Safe Blood: Purifying the Nations Blood Supply in the Age of A

SAFE BLOOD

SAFE BLOOD

Purifying the Nation’s

Blood Supply

in the Age of AIDS

Joseph Feldschuh, M.D.

with

Doron Weber

THE FREE PRESS

Atheneum Books for Young Readers

An imprint of Simon & Schuster Children’s Publishing Division

1230 Avenue of the Americas, New York, New York 10020

www.SimonandSchuster.com

This book is a work of fiction. Any references to historical events, real people, or real locales are used fictitiously. Other names, characters, places, and incidents are products of the author’s imagination, and any resemblance to actual events or locales or persons, living or dead, is entirely coincidental.

A Division of Macmillan, Inc.

NEW YORK

Collier Macmillan Canada

TORONTO

Maxwell Macmillan International

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Copyright © 1990 by Joseph Feldschuh, M.D.

All rights reserved. No part of this book may be reproduced

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Collier Macmillan Canada, Inc.

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Printed in the United States of America

printing number

1 2 3 4 5 6 7 8 9 10

Library of Congress Cataloging-in-Publication Data

Feldschuh, Joseph.

Safe blood : purifying the nation’s blood supply in the age of

  AIDS / Joseph Feldschuh with Doron Weber.

  p.  cm.

ISBN 0-68-486386-3

ISBN-13: 978-0-6848-6386-3

eISBN-13: 978-1-4391-1987-7

1. Blood—transfusion—Safety measures.

2. Blood banks—Quality control.

3. Health risk factors.

I. Weber, Doron.

II. Title.

  [DNLM]: 1. Blood Banks. 2. Blood Transfusions. 3. Quality Control. 4. Risk Factors. WB356F312s]

RM171.F43  1990

362.1′784′0973—dc20

DNLM/DLC

for Library of Congress               89-23758

                              CIP

Contents

Preface

1. A Dangerous Misunderstanding

2. Transfusion History and Practice

3. The Blood Supply I: The Voluntary Sector

and Nonprofit Organizations

4. The Blood Supply II: The Plasma Sector

and the Role of the Drug Companies

5. The Risks of Transfusion Today

6. AIDS: A Special Case

7. Undertransfusion

8. The Blood Bank of the Future

Notes

Glossary

Index

Preface

The origins of this book go back to a quiet day in October 1959, when a young medical student sitting in anatomy class at New York University Medical School was suddenly called out of the classroom. There is a special anxiety and dread that grips people when their routine is suddenly disrupted; they know something bad is about to happen.

The student was informed that his father had collapsed in Grand Central Station and had been rushed to the emergency room of Bellevue Hospital. The father had hemorrhaged from a bleeding ulcer and had lost considerable amounts of blood. His condition had been stabilized with blood substitutes, but he was clearly going to require transfusions in order to survive.

The son quickly offered to donate his own blood and recruited three of his classmates with similar blood types to donate theirs. In 1959, minimal testing was performed on blood, and over a 48-hour period the father was successfully transfused with four pints of blood.

Such was my personal initiation into the world of blood transfusion and my introduction to the blood banking system. My knowledge of transfusion was extremely limited at the time, although I was vaguely aware that there were some possible dangers. Over the next 29 years, my father was to receive a total of 20 pints of blood (11 donated by me) on six separate occasions for a number of medical and surgical conditions, and I was to become intimately acquainted with all the benefits, as well as the dangers, of transfusion. Had the blood transfusion system not been in existence, my father’s life would have ended in 1959. However, had there been a better system, my father might still be alive today.

Six years after his initial episode, my father hemorrhaged again and received further transfusions. After one of them he developed a severe, shaking reaction. It seems that as a result of his previous transfusions, my father had developed antibodies to one of the numerous human blood subtypes. These antibodies now brought on an allergic reaction to the new, incompatible blood he had received, blood that was being attacked and destroyed inside his body.

My father was in a precarious state. He required a transfusion, but it was very difficult to give him additional blood because a similar reaction might occur. I had already given him a unit of my own blood and pleaded with the doctors to take a second pint from me. The best chance of a close match is between blood relatives; my father had previously been exposed to my blood, so I knew we were compatible.

However, the hospital guidelines stipulated that a donor could give no more than one pint of blood in an eight-week period.* Despite my pleading, the offer to donate additional blood was refused, and a mad scramble ensued to find a safe unit of blood before my father’s blood pressure sank too low. Fortunately such a unit was located, and my father’s life was saved.

On that day in 1964, I learned that there are hundreds of blood subtypes in addition to the basic ABO groups and that the chances of getting an exact, matching blood transfusion from a total stranger are less than 1 in 100,000. I will never forget the helpless feeling that overcame me at the thought that my father might die because he could not get safe, matching blood.

I now embarked on a study of the blood banking situation, and what I found shocked and dismayed me. My first realization, of course, was that blood typing is not as simple as I had always assumed. I learned that it is very common for people to have minor reactions from transfused blood because of incompatibilities between donor and recipient. Occasionally, these incompatibilities could result in a severe transfusion reaction, as in my father’s case. In even more drastic circumstances, where, for example, type A blood is mistakenly given to a type B person, death is very likely.

I also discovered that hepatitis infections are a relatively common consequence of blood transfusion, a risk of which the public and most physicians seemed unaware. Yet most studies at the time suggested that at least one in ten individuals who received a transfusion developed hepatitis, an alarming rate considering that several million Americans each year needed a blood transfusion.

I was grateful to a system that had saved my father’s life. But mindful of his severe reaction and the other disturbing facts I had unearthed, I wondered if there were not a better way to supply blood to those who needed it; at that time, I made a promise to myself that if I were ever in a position to reform and improve the system, I would do it.

In 1966, after completing two successive fellowships in endocrinology and cardiology, respectively, I accepted a half-time teaching position at New York Medical College. As a recipient of a fellowship from the New York Heart Association, I had worked at the laboratory of Columbia University’s Nobel Prize winner Dr. André Cournand, where I began research into human blood volume measurement. Along with Dr. Yale Enson, I discovered the first accurate method for gauging how much blood an individual has in his body, providing a high degree of accuracy not achievable previously.

In the course of my research, I had also developed emergency laboratory systems and often found my services requested by companies developing new products for the health care field. In 1974, I was asked to consult for a company called Idant, which was founded in 1971 to provide frozen semen for artificial insemination. This pioneering company was practically bankrupt and its technological premise—that it is possible to freeze and preserve human semen for years—was regarded with disbelief. Physicians at the time said that frozen semen was unnecessary, did not work, and was far inferior to fresh semen—despite the fact that fresh semen could not be tested for infectious agents prior to use.

Although I worked in the laboratory primarily on cardiac problems, I was originally trained in endocrinology, a field that encompasses fertility problems. I became convinced that freezing human semen was truly a unique advance in the treatment of male infertility. By matching the sperm donor to a husband’s characteristics—with regard to race, ethnic background, height, weight, hair and eye color, blood group and type—it would now be possible for an infertile man to have a child by a genetically similar donor with respect to the above characteristics. The sperm from a semen donor could be cultured to make sure it was bacteria free, and the donor extensively tested prior to use of the semen. In addition, men undergoing chemotherapy for treatable cancers that would leave them sterile could now actually store their semen and have children at a later date.

Against the prevailing view that such a concept was doomed to failure, I joined my private scientific services consulting company to this pioneering cryobiology* laboratory and accepted the post of medical director of a new, combined corporation called Daxor, which included the Idant sperm bank. Within a year, some of the technical problems plaguing the process of freezing human semen and shipping it to doctors across the country were solved. Most of the other dozen human sperm banks started at this time went bankrupt but, despite several difficult years, Idant managed to survive, and frozen semen slowly began to gain acceptance as the best possible treatment for male sterility.

Acceptance was not immediate, however, and a majority of physicians continued to use fresh, untested semen. It was not until 1988, 14 years later, in the wake of AIDS, that the American Fertility Society and the federal Centers for Disease Control finally and officially stated that frozen semen and not fresh semen should be used for artificial insemination. It was a gratifying, if somewhat belated, recognition that only frozen, extensively tested semen was safe for artificial human insemination. By this time, Idant, the first public frozen sperm bank in the United States (and in the world), had also become the world’s largest public frozen sperm bank, responsible for an estimated 15,000 births.

Soon after my involvement with Idant, it became apparent to me that if human sperm could be stored almost indefinitely at superlow temperatures, it should also be possible to store blood for prolonged periods of time. Pioneering researchers like Drs. Charles Huggins, Arthur Rowe, and Edmund Valeri had already proved that blood could be safely stored for several years in a frozen state. It occurred to me that just as individuals could store their own sperm for later use, it should be possible to store one’s own blood for future use.

Almost immediately I began to investigate and test the feasibility of storing one’s own blood as a practical matter. I soon discovered that the public at large, as well as most physicians, mistakenly thought that the available blood supply was quite safe. It became clear that the practice of storing blood for future use, especially if one had to pay for it, was a service very few people would utilize. Since sperm banking was not to gain acceptance for another five years, the concept of storing blood had to be shelved.

In 1985, an underwriter named D. H. Blair raised significant sums of money for the development of a blood-volume analyzer, an instrument designed by me on the basis of my years of research in human blood-volume measurement. That same year, with the death of movie star Rock Hudson from AIDS, the American public first became aware in a significant way that a new epidemic was threatening the country. By focusing attention on the mechanism of AIDS transmission, Hudson’s death made clear that the epidemic was transmitted by a virus that could spread through the blood supply. Even beyond AIDS, the American people began to understand that blood transfusions were inherently dangerous, and autologous* donation—self-storage of blood—first received public notice. It appeared that the only safe blood was blood donated by an individual to himself, since this eliminated the danger of AIDS, hepatitis, or any transfusion reaction while guaranteeing a perfect match in blood types.

Repeated surveys during the eighties continued to show that a program for storing one’s own blood would not be financially viable nor self-sustaining for many years, just as sperm-banking required years to become self-sustaining. I was also aware of repeated misleading asurances by most members of the blood banking establishment about the safety of the blood supply. It was clear that I would be subject to severe personal attacks were I to challenge the accepted wisdom and the power of this establishment. I had no illusions about the depth of the probable opposition, nor any doubt that the suggested reforms would be characterized as opportunistic in the face of public fears about the spreading AIDS epidemic. As this book will make abundantly clear, however, even if there were no AIDS epidemic, the blood banking system should have been reformed years before.

Despite these obstacles, in 1985 I elected to use a portion of the underwriting funds from my blood-volume analyzer to inaugurate the world’s first public autologous blood bank—a respository where individuals could store blood for their own use or for the use of anyone else whom they might designate. It seems incredible that the obvious, inherent superiority of self-donated blood was not publicly acknowledged until 1986 by most segments of the medical and blood banking establishment. Just as there are now over 15,000 living children conceived from semen stored at Idant who would otherwise not have been born, as well as thousands of other children born from semen stored at other banks inspired by Idant’s pioneering example, it was clear to me that a historic opportunity was at hand to provide a major advance in human blood transfusion technology.

Wartime sometimes stimulates research that has peacetime uses and saves thousands of lives; similarly, the AIDS crisis, by focusing attention on the blood banking system, might serve as the catalyst needed for the transition to a safe blood banking system. The opportunity to put into practice a program that could save thousands of lives and improve the health of hundreds of thousands of people comes to very few physcians in a lifetime. Accomplishing this would also enable me to redeem the promise I had made years earlier.

For the record, I would also like to state that to date neither I nor the company with which I am affiliated has made any profit from blood banking. In fact, we have subsidized our blood service at an extensive cost since its inception five years ago (meanwhile 19 other companies who entered the field have either gone bankrupt or out of business). From the beginning, we were aware that our blood service would not be profitable for a long time, but we agreed to subsidize it indefinitely because we believed it was a vital innovation whose time would come.

In this book I have tried to outline some of the safe alternatives that an informed public must choose if it wishes to protect itself from current unsafe blood banking practices. In taking a voyage through the history of the American blood banking system and exposing many of the hidden flaws that still exist today, Safe Blood will have some unsettling, even shocking things to say. For all our effort at rational, scientific discussion, human blood is a symbolic, emotionally charged subject. We are all aware from early childhood that blood is essential to life. The sight of its fresh brilliant red color has such a powerful effect that many people will faint at the sight of blood—particularly their own. In many primitive religions—and even among some tribes today—man has practiced the ritual of drinking blood from animals or humans. Universally, the shedding of blood has long been a symbol of death.

Given this powerful cluster of associations, we do not like to hear bad news about blood—or about the organizations responsible for safeguarding the nation’s blood supply, which we prefer to think of as altruistic, charitable public servants. Unfortunately, this convenient mythology has long masked many other realities. Today, with the discovery of a host of life-threatening viruses—including, but in no way confined to, the AIDS virus—we can no longer afford to ignore the unnecessary dangers of our blood transfusion system or the failings of our blood banking organizations:

Despite repeated assertions to the contrary, the current blood supply in the United States is unacceptably dangerous. The risk of contracting AIDS from a blood transfusion is significantly higher than the public has been led to believe.

The risk of transfusion hepatitis, and cirrhosis of the liver from hepatitis leading to death, is even higher than the risk of contracting AIDS.

Blood is a multibillion dollar business and, contrary to their reputations, blood banking organizations do not always serve the best interests of American health, sometimes behaving more like business corporations than charities.*

Today, the blood banking establishment employs a double standard in dealing with the dangers of the blood supply. The public at large is reassured that blood is safe, while special precautions are taken for selected groups (to be discussed in the following chapters), leaving the bulk of the 4 million Americans who receive a blood transfusion each year without necessary, additional safeguards that could be immediately implemented.

The knowledge and the technology already exist for a safe blood banking system for all Americans.

In February 1988, on his 81st birthday, against all medical advice, my father went skiing. He took with him his 76-year-old brother-in-law, a physician who had previously undergone cardiac bypass surgery. To my father and uncle, skiing down a snowy slope was a celebration of life and their own indomitability.

In June 1988, my father developed chest pains and was rushed to Montefiore Hospital in the middle of the night. He was found to be anemic and received two units of blood donated by me, one fresh unit and one that I had previously frozen.

What originally appeared to be a heart attack turned out to be heart pain due to inadequate blood levels in the body. Further tests revealed a combination of cirrhosis of the liver and a possible tumor. Eight years earlier, when part of his colon was removed for cancer, my father had developed hepatitis from a transfusion. Now, the consulting hematologist told me that the liver-destroying cirrhosis caused by his previous hepatitis was my father’s main medical problem.

Over the next three months my father was to receive more transfusions from me and my children. Liver failure from his chronic hepatitis reduced him to 104 pounds, unable to stand but completely lucid to the end. Like most people who develop hepatitis from a transfusion, my father was unaware in 1980 that he had contracted the disease, because it is apparent only if the appropriate liver tests are performed. It was only after my father became hopelessly ill that I informed him of his hepatitis as it is basically untreatable and I did not wish to worry him needlessly. Yet as I watched him wasting away in the final stages of his illness, I knew that he was dying from a disease that might have been avoided had safe blood been available. Four days after formally blessing his three grandsons, he expired, saying that he had made his peace with God and was prepared to leave.

In the fall of 1988, my 76-year-old physician uncle, a general practitioner who had won the 1944 Gold Medal from the Welcome Foundation (for the best research done in the military), suffered a stroke. In February 1989, he announced to his thousands of patients in Pittsfield, Massachusetts that after 50 years, the time had come for him to give up the practice of medicine.

This book is dedicated to my uncle, Dr. Carl Wildman, who was my inspiration to become a physician; and to my father, Carl Feldschuh, a man of courage whose personal experience with transfusion was a constant spur to develop a system that I strongly hope will save many lives.

Doron Weber wishes to acknowledge Dr. Joseph Feldschuh for the steadfastness, vision, and enterprise of the genuine reformer; Erwin Glikes for his solid commitment and intelligent stewardship of the book; Adam Bellow for his fine, skillful editing and his friendship; Edith Lewis for her patient guidance through the indispensable tasks of editorial production; also Renata and Nancy and the entire gang at the Writers Room in New York, for the space and support to write; and a special acknowledgment of gratitude and love to Shealagh, my wife, and Damon, my son.

*This eight-week guideline was subsequently adopted by the Food and Drug Administration (FDA) and has been official policy for many years.

*Cryobiology is the science of freezing cells and tissue for long-term preservation.

*Autologous means related to self, belonging to the same organism.

*As this book was being prepared for publication, Gilbert Gaul, a reporter for the Philadelphia Inquirer, won the Pulitzer Prize for his exposé of the blood industry, The Blood Brokers. Gaul’s series of articles led a congressional panel to open a wide-ranging investigation into the Food and Drug Administration’s oversight of the blood industry. The House Energy and Commerce Subcommittee on Oversight and Investigations is looking at whether the FDA has the staff and the independence to regulate the billion-dollar industry, especially in the light of recent blood safety problems.

A Dangerous

Misunderstanding

Dr. Edgar G. Engleman, Stanford University Blood Center, before the Presidential Commission on the HIV Epidemic, May 1988

Does this mean that all is now well and that the future safety of the blood supply is assured? We don’t think so. First, we are distressed that so many blood bankers and organizations still do not understand that more could have been done from 1983-5 to prevent transfusion-associated AIDS. This suggests that they simply don’t realize that the system failed or that it has flaws.

Professor Ross Eckert, member of FDA Blood Products Advisory Committee, Statement on Blood Safety, May 1988 American public health is lower than necessary because the quality of our blood is lower than necessary.

I n the United States right now, someone needs a blood transfusion every 3.75 seconds.¹ Before the year is out, this will add up to 4 million newly transfused Americans. There is a high statistical probability that you—whoever you are and whatever you do—will require at least one transfusion of blood by the time you are 72. Indeed, some estimates claim that there is a 95 percent chance that you will require either a blood transfusion or a blood product at some point in your lifetime.²

Blood transfusions often begin with birth, as a vital aid to obstetric care—and they may be the last form of therapy for patients on a hospital deathbed. From cradle to grave, blood transfusions affect our lives.

Blood is the most precious fluid on earth, yet it can also be one of the most toxic. Of the 4 million Americans who received blood last year, between 200,000 and 400,000—or at least 500 people a day—will contract hepatitis alone.³ Thousands of these will eventually die from cirrhosis of the liver. Disease-causing viruses such as cytomega-lovirus (CMV), Epstein-Barr virus, HTLV-I, HTLV-II, HIV 2, and diseases such as malaria, Lyme disease, Chagas’ disease, and occasionally even syphilis, as well as other diseases, will continue to spread through the blood supply and infect increasing numbers of transfusion recipients. Perhaps most alarming of all, in 1990 the risk of contracting AIDS from a blood transfusion is significantly higher than the public perceives. While most attention has focused on those who contracted acquired immune deficiency syndrome, or AIDS, from a blood transfusion before mandatory AIDS testing was initiated in 1985-12,000 to 15,000 transfusion recipients are known to have been infected before 1985,⁴ plus an additional 10,000 hemophiliacs⁵—the safety of the American blood supply today is still dangerously compromised by the presence of the AIDS virus. While no one knows exactly how widespread the danger is, estimates are significantly higher than we have been led to believe. For example:

Based on figures from the Centers for Disease Control (CDC), we may conclude that as many as 1 in 7,400 patients nationwide who receive transfusions will contract AIDS from tainted blood.⁶*

Based on CDC figures, in New York and other high-risk urban centers, the risk of AIDS could be five to ten times higher than in the rest of the country, which suggests that anywhere from 1 in 750 to 1 in 1,500 patients receiving blood transfusions may contract AIDS from contaminated blood.

Given these risks, is our society now getting the safest available blood for transfusion? The answer is no. Do safer alternatives exist? The answer is yes.

Of course, any medical procedure involves a certain element of risk, and doctors are generally willing to accept a degree of mortality as long as the overall results are beneficial. Absolute safety or perfection is not attainable and can never be guaranteed for blood transfusions or for any other major therapeutic procedure. However, this qualification can itself become an excuse for not doing all that we can. When it comes to transfusion therapy today, there are several known, well-documented improvements which could go far toward reducing the high rate of infection in the blood supply, but these precautions are being resisted by an entrenched and powerful bureaucracy. The result is that the majority of the 4 million blood recipients in the United States are placed in unnecessary danger each year and prevented from making their own decisions about the best available treatment for them.

Unfortunately, the blood banking establishment employs a double standard in dealing with the known dangers of the blood supply. The public at large is assured that blood is safe, while special precautions are taken for selected groups. For example, according to a 1988