going to 80 cents, page-62

this is a must read Busting Big Pharma
Robert Lusetich
16dec04

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 $US2.5billion ($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 marked by fatigue, apathy, bad mood and an inability to communicate clearly. Yet even those who 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.