Pharmaceuticals

Cognitive enhancement may be defined as the amplification or extension of core capacities of the mind through improvement or augmentation of internal or external information processing systems. Cognition refers to the processes an organism uses to organize information. These include acquiring information (perception), selecting (attention), representing (understanding) and retaining (memory) information, and using it to guide behavior (reasoning and coordination of motor outputs). Interventions to improve cognitive function may be directed at any of these core faculties.

According to what Douglas calls ‘the consent requirement’, neuro-correctives can only permissibly be provided with the valid consent of the offender who will undergo the intervention. Some of those who endorse the consent requirement have claimed that even though the requirement prohibits the imposition of mandatory neurocorrectives on criminal offenders, it may yet be permissible to offer offenders the opportunity to consent to undergoing such an intervention, in return for a reduction to their penal sentence. I call this the neurocorrective (...) offer. In this chapter I consider the coercion-based objection to the neurocorrective offer, which claims that offenders cannot provide valid consent to undergoing a neurocorrective on the basis of this offer because it is inherently coercive. Having outlined early formulations of this argument, I point out that there are in fact two different versions of this objection, which appeal to different understandings of the concepts of coercion, consent and voluntariness. (shrink)

Time-tested commons characterize by having instituted sanctioning mechanisms that are sensitive to the circumstances and motivations of non-compliers. As a proposed Global Antimicrobial Commons cannot cost-effectively develop sanctioning mechanisms that are consistently sensitive to the circumstances of the global poor, I suggest concentrating on establishing a wider set of incentives that encourages both compliance and participation.

Conservative assumptions in medical ethics risk immense harms during a pandemic. Public health institutions and public discourse alike have repeatedly privileged inaction over aggressive medical interventions to address the pandemic, perversely increasing population-wide risks while claiming to be guided by ‘caution’. This puzzling disconnect between rhetoric and reality is suggestive of an underlying philosophical confusion. In this paper, I argue that we have been misled by status quo bias—exaggerating the moral significance of the risks inherent in medical interventions, while systematically (...) neglecting the risks inherent in the status quo prospect of an out-of-control pandemic. By coming to appreciate the possibility and significance of status quo risk, we will be better prepared to respond appropriately when the next pandemic strikes. (shrink)

This commentary defends 3 arguments for changing the label of levonorgestrel-based emergency contraception (LNG EC) so that it no longer supports the possibility of a mechanism of action after fertilization. First, there is no direct scientific evidence confirming any postfertilization mechanisms. Second, despite the weight of evidence, there is still widespread public misunderstanding over the mechanism of LNG EC. Third, this FDA label is not a value-free claim, but instead it has functioned like a political tool for reducing contraceptive access. (...) The label is laden with antiabortion values (even though EC is contraception, not abortion), and it imposes these values on potential users, resulting in barriers to access such as with Burwell v. Hobby Lobby. These 3 arguments together provide scientific, social, and ethical grounds for the FDA to take the initiate in changing Plan B's drug label. (shrink)

Objective: A deep understanding of the relationship between a scarce drug's dose and clinical response is necessary to appropriately distribute a supply-constrained drug along these lines. -/- Summary of key data: The vast majority of drug development and repurposing during the COVID-19 pandemic – an event that has made clear the ever-present scarcity in healthcare systems –has been ignorant of scarcity and dose optimisation's ability to help address it. -/- Conclusions: Future pandemic clinical trials systems should obtain dose optimisation data, (...) as these appear necessary to enable appropriate scarce resource allocation according to societal values. (shrink)

Philosophers of science and medicine now aspire to provide useful, socially relevant accounts of mechanism. Existing accounts have forged the path by attending to mechanisms in historical context, scientific practice, the special sciences, and policy. Yet, their primary focus has been on more proximate issues related to therapeutic effectiveness. To take the next step toward social relevance, we must investigate the challenges facing researchers, clinicians, and policy makers involving values and social context. Accordingly, we learn valuable lessons about the connections (...) between mechanistic processes and more fundamental reasons for medical interventions, particularly moral, ethical, religious, and political concerns about health, agency, and power. This paper uses debates over the controversial morning-after pill to gain insight into the deeper reasons for the production and use of mechanistic knowledge throughout biomedical research, clinical practice, and governmental regulation. To practice socially relevant philosophy of science, I argue that we need to account for mechanistic knowledge beyond immediate effectiveness, such as how it can also provide moral guidance, aid ethical categorization in the clinic, and function as a political instrument. Such insights have implications for medical epistemology, including the value-laden dimensions of mechanistic reasoning and the “epistemic friction” of values. Furthermore, there are broader impacts for teaching research ethics and understanding the role of science advisors as political advocates. (shrink)

Antibiotic resistance is one of the most pressing public health problems humanity faces. Research into new classes of antibiotics and new kinds of treatments – including risky experimental treatments such as phage therapy and vaccines – is an important part of improving our ability to treat infectious diseases. In order to aid this research, we will argue that we should permit researchers to pay people any amount of money to compensate for the risks of participating in clinical trials, including ‘challenge (...) studies’ that involve deliberately infecting patients. We think that standard worries about paying for participation in risky research are reducible to concerns that can be addressed with the right screening mechanisms. (shrink)

Should the development of pharmacological cognitive enhancers raise worries about doping in cognitively demanding activities? In this paper, we argue against using current evidence relating to enhancement to justify a ban on cognitive enhancers using the example of chess. It is a mistake to assume that enhanced cognitive functioning on psychometric testing is transferable to chess performance because cognitive expertise is highly complex and in large part not merely a function of the sum specific sub-processes. A deeper reason to doubt (...) that pharmacological cognitive enhancers would be as significant in mind sports is the misleading parallel with physical enhancement. We will make the case that cognitive performance is less mechanical in nature than physical performance. We draw lessons from this case example of chess for the regulation of cognitive enhancement more generally in education and the professions. Premature regulation runs the risk of creating a detrimental culture of suspicion that ascribes unwarranted blame. (shrink)

The paper discusses the possibility that the benefits of pharmacogenomics will not be distributed equally and will create orphan populations. I argue that since these inequalities are not substantially different from those produced by ‘traditional’ drugs and are not generated with the intention to discriminate, their production needs not be unethical. Still, the final result is going against deep-seated moral feelings and intuitions, as well as broadly accepted principles of just distribution of health outcomes and healthcare. I thus propose two (...) provisos that would prevent the most offensive outcomes and moderate the scope of the produced inequalities. The first proviso rejects pharmacogenomics innovations that worsen existing group inequalities and aggravate the disadvantage of communities with a history of discrimination. The second proviso requires that there is a strategy in place to even out as much as possible the distribution of benefits in the future and that a system of compensations is in place for pharmacogenomic orphans. Given that only one moral problem generated by pharmacogenomics has been tackled, the list of provisos might be expanded when other issues are considered. (shrink)

Antibiotic-resistant bacteria pose a serious threat to our health. Our ability to destroy deadly bacteria by using antibiotics have not only improved our lives by curing infections, it also allows us to undertake otherwise dangerous treatments from chemotherapies to invasive surgeries. The emergence of antibiotic resistance, I argue, is a consequence of various iterations of prisoner’s dilemmas. To wit, each participant (from patients to nations) has rational self-interest to pursue a course of action that is suboptimal for all of us. (...) The standard solutions to prisoner’s dilemma look to realign cost-benefit such that individuals’ interests match those of the collective. However, the lack of a global organization to enforce an effective carrot-and-stick system makes it unlikely that we can solve the antibiotic resistance problem this way. I argue that our best chance might be an attempt to teach altruism and convince individuals to act not out of their self-interests. (shrink)

Intellectual property regimes necessarily create artificial scarcity leading to wastage, both by blocking follow-up research and hindering access to those who are only able to pay less then the actual retail price. After revising the traditional arguments to hinder access to people’s intellectual labour we will examine why we should be more open to allow free-riding of inventive efforts, especially in cases where innovators have not secured the widest access to the fruits of their research and failed to cooperate with (...) follow-up innovators. We will do so by questioning the voluntariness involved in consumption of objects of innovation, restating the positive social externalities that arise when wider access to the fruits of innovation is assured, and examining the eventual harms innovators face. (shrink)

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...) (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

Business models for biomedical research prescribe decentralization due to market selection pressures. I argue that decentralized biomedical research does not match four normative philosophical models of the role of values in science. Non-epistemic values affect the internal stages of for-profit biomedical science. Publication planning, effected by Contract Research Organizations, inhibits mechanisms for transformative criticism. The structure of contracted research precludes attribution of responsibility for foreseeable harm resulting from methodological choices. The effectiveness of business strategies leads to overrepresentation of profit values (...) versus the values of the general public. These disconnects in respect to the proper role of values in science results from structural issues ultimately linked to the distinct goals of business versus applied science, and so it seems likely that disconnects will also be found in other dimensions of attempts to combine business and science. The volume and integration in the publishing community of decentralized biomedical research imply that the entire community of biomedical research science cannot match the normative criteria of community-focused models of values in science. Several proposals for changing research funding structure might successfully relieve market pressures that drive decentralization. (shrink)

This is an early volume from a much respected psychedelic psychotherapist. He has written several other books since this one but until recently none of his books were on Amazon and still you can only find a German edition and a Spanish one (from 1993) but no English one (except a couple used copies). This is sad since these drugs have enormous therapeutic potential but afaik government suppression still prevents their use. The most interesting and readable parts are the case (...) histories of drug therapy, especially his own-e.g., on pages 114, 166 and 178. Though a very advanced therapist compared to many, he is far from finished with his intellectual growing up and clings to his psychoanalytic background even though he often mentions its extreme shortcomings. The often painfully awkward text is full of insights from his own therapeutic voyages and those of his patients interspersed with psychoanalytic nonsense. Part of the awkwardness may be due to bad translation from the German but the lack of a rational spiritual framework is a major problem (as with most therapy-or most life for that matter) that he only occasionally seems to recognize. He also sometimes veers off into the ozone-e.g., after many pages of sensible dialog he can opine that varicose veins and cancer are a result of the splitting of a psychosis (p99)! He quotes Zen and Sufi stories, Krishnamurti and Al Ghazali and even Castenada (seemingly unaware of his exposure as a fraud 20 years ago!), yet he seems oblivious to the fact that meditation is the most powerful therapy there is and to the presence around him in his own country and all over the globe of the most diverse and effective therapeutic community that has ever existed-that of the students of the great Indian mystic (ie, psychotherapist) Osho. What a great pity! He could have learned so much and advanced his therapy so far. But like most people he deliberately or unconsciously avoids anything which might wake him up too much. It's possible however that he just avoids mentioning Osho as he's radical enough to trigger the control templates in the monkey brain and enlightenment has the power to change one's whole life and not just put a bandaid on as other therapies usually do. Widmer refers repeatedly to the great LSD therapy pioneer Stanislav Grof, whose writings are one of the first that the interested reader may want to consult. Also, anyone who has a serious interest in psychedelic therapy should read Myron Stolaroff´s " The Secret Chief "-an account of the most remarkable clandestine therapist of this type of all time. It tells the story of the late Leo Zeff, who helped thousands to find themselves with the skilled and varied use of a wide variety of psychedelics. As the book is hard to find you may wish to read the info on Zeff on the web. In addition the clinical chapters in the excellent Ecstasy:the complete guide by J. Holland(2001) and her web page www.drholland.com (and elsewhere on the net) provide a broad framework and guide to therapy that is lacking here. A lovely book to add to any drug or therapy library, if you can find it. -/- Those wishing a comprehensive up to date framework for human behavior from the modern two systems view may consult my article The Logical Structure of Philosophy, Psychology, Mind and Language as Revealed in Wittgenstein and Searle 59p(2016). For all my articles on Wittgenstein and Searle see my e-book ‘The Logical Structure of Philosophy, Psychology, Mind and Language in Wittgenstein and Searle 367p (2016). Those interested in all my writings in their most recent versions may consult my e-book Philosophy, Human Nature and the Collapse of Civilization - Articles and Reviews 2006-2016 662p (2016). -/- All of my papers and books have now been published in revised versions both in ebooks and in printed books. -/- Talking Monkeys: Philosophy, Psychology, Science, Religion and Politics on a Doomed Planet - Articles and Reviews 2006-2017 (2017) https://www.amazon.com/dp/B071HVC7YP. -/- The Logical Structure of Philosophy, Psychology, Mind and Language in Ludwig Wittgenstein and John Searle--Articles and Reviews 2006-2016 (2017) https://www.amazon.com/dp/B071P1RP1B. -/- Suicidal Utopian Delusions in the 21st century: Philosophy, Human Nature and the Collapse of Civilization - Articles and Reviews 2006-2017 (2017) https://www.amazon.com/dp/B0711R5LGX -/- . (shrink)

Factory farming continues to grow around the world as a low-cost way of producing animal products for human consumption. However, many of the practices associated with intensive animal farming have been criticized by public health professionals and animal welfare advocates. The aim of this essay is to raise three independent moral concerns with factory farming, and to explain why the practices associated with factory farming flourish despite the cruelty inflicted on animals and the public health risks imposed on people. I (...) conclude that the costs of factory farming as it is currently practiced far outweigh the benefits, and offer a few suggestions for how to improve the situation for animals and people. (shrink)

Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising. However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns (...) as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA. (shrink)

A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health. Description: The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to standardize and integrate data (...) relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term ‘adverse event’ denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data. (shrink)

El presente artículo tiene como objetivo destacar la problemática de las prácticas de extensión o prolongación de los derechos de exclusividad sobre los medicamentos, llevadas a cabo por la industria farmacéutica, una vez el término de protección vía patente está por finalizar. A través de tres escenarios se pone de manifiesto las implicaciones de este fenómeno, destacándose la necesidad de involucrar activamente al Estado para garantizar así unas condiciones equitativas de acceso a los medicamentos.

Is the boundary between the normal and the pathological real or fiction? Are health and disease just a matter of fact or are they value-laden? Here we present some examples of how alleged diseases can be invented and propagated by the industry (disease mongering) or by the methodology of medical science itself. We show that the boundary between health and disease is blurred and depends on individual and social representations, culture relative ways of categorising things and people, and by the (...) society’s degree of medicalisation. However, we do not mean that it is not real, rather that it is more complex than expected, as the subjectivity of social constructions and individual experiences makes them no less real. Finally, we conclude that health and disease belong to both objective and subjective kinds of reality, so the fictional can be real. (shrink)

Among the many potential benefits arising from the rapidly advancing field of nanomedicine is the possibility of a whole new range of nanovaccines in which novel delivery mechanisms utilizing nanoparticles could make obsolete the use of needles for administering any vaccine. However, as the massive resources of the worldwide pharmaceutical industry are deployed to develop nanovaccines, urgent questions arise as to which diseases should be targeted and which populations will benefit most. -/- This paper explores how such targeting of nanovaccines (...) might be decided in an ethically optimal way and considers some of the practical considerations and potential problems of implementing such a global nanovaccine policy. There seems little doubt that nanomedical research could develop vaccines against most major global infectious diseases. Throughout the history of medicine, however, it is well recognized that insufficient attention and resources have been given to public health and preventive medicine and the environmental causes of ill-health remain under-researched. We urge that national governments and regional authorities of wealthier countries incentivise their powerful pharmaceutical corporations to develop nanovaccines within a global and long term perspective and not just to focus on the diseases of the developed world. (shrink)

In this thesis we have examined the complex interaction between intellectual property rights, life sciences and global justice. Science and the innovations developed in its wake have an enormous effect on our daily lives, providing countless opportunities but also raising numerous problems of justice. The complexity of a problem however does not liberate society as a whole from moral responsibilities. Our intellectual property regimes clash at various points with human rights law and commonly held notions of justice.

We argue that the fragility of contemporary marriages—and the corresponding high rates of divorce—can be explained (in large part) by a three-part mismatch: between our relationship values, our evolved psychobiological natures, and our modern social, physical, and technological environment. “Love drugs” could help address this mismatch by boosting our psychobiologies while keeping our values and our environment intact. While individual couples should be free to use pharmacological interventions to sustain and improve their romantic connection, we suggest that they may have (...) an obligation to do so as well, in certain cases. Specifically, we argue that couples with offspring may have a special responsibility to enhance their relationships for the sake of their children. We outline an evolutionarily informed research program for identifying promising biomedical enhancements of love and commitment. (shrink)

Taking into consideration the extremely harsh public health conditions faced by the majority of the world population, the Health Impact Fund (HIF) proposal seeks to make the intellectual property regimes more in line with human rights obligations. While prioritizing access to medicines and research on neglected diseases, the HIF makes many compromises in order to be conceived as politically feasible and to retain a compensation character that makes its implementation justified solely on basis of negative duties. Despite that current global (...) health realities make such steps reasonable, the paper looks up the negative effects on one overlooked human right: the right to participate in scientific advancement. (shrink)

We live in times where it is possible to control our emotions using biomedical means – for example by taking pills that make us feel better. This chapter discusses one worry about the biomedical enhancement of mood. It is a worry that seems to play an important role in more familiar objections to biomedical enhancement of mood, such as the objection that it would lead to inauthenticity. The worry is that the use of positive mood enhancers will corrupt emotional lives. (...) Ethical questions about the biomedical enhancement of mood are often really questions about our affective reasons. Negative emotions typically feel bad, positive ones typically feel good. Here our hedonic reasons come into direct competition with affective reasons. Those who entirely dismiss affective reasons, or at least think that negative affective reasons are extremely weak, are likely to see little problem with positive mood enhancers. (shrink)

Die Frage nach der Definition von Doping basiert nicht zuletzt auf naturwissenschaftlicher Forschung. Aus einer naturwissenschaftlichen Perspektive könnte man sogar behaupten, dass die aktuelle Dopingdebatte ihre Ursachen gerade in der pharmazeutischen Forschung hat, da sich das Problem des Dopings erst mit dem Vorhandensein entsprechender Mittel bzw. Methoden zur Leistungssteigerung stellt. Allerdings wird die Frage der Dopingdefinition im Folgenden nicht auf einen naturwissenschaftlichen Referenzrahmen reduziert, wie dies in den aktuellen Dopingdefinitionen häufig der Fall ist. Vielmehr werde ich die spezifische Rolle naturwissenschaftlicher (...) Forschung mit Blick auf die Dopingdefinition und die daraus resultierenden strukturellen Schwierigkeiten darstellen. (shrink)

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 the (...) declaration of side effects associated with pharmaceutical products or when a decision about drug approval or retirement must be delivered on the available evidence. In these cases, risk communication seems to accomplish other tasks than preventing risk or reducing uncertainty. The present paper analyzes the legal instruments which have been developed in order to control and manage the risks related to drugs – such as the notion of “development risk” or “residual risk” – and relates them to different kinds of uncertainty. These are conceptualized as epistemic, ecological, metric, ethical, and stochastic, depending on their nature. By referring to this taxonomy, different functions of pharmaceutical risk communication are identified and connected with the legal tools of uncertainty management. The purpose is to distinguish the different functions of risk communication and make explicit their different legal nature and implications. (shrink)

In this paper, I sound a warning note about the medicalization of risk conditions such as high cholesterol, especially in a health care climate of resource scarcity.

Despite analgesic and emetogenic benefits, cannabis has been banned from prescription in a number of western countries. Although some benefits are shared by drugs already available, the options of prescription are limited to the physician. The negative side-effects of cannabis do not justify this limitation on freedom and autonomy. Recreational use warrants limitations, as the search for euphoria is regularly believed to be a non-autonomous behavior. Medical prescriptions serve an analgesic and emetogenic purpose comparable to other prescribed drugs. This vindicates (...) the right for a physician to prescribe cannabis to qualified patients. For a patient to be considered qualified, they must be an adult that does not drive often, is not pregnant, and not at risk of schizophrenia or cardiovascular disease. If possible, cannabis should be eaten in an effort to avoid smoke irritation in the lungs and aerodigestive tract. In the end, the question is not whether cannabis use is efficable, but rather is the limitation of medical treatments to patients in need ethical? In light of the medical benefits, the banning of cannabis is simply immoral. Keywords: cannabis, banned substance, prescription, analgesic, emetogenic Note. Authors did not receive any external funding, nor display conflict of interest. (shrink)