Basara L R, Montagne M
Searching for Magic Bullets: Orphan Drugs, Consumer Activism,
and Pharmaceutical Development.
New York: Haworth Press, 1994, 266 pp., illustrations and appendices,
$39.95 (hardcover), $14.95 (softcover).
Bleidt B, Montagne M, (eds.)
Clinical Research in Pharmaceutical Development.
New York: Marcel Dekker, 1996, 384 pp., illustrations and appendices,
$135.00 (hardcover).
Two recent books by Michael Montagne and co-authors present valuable
information to MAPS readers on the drug discovery, development, and
approval process in the U.S., which has great implications for the
future therapeutic use of psychedelic drugs. Searching for Magic Bullets
is written for the general public, and it reveals the quest of consumers,
health professionals, and drug developers to find safer and faster methods
of bringing new medications to the marketplace. The current U.S. drug
development and approval process is explored, identifying its strengths
and weaknesses, and describing mechanisms by which patients and consumer
support groups evade this process as they search for new treatments.
The book is divided into three parts. The first five chapters outline the
drug development and approval process, its historical background and modern
problems and concerns with it. Illustrations of the process of drug
discovery portray Dr. Robert Raffauf (co-author of The Healing Forest)
in the field and in his laboratory.
The role of the FDA in approving new medications is described and recent
changes in the approval process are detailed. The next three chapters
provide a case study of the whole process by focusing on the development
and approval of orphan drugs. The final three chapters describe how and
why consumers evade the traditional system and process to seek alternative
treatments from nontraditional sources. Information is provided on
empowering both health consumers and professionals in searching for
solutions to health problems.
Clinical Research in Pharmaceutical Development is a technical textbook
and multidisciplinary resource that examines the role of the clinical
research process in development and approval of new pharmaceutical agents.
It pro-vides both a theoretical foundation and practical application to
the creation of novel drugs.
There are three sections, along with a keynote chapter by Albert Hofmann.
The first section outlines, in three chapters, the U.S. drug development
process, a briefer but more technical version of what is covered in
Searching for Magic Bullets. The second section introduces in detail
the clinical drug research process, and the planning, coordinating
and monitoring of clinical trials in five information-packed chapters.
It includes many useful forms and tools for documentation of clinical
trial data. The third section consists of four chapters that discuss
the social, ethical, legal and marketing aspects of clinical drug development.
The keynote chapter that leads off the book is a wonderful description of
the role of both planned research and chance discovery in pharmaceutical
development, portrayed by the 40-year career of Albert Hofmann. Dr. Hofmann
is known to MAPS readers for his discovery of LSD and isolation of
psilocybin, but he is also responsible for developing a wide variety of
products for the Sandoz Pharmaceutical company, including one of their
most popular products, Hydergine. His research developing innumerable
compounds shows the true consequence of basic research: only a very small
portion of the experimental products that are synthesized in the laboratory
and come to a clinical trial prove to be therapeutically useful in humans.
Besides the insight provided by his amazing career, this chapter guides us
through the drug discovery process along four paths.
- From the ancient sources of folk medicine and from the study of the
active principles of medicinal plants.
- From modern biological research, from the investigation of substances
with physiological activity.
- From the pharmacological screening of a very large number of synthetic
compounds and natural materials.
- From the observed effects of drugs in the patient.
Yet, Dr. Hofmann points out that "today we can say of many drugs
that we know how they act and in what way, but we are still quite unable
to say why they act as they do. There are no known laws defining the
relation between chemical constitution and pharmacological effects. All
knowledge of the relations between chemical structure and pharmacological
action is ultimately based on empirical data."
He also notes that "not only is it impossible to predict the biological
activity of a substance from its chemical structure, it is also impossible
to predict its activity in human beings from the pattern of activity
demonstrated in laboratory animals." Dr. Hofmann's remarks serve to
show that pharmaceutical research does not and can not always proceed as
rigidly along a planned approach as might appear from publications in
scientific and technical journals, but that chance, or rather what Walpole
called "serendipity" very often contributes much more to success
and will probably continue to do so in the future.
June Riedlinger, R.Ph., Pharm.D.
MA College of Pharmacy and Allied Health Science
179 Longwood Ave.
Boston, MA 02115-5896
E-mail: jreidlinger@mcp.edu
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