E-DRUG: Book review - Bitter Pills

[ahmads@cder.fda.gov]

E-DRUG: Book review - Bitter Pills
----------------------------------

Dear e-druggers,

Seasons' greetings!

Here's a review of a book 'Bitter Pills' by Stephen Fried, who some of
you may remember also utilized the E-DRUG forum to do research for the
book. I am copying the review of 'Bitter Pills' which was published in
The Lancet a couple of months ago (permission obtained). Some of you may
be happy to know that the author mentioned E-Drug in the book. If you
wish to know more about the book, please visit the following website:
http://www.bitter-pills.com. Thanks.

Cheers!

Syed Rizwanuddin Ahmad,MD, MPH
Division of Drug Risk Evaluation
Office of Postmarketing Drug Risk Assessment
Center for Drug Evaluation and Research
Food and Drug Administration
HFD-733, Room 15B-18
5600 Fishers Lane
Rockville, Maryland 20857, USA
Phone: 1-301-827-3174
Email: ahmads@cder.fda.gov

PS: The views expressed in this posting are my own and do not represent
the views of the FDA.

-------------------------

Volume 352, Number 9134 October 03, 1998
Harmful legal drugs: will anyone listen? 

Bitter Pills: Inside the Hazardous World of Legal Drugs 
Stephen Fried. New York, Bantam Books. 1998. Pp 417. $24.95 
ISBN 0-553-10383-0 

Stephen Fried's Bitter Pills takes us on a long, dark walk into the
world of harmful legal drugs and shows us the process by which they get
approved. His experience provides a close-up look at the interactions
between the US Food and Drug Administration (FDA) and the pharmaceutical
industry. 

The author's odyssey began in 1992 when his wife took a single pill of
the antibiotic Floxin (ofloxacin) to treat a minor urinary tract
infection and, in so doing, triggered severe and long-lasting central
nervous system problems including visual distortions, insomnia, aphasia,
and manic depression. To understand how such serious effects could
result from an approved drug, Fried, a journalist, began to gather all
the information available on Floxin, through literature searches and
talking to scientists, FDA personnel, injured patients, and lawyers. The
process triggered his interest into other drugs that had caused serious
adverse reactions. Along the way, he discovered the enormous power of
the pharmaceutical industry, something that I, as a former FDA
pharmacology reviewer, witnessed. 

Fried found many reasons why approved drugs must either be removed from
the market or have warnings added: most trial designs mandate the use of
a relatively healthy group of patients, and there is a disinclination to
allocate blame for adverse reactions on the drug being tested.
Consequently, we seldom learn of potential serious side-effects in a
diverse population until after the drug is marketed; at that point, it
is more difficult to ascertain cause and effect since only 1-10% of all
drug adverse reactions are reported to the manufacturer or FDA. Since
most drug research is being conducted by doctors on drug-company
payrolls and with scientists hired as experts to argue the case before
the FDA at advisory committee hearings, there is scant unbiased
information. Even advisory committee members are often recipients of
grants from drug companies. 

Further complicating doctors' abilities to prescribe the "best" drug for
their patients, are the massive direct-to-consumer advertising
campaigns, the consumers now being both doctors and their patients.
Fried reports that this advertising has been shown to provide much of
the information that doctors and consumers use, and the massive sums
channelled to this purpose attest to its success. Fried makes the point
that with such advertising, the line between over-the-counter and
prescribed drugs has dimmed and that patients (and doctors?) begin to
view all advertised drugs as innocuous. 

There is a need for this complex web of vested interests to be
untangled. Fried's pharmacologist friends have championed the idea of
establishing a network of independent centres for drug research that
would be a source of unbiased information. However, doctors also need to
have as much savvy as any other group of consumers in terms of dealing
with the marketing of legal drugs. They need to know how labels are
written and what is left unsaid. 

One of the few things in Bitter Pills that I would disagree with is the
use of the group, Motherisk, as an uncritical source of information on
the teratogenicity of drugs. Motherisk uses human data from small groups
of women referred to them for counselling after taking prescription
drugs. Since Motherisk's purpose is "protecting babies from unnecessary
abortions", there is an additional emotional element thrown into an
already messy brew. Their comment that "Your baby has the same chance of
being normal and going to college as the baby of a woman who was not
treated" seems to extend beyond the available database since these
children's development is rarely systematically followed. 

The appendix has a section for consumers on how to read a drug "label"
plus hints on how to avoid adverse drug reactions (but omits suggesting
a waiting period to see what adverse events show up after approval).
Fried has done a useful job in bringing together several examples where
the drug approval system went awry along with some ideas as to how to
prevent history from repeating itself. The question, as always, is: will
anyone listen? 

Elizabeth K Barbehenn 
------------------------------------------------------------------------
Public Citizen's Health Research Group, 1600 20th Street NW, Washington,
DC 20009-1001, USA 

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