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Science on trial. Marcia Angell MD. New York W. W. Norton 1996. 256 pp. Indexed. 27.50

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LETTERS
Hans Peter Seelig, MD
Manfred Renz, PhD
Institute of Immunology and Molecular Genetics
Karlsruhe, Germany
Ira N. Targoff, MD
University of Oklahoma Health Sciences Center
Veterans Affairs Medical Center
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma
Qun Ge, MD
Mark Barton Frank, PhD
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma
1771
1. Ge Q, Nilasena DS, O’Brien CA, Frank MB, Targoff IN: Molecular
analysis of a major antigenic region of the 240-kD protein of Mi-2
autoantigen. J Clin Invest 96:1730-1737, 1995
2. Seelig HP, Moosbrugger I, Ehrfeld H, Fink T, Renz M, Genth E:
The major dermatomyositis-specific Mi-2 autoantigen is a presumed helicase involved in transcriptional activation. Arthritis
Rheum 38:1389-1399, 1995
3. Aasland R, Gibson TJ, Stewart AF: The PHD finger: implications
for chromatin-mediated transcriptional regulation. Trends Biochem
Sci 2056-59, 1995
4. Nilasena DS, Trieu EP, Targoff IN: Analysis of the Mi-2 autoantigen of dermatomyositis. Arthritis Rheum 38:lZ-128, 1995
BOOK REVIEWS
Science on Trial. Marcia Angell, MD. New York, W. W.Norton,
1996. 256 pp. Indexed. $27.50.
Dr. Angell, Executive Editor of the New England
Journal of Medicine, has written a thought-provoking and
highly engrossing account of the breast implant story. This
book moves beyond a detailing of the medical and legal aspects
to interpret why this on-going saga occurred and what might be
its deeper significance. Angell cogently summarizes the importance of obtaining scientific evidence in questions regarding
the safety of therapeutic agents or devices, the current failure
to appropriately use this evidence in civil cases, and the
dangers of a pervasive anti-science movement in this country.
The facts of the breast implant story are first related,
then the broader implications are discussed in relationship to 6
themes that permeate and shape American society: 1) the
place of regulation, 2) the impact of tort law, 3) the marginal
and ambiguous role of scientific evidence, 4) the use of science
in the courtroom, 5) the pervasive effect of the profit motive in
public life, and 6) the way in which the media present medical
issues to the public. None of the major players in this drama,
particularly the professions of medicine, law, and journalism,
as well as the manufacturers, emerge unscathed from this
portrayal.
Although silicone and other materials had been used in
breast implants for many years prior, the FDA decreed in 1982
that the safety of the materials used must be established. This
request was initially ignored by the manufacturers, who were
subsequently goaded by another warning issued by the FDA in
1988. During the same time period, case reports of a possible
association between silicone breast implants and connective
tissue diseases were published. Aggressive trial attorneys were
successful in winning large settlements for their clients. In the
absence of any scientific evidence of risk to patients, in 1992
the FDA banned the general use of silicone breast implants.
On the basis of epidemiologic studies first published in 1994,
the American College of Rheumatology issued a statement in
1995 “that silicone implants expose patients to no demonstrable additional risk for connective tissue disease.” However, the
1992 federal ban led to a further frenzy of litigation that
remains ongoing. A proposed $4.25 billion settlement for a
class action lawsuit was agreed to in 1994 by the attorneys for
both the plaintiffs and the manufacturers, but this deal has
since fallen apart.
Angell proceeds to discuss in a most engrossing and
compelling manner the implications of this story for American
society under the 6 themes mentioned earlier. The present
Congress has attempted to curb the activities of the FDA,
reflecting a continuing tension between advocates of legislated
protection versus free choice. Expensive medical care and the
lack of universal insurance coverage may be contributing
factors further stimulating lawsuits for perceived injury. Lastly,
the author concludes that excesses of the contigency fee
system, inappropriately high awards for damages, mass litigation for product liability cases, and class action lawsuits in tort
cases have all led to efforts in Congress to reform the tort
system.
Of greatest interest to rheumatologists are the sections
in this book on scientific evidence, science in the courtroom,
the profit motive, and the role of the media in presentation of
medical controversies. Science relies on concrete and objective
evidence, where conclusions follow logically from the data.
However, Angell points out that the results of clinical research
studies are usually tentative and seldom conclusive; certainty is
replaced by probabilities. In product liability cases, attorneys
for the plaintiffs must convince the jury only that the “preponderance of the evidence” suggests a causative role of the
product in the patient’s complaints. The author states that the
system of expert witnesses lacks standards, and “scientific
testimony in the courtroom is often at most only marginally
related to scientific evidence.” Angell observes that the potential for financial gain may be a motivating factor for patients,
lawyers, and physicians, the latter in their roles as consultants
and as expert witnesses. The author relates the efforts of
plaintiffs’ attorneys to discredit authors and institutions
where negative epidemiologic studies were performed, as
well as editors of journals where these studies were published.
One result may be a chilling effect on implant research;
scientists may refuse involvement because of the potential for
harrassment .
BOOK REVIEWS
1772
Angell states, “the breast implant story was . . . all but
inevitable, given the social context in which it unfolded. Its
shape conformed almost exactly to a number of features in
contemporary society.” She summarizes the role of the media
in contributing to a distrust of big business and big government
by featuring stories on dangers and threats in our lives,
supposedly engendered by these groups, without a serious
concern for the truth. Citizen groups may have inadvertently
contributed to this paranoia, reflecting a strong anti-science
mood among many Americans. Angell concludes that “only by
relying on scientific evidence can we hope to curb the greed,
fear, and self-indulgence that too often governs such disputes.
That is the lesson of the breast implant story.”
Science on Trial leaves the reader with the sense that all
parties involved in the breast implant story are passive participants in a drama controlled by larger forces. Have individual
actions by physicians motivated by conscience, responsibility,
and concern for patients played no role, or have these actions
been swallowed up in the apparent greed? The author could
have acknowledged that not all scientific aspects of the breast
implant story are settled. The issue of positive antinuclear
antibodies has been difficult to resolve. Lastly, whether silicone
breast implants predispose to an ill-defined and nonspecific
syndrome of musculoskeletal aches and pains may be impossible to ascertain by epidemiologic studies.
Rheumatologists have been participants in this story as
well as interested obseivers and victims. This fast-paced and
stimulating book is highly recommended to scientists and
clinicians. This sobering and somewhat frightening interpretation of some deeper implications of the breast implant story is
certain to elicit a variety of strong responses in readers.
William P. Arend, M D
Denver, CO
Arthritis. John Marcus Thompson, MD. Toronto, Key Porter
Books, 1995. 292 pp. Illustrated. Indexed. $I 7.95 (Canadian).
“In today’s cost-conscious world . . . the cheapest and
best ‘test’ is a referral to an appropriate specialist. This is
especially important in rheumatology because-despite
the
fact that ‘rheumatism’ makes up the largest part of general
practice-most of today’s medical graduates have had little o r
no experience with arthritis.” Thus states Dr. John Marcus
Thompson, an experienced clinician in London, Ontario, in his
book, Arthritis. Strong words indeed in a country with health
care coverage for all, where influencing the latest health
maintenance organization for coverage of rheumatology services is not necessary.
This book is one of a series of books supported by the
Canadian Medical Association for the general public. It is a
292-page discussion of the broad world of rheumatic diseases,
with thoughtful and detailed information about individual
illnesses, meant to enable patients “to know as much about
their arthritis as their doctor knows.” Dr. Thompson proceeds
to use case presentations to introduce the various topics,
tapping his obviously vast experience of 35 years of medical
practice to do so. The book is divided into sections, including
an overview of rheumatic conditions and initial evaluation. He
emphasizes the necessary tests for diagnosis, taking a costeffectiveness point-of-view. (“In the routine assessment of
arthritis, X-rays should b e used even less than laboratory
tests.”) H e then divides the discussions into inflammatory,
crystal-induced, noninflammatory, and uncommon types of
arthritis. The final 2 chapters are devoted to presenting
symptoms and treatments of the conditions.
Dr. Thompson’s approach to patient education diverts
from most similar discussions available in the US, because the
book is written at a level of reading comprehension much
higher than we usually see. In fact, I would recommend this
book to the primary care doctor who wants to develop a good
perspective of the rheumatic diseases outside of a textbook
format.
This book also serves to highlight some of the differences between Canadian and US life, other than the average
level of reading comprehension. Availability of orthopedic
surgery is significantly less in Canada: the author states that it
is likely to be many months before a patient would be able to
see a surgeon for joint replacement consideration, and, possibly, more than a year before surgery could be performed. In
addition, the role of the Arthritis Society in Canada is contrasted with that of the Arthritis Foundation in the US. The
Arthritis Society provides social workers, physiotherapists, and
occupational therapists to treat patients, whereas the Arthritis
Foundation plays mostly an educational role and is just
beginning to devote more effort toward patient treatment and
advocacy.
In summary, I feel confident in endorsing this book for
patient information, as well as for use as a good overview for
physicians interested in expanding their knowledge of the
rheumatic diseases.
Justus Fiechtner, MD, M P H
East Lansing, MI
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1996, york, angel, norton, marcia, indexes, 256, tria, new, science
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