Many health care systems include programs that allow patients in exceptional circumstances to access medical interventions of as yet unproven benefit. In this article we consider the ethical justifications for—and demands on—these special access programs (SAPs). SAPs have a compassionate basis: They give patients with limited options the opportunity to try interventions that are not yet approved by standard regulatory processes. But while they signal that health care systems can and will respond to individual suffering, SAPs have several disadvantages, including (...) the potential to undermine regulatory and knowledge-generation structures that constitute significant public goods. The “balance” between these considerations depends in part on how broadly SAPs are used, but also on whether SAPs can be made to contribute to the generation of knowledge about the effects of health interventions. We argue that patients should usually be required to contribute outcome data while using SAPs. (shrink)

When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years. This raises an issue for drugs which could benefit terminally ill patients. These patients might set their hopes on the experimental drug but are unable to wait since they are likely to pass away before the drug is available. As a means of nevertheless getting access to experimental drug, many seriously ill and (...) terminally ill patients are therefore very willing to participate in randomised controlled trials. However, only very few terminally ill patients are able to actually participate, and those that do participate are at risk of participating solely as a way of getting experimental drugs. Currently, there are, however, ways of getting access to drugs that have not gained market approval. One such mean is via expanded access or compassionate use programs where terminally ill patients receive experimental new drugs that are not yet market approved. In this paper, I examine some of the common justifications for such programs. The most frequently voiced justifications for compassionate use or expanded access programs could be put in one of three categories. First, there are justifications of justice, where compassionate use programs could be seen as a just or fair way to distribute experimental new drugs to patients who are denied access to RCT’s through no fault of their own. Second, such programs could be justified by reference to the ethical principle of beneficence where it could be claimed that terminally ill patients stand to benefit greatly at very little risk. Third, there are considerations of autonomy where, it is claimed, patients should be able to exercise their autonomy and have access to such drugs if that is there free choice and they are fully aware of the risks associated with that choice. In this paper, I argue currently all justifications are potentially problematic. If they truly form the basis for justification, compassionate use programs should be designed to maximize justice, beneficence and autonomy. (shrink)

One recent development in epistemology, the philosophical study of knowledge, is the notion of ‘epistemic innocence’ introduced by Bortolotti and colleagues. This concept expresses the idea that certain suboptimal cognitive processes may nonetheless have epistemic (knowledge-related) benefits. The idea that delusion or confabulation may have psychological benefits is familiar enough. What is novel and interesting is the idea that such conditions may also yield significant and otherwise unavailable epistemic benefits. I apply the notion of epistemic innocence to research on the (...) transformative potential of psychedelic drugs. The popular epithet ‘hallucinogen’ exemplifies a view of these substances as fundamentally epistemically detrimental. I argue that the picture is more complicated and that some psychedelic states can be epistemically innocent. This conclusion is highly relevant to policy debates about psychedelic therapy. Moreover, analysing the case of psychedelics can shed further light on the concept of epistemic innocence itself. (shrink)

A pressing philosophical problem is how to respond to the existential, anxiety and disenchantment resulting from a naturalistic worldview that eschews transcendent foundations for meaning and value. This problem is becoming more urgent as the popularization of neuroscientific findings renders a disenchanted conception of human beings ever more vivid, compelling, and widespread. I argue that the study of transformative experiences occasioned by classic psychedelic drugs such as lysergic acid diethylamide and psilocybin may reveal the nature of a viable practical solution (...) to this problem. Despite the apparent centrality of nonnaturalistic metaphysical apprehensions to psychedelic transformation, findings from psychedelic research suggest that key elements of psychedelic or “entheogenic” spirituality are consistent with naturalism. These include disruption to neurocognitive mechanisms underpinning the sense of self, and consequent experiences of self-transcendence and of the decoupling of attention from personal concerns. This liberation of attention can result in the availability of broader perspectives and the development of wonder and appreciation for life. (shrink)

ABSTRACT In this paper, I support the claim that placing certain restrictions on public access to possible new treatments is morally problematic under some exceptional circumstances. Very ill patients may find that all available standard treatments are unacceptable, either because they are ineffective or have serious adverse effects, and these patients may understandably be desperate to try something new even if this means stepping into the unknown. Faced with certain death, it is rational to want to try something new and (...) to chance a dire outcome. Restricting possible new treatments to research trials may put these treatments scientifically, geographically or economically out of reach of these patients. For those who can get access, research restrictions could weaken, though not necessarily eliminate, the value of consent participants of such trials are able to give. Some participants may therefore be exploited for scientific purposes in the name of public interest. There are nonetheless compelling reasons for keeping some restrictive regulation in this area. (shrink)

Why does American law allow the recreational use of some drugs, such as alcohol, tobacco, and caffeine, but not others, such as marijuana, cocaine, and heroin? The answer lies not simply in the harm the use of these drugs might cause, but in the perceived morality—or lack thereof—of their recreational use. Despite strong rhetoric from moral critics of recreational drug use, however, it is surprisingly difficult to discern the reasons they have for deeming the recreational use of (some) drugs morally (...) wrong. In this book, Rob Lovering lays out and dissects various arguments for the immorality of using marijuana, cocaine, heroin, and other drugs recreationally. He contends that, by and large, these arguments do not succeed. Lovering's book represents one of the first works to systematically present, analyze, and critique arguments for the moral wrongness of recreational drug use. Given this, as well as the popularity of the morality-based defense of the United States' drug laws, this book is an important and timely contribution to the debate on the recreational use of drugs. (shrink)

Recent scientific research into the therapeutic potential and mechanisms of psychedelic drugs raises intriguing and hitherto largely unexplored philosophical questions. A brief overview of the relevant science is given before addressing these questions. It is argued that psychedelic transformation is a distinctive psycho- pharmacological intervention because its mechanism of action ineliminably involves conscious mental representations, and thus is more transparent to the subject than the mechanisms of other drug therapies. This argument connects with issues in the philosophy of (cognitive) scientific (...) explanation. It is also argued that transformative psychedelic experiences may well confer three distinct kinds of epistemic benefits: knowledge by acquaintance of the subject's psychological potential, knowledge by acquaintance of the meta-physical nature of the (sense of) self, and revitalized capacities for the acquisition of modal knowledge. Non-naturalistic metaphysical and epistemological claims abound in psychedelic circles; thus, it is important to realize that psychedelics may yield naturalistically acceptable epistemic benefits. (shrink)