Pharmaceuticals

Over one million annual deaths have been attributed to bacterial antimicrobial resistance. Although antibiotics have saved countless other lives, overuse and misuse of antibiotics increases this global threat. Developing new antibiotics and retraining clinicians can be undermined by patients who pressure clinicians to prescribe unnecessary antibiotics. So we validated two low-cost, scalable interventions for improving antibiotic decisions in an online randomized control trial and a pre-registered replication (N = 985). Both first-person vignette experiments found that an infographic and text message (...) caused intermediate to large improvements in antibiotic decisions compared to active controls — even when controlling for a dozen confounds. Notably, these educational interventions also reduced trust in a clinician who offered antibiotics for an upper respiratory infection. These data show how low-cost adjustments to existing communication systems can teach people to reduce the existential risks of antibiotic resistance and how inappropriate antibiotic prescribing can erode trust in health systems. (shrink)

This article analyzes two interrelated strategies for using mechanistic evidence as a political instrument of social power, the wedge and the buttress. I compare two policy skirmishes over contraception and abortion pills. First, pro-life critics of emergency contraception aimed to undermine the switch to over-the-counter access. They drove a wedge into the proposed mechanism, stalling policy change by raising politically motivated doubts. Second, pro-choice advocates of medication abortion tried to counteract mail-order restrictions. They buttressed with new evidence to preempt their (...) opponents before the COVID-19 pandemic. I explain the interplay between these strategies, their political motivations, and their relative empirical character. (shrink)

This article evaluates seven strategies for managing the high costs of GLP-1 receptor agonists (GLP-1RAs) like semaglutide and tirzepatide for weight management: complete exclusion of coverage, annual cost increase caps, lifetime cost caps, tiered access, formulary reevaluation, subscription payment models, and patent reform. The authors assess each strategy against three ethical objectives: benefiting people and preventing harm, showing equal moral concern, and mitigating disadvantage. Complete coverage exclusions, arbitrary reimbursement caps, and lifetime limits are deemed unethical as they fail to meet (...) these objectives. Tiering access based on relative benefit is considered justifiable, though current implementation often unfairly favors diabetes over obesity treatment. The authors recommend formulary reevaluation as the most ethical approach for smaller health plans, allowing them to prioritize more cost-effective treatments. For larger payers with market power and for governments, subscription payment models and patent reforms are potentially ethical solutions if implemented sustainably. The authors conclude that health plans should avoid ad hoc restrictions on GLP-1RAs in favor of comprehensive policy reforms that ensure sustainable access to these and future breakthrough treatments. (shrink)

Drugs given to reduce suffering in palliative care often cause adverse consciousness diminishment. The causing of this consciousness diminishment is often justified appealing to the Doctrine of Double Effect. This justification relies on consciousness diminishment being unintended and a side effect in such cases. Arima (2025) argues that in many of these cases, consciousness diminishment is actually intended and not a side effect at all. If that is so, in those cases the use of drugs that cause consciousness diminishment cannot (...) be justified by appeal to the Doctrine of Double Effect alone. Here I aim to challenge two points that play a central role bolstering Arima’s conclusion. The first I call the ‘instrumental rationality’ point: if something is causally necessary to bring about an intended end, that causally necessary thing must likewise be intended. The second I call the ‘dissimilarity’ point: consciousness diminishment in this context is unlike a side effect insofar as side effects do not contribute causally to the intended aims of an intervention. I challenge both of these points by appealing to recent work on defining medical side effects. I conclude that Arima is likely right that the number of instances where the Doctrine of Double Effect justifies consciousness diminishment in palliative care is less than commonly thought, though it is not as rare as Arima’s argument leads one to believe. (shrink)

Perhaps the most infamous class of chemical compounds in history, organophosphonates have indubitably haunted the minds and memories of generations, and will continue to do so for many more to come. From their mass development as chemical weapons by Nazi Germany in the 1930s, to their notoriety as potent, noxious pesticides, their usefulness in human medicine remains often overlooked by laymen and researchers alike. This book hence offers a comprehensive analysis of organophosphonates, from their chemical structures and syntheses, to their (...) pharmacological and toxicological reports—the first of its kind in phosphorus chemistry. Latkovic aims not only to analyze a certain chemical class from a unifocal paradigm, but extends a novel perspective to this peculiar class of compounds in this pioneering review of decades' worth of research and development. A daring thesis and a riveting monograph—no less potent words than these can be used to describe this work, much like its compounds of interest therein. (shrink)

The medical and public health communities are divided around the use of benzodiazepine (“benzo”) pharmacotherapy for anxiety disorders. Recent years have seen increased attention to benzo overprescription and its risks, leading to a pervasive emphasis on deprescribing. Some have resisted this trend, arguing that the balance of evidence supports the safety and efficacy of benzo pharmacotherapy for both short-term and long-term treatment of anxiety disorders. Given that rising rates of anxiety disorders and benzo misuse are both serious public health concerns, (...) there is an urgent need for comprehensive evidence-based best practices for the prescription of benzos for anxiety. At present, however, major scientific gaps make it impossible to formulate such guidance. Most concerning is the lack of research into as-needed and intermittent prescription and use, which are both what benzos are best suited for, and likely, how they are most commonly administered. Further research into the safety and efficacy of both long-term daily and intermittent, as-needed benzo prescription and use are badly needed. But a roundly “anti-benzo” sentiment may be causing problematic underprescription of benzos, particularly when superior alternatives like cognitive-behavioral therapy are not widely available. (shrink)

This paper brings the concept of affective scaffolding to bear on a much-debated controversy: the expanding use of psychiatric medications to treat an increasingly broad range of human discontents. ‘Affective scaffolding’ refers to the variety of ways that agents engage with, recruit or modify their environments to actively shape their emotions, moods, or other affective phenomena. Psychiatric drugs are designed, marketed, and prescribed as technologies that have the special power to transform affective life by intervening on the pathological underpinnings of (...) distress and suffering to change how we feel. The paper develops an account of psychiatric drug use as affective scaffolding and examines how psychiatrization – the complex social process through which psychiatry comes to influence more and more domains of human life – impacts this form of scaffolding. I propose that psychiatrization influences affective scaffolding by biasing individuals toward psychiatric drugs to manage an expanding array of affective experiences. In some cases, I argue, this results in bad pharmaceutical scaffolding. Bad pharmaceutical scaffolding emerges when an agent is influenced to select and rely upon psychiatric drugs in attempts to exert individual control over distress and suffering where (1) at least some of the key determinants of these affective experiences are properties of the agent’s environment, in contrast to, in a strict sense, properties internal to the person, and (2) pharmaceutical scaffolding obviates the need for or displaces other non-pharmaceutical options that would better serve the agent's affective needs and interests. (shrink)

Consumers spend billions of dollars per year on homeopathic products. But there is powerful evidence that these products don’t work, i.e., they are not medically effective. Should homeopathic products be for sale? I give reason for thinking that the answer is ‘no.’ It has been suggested that the sale of homeopathic products involves deception. This might be so in some cases, but the problem is simpler: it is that these products don’t do what people buy them to do. More precisely, (...) homeopathic products don’t meet the “desire-satisfaction condition,” according to which products for sale in markets should satisfy the desires that people buy them to satisfy. I defend my view against objections, and conclude by acknowledging some of the practical difficulties of banning products people want to buy. (shrink)

This Viewpoint analyzes policies for covering GLP-1 receptor agonist drugs for obesity treatment across 13 high-income countries. It identifies four key lessons for developing coverage policies: 1) using up-to-date cost-effectiveness analyses that incorporate new evidence of benefits, 2) negotiating lower prices while preserving innovation incentives, 3) prioritizing coverage for specific populations rather than issuing blanket denials, and 4) treating obesity medications similarly to high-cost drugs for other conditions. It argues that blanket coverage denials are unethical and that countries should implement (...) targeted coverage policies that maximize benefits while managing costs. (shrink)

Consumers spend billions of dollars per year on homeopathic products. But there is powerful evidence that these products don’t work, i.e., they are not medically effective. Should homeopathic products be for sale? I give reason for thinking that the answer is ‘no.’ It has been suggested that the sale of homeopathic products involves deception. This might be so in some cases, but the problem is simpler: it is that these products don’t do what people buy them to do. More precisely, (...) homeopathic products don’t meet the “desire-satisfaction condition,” according to which products for sale in markets should satisfy the desires that people buy them to satisfy. I defend my view against objections, and conclude by acknowledging some of the practical difficulties of banning products people want to buy. (shrink)

In our reply to critiques of our GLP-1 receptor agonist allocation framework, we explain that using potential years of life lost (PYLL) as a metric addresses racial health disparities without explicitly allocating resources based on race. This approach is "racism-conscious" and has legal and ethical challenges over race-based approaches. Meanwhile, though acknowledging the importance of cardiovascular risk assessment, we maintain in response to other interlocutors that focusing solely on immediate risk would ignore the broader goal of mitigating disadvantage. We emphasize (...) that our framework balances multiple ethical objectives beyond just maximizing medical benefits. (shrink)

This commentary examines the role of sustainability in the latest draft of the WHO pandemic accord, highlighting its notable absence from the official list of guiding principles despite being mentioned frequently throughout the text. It argues that sustainability should be explicitly acknowledged as a core principle and given a clear definition tailored to pandemic preparedness, and proposes defining sustainability as ensuring that immediate emergency responses don't compromise future pandemic preparedness and response capabilities. Including sustainability as a guiding principle would serve (...) two key purposes: validating the relevance of ethical principles in the accord's provisions and emphasizing the importance of long-term planning in pandemic preparedness. The commentary notes that while humans naturally discount future consequences, sustainable pandemic planning requires considering impacts beyond the next pandemic. It recommends coupling any reforms, such as intellectual property changes, with alternative innovation incentives to maintain a balanced approach to pandemic preparedness and response. (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 (objectively greater) 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)

Pharmacological cognitive enhancement (PCE) refers to the use of pharmaceuticals to improve cognitive function when that use is not intended to prevent or treat disease. Those who favour a liberal approach to PCE trust users to make informed decisions about whether enhancing is in their best interest. The author argues that making informed decisions about PCE requires a nuanced risk-benefit analysis that is not accessible to many users. Presently, the PCE use of prescription medications such as methylphenidate and modafinil is (...) widespread but most commonly happens without medical supervision. Direct and indirect barriers generate a situation where the risks and benefits of PCE are inequitably distributed; as a result, PCE is sometimes not in the user’s best interest. This is likely to also be the case for future pharmaceuticals. As a result, even if PCE pharmaceuticals were equitably distributed, its associated risks and benefits would not be. The article concludes with a discussion of the prospects of the clinical consultation on one hand, and e-health solutions on the other, in ameliorating the situation, arguing for cautious optimism. (shrink)

Globalized in 1995 through the TRIPs Agreement, humanity’s dominant mechanism for encouraging innovations involves 20-year product patents, whose monopoly features enable innovators to reap large markups or licensing fees from early users. Exclusive reliance on this reward mechanism in the pharmaceutical sector is morally problematic for two main reasons. First, it imposes a great burden on poor people who cannot afford to buy patented treatments at monopoly prices and whose specific health problems are therefore neglected by pharmacological research. Second, it (...) discourages pharmaceutical firms from fighting diseases at the population level with the aim of slashing their incidence. These problems can be alleviated by establishing a supplementary alternative reward mechanism that would enable pharmaceutical innovators to exchange their monopoly privileges on a patented product for impact rewards based on the actual health gains achieved with this product. As such, an international Health Impact Fund (HIF) would create powerful new incentives to rapidly develop remedies against diseases concentrated among the poor, provide such remedies with ample care at very low prices, and deploy them strategically to contain, suppress, and ideally eradicate the target disease. By promoting innovations and their diffusion together, the HIF would greatly enlarge the benefits, and thereby also the cost-effectiveness, of the pharmaceutical sector, especially in favor of the world’s poor. (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)

Photo by National Cancer Institute on Unsplash INTRODUCTION Since the start of the COVID-19 pandemic, there have been calls for the President to invoke a Korean-war-era law, the Defense Production Act, to effectively nationalize the supply of critical medical supplies and speed up vaccine production. The reasoning for employing the DPA is simple: it can immediately ramp up the industrial production of critical supplies and material resources and direct their distribution to areas of greatest need.[1] The Trump administration used the (...) DPA 18 times to aid vaccine development.[2] The Biden administration has followed suit, invoking the DPA in February.[3] While the Defense Production Act has enabled a massive mobilization of crucial resources for vaccine development, it has also had negative, downstream effects, which raise ethical concerns surrounding resource allocation. Evaluating the effect of the DPA on Tepezza, a non-COVID-19 medication, demonstrates how the DPA is not adequately designed to address pharmaceutical manufacturing, and point to a potential need for further legislation. ANALYSIS By its nature, the DPA is a very blunt and fast-moving instrument that should be used sparingly. Originally signed into law by President Truman at the outset of the Korean War in 1950, the DPA gives the President the authority to order private sectors to produce essential goods in times of emergency.[4] In particular, it allows the President to compel corporations to immediately prioritize orders from the federal government irrespective of previously agreed-upon contracts. The typical rules of supply and demand economics are overridden, and legally binding agreements are nullified. Thus, the power of the DPA facilitates its ability to redirect resources in a swift, absolute manner. Over the years, the general scope of the DPA has steadily extended beyond military preparedness to include natural disasters and homeland security. In January 2001, both President Clinton and President G. W. Bush invoked DPA powers to ensure that emergency supplies of electrical power and natural gas continued flowing to California utilities during the 2000 - 2001 energy crisis.[5] In 2017, the Federal Emergency Management Agency used the DPA to prioritize contracts for food, bottled water, and the restoration of electrical systems after Hurricane Maria struck Puerto Rico.[6] December 2020 had a record number of US COVID-19 deaths and over 118,000 COVID-19 patients in U.S. hospitals.[7] Vaccines were still predominantly being allocated to healthcare workers and residents of long-term care and assisted living facilities. While the federal government created demand for COVID-19 vaccines by contracting with pharmaceutical and manufacturing companies, vaccine supply remained low. Private companies needed more time to alter their production schedules and get out of existing contracts before they could fulfill the government contracts. The government invoked the DPA to expedite vaccine production, enabling companies to break existing contracts and start production. On December 17, 2020, Horizon Therapeutics, a biopharmaceutical company, announced that its drug Tepezza would experience a serious supply shortage[8] due to the abrupt cancellation of manufacturing slots at Horizon’s sub-contractor Catalent Pharma Solutions. Catalent, a drug manufacturer, packager, and distributor, was also a producer of Moderna’s new COVID-19 vaccine, manufacturing both Tepezza and the Moderna vaccine on the same production line. Operation Warp Speed, used the DPA to direct the immediate reallocation of Catalent’s manufacturing slots to Moderna.[9] The abrupt disruption of Tepezza production had a “dramatic effect” on patients.[10] Tepezza is the only FDA-approved medication to treat adults with Thyroid Eye Disease, also known as Graves’ Ophthalmopathy, a rare autoimmune condition wherein the muscles and fatty tissues behind the eye become inflamed, causing the eyes to push forward and bulge outward. Symptoms include eye pain, light sensitivity, difficulty closing the eye, and, in severe cases, blindness.[11] While TED impacts a small number of individuals, the disease can be incapacitating, preventing individuals from performing important daily activities, like driving or working. On the prescribed course of treatment for TED, patients take a total of eight intravenous injections of Tepezza, one every three weeks.[12] When supplies were disrupted, some patients stopped receiving Tepezza in the middle of treatment. While the effects of stopping midway are unknown, symptoms may worsen during the hiatus or premature stoppage. People who had not yet begun treatment had to delay starting, sometimes remaining in pain and risking vision loss from optic nerve compression. To alleviate symptoms, some patients may have opted for eye surgeries instead of waiting for Tepezza.[13] When the federal government invoked the DPA, it inadvertently put two interests at odds with each other – providing medication for a rare but serious disease and speeding up vaccination rates against the coronavirus. Prior applications of the DPA affected the supply and demand of machinery and raw materials – not pharmaceuticals, which have a direct and immediate impact on human health. In 1967, for instance, President Johnson invoked the DPA requiring Chrysler to prioritize production of the M1 Abrams Tank, the Army’s new main battle tank, over cars. Around the same time, President Johnson also used the DPA to expand chemical plants’ production of herbicides, such as 2,4,5-T and 2,4-D, to make Agent Orange.[14] Most recently, the Trump administration used the DPA to require GE and 3M to prioritize the production of critical medical equipment.[15] None of these examples impacted access to pharmaceuticals. There are, however, significant ethical issues at stake in the use of the DPA to abruptly alter pharmaceutical manufacturing, even temporarily. Catalent was just one of many Moderna COVID-19 vaccine manufacturers. The number of doses of Tepezza needed to supply patients was small given the low prevalence of TED. An investor reported that if Horizon had access to the facility for even a few hours, it could have met the demand.[16] If Operation Warp Speed had worked more closely with Horizon Therapeutics and asked Catalent to briefly make additional doses given its short manufacturing time, the negative effects on patients with TED could have been avoided. But the DPA, by design, approaches an emergency from a utilitarian perspective, rapidly redirecting resources to achieve the greatest good for the greatest number of people. A significant portion of the American population, including Tepezza’s patient population, was at risk of contracting the coronavirus and experiencing severe symptoms, and the DPA order had the potential to save many lives. But pharmaceutical supply chains are complex, fragile, and highly time sensitive. A sudden disruption can have a significant, long-lasting effect on patients’ health. We need to be cognizant of these ethical issues and weigh competing claims before proceeding. The decision to employ the DPA to take over the assembly line of Tepezza resulted in de facto rationing of supplies without proper ethical analysis. During the COVID-19 pandemic, we have been fortunate that the DPA did not do more damage to the supply chains of life-saving drugs. CONCLUSION We should reconsider whether the DPA, in its current form, should apply to the pharmaceutical industry. The government should carefully analyze the ethics before redirecting pharmaceutical production. Instead, the federal government should create a different process in the DPA, which I call the “Pharmaceutical DPA”, for assessing when to divert pharmaceutical production, perhaps with a goal of preserving the ability to produce drugs for serious illnesses, even if the illnesses are rare. While a pharmaceutical DPA could still compel pharmaceutical and manufacturing companies to prioritize government contracts and break pre-existing contracts, the companies should have more latitude to decide when and how to start complying with the DPA’s directives. With a new two-tiered law, the federal government would have the ability to redirect non-pharmaceutical resources as it does currently and pharmaceutical ones in a way that gives a limited amount of discretion to pharmaceutical companies. Given that so many excess doses of the vaccine remain unused,[17] arguably the diversion of resources away from Tepezza did not effectively further the government‘s target vaccination goals due to a decision by many people not to receive the vaccine. Production of Tepezza resumed in April 2021, not because the DPA was lifted, but because Horizon submitted a prior approval supplement to the Food and Drug Administration to support the increased scale production of Tepezza by other manufacturers.[18] Although the short-term supply shortage has been corrected, the case of Tepezza shows that the DPA needs to be carefully reconsidered in the context of the pharmaceutical industry because of the potential consequences to patients. If the DPA were flexible enough to allow Catalent to manufacture Tepezza for a few more hours in total, the company could have avoided the shortage. The creation of a pharmaceutical DPA would prevent this from happening in the future, enabling the original Act’s provisions to be used more like a scalpel than a blunt instrument. - [1] Fox, L., Collins, K., & Holmes, K. “Pressure mounts for Trump to actually use Defense Production Act,” CNN,, accessed July 23, 2021, https://www.cnn.com/2020/03/20/politics/defense-production-act-trump/index.html [2] “Statement from the Press Secretary,” Trump White House Archives, accessed July 23, 2021, https://trumpwhitehouse.archives.gov/briefings-statements/statement-press-secretary-123020/ [3] Court, E. & Wingrove, J. “Biden Team to Use DPA for Vaccine Manufacturing, Testing,” Bloomberg, accessed July 23, 2021, https://www.bloomberg.com/news/articles/2021-02-05/biden-team-to-use-dpa-for-vaccine-manufacturing-t esting?srnd=premium [4] “The Defense Production Act of 1950: History, Authorities, and Considerations for Congress,” Congressional Research Service, accessed July 23, 2021, https://fas.org/sgp/crs/natsec/R43767.pdf [5] Else, D. H. “Defense Production Act: Purpose and Scope,” Congressional Research Service, accessed September 23, 2021, https://sgp.fas.org/crs/natsec/RS20587.pdf [6] “The Defense Production Act: The Obscure Law that Industry and Government Should be Talking About Today, accessed July 23, 2021, https://www.cidrap.umn.edu/news-perspective/2020/12/us-sees-record-number-covid-19-deaths-december [8] “Horizon Therapeutics plc Announces Short-Term TEPEZZA® Supply Disruption Due to Government-Mandated COVID-19 Vaccine Production,” Horizon Therapeutics, accessed July 22, 2021, https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-therapeutics-plc-annou nces-short-term-tepezzar [9] Kansteiner, F. “Horizon’s Tepezza supply dwindles as manufacturer Catalent pivots to Warp Speed vaccines” Fierce Pharma, accessed July 23, 2021, https://www.fiercepharma.com/manufacturing/horizon-faces-tepezza-disruptions-as-manufacturer-catalen t-tapped-for-warp-speed [10] Kuchler, H. “Push to make Covid vaccines causes US drug shortages,” Financial Times, accessed July 22, 2021, https://www.ft.com/content/b3ac261e-2675-4679-9356-53aa6d812ad7 [11] “FDA approves first treatment for thyroid eye disease,” FDA, accessed July 22, 2021, https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-thyroid-eye-disease [12] “Tepezza Dosing and Administration” Tepezza, accessed July 23, 2021, https://www.tepezza.com/hcp/tepezza-dosing-and-infusion-information [13] It should be noted that there are currently no academic sources on the effects of the Tepezza shortage to the TED patient population. [14] Bell, D. “’A Little-known Bill of Great National Significance’: The Uses and Evolution of the Defense Production Act, 1950 – 2020,” US Army Heritage and Education Center, accessed September 23, 2021, https://ahec.armywarcollege.edu/documents/Defense_Production_Act_1950-2020.pdf [15] “Applying the Defense Production Act,” FEMA, accessed September 23, 2021, https://www.fema.gov/press-release/20210420/applying-defense-production-act [16] Author personally attended a small group conversation with the investor and attests to the accuracy of the statement. [17] Eaton J., Murphy, J. “15 million Covid vaccine doses thrown away in the U.S. since March, new data shows,” NBC News, accessed October 1, 2021, https://www.nbcnews.com/news/us-news/america-has-wasted-least-15-million-covid-vaccine-doses-march-n 1278211 [18] “Statement on TEPEZZA® Availability,” Horizon, accessed July 22, 2021, https://www.horizontherapeutics.com/media-center/horizon-resources/statement-on-short-term-tepezza-s upply-disruption. (shrink)

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)

The sixth chapter suggests that examining the prospects for a Global Health Impact labeling and certification campaign might expand the domain of traditional philosophical inquiry in an important way. It presents a proposal for testing consumers’ willingness to make decisions based on a Global Health Impact label. The basic idea is to put a Global Health Impact label on a few over-the-counter products and to collect data on changes in consumers’ willingness to purchase these products compared to otherwise similar generic (...) versions of the products from sales. The chapter explains how carrying out this test might provide an example of a new kind of experimental philosophy. Although most experimental philosophy has focused on individuals’ intuitions and is modeled on the psychological literature, there is a lot of empirical work in other disciplines, and many useful methods are available for answering important questions experimental philosophers might want to address. (shrink)

Some maintain that people lack a human right to health because this right cannot provide guidance for distributing scarce resources. Even if the skeptics are right on this point, the second chapter suggests that is not a reason to reject the right; the role of the human right to health is to provide a kind of hope that can foster the _virtue of creative resolve_. This resolve is a fundamental commitment to finding creative solutions to what appear to be tragic (...) dilemmas. Rather than helping one decide how to ration scarce resources, the human right to health provides reason to find ways to fulfill everyone’s claims. The hope this right provides gives us a response to apparent tragedy in motivating us to search for ways of avoiding it—rather than an account of distributive justice. (shrink)

Living with untreated AIDS is devastating. Patients often suffer from terrible lesions, pneumonia, and nausea; become emaciated; have seizures; and eventually die. The first chapter argues that there should be an enforceable legal human right to health that includes a right to access essential medicines to treat diseases like AIDS. The chapter does not provide a complete account of the right’s basis; the right may also have to protect our basic equality and dignity, for instance. Nevertheless, it argues that health (...) is necessary for, and partly constitutive of, a minimally good life. Lack of access to essential medicines characteristically undermines individuals’ ability to live such lives. So people should have a human right to health that grounds rights to access essential medicines. (shrink)

The third chapter presents the book’s new proposal for addressing the access to medicines problem. It suggests that by collecting and analyzing data on global health, people can come up with new ways to improve poor people’s access to essential drugs and technologies. It suggests utilizing information about medicines’ global health impact (organized by drug, disease, country, and company) to create incentives for positive change. One possibility is to give pharmaceutical companies with the most impactful drugs a Global Health Impact (...) label to use on all their products. Highly rated companies will have an incentive to use the label to get a larger share of the market. Further, socially responsible investment companies could include Global Health Impact companies in their portfolios. Finally, having a Global Health Impact certification system for pharmaceutical companies would open the door to all kinds of fruitful social activism. One possibility is a Global Health Impact licensing campaign. Pharmaceutical companies rely, to a large extent, on university research and development. So, if universities allow only certified companies to benefit from their technology, companies will have an incentive to abide by Global Health Impact standards. (shrink)

If Global Health Impact labeling is successful, it will give companies a reason to produce drugs that will save millions of lives. One might wonder, however, whether consumers have any moral obligation to purchase goods from Global Health Impact–certified companies or whether purchasing these goods is even morally permissible. The fourth chapter suggests that, if the proposal is implemented, there is reason to purchase goods from Global Health Impact–certified companies. It defends something along the lines of this argument: (1) pharmaceutical (...) companies violate rights and (2) do not do enough to address the access to medicines issue, so (3) if the Global Health Impact initiative helps rectify these problems, people should generally purchase goods from certified companies. (shrink)

Nicole Hassoun here makes a philosophical argument for health, and access to essential medicines, as essential human rights, and she proposes the Global Health Impact system as a way to ensure those rights. She reports how life-saving medicines are inaccessible and costly for the global poor, and that rather than focusing on treatments for critical, deadly global health problems, pharmaceutical companies instead invest in more profitable drugs. To address this problem, Hassoun's proposal will rate pharmaceutical companies based on their medicines' (...) impact on the improvement of global health, and will reward highly-rated medicines with a Global Health Impact label. (shrink)

Finally, the book concludes that even if creating a Global Health Impact label proves impossible, or undesirable, data on medicines’ health consequences are incredibly valuable. Researchers can use such data to look at the determinants and consequences of health impact, and international organizations and country-level ministries of health can use them to evaluate performance, set targets, and guide the distribution of health resources to countries. In short, better understanding the effect of key medicines on the global burden of disease will (...) help policymakers better treat and prevent infectious diseases. Although data alone will not solve any of the health problems people face, the Global Health Impact index can help many people secure essential medicines that save millions of lives every year. (shrink)

How should consumers think about their basic economic powers? The fifth chapter defends _positive change consumption_: under just institutions people should be free to consume as they like as long as they respect the institutions’ rules. In the absence of such institutions, there are significant moral constraints on consumption. Against recent critics, the fifth chapter argues that it is legitimate to aim at democratic change but that doing so is not always required. It argues that if democracy is too central, (...) it can prevent truly positive change; but, at the same time, we must recognize the importance of democracy for bringing about such change. (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)

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)

In this essay, I argue that at least in two phases of pharmaceutical research, especially while assessing the adequacy of the accumulated data and its interpretation, the influence of non-epistemic values is necessary. I examine a specific case from the domain of pharmaceutical research and demonstrate that there are multiple competing sets of values which may legitimately or illegitimately influence different phases of the inquiry. In such cases, the choice of the appropriate set of values—epistemic as well as non-epistemic—should be (...) made on the basis of the set’s viability to promote specific epistemic and social aims of the research, in the case at hand, rather than other competing aims. I put forth an account which addresses two philosophically significant and interrelated questions in the context of values in science debates: which aim should be prioritized when there are different stakeholders who try to achieve competing but, sometimes, conflicting goals; and what should be the criteria according to which the prioritization of a particular goal over other competing goals can be determined? I argue that both these questions can be addressed by invoking the principle of non-arbitrariness and the mere means principle and self-determination right. The philosophical import of raising and addressing these questions from an ethical perspective is that this approach leads to a better understanding of problems in today’s pharmaceutical research and guides us in efforts to alleviate these problems. (shrink)

Background European legislation prohibits direct-to-consumer advertising of prescription medicines, but allows drug manufacturers to provide information to the public on health and diseases. Our aim was to measure the frequency of disease awareness campaigns in Latvian media and assess their compliance with international and European standards. Methods Materials on health/disease and treatments were collected between April and September 2015 from 12 newspapers and magazines and six online portals. Disease awareness campaigns were assessed using a previously developed instrument based on the (...) WHO Ethical Criteria for Medicinal Drug promotion and European standards (EU law and pharmaceutical industry self-regulatory guidelines). Collected materials were used to examine the information provided on medical conditions and their diagnosis and treatment. The inter-rater reliability was calculated. Results We collected 263 materials from print (n = 149) and online media (n = 114); 94 were news items and 169 were disease-awareness advertisements. Cancer, cardiovascular problems, allergies and respiratory diseases were common topics. Of the 157 campaigns assessed, non-compliance was identified in 149 cases (inter-rater reliability 90%), mainly due to misleading or incomplete information, lack of balance and the absence of a listed author/sponsor. Six disease awareness campaigns directly mentioned a pharmaceutical product by brand name and other four included the logo or name of a manufacturer, referred to a condition and indirectly mentioned a treatment, all in contravention with European law. Conclusions The compliance of disease awareness campaigns in Latvian media with international and European standards is low. This raises concerns about the nature of information being conveyed. Through lack of balance, missing sponsorship information, and misleading or incomplete information, these campaigns could contribute to inaccurate self-diagnosis and generate demand among those who might not need medical treatment. (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)

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)

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)

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)

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)

This anthology provides a collection of new essays on ethical and philosophical issues that concern the development, dispensing, and use of pharmaceuticals. It brings together critical ethical issues in pharmaceutics that have not been included in any collection (e.g., the ethics of patients as researchers). In addition, it includes philosophical issues that are not within the traditional domain of applied ethics. For example, a game-theoretic approach to combating the emergence of antibiotic-resistent pathogens by spreading altruism. A tripartite distinction provides an (...) organized series of discussions that shows the interrelatedness of philosophical issues from the creation of pharmaceuticals, the creation of demand for them, through their delivery to their ultimate consumption. (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)

Hat die subjektive Erfahrung, uns selbst und anderen als eine bestimmte Person zu erscheinen, eine ethische Orientierungsfunktion? Und wenn ja, was geschieht, wenn wir uns auf eine Weise verändern, die uns an der Kontinuität dieser Erfahrung zweifeln lässt? Ausgehend von Schilderungen von Nicht-Authentizitäts-Erfahrungen wird in diesem Buch der Versuch unternommen, einen Begriff personaler Authentizität zu rekonstruieren, der für Fragen der angewandten Ethik handhabbar ist. Dabei verbindet das Buch auf innovative Weise zwei Diskussionsstränge aus der Bioethik und der praktischen Philosophie: die (...) bioethische Diskussion um das Neuro-Enhancement und die Debatte um das richtige Verständnis »personaler Autonomie« in der analytischen Philosophie. Dieser Ansatz erlaubt zu zeigen, dass der Begriff der Authentizität nicht im Begriff der Autonomie aufgeht und dass ersterer für die angewandte Ethik am besten als eine Fähigkeit zu rekonstruieren ist. Dadurch kann nicht nur die Bedeutung von Selbstwissen für eine verantwortungsvolle technische Selbstgestaltung thematisiert, sondern auch die in der Enhancement-Debatte häufig stiefmütterlich behandelte Perspektive des guten Lebens hervorgehoben werden. (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)

. The potential for financial conflicts of interest to influence scientific research has become a significant concern. Some commentators have suggested that the development of standardized study protocols could help to alleviate these problems. This paper identifies two problems with this solution: scientific research incorporates numerous methodological judgments that cannot be constrained by standardized protocols; and standardization can hide significant value judgments. These problems arise because of four weaknesses of standardized guidelines: incompleteness, limited applicability, selective ignorance, and ossification. Therefore, the (...) standardization of study designs should not serve as an alternative to addressing the interests and power relations that pervade science policy-making. Policy makers should take at least two steps to prevent powerful interest groups from co-opting standardized guidelines. First, their development and review should be made as transparent as possible and should be subjected to broadly-based deliberation. Second, standardized guidelines should be supplemented with efforts to scrutinize the conditions under which financial COIs tend to have the most worrisome effects so that additional steps can be taken to eliminate and mitigate those conditions. (shrink)