BITTER PILLS: INSIDE THE HAZARDOUS WORLD OF LEGAL DRUGS, by Stephen Fried,
432 pp, $24.95, ISBN 0-533-10383-0, New York, NY, Bantam Books, 1998.

Bitter Pills is three books in one. The author, a medical investigative
reporter from Philadelphia, describes his wife's misfortune when samples of
a quinolone antibiotic led to neurologic and psychiatric sequelae and his
own reactions and interactions. Over several years he grew aware that his
wife not the only one who had suffered--severe complications from use of a
medication are widespread. These complications included neurological and
neuromuscular problems such as confusion, disorientation, seizures, and
weakness. Initially, dozens and then more than 100 patients were identified
with such problems.

Fried intertwines his wife's story with what initially seems a vendetta
against drug companies and the US Food and Drug Administration (FDA). Much
of the book describes in detail drug research, drug approval, market forces
on drug companies and the medical industrial complex, and the FDA
regulatory process. In the course of the descriptions, which are narrative
and anecdotal rather than analytical, the reader learns about the
pharmaceutical industry and the authors' investigative findings.

The third portion of the book is meant as an aid for the lay reader. It
features a glossary of drug terms, a useful interpretation of the package
insert, and a directory of Web sites for more information. Included are
suggestions for how to make your physician aware of appropriate drug
history information. An example of a personal-medication portion of a
medical history is included for the reader's use.

Bitter Pills is not kind to any of the major players. The public is
portrayed as naive, physicians as defensive, ignorant, or greedy. Drug
detail staff are seen as manipulative salespeople pushing products from
unethical manufacturers, and the FDA is "understaffed, overwhelmed and
unduly bureaucratic." Yet, positive aspects of each are also highlighted.
Readers will be educated as to the history of the FDA, the drug regulatory
process, and recent behind-the-scenes activities in drug withdrawals.
Readers may be chagrined to realize that they have consumed or prescribed
pharmaceuticals with a much higher level of ignorance than they had
imagined. The book does a good job of explaining such terms as "drug detail
person," "FDA approval," "black box warning," "indication," "adverse
reaction," "formulary," and "post-market surveillance." The author recounts
the adventures and misadventures of FDA involvements with thalidomide,
Halcion, Omniflox, Seldane, and Primatene Mist.

I had a lot to learn, despite an unusual level of awareness regarding
medication problems (I am a physician and inventor who has devoted part of
his career to solving drug compliance problems by developing medication
dispensing systems, MedSelect Systems). Nevertheless, I learned a great
deal about the package insert and problems with postmarketing surveillance
for drug complications.

With limited time for reading, I found myself annoyed by the book's format.
It could be considerably shorter had it not been written in the first
person, intertwining the wife's experiences and the investigation into FDA
pharmaceutical issues. I would have made better use of a concise treatise
on the pharmacological industry and its regulation, while the personal
story could stand alone and the guide for consumers be reduced to a
pamphlet for widespread distribution.

Criticisms aside, the book is overall informative and engaging. It serves
as an excellent primer and source of information for consumers of
medication and professionals alike and is well indexed and readable. I
would recommend Bitter Pills to anyone who uses or prescribes pharmaceuticals.