Government, Big Pharma, and The People : A Century of Dis-Ease book cover
1st Edition

Government, Big Pharma, and The People
A Century of Dis-Ease

ISBN 9780367432447
Published December 3, 2020 by Productivity Press
502 Pages 10 B/W Illustrations

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Book Description

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.

Table of Contents




about the author


Chapter One – Introductions


Woman as a Biological and Social Entity

A Different Paradigm

Health Care and Rights

Drugs and Their Role in Society

Drug Policy

Big Pharma

Drug-Related Problems

The People

What’s Ahead


Chapter Two – The Four "P’s"


Marketing as an Actualizing Process

The Marketing Mix/The Four "P’s"

Government and the Four "P’s"


Chapter Three – Investigators and Investigations


The Hearings

The Grand Inquisitor

Gaylord Nelson – Son of Torquemada

The Fountain Hearings

Senator Kennedy Joins the Fray

Small Business Problems – Dingell

Drug Efficacy Problems – Fountain

Moss on Drug Abuse

Fountain Redux

Congressman Rogers on Transition

Senator Humphrey and the Literature

A Newcomer – Congressman Van Deerlin

Senator Fountain – "One More Time"

Senator Kennedy Returns

FDA Under the Microscope Again

Kennedy – Not Too Tranquil

Gore on Pharmaceutical R & D

Senator Fountain Again

Claude Pepper for the Old Folks

Zomax in the Spotlight

A Pryor Engatement

The Task Force on Prescription Drugs

Research Findings and Recommendations


Chapter Four – Legislators and Legislation


Laws and Policy

Bills and Sponsors

The Process


Chapter Five – Regulators and Regulations


The Food and Drug Administration

Other Regulators and Regulations

Federal Trade Commission

Federal Communications Commission

Drug Enforcement Administration

Centers for Medicare and Medicaid Services

Patents and Trademarks

State Regulations

Drug Names


Chapter Six – Non-Government Influence



Third Parties – Managed Care Controls

Formularies and Prescription Limitations


Advocates and Adversaries

Mail Order Pharmacy

Pharmacy Benefit Managers and Outcomes Management


Chapter Seven – The People and Their Drugs


The People as Patients

Health Belief Model

Case – Health Belief Model

Attitudes and Evaluation of Drugs

The Sickness Career

The Sick Role

The Sick Role in Acute and Chronic Illness

Compliance with Medication Regimens

Other Influences on Medication Use

What to Do

Death or Maybe Not


Chapter Eight – Response of Big Pharma


Response to Government

Big Pharma Speaks

Response of Big Pharma to the People

Some Ideas for Big Pharma

PMA Monographs



Chapter Nine – Little Pharma and Friends


Generic Pharma – Not So Little

Big Bio

What is Special about Specialty Drugs?

Little Boutiques

Back to the Future – Compounding Pharmacists



Chapter Ten – Greedy Big Pharma


Two Parts of Greedy

AARP and Greedy Big Pharma

Congress and Greedy Big Pharma

Risk vs. Reward

Greedy Big Tech


Chapter Eleven – Whence the Drugs?


Origins of Drugs

Drug Product Development

Marketing in the Last Century

Invention, Discovery, Development

Curiosities and Surprises

Recommended Reading


Chapter Twelve – Drugs of the Future


But Seriously

Drugs in an Aging Society

Future Drugs for the Aged

Lifestyle Drugs


Chapter Thirteen – The Non-Prescription Products Market-Dr. W. Steven Pray


Patent Medicines

Laws That Regulated Non-Prescription Products

FDA’s Review of O-T-C Products

The Prescription to O-T-C Switch

A Third Class of Drugs

Quackery – Lacking Proof of Efficacy

Quackery – New Names Confer False Respectability



Chapter Fourteen – Issues and Studies in Pharmacoeconomics


The Emergence of Pharmacoeconomic Research

The Cost of Illness

Quality of Life Assessment

The Economics of Non-Compliance

Economic Epidemiology


Chapter Fifteen – On Drug Prices – Dr. E. M. "Mick" Kolassa

Pricing: The Forgotten "P"

The Growing Importance of Pharmaceutical Prices

Prices, Politics and Problems

Pricing Terminology

What is a Pharmaceutical Price?

Price Decision Making

The Value of Pharmaceuticals

The Future of Pharmaceutical Pricing

Chapter Sixteen – Summary, Ruminations and Apologia




What If’s


Author’s Notes


Appendix A – Annotated References and Cross Index


Annotated References

Cross Index – Authors and Reference Numbers

Appendix B – Some Useful Quotes

Appendix C – The Saga of Vitamin B13

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Dr. Mickey C. Smith is author or editor of more than a score of books as well as 400+ papers in more than 100 different journals. His work has been translated into Chinese, Japanese, Russian, Spanish and Korean. Among his national and international awards are: Distinguished Educator from the American Association of Colleges of Pharmacy (first time given), Fellowship in the Institute of Pharmacy International, Australian Institute of Pharmacy Management, and an Honorary Doctorate from his alma mater, the St. Louis College of Pharmacy. Smith has served as a consultant to the FDA, FTC, WHO and served as a member of Big Pharma. Smith is Barnard Professor Emeritus of Pharmacy Administration and of Management and Marketing at the University of Mississippi.