1st Edition

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

By Mickey Smith Copyright 2021
    502 Pages 10 B/W Illustrations
    by Productivity Press

    502 Pages 10 B/W Illustrations
    by Productivity Press

    502 Pages 10 B/W Illustrations
    by Productivity Press

    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.




    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


    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.