Pharmaceuticals

Opioid treatment agreements are written agreements between physicians and patients enumerating the risks associated with opioid medications along with the requirements that patients must meet to receive these medications on an ongoing basis. The choice to use such agreements goes beyond the standard informed consent process, and has a distinctive symbolic significance. Specifically, it suggests that physicians regard it as important to hold their patients accountable for adhering to various protocols regarding the use of their opioid medications. After laying out (...) a taxonomy of accountability relationships between physicians and patients, I argue that opioid treatment agreements are only justifiable for physicians to use in their provision of care if they improve public health outcomes, which has yet to be demonstrated. (shrink)

We live in an age alleged devoted to evidence-based medicine. Evidence-based medicine, however, depends on reliable data and if the data are largely, if not completely, manipulated by the manufacturer of pharmaceuticals, then the data are not reliable. Evidence-based medicine is an illusion. -/- This book raises and attempts to answer the following questions: What are the ways in which the profit motive of industry undermines the integrity of science? How is science protected from corporate malfeasance in a capitalist economy? (...) Our particular focus is the relationship between the pharmaceutical industry and medicine. We argue that medicine desperately needs to re-evaluate its relationship with the pharmaceutical industry and re-affirm the ideal of evidence-based medicine. In our view, Karl Popper’s philosophy of science, Falsificationism and Critical Rationalism, provides a rigorous conception of science required to preserve the integrity of the scientific basis of medicine against the commercial influences. (shrink)

An apparent ethical dilemma arises when physicians consider enrolling their patients in randomized clinical trials. Suppose that a randomized clinical trial comparing two treatments is in progress, and a physician has an opinion about which treatment is better. The physician has a duty to promote the patient's best medical interests and therefore seems to be obliged to advise the patient to receive the treatment that the physician prefers. This duty creates a barrier to the enrollment of patients in randomized clinical (...) trials.1-10 Two strategies are often used to resolve the dilemma in favor of enrolling patients in clinical trials. (shrink)

This work is a reappraisal of the nature of psychiatric illness and therapeutic approaches to it. It looks at how current classifications and treatment derive from a century-old framework which is now incoherent.

Ketamine, a dissociative anesthetic commonly used by US physicians, has recently been shown to be a powerful anti-depressant and is also capable of eliciting transpersonal experiences that can be transformative. Although currently approved in the US only for use as an anesthetic, physicians there can legally prescribe it off-label to treat various psychological/ psychiatric problems and it has been used for these non-anesthetic purposes in Argentina, Iran, Mexico, Russia, and the UK, as well as in the US. The literature on (...) using ketamine psychotherapeutically is reviewed and two case studies using ketamine-enhanced psychotherapy for treating death anxiety in terminally-ill people are reported. The potential importance of beginning formal research on using KEP during end-of-life for those suffering death anxiety is emphasized. (shrink)

A single-blind run-in phase is often employed in randomized controlled trials. During these types of trials, all participants are given a placebo but are not informed of this fact. In many trials, participants who are judged to be “placebo responders” or who don’t follow instructions for taking the drug are excluded from further participation at the conclusion of this phase. Because participants are not informed of these procedures, this represents the use of deception in research.

In this dissertation, I use recent theoretical approaches in the human sciences to reconsider fundamental organizing structures of psychiatric knowledge. Chapter 1 outlines how the tropes of "theory" and "a-theory" are used in the human sciences and in psychiatry, critiques psychiatry's a-theoretical approach, and explores the possibilities for a retheorized psychiatry along the lines of work in the human sciences. Chapter 2 and 3 concentrate respectively on two key aspects of "theory"---language and power---and considers their role in shaping and fixing (...) psychiatric knowledge structures. Chapter 4 organizes the theoretical discussion thus far around a sustained reflection on "modernism" and "postmodernism" as relevant to psychiatry. Three themes of psychiatric modernism are outlined and contrasted with three themes of psychiatric postmodernism. I argue in favor of psychiatry, or some branch of psychiatry, shifting toward more postmodern paradigm. ;Chapter 5 is a bridge chapter, which explores other recent theoretical scholarship similar to mine applied in the new genre I call "medical cultural studies." I make this shift to medicine primarily for the practical reason that there has been more work in cultural studies of medicine than there has in cultural studies of psychiatry. The next two chapters start the process of cultural studies of psychiatry. Chapter 6 is devoted to the dramatic rise of pharmaceuticals in psychiatry, and chapter 7 is devoted to the controversial role of DSM---psychiatry's dominant diagnostic manual. The last chapter imagines a possible feminist successor science for psychiatry. After reviewing the main themes of feminist epistemology, I apply their efforts to a "re-formed" psychiatry. In this chapter, I imagine, based on my research but without regard for politically practicalities, how things might be otherwise in psychiatry. Of course, imagination doesn't make it so, but; imagination can guide our efforts toward change. (shrink)

The traditional gap between scholarly studies of facts and principles on the one hand, and the practical solution of human problems concerning these facts, on the other hand, has in certain fields been considerably narrowed. The mathematical and empirical sciences have been able to directly apply their theories through universal techniques to the needs of human life. The classic discrepancy between theory and practice seems to have been overcome by the latter. Psychiatry, however, remains ambivalent about its ability to integrate (...) psychiatric theory and practice. For example, in spite of enormous advances in the scientific study of human behavior and mental disorders over the past twenty-five years, public mental health services are in disarray.1 In addition, a proliferation of competing theoretical and treatment programs has emerged. Estimates indicate up to 200 or more “brand names” of psychotherapies.2 In 1984, an editorial in a leading medical journal, Lancet,.challenged the psychotherapies to demonstrate their effectiveness.3 The psychiatric field’s difficulties in extending its scientific advances to its practical domain partially lie in its dual nature. Psychiatry simultaneously belongs to the empirical study of mental illness and human behavior as well as to the humanistic study and treatment of the human mind and emotional suffering. In spite of psychiatry’s striving to achieve scientific universality in its practical usefulness, it still remains in reality much closer in its applications to art than to technique.4 [This fact generates considerable criticism and controversy.] The humanistic domain of psychiatry brings the scholar and the scientist into a confrontation between lived human experience and theoretical conjecture about it. In fact, reality keeps the scientific imagination in check. For example, empirical approaches provide inadequate solutions to the suffering of the homeless patients living on our country’s streets. Like any technical application of science to the practical needs of human life, psychiatry deals directly with the concrete: in concurrence with the concrete human person. However, while the technical application of science deals with the application of universal principles, psychiatry in radical contrast deals more often than not with unique concrete situations.5 For example, although depressive illness might exhibit core depressive symptoms, each individual experiences his or her sadness within a unique and highly personal social and psychological context. However, each situation is a unique and unrepeatable occasion for the practitioner to apply whatever the scientific theories may support. Groping for the appropriate attitude toward the psychiatric patient, the practitioner has to have clearly in mind an aim and a direction toward which to direct his treatment. (shrink)

Experimental randomization is defended as a procedure to select an allocation of treatments in comparative experiments. To be convincing, a comparative experiment should allow many alternative allocations of treatments over experimental units, that look equally informative "on paper," but may have underlying differences. Randomization prevents these underlying differences to be causally influential when an allocation is chosen for implementation. Randomization helps prevent bias. ;Both Bayesian criticisms of randomization and what seems to be the opinion of the early Fisher are rejected. (...) The Bayesian decision theoretic argument against randomization is shown to rest on a faulty analysis of experimental randomization that goes back, at least, to Abraham Wald. An improved decision theoretic framework is formulated in which randomization can indeed give higher expected utility. Against the early Fisher it is argued that the choice of a randomization scheme depends on the identification of equally informative, alternative allocations. Randomization alone can never validate a statistical analysis because what allocation is actually implemented, is relevant information that has to be taken into account in the statistical analysis. This does not, however, turn randomization into a useless ritual. The manner in which an allocation is obtained is equally relevant information. (shrink)

In light of the central role that medications play in medical progress, the declining rate of new drug development over the past decade is cause for concern . Without important breakthroughs in drug discovery, the future will not be auspicious for the many people suffering from chronic and incurable illnesses. The sluggish pace of pharmaceutical innovation has been particularly characteristic of the largest drug manufacturers, which have generally focused their energies on potential blockbuster medications, those that can generate over $1 (...) billion in annual revenue . Given Pharma’s struggles, the success of the country’s largest drug manufacturer in bringing the .. (shrink)

Mumbai, like any other Metro city, has its own share of contentious issues influencing psychiatric management. These could be old ongoing issues like myths about medications, electroconvulsive therapy and counselling, or newer ones like our stand on homosexuality and crime related to psychosocial factors. A range of these issues is considered in this paper along with some possible solutions. Getting due credit and status for psychiatry as a medical branch is also a challenge we need to address.

Novel therapeutics enter human testing after they show promise in animal and in vitro studies. They then begin a life cycle that extends from early phase trials without control groups, to randomized trials, to approval by regulatory authorities, to coverage by payers, to use in clinical practice. At each stage, scientific evidence is critical to determining whether to progress to the next step in this life cycle. Each of these decisions also implicitly involves issues of value and ethical norms based (...) on how the decision-makers weigh the risks of two types of errors: false positives and false negatives. For example, in determining whether to approve a new molecular entity based on evidence submitted by a.. (shrink)

In the atavistic model of cancer progression, tumor cell dedifferentiation is interpreted as a reversion to phylogenetically earlier capabilities. The more recently evolved capabilities are compromised first during cancer progression. This suggests a therapeutic strategy for targeting cancer: design challenges to cancer that can only be met by the recently evolved capabilities no longer functional in cancer cells. We describe several examples of this target‐the‐weakness strategy. Our most detailed example involves the immune system. The absence of adaptive immunity in immunosuppressed (...) tumor environments is an irreversible weakness of cancer that can be exploited by creating a challenge that only the presence of adaptive immunity can meet. This leaves tumor cells more vulnerable than healthy tissue to pathogenic attack. Such a target‐the‐weakness therapeutic strategy has broad applications, and contrasts with current therapies that target the main strength of cancer: cell proliferation. (shrink)

Stein & Glasier suggest embryonic neural tissue grafts as a potential treatment strategy for Alzheimer's and Parkinson's disease. As an alternative, we suggest that the family of nerve growth factor-related neurotrophins and their trk (tyrosine kinase) receptors underlie cholinergic basal forebrain (CBF) and dopaminergic substantia nigra neuron degeneration in these diseases, respectively. Therefore, treatment approaches for these disorders could utilize neurotrophins.

Advocates, activists, and academics have criticized pharmaceutical intellectual property ("pharma IP") rights as obstacles to access to medicines for the global poor. These criticisms of pharma IP holders are frequently exceptionalist: they focus on pharma IP holders while ignoring whether others also bear obligations to assist patients in need. These others include holders of other lucrative IP rights, such as music copyrights or technology patents; firms, such as energy companies and banks, that do not rely on IP; and wealthy private (...) individuals. Their resources could be used to aid patients by providing direct medical assistance, funding prizes or biomedical research, or purchasing pharmaceutical patents and granting rights to the disadvantaged. -/- After identifying this exceptionalism, this Article evaluates several arguments in its defense. These are that pharma IP holders are unique in (1) owning what poor patients need, (2) being in special proximity to these patients, (3) being able to assist at low cost to themselves, (4) having a professional duty to help these patients, or (5) being implicated by their past conduct in these patients' plight. It concludes that none of these arguments are compelling: while IP holders have a duty to help, this duty is not fundamentally different from the duties others owe. -/- Even though this project criticizes exceptionalism, it does not absolve pharma IP holders of duties to help the sick. Rather, it argues that spreading the costs of aiding patients in need across a greater number of market actors, via publicly funded "pull" programs like prizes and patent buyouts or "push" programs like grants, would be preferable. So would allowing pharmaceutical firms to seek contribution from others who are able to help. However, if others cannot be held to account, imposing burdens on pharma IP holders can be justified in order to promote global health: treating wealthy firms arbitrarily is preferable to ignoring the urgent needs of the global poor. (shrink)

State Medicaid programs have proposed closed formularies to limit spending on drugs. Closed formularies can be justified when they enable spending on other socially valuable aims. However, it is still necessary to justify guidelines informing formulary design, which can be done through a process of decision making that includes the public. This article examines criticisms that Medicaid closed formularies limit deliberation about decisions that affect drug access and unfairly disadvantage poor patients. Although unfairness to poor patients is a risk, it (...) is not a problem unique to Medicaid, since private insurance programs have also implemented closed formularies. (shrink)

When I arrived at Harvard as an incoming graduate student in the fall of 1964, I soon received a telephone call from a gentleman who introduced himself as Henry Beecher. I was in the process of shifting my graduate studies from research neuropharmacology to the study of ethics. Robert Featherstone, the head of the Department of Pharmacology at the University of California Medical Center, San Francisco, where I had been studying, was a specialist in anesthesiology and knew Henry Beecher, who (...) was also working in anesthesiology, well. He had contacted Beecher, alerting him to the fact that a new graduate student was arriving and that it appeared that the two of us had much in common. The phone call from Beecher... (shrink)

The potential for financial conflicts of interest to influence scientific research in problematic ways has recently become a significant topic of discussion across numerous fields. The chemical, petroleum, pharmaceutical, and tobacco industries have all been accused of suppressing evidence that their products are harmful, producing studies with questionable methodologies, generating questionable reinterpretations of studies that challenge their products, and working with public relations firms and front groups to mislead the public about relevant science. In an effort to address these influences, (...) government... (shrink)

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)

It has been more than 20 years since the U.S. Supreme Court's landmark decision in Daubert v. Merrell Dow Pharmaceuticals, Inc. on the admissibility of scientific expert witness testimony in legal proceedings. It is time, perhaps, to look back at the history of Daubert decisions to determine whether it and its progeny have lived up to their collective promises to keep bad science out of the courtroom, while allowing in good, especially where the mind and brain sciences are concerned.In this (...) essay, I argue that, although the decision in Daubert describes a general test for the admissibility of scientific evidence, it has not been applied consistently to data and conclusions drawn from the behavioral sciences.... (shrink)

A primary intention of our original manuscript was to provide examples of both harmful and helpful influences of one cultural artifact—depression memoirs—on who female readers take their selves to be, and who they may actually end up being. Bradley Lewis beautifully articulated our strategy as “chart[ing] out … conflicting vectors” : that is, delineating select examples of how certain outer narratives conveyed in depression memoirs may kindle sexist and sanist modes of being. Our hope was that making these vectors explicit (...) could ultimately be liberating for some individuals by “opening up... (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)

The division of interests in key health policy areas are not necessarily between rich and poor countries, but between pharmaceutical industry interests and health policy interests on the one hand, and national industrial and trade policy interests and public health policies on the other.

In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to essential medicines can collaborate (...) in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends by defending the legality of recent measures taken to promote public health in developing countries, and by reminding developed countries that unilateral retaliation against such measures is demonstratably illegal under WTO foundational law and jurisprudence. (shrink)

There are deep structural conflicts between the mission of healthcare as cooperative care to the sick and injured and that of healthcare as a business whose mission is maximizing profits. These conflicts come to the fore in the medical pharmaceutical industry. I first set these out in a context that addresses the mission of healthcare, then examine the relative roles of competitive and cooperative systems of distributive justice, and then argue for the creation of nonprofit pharmaceutical companies and the transformation (...) of many for-profit companies into companies subject to public oversight and profit curbs. The recommendations are aspirational for the United States but it is meant to be action guiding for those industrialized countries wealthy enough to provide universal health coverage. (shrink)

The creation of transgenic animals has application in the following areas of pharmaceutical and biomedical research: the production of biopharmaceuticals for human use; the production of organs for xenotransplantation; and the generation of animal models for human genetic diseases. Nuclear transfer technology offers a more precise and efficient way of performing genetic modification and creating transgenic animals than the more traditional method of pronuclear microinjection. This paper will review nuclear transfer as ameans of producing transgenic animals; introduce advantages nuclear transfer (...) technology offers in the field of animal transgenesis; and highlight some of the animal welfare issues and ethical concerns raised by the generation and use of transgenic animals in the aforementioned fields of study. Finally, the influence of objectifying language and terminology used to describe transgenic animals will be considered, and the impact of phrases such as “living bioreactor” and “spare part supplier” examined. (shrink)