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Stricter rules governing drug trialling are promised. But
they shouldn't be necessary if doctors stick to their guidelines.
Gerard Ryle reports.
Embarrassment has done its work. Those who run the system always
knew. Now that the public knows, they've promised reforms. That anyone was
surprised by the news this week that doctors were getting paid by global
pharmaceutical firms to do drug trials on their patients might be considered an
extraordinary oversight for a profession that likes to stand on a platform of
ethics.
The response from authorities was immediate. The State Health Minister,
Craig Knowles, announced two inquiries into the matter, one by his department
and one by the NSW Medical Board.
He also set about creating Australia's first publicly accessible register
of clinical trials by ordering that all hospitals list all such trials - and
moneys received from pharmaceutical firms - in their annual reports.
The chief medical officer of Australia, Professor Richard Smallwood, said
that an even more comprehensive register of clinical trials should be compiled
at a national level.
Meanwhile, the leader of the Australian Democrats, Meg Lees, said her party
would ensure that laws were changed so that doctors would have to tell patients
who volunteered for trials of financial arrangements the doctors had with
pharmaceutical firms.
But in view of doctors' own self-imposed rules, such legal reform should
not be necessary.
At least two medical codes of conduct in Australia refer to the commercial
relationships between the pharmaceutical industry and the medical profession.
The guidelines attempt to moderate between the ever increasing needs of big
business and the delicate patient-doctor relationship.
The latest code of ethics issued by the Royal Australasian College of
Physicians couldn't spell it out more clearly: "The nature of the compensation
to be paid to the investigators or the institution should be declared to, and
approved by, the ethics committee and this fact should be noted in the
explanatory statement provided to potential volunteers."
The fact is, this hasn't always happened. More ...
THE EXPOSEAustralians used as guinea pigs for global drug
marketThousands of Australian
patients are being used as guinea pigs in drug trials for global pharmaceutical
companies without explicit laws to adequately protect their rights.
Full report
Australians used as guinea pigs for
global drug market
A HERALD INVESTIGATION
By Gerard Ryle
Thousands of Australian patients are being used as guineapigs in
drug trials for global pharmaceutical companies without explicit laws to
adequately protect their rights.
Intellectually disabled men and women, incapable of giving consent on their
own behalf, are being included in the trials, which are largely aimed at getting
new drugs to the United States and European markets.
Pharmaceutical companies are paying private doctors up to $6,000 for every
patient they recruit but the patients do not have to be told of the financial
arrangement. The money covers trial expenses and allows a profit for the
doctors.
Drug trials are vital in bringing life-saving medicines to market but the
number being conducted in Australia has risen 20-fold since 1990 and many never
result in approval for the drug.
Some trials are abandoned after reports of side-effects and deaths, either
here or overseas, or because the drug simply does not work.
The chairman of the Australian Drug Evaluation Committee, Professor Martin
Tattersall, who is at the forefront of medical research in Australia, believes
the protection of patients' rights in drug trials needs a major overhaul.
"Basically most patients do what their doctors say," he said. "They do that
because they want to trust their doctors. Some patients taking part in clinical
trials don't appreciate that they are in a clinical trial."
A Herald investigation has found that:
Patients are being bought and sold like commodities by doctors and
pharmaceutical companies but are not being told that money changes hands when
they volunteer for new treatments.
The Therapeutic Goods Administration, the main responsible Federal
Government authority, was obliged to directly review only two of the 1,712
clinical trials done in Australia last year.
Patients are not always given copies of the consent forms they sign and are
often not in a position to question their doctor's suggestion that they join a
trial.
Nearly one in six of the 210 medical bodies which approve trials - known as
ethics committees - are being run out of private organisations.
One Sydney doctor who conducted trials on his patients got approval from an
ethics committee that included, among others, his former lawyer, his former
patient, his rabbi and his sister.
Global pharmaceutical companies have rushed to Australia at a time when
debates have arisen over similar trials in Europe and the US, and because of the
relative cheapness and ease of getting approval here.
Australian trials include experiments on dementia patients, the testing of
hormone creams on menopausal women, and new vaccines in children.
One experiment, approved by the NSW Guardianship Tribunal, involved putting
intellectually disabled people on an anti-epileptic drug which never succeeded
in being registered anywhere in the world.
Professor Tattersall said many trials which harmed patients may be hidden
from public view because pharmaceutical companies controlled the data.
"One of the main flaws in the process of [drug] registration is that you only
know the studies which are shown to you," he said. "You don't know the studies
that were done and weren't shown to you.
"Clearly there is an opportunity for a company which is sponsoring a study to
hide the dirty washing.
"I think the other thing that is true is that while the barriers for buying
doctors have gone up quite a lot in North America and increasingly in Europe,
they haven't gone up here yet."
Professor John Simes, director of the National Health and Medical Research
Council's clinical trial centre, said the lack of a publicly accessible central
trials register in Australia meant there was no accurate way of knowing what
trials were being done, and by whom.
Associate Professor Paul Komesaroff, chairman of the ethics committee of the
Royal Australasian College of Physicians, said industry funded research was
easier to obtain and much more lucrative than government-funded research.
"In many cases the industry sponsored trial doesn't have a valid scientific
intention. It is eroding research that is truly innovative in favour of research
that satisfies commercial purposes." TOMORROW: How Sydney public hospitals
earn cash trialling drugs on their patients
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