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Pill pushers
Two players add to the crisis of confidence over the drug industry The
Celebrex and Vioxx uproar is but a symptom, fears Ann Silversides


Overdosed America:

The Broken Promise Of American Medicine

by John Abramson, M.D.

HarperCollins, 332 pages, $34.95


The Truth About The Drug Companies:

How They Deceive Us And What To Do About It

by Marcia Angell, M.D.

Random House, 305 pages 34.95
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The pharmaceutical industry lies about its role in discovering innovative
and lifesaving medicines; rigs the clinical trials it must conduct to get
market authorization; bribes doctors, government officials and politicians;
and pushes unnecessary and sometimes dangerous drugs on an unsuspecting
public.

These are just some of the volleys the authors of both these books aim at
the operations of the U.S.-based and international pharmaceutical giants —
and back up with extensive and compelling evidence. Both come to the task
with establishment credentials: Marcia Angell is the former editor in chief
of the prestigious New England Journal Of Medicine. John Abramson is a
faculty member and researcher at Harvard medical school who spent 20 years
in the trenches as a family doctor, and uses stories from his medical
practice to illustrate some of his arguments. That professionals of this
stature have begun to so publicly criticize this industry indicates the
extent of the growing crisis of confidence concerning the operations of big
pharma (as the critics refer to it).

At risk, both authors argue, is the health of the public, which is being
compromised by a dangerous and unnecessary reliance on expensive medication
that is diverting money from more necessary health care and, Abramson
argues eloquently, from more cost-effective ways to actually preserve and
improve health.

But the books differ in style and content. Angell's book is written
bluntly, with a wide audience in mind. She focuses on many of the larger
political, procedural and financial issues, putting these in the context of
the out-of-this world profit levels of the Fortune 500 drug companies
(about three times as high as the median for all other industries). These
companies, she notes, argue that high drug prices reflect high research
costs, yet they rely on publicly-funded research in the United States for a
significant proportion of the innovative drugs they market, and they spend
far more on marketing than on research.

Big pharma, she points out, employs more Washington lobbyists than there
are members of the U.S. Congress, lobbyists who typically succeed at
convincing legislators to put industry interests above the interests of the
U.S. public. Their latest victory is a new Medicare prescription drug
program that forbids Medicare from using its purchasing power to bargain
for lower drug prices (something every other large U.S. purchaser,
including Veterans Affairs, does).

Meanwhile, fully 77 per cent of the 415 drugs approved by the U.S. Food and
Drug Administration from 1998 to 2002 were no better than drugs already on
the market, Angell notes. These "me-too" drugs are new versions of existing
drugs known as "blockbusters," which are profitable since they treat
lifelong, chronic or widespread health problems (such as depression,
diabetes and allergies). Companies then spend huge amounts of money
convincing doctors and consumers to switch to the new, invariably more
expensive, less tested, prescription drugs.

While Angell and Abramson aim at the same target, their approaches differ:
Hers is a broader-brush approach, setting the scene with enough detail to
convince and frighten readers who may not have previously paid much
attention to this industry. The Truth About The Drug Companies concludes
with suggested political and procedural reforms, and a series of questions
patients should ask their doctor.

Abramson, who has also written with a general audience in mind, provides
more detail about the drugs themselves, uses illustrations based on
experiences with his former patients, and demonstrates why busy doctors are
so easily co-opted by drug companies to rely on marketing instead of
evidence. Overdosed America concludes with suggestions for improving health
that lie outside the heavily marketed "commercial-biomedical" model.

While both authors explain how clinical trials for drugs are rigged by
pharmaceutical companies to promote their drugs, Agnell's focus is on how
the companies now effectively control testing and reporting. Most clinical
trials are now conducted by private contract research organizations, hired
by drug companies, with for-hire ethics boards, which in turn hire doctors
to enrol patients in trials. This structure is riddled with conflicts of
interest.

Abramson, on the other hand, drills down and provides case study detail of
how trials are rigged or otherwise manipulated. His discussion of the
trials conducted on the drugs involved in the hottest controversy of the
moment — the arthritis anti-inflammatories Vioxx, now pulled from the
market, and competitor Celebrex, under renewed attack for possibly raising
heart attack risks among users — is fascinating and cautionary.

Similarly, his discussion of the advent of widespread bone mass density
testing and the overall lack of efficacy of so-called "osteoporosis" drugs
is disturbing. With osteoporosis, he argues, the drug industry has once
again succeeded — as it did for decades with hormone replacement therapy —
in reframing normal aging into a pathological process.

Both authors also target the growing problem of off-label promotion of
drugs — when companies expand their market by promoting drugs for
indications that they were not approved to treat. A Canadian example is
Diane 35, a drug approved only for very severe acne that is promoted as a
conceptive, a use not approved by Health Canada.

While both authors focus on the United States, most of their critiques also
apply to Canada. The two key areas of difference are the significantly
higher price of drugs in the United States, since that country alone among
developed nations does not regulate drug prices, and the prevalence there
of consumer advertising for prescription drugs. (This is formally illegal
in Canada, although Health Canada has turned a blind eye to home-grown
contraventions.)

I have minor quibbles with both books. Angell nowhere even acknowledges the
great harm that the drug industry and its U.S. government backers have done
in the developing world by actively denying life-saving medicines through
various procedural and trade agreement manoeuvres. Nor does Abramson
acknowledge the role of income inequality and poverty.

But he is on the money with this assessment: "The challenge in providing
optimal medical care is to identify the boundary between the effective care
that truly improves health and the commercially-driven care that at best
misdirects our efforts to stay healthy and at worst is actually harmful."


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Toronto author and journalist Ann Silversides is a current Atkinson Fellow
in Public Policy.