Pharmaceuticals

Cognitive enhancement may be defined as the amplification or extension of core capacities of the mind through improvement or augmentation of internal or external information processing systems. Cognition refers to the processes an organism uses to organize information. These include acquiring information (perception), selecting (attention), representing (understanding) and retaining (memory) information, and using it to guide behavior (reasoning and coordination of motor outputs). Interventions to improve cognitive function may be directed at any of these core faculties.

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)

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 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)

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 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)

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)

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)

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)

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)

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)

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)

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)

One of the central goals of precision medicine is to dissolve the long-standing tension between the population-level data provided by traditional randomized controlled trials and the physician’s need to prescribe therapies for their individual patient. The RCT can tell the physician that therapy A is, on average, more effective than therapy B for a population of patients, P, but this does not tell her whether A is more effective for the particular patient, p1, in front of her. However, by leveraging (...) the tools and insights of molecular biology, precision medicine hopes to prospectively determine which therapies will work for which patients and overcome this problem. Fundamental to the... (shrink)

Business models for biomedical research prescribe decentralization due to market selection pressures. I argue that decentralized biomedical research does not match four normative philosophical models of the role of values in science. Non-epistemic values affect the internal stages of for-profit biomedical science. Publication planning, effected by Contract Research Organizations, inhibits mechanisms for transformative criticism. The structure of contracted research precludes attribution of responsibility for foreseeable harm resulting from methodological choices. The effectiveness of business strategies leads to overrepresentation of profit values (...) versus the values of the general public. These disconnects in respect to the proper role of values in science results from structural issues ultimately linked to the distinct goals of business versus applied science, and so it seems likely that disconnects will also be found in other dimensions of attempts to combine business and science. The volume and integration in the publishing community of decentralized biomedical research imply that the entire community of biomedical research science cannot match the normative criteria of community-focused models of values in science. Several proposals for changing research funding structure might successfully relieve market pressures that drive decentralization. (shrink)

This is an early volume from a much respected psychedelic psychotherapist. He has written several other books since this one but until recently none of his books were on Amazon and still you can only find a German edition and a Spanish one (from 1993) but no English one (except a couple used copies). This is sad since these drugs have enormous therapeutic potential but afaik government suppression still prevents their use. The most interesting and readable parts are the case (...) histories of drug therapy, especially his own-e.g., on pages 114, 166 and 178. Though a very advanced therapist compared to many, he is far from finished with his intellectual growing up and clings to his psychoanalytic background even though he often mentions its extreme shortcomings. The often painfully awkward text is full of insights from his own therapeutic voyages and those of his patients interspersed with psychoanalytic nonsense. Part of the awkwardness may be due to bad translation from the German but the lack of a rational spiritual framework is a major problem (as with most therapy-or most life for that matter) that he only occasionally seems to recognize. He also sometimes veers off into the ozone-e.g., after many pages of sensible dialog he can opine that varicose veins and cancer are a result of the splitting of a psychosis (p99)! He quotes Zen and Sufi stories, Krishnamurti and Al Ghazali and even Castenada (seemingly unaware of his exposure as a fraud 20 years ago!), yet he seems oblivious to the fact that meditation is the most powerful therapy there is and to the presence around him in his own country and all over the globe of the most diverse and effective therapeutic community that has ever existed-that of the students of the great Indian mystic (ie, psychotherapist) Osho. What a great pity! He could have learned so much and advanced his therapy so far. But like most people he deliberately or unconsciously avoids anything which might wake him up too much. It's possible however that he just avoids mentioning Osho as he's radical enough to trigger the control templates in the monkey brain and enlightenment has the power to change one's whole life and not just put a bandaid on as other therapies usually do. Widmer refers repeatedly to the great LSD therapy pioneer Stanislav Grof, whose writings are one of the first that the interested reader may want to consult. Also, anyone who has a serious interest in psychedelic therapy should read Myron Stolaroff´s " The Secret Chief "-an account of the most remarkable clandestine therapist of this type of all time. It tells the story of the late Leo Zeff, who helped thousands to find themselves with the skilled and varied use of a wide variety of psychedelics. As the book is hard to find you may wish to read the info on Zeff on the web. In addition the clinical chapters in the excellent Ecstasy:the complete guide by J. Holland(2001) and her web page www.drholland.com (and elsewhere on the net) provide a broad framework and guide to therapy that is lacking here. A lovely book to add to any drug or therapy library, if you can find it. -/- Those wishing a comprehensive up to date framework for human behavior from the modern two systems view may consult my article The Logical Structure of Philosophy, Psychology, Mind and Language as Revealed in Wittgenstein and Searle 59p(2016). For all my articles on Wittgenstein and Searle see my e-book ‘The Logical Structure of Philosophy, Psychology, Mind and Language in Wittgenstein and Searle 367p (2016). Those interested in all my writings in their most recent versions may consult my e-book Philosophy, Human Nature and the Collapse of Civilization - Articles and Reviews 2006-2016 662p (2016). -/- All of my papers and books have now been published in revised versions both in ebooks and in printed books. -/- Talking Monkeys: Philosophy, Psychology, Science, Religion and Politics on a Doomed Planet - Articles and Reviews 2006-2017 (2017) https://www.amazon.com/dp/B071HVC7YP. -/- The Logical Structure of Philosophy, Psychology, Mind and Language in Ludwig Wittgenstein and John Searle--Articles and Reviews 2006-2016 (2017) https://www.amazon.com/dp/B071P1RP1B. -/- Suicidal Utopian Delusions in the 21st century: Philosophy, Human Nature and the Collapse of Civilization - Articles and Reviews 2006-2017 (2017) https://www.amazon.com/dp/B0711R5LGX -/- . (shrink)

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

Factory farming continues to grow around the world as a low-cost way of producing animal products for human consumption. However, many of the practices associated with intensive animal farming have been criticized by public health professionals and animal welfare advocates. The aim of this essay is to raise three independent moral concerns with factory farming, and to explain why the practices associated with factory farming flourish despite the cruelty inflicted on animals and the public health risks imposed on people. I (...) conclude that the costs of factory farming as it is currently practiced far outweigh the benefits, and offer a few suggestions for how to improve the situation for animals and people. (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)

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

A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health. Description: The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to standardize and integrate data (...) relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term ‘adverse event’ denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data. (shrink)

Globalization, political upheavals, and Western economic struggles have caused a geographical reprioritization in the realm of drug development and human clinical research. Regulatory and cost hurdles as well as a saturation of research sites and subjects in Western countries have forced the pharmaceutical industry to place an unprecedented level of importance on emerging markets, injecting Western corporate initiatives into cultures historically and socially isolated from Western-centric value systems. One of the greatest recipients of this onslaught of Western business and research (...) practices is the Russian Federation. Namely, market forces are dictating a focused research initiative in the traditional emerging markets, but this focus may be at the expense of individual and societal dignity. (shrink)

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

In a recent article in this journal, Schaefer et al. argue that it might be possible to enhance autonomy through the use of cognitive enhancements. In this article, I highlight an example that Schaefer et al. do not acknowledge of a way in which we already seem to be using pharmacological agents in a manner that can be understood as enhancing an agent’s autonomy. To make this argument, I begin by following other theorists in the philosophical literature in claiming that (...) impulsivity can serve to undermine an agent’s autonomy. I then explain that we are already able to reduce impulsivity through the use of pharmacological interventions, as is evidenced by the use of Methylphenidate in the treatment of ADHD. (shrink)

The neuro-enhancement Modafinil promises to dramatically increase users' waking hours without much sacrifice to clarity of thought and without serious side effects (inducing addiction). For Modafinil to be advantageous, its usage must enable access to goods that themselves improve the quality of one's life. I draw attention to a variety of conditions that must be met for an experience, activity or object to improve the quality of one's life, such as positional, relational, and saturation conditions, as well as it's being (...) good for its own sake. I discuss and describe the contexts in which widespread usage (legal or not) of Modafinil would undermine these conditions being met, and thus users would fail to significantly improve the quality of their lives and would in fact potentially make both themselves and nonusers worse off in important respects thus far overlooked by critics. In the right contexts, where free time is protected and prolonged, Modafinil does have a variety of potential benefits including, most interestingly, a distinctive form of agency possible only in free time. The potential disadvantages and advantages highlighted in this article are relevant not only to public institutions deciding whether to legalize Modafinil's use as an enhancement but also to individuals deciding whether to use it illegally, as well as to the questions of how and whether to alter key features of one's context (e.g. regulating work hours or extending social services) rather than, or in addition, to regulating the use of enhancement drugs such as Modafinil. (shrink)

El presente artículo tiene como objetivo destacar la problemática de las prácticas de extensión o prolongación de los derechos de exclusividad sobre los medicamentos, llevadas a cabo por la industria farmacéutica, una vez el término de protección vía patente está por finalizar. A través de tres escenarios se pone de manifiesto las implicaciones de este fenómeno, destacándose la necesidad de involucrar activamente al Estado para garantizar así unas condiciones equitativas de acceso a los medicamentos.

There is no lack of criticisms frequently levelled against the international pharmaceutical industry (Big Pharma): excessive profits, dubious or even dishonest practices, exploiting the sick and selective use of research data. Neither is there a shortage of examples used to support such opinions. A recent book by Brody (Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry, 2008) provides a précis of the main areas of criticism, adopting a twofold strategy: (1) An assumption that the special nature and human need (...) for pharmaceutical medicines requires that such products should not be treated like other commodities and (2) A multilevel descriptive approach that facilitates an ethical analysis of relationships and practices. At the same time, Brody is fully aware of the nature of the fundamental dilemma: the apparent addiction to (and denial of) the widespread availability of gifts and financial support for conferences etc., but recognises that ‘Remove the industry and its products, and a considerable portion of scientific medicine’s power to help the patient vanishes’ (Brody 2008, p. 5). The paper explores some of the relevant issues, and argues that despite the identified shortcomings and a need for rigorous and perhaps enhanced regulation, and realistic price control, the commercially competitive pharmaceutical industry remains the best option for developing safer and more effective medicinal treatments. At the same time, adoption of a broader ethical basis for the industry’s activities, such as a triple bottom line policy, would register an important move in the right direction and go some way toward answering critics. (shrink)

In this paper, I will argue that the current discussions about regulating certain activities concerning the pharmaceutical industry do miss a crucial point. The Pharmaceutical Industry is a story of success, providing a wealth of new discoveries and applied technologies, which have greatly enhanced our lives. The current call for strict regulation of the Pharmaceutical Industry makes the unwarranted assumption that such regulation will not disturb the mechanisms of the Industry’s success. I will claim that a centralised regulation profoundly transforms (...) the direction of travel. I will also claim that the role of the executive in bypassing regulations creates a parallel industry of subsidiary regulations to counter such bypassing. The predictable consequence is the increasing role of central regulatory control and the progressive slowing down of the success of the Pharmaceutical Industry leading towards an undesirable mediocrity. The conclusion I wish to advance is that our choices are not limited to ‘a wild open market’ and ‘a regulated open market’ scenarios, and the strategy to avoid a robustly regulated but mediocre Pharmaceutical Industry may involve ‘non-open market scenarios’ which have so far been absent from the alternatives discussed. (shrink)