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by Susan Quinn Perseus Publishing, 2001 Review by Larry D. Hultgren, Ph.D. on Jun 27th 2002 
. It is
estimated that there are currently 14,000 human trials being conducted at
research institutions, universities and hospitals, and that each year approximately
100,000 new volunteers enroll in clinical trials (Maureen Milford, The National
Law Journal August 20, 2001). In
support of this enormous growth in medical or health-related research, there
are approximately 48,000 clinical researchers practicing today. In Human Trials: Scientists, Investors
and Patients in the Quest for a Cure, Susan Quinn focuses on human subject
research on debilitating autoimmune diseases, especially multiple sclerosis and
rheumatoid arthritis, and introduces her reader to a brave new world of human
experimentation.
As we might expect, Quinns title
expresses a double entendre. On the one
hand, human trials refers to therapeutic research involving human beings that
is an essential and necessary part of the process of determining if a new drug
or therapy will prove effective in curing disease or saving lives. Our author focuses on the struggles of
polymath physician Howard Weiner, a Harvard Medical School professor and
researcher, to demonstrate that a particular therapeutic approach, oral
tolerance, will provide a viable treatment for people suffering from autoimmune
diseases such as multiple sclerosis (MS).
MS is not just a disease of the nervous system that affects 350,000
people in the United States alone, but one of a family of autoimmune diseases,
such as rheumatoid arthritis and lupus, that affect millions.
Weiner believes that he has
discovered a new drug that will bring relief to sufferers of autoimmune
disease, particularly MS, for which there is no viable treatment. But to move from scientific discovery to
clinical application will require a series of make-or-break human trials
designed to determine whether the drug has an effect that is statistically
significant (94). According to
Weiner, It takes as long as 15-30 years...from the time of a basic science
observation for that finding to be reduced to practice in the clinic. (216)
Human trials, as partially described in this book, are the process through
which a promising drug or therapy must go before it ends up in the medical
cabinet.
Such clinical research will also be
quite expensive. Weiner appears to have
discovered, in the language of the business world, a platform technology, in
which researchers might be able to build approaches to a range of autoimmune
diseases (58). But such technology,
as research is usually called in the corporate world, is quite costly both in
terms of time and money [s]ince it takes ten to twenty years, and from $100
million to $300 million to develop a drug (69). This forces Weiner to move his research away from non-profit
academic benchwork and into, for him, the unchartered waters of the investment
community. Here we witness Weiner
joining with other venture capitalists to put together, and attempt to grow, a
biotechnology company into a viable entity so that its shares could be sold to
the public (83). And grow it does as
soon discover ourselves following the true life adventure of a drug on its
journey from synthesis in the laboratory to our medicine cabinet, a journey
that takes it through human trials.
But the story is also a tragedy as the book ends with the company
founded on Weiners ideas and research, AutoImmune, barely on life support (capital-support)
and struggling to survive.
However, there is a second meaning
to Quinns title. She wants to move
beyond the discussion of the role of human experimentation in phase 3 research,
human trials, to an examination of the human trials involved in
such research. Throughout seventeen crisp chapters, we meet patients,
physicians, scientists, and investors whose careers and very lives depend on
the results of human trials. However,
her focus is on Weiners faith in oral tolerance and his patience as he
attempts to move from passive observation of the disease in his clinic patients
to some kind of active intervention or therapy for MS.
At first we discover Weiner living
a kind of double life as he moves back and forth between the clinic and the
lab. Soon we see him enter a third
world, that of academic politics, and then a fourth as an entrepreneur, quick
to seize the commercial possibilities of his discovery. Sometimes these worlds
rest in conjunction; sometimes they move in parallel fashion rarely touching;
but often they collide. Throughout the
book we get quick glimpses of a man who didnt hold back(124) shuttling
between various obligations - the lab, the clinic, scientific meetings, and
Wall Street, but always obsessed with finding a cure for MS. However, we never see someone able to meld
his scientific interests, his unabashed bid for immortality (64), his wish to
take care of patients, and his ambition for profit.
In her introductory Note to the
Reader, Quinn promises us a window into a world that is usually inaccessible(XI). However, the world opened for viewing is not
really the one that we initially expect. Yes, there is discussion of human
trials in medicine, especially a somewhat detailed following of a phase 3
trial. (Unfortunately, there is little
explanation or clarification of the three phases of testing or human trials
usually involved in medical research.)
Yes, there is a narrative nod here and there to the trials of patients,
the researchers, and the clinicians who are engaged in the clinical
studies. However, our initial concern
with the MS patient, and later the rheumatoid arthritis (RA) patent, is soon
replaced with a new patient - AutoImmune, Weiners biotech startup
company. Instead of following the vital
signs of human patients or research subjects, we find ourselves monitoring the
stock of AutoImmune as it loses 69% of its value after human trials with the MS
drug and another 42% after the announcement of the results of human trials with
an RA drug. By the books end, we have
traveled from clinical experiences with aa frightening and capricious
disease, from the academic triumphs of Howard Weiner in the lab, to a new
realism about biotechnology. As one of
the venture capitalists in the industry concludes, biotechnology has been good
for innovation but bad for investment (244).
Only slight mention is made of the effect of all of this on patients.
In her writing, Quinn always seeks
to inform, to eschew heated controversy about human trials. Thus, some readers will be relieved that the
banner for this book or subject will not read: Watch as scientists gamble their
reputations! Thrill as capitalists
venture their capital! Shudder in
horror as patients risk their very lives in human trials! However, other readers will be disappointed
to discover that the author neglects to follow up on any of the moral issues
and ethical conflicts that emerge from her chronicle of the role of human
trials in the life cycle of a startup biotech company. Although she acknowledges that we have
entered the age of informed consent, she never really explores the concept or
its work in human trials. There is
little comment on research activities where patients seem to be mere ends to
scientists and AuthImmunes ends, rather than collaborators with investigators. Thus possible controversy over patients who
are never told about risks, or informed that the trial will involve placebo, or
apprised of their physicians possible conflict of interest seems glossed
over. As one physician puts it, no
doubt out of hearing range of the patient, the focus one has to keep in this
game is that what I am doing is not trying to help individual patients, what
Im trying to do is to help populations who have a disease (201).
Human Trials emerges from
Quinns close reading of Howard Weiners carefully kept journals, extensive
interviews with patients and physicians in the clinic, and researchers in the
lab, and her observations of key public and closed-door meetings with investors
at AutoImmune. She writes clearly of
the major problems and lessons learned in one important quest for a cure for
debilitating autoimmune diseases.
Although not mentioned in her book, in the past four years government
regulators have restricted or shut down human trials at twenty institutions for
not following standards of good clinical practice. This is book that speaks to such issues and thus needs to be read
by patients, physicians, researchers, investors, and especially potential
research subjects who must decide whether or not to enter a human trial.
© 2002 Larry D. Hultgren
Larry Hultgren describes himself as
follows:
A.B.
Grinnell College majoring in Philosophy and Religion; Ph.D. Vanderbilt
University in Philosophy. Currently Professor of Philosophy
at Virginia Wesleyan College, Norfolk, VA.
Since I am at a liberal arts college, my teaching runs the gamut of philosophy
offerings. I am especially interested in interdisciplinary pursuits, and I
direct the college's Social Ecology Program and our innovative PORTfolio Project,
which attempts to bring the liberal arts to life for our students by connecting
the classroom with real world experiences. I also serve on the Bioethics
Committee of the Children's Hospital of the
King's Daughters in Norfolk, VA, and serve on the Board of Directors of the
Bioethics Network of Southeast Virginia.
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