By Susan Quinn
Reviewed by: David S. Shimm, MD,
FACP
Popular accounts of pioneering scientists
and physicians have long fascinated the public. Indeed, the somewhat 1-dimensional
picture of the dedicated researcher or clinician struggling against disease,
not to mention skeptical or jealous colleagues, is a compelling one. However,
although books such as Paul DeKruif's Microbe Hunters; Devils, Drugs and
Doctors, by Howard Wilcox; and Magic, Myth and Medicine, by John Camp,
do mention their protagonists' struggles, they have a fairy tale "and they
all lived happily ever after" denouement -- Paul Ehrlich discovers salvarsan
and Marie Curie gets the Nobel Prize.
In Human Trials: Scientists, Investors,
and Patients in the Quest for a Cure, however, Susan Quinn, who has written
biographies of physicist Marie Curie and psychologist Karen Horney, gives
the reader a Paul Harvey-esque "here's the rest of the story" look at clinical
research -- specifically, a look at the tensions among venture capitalists,
start-up biotechnology companies, and clinical researchers.
The book tells the story of Howard
Weiner, a professor of neurology at Harvard conducting research on multiple
sclerosis (MS), who develops a technique for inducing immunologic tolerance
by oral administration of antigen. He forms a company, Autoimmune, Inc.,
which attempts 2 clinical trials -- one a trial of myelin basic protein
to treat MS, and the other a trial of collagen to treat rheumatoid arthritis
(RA). In neither trial does he show a significant difference between the
experimental agent and placebo, due to an unusually high placebo response
rate. This leads to the failure of Autoimmune, Inc.
Quinn's depiction of the science
behind her story seems appropriate for the book's audience. Her description
of immunologic tolerance gives the reader sufficient background to understand
where Dr. Weiner is trying to go with his technology, without confusing
the reader or providing excessive detail. Her portrayals of individual
MS and RA patients enrolled in the clinical trials are engaging and add
a human dimension to her story. Some of her second-level characters --
such as Weiner's laboratory colleague, Ruth Maron, and Autoimmune's CEO,
Bob Bishop -- are also interesting. Particularly compelling portions of
the book ("the rest of the story") include Quinn's narrative of Weiner's
meeting with venture capitalists on behalf of Autoimmune, Inc., and her
depiction of the competitive atmosphere that exists among the clinical
researchers when they discover how much money each is being paid for accruing
patients to clinical trials.
While Quinn may draw a deft portrait
of Ruth Maron and Bob Bishop, her depictions of the protagonist and some
of the bit players seem more 1-dimensional. Perhaps Dr. Weiner is a candidate
for beatification, but Quinn's saintly description of him does not ring
entirely true. While she does cite some narcissistic passages from his
personal journal, which he has apparently kept at least since medical school
--perhaps to show that her saint has feet of clay, Weiner does not appear
as a real, 3-dimensional individual. At the other end of the spectrum,
for example, Quinn's passing description of a spokeswoman for a consulting
company as "a bleached blonde in her thirties with bright red lipstick"
is gratuitously demeaning and distracting.
Quinn's discussion of the payment
of capitation fees to clinical researchers was not entirely satisfying.
Here, she discusses the financial benefits of doing clinical research for
one academic physician:
The one thing that gives Sewell [a
Harvard rheumatologist] some autonomy and fiscal clout within the increasingly
burdensome bureaucracy is clinical research.... Lea Sewell, situated at
a Harvard teaching hospital that is a magnet for patients with unusual
diseases, manages to attract a lot of drug company research at a decent
per-patient fee. Even after she pays out a large percentage of the money
to cover office space, laboratory, and administrative costs, Sewell manages
to support a part time research nurse and to augment her own salary from
her clinical research. (pp. 217-218)
And here is her description of a
private practice physician who does pharmaceutical industry-sponsored clinical
trials:
... there is no doubt that clinical
trials are also sustaining to [Dr.] Ron Rapoport and his operation. "The
income from studies is valuable," he acknowledges. Rapoport has an office
staff of five, including his wife Jenny, a former surgical nurse who comes
in three days a week. And he has three children... who go to private school.
"That's another thing the studies have helped," he says. "I can afford
to send them to private school. And if I did not do studies or give lectures,
it might not be affordable."
Rapoport... is also attracted to
the entrepreneurial side of trial work. He has a card that promotes his
clinical research... "It's not just making the money that's exciting,"
he explains, "it's making a successful venture." (p. 234)
Quinn has shown how performing industry-sponsored
clinical trials provides extra money above and beyond expenses for Dr.
Sewell, in academic practice, and for Dr. Rapoport, in private practice.
For Dr. Sewell, this money helps to defray some of her overhead and to
augment her salary, giving her some leverage with the university and hospital
administration as well as some direct personal gain. Dr. Rapoport clearly
acknowledges the personal financial benefits of performing clinical trials.
Clearly, drug company capitation
payments are more than simply compensation for overhead, analogous to the
overhead paid along with NIH grants, as some have suggested. It is frustrating
that in one paragraph Quinn glosses over the very real possibility that
clinical researchers, squeezed by decreasing patient revenue due to managed
care and by decreasing peer-reviewed research money, might be a little
too persuasive or encouraging with regard to clinical trials (pp. 228-229).
Because of possible financial benefit to the clinical researcher, danger
lies in the fact that he or she might (consciously or unconsciously) steer
a patient toward a clinical trial when conventional treatment, or even
no treatment at all, might be in a patient's best interest. While physicians
make more for doing more under fee-for-service reimbursement, this situation
differs from instances in which physicians are paid for enrolling patients
into clinical trials. Patients understand that doctors are paid for performing
clinical activities, and if they believe that the physician might be suggesting
a particular course of treatment for financial reasons, they can question
him or her, just as they would question an auto mechanic suggesting expensive
repairs. However, since most patients are not even aware of capitation
payments to clinical researchers, they would not even have reason to consider
that a recommendation to enter a trial might have financial motivations.
In a book directed at the lay public, more attention to this issue would
have been very valuable.
In summary, Quinn has written a very
readable accounting of modern clinical research. She covers the science
and medicine in understandable language, and perhaps most important, she
discusses the financial and regulatory issues in a way that makes the reader
understand that drug development has come a long way from the times of
Paul Ehrlich and Alexander Fleming.
David S. Shimm, MD, FACP, is in private
practice at Porter Hospital in Denver, Colorado. Until recently, he was
a Professor in the Department of Radiation Oncology at the University of
Arizona. He has co-edited Conflicts of Interest in Clinical Practice and
Research (Oxford University Press, 1999).
Copyright © 1994-2001 by Medscape
Inc.
Perseus Publishing
Copyright 2001
295 pages
ISBN: 0-7382-0182-0
US $26.00
[MedGenMed, July 31, 2001. ©
Medscape, Inc.]