Defining Drugs

How Government Became the Arbiter of Pharmaceutical Fact

Richard Henry Parrish II

• Publisher: Routledge
• Year: 2017
• eBook ISBN: 9781351523141
• Topic: Social Sciences
• Subtopic: Sociology
• Index: Social Sciences

Drug-related morbidity and mortality is rampant in contemporary industrial society, despite or perhaps because, government has assumed a critical role in the process by which drugs are developed and approved. Parrish asserts that, as a people, Americans need to understand how it is that government became the arbiter of pharmaceutical fact. The consequences of our failure to understand, he argues, may threaten individual choice and forestall the development of responsible therapeutics. Moreover, if current standards and control continues unabated, the next therapeutic reformation might well make possible the sanctioned commercial exploitation of patients. In Defining Drugs, Parrish argues that the federal government became arbiter of pharmaceutical fact because the professions of pharmacy and medicine, as well as the pharmaceutical industry, could enforce these definitions and standards only through police powers reserved to government. Parrish begins his provocative study by examining the development of the social system for regulating drug therapy in the United States. He reviews the standards that were negotiated, and the tensions of the period between Progressivism and the New Deal that gave cultural context and historical meaning to drug use in American society. Parrish describes issues related to the development of narcotics policy through education and legislation facilitated by James Beal and Edward Kremers, and documents the federal government's evolving role as arbiter of market tensions between pharmaceutical producers, government officials, and private citizens in professional groups, illustrating the influence of government in writing enforceable standards for pharmaceutical therapies. He shows how the expansion of political rights for practitioners and producers has shifted responsibility for therapeutic consequences from individual practitioners and patients to government. This timely and controversial volume is written for the scholar and the compassionate practitioner alike, and a general public concerned with pharmacy regulation in a free society.

Introduction to the Paperback Edition

Since publication of Defining Drugs, much of the science of molecular pharmacology and state-crafted prescription financing schemes has changed.¹ In the 1990s, outpatient prescription drugs were not a covered benefit under Medicare, and the prevalence and economic costs of drug-related morbidity and mortality were staggering. Prescribed medications killed more Americans annually than automobile accidents, alcohol and tobacco use, and guns combined, at an estimated cost of $77 billion.² Unfortunately, the practices of pharmacy and medicine, relative to safe and responsive pharmacotherapy at the point of care, have not changed appreciably, despite unrelenting calls for system reform. As a result of the Medicare Modernization Act of 2003, the US federal government initiated funding via Medicare Part D in 2006 using an industrial approach administered primarily through a pharmacy benefit management (PBM) schema.³ When asked about this new funding scheme, one eminent health economist commented to the author that the program’s conception and implementation amounted to “overt, political corruption.”⁴ Others have voiced similar sentiments.⁵ According to current conservative estimates, pharmacotherapies that healthcare providers prescribed and dispensed (primarily physicians and pharmacists) have been a direct cause of over 100,000 drug-related deaths per year in ambulant patients at a cost of almost $200 billion.⁶ Moreover, while the incidence and prevalence of narcotic overdoses and recreational cannabis use have captured public and professional attention, the fact remains that medication-taking is a very hazardous behavior, no matter the purpose or context in which they are used. Vigilance for safety-related events in clinical trials and in practice is constructed poorly and fraught with mismanagement.⁷

Pharmaceutical Fact Revisited

Together, these drug-related incidents and their management constitute the federal government’s approach to the validation of pharmaceutical facts.⁸ As presented initially in Defining Drugs, pharmaceutical fact is a social conception of prescription drug therapy and its control in society, comprised of the way we think about medicines separately from their actual properties, i.e., in abstraction. Pharmaceutical facts emerge from collective elaboration and impose their existence on individuals to constrain their actions about medicinal substances within a body of beliefs and sentiments of an average of members in a society. Pharmaceutical fact is a concept of consciousness and a result of a collective transfiguration of the physically perceived characteristics of these therapeutic agents into a polity for governing pharmaceutical therapies. It bursts forth when two or more parties negotiate a discovery about the physical constants and effects of chemicals on living organisms. Further, it subsumes the respective roles of practitioners involved, such as medicine and pharmacy, relative to state pharmaceutical control mechanisms. It also includes the transformation of polity to policy (law and regulation) with the use of police power to enforce the monopolization of pharmaceutical mass production and use.

The Age of Biological Drugs

With pharmaceutical fact as a backdrop, the age of biological drugs, creations of our collective understanding of discoveries in the Human Genome Project, is now upon us, with hundreds of billions invested already in bio-similar monoclonal anti-body products, metabolomics, proteomics, and nanotechnologies.⁹ Both the promises and perils of genome therapeutics have been explored within the context of the current state approval system for pharmacotherapy. Ideas for how to deal with emerging issues involving biotechnology transfer now dominate concerns in industrial, regulatory, and professional venues. Quite likely, however, many readers may conclude from this introduction that the author is not an advocate of pharmacotherapy based on genomics: Nothing could be further from my position. Mine is not an argument against science for the sake of saving humanity from the onslaught of possibly grotesque science fiction or, what Baldi has coined, fiction science.¹⁰ Scientific progress leading to technological change—especially in public sanitation, animal and human vaccination, and personal hygiene— has improved the general standard for living almost everywhere it has been applied. For reasons often not known clearly, the simultaneous application of state power and physical force became the means for advancing science in an effort to achieve a higher standard for the general population.¹¹ The author’s main question is: Since the truth of these scientific achievements is so irrefutable, why was and is state power needed to arbitrate the truth of these discoveries? If they are refutable, why must state power at state and federal levels take sides with any particular industry or mode of healthcare? This is my concern, as a scholar and as a citizen.

Health Choices in the Context of Individual Sovereignty

I propose another viewpoint that respects the sovereignty of each individual citizen in the United States. I believe that, as a nation, we have forgotten what sovereignty means in our everyday lives, and drifted away from what we should expect from republican government as well as the limits we place on it.¹² Sovereignty in a free country means that each individual person has rights of life, liberty, and property. It means that you are protected from criminals and from foreign aggressors. It entails directing the course of your own life without interference from others, if that’s what you choose. It also means that you accept and are responsible for the consequences of those choices you make. You must, however, constrain your own capacity to initiate physical force.

This period in the history of genetics is particularly important because, for the first time, opportunities have become available to change the genome of both existing individuals and their germ lines (governing their offspring), and perhaps initiate what some social historians have called the end of (human) history.¹³ An institutionalized fixation with genotypic identification of phenotypic manifestations, that is, the quest to find the genetic basis of health behaviors, could complete the feedback loop of what social scientists have called the Therapeutic Culture¹⁴ of a Therapeutic State.¹⁵ So long as individuals initiate these changes within their own means and for their own purposes, the prospect for the protection of rights is favorable and the promises achievable. However, if done by those external to an individual’s purpose, choice, and/ or knowledge, the perils for self-disintegration are imminent. Ethical action truly depends both on the initiator and purposes of genomic alteration. However conceived, institutionalized self-sacrifice is neither noble nor inspiring.

Genomic science has a number of issues related to questions on the nature of life itself, not necessary human life alone. Major political attention has been focused on the biological source of and federal research support for pluripotent stem cells. These cells exist in all multi-cellular life forms. Hynes discussed the manifold implications of genomic science for healthcare practices.¹⁶ They include understanding the relationships between particular gene sequences and the production of life-promoting (as well as toxic) proteins. In addition, various genetic microsurgeries based on gene mapping results and nanotechiques could revolutionize how patients and germ lines survive, how surgery is performed, and who derives benefit. What is important to realize in this context is that often, in the quest for control of the unknown, man has sacrificed the known, living beings endowed with their own purposes, concerns, and motives.

Promises and Perils: The Quest for a More Perfect Drug¹⁷

The promises of genomics fall under three major headings: (1) personalized pharmacotherapies (also called precision medicine, personalized medicine, and pharmacogenetics, among others); (2) multi-national industrial economic growth; and (3) national security concerns. Personalized pharmacotherapy entails the selection of active pharmaceutical ingredients (APIs) and the design of therapeutic dosage forms based on an individual’s genetic constitution. No longer will people suffer from their inherent biological variation in drug absorption, distribution, metabolism, and elimination. Prescriptions would be tailored for each individual using a genetic sample collected just prior to beginning treatment, with changes to target organs or tissues followed throughout the course of therapy.¹⁸ Economic growth around the world would be stimulated by research and development in genomic applications to health conditions, many of which industry creates in a “medicamentation” strategy.¹⁹ Corporate-government partnerships to protect and distribute intellectual property rights ensure that patents are upheld as the basis of market exchange and economic value calculation. Because much of the Human Genome Project research was funded with tax dollars, prices for resultant therapies will be determined primarily by a residual development and marketing expense within a particular application that would theoretically reduce prescription drug costs. National security would be strengthened because access to this genomic information would be given only to those with governmental, military, and health exchange top-secret clearance. Internal genetic weaknesses in the civilian and armed forces populations could be located and minimized; weaknesses of potential external aggressors identified, magnified, and exploited.

The perils of genomics are summarized by: (1) the specter of eugenics; (2) state secrecy; (3) expropriation of self and exploitative duplicity; and (4) historical regulatory predispositions. The history of eugenics raises real concerns about the use of science to rationalize political and societal goals. From mass sterilization to mass extermination and genocide, proponents of ...

Table of contents

• Cover Page
• Title Page
• Copyright Page
• Table of Contents
• Foreword to the Paperback Edition
• Introduction to the Paperback Edition
• Dénouement
• Methodology and Bibliographic Sources
• Bibliography
• Index