Anti-Psychotic Drug Trial On Teens Abandoned In Australia

An anti-psychotic drug trial on teenagers has been given up in Australia, following strong protests from the international scientific community, reports say.

The controversy revolves around Quetiapine, sold as Seroquel and manufactured by AstraZeneca. They were to fund the trial.

Experts were concerned children who had not yet been diagnosed with a psychotic illness would be unnecessarily given drugs with potentially dangerous side effects. Anti-psychotics are vital, but should not be used without clear evidence of the benefits, many scientists argue.

The drug has already been linked to weight gain and last month Zenca paid US$647 million ($622 million) to settle a lawsuit in the US, alleging there was insufficient warning the drug may cause diabetes.

Professor Patrick McGorry, one of the Prime Minister's key mental health advisers, had planned the trial at Orygen Youth Health in Melbourne, listing it on the Australian New Zealand Clinical Trials Registry last March.

It was to investigate whether the drug would decrease or delay the risk of people aged between 15 and 40 with early signs of mental illness, developing a psychotic disorder such as schizophrenia.

Last month, psychiatrists, psychologists and researchers from Australia, New Zealand, Canada, Britain and the US lodged a complaint with the ethics committee of Melbourne Health, the umbrella service which includes Orygen. They contended there was little evidence the onset of psychosis can be prevented and it was potentially dangerous to use anti-psychotics on those who merely had risk factors such as a family history or deterioration in mental health, with evidence showing up to 80 per cent will never develop a disorder.

Associate Professor Geoff Stuart from La Trobe University's school of psychological sciences, who signed the complaint, said serious questions about the aborted trial remain.

''He [Professor McGorry] was willing to endorse a trial which was exploring the use of anti-psychotic medication in an at-risk group,'' he said. ''There's a major ethical issue about medicating four people to supposedly save the fifth when you're not saving them anyway, you're just masking their symptoms.

''We're talking about kids as young as 15 who could get a full dose of anti-psychotics and they're not psychotic.''

Professor McGorry insists the decision to scrap the trial was made in June and is unrelated to the complaint, which he said he was only alerted to just over a week ago.

He said Orygen had to choose between the drug trial or pursuing another trial using fish oil - which had proven useful as an early intervention treatment for schizophrenia in a smaller study. It opted for fish oil because it had less potential for side effects.

He admitted the evidence suggested anti-psychotics were not effective as a first-line treatment for the at-risk group. But he said the risks had been exaggerated and he would consider a similar trial on patients for whom other treatments had failed.

He says an early psychosis program will end up costing per patient per annum about a third of what the standard adult mental health care costs. Early intervention was something that was pioneered in Australia in the '90s. "We had a national early psychosis project in the late '90s which started to build that infrastructure in this country. It was allowed to just ebb away and nothing happened in this country for 10 years.

"Let's be clear: what happens when - to young people and their families when we don't have these programs is long delays in getting access to care, even for severe psychotic illnesses, and when they do get access, it's very cursory and there is no psycho-social wrap-around or recovery program for these patients to make a proper recovery and reintegrate back into society," he told ABC News.

He also argues it is a most evidence-based reform. " It's been going for 20 years, countries all round the world have contributed to the evidence base.

"Because we dropped the ball in the '90s, it's been on the backburner in Australia, so other countries have gone ahead, implemented these reforms across the board in many, many Western countries and much of the evidence has come from overseas. So, Australians have been missing out because of these misinformed critics who are actually giving the wrong impression about this reform. There is very good evidence."

Melbourne Health's research ethics committee will still consider the complaint in September.



Source: Medindia