3. when n=a few needs n=a few more

Posted on Monday 29 August 2011

I think we should give credit where credit is due. Drs. McGorry, Yung, and their colleagues have focused our attention on practical ways of identifying patients at risk for developing manifest Schizophrenic Illness. Even though the predictive power of their criteria is lower than we’d all like at its best [and sometimes downright disappointing as in their own big study], their concept of the "ultra high risk" group is a move beyond Bleuler and offers promise for the future. They’ve spearheaded an approach that may well inform us all about how we view and treat Schizophrenia at some point in our history, but this isn’t that point just yet. It’s still a taste test, hardly ready for the main menu. But the complaints are not about their contributions. We’re complaining about other things – obvious things:
  • Adding Psychosis Risk Disorder to the DSM-5:
    The majority of Dr. McGorry’s ultra high risk [UHR] group do not develop psychosis [Schizophrenia]. The idea of declaring a group as having a disorder because a third of the group might develop a disorder is absurd in its own right. But anyone who hasn’t been living on a desert island since 1980 knows that declaring something a disorder invites clinical drug trials and the probability of inappropriate medication. The UHR group is only a research category, not a clinical diagnosis. Dr. Frances reports that Dr. McGorry has withdrawn his support from inclusion. I hope that’s right.
  • Preventive Medicine in UHR using antipsychotics:
    Even if he’d shown that the medication had a long term benefit to the people who became psychotic [which he hasn’t], we’d object to exposing the remaining 70%+ to potentially toxic drugs. There’s no rational Preventive Medicine principle that would support that idea.
  • Involvement with the Pharmaceutical Industry:
    Two of McGorry’s three studies of treatment of UHD included Risperdal [whose manufacturer, Janssen-Cilag Pharmaceuticals funded the studies] and until very recently, he planned yet a further study funded by AstraZeneca, maker of the study drug, Seroquel. His work inspired a third drug company, Eli Lilly to fund a study of their drug, Olanzapine in UHR subjects. His snippy response to being challenged on this topic is baseless:
      "But what the studies actually show is there is no need to use anti-psychotic medications as first line in these patients. So the fears that Dr Francis is fanning in this country are actually the converse of what the reality actually shows from the research. So, I think we’re on very firm ground knowing how to help these young people and they certainly need help. And they shouldn’t be turned away, as Dr Jureidini implied. They should be helped and they can be helped within this new blend of Headspace and EPPIC models which will be rolled out hopefully to most of Australia over the next few years"…

    If he doesn’t want us to worry about it, he should stop doing it.
  • Prematurely launching a Mental Health Initiative:
    McGorry’s data [nor the data of others] in no way supports a massive implementation like the one in Australia. In the recent era of "Translational Science," there’s an injunction to move things from the "bench to the bedside" that has been used as an excuse to charge ahead with only preliminary and tentative evidence. Dr. Allen Frances’ warning to Australia is not an attack on McGorry, it’s a call for reason.
Dr. McGorry says:
"… we learned that they had a very high risk of transitional to psychosis, something like 30 to 40 per cent within 12 months, which is very, very high, about 400 times higher than the general population. And so obviously there was a need to try to reduce that risk, so a number of research studies… were conducted both here and overseas. There are about six randomised control trials, if he wants to talk evidence, showing that a range of treatments will reduce that risk to about 10 per cent.  Now, the sort of things that work in reducing risk are cognitive behaviour therapy, a psychological treatment, omega three fatty acids, a fish oil, both of which studies we have done, and low-dose anti-psychotic medication. Now that’s the controversial bit."
The "six randomized control trials" are abstracted in the last two posts. I can find no reading of those studies that supports "that a range of treatments will reduce that risk to about 10 per cent." The number comes from the 6 month value in their very first study, a number whose significance disappeared by 12 months. I admire his conviction but not his rhetoric.

I thought, however, that the articles from Manchester and Denmark were very interesting. They’re onto something in extending McGorry’s ideas about psychological intervention. I particularly liked the Danish study that seemed to see the UHR patients in the same light as the first episode patients they were already focused on. I’m not sure that postponing or averting the psychotic transition is the needed target outcome. They seemed more interested in developing an approach towards early Schizophrenia no matter where they came in on the process – and that makes good  sense to me.

In medicine, we often generalize from n=a few to n=many. In this case, it’s too early to make that jump. How about n=a few more at this point?

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