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Introduction

Dien Ho

The ubiquitous presence of pharmaceuticals in our lives is underappreciated. In the United States between 2009 and 2012, almost half the population used at least one prescription drug and more than one in ten Americans used five or more prescription drugs within a 30-day period (Centers for Disease Control and Prevention 2015). The use of pharmaceuticals is so widespread that runoffs from incorrect disposal of drugs have become a pollutant in our drinking water. In 2009, researchers found 51 different pharmaceuticals from beta-blockers to antianxiety medications to anticonvulsants in 19 water treatment plants (Benotti et al. 2009). Environmental impacts are worrisome for sure, but the effects of drugs on us raise far deeper concerns.

The line between therapies and enhancements has been blurred. Consider the recent class of medications that aim to “treat” erectile dysfunction. Are these drugs treatments or are they enhancers? The answer depends on our understanding of what is healthy or biologically normal. If we believe that as men age, their sexual function naturally declines, then drugs like Viagra are enhancers—they allow men to do what they naturally wouldn’t be able to. On the other hand, if we believe declining sexual function is not a necessary comorbidity of senescence, then these drugs are treatments. If we take “normal” and “healthy” as normatively loaded, then drawing the line between treatments and enhancements essentially involves defining who we are. To be sure, confronting the line between treatments and enhancements is not unique to pharmaceuticals. All of medicine, indeed, all human modifications (from education to cyberware implants), challenge our concepts of ourselves. Yet drugs offer the easiest and most socially accepted ways of selfmodification. We take dietary supplements in the hope of preventing diseases and slowing down aging. Millions of Americans take antidepressants to “feel better than well” (to borrow a phrase from Peter Kramer). Diabetics use insulin pumps to

D. Ho (*)

School of Arts and Sciences, MCPHS University, Boston, MA, USA e-mail: This email address is being protected from spam bots, you need Javascript enabled to view it

© Springer Science+Business Media B.V. 2017

D. Ho (ed.), Philosophical Issues in Pharmaceutics, Philosophy and Medicine 122, DOI 10.1007/978-94-024-0979-6_1

regulate their blood sugar levels. Chemotherapies continue to be a mainstay in our fight against cancer. Cholesterol-lowering drugs like statins claim to decrease the odds of someone suffering a stroke or a heart attack. Given the fact that cancer and heart diseases are the two leading causes of death in the USA, successes in drug therapies contribute significantly to the life expectancy of the average American. In other words, how long we normally live has been altered, and, with it, the range of activities possible for an average human has changed. Drugs, in this sense, transform the human experience.

At the same time, the proliferation of drug use has also created serious social and medical problems. The abuse of prescription painkillers is a national epidemic. Addiction to painkillers often begins with prescribed use, and patients simply continue to take them long after medically indicated need for pain management. Likewise, in a recent study, almost 7% of college students surveyed have used prescription stimulants for nonmedical purposes at some point in their lives (McCabe et al. 2005). These “spillovers” from prescription to nonprescription use point out one of the unique properties of pharmaceuticals. Unlike surgeries, for example, nonmedically indicated uses of prescription drugs are easily accessible, resulting in unsupervised medical treatments. Drugs are easy to abuse, misuse, buy and sell, and transport to and from faraway places. They can be as powerful as any other medical interventions but as portable and accessible as a bag of candies.

More worrisome, however, is the fact that drugs and their development can shape who we are in a far more conceptual sense. As with any product, drug manufacturers can only make money if there is a demand creating a financial incentive for the drug tail to wag the disease dog. Medicalization of human differences and conditions makes money. The combination of capitalism and drugs means that there will always be financial pressure to look for biological traits that can be fixed and controlled by drugs. In other words, our human imperfection is the source of tremendous profits, and our future identities are the results of scientific progress shaped by market forces.

Given the impact pharmaceuticals have on our social, political, biological, and philosophical identities, it is alarming that there has been a lack of a coherent treatment of philosophy and pharmaceutics. This volume aims to fill that gap and identify some of the major areas of philosophical interest. The book proceeds by tracing the flow of drugs from development through dispensing to their eventual use. At each point, there are fascinating and urgent philosophical issues that need to be addressed. Not only do millions of lives hang in the balance (e.g., how should antibiotics be developed and distributed in developing nations?), the very conception of who we are and who we will be as a species depends on our capacity and willingness to modify ourselves with drugs.

The book begins with a section on philosophical issues relating to the development of drugs. Jessica Flanigan begins by challenging the conventional model of drug development. Flanigan draws on our experience with a patient-driven approach to drug development for rare diseases, such as Niemann-Pick disease, type C. She argues that our respect for patient autonomy, the potential clinical benefits, and the advances in research all support her conclusion that patients should be permitted to undertake a more active role in drug development, including experimenting with not-yet-approved drugs. Anita Ho tackles the issue of pharmaceutical companies’ responsibility to develop and provide affordable drugs for the least developed nations. Focusing on the current HIV/AIDS epidemic, she examines the arguments in favor of holding manufacturers responsible for easing the disproportionate disease burden placed on these nations. Her conclusion is that these arguments are at once too weak and too strong. The fact that many of the least developed nations assisted in the development of HIV/AIDS treatments means that pharmaceutical developers have a special reciprocity-based duty to help provide affordable drugs to them.

Sergio Sismondo’s essay takes a close look at how pharmaceutical companies have enormous influence on the development of scientific knowledge. Framing his investigation within a political economy of knowledge in which knowledge is produced and justified not by individuals but by social institutions and forces (e.g., pharmaceutical companies), Sismondo traces how pharmaceutical companies sponsor clinical trials, pay scientists to sign on as authors of the trials, disseminate the information to clinicians at continual medical education courses, and plant key opinion leaders who reinforce the scientific legitimacy of these trials. The picture Sismondo paints is one in which the pharmaceutical industry has a great deal of control over the scientific landscape, much to their financial benefit. Lance Stell, on the other hand, challenges the notion that the close (and often, mutually beneficial) relationship between pharmaceutical companies and clinicians in fact poses a moral problem. Specifically, Stell examines the effect strict anti-conflict of interest policies has on patients’ care. He concludes that there is simply no evidence to warrant a hypervigilant stance against close financial relationship between drug developers and clinicians.

To complete our section on the philosophical issues relating to the development of drugs, Leah McClimans explores the use of Patient-Reported Outcome Measures (PROMs) as endpoint measurements for clinical trials. McClimans argues that recent attempts to improve PROMs contain hidden values that may make positive outcomes more likely for a clinical trial. Although this consequence might align with the interests of pharmaceutical developers, it is not necessary in patients’ best interests.

In the second section of our volume, we explore philosophical issues that arise in the distribution and dispensing of pharmaceuticals. We begin with an essay by Howard Brody, who argues that pharmaceutical companies have a financial incentive to increase the prescription rates of their products. They do so by heavy-handed marketing strategies that bombard clinicians and patients with drug advertisements. Moreover, they also create new clinical avenues and justifications for prescribing medications. Using antidepressants and diabetes as case studies, Brody argues that pharmaceutical companies subtly influence prescription habits to increase their market share. He calls this “drug-centered care.” Kenneth Richman follows Brody’s essay with a reexamination of drug-centered care. Richman argues that searching for additional uses of a product is not entirely unique to drugs; for example, we make meals on the basis of what ingredients we have available. If we reconceptualize drug-centered care, he argues that it is not obviously at odds with the goals of medicine.

Robert Veatch follows the discussion of drug-centered care with a look at our current laws regulating patients’ access to prescription drugs. Echoing Flanigan’s discussion, Veatch argues that respecting patients’ autonomy means that we should permit certain patients to have access to drugs without prescriptions. There are simply no convincing reasons, according to Veatch, to justify the paternalism that grounds our current policies regulating the dispensing of prescription drugs. Zuzana Deans continues the focus on pharmacies and dispensing policies by examining the ethics of pharmacists’ refusals to dispense certain medications on the basis of their personal moral beliefs. Deans surveys a broad range of key issues in conscientious refusals from philosophical concepts such as conscience and integrity to the application of the conventional compromise (often used to justify physicians’ conscientious refusals) to the pharmacist setting.

In the third section of our volume, we look at how drug use affects individuals from a philosophical point of view. David DeGrazia begins with an examination of the ethics of human enhancements via the use of pharmaceuticals. Specifically, DeGrazia responds to the objections that enhancements threaten individual identity and authenticity. A close examination of these concepts, he concludes, shows that some enhancive self-transformations using pharmaceuticals are not morally problematic.

In their piece “The Wisdom of Nature: An Evolutionary Heuristic for Human Enhancement,” Nick Bostrom and Anders Sandberg further explore the ethics of human enhancements. Bostrom and Sandberg critically explore arguments against human enhancement that appeal to nature’s wisdom. To wit, these arguments, according to Bostrom and Sandberg, can draw from a number of different intuitions: from favoring the status quo to the superiority of nature. They develop a heuristic based on evolutionary medicine that captures some of the intuitions behind nature’s wisdom while showing that it is morally permissible for us to improve on nature. §erife Tekin, Owen Flanagan, and George Graham’s essay nicely contrasts the two entries before. Tekin et al. highlight the limits of pharmaceutical interventions for medical conditions like addictions. Taking a new look at the nature of addiction, they argue that additive behaviors involve not just neurochemistry but also social and physical relationships. A reliance on pharmaceuticals to cure or improve a person’s addiction is not scientifically justified.

Jennifer Radden follows with a discussion of the history of melancholy. The seventeenth-century writer Robert Burton argued that treatments of melancholy must be broadly based to include not only medicinal remedies like herbs but also proper exercises, fresh air, good diet, and so on. The principle responsibility of adhering to one’s treatment falls on the patients. Radden draws from this holistic (and essentially self-help) approach and argues that it resonates well with contemporary treatments of mood disorders, such as network-based disorders consisting of diverse causes and requiring multimodal treatments (i.e., more than just the use of pharmaceuticals).

Dien Ho finishes the anthology with a look at the growing problem of antibiotic- resistant bacteria. Ho argues that slowing the emergence of antibiotic resistance requires solving a game of n-person prisoner’s dilemma at a number of different levels: from the personal to the global. The standard solutions all assume participants are acting out of rational self-interest. As such, in order to convince participants to cooperate, we need to either change their payoffs (via fines or incentives) or remove the element of choice. Given the slim chance that such an international overseeing body can exist and function effectively, we should instead try to convince participants not to act out of self-interest. It is perhaps a fitting end to the anthology. Philosophical problems pepper the flow of drugs from development to usage. They are not only of deep intellectual interests but they raise some fundamental questions about who we are and what we want to be.

Acknowledgments I want to extend my deep gratitude to Provost Doug Pisano and Dean Delia Anderson of MCPHS University, who helped secure my sabbatical. Without their assistance, I would not have had the necessary time to undertake this project. I would also like to thank the Institute of Medical Humanities at the University of Texas Medical Branch, who awarded me a visiting fellowship in the spring of 2015. Their support was indispensable. In addition, I am grateful for the support I received as a visiting scholar at University of Akureyri in Iceland. Professor Sigurdur Kristinsson was not only a great host and helpful colleague, but he has also become a dear friend.

The editing help I received from Peter Leo made finishing this project possible. His editorial instincts and sharp mind spotted improvements that I would have missed. My assistant Amanda Braconnier took care of some of the most demanding and tedious tasks with grace and aplomb. I am deeply grateful for her help. Finally, I dedicate this book to my wife Jane Leo whose comments on my essay and the introduction helped sharpen my thoughts. I also thank her for taking care of our feline daughters Sophie and Wilma while I was away for my visiting posts.

References

Benotti, M.J., R.A. Trenholm, B.J. Vanderford, J.C. Holady, B.D. Stanford, and S.A. Snyder. 2009. Pharmaceuticals and Endocrine Disrupting Compounds in U.S. Drinking Water. Environmental Science & Technology 43(3): 597-603.

Centers for Disease Control and Prevention. 2015. Therapeutic Drug Use. http://www.cdc.gov/ nchs/fastats/drug-use-therapeutic.htm. Accessed 23 May 2015.

McCabe, S.E., J.R. Knight, C.J. Teter, and H. Wechsler. 2005. Non-medical Use of Prescription Stimulants among US College Students: Prevalence and Correlates from a National Survey. Addiction 100(1): 96-106.

 
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