Book reviews: Pill Pushers

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Book Reviews

 

Dec. 19, 2004. 01:00 AM

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

 

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. "

 

Toronto author and journalist Ann Silversides is a current Atkinson Fellow

in Public Policy.