'The Truth About the Drug Companies'
and 'Powerful Medicines': The Drug Lords
November 14, 2004
By STEPHEN S. HALL
DURING the past year, when I was
driving my children to
school, I'd hear the same advertisement on the radio
again
and again. You've probably heard it too: as somber
music
played in the background, a young man, his voice
cracking,
explains how he developed a rare and deadly form of
cancer.
He wonders if he will ever play baseball with his
son, and
then relates how, thanks to a company called Novartis
and
its new cancer treatment (never mentioned, but a drug
called Gleevec), he's been given a new lease on life.
What is most fascinating about this
ad is that it should
seem necessary. As Marcia Angell points out in ''The
Truth
About the Drug Companies: How They Deceive Us and
What to
Do About It'': ''Truly good drugs don't have to be
promoted. A genuinely important new drug, such as
Gleevec,
sells itself.'' So why advertise a cancer drug that
cures a
fatal leukemia and has no competition? The answer, of
course, is that Novartis is not advertising Gleevec,
but
the company itself -- and the virtues of the drug
industry
as a whole. Why? Because, as Angell notes, a
''perfect
storm'' of indignation -- on the part of consumers,
regulators+and even doctors -- may be developing
around the
pharmaceutical business.
In just one week this summer, the
news included reports
that Schering-Plough pleaded guilty to cheating
Medicaid;
the city of New York sued leading pharmaceutical
companies,
including Amgen, Bayer, Bristol-Myers Squibb, Eli
Lilly,
Johnson & Johnson and Merck, for inflating costs and
defrauding taxpayers; Janssen Pharmaceutica Products
admitted it had withheld from the public information
about
potentially fatal side effects in a schizophrenia
drug it
markets; and Wyeth settled yet another in the
multibillion
dollars' worth of lawsuits against it by people who
suffered permanent injury from use of the fen-phen
weight-loss drugs. All this against a broad public
perception of price-gouging, lack of innovation and
bombastic self-congratulation. And that brings me
back to
the Novartis ad.
An alternative history for Gleevec is
recounted in both
Angell's methodical multicount indictment of the drug
industry and Jerry Avorn's entertaining jeremiad,
''Powerful Medicines: The Benefits, Risks and Costs
of
Prescription Drugs.'' In this less heroic version,
several
decades of dogged research by academic scientists --
much
of it paid for by American taxpayers through the
National
Institutes of Health -- had teased out the molecular
details of chronic myelogenous leukemia, a rare and
fatal
hematological cancer. Researchers at Novartis (then
Ciba-Geigy) created several compounds that in theory
might
throw a monkey wrench into the process by which blood
cells
become cancerous. But these potential miracle drugs
sat on
the shelf untested, until Brian Druker, a researcher
at the
Oregon Health and Science University, asked for the
compounds and became the first to discern their
anticancer
properties in the lab dish. Even that wasn't enough.
As
Avorn tells it, ''Novartis had so little interest in
committing resources to the drug's development that
cancer
researchers had to resort to the bizarre tactic of
sending
a petition to the company's C.E.O., signed by
scientists in
the Leukemia and Lymphoma Society of America,
imploring him
to make more drug available for clinical studies.''
Novartis has overcome its lack of
enthusiasm -- it now
charges $27,000 for a year's supply of Gleevec. But
those
heart-warming ads, now the centerpiece of the
Novartis
corporate identity, say more than intended about how
today's pharmaceutical industry takes credit where
little
is due. As both Angell and Avorn lay out in
painstaking,
often enraging, detail, a self-serving mythology --
promulgated on a scale possible only in a business
with
annual worldwide revenues of $400 billion -- has
enveloped
the pharmaceutical industry. Angell and Avorn cut
through
the haze, arguing persuasively that Americans are
paying an
enormous amount of money for some very mediocre
medicines.
The rising voices of disillusionment
have the credentials
to back up their scorn. Two of the season's most
stinging
anti-drug-industry analyses come from former editors
in
chief of The New England Journal of Medicine. Marcia
Angell
is one. Jerome P. Kassirer is the other; the title of
his
book, ''On the Take: How America's Complicity With
Big
Business Can Endanger Your Health'' (Oxford
University,
$26), says it all. Jerry Avorn, a professor at
Harvard
Medical School, helps decide what drugs are used in
Boston's Brigham and Women's Hospital. And John
Abramson
was a doctor in family practice until, as he recounts
in
''Overdosed America: The Broken Promise of American
Medicine'' (HarperCollins, $24.95), he began to
detect what
might politely be called statistical legerdemain in
articles promoting new drugs in the aforementioned
New
England Journal.
These books are not simply diatribes
against high prices
and lagging development of new medicines. More
disturbingly, the authors contend that the drug
industry
has polluted the scientific basis of modern medicine
with
rigged market-driven clinical studies that inflate
the
effectiveness of new, high-priced drugs while
concealing
their risks to patient safety. Angell's occasionally
strident language, laced with terms like ''bribes and
kickbacks'' and ''faux research'' seems hyperbolic --
until
you consider that one week's worth of headlines.
The reasons for the transformation of
the industry's image
from life-saving pioneer to robber baron are many.
But at
root is a profound shift in the hierarchy of
influence and
decision making within the companies themselves over
the
last two decades, as the traditional emphasis on
research
and development has given way to marketing. The
change is
everywhere apparent: in the background of many
company
executives, in the annual balance sheets (in 2001,
Angell
estimates industrywide marketing budgets at $54
billion,
almost double research-and-development outlays, which
the
industry lobby puts at $30 billion), in the army of
88,000
salesmen (or detailers), trained to bird-dog doctors
and
persuade them to prescribe their company's drugs.
Though
much drug industry research remains outstanding, the
system
rewards what Avorn calls ''trivial
pseudo-innovation'';
shifting the emphasis from research to marketing was,
he
says, ''just responding rationally to the legal,
regulatory
and economic pressures of a marketplace that had
become
perverse.''
Angell, who gives a vivid historical
context, dates the
''watershed year'' to 1980, on the cusp of a era in
which
it became ''not only reputable to be wealthy, but
something
close to virtuous.'' The Bayh-Dole Act of 1980
basically
turned academic labs into farm teams for industry
research,
allowing publicly funded researchers in academic
institutions (where much of the real enterprise and
innovation occur) to patent their discoveries and
license
them to the private sector; the law has created a
thicket
of licensing and royalty relationships, wink-and-nod
consultancies and conflicts of interest. As Angell
tellingly relates, the authors of one New England
Journal
article collectively owned up to so many financial
conflicts that they had to be listed separately on a
Web
site. The headline on the editorial she wrote about
the
episode was ''Is Academic Medicine for Sale?'' One
cynical
reader replied: ''No. The current owner is very happy
with
it.''
Then there was was the Hatch-Waxman
Act of 1984, which did
what it was ostensibly designed to do, make it easier
for
generic drug makers to put cheaper medicines on the
market
-- but at enormous cost to the consumer. In Angell's
view,
Hatch-Waxman was a Trojan horse bill; its loopholes
meant
that pharmaceutical companies could, with patent
infringement suits costing, say, a mere $5 million,
extend
government-granted monopolies on popular drugs like
Prilosec and Claritin, in some cases for more than
four
years, yielding them billions of dollars in
additional
revenue.
It gets worse. Laws passed in the
1990's gave drug
companies extraordinary financial influence over
their
primary regulator, the Food and Drug Administration,
through so-called user's fees to expedite reviews of
new
drugs. And both Angell and Avorn quote Senator Bill
Frist's
devastatingly candid remark revealing that one
respected
candidate for the agency's top job in 2002 apparently
lost
industry support because ''there was a great deal of
concern that he put too much emphasis on safety.''
As for the recent Medicare reform
bill, with its
prescription drug benefit, Angell considers the
measure a
huge windfall for industry, because it explicitly
forbids
Medicare to bargain on prices. Indeed, Angell
foresees a
grim day of reckoning, and calls for its immediate
repeal.
Pharmaceutical Research and
Manufacturers of America, the
industry's lobbying group, has tirelessly argued that
high
drug prices are needed to support the high-risk
endeavor of
drug discovery and development. Yes, the business is
risky.
But Angell gives us good reason to dispute the
much-quoted
figure of $802 million as the average cost for
developing a
new drug, and the assertions of innovative research
and
development. She cites studies showing that between
1998
and 2002, 415 new drugs received F.D.A. approval;
only 133
were ''new molecular entities,'' or genuinely novel
compounds, and of those, only 58 -- or 14 percent of
all
new drugs for the five-year period -- were considered
likely by the F.D.A. to be ''a significant
improvement''
over existing products.
Avorn covers much the same ground,
but comes at it by
statistical analysis of drug effectiveness and
safety. As a
''pharmacoepidemiologist,'' he studies large patient
databases to determine how often certain medications
are
used and how well they work. His watchword is
''evidence-based medicine'' -- the use of randomized
controlled clinical trials, in which participants are
randomly assigned to receive, for example, a drug
being
tested or a dummy pill, or of large-scale
epidemiological
studies to determine with statistical rigor exactly
which
drugs are safest, most effective and, increasingly,
most
cost-effective. He laments that ''we have begun to
allow
the marketplace to usurp the place of evidence in
determining which treatments are effective.'' The
marketplace has also been very good about playing
down side
effects: Avorn's accounts of the systematic
''obfuscation
of risk'' for two drugs ultimately withdrawn from the
market, the diet drug Redux and the diabetes drug
Rezulin,
are stomach-turning in their detailing of corporate
indifference.
What to do? Angell's most urgent
recommendation (among
many) is to establish an independent mechanism within
the
National Institutes of Health, for testing
prescription
drugs against each other without involving the
industry.
Avorn, in arguing for more evidence-based medicine,
lays
out several nonprofit and for-profit scenarios for
precisely that kind of independent, data-driven drug
assessment. (My own view is that there will be a
McDonald's
on Mars before drug companies relinquish head-to-head
clinical testing of their products -- precisely
because
high-quality data is a poison pill to most of their
marketing.)
In 1906, Upton Sinclair documented
abuses in the
meat-packing industry; his book, ''The Jungle,''
catalyzed
outrage and helped lead to the Food and Drug Act of
1906,
which set the first national food and drug regulatory
processes. I doubt either of these books will have a
similar impact. Public policy these days is mostly
driven
by events, not books. My guess is that it will take
the
pharmaceutical equivalent of a plane crash -- perhaps
a
devastating new influenza epidemic, a disease for
which, as
this flu season's experience makes painfully clear,
fewer
and fewer companies bother to make vaccines; or a
hugely
successful life-saving cancer drug whose high cost
would
make the economic wall between the haves (who get to
live)
and the have-nots (who don't) politically
unsustainable.
That unpleasant day of reckoning is almost upon us.
These
fine books go a long way in explaining how our
medicine,
once so vaunted, has become so bitter. hThe authors
of one
scientific article had so many conflicts, they needed
a Web
site to list them.
Stephen S. Hall is the author, most
recently, of
''Merchants of Immortality: Chasing the Dream of
Human Life
Extension.''
http://www.nytimes.com/2004/11/14/books/review/14HALL.html?ex=1101489223&ei=1&en=8d8296cfe5bca074
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