'Big risks' from quick drugs trials | Australia

'Big risks' from quick drugs trials

THE spectre of AIDS first brought home to Australia the importance of testing drugs in order to get better medicines to market.

The HIV epidemic in the late 1980s meant people were faced with a disease for which there was no cure.

Bureaucratic and regulatory barriers meant pharmaceutical companies sometimes had to wait three years for proper approval to test new drugs.

But in 1991, under pressure from consumer and industry lobbies, the Federal Government commissioned a report from a former federal health minister, Peter Baume, which cleared the way to a quicker approval process for clinical trials, the mechanism by which new drugs are tested.

Dr Baume recommended shifting the clinical trial approval process away from the Therapeutic Goods Administration, and on to ethics committees.

Ethics committees are bodies made up of medical professionals and lay people that are usually, but not always, attached to universities or hospitals.

The changes, adopted that year, meant drug companies could simply have an ethics committee evaluate a study in order to get a new trial under way.

The make-up of a committee was not questioned as long as it followed self-regulating guidelines set by the National Health and Medical Research Council.

The effect was almost immediate. The waiting period for new trials was cut from three years to three months and this was reflected in the number of trials being registered with the TGA, which retained that role.

For instance, in 1990 there were only 78 clinical trials in Australia. Last year more than 3000 clinical trial site notifications were registered with the TGA, an indication of a similar number of trials.

Donna Edman, of Medicines Australia, says the local drug industry invests about $520 million a year on research and development, making it second to the automotive industry.

About 90 per cent of that money is spent on clinical trials, and some of this money finds its way to private doctors and to public hospitals by way of payments for each patient signed up for a trial. The money is to offset the cost of conducting the trial.

The remarkable increase in trials can be partly explained by the intense interest taken in Australia by giant US-based medical testing companies. But this injection of big-business interests into the fragile patient-doctor relationship was not accompanied by any new safeguards, and the rules surrounding research continue to be largely self-regulated.

"It is still an inherent risk in the system," says Professor Paul Komesaroff, the director of the Monash Centre for the Study of Ethics in Medicine and Society.

"The fact that 16 years have gone by and there has not been any significant misadventure suggests that something is basically going OK, but there have been some areas of concern."

A drug trial that nearly killed six healthy volunteers at an English hospital last year demonstrated the huge risks, he said. "Ethics committees are good at ethics but they are not automatically good at science."

http://www.smh.com.au

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