corner on the market…

Posted on Friday 30 September 2011

Dispute as McGorry complaint dismissed
The Australian
by Stuart Rintoul
September 30, 2011

A complaint against former Australian of the Year Patrick McGorry for planning a trial of drugs on children has been dismissed. But the 13 international health experts who lodged the complaint with the ethics committee at Melbourne Health calling for the trial to be abandoned say they are dissatisfied with the finding and have lodged a complaint against the ethics committee. Geoff Stuart from La Trobe University’s school of psychological sciences, who signed the complaint, said there were concerns about the circumstances in which the proposed trial was aborted that deserved to be examined. He said the "derisory and dismissive" one-sentence response of the ethics committee fell well short of explaining the "huge error" that was made in approving the trial.

Professor McGorry, executive director of the Orygen Research Centre and one of the Prime Minister’s key mental health advisers, planned to trial the effectiveness of the drug Quetiapine on patients "who are deemed at risk of developing a psychotic disorder", listing it on the Australian New Zealand Clinical Trials Registry last March. The trial, funded by the drug’s manufacturer, was to investigate whether it would decrease or delay the risk of people between 15 and 40 with early signs of mental illness developing a psychotic disorder such as schizophrenia.

On July 31, 13 psychiatrists, psychologists and researchers from Australia, New Zealand, Canada, Britain and the US objected to the trial for reasons including "the ethics of causing unnecessary harm to individuals not requiring treatment, to possibly prevent harm to a smaller number who do require treatment". Professor McGorry said last night the study was approved by the ethics committee after a "very rigorous process" before being "reluctantly" abandoned in June, when it was decided to proceed with a more promising trial involving fish oil. "As far as I’m concerned, the trial isn’t going ahead – it was ethically approved to do so, the committee has considered the complaint very carefully and has made a decision," he said. He said the complaint against the trial was "able to be defended on every level".

But Associate Professor Stuart said there was a lack of transparency in how such a controversial trial was ethically approved. He said Professor McGorry’s plan to use anti-psychotic drugs on children as young as 15 had "raised alarm bells around the world". Melbourne Health said last night its mental health research ethics committee was "satisfied the process and the decision to give ethics committee approval of the study were appropriate". The health organisation said the study had been abandoned by the research team for "logistical reasons".
In a rational world, seniority or celebrity is no reason for immunity in matters ethical. And in this story, the complaint is that this Clinical Trial shouldn’t have been approved by the ethics committee of Melbourne Health in the first place. I suppose that McGorry could argue that there have already been three trials where medicating the ultra high risk group with Atypical Antipsychotics had apparently been approved by ethics committees in industry-financed drug trials:
The other side of that argument would be that the first two studies were initiated around 2000 when the toxicity of the drugs was largely unknown, and that is somewhat true of the third study. Likewise, none of the studies reported data suggesting that the medication was very helpful. Why do it again?

But, perhaps the most compelling argument against approving this trial was made by Dr. McGorry himself in his patent application for Omega-3 Fatty Acids:

However, the use of antipsychotic medication for indicated prevention remains controversial even in research settings because of the high number of false positives [about 70-80% of people who meet ultra-high-risk criteria do not progress to psychotic disorder within one year]. Stigmatization associated with the use antipsychotics, and unwanted side effects which include metabolic changes, sexual dysfunction and weight gain are often not acceptable. Other side effects may include dyslipidaemia, cardiac arrhythmia and osteoporosis.
Prevention of Psychotic Disorders and/or Treatment of Pychotic Symptoms

The letter to the ethics committee is well-written, clear in scope, and deserves a full public hearing not just for this instance, but for the ones that will follow. I’ve already commented on Dr. McGorry’s disdainful and self righteous way of dealing with critics [the internal critic…, hubris…] as well as his eloquence [speaking of Patrick McGorry…]. He appears to be one of those people with a true Achilles Heel, an inability to listen to criticism and learn from it. Instead, he interprets his critics as attacking him personally and becomes haughty or retaliates sarcastically. It will be his downfall if he’s not careful.

He hasn’t realized that those of us who criticize some of his choices want to help young mentally ill people too. We’re actually on his side. He doesn’t have a corner on the market…
    September 30, 2011 | 2:26 PM

    huh, in his quest to make his Omega 3 sound better than antipsychotics, he forgot to add increased chances of blood clots, Seroquel being the top of that list….

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