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An unhealthy influence on the medical
establishment

September 16, 2004

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Drug companies need reining in so doctors and patients get
independent information, argues Ray Moynihan.

For many of the families who attended the historic public hearings in
Washington this week, the tough new warnings that antidepressants can cause
suicidal behaviour in children will come far too late.

Certainly they'll be too late for Sara Bostock, whose teenage daughter Cecily
stabbed herself to death with a kitchen knife soon after taking Aropax. Too late
as well for Tom Woodward, whose daughter Julie hanged herself only a week after
starting on Zoloft.

The scandal over suicide and the antidepressants exploded again on Tuesday
when an expert panel of advisers demanded the US Food and Drug Administration
(FDA) put "Black Box" warnings on this class of drugs, including Prozac, Zoloft,
Aropax and Effexor.

If the FDA accepts the advisers' recommendations - as it usually does -
highly visible warnings will have to appear on labels and on all future
promotion, which is likely to dramatically reduce drug sales in the US and
around the world.

Similar warnings will flow quickly to Australia, because the Therapeutic
Goods Administration (TGA) in Canberra watches the FDA like a hawk, even sending
an officer to Washington to attend this week's hearings.

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While there is a widespread belief that antidepressants can offer important
benefits and even prevent suicide for some children, there is now convincing
scientific evidence that these drugs do more harm than good.

For children, they essentially double the risk of suicidal thoughts and
behaviours, without providing any real benefit, with the possible exception of
Prozac. Of every hundred youngsters treated with these drugs, the pills will
cause an extra two or three to seriously consider killing themselves.

Almost all the companies' clinical trials of these drugs in children failed
to show they were significantly more effective than a placebo or dummy pill.

Yet despite a lack of evidence that they work, and convincing data showing
they cause harm, the use of these antidepressants among the young has
skyrocketed. In the US more than 11 million scripts are written every year for
people under 18. In Australia, the use of antidepressants among people aged 15
to 24, has increased 10-fold in 10 years.

So why have rates soared so high and why have regulators taken so long to
tell people the truth about antidepressants? The answer is simple: drug company
influence has fundamentally corrupted the medical establishment, from the GP
surgeries to the world's most respected regulators.

Most doctors still learn about drugs from the visits of drug representatives,
who bring food, flattery and friendship. Much of doctors' ongoing medical
"education" is funded directly by drug companies, as are most clinical trials.
As a result, unfavourable trial findings are often buried, while modest benefits
are exaggerated by so-called "thought leaders", also on company payrolls.

Prestigious royal colleges are themselves awash with pharmaceutical funding,
and many patient groups have their noses in the trough, too. Even the supposedly
independent regulators are sponsored by industry.

In the US, drug companies fund more than 50 per cent of the FDA's drug review
work. In the case of Australia's TGA, the figure is 100 per cent. It doesn't
mean all the hard-working bureaucrats are bought off, it just means the drug
companies are paying the bulk of their salaries.

At the FDA there is clear evidence that company funding has helped create a
culture of timidity, and the tardiness to warn about the risks of these drugs in
children is just the latest example of that problem. Here, the TGA, loudly
proclaims its independence. If so, why has antidepressant use in Australia
skyrocketed 10-fold in 10 years among the young? But while there seems little
political will to reform the current user-pays system of regulation, there are
encouraging signs of change. Editors of the world's most influential medical
journals have decided to get tough, demanding that all trials be registered so
the results can be publicly scrutinised, whether positive or negative - and
companies are falling into line.

In New York, the attorney-general has taken legal action against the giant
drug manufacturer GSK, the maker of Aropax, accusing the company of fraudulently
concealing data and misleading doctors and the public about the drug's risks and
benefits in children. GSK has settled.

In Britain, a far-reaching parliamentary inquiry into industry's influence
over the health-care system has just opened. That inquiry, being run by the
powerful Commons Health Committee, is examining drug company impact on doctors'
prescribing, medical education and scientific research, and it is scheduled to
take evidence in Australia soon.

It will also examine drug company funded "awareness raising" and investigate
whether such campaigns are inappropriately widening the definitions of disease
in order to expand markets for new medicines.

While many public hearings are yet to come, it is expected the British
inquiry's final report will call for a major winding back of drug company
influence, and send a strong message to the world that doctors and the public
should be getting much more independent information about medicines and health
conditions.

There is little doubt that the debacle over the antidepressants will make a
lot more people receptive to any such message.

Ray Moynihan's new book Selling Sickness will be published by Allen &
Unwin next year. The tie-in SBS TV documentary Selling Sickness will be screened
on October 5.

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