New York Times
September 6, 2004
Book Review
Indicting the Drug Industry's Practices

By JANET MASLIN

Dr. Marcia Angell is a former editor in chief of The New England Journal
of Medicine and spent two decades on the staff of that publication. If
much of that time was devoted to reviewing papers on pharmacological
research, it must have been spent in a state of near-apoplexy.

Her new book is a scorching indictment of drug companies and their
research and business practices. "Despite all its excesses, this is an
important industry that should be saved - mainly from itself," she
writes.
This turns out to be one of her book's more forgiving pronouncements,
since the rest of it is devoted to assertions of shady, misleading
corporate behavior. If she is accurate in her assumptions about big drug
companies' feistiness and tenacity, Dr. Angell is likely to be on the
receiving end of angry rebuttals. She is sometimes vague enough to leave
room for such attacks. ("I have heard that morale in some parts of the
F.D.A. is extremely low, and I can certainly understand why it might
be.")

But over all, Dr. Angell's case is tough, persuasive and troubling.

Arguing that in 1980 drug manufacturing changed from a good business
into "a stupendous one," thanks to changes in government regulations.
She adds, "Of the many events that contributed to their sudden great and
good fortune, none had to do with the quality of the drugs the companies
were selling."
In the past, drug discoveries made through government research remained
in the public domain. Beginning in 1980 those breakthroughs could be
patented, even if their research was sponsored by the National
Institutes of Health. As a consequence, Dr. Angell says, patent
shenanigans have reshaped the drug business, as have the recent
government regulations that expedite direct-to-consumer drug
advertising. "Once upon a time, drug companies promoted drugs to treat
diseases," Dr. Angell writes. "Now it is often the opposite. They
promote diseases to fit their drugs."
Consider the consumer who exclaims, in Dr. Angell's words, "Omigosh,
this Clarinex ad makes me realize I have hay fever!"

According to her
book, this individual is being snookered in several ways. First of all,
there is the drug itself: she calls Schering-Plough's Clarinex a "me
too" variant of the same company's popular allergy drug Claritin. But
Claritin's patent expired in 2002, so the new version has been heavily
marketed.

Dr. Angell maintains that while Claritin was approved as a hay fever
remedy, Clarinex is an improvement only because it has been approved for
the treatment of both indoor and outdoor allergies. "It was approved for
the additional use only because the company decided to test it for that
use," she says.

And why all the advertising? "If prescription drugs are so good, why do
they need to be pushed so hard?" she asks, citing Nexium, Lipitor and
Paxil as other me-too products with whopping ad campaigns. As for
Nexium, the new purple heartburn pill meant to replace Prilosec (which
went off patent in 2001), Dr. Angell proposes a "big bang theory of
Mom's cooking." She invites the reader to imagine a single, protean meal
that has spun off "a seemingly inexhaustible supply of leftovers" in the
form of renamed and repackaged versions of established drugs. "It
wouldn't have done to call it 'Half-o'-Prilosec,' but that is what it
was," she says about Nexium.

"The big drug companies are competing not so much to find new drugs but
for the limited number of drugs to license," she argues. The enormous
research-and-development budgets that are invoked to justify high drug
prices, she claims, also pay for questionable forms of education for
doctors and all manner of barely concealed incentives for them to
prescribe certain drugs. While much of this material is drawn from
investigative reporting published in magazines and newspapers, Dr.
Angell effectively heightens its impact by shaping it into one long,
angry accusation.
"The Truth About the Drug Companies" is unrelenting enough to sound
scoldy and pedantic at times. (Dr. Angell is now a senior lecturer at
Harvard Medical School.) And the book repeats certain complaints in ways
indicative of padding. But Dr. Angell's overall questions about drug
companies' finances, their influence on government regulation and their
methods of testing new medicines are enhanced by her dogged, contentious
tone.

Though she proposes a list of changes at the book's end, in hopes of
improving the way drug companies operate, her most-repeated suggestion
is one of her most persuasive. Why, she asks, should new drugs be tested
against placebos, and sometimes tested in such high doses that their
effectiveness is guaranteed? Why shouldn't they be tested in equivalent
doses against drugs that already exist - and already work?

While awaiting the storm of rebuttal sure to greet Dr. Angell's version
of the facts, her readers will be galvanized to look at the drug
industry with closer scrutiny. Is the new pink and lavender pill called
Sarafem really just Prozac in a different casing? Has the Eli Lilly
company really tested it on children (one way of extending an exclusive
patent) yet sold it as a remedy for premenstrual problems? And is
erectile dysfunction actually caused by watching the Super Bowl, on the
evidence of so many Viagra, Levitra and Cialis ads? In a book as
alarming as Dr. Angell's, the last thought is what passes for a joke.