Government, Big Pharma, and The People

A Century of Dis-Ease

Mickey Smith

• Publisher: Productivity Press
• Year: 2020
• ISBN:
  9781000263657
• Edition: 1
• Topic: Business
• Subtopic: Leadership
• Index: Business

Pharmaceuticals constitute a relatively small share of the total Health Care expenditure in most developed economies, and yet they play a critical role in the ongoing debate over how best to advance, improve, and afford Health Care. Despite this, and perhaps because of this, the industry has had, for many years, an outsized claim to fame and controversy, praise and criticisms, and support and condemnation. Unfortunately, many participants in the debate do not fully understand the complexities of the industry and its role in the overall Health Care system.

The analytical tools of economics provide a strong foundation for a better understanding of the dynamics of the pharmaceutical industry, its contribution to Health and Health Care, and its dual and often conflicting priorities of affordability and innovation, as well as the various Private and Public Policy initiatives directed at the sector. Everyone is affected by Big Pharma and the products they produce. At the Drug store, the physician's office, in front of the television, in everyday conversations, Drugs are a part of our lives. Society shapes our values toward Drugs and Drugs shape society. ("The Pill" and minor tranquilizers are good examples.) And, of course, the way Congress deliberates and Big Pharma responds has a huge impact on how Drugs affect our lives.

This book is well-researched on the subject of the pharmaceutical industry, its struggles with Government, and its relationship to the consumer from the early twentieth century until the present. The Dynamic Tension between the three participants – Government, Big Pharma, and the People – is described and explained to lead to an understanding of the controversies that rage today. The author describes how the Government, its many investigatory efforts, and the ultimate legislative results affect the industry and the consequences of their activities are explored in light of their effects on other players, including the patients and consumers who rely on both Government and Big Pharma for their well-being and who find sometimes unexpected consequences while giving special attention to the attitudes, beliefs, and misadventures of less-than-optimal Drug use. Stakeholders are identified with physicians as a major focus, as well as describing the significance of prescriptions as social objects and the processes by which physicians make choices on behalf of their patients. The author ties it all together with how Big Pharma affects and is affected by each of these groups.

The author utilizes his 50-plus years' experience as an academic, practicing pharmacist, and Big Pharma employee to describe the scope of the pharmaceutical industry and how it affects us on a daily basis, concluding with an inside look at Big Pharma and how regulations, marketing, and the press have affected their business, both good and bad.

Chapter 1

Introduction

What follows is a description of an advertisement that appeared on the front cover of The Pharmaceutical Journal, February 1961, the official organ of the Pharmaceutical Society of Great Britain. The illustration depicts a small child looking into an open prescription container. The text reads: This child’s life may depend on the safety of “Distaval”. The text continues:

Consider the possible outcome in a case such as this-had the bottle contained a conventional barbiturate. Year by year, the barbiturates claim a mounting toll of childhood victims. Yet it is simple enough to use a sedative and hypnotic, which is both highly effective…and outstandingly safe. “Distaval” has been prescribed for over three years in this country, where the accidental poisonings rate is notoriously high: but there is no case on record which even gross over-dosage with “Distaval” has had harmful results.

Distaval was the trade name for thalidomide. As some of the Readers probably know, thalidomide was the centerpiece for one of the most tragic stories in the history of the Drug industry. What most probably don’t know is that thalidomide was available without a prescription! The United States barely avoided being a major victim of this tragedy. Thalidomide was a terrible, horrific tragedy. There have been others, smaller, but no less tragic. I will speak more about them later.

In fact, any death as a result of any kind of Drug misadventure is no less tragic. If there is one issue on which all the players in this narrative are of one mind, it is to prevent Drug-related tragedies, whatever the cause. But how can one safeguard against such terrible anomalies, without stifling the often wonderful results of the process of Drug research and development?

What kinds of policies are needed? What Legislation and regulation can the People look to for a proper balance between danger and achievement? How can such balance be attained? That struggle is described in the pages which follow. It is a struggle which affects us all and, in which, individually and collectively we can all play a part. And we must!

I chose to begin the Preface with the “Thalidomide Incident” for two reasons. First, my informal polling convinces me that very few Americans under the age of 50 have ever heard of the Drug, and if they have heard of it, their understanding is vague at best. Just as with Pearl Harbor and the Alamo, thalidomide must be remembered. The second reason is that the story embodies many of the issues described in this Book.

The human elements of the thalidomide event have been chronicled by many writers. One of the best is that by Hilts (368).

As we shall see, there have been other, perhaps less traumatizing, Drug misadventures, but none raised the degree of Public awareness of the potential hazards of medication use than did this one. Despite the earnest and best efforts of Government and Big Pharma, the ever-present threat of the unforeseen always looms. What follows in this chapter is an overview of most of the topics covered in this Book. Each will surface many times and will be examined in much more detail.

Health

Having begun this introduction with a dramatic and tragic episode in history, let us turn to some problems of definition, in this case, Health. In 1948, the World Health Organization (WHO) defined Health as “a state of complete physical, mental and social well-being, not merely the absence of disease or infirmity”. WHO has held steadfastly to that definition, in spite of efforts to induce some modifications.

Sartorius (377) noted that the WHO definition may be inadequate to the task. He added two alternative definitions. The first definition is “a state that allows the individual to adequately cope with all the demands of daily life”. The second States that Health is “a state of balance, or equilibrium that an individual has established within himself, and between himself, and his social and physical environment”. Regarding the Health of an individual, it is the physician (or other health care provider), whose responsibility it is to determine, the presence or absence, of disease or disability. The individual is not truly involved in that decision. Others are.

The second definition requires a direct quote from Sartorius: “Health would thus be a dimension of human existence that remains in existence regardless of the presence of disease, somewhat like the sky that remains in place even when covered with clouds”.

Sartorius brilliantly observes that by his definition “He (the healthcare provider) must explore how individuals who have a disease feel about it, how the disease influences their lives, how they propose to fight the disease or live with it”. Surely, he notes, this would “improve the practice of medicine and make it a more realistic as well as humane endeavor”. His eloquent paper continues with a description of implications for health Promotion and health Policy. It is well worth reading in its entirety.

From the foregoing, one can see that Health is a relative and elusive concept. Perhaps a (very) personal description of the “Health” of the author will serve to illustrate. At the age of 81, at the time of this writing, I consider myself to be, and in the expressed opinions of significant others, “healthy” – “for my age”. The qualifier is always used.

I am relatively mobile, although I have given up driving an automobile (for the sake of the safety of others on the road). I still travel, although finding airlines troublesome. But that difficulty is certainly not the province of the elderly alone. I remain interested in national and world affairs. I read voraciously good stuff – biographies, history, Churchill and Dickens, as well as a healthy (?) dose of trashy mysteries and thrillers. My social networks are intact, and I take care of matters of nutrition, exercise, and hygiene. I believe my writing is reasonably coherent. (The Reader will be the judge!) But, I have carpal tunnel syndrome (CTS), neuropathy, recurrent minor episodes of skin cancer, a balance problem, and a bit of difficulty with names. You get the picture.

As well as others my age, and older, I have concerns, even fears, about the future. Not so much of dying, but of not dying. What if I succumb to dementia as did my wife? What about a lingering, painful illness? The various concerns, these and others, are laid out in Chapter 7. All of this, and more, is real and relevant to the struggles of the various parties involved in the Dynamic Tension which is the subject of this Book.

Woman as a Biological and Social Entity

Without being schizophrenic, each of us is, at the same time, many things. We are first of all individuals, and the kind of individual affects our responsibility and response to illness.

In addition, to our individual characteristics and behavior, each of us has other identities as parts of ever larger groups, including family, various formal and informal communities, and finally the total society. There is some value in understanding the Parallels illustrated in Figure 1.1, which shows the dual position of woman in nature. Just as woman as the entire organism must often take action to correct disruptions at the lower levels of the mental, physical organization, so the total society must frequently initiate programs to correct health problems among its individual members.

Figure 1.1 Dual position of woman in nature.

Dubos found in earlier writings of famed medical scholar Virchow further justification for studying society in order to study health care (226). In Virchow’s words, “Epidemics resemble great warnings from which a statesman in the grand style can read that a disturbance has taken place in the development of his People, a disturbance that not even a carefree Policy can long overlook”. Thus, according to Virchow, the treatment of individual cases is only a small aspect of medicine. More important is the control of crowd diseases which demand social and, if need be, political actions. In this light, medicine is a social science.

The study of a society and its goals is imperative for anyone who intends to operate in the health system which the society has developed. For, in spite of its failure to reach unanimity of purpose consistently, society does on occasion Act as one organism: setting priorities, defining goals, choosing methods. When society is the pati...