Busting Big Pharma
Robert Lusetich
16 Dec 04
The Australian

WHAT happens when a slick sales force of 87,000 is set loose with
billions of dollars to wine and dine, entertain and educate the US's
600,000 doctors?

The short answer is that six years ago Americans spent $US89 billion
on prescription drugs. Last year the amount exploded to $US149 billion.
In the year to March 2004, Australia spent $5.8 billion on prescription
drugs.

The US accounts for half of all global profits for Big Pharma, as the
pharmaceutical corporations are known.

"The result of all those attractive women in short skirts armed with
pseudo-science invading the practices of doctors is that Americans are
over-medicated, taking far too many drugs, most of which they don't even
need, and they are paying too much for them," says Jerome Kassirer, a
former editor of The New England Journal of Medicine and prominent
critic of Big Pharma.

Beyond the skyrocketing profits, however, lies a darker picture of a
virtually unregulated omnipotent industry whose questionable practices
some call them criminal  in the quest for higher revenues has turned
Big Pharma into the latest corporate villain.

As a growing army of critics  and the courts  fling open the doors of
the world's leading drug companies to reveal unfavourable buried studies,
the parallels to Big Oil, Big Banking and, the most notorious of all, Big
Tobacco are striking.

"These guys and their ethics are precisely where Big Tobacco was 20 years
ago," says Peter Breggin, a prominent New York psychiatrist who has
campaigned against the spread of controversial antidepressants.

Scandals, such as US pharmaceutical giant Merck & Co yanking its $US2.5
billion ($3.3 billion) a year blockbuster painkiller Vioxx off the market
on September 30 after the company belatedly conceded it was causing heart
attacks and strokes, have led to an unprecedented erosion in public trust.

In the past year 300,000 Australians  about one-third of patients suffering
osteoarthritis  used Vioxx. Since its September withdrawal more than 600
Australians who suffered heart attacks, strokes and blood-related illnesses
after taking the drug have joined a multi-billion-dollar class action against
Merck.

"For decades both the public and physicians thought the pharmaceuticals were
looking out for the health and welfare of society and never challenged what
the industry claimed," says Arnold Relman, emeritus professor of medicine at
Harvard Medical School.

"Now everyone is starting to wise up to an industry [that] is hugely
profitable and driven, obsessed with making more profits and to do that by
any means it can, even if it means stretching laws, stretching ethics."

A flurry of new books by high-profile authors  including Kassirer and Marcia
Angell, another former editor at The New England Journal of Medicine  as well
as court cases, such as the one against the antidepressant Paxil brought by
New York's crusading Attorney-General Eliot Spitzer, reveals the way in which
Big Pharma has managed to generate profits and cover up its skeletons.

The system is enabled, say reform-minded doctors, by the US Food and Drug
Administration  which generates most of its budget from drug companies and
has proven to be "nothing but a lapdog", Angell says  as well as by physicians
who blithely accept dubious studies provided by drug company sales
representatives.

"Suppose you are a big pharmaceutical company. You make a drug that is
approved for a very limited use. How could you turn it into a blockbuster?"
Angell says.

"You could simply market the drug for unapproved, or off-label, uses even
though it's against the law to do so. You do that by carrying out 'research'
that falls way below the standard required for FDA approval, then 'educating'
doctors about any favourable results. That way you circumvent the law [because
doctors can prescribe whatever drugs they see fit].

"You could say you were not marketing for unapproved uses; you were merely
disseminating the results of research to doctors, who can legally prescribe a
drug for any use. But it would be bogus education about bogus research. It
would really be marketing."

Nowhere is this better illustrated than with the antidepressants known as
selective serotonin reuptake inhibitors, a class of drug of dubious benefit
that, through savvy marketing, has become a multi-billion-dollar cash cow.

A staggering one in 10 women in the US are on these drugs. In Australia,
there was a 350 per cent increase in prescriptions for SSRIs such as Prozac,
Zoloft and Paxil  between 1990 and 2002.

Yet, says Breggin, who has appeared at trials on behalf of people who commit
crimes or of families who have lost a family member to suicide while under
the influence of SSRIs, "not only do these drugs not work but they're [also]
dangerous".

Karen Barth Menzies, a Los Angeles lawyer who is perhaps the leading
antidepressant litigation attorney in the world, explains the disease is
marketed and sold in order to sell the drugs.

"That's why it's been so successful," she says. "The drug's a narcotic, it's
an upper, so no wonder you feel better."

Kassirer says drug companies  the most powerful special interest in Washington,
with an army of 700 lobbyists  have public relations firms draw up "research
papers" based on selective studies, conducted by medical researchers who dare
not go against the company line, to promote their drugs and then have "experts"
put their names to them, often just parroting what the company wants
disseminated.

"These councils with the official sounding names, the alliance of something or
the foundation for something, what are they doing?" he asks. "They're doctors
who are being paid to promote awareness of some condition [that] invariably is
treated by a drug made by the drug company [that] is bankrolling the council.

"The system is awash in drug company money and it's corrupt. All this money and
favours is forcing doctors to do things that I think are pretty terrible. It
creates deception, erodes professionalism and is destroying the profession.

"If anybody is up to their ears in conflicts of interest, it's psychiatrists."

Critics say some mental illnesses are invented by panels of psychiatrists
who in turn are paid large sums by drug companies  to sell drugs. Kassirer
cites the example of executive dysfunction, a new-found disease supposedly
o diagnose executive dysfunction say that it has no standard medical
definition and is better regarded as a concept, he says.

"But it doesn't stop them prescribing drugs for the so-called condition,"
Kassirer says.

Barth Menzies says she has seen evidence for years that the drug companies
knew their antidepressants not only didn't work but were causing suicidal
or violent tendencies among some users, yet tried to hide the evidence for
fear of financial loss.

"The internal documents we've found through discovery show what a total sham
these antidepressants are," she says. "The science is bought and paid for,
experts are willing to sell their names and their souls, the whole thing's
been an amazing web of lies and fraud.

"I used to think, 'How many people have to die before someone does something
about it?' And then I saw the answer. In their greed to find new markets,
they started pushing SSRIs on kids. I knew that once kids started dying,
someone would finally say enough is enough."

Authorities in Britain were the first to ban the prescribing of SSRIs
except Prozac, although even the FDA now agrees that Prozac works in the
same way and has the same inherent dangers  to children and adolescents.

In the US  where more than 1 million youngsters are on these drugs the FDA
was forced to issue a black box warning on the SSRIs, while Spitzer has
filed fraud charges against GlaxoSmithKline, the world's second largest
drug maker, for blatantly hiding or trying to spin negative findings of
clinical trials of Paxil's effects on children and teenagers.

GSK settled the suit but is facing an avalanche of lawsuits from people
whose children hurt or even killed themselves  or others  while on the
drugs. Part of GSK's settlement forced it to publish findings of all
trials on its website, though critics say this needs to be independently
monitored. Meanwhile, Big Pharma is fighting efforts in Washington to
force all trials, irrespective of their results, to be made public.

"I'm not that hopeful for any real change," Angell says. "They have bought
politicians and doctors. They've looked at everyone and anyone who could
stand in their way and they've thrown money at them. The only hope we have
is a grassroots revolution that will make the politicians decide they love
votes more than drug company money."

It is little wonder that Michael Moore, whose scathing films on the gun
lobby and President George W. Bush have been among the most successful
documentaries in history, is pointing his lens at Big Pharma. And the
working title of his proposed documentary? Sicko.


Robert Lusetich is The Australian's Los Angeles correspondent.

© The Australian

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