Drugs

In 1997 the FDA relaxed restrictions on the practice of direct-to-consumer pharmaceutical advertising . The subsequent increase in advertisements aimed at potential patients had a signifi cant impact on rates of drug prescription. This paper gives a brief history of visual representations of mental illness used by DTCA and examines ethical concerns raised by DTCA, specifi cally for psychotropic medications. Issues discussed include overestimation of symptoms and over-prescription of unnecessary drugs, modifi cation of social perception and the perpetuation of stigma, (...) and exploitation of vulnerable potential patient groups. (shrink)

Industrial drug design methodology has undergone remarkable changes in the recent history. Up to the 1970s, the screening of large numbers of randomly selected substances in biological test system was often a crucial step in the development of novel drugs. From the early 1980s, such ‘blind’ screening was increasingly rejected by many pharmaceutical researchers and gave way to ‘rational drug design’, a method that grounds the design of new drugs on a detailed mechanistic understanding of the drug action. Surprisingly, however, (...) the chance-based method of random screening returned to center stage of industrial drug development in the 1990s in the form of ‘high-throughput screening’ (HTS). I will argue in this paper that this to-and-fro in the prominence of random screening comes with fundamental changes in the epistemic significance of chance experiments in pharmaceutical development. While up to the 1970s, random screening used to be chosen as an empirical search strategy primarily because suffi- cient knowledge of the mechanistic basis of drug action was lacking, it has turned with high-throughput screening into an experimental method that employs chance variation and testing to illuminate this mechanistic basis. As a consequence, research into the underlying mechanisms of drug action and the development of new drugs have become closely integrated. The rise of HTS therefore not only shows how chance experiments have assumed a new epistemic role in drug development. It also allows for a detailed study of the much debated emergence of a new relationship between scientific understanding and the development of technological artifacts. (shrink)

Rational drug design is a method for developing new pharmaceuticals that typically involves the elucidation of fundamental physiological mechanisms. It thus combines the quest for a scientific understanding of natural phenomena with the design of useful technology and hence integrates epistemic and practical aims of research and development. Case studies of the rational design of the cardiovascular drugs propranolol, captopril and losartan provide insights into characteristics and conditions of this integration. Rational drug design became possible in the 1950s when theoretical (...) knowledge of drug-target interaction and experimental drug testing could interlock in cycles of mutual advancement. The integration does not, however, diminish the importance of basic research for pharmaceutical development. Rather, it can be shown that still in the 1990s, linear processes of innovation and the close combination of practical and epistemic work were interdependent. (shrink)

ABSTRACTIn April of 2000, Diana Levine went to a clinic in Vermont suffering from a migraine headache. She was given the drug Demerol for the migraine symptoms and Phenergan for nausea. Complications with the administration of Phenergan ultimately resulted in Ms. Levine contracting gangrene, necessitating the amputation of her right arm. Ms. Levine sued the drug maker, Wyeth Pharmaceutical, in state court and prevailed. The lower court's decision was appealed by Wyeth to the state supreme court where the ruling was (...) confirmed. Wyeth next appealed to the U.S. Supreme Court which, to the surprise of many observers, affirmed the judgment of the state supreme court. At issue was the fundamental question of the ability of consumers to obtain redress against negligent manufacturers in state courts. Wyeth's arguments to the Court were based upon preemption: Foodand Drug Administration approval of a drug preempts the ability of injured consumers like Ms. Levine to recover in state courts despite years of precedent to the contrary. Ability to recover damages in state courts represents, perhaps, the most important safety net available to consumers injured by defective products. A ruling by the Supreme Court that FDA‐approved labeling of pharmaceuticals preempts the reach of the state courts would have severely compromised the balance of power between consumers and producers. (shrink)

Pharmaceutical companies can dramatically improve their understanding of how certain drugs work by having access to data from prospective research participants and those enrolled in clinical trials. Yet can data legitimately be used in ways that these individuals have not specifically authorized? In some cases it is ethically acceptable to share data with pharmaceutical companies even if there was no specific consent to do so by appealing to the principles of beneficence and respect for persons. These principles require us to (...) look not just at how well the process and documentation of consent conform to regulatory requirements, but also at how well they minimize harm and maximize benefit for research participants and future beneficiaries of the research. (shrink)

Instead of impeding access to essential medicines in developing countries, the essay explores why and how patents can serve as a source of funding for the much needed access to medicine. Instead of a weakening of patents, prolonged protection periods are suggested in circumstances where there is widespread lack of access. The revenues from extended patents are seen as a source of funding for drug donations to the least developed countries.

Alcohol and substance abuse are prevalent in our society. Advances in neuroscience have led to a clearer understanding of the effects of abused substances on the brain. Clues are now available regarding how a person goes from a “user” to being addicted based on brain chemistry, anatomy, and genetic risk. During this process the person loses at least partial, if not complete, control, over their compulsive substance use. This article attempts to put modern notions of alcohol and substance abuse and (...) dependency into a societal and cultural context with the hope of reducing the stigma of this illness while shifting the focus a bit more away from criminal solutions to those offered by health care and treatment options. (shrink)

Using material from the Pfizer sponsored website providing health information on erectile dysfunction to potential Swedish Viagra customers (www.potenslinjen.se), this article explores the public image of masculinity in relation to sexual health and the cultural techniques for creating pharmaceutical appeal. We zoom in on the targeted ideal users of Viagra, and the nationalized, racialized and sexualized identities they are assigned. As part of Pfizer’s marketing strategy of adjustments to fit the local consumer base, the ways in which Viagra is promoted (...) for the Swedish setting is telling of what concepts of masculinity are so stable and unassailable that they can withstand the association with a drug that is, in essence, an acknowledgement of ‘failed’ masculinity and ‘dysfunctional’ sexuality. With comparative national examples, this study presents an interdisciplinary take on the ‘glocalized’ cultural imaginary of Viagra, and the masculine subject positions it engenders. (shrink)

ABSTRACTMedicines that are vital for the saving and preserving of life in conditions of public health emergency or endemic serious disease are known as essential medicines. In many developing world settings such medicines may be unavailable, or unaffordably expensive for the majority of those in need of them. Furthermore, for many serious diseases these essential medicines are protected by patents that permit the patent‐holder to operate a monopoly on their manufacture and supply, and to price these medicines well above marginal (...) cost. Recent international legal doctrine has placed great stress on the need to globalise intellectual property rights protections, and on the rights of intellectual property rights holders to have their property rights enforced. Although international intellectual property rights law does permit compulsory licensing of protected inventions in the interests of public health, the use of this right by sovereign states has proved highly controversial. In this paper I give an argument in support of states’ sovereign right to expropriate private intellectual property in conditions of public health emergency. This argument turns on a social contract argument for the legitimacy of states. The argument shows, further, that under some circumstances states are not merely permitted compulsory to license inventions, but are actually obliged to do so, on pain of failure of their legitimacy as sovereign states. The argument draws freely on a loose interpretation of Thomas Hobbes's arguments in his Leviathan, and on an analogy between his state of War and the situation of public health disasters. (shrink)

The American Journal of Bioethics, Volume 12, Issue 1, Page 16-18, January 2012.

John Kaplan, The Hardest Drug: Heroin and Public Policy Chicago: The University of Chicago Press, 1983, xi + 247 pp.

In Africa fewer than 50,000 people—less than 2 percent of the people in need—currently receive ARV therapy. These facts have elicited strongly divergent reactions, and views about the appropriate response to this crisis have varied widely.

A much-debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics “pharmascolds.” Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these questions in (...) mind. Deadly Medicine and Organized Crime, by Peter Gøtzsche, Bad Pharma, by Ben Goldacre, and Good Pharma, by Donald Light and Antonio Maturo, all situate their critical assessments in high-income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative. (shrink)

This compact and innovative book tackles one of the central issues in drug policy: the lack of a coherent conceptual structure for thinking about drugs. Drugs generally fall into one of seven categories: prescription, over the counter, alternative medicine, common-use drugs like alcohol, tobacco and caffeine; religious-use, sports enhancement; and of course illegal street drugs like cocaine and marijuana. Our thinking and policies varies wildly from one to the other, with inconsistencies that derive more from cultural and social values than (...) from medical or scientific facts. Penalties exist for steroid use, while herbal remedies or cold medication are legal. Native Americans may legally use peyote, but others may not. Penalties may vary for using different forms of the same drug, such as crack vs. powder cocaine. Herbal remedies are unregulated by the FDA; but medical marijuana is illegal in most states. -/- Battin and her contributors lay a foundation for a wiser drug policy by promoting consistency and coherency in the discussion of drug issues and by encouraging a unique dialogue across disciplines. The contributors are an interdisciplinary group of scholars mostly based at the University of Utah, and include a pharmacologist, a psychiatrist, a toxicologist, a trial court judge, a law professor, an attorney, a diatary specialist, a physician, a health expert on substance abuse, and Battin herself who is a philosopher. They consider questions like the historical development of current policy and the rationales for it; scientific views on how drugs actually cause harm; how to define the key notions of harm and addiction; and ways in which drug policy can be made more consistent. They conclude with an examination of the implications of a consistent policy for various disciplines and society generally. -/- The book is written accessibly with little need for expert knowledge, and will appeal to a diverse audience of philosophers, bioethicists, clinicians, policy makers, law enforcement, legal scholars and practitioners, social workers, and general readers, as well as to students in areas like pharmacy, medicine, law, nursing, sociology, social work, psychology, and bioethics. (shrink)

Since 1981 AIDS has illuminated, like a roving searchlight, a series of ethical questions, which extend far beyond the apparently narrow limits of one disease. It has revealed, one by one, human attitudes and behaviours that were previously unquestioned, or unobserved - based on unidentified but shaky pre-suppositions.This commentary offers two contrasting perspectives on the problems facing developing countries. In the first part, I comment on the preceding article, from the perspective of a clinician who has worked for many years (...) in Africa, and who witnessed the emergence of AIDS in the early 1980s and its medical, social, political and economic consequences.1 In the second, I comment on a conference in Lusaka in September 1999 that addressed many of the issues.Narrowing the gap?“Narrowing the gap” raises questions about truth or transparency in the activities of multinational companies, the ethics and economics of health care in global society and the distribution of responsibility for unwanted side effects of new treatments. The scale of HIV infection in developing countries draws attention to weaknesses or instability in theoretical and practical structures, which serve - or should serve - human wellbeing, whenever it is disturbed by disease.Truth and transparencyDuring the last 60 years, combined with improved standards of living, the products of pharmaceutical effort and ingenuity have resulted in large gains in life expectancy. These were most marked in rich northern societies, but even poor southern countries had seen it extended by 15 to 20 years, until recently.However, “the costs of drug development are not small”.2 A detailed study of costs of clinical trials found that the total cost of new drug development can be as high as $500 million per drug.3 Patent laws allow a temporary monopoly for the production and sale for a number of years. During this “protected” …. (shrink)

Firstly I would like to acknowledge the Traditional Owners whose land we are meeting on today. I acknowledge that I stand before you on the shoulders of Indigenous Peoples globally, past and present that have been marginalised, had their knowledge exploited, and generally had their inherent native title rights ripped off for the financial and health benefit of others.

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)

Direct to consumer (DTC) advertising has attracted significant research attention, yet none has focused on empirical assessments of its overall impact on U.S. consumers nationally, and tying assessment to relevant behavioral outcomes. This paper addresses the ethical issue of DTC advertising providing a balance of product and risk information that is both understandable and believable, and contributes direction to those exploring this phenomenon.

"Before they were 'junkies,' they were kids." The words appear on a poster, beneath a montage of photographs of children and the text: "Save Insite." Insite, located in Vancouver, Canada, is North America's first and only supervised injection facility (SIF). At Insite, people who use injection drugs can inject previously obtained drugs, such as heroin and cocaine, under medical supervision, using sterile equipment provided by this government-run facility. Opened under the auspices of a three-year exemption from federal drug laws in (...) 2003, the site was initially the focus of a research study aiming to determine whether such a service would be effective in reducing the harms associated with injection drug use. After .. (shrink)

In 2001 the Italian Government defined Essential Assistance Levels (LEA), which can be considered as an important step forward in the health care system. The Italian health care system would provide payment of essential and uniform aid services in order to safeguard many values such as human dignity, personal health, equal assistance and good health practices. The Ministry of Health has worked to rationalize the National Formulary and to define evaluation methods for drugs in order to choose what to reimburse (...) without penalizing the rights of the individual and society.This paper describes how this job of rationalization was done and tries to illustrate the choices made in Italy by the use of two meaningful examples (statins and rivastigmine). (shrink)

Many observers now acknowledge that there are serious problems with the way in which pharmaceutical research is currently practiced. These problems include the suppression of undesirable results, bias in the design of studies and in the interpretation of results, and neglect of diseases that afflict the poor in developing countries. These problems can be traced at least in part to the influence of commercial interests on research. In what follows, I will discuss some of the main deficiencies of current pharmaceutical (...) research, and I will argue that an important one is inadequate dissent. As many have argued, rigorous scientific research requires dissent, or what Robert Merton called “organized skepticism” (1942). .. (shrink)

From the title, Deadly Medicines and Organised Crime: How Big Pharma has Corrupted Healthcare, Peter Gøtzsche makes the thesis of his book very clear. Not only does the pharmaceutical industry contribute to detrimental health outcomes through biased research, deceptive marketing, and disease mongering, but the industry’s business model meets the criteria of an organized criminal operation. Gøtzsche argues for this in two parts. First, he defines organized crime by drawing upon the United States Organized Crime Control Act of 1970, the (...) centerpiece of which is the Racketeer Influenced and Corrupt Organizations Act. RICO prohibits deriving income from a pattern of racketeering... (shrink)

A central goal in regulating direct-to-consumer advertising of prescription pharmaceuticals is to ensure that explicit drug claims are truthful. Yet imagery can also alter viewer attitudes, and the degree to which this occurs in DTCA is uncertain. Addressing this data gap, we provide evidence that positive feelings produced by images can promote favourable beliefs about pharmaceuticals. We had participants view a fictitious anti-influenza drug paired with unrelated images that elicited either positive, neutral or negative feelings. Participants who viewed positive images (...) rated the influenza drug as significantly more effective, safe, and beneficial than did participants who viewed negative images. This effect, known as evaluative conditioning, is well described in experimental social psychology but has not previously been shown with pharmaceuticals. We discuss how evaluative conditioning in DTCA may compromise viewer autonomy, and canvass possible regulatory responses. (shrink)

The risk that direct-to-consumer advertising of prescription pharmaceuticals (DTCA) may increase inappropriate medicine use is well recognized. The U.S. Food and Drug Administration addresses this concern by subjecting DTCA content to strict scrutiny. Its strictures are, however, heavily focused on the explicit claims made in commercials, what we term their ?propositional content.? Yet research in social psychology suggests advertising employs techniques to influence viewers via nonpropositional content, for example, images and music. We argue that one such technique, evaluative conditioning, is (...) operative in DTCA. We further argue that evaluative conditioning fosters unjustified beliefs about drug safety and efficacy, antagonising the autonomy of viewers? choices about advertised medicines. We conclude that current guidelines are deficient in failing to account for evaluative conditioning, and that more research and debate are needed to determine the permissibility of this and other forms of nonpropositional persuasion. (shrink)

This manuscript addresses how developing countries can maximize access to essential medicines and minimize unwanted side-effects within the legal environment of a compulsory license regime. While compulsory licensing can play a role in improving public health, external social and political conditions must be considered in order to make licensing an effective practice.

Abstract The leadership of the black community is concerned with welfare, with equality, with unemployment, with discrimination, with racism, with the pay gap, and with dozens of other such traditional issues. Oh, yes, they are also apprehensive about the use of addictive drugs. But, as we speak, young male members of this community are being incarcerated at frightful rates, and, even worse, are killing each other to boot. One would think that this latter issue would occupy the interest of black (...) leaders front and center. After all, there are few worse problems than being jailed or killed. The present paper is dedicated to making the case that the black leadership has its priorities all wrong; that if they were to exercise true leadership, they would see the jailing and murder of young black men as perhaps the greatest threat to their community; and, if so, they would fervently support the legalization of all drugs. (shrink)

Separate from the question of whether our patients believe us as doctors is the question of whether we ourselves believe in our healing ‘performances’. Borrowing from Bernard Williams’ model of truth based on the two irreducible virtues of sincerity and accuracy, this article describes a spectrum of states of self-belief, from the quack who does not believe in his acts to the fanatic who does not ‘dis-believe’, with ranges of pious fraud and bad faith in between and on either side (...) of a variable range of justified self-belief. I describe how as practitioners we move and are moved up and down this range throughout our careers and as a result of the behaviors of others. The model provides the basis for a critique of the marketing efforts of industries related to medical practice. (shrink)

Mucopolysaccharidosis type I (MPS I) is a rare lysosomal storage disorder treated with bone marrow transplantation or enzyme replacement therapy with laronidase, a high-cost orphan drug. Laronidase was approved by the US Food and Drug Administration and the European Medicines Agency in 2003 and by the Brazilian National Health Surveillance Agency in 2005. Many Brazilian MPS I patients have been receiving laronidase despite the absence of a governmental policy regulating access to the drug. Epidemiological and treatment data concerning MPS I (...) are scarce. This study aims to present a demographic profile of Brazilian patients with MPS I, describe the routes of access to laronidase in Brazil, and discuss associated ethical issues relating to public funding of orphan drugs. (shrink)