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)

Nurses in all practice roles and settings need to understand the therapeutic use and potential for abuse of prescription drugs. Nursing roles, which include the administration and prescription of medication, health teaching and the implications of application, and the detection of drug-related problems, require that such education be timely and comprehensive. This paper discusses the state of knowledge dissemination about prescription drugs within the general context of nursing education. It highlights educational needs and explores the (...) attitudinal factors and knowledge deficits that influence the nursing practices of prescribing, pain management, nursing assessment, and care of persons with drug problems.Standard educational requirements in all nursing curricula undergird teaching about licit and illicit drugs and medication, as well as their therapeutic use, misuse, and abuse. It has been recognized widely since the early 1980s, however, that clinical experiences and didactic content on licit and illicit drugs presented in nursing programs is inadequate. (shrink)

Nurses in all practice roles and settings need to understand the therapeutic use and potential for abuse of prescription drugs. Nursing roles, which include the administration and prescription of medication, health teaching and the implications of application, and the detection of drug-related problems, require that such education be timely and comprehensive. This paper discusses the state of knowledge dissemination about prescription drugs within the general context of nursing education. It highlights educational needs and explores the (...) attitudinal factors and knowledge deficits that influence the nursing practices of prescribing, pain management, nursing assessment, and care of persons with drug problems.Standard educational requirements in all nursing curricula undergird teaching about licit and illicit drugs and medication, as well as their therapeutic use, misuse, and abuse. It has been recognized widely since the early 1980s, however, that clinical experiences and didactic content on licit and illicit drugs presented in nursing programs is inadequate. (shrink)

Under what circumstances should the federal government pay for outpatient prescription drugs? Should the government (and by extension, taxpayers) pay for all of the drugs prescribed by health care providers, regardless of price or use—adhering to a medical standard? Or should taxpayers only pay for prescriptions supported by scientific evidence of effectiveness—a scientific standard?

This paper seeks to understand the treatment effect of Prescription Drug Monitoring Programs on opioid prescription rates. Using county-level panel data on all opioid prescriptions in the U.S. between 2006 and 2015, we investigate whether state interventions like PDMPs have heterogeneous treatment effects at the sub-state level, based on regional and temporal variations in policy design, extent of urbanization, race, and income. Our models comprehensively control for a set of county and time fixed effects, countyspecific and time-varying demographic (...) controls, potentially endogenous time-series trends in prescription rates, and other state-level opioid interventions such as Naloxone Access and Good Samaritan laws, Medicaid expansion, and the provision of Methadone Assistance Treatment. We find that PDMPs are only effective in reducing prescription rates if they obligate doctors to check for patients' history prior to filling out a prescription, but the frequency at which a state requires its PDMP to be updated is irrelevant to its effectiveness. Moreover, the significant treatment effects of PDMPs are almost exclusively driven by urban and predominantly white counties, with the relatively more affluent regions showing greater responsiveness than their less affluent counterparts. (shrink)

Fair competition law and public health law talk past each other when discussing pharmaceutical pricing and distribution. The former cannot agree on the relevant definition of consumer welfare. The latter does not fully comprehend the highly complex but inherently collective nature of pharmaceutical drug acquisition in the United States. This essay proposes to inject public health discourse into this debate to enrich it, focus it, and render it more accessible to those who must live by its outcome.

The prospects of enhancing cognitive or motor functions using neuroscience in otherwise healthy individuals has attracted considerable attention and interest in neuroethics (Farah et al., Nature Reviews Neuroscience 5:421–425, 2004; Glannon Journal of Medical Ethics 32:74–78, 2006). The use of stimulants is one of the areas which has propelled the discussion on the potential for neuroscience to yield cognition-enhancing products. However, we have found in our review of the literature that the paradigms used to discuss the non-medical use of stimulant (...) drugs prescribed for attention deficit/hyperactivity disorder (ADHD) vary considerably. In this brief communication, we identify three common paradigms—prescription drug abuse, cognitive enhancement, and lifestyle use of pharmaceuticals—and briefly highlight how divergences between paradigms create important “ethics blind spots”. (shrink)

The experience of having to suffer debilitating pain is far too common in the United States, and many patients continue to be inadequately treated by their doctors. Although many physicians freely admit that their pain management practices may have been somewhat lacking, many more express concern that the prescribing of heightened levels of opioid analgesics may result in closer regulatory scrutiny, criminal investigation, or even criminal prosecution.Although several researchers have examined the regulatory environment and the threat of sanction or harm (...) it poses to physicians and patients, few have examined the likelihood of investigation or prosecution stemming from the aggressive use of opioids in physician-directed pain management. Accordingly, in an effort to assess whether the fear of prosecution is realistic and, if so, what factors contribute to its likelihood, we surveyed chief prosecutors in four states about their knowledge, opinions, and attitudes concerning opioids and the prosecution of physicians stemming from the treatment of patients who were either terminally ill or suffering from chronic noncancer pain. (shrink)

The experience of having to suffer debilitating pain is far too common in the United States, and many patients continue to be inadequately treated by their doctors. Although many physicians freely admit that their pain management practices may have been somewhat lacking, many more express concern that the prescribing of heightened levels of opioid analgesics may result in closer regulatory scrutiny, criminal investigation, or even criminal prosecution.Although several researchers have examined the regulatory environment and the threat of sanction or harm (...) it poses to physicians and patients, few have examined the likelihood of investigation or prosecution stemming from the aggressive use of opioids in physician-directed pain management. Accordingly, in an effort to assess whether the fear of prosecution is realistic and, if so, what factors contribute to its likelihood, we surveyed chief prosecutors in four states about their knowledge, opinions, and attitudes concerning opioids and the prosecution of physicians stemming from the treatment of patients who were either terminally ill or suffering from chronic noncancer pain. (shrink)

Each year, millions of individuals in the United States are treated for a variety of serious medical conditions with prescription drugs whose therapeutic benefits are well known. The vast majority of these medications are used to treat medical and psychiatric illnesses. Generally, they are used as prescribed, and contribute to a better quality of life for persons suffering from debilitating or life-threatening disorders.The fact that a small portion of these medications is diverted by those who seek their psychoactive (...) effects raises the important policy issue: how to make drugs easily available for medical use while limiting access for purposes of abuse.Such a responsibility poses challenges very different from those of the so-called “war” on illicit drugs, because this control must be achieved without impeding patients’ access to medical care. A rational public policy would attempt to achieve a balance between the need to minimize abuse and the need to provide relief. (shrink)

Each year, millions of individuals in the United States are treated for a variety of serious medical conditions with prescription drugs whose therapeutic benefits are well known. The vast majority of these medications are used to treat medical and psychiatric illnesses. Generally, they are used as prescribed, and contribute to a better quality of life for persons suffering from debilitating or life-threatening disorders.The fact that a small portion of these medications is diverted by those who seek their psychoactive (...) effects raises the important policy issue: how to make drugs easily available for medical use while limiting access for purposes of abuse.Such a responsibility poses challenges very different from those of the so-called “war” on illicit drugs, because this control must be achieved without impeding patients’ access to medical care. A rational public policy would attempt to achieve a balance between the need to minimize abuse and the need to provide relief. (shrink)

The purpose of this essay is to make the case that the ethical issues raised by the current U.S. practice of direct-to-consumer prescription drug advertising are worthy of study in philosophy courses, and to provide instructors with some ideas for how they might approach teaching the topic, despite the current relative scarcity of philosophical literature published on it. This topic presents a unique opportunity to cover ground in ethics, critical thinking, and scientific literacy simultaneously. As a case study, the (...) practice of DTC advertising is both theoretically rich and universally relevant to students’ lives. The nature of these ads—numerous, diverse, visually and thematically entertaining—makes them delicious fodder for in-class activities, small group work, discussion-based learning, creative projects, and customizable essay topics. I offer a set of suggestions for approaching the study of DTC drug ads that is informed by my own experience doing so in bioethics courses. Ultimately, including this topic on your syllabus not only contributes to students’ philosophical skills and knowledge, but also helps them become better informed as citizens and potential “consumers” of health care. (shrink)

Many people have been enraged lately by the enormous increases in certain generic prescription drugs. But free marketeers defend these prices by arguing that they simply represent what the market will bear, and in a capitalist society there is accordingly nothing wrong with charging them. This paper argues that such a defense is actually contrary to the very principles that free marketeers claim to embrace. These prices are not only unjust and exploitative, but government interference with them would (...) not render the market less free, at least if what it means for a market to be “free” is properly understood. Everyone, even free marketeers with a libertarian or neoliberal bent, should accordingly be against this kind of profiteering. (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.

With direct-to-consumer advertisements (DTCA), pharmaceutical companies can market their prescription drugs directly to consumers. In order to properly study the argumentative aspect of these advertisements from a pragma-dialectical perspective, it is necessary to characterize DTCA as an ‘argumentative activity type’. This characterization shows that in DTCA, the advertiser combines two genres of communicative activity: promotion and consultation. The use of promotion stems from the advertiser’s commercial objective of selling products, while the use of consultation is a result of (...) the legal obligation to present a fair balance between arguments for and against the use of a drug. (shrink)

A study of the international pharmaceutical industry discusses the uses and abuses of prescription drugs and details the dangers and adverse impact of disease treatment with drugs.

Direct to consumer 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.

In the wake of several highly publicized lawsuits over drugs recalled for safety – most notably, Vioxx and Paxil – the Food and Drug Administration and the pharmaceutical industry have faced increasingly intense public scrutiny over the drug testing and approval process. Critics blame the FDA's shorter pre-market approval process that has resulted from the enactment of the Prescription Drug User Fee Act, which effected, among other changes, an increased number of reviewers, a higher review load for each (...) reviewer, and the implementation of “user fees” from companies submitting drugs for review. While many have posited that the lack of safety in some FDA-approved drugs was caused by the enactment of PDUFA, the results of a recent study from the Tufts Center for the Study of Drug Development have indicated that there is no statistically significant correlation between the number of drugs recalled for safety and the enactment of PDUFA. (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)

Social scientists have expended substantial effort to identify group patterns of deviant behavior. Yet beyond the ill-conceived treatment of sexual minorities as inherently deviant, they have rarely considered how gendered sexual identities shape participation in deviance. We argue for the utility of centering theories of gender and sexuality in intersectional deviance research. We demonstrate how this intentional focus on gender and sexuality provides important empirical insights while avoiding past pitfalls of stigmatizing sexual minorities. Drawing on theories of hegemonic masculinity, emphasized (...) femininity, and minority stress together with criminological general strain theory, we demonstrate how societal expectations and constraints generate strains among GSI groups that may lead to distinctly patterned deviance, using the case of prescription drug misuse during sex. We employ thematic analysis of 120 in-depth interviews with people who misuse prescription drugs, stratified by GSI. We identify six themes highlighting distinct pathways from strain to misuse during sex for different GSI groups: intimacy management, achieving sexual freedom, regulating sexual mood, performance confidence, increased sense of control, and managing sexual identity conflict. In this article, we demonstrate the empirical and theoretical importance of centering gender and sexuality in deviance research and provide a roadmap for theoretical integration. (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.

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)

New technologies regularly bring about profound changes in our daily lives. Romantic relationships are no exception to these transformations. Some philosophers expect the emergence in the near future of love drugs: a theoretically achievable biotechnological intervention that could be designed to strengthen and maintain love in romantic relationships. We investigated laypeople’s resistance to the use of such technologies and its sources. Across two studies (Study 1, French and Peruvian university students, N after exclusion = 186; Study 2, Amazon Mechanical (...) Turk sample, N after exclusion = 693, pre-registered), we found that the use of love drugs designed to strengthen and maintain love in romantic relationships are considered as more morally problematic than psychological therapy with the same aim. In Study 2, we show that this last effect is partially due to the fact that the love resulting from the use of love drugs is perceived as less authentic, intense, and durable. We discuss the specific role of authenticity in the relative moral disapproval of love drugs. (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)

It is often claimed that the autonomy of heroin addicts is compromised when they are choosing between taking their drug of addiction and abstaining. This is the basis of claims that they are incompetent to give consent to be prescribed heroin. We reject these claims on a number of empirical and theoretical grounds. First we argue that addicts are likely to be sober, and thus capable of rational thought, when approaching researchers to participate in research. We reject behavioural evidence purported (...) to establish that addicts lack autonomy. We present an argument that extrinsic forces must be irresistible in order to make a choice non-autonomous. We argue that heroin does not present such an irresistible force. We make a case that drug-oriented desires are strong regular appetitive desires, which do not compromise consent. Finally we argue that an addict’s apparent desire to engage in a harmful act cannot be construed as evidence of irrational or compulsive thought. On these arguments, a sober heroin addict must be considered competent, autonomous and capable of giving consent. More generally, any argument against legalisation of drugs or supporting infringement of the liberty of those desiring to take drugs of addiction must be based on considerations of harm and paternalism, and not on false claims that addicts lack freedom of the will. (shrink)