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




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ISBN 9780367432447
December 3, 2020 Forthcoming by Productivity Press
400 Pages - 10 B/W Illustrations

 
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Book Description

Pharmaceuticals constitute a relatively small share of the total healthcare expenditure in most developed economies, and yet they play a critical role in the ongoing debate over how best to advance, improve, and afford healthcare. Despite this, and perhaps because of this, the industry has had, for many years, an outsized claim to fame and controversy, praise and criticisms, support and condemnation. Unfortunately, many participants in the debate do not fully understand the complexities of the industry and its role in the overall healthcare system. The analytical tools of economics provide a strong foundation for a better understanding of the dynamics of the pharmaceutical industry, it’s contribution to health and healthcare, 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 Pharm 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 Pharm and the People – is described and explained to lead to an understanding of the controversies that rage today. In this book, the author describes how the Government, its many investigatory efforts and the ultimate legislative results impact the industry. Regulatory developments are notably but not limited to the FDA and the consequences of their actives are explored in light of their effects on other players. The people are the patients and consumers who rely on both Government and Big Pharma for their well-being, and who finds sometime unexpected consequences. The author gives special attention to the attitudes, beliefs and misadventures of less than optimal drug use. Stakeholders are identified with physicians as a major focus. The mysterious prescription and its significance as a social objects are described as are the processes by which physicians make choices on behalf of their patients. The author ties it all together with how Big Pharma impacts and is impacted by each of these groups. The author utilizes his fifty-plus years’ experience as an academic, practicing pharmacist and Big Pharma employee to describe the scope of the pharmaceutical industry and how it impacts us on a daily basis. he starts with a brief history and defines the stakeholders. Then moves on to governmental investigations, legislations and regulations, their roles and activities, in a pursuit to protect patients, consumers and other stakeholders. The author concludes with an inside look at Big Pharma and how regulations, marketing and the press has impacted their business – both good and bad.

Table of Contents

Dedication

Acknowledgements

Preface

about the author

 

Chapter One – Introductions

Health

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

Conclusion

Chapter Two – The Four "P’s"

Introduction

Marketing as an Actualizing Process

The Marketing Mix/The Four "P’s"

Government and the Four "P’s"

Conclusion

Chapter Three – Investigators and Investigations

Introduction

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

Conclusion

Chapter Four – Legislators and Legislation

Introduction

Laws and Policy

Bills and Sponsors

The Process

Conclusion

Chapter Five – Regulators and Regulations

Introduction

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

Conclusion

Chapter Six – Non-Government Influence

Introduction

Self-Regulation

Third Parties – Managed Care Controls

Formularies and Prescription Limitations

Lawyers

Advocates and Adversaries

Mail Order Pharmacy

Pharmacy Benefit Managers and Outcomes Management

Conclusion

Chapter Seven – The People and Their Drugs

Introduction

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

Conclusion

Chapter Eight – Response of Big Pharma

Introduction

Response to Government

Big Pharma Speaks

Response of Big Pharma to the People

Some Ideas for Big Pharma

PMA Monographs

Statesmanship

Conclusion

Chapter Nine – Little Pharma and Friends

Introduction

Generic Pharma – Not So Little

Big Bio

What is Special about Specialty Drugs?

Little Boutiques

Back to the Future – Compounding Pharmacists

Friends

Conclusion

Chapter Ten – Greedy Big Pharma

Introduction

Two Parts of Greedy

AARP and Greedy Big Pharma

Congress and Greedy Big Pharma

Risk vs. Reward

Greedy Big Tech

Conclusion

Chapter Eleven – Whence the Drugs?

Introduction

Origins of Drugs

Drug Product Development

Marketing in the Last Century

Invention, Discovery, Development

Curiosities and Surprises

Recommended Reading

Conclusion

Chapter Twelve – Drugs of the Future

Introduction

But Seriously

Drugs in an Aging Society

Future Drugs for the Aged

Lifestyle Drugs

Conclusion

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

Introduction

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

Conclusion

 

Chapter Fourteen – Issues and Studies in Pharmacoeconomics

Introduction

The Emergence of Pharmacoeconomic Research

The Cost of Illness

Quality of Life Assessment

The Economics of Non-Compliance

Economic Epidemiology

Conclusion

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

Introduction

Ruminations

Trends

What If’s

Apologia

Author’s Notes

 

Appendix A – Annotated References and Cross Index

Introduction

Annotated References

Cross Index – Authors and Reference Numbers

Appendix B – Some Useful Quotes

Appendix C – The Saga of Vitamin B13

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Author(s)

Biography

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.