Robert L. Shook - Miracle Medicines: Seven Lifesaving Drugs and the People Who Created Them
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400 pages
Published March 1st 2007
A sympathetic exploration of the efforts of pharmaceutical companies and their employees to discover and distribute beneficial medications traces the arduous process through which drugs are developed, tested, and approved, in an account that offers specific profiles of mainstream medications.
Its the business of saving lives.
Miracle Medicines goes behind the scenes of the pharmaceutical industry and into the high-security laboratories to tell the stories of the men and women---chemists, physiologists, medical and clinical researchers, engineers---who have chosen to toil for years in the lab in order to transform scientific theories into new lifesaving medicines.
Youll witness the day-to-day labors, victories and defeats of the dedicated professionals who are waging a war against the diseases that still plague mankind. From the confines of their laboratories, these pharmaceutical adventurers explore unknown territories in health and science.
Miracle Medicines reveals what really happens during the long and uncertain journey that each new drug and its creators must endure from theory, to research, to testing and, finally, FDA approval and delivery to the public. Its a very human story within the context of fascinating scientific innovation.
Through first hand interviews youll also meet the patients who benefit from these manmade miracles and learn how, within their bloodstreams, an ongoing battle is raging. The drugs profiled are:
Advair: GlaxoSmithKlines revolutionary asthma medication, the first packaged as both a control and emergency drug. Gleevec: The Novartis chronic myeloid leukemia treatment born from decades of medical research in a field of study that was once considered hopeless. Humalog: Eli Lillys reinvention of insulin to control diabetes has been described as being better than nature Lipitor: Pfizers miracle antidote for high cholesterol that was nearly lost to the pharmaceutical vaults and has since become the worlds top-selling medicine. Norvir: Abbotts contribution to the fight against HIV that nearly erases all traces of the disease from the bloodstream and prolongs the life of patients. Remicade: Created for the treatment of Crohns disease, rheumatoid arthritis and other Immune Mediated Inflammatory Diseases, Johnson & Johnsons revolutionary biomedicine was developed from technology that once was only found in science fiction. Seroquel: AstraZenecas treatment for both schizophrenia and bipolar mania that has given millions of psychiatrics a new lease on life.
This compelling and truth-revealing book will forever change the way you view the medicines in your medicine cabinet, and the people who create them.
Published March 1st 2007
A sympathetic exploration of the efforts of pharmaceutical companies and their employees to discover and distribute beneficial medications traces the arduous process through which drugs are developed, tested, and approved, in an account that offers specific profiles of mainstream medications.
Its the business of saving lives.
Miracle Medicines goes behind the scenes of the pharmaceutical industry and into the high-security laboratories to tell the stories of the men and women---chemists, physiologists, medical and clinical researchers, engineers---who have chosen to toil for years in the lab in order to transform scientific theories into new lifesaving medicines.
Youll witness the day-to-day labors, victories and defeats of the dedicated professionals who are waging a war against the diseases that still plague mankind. From the confines of their laboratories, these pharmaceutical adventurers explore unknown territories in health and science.
Miracle Medicines reveals what really happens during the long and uncertain journey that each new drug and its creators must endure from theory, to research, to testing and, finally, FDA approval and delivery to the public. Its a very human story within the context of fascinating scientific innovation.
Through first hand interviews youll also meet the patients who benefit from these manmade miracles and learn how, within their bloodstreams, an ongoing battle is raging. The drugs profiled are:
Advair: GlaxoSmithKlines revolutionary asthma medication, the first packaged as both a control and emergency drug. Gleevec: The Novartis chronic myeloid leukemia treatment born from decades of medical research in a field of study that was once considered hopeless. Humalog: Eli Lillys reinvention of insulin to control diabetes has been described as being better than nature Lipitor: Pfizers miracle antidote for high cholesterol that was nearly lost to the pharmaceutical vaults and has since become the worlds top-selling medicine. Norvir: Abbotts contribution to the fight against HIV that nearly erases all traces of the disease from the bloodstream and prolongs the life of patients. Remicade: Created for the treatment of Crohns disease, rheumatoid arthritis and other Immune Mediated Inflammatory Diseases, Johnson & Johnsons revolutionary biomedicine was developed from technology that once was only found in science fiction. Seroquel: AstraZenecas treatment for both schizophrenia and bipolar mania that has given millions of psychiatrics a new lease on life.
This compelling and truth-revealing book will forever change the way you view the medicines in your medicine cabinet, and the people who create them.
Robert L. Shook: author's other books
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Edward A. Bell
Leena Peltonen
Kirsch Donald R.
Susan Aldridge
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Table of Contents
PORTFOLIO
Published by the Penguin Group
Penguin Group (USA) Inc., 375 Hudson Street, New York, New York 10014, U.S.A.
Penguin Group (Canada), 90 Eglinton Avenue East, Suite 700, Toronto, Ontario, Canada M4P 2Y3
(a division of Pearson Penguin Canada Inc.)
Penguin Books Ltd, 80 Strand, London WC2R 0RL, England
Penguin Ireland, 25 St. Stephens Green, Dublin 2, Ireland (a division of Penguin Books Ltd)
Penguin Books Australia Ltd, 250 Camberwell Road, Camberwell,
Victoria 3124, Australia (a division of Pearson Australia Group Pty Ltd)
Penguin Books India Pvt Ltd, 11 Community Centre, Panchsheel Park,
New Delhi - 110 017, India
Penguin Group (NZ), 67 Apollo Drive, Mairangi Bay, Auckland 1311,
New Zealand (a division of Pearson New Zealand Ltd)
Penguin Books (South Africa) (Pty) Ltd, 24 Sturdee Avenue,
Rosebank, Johannesburg 2196, South Africa
Penguin Books Ltd, Registered Offices: 80 Strand, London WC2R 0RL, England
First published in 2007 by Portfolio, a member of Penguin Group (USA) Inc.
Published by the Penguin Group
Penguin Group (USA) Inc., 375 Hudson Street, New York, New York 10014, U.S.A.
Penguin Group (Canada), 90 Eglinton Avenue East, Suite 700, Toronto, Ontario, Canada M4P 2Y3
(a division of Pearson Penguin Canada Inc.)
Penguin Books Ltd, 80 Strand, London WC2R 0RL, England
Penguin Ireland, 25 St. Stephens Green, Dublin 2, Ireland (a division of Penguin Books Ltd)
Penguin Books Australia Ltd, 250 Camberwell Road, Camberwell,
Victoria 3124, Australia (a division of Pearson Australia Group Pty Ltd)
Penguin Books India Pvt Ltd, 11 Community Centre, Panchsheel Park,
New Delhi - 110 017, India
Penguin Group (NZ), 67 Apollo Drive, Mairangi Bay, Auckland 1311,
New Zealand (a division of Pearson New Zealand Ltd)
Penguin Books (South Africa) (Pty) Ltd, 24 Sturdee Avenue,
Rosebank, Johannesburg 2196, South Africa
Penguin Books Ltd, Registered Offices: 80 Strand, London WC2R 0RL, England
First published in 2007 by Portfolio, a member of Penguin Group (USA) Inc.
Copyright Robert L. Shook, 2007
All rights reserved
Many of the designations used by manufacturers and sellers to distinguish their products are
claimed as trademarks. Where those designations appear in this book and the publisher was aware
of a trademark claim, the designations have been .g. Tylenol).
claimed as trademarks. Where those designations appear in this book and the publisher was aware
of a trademark claim, the designations have been .g. Tylenol).
LIBRARY OF CONGRESS CATALOGING-IN-PUBLICATION DATA
Shook, Robert L., 1938
Miracle medicines : seven amazing drugs and the people who created them / Robert L. Shook.
p. cm.
Includes bibliographical references.
Shook, Robert L., 1938
Miracle medicines : seven amazing drugs and the people who created them / Robert L. Shook.
p. cm.
Includes bibliographical references.
ISBN: 978-1-4406-9607-7
Without limiting the rights under copyright reserved above, no part of this publication may be
reproduced, stored in or introduced into a retrieval system, or transmitted, in any form or by any
means (electronic, mechanical, photocopying, recording or otherwise), without the prior written
permission of both the copyright owner and the above publisher of this book.
reproduced, stored in or introduced into a retrieval system, or transmitted, in any form or by any
means (electronic, mechanical, photocopying, recording or otherwise), without the prior written
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The scanning, uploading, and distribution of this book via the Internet or via any other means
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http://us.penguingroup.com
To Elinor
I love and adore you
I love and adore you
INTRODUCTION
While I wont promise that the miracles dealt with in this book are all of biblical dimensions, the millions who now continue to enjoy life because of these miracle medicines know firsthand that they save lives and reduce pain and suffering. These exotic man-made products were created and developed by the labor of tens of thousands of dedicated men and women working in the laboratories and manufacturing facilities of major pharmaceutical companies. And its been only within the last fifty years or so that weve seen so many new and remarkable medicines that cure diseases and lessen chronic ailments.
It was heartening for me to learn that the individuals who devote their working lives to these scientific endeavors measure their worth by the good they do for others. It is rarely money that motivates them. Considering the contributions they make to humankind, and compared to the millions paid to entertainers, professional athletes, and senior executives, their paychecks are paltry. Physicians who have graduated with highest honors from our top medical schools and who work at these pharmaceutical labs could make far more money in private medical practice.
One astute Ph.D. cum laude graduate in chemistry said, At a job interview with a pharmaceutical company, the recruiter told me, With your grades, you can make far more with a petroleum company. So then why are you interested in working for our company?
I had to convince him that my interest was in the good I wanted to do, the chemist said. The interviewer gave me a doubtful look, but he must have felt I was sincere because I got the job.
During my past twenty-five years as a writer, I have interviewed hundreds of successful people who were at the top in their fields. Never have I met, as a group, so many brilliant and dedicated professionals as I did while researching this book. I came away with deep respect and admiration for them.
Big Pharma is big business, and to many Americans most multibillion-dollar entities are faceless, monolithic corporations controlled by uncaring, mercenary managers. In this book, however, you will meet brilliant and indefatigable men and women who struggle for years to transform a strand of scientific theory into a new medicine. Dedicated scientists at such companies as Abbott, Johnson & Johnson, and AstraZeneca will come alive in their day-to-day labors and in their victories and defeats. As you will see, the failures far outnumber the successes. Its not unusual for chemists to work their entire careers in a laboratory and never have a discovery that makes it to the marketplace.
Within the confines of their laboratories, in their microbiologic worlds, these pharmaceutical adventurers trek to minuscule places, venturing into unknown territories, akin to the celebrated explorers of darkest Africa and Antarctica, and, more recently, the astronomers in outer space. Their discoveries can be equally exhilarating and also hugely beneficial.
In a November 2003 speech to the National Press Club in Washington, D.C., Sidney Taurel, CEO of Eli Lilly, told his audience about the tortuous coming-of-age of a new medicine: The usual point of invention for pharmaceutical researchers is called the generation of a new chemical entity. Here, a molecule shows some desired activity against the target. We call these molecules leads. A lead is no more a drug than an acorn is an oak tree. It is indeed something like a chemical seed that must be tended and pruned and shaped through a very long and costly process. It has to be grown into a marketable medicine. Each stage of growth takes many years and requires a staggering investment.
Once you have a lead, you have a molecule that has shown activity in a test tube. But you know next to nothing about how it will work in a living organism. Can the molecule be dissolved in a medium that can enter the body? After it enters the bloodstream, does it get to the target? What happens when the body tries to metabolize it? How does it interact with other chemicals in the body? What might its safety profile look like? There are a host of such questions you must answer and, based on the answers, changes you must try to engineer in the original molecule before you can begin to find out whether it will help patients in the real world. The key about this part of drug development is that it combines high costs with high technological risk.
Moving a compound through these early stages of development takes six or seven years, Taurel continued. It involves a lot of people putting in thousands of hours in many disciplines. By the time you reach the end of Phase Ithe earliest phase of testing in human volunteerswhen you include the cost of all the failures and the cost of capital, you may have more than $100 million invested in that compound. Yet 70 percent of the molecules that make it this far will never make to the market, and none of this work tells you what you most want to know: will it work in patients?
To answer that question, you have to send the drug candidate through six or seven more years of very costly clinical trials, and the odds are still formidable. Somewhere between 40 to 50 percent of drug candidates that enter the third and final phase of trials fails to make it to market.
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