs reveal an emotionally charged subject related to the structural organization of addiction management in France. Such education is marked by an arduous history of harm reduction policies in France. IRB registration: #00011928. (shrink)

Organized religion has played a key role in shaping national and international policy for millennia. This paper discusses the parts some Christian churches have played in creating and supporting drug control policies stipulated inunmultilateral treaties. Mainstream churches have largely ignored the harms these policies inflict on vulnerable populations, including both people who use drugs, and those who are terminally ill and cannot access controlled medicines for pain relief. Mainstream – especially theologically “conservative” – churches reject people who use (...) class='Hi'>drugs, an approach that damages individuals, families, and communities both inside and outside the church, along multiple dimensions. This damage has, dialectically, produced a counter-theology and praxis that prioritizes compassionate ministry and insists on metanoia, a scriptural ethic of hospitality and evidence based care. Churches must play a prophetic role according to scripture, contemporary theologians, and Christians engaged in social justice praxis, in ministering to individuals who are marginalized and criminalized for using prohibited substances. (shrink)

In many countries, health technology assessment organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries’ methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in the methodologies HTA organizations use to (...) conduct their evaluations and considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy. (shrink)

ArgumentThis article examines the medical and political discussions regarding a controversial medicinal bark from Ecuador – cundurango – that was actively sponsored by the Ecuadorian government as a new botanical cure for cancer in the late nineteenth century United States and elsewhere. The article focuses on the commercial and diplomatic interests behind the public discussion and advertising techniques of this drug. It argues that diverse elements – including the struggle for positioning scientific societies and the disapproval of the capacities of (...) Ecuadorian doctors, US abolitionist history, regional and local political struggles – played a role in the quackery accusations against cundurango and its promoters. The development and international trade of this remedy offer interesting insights into the global history of drugs, particularly how medical knowledge was challenged during a period when scientific medicine was struggling for hegemony. It explores how newspapers expanded “the public interest” in a possible cancer cure. (shrink)

A major problem in the treatment of cancer is the specific targeting of anti‐tumor drugs to these abnormal cells. Ideally, such a drug should act over short distances to minimize damage to healthy cells, and target subcellular compartments that have the highest sensitivity to the drug. Photosensitizers, alpha‐emitting radionuclides and many other medicines could be considered as such drugs if they possessed cellular and subcellular specificity. The author describes a novel approach of using modular recombinant transporters to target (...) photosensitizers and alpha‐emitting radionuclides to the nucleus, where their action is most pronounced, of cancer cells. Photosensitizer‐transporter conjugates have up to 3000 times greater efficacy than free photosensitizers and display cell specificity in contrast to free photosensitizers. Alpha‐emitting radionuclides, conjugated with the modular transporters, acquired similar properties. The different modules of the transporters are interchangeable, meaning that they can be tailored for particular applications. BioEssays 30:278–287, 2008. © 2008 Wiley Periodicals, Inc. (shrink)

In Stovall v. Confimed.com, the Kansas Supreme Court held that an out-of-state medical doctor who sold a prescription drug to a Kansas minor over the Internet did not commit an unconscionable act under the Kansas Consumer Protection Act. The Shawnee Country District Court had enjoined the doctor from prescribing or dispensing prescription medicine within the state of Kansas, and the doctor appealed the injunction to the Kansas Supreme Court. The Supreme Court affirmed the district court's decision to grant injunctive relief, (...) but found no unconscionable conduct under the KCPA.The appellee, Washington physician Dr. Howard J. Levine, sold the sexual enhancement drug Viagra over the Internet through his online pharmacy. Neither the physician nor the online pharmacy was licensed to practice in Kansas. The purchasers were two Kansas residents, one of whom was a minor. Both purchased the drugs in a sting operation conducted by the Kansas Attorney General and received the drugs after completing an online application. (shrink)

Drawing on ethical and legal frameworks in the Netherlands, the United States and France, we examine whether physicians are expected to inform patients about potentially relevant opportunities for expanded access to investigational drugs. While we found no definitive legal obligation, we argue that physicians have a moral obligation to discuss opportunities for expanded access with patients who have run out of treatment options to prevent inequality, to promote autonomy, and to achieve beneficence.

Recent research offers good reason to think that various psychedelic drugs—including psilocybin, ayahuasca, ketamine, MDMA, and LSD—may have significant therapeutic potential in the treatment of various mental health conditions, including post-traumatic stress disorder, depression, existential distress, and addiction. Although the use of psychoactive drugs, such as Diazepam or Ritalin, is well established, psychedelics arguably represent a therapeutic step change. As experiential therapies, their value would seem to lie in the subjective experiences they induce. As it is the only (...) way for trainee psychedelic therapists to fully understand their subjective effects, some have suggested that firsthand experience of psychedelics should form part of training programs. We question this notion. First, we consider whether the epistemic benefits offered by drug-induced psychedelic experience are as unique as is supposed. We then reflect on the value it might have in regard to the training of psychedelic therapists. We conclude that, absent stronger evidence of the contribution drug-induced experiences make to the training of psychedelic therapists, requiring trainees to take psychedelic drugs does not seem ethically legitimate. However, given the potential for epistemic benefit cannot be entirely ruled out, permitting trainees who wish to gain first-hand experience of psychedelics may be permissible. (shrink)

Recent research conducted in Australia shows that many oncologists withhold information about expensive unfunded drugs in what the authors of the study suggest is unacceptable medical paternalism. Surprised by the Australian results, we ran a version of the study in New Zealand and received very different results. While the percentages of clinicians who would prescribe the drugs described in the scenarios were very similar (73–99% in New Zealand and 72–94% in Australia depending on the scenario) the percentage who (...) would not discuss expensive unfunded drugs was substantially lower in New Zealand (6.4–11.1%) than it was in Australia (28–41%). This seems surprising given the substantial similarities between the two countries, and the extensive interaction between their medical professions. We use the contrast between the two studies to examine the generalisability of the Australian results, to identify influences on clinicians' decisions about what treatment information to give patients, and so the tendency towards medical paternalism and, more pragmatically, about how such decisions might be influenced. (shrink)

We reply to the Ioannidis's paper "Effectiveness of antidepressants; an evidence based myth constructed from a thousand controlled trials." We disagree that antidepressants have no greater efficacy than placebo. We present the efficacy from hundreds of trials in terms of the percentage of patients with a substantial clinical response (a 50% improvement or more symptomatic reduction). This meta-analysis finds that 42-70% of depressed patients improve with drug and 21%-39% improve with placebo. The response benefit of antidepressant treatment is 33%-11% greater (...) than placebo. Ioannidis argues that it would be vanishingly smaller because systematic biasing in these clinical trials would reduce the drug-placebo difference to zero. Ioannidis' argument that antidepressants have no benefit is eroded by his failures of logic because he does not present any evidence that there are a large number of studies where placebo is substantially more effective than drug. (To reduce to zero, one would also have to show that some of the unpublished studies find placebo better than drug and have substantial systematic or methodological bias). We also present the empirical evidence showing that these methodological concerns generally have the opposite effect of what Ioannidis argues, supporting our contention that the measured efficacy of antidepressants likely underestimates true efficacy.Our most important criticism is Ioannidis’ basic underlying argument about antidepressants that if the existing evidence is imperfect and methods can be criticized, then this proves that antidepressant are not efficacious. He presents no credible evidence that antidepressants have zero effect size. Valid arguments can point out difficulties with the data but do not prove that a given drug had no efficacy. Indeed better evidence might prove it was more efficacious that originally found.We find no empirical or ethical reason why psychiatrists should not try to help depressed patients with drugs and/or with psychotherapeutic/behavioral treatments given evidence of efficacy even though our treatment knowledge has limitations. The immense suffering of patients with major depression leads to ethical, moral, professional and legal obligations to treat patients with the best available tools at our disposal, while diligently and actively monitoring for adverse effects and actively revising treatment components as necessary. (shrink)

Volume 20, Issue 9, September 2020, Page W1-W4.

During the process of in vitro fertilization (IVF), hormonal drugs are used to stimulate the woman's ovaries to produce multiple eggs. The injecting of the drugs is often performed by the women themselves outside of the clinical context, constituting a gendered burden of work that is rendered invisible by the dominant representations of treatment as undergone by couples and performed by doctors. Based on a series of interviews with women and couples who have undergone IVF unsuccessfully and who (...) have ended treatment at least two years previously, this paper focuses on two aspects of the self-injection of hormonal drugs that emerged from the participants accounts: firstly, the gendered ways in which the drug regimen was experienced as compromising privacy and secondly, the strategic use of images of both illicit and medical drug use in the accounts. The paper argues that in spite of the dominant representation of IVF as a couples’ technology, the IVF process is profoundly gendered, both in terms of bodily intervention and in the distribution of labour in the implementation of treatment; that the invisibility of the drug regimens from dominant representations of IVF can leave those undergoing treatment unprepared for some of the problems that the self-administration of the drugs can raise, particularly in terms of maintaining privacy; and finally, that images of the drug injection are mobilized strategically in the accounts to locate themselves within normative social reproductive standards. This highlights the extent to which the enduring ideological construction of proper womanhood as defined by motherhood continues to pose a dilemma for those who are involuntarily childless. (shrink)

In this article C. L. Tsou, of the Institute of Biophysics, Beijing, criticizes the use of the expression I50, the inhibitor concentration to produce 50% inhibition of a particular enzyme as a ‘most unfortunate’ parameter, when screening enzyme inhibitors designed as drugs. Comments on Dr Tsou's point of view will be welcomed from readers.