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Gene Jockeys
This page intentionally left blank
 Gene Jockeys

Life Science and the Rise of Biotech Enterprise

NICOL AS R ASMUSSEN

Johns Hopkins University Press

Baltimore
 © 2014 Johns Hopkins University Press
All rights reserved. Published 2014
Printed in the United States of America on acid-�free paper
2â•…4â•…6â•…8â•…9â•…7â•…5â•…3â•…1

Johns Hopkins University Press

2715 North Charles Street
Baltimore, Maryland 21218-4363
www╉.press╉.jhu╉.edu

Library of Congress Cataloging-�in-�Publication Data

Rasmussen, Nicolas, 1962– author.
Gene jockeys : life science and the rise of biotech
enterpriseâ•›/â•›Nicolas Rasmussen.
p. ; cm.
Includes bibliographical references and index.
ISBN 978-1-4214-1340-2 (hardcover : alk. paper) — ISBN 1-4214-1340-X
(hardcover : alk. paper) — ISBN 978-1-4214-1341-9 (electronic) —
ISBN 1-4214-1341-8 (electronic)
I. Title.
[DNLM: 1. Drug Discovery—history—United States. 2. Biotechnology—
history—United States. 3. Entrepreneurship—history—United States.
4. History, 20th Century—United States. 5. Technology,
Pharmaceutical—history—United States. QV 711 AA1]
RS380
338.4ʹ76151—dc23â•…â•…2013028965

A catalog record for this book is available from the British Library.

Illustrations by Cheri Cunningham and Nicolas Rasmussen

Special discounts are available for bulk purchases of this book.

For more information, please contact Special Sales at
410-516-6936 or specialsales@press╉.jhu╉. edu.

Johns Hopkins University Press uses environmentally friendly

book materials, including recycled text paper that is composed of at least
30 percent post-�consumer waste, whenever possible.
 Contents

Acknowledgmentsâ•…â•…vii

Introduction. Biology’s Day at the Racesâ•…â•… 1

1╇ Biology, Industry, and the Cold War╅╅ 9

2╇ The Insulin Trophy╅╅ 40

3╇ Growing Pains: Commercial Strains on a Way of Life╅╅72

4╇ The Interferon Derby: Markets in Credit, Tournaments of Value╅╅101

5╇Epo: The Making of the Biotech Blockbuster╅╅131

6╇tPA: The End of the Beginning╅╅160

Conclusion. Science, Business, and Medicine in the

First Age of Biotechâ•…â•… 183

Cited Sourcesâ•…â•…193
Notesâ•…â•…195
Glossary of Technical Termsâ•…â•… 241
Indexâ•…â•…245
This page intentionally left blank
 Acknowledgments

More than any other book I can imagine, this is the work of a lifetime in that I
am drawing upon experiences since my teenage years, all specifically related to
this work. I therefore owe debts to an unusually long series of people for enabling
it. These include the biologists who took me into their laboratories and trained
me in several fields, especially Michael Lew and fellow clinical microbiologists
at the Dana-�Farber, and Bruce Zetter and fellow angiogenesis researchers at
Children’s Hospital in Boston; Lucia Rothman-Â�Denes and Peter Markiewicz and
other prokaryotic molecular geneticists in the University of Chicago’s BioÂ�physics
department; and all the outstanding biologists—too many to name—that I stud-
ied with at Stanford. They also include Tom Furlong and my business profes-
sors and my drug industry friends, and the fine people I worked with briefly
in marketing services at a certain biotech company. They include my recent
teachers and colleagues in public health and pharmaco-�epidemiology, espe-
cially Lisa Bero, Simon Chapman, Ben Djulbegovic, and Adriane Fugh-�Berman,
from whom I have come to appreciate evidence-based medicine (EBM) both as
a research program and an ethical perspective. Some readers may not appreci-
ate the occasional “activist” stance in this book stemming from this perspec-
tive. I make no apology for holding that sick people should only be sold drugs
proven equal to existing therapies for their condition; and that when patients are
given drugs on an experimental basis in clinical trials, the results of this human
experimentation should be available to all of medicine—no matter who pays the
bills. Like EBM, this book is proscience, not antibusiness.
Of course I owe a great debt to a list of colleagues in history and philosophy
of science too long even to begin, but one that particularly needs to include, for
specific conversations that have informed this work over recent years, John Abra-
ham, Mario Biagioli, Robert Bud, Bob Cook-�Deegan, Ric Day, Jeremy Greene, Jim
Griesemer, Paul Griffiths, Mary Hancock, Jon Harkness, Steve Hubicki, John
 viiiâ•…â•…Acknowledgments

Krige, Toby Lazarowitz, Tim Lenoir, Harry Marks, Patrick McCray, �Maureen
O’Malley, Phil Mirowski, Peter Neushul, Scott Podolsky, Brad Sherman, Gabri-
ela Soto-�Laveaga, Karola Stotz, Bruno Strasser, and Peter Westwick. I also owe
an enormous debt to all the scientists who took the time to interview with me:
Julian Davies, Bruce Eisen, Ed Fritsch, Wally Gilbert, Alan Hall, Robert Kay,
Glenn Larsen, Peter Lomedico, Tom Maniatis, Shige Nagata, Joseph Rosa, Peter
Seeburg, John Shine, Daniel Vapnek, and Lydia Villa-�Komaroff. I am very grate-
ful to the Australian Research Council for funding the research, and to the Syd-
ney Centre for the Foundations of Science for a sabbatical visit working on it.
Finally, I must express my most grateful thanks to those who gave their time
directly to this book: my partner, Jackie, for giving me space to write it, Andrea
Gaede and Audra Wolfe for helping me research it and put it together, Cheri
Cunningham for helping me realize the illustrations, Bill Summers and two
anonymous referees for giving such constructive feedback on the manuscript,
and Jackie Wehmueller for doing such a fine job in its publication.
Gene Jockeys
This page intentionally left blank
 Introduc tion

Biology’s Day at the Races╇

“Gene
â•› jockeys”—as I learned as a biology graduate student at Stanford during the
1980s—were biologists working in the biotechnology firms that hired so many
of my fellows at the time. Soon after, the term became the name of a lab com-
puter program that found the correct position of DNA sequences. At a superfi-
cial level, the metaphor makes sense, because as a “gene jockey” a biologist spent
most of his time moving DNA pieces from one place to another. But like many
metaphors that catch on, this one is apt on a deeper level. Biotech in this early
era was a festive contest closely akin to the premier horse racing circuit. Its ven-
ture capitalists, charismatic scientist-�entrepreneurs, stock market investors, and
of course its cloning races all have their close racecourse counterparts. And what
does the metaphor say about the scientists, the main characters in this book?
The typically ironic, self-�deprecating but defiant usage reminds us that a gene
jockey felt himself a smaller man in the eyes of academic counterparts, even if
respected as an athlete.
Essentially, this book is about how the biotech arena emerged when molecu-
lar biology, one of the fastest-�moving and most important areas of basic science
in the twentieth century, met the business world during the 1970s and 1980s. It
studies five of the first products to come from the new enterprise of genetic engi-
neering. All these products were drugs, and all were previously known natural
proteins, commercialized by cloning the human genes into microbes or other
cells that could be grown in vats. Since pharmaceuticals were always the eco-
nomic driver of the biotech sector, and furthermore since these same five drugs
(and minor variants) today still account for an enormous share of the wealth
said to be created by biotechnology, I think this study represents a fair basis for
generalizations about the interactions of science and commerce in the biotech-
nology of the period.
 2â•…â•…Gene Jockeys

Although it does not directly address the biotechnology industry of today, this
book may interest business scholars and economists, among whom there rages
debate about the extent to which biotech has lived up to the economic promises
trumpeted in its early days, and the extent to which biotech’s benefits have been
increased or impaired by economic policies like the 1980 Bayh-�Dole act that
made it easier for US universities to patent publicly funded research.1 In brief,
the relevant implications of my story are that the early fruits of genetic engineer-
ing, low-�hanging and ripened through decades of publicly financed biological
research, may have been harvested earlier through the policy-�stimulated, entre-
preneurial rush for profit around 1980. However, with the general advance of
molecular biology they would soon have been developed into medicines regard-
less—when the established drug firms learned how to clone. And for reasons
just as firmly grounded in biology rather than economics, these findings imply
that after this rich early harvest the field would necessarily yield less, and more
grudgingly. There is no longer such a large backlog of fundamental knowledge
ripe for “application” or, as current jargon puts it, “translation” as medical tech-
nology. Thus policies based on the premise that anything like this first bounty
can ever recur are flawed. Moreover, I shall, on several grounds, suggest that
in calculating the benefits from biotech enterprise in the era, there were also
social costs, among which even the economically assessable ones are overlooked
by economists, that need to be weighed along with the economic benefits as
measured by sales revenues. For these mixed outcomes the policies that encour-
aged the rapid flourishing of recombinant drug development described here also
need to be held accountable.2
But the focus in this book is on the science, and money’s effect upon it and
vice versa, rather than on the money per se. I will show that the development of
the first-�generation recombinant DNA drugs did not entail any great diversion
or distortion of science. These projects were driven by biologists themselves,
and in ways that grew out from traditional problems and values of the science(s)
of molecular biology. Yet this is no “internalist” story of autonomous science,
interacting only with society “outside” it to the extent that predestined discover-
ies are quickened or slowed (by funding, laws, etc.). Rather, this book’s perspec-
tive is that the science of genetic engineering was—like all science—shaped by
reciprocal interaction between the tradition-�bound ideas and values of scientific
fields, and the social institutions in which scientists participate, such as uni-
versities, funding agencies, philanthropies, medicine, and certain industries.
When social conditions changed during the late Cold War period, particularly in
the United States, this change affected these institutions and encouraged adap-
 Biology’s Day at the Races╇╅╅ 3

tation in the field of molecular biology. The already-�perceived possibility of mak-

ing drugs by genetically modifying microbes became more attractive, just at the
same time that it was becoming more technically feasible. Rushing into the new
socioeconomic niche that began (at first obscurely) opening before them, biol-
ogists actively reshaped institutions to facilitate their new activity: government
funding agencies, their universities, regulatory law, intellectual property law,
the stock markets, medicine, and also the popular understanding of life science.
They also—more conservatively than often imagined—worked to adjust the val-
ues, intellectual focus, and reward systems in the scientific fields to which they
still belonged. This book describes all these changes, while it also chronicles the
remarkable, competitive, and at once secretive and spectacular science done by
the gene jockeys who made the first generation of genetic engineering drugs.
Reconstructing this socially embedded story of the cloning races behind the
drugs, while a novel and formidable project in itself, has also allowed the book to
address some persistent arguments about whether close involvement with com-
merce is good or bad for science. When sociologist Emile Durkheim worried in
the 1890s that industrial capitalism’s huge success came at the expense of other
social institutions, such as government and religion, he warned that science’s
quest for truth was similarly becoming subordinated to industrial ends.3 The
years around 1980 were experienced as the start of a similar period of crisis,
this time deeply affecting science, as the postwar industrial preeminence of the
United States waned, and the regime of generous state funding that had charac-
terized early Cold War science policy began to falter. In the wider changes asso-
ciated with Ronald Reagan, Margaret Thatcher, and the rise of neoliberal eco-
nomic policy, social functions previously assigned to public institutions based
on elite expertise began to be given over to “market forces,” and the corporation
again began growing in power at the expense of other institutions. In pharma-
ceuticals, regulation would be made less stringent on the grounds that rigorous
testing before market approval unproductively delayed valuable innovations. In
science, more university research would be funded by private investment, and
thus produced for a commercial marketplace rather than scientific peers, on the
grounds that the private sector generated useful goods more efficiently.
The move of academic molecular biologists into biotechnology projects—
drug development being the most economically attractive—was immediately
recognized as the vanguard of this shift in science, attracting hymns of praise
and tempests of criticism from ideologues on opposing sides. Privately funded
molecular biology would free a cornucopia of lifesaving new medicines from
imprisonment in ivory towers, unleashing a storm of creative destruction in
 4â•…â•…Gene Jockeys

the pharmaceutical and agricultural sectors that might (incidentally) restore an

American lead in high technology fast ebbing away to Japan. Alternatively, pri-
vately funded biology was gutting universities and diverting research away from
areas of long-Â�term benefit—discoveries about nature’s basic laws with potential
to spawn whole new industries, yet no immediate commercial product to offer.
For example, the very techniques of molecular biology that enabled genetic engi-
neering might never have been developed under this new regime; they came
from government-�funded academic research into bacteria and their obscure
viruses over two decades, the 1950s and 1960s. So in effect, making science pay
its way in the short run means killing the goose that lays the golden eggs.4
More recently, the critique has been refined, in ways at least a little less nos-
talgic for the Cold War, and the problematic features of market-�oriented science
better defined. As neoliberal state policy aims to produce public goods through
private profit seeking, in science it encourages investment in publicly funded
research and institutions by allowing private ownership of research outcomes.
Market uptake of the resulting technology, not the judgement of impartial sci-
entific experts, determines the success of research for those ascribing to these
values—effectively leaving questions of scientific truth to the purported wis-
dom of nonscientist crowds. Leading critic Philip Mirowski, in particular, has
charged that biotech was nothing but a business model imposed from outside
biology, a deceptive investment scheme amounting simply to selling off publicly
owned scientific assets to investors or big drug firms. Moreover, he argues, the
model did not achieve its avowed goal of spurring biomedical innovation, pro-
ducing instead a decline in the productivity of the life sciences by restricting co-
operation between biologists and weakening peer-�based quality control, by tak-
ing resources from the basic research in universities that generates fundamental
value, and by hobbling efforts to bring new medical products to the clinic with
excessive intellectual property baggage.5
In a number of ways the detailed story I tell fits with this broad brushstroke
critique. However, I must differ on several points. Biotech was not a simple swin-
dle, even if the public did pay a very high price for the development of preexist-
ing public scientific resources (due, I argue, to a US intellectual property regime
growing overgenerous in the 1980s). The work that scientists in the firms did
went well beyond what biologists had already done in universities, and it cer-
tainly brought forward the medical use of the protein drugs I discuss by several
years. Furthermore, and most importantly, we must remember that even if it
was encouraged from outside, the biotech enterprise was one produced largely
by biologists—and one with partial historical precedent in biology of the 1920s
 Biology’s Day at the Races╇╅╅ 5

and 1930s. But there is one related aspect of this critique I must particularly
endorse. Rather than an all-�wise market guided by some superhuman invisible
hand, there are visible and often heavy hands that construct and maintain the
markets in public goods like science (which for ideological reasons are often pre-
tended invisible). As I will show, in the rise of biotechnology many of the hands
crafting the markets for genetic engineering drugs belonged to biologists, try-
ing with their other hands (so to speak) to do science. There really was a moment
when biologists could expect to do great science through the private sector, and
hope at the same time for scientific acclaim and for material reward. This book
tries to capture that moment—and the way the life sciences did begin to change,
in what some might read as their tragic Faustian bargain.6

Structure, Sources, and Method

Conceived as a synoptic look at the whole realm of biotech from the late 1970s
into the early 1990s, this book is a detailed study of the scientific and business
projects leading to five of the first ten recombinant DNA drugs to be approved
for medical use in the United States: human insulin, human growth hormone,
alpha interferon, erythropoietin, and tissue plasminogen activator. Reflecting
typical biotechnology in the era, these drugs are all first-�generation recombinant
products by a standard definition: naturally occurring proteins produced by
recombinant DNA in such a way that they retain their native biological action.7
The story of each captures in many ways a phase in the rapidly evolving field of
genetic engineering. Because of its design around particular products and proj-
ects, the book focuses on the few firms and people most prominent in these five
highly competitive drug development stories. The firms are paradigmatic and
their activities fully worthy of detailed attention: Genentech, Biogen, Genetics
Institute, and Amgen receive the most discussion because, scientifically, they
did the most. (Granted, a selection of five different drugs among the first ten
might have resulted in a somewhat different cast of main characters, but the
overall picture would not differ much.)
In addition to a first chapter setting the stage, the chapters each describe one
of these drug stories, cutting back and forth between the different scientists
and firms at the forefront of their nearly simultaneous, rival efforts in molecular
cloning—the process of isolating a desired human gene, splicing it into bacterial
DNA, and moving that into a cultured cell where it will be reproduced (and, ide-
ally, expressed). The different chapters, while ordered roughly chronologically,
also overlap in time and are partly simultaneous, creating further narrative chal-
lenges that require references forward and back between chapters. The inevita-
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