From Outside Looking Further Out: Essays on Current Issues in Medical Care

By Thomas C. Jones

This publication is a personal account of experiences in the world of science, medicine, public health, drug development, and international health care, obtained from many different areas of the world during the rewarding and diverse fifty-year career of Thomas Jones, MD. That career has included major activities in the United States, Switzerland, the Philippines, Thailand, and Brazil, as well as smaller experiences in virtually every corner of the globe. It has included work in universities, the corporate world of drug research, and work with government organizations.

There have been misdirections in health care that have been partially overlooked, perhaps because of attention given to the numerousprimarily technicaladvances that have been made. The essays, in spite of their rather negative message, are intended to be a pleasure to readcoherent, logical, tasteful, and accurate, with humor where appropriate but severity where needed.

The essays have been divided into three types: first, those that are relevant to social, governmental, and drug policy issues in our society; second, those relevant to special approaches to health care from the viewpoint of a specialist in infectious diseases; and third, those regarding specific infectious diseases. These three areas overlap at numerous points, but they allow the reader to direct his or her attention to policy issues, health care approaches, or the specific disease.

• Language: English
• Publisher: Balboa Press
• Release date: Mar 27, 2014
• ISBN: 9781452594941

Thomas C. Jones

The authors of this book experienced family medicine and patient care in the 1960s and 1970s. They watched as the corporate world took over health care. They saw the financial benefit to doctors, to hospitals, and to the pharmaceutical industry replace the process of patient care by a concerned family doctor. Here, they detail the problem as it emerged and offer possible solutions. We also issue a request to patients and future patients alike—please help us return to real patient care. Thomas C. Jones, MD, graduated from Case Western Reserve Medical School. He became professor and chief of the Division of International Medicine at Cornell University Medical College (1972–1985). He has authored three books and over two hundred research articles. Betsy M. Chalfin, MEd, received a master’s degree from the University of Illinois. She was program coordinator for the Division of International Medicine at Cornell, then academic administrator in the Department of Neurology at the Mount Sinai School of Medicine and Beth Israel Medical Center, New York. She was copyeditor of the Brazilian Journal of Infectious Diseases.

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FROM OUTSIDE

LOOKING

FURTHER OUT

ESSAYS ON CURRENT

ISSUES IN MEDICAL CARE

BY

THOMAS C. JONES

Emeratus Professor of Medicine and Public Health Weill-Cornell Medical College, New York, NY.

Previously:

Assistant Professor, Associate Professor, Professor, Head of the Division of International Medicine, Weill-Cornell Medical School

Head, Section of Infectious Diseases, Dermatology and Pulmonology, Sandoz Pharmaceutical Co., Basle , Switzerland

Medical Advisor to World Health Organization (WHO), Geneva, Switzerland– Editor, Brazilian Journal of Infectious Diseases, Salvador, Brazil

EDITED BY BETSY M. CHALFIN M. ED

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Copyright © 2014 Thomas C. Jones.

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The author of this book does not dispense medical advice or prescribe the use of any technique as a form of treatment for physical, emotional, or medical problems without the advice of a physician, either directly or indirectly. The intent of the author is only to offer information of a general nature to help you in your quest for emotional and spiritual well-being. In the event you use any of the information in this book for yourself, which is your constitutional right, the author and the publisher assume no responsibility for your actions.

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Printed in the United States of America.

ISBN: 978-1-4525-9493-4 (sc)

ISBN: 978-1-4525-9495-8 (hc)

ISBN: 978-1-4525-9494-1 (e)

Library of Congress Control Number: 2014905599

Balboa Press rev. date: 03/27/2014

CONTENTS

Introduction

Social, Governmental, and Drug Policy Essays

Chapter 1   Institutionalized Mislabeling: A Disaster for Information Exchange and Problem Solving

Chapter 2   Clinical Research in the Pharmaceutical Industry and Government Regulatory Processes must meet the Challenges of Rapid Drug Discovery

Chapter 3   Suggested New Approach to Clinical Trials and Drug Registration

Chapter 4   Ethical Issues Regarding Randomisation, Placebo-Controlled Clinical Trials and their Publication in Medical Journals

Chapter 5   Incentives and Penalties in Health Care: Getting the Best from the Pharmaceutical Industry

Chapter 6   Risks and Benefits of the Drug Regulatory Process

Chapter 7   Distribution of Health Care– Learning from the Managed Health Care Experiment in the United States

Chapter 8   Vaccines for the Future–Problems and Potential Solutions from the Countries that Need Them

Chapter 9   In Health Care, as in Politics, we Need Justice and Humanity

Essays Regarding Special Activities in Medical Care

Chapter 10   Careful Evaluation of Clinical and Pre-Clinical Data is Needed, –-Not More Clinical Trials!

Chapter 11   Case Reports and Qualitative Research–Two Important Approaches to Evaluation and Communication in Medical Science

Chapter 12   New Roles for Infectious Diseases Physicians in the Hospital; Leadership, Organization, and Teaching by Example

Chapter 13   Control of Spread of Microorganisms in the Hospital– Back to the Basics of Hand and Glove Antiseptics

Chapter 14   Pharmacists, Physicians and the Delivery of Health Care

Chapter 15   Physician Alert–Your attitudes may be spreading infectious diseases!

Chapter 16   The Infectious Disease Physician and the Veterinarian–A Need for Dialog, Cooperation and Action

Chapter 17   Conflicting Messages Regarding Emerging Microbial Resistance, Microbial Sensitivity Testing and Control of Antibiotic Use in Hospitals

Chapter 18   Statistics in Medicine; A Look at the Problems, A Challenge for the Future

Chapter 19   Communicating Clinical Science- a Challenge for us all

Chapter 20   Preventive Health Care for an Endangerd Species– the Physician Scientist

Issues Relevant to Special Infectious Diseases

Chapter 21   The Role for the Infectious Diseases Specialist in the Prevention of Dengue Fever and Yellow Fever

Chapter 22   The Challenge of Surveillance and Control of Emerging Communicable Diseases

Chapter 23   Blastocystis hominis— more than 70 years of debate regarding pathogenicity!

Chapter 24   Can we Alter the Cytokine Balance in the Management of Infectious Diseases?

Chapter 25   Immunomodulation–An Idea from the Past Looks more Promising than Ever.

Chapter 26   Will Immunotherapy and Vaccination Replace Antimicrobials? The Future may be Closer than we Think!

References

About the Author

INTRODUCTION

T his publication is a personal account of experiences in the world of science, medicine, public health, drug development, and international health care, obtained from many different areas of the world, in the midst of a rewarding and diverse career. That career has spanned 50 years. It has included major activities in the United States, Switzerland, the Philippines, Thailand and Brazil, as well as smaller experiences in virtually every corner of the globe; and it has included work in universities, the corporate world of drug research, and work with government organizations. This diverse experience, particularly outside of the United States, has given me a perspective that may allow the objective reader to pause and consider new directions in health care. The basic message is that there have been misdirections in health care that I believe have been partially overlooked, perhaps because of attention given to the numerous advances that have been made. My fear is that by overlooking these misdirections we run the danger of undoing all those advances.

I would like in these essays to attempt to get the balance right. As you will note, almost all of the essays are based on editorials I wrote for the Brazilian Journal of Infectious Diseases between 1987 and 2002. These editorials were each prompted by a submission of an article to the journal and I wanted, by my editorial, to expand the message being presented. The sad news is that 15 years later the problems remain the same. The good news is that by restating these issue here perhaps the time for action has arrived—I hope so. Perhaps, I can provide a small amount of enrichment regarding needed new directions by reviewing my experiences, by identifying those in society who have recognized and written about these various problems as well, and by reporting in a single document a summary of the problems and potential solutions.

I want this to be an account that, in spite of its rather negative message, is a pleasure to read– that is, coherent, logical, tasteful, and accurate, with humor where appropriate but severity where needed. In addition, I have tried to offer solutions to the problems raised, in the hope that this contribution is viewed overall as a positive force to our various social ills. I realize this is a most difficult challenge because my examples are real and concrete, whereas any solutions are filled with fantasy and speculation. As a part of the fantasy I have sometimes focused more on preventing the spread of various problems to other parts of the world rather than correcting the problems where they have emerged. This will be disappointing to those in the United States, but I believe it is a realistic step. Perhaps those in the US that observe my preventive health care approach to these issues will also be able to see therapeutic modalities useful for the problem already in existence at their origin. The reader will judge the success of my efforts, I only ask that he or she keep in mind the intent.

The Essays have been divided into three types: 1) those that are relevant to social, governmental, and drug policy issues in our society, 2) those relevant to special approaches to health care from the viewpoint of a specialist in infectious diseases, and 3) those regarding specific infectious diseases. These three areas overlap at numerous points, but they allow the reader to direct his or her attention to policy issues, health care approaches or specific disease.

SOCIAL, GOVERNMENTAL, AND DRUG POLICY ESSAYS

CHAPTER

1

INSTITUTIONALIZED MISLABELING: A DISASTER FOR INFORMATION EXCHANGE AND PROBLEM SOLVING

M islabeling is a sinister process in our society that affects all aspects of life. Mislabel occurs as a result of a complex series of psychological adjustments made by decision-makers. Many times these adjustments are even made subconsciously, not maliciously, or with intent to camouflage. Occasionally these mislabels are made with the best of intentions, such as; to show a level of respect by calling a country developing when it is just poor, or to refer to world health, when one means world political organization, or to regulate drug safety when indeed one means control drug use. Other more sinister, recent examples include the attempts to block all kinds of social developments in the Untied States by terming the directions as in need of more research, or by calling protests against globalization acts of terror, or by calling corporate takeover of health care, managed care.

The reader should understand that this is not a comprehensive treatise concerning the problem of institutionalized mislabeling, but an attempt to allow my personal experience to give some life to the problem. The reader should view any criticism as collective, that is, toward the entire institution, not toward any specific individuals involved in the examples. Indeed, one of the problems in these institutions is the absence of institutional memory and it is likely that those involved during the times I am reviewing are no longer around. This is exemplified by the anger I felt a few years ago when Robert McNamara apologized for the Vietnam War, years after we, who were caring for the young people with missing limbs, knew the whole thing was wrong. It was not that single individual, but the institutionalized mislabeling process that allowed the catastrophe to happen, and to allow an apology to resolve it. In this case, as in many others, an apology was simply not good enough. There are indeed examples of personal guilt for the policies developed, but these special cases should be handled in the proper courts of law if perjury or civil injury can be shown. My attention here is directed at the collective guilt of all of us who have allowed these mislabeling practices to continue unchallenged. One danger is that because the examples I give are in the past, arguments can be made that things have improved since then, the problems have been solved, or are being properly studied and dealt with. I would hope that were the case, but, because I have heard these statements for so many years without any results, I must state that it is very likely that the mislabeling activities are just as prominent today as they were during the time of the above cited examples.

The following examples draw attention to three areas where mislabeling has prevented understanding of what is really going on, and, as a result, prevented proper information exchange to allow us to solve the underlying problems. The areas focused upon in this review are 1) drug regulation, particularly by the FDA, 2) language within pharmaceutical companies, and 3) language used in the clinical trials research process.

Examples of Institutionalized Mislabeling

1.0 U. S. Food and Drug Administration (FDA) and other Regulatory Agencies

The FDA has been a powerful force in the regulation of medicines and devices in the United States for 35 years, and during the past 10 years its policies have begun to be mirrored in many other parts of the world, most notably the European Community. The power of this agency, and its expanding influence have derived from several factors, but most importantly the desire of citizens to feel comfortable that a medicine they are prescribed or is available without a prescription has been properly tested and is safe for use. However, due to a number of subtle mislabeling practices by the FDA it has expanded its role significantly, and at a tremendous cost, to include the entire process of regulating health care. The FDA continues to promote itself as a government agency to protect the public, but under this label it has become a micro-manager of all aspects of health care in our society. The personal examples cited below demonstrate how this micro-management has led in many directions other than public safety. If each citizen knew what he or she had given up in the process of this evolution from drug safety to total drug control, I am certain he or she would ask for some of their own decision making back. They would ask for a marked reduction in the power of this agency, and for a return to its role as a safety monitor rather than a drug controller.

The very high level of expense, blunting of drug development, and delay in drug and device availability has been well detailed in the book edited by Robert Higgs, Hazardous to Our Health?: FDA Regulation of Health Care Products (1). I will only quote the major points from this book by way of introduction to my personal experiences. It is reviewed in this book that indeed the FDA is not a body to ensure drug safety, it is a law-enforcement, political body which has the goal to regulate, supervise and partly determine the manufacture, development, advertising, and availability of all drugs. The cost of drug development has increased up to 10 fold, and the delay in drug availability increased 2-3 fold as a result of the processes in place. This, however, in my experience, is the tip of an iceberg of effects resulting from this misdirection of society’s trust in the request for an agency to supervise drug and devise safety. I will provide some examples.

I worked for 10 years in the pharmaceutical company, Sandoz Pharma Ltd, as a medical expert in the clinical development of several drugs. I was stationed at the international headquarters of the company in Basle, Switzerland, and participated in the process of clinical trials preparation which would allow registration of the drugs in many different countries. In the early part of my time with this company, before the concepts of globalization attempted to make the drug development process standard worldwide, we had to orchestrate separate development processes for Europe, Asia, Africa and Latin America as one development approach, then the USA as another, and Japan as a third. Because of the restrictions by USA and Japan, each different from the other, it was understood that the drugs would be available 2-3 years earlier in Europe, primarily because the two countries had special requirements that clinical trials had to usually be done in each of the countries. This, of course, usually meant redoing the trials already done elsewhere, with trial designs often altered to satisfy opinions from the regulators, and the use of different processes of data entry, presentation and review. As the globalization, and harmonization, processes evolved the regulation approach used by the FDA was gradually adopted in many other areas including the European Community. I had the opportunity to see how this process gradually changed the entire corporate make-up of the company, including the most impressive alterations in the number and qualifications of medical expertise (both went down), the number of regulatory managers, statisticians, and corporate conferences (each went up). Medical opinions disappeared and were replaced by paper documents. This was a direct result of the law-enforcement attitudes of the FDA, since paper could be supervised. Medical opinion, particularly regarding an innovative product, just confused the process both within the company and in its discussions with the FDA. The cost of this subtle effect, perhaps not even intended by the FDA in their zeal for proper regulation, can not be measured, but it is very large by any standard. If we could count the number of drugs that were blocked from development as a result of these policies we might begin to see the damage done. We would see that society has witnessed the conversion of a creative process into a bureaucratic one with losses 10-100 times higher than those of the higher costs and delays in development of the drugs that were finally approved.

The following is one example of delays and their cost. The drug, terbinafine, now marketed worldwide, including the USA, as Lamisil, is used to treat fungal infections of the skin, nails and hair (2). In 1991 the orally active form of the drug was registered throughout most of the world based to a large degree on studies done in the United States, but it was not registered in the United States until 1995, 4 years later, and then only to treat one condition, nail infections. Why? During the development of the drug, and prior to its use in humans, a required toxicology study was done in rats. This study showed that male rats who got the drug in their drinking water during their entire life had 8/50 liver cancers, instead of the anticipated 5/50 in historical controls and in the female rats in the study. This difference, although small, was statistically significant, and it led to a delay in the development of the drug worldwide while