{"id":12501,"date":"2011-08-25T22:32:55","date_gmt":"2011-08-26T02:32:55","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=12501"},"modified":"2011-08-25T23:50:39","modified_gmt":"2011-08-26T03:50:39","slug":"3-when-nmany","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/08\/25\/3-when-nmany\/","title":{"rendered":"3. <em>when n=many<\/em>&#8230;"},"content":{"rendered":"<br \/>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/m.smh.com.au\/national\/health\/mcgorry-aborts-teen-drug-trial-20110820-1j3k1.html\" target=\"_blank\"><u><strong><font color=\"#200020\">McGorry aborts teen drug trial<\/font><\/strong><\/u><\/a><br \/>        <strong><font color=\"#200020\">Sydney Morning Herald<\/font><\/strong><br \/>        by Jill Stark<br \/>        August 21, 2011<\/div>\n<p align=\"justify\"><sup>THE FORMER Australian of the year Patrick McGorry has aborted  a controversial trial of anti-psychotic drugs on children as young as  15 who are &#8221;at risk&#8221; of psychosis, amid complaints the study was  unethical.<em> The Sun-Herald<\/em> can reveal 13 international health experts lodged a formal complaint calling for the trial not to go ahead. They were concerned children who had not yet been diagnosed  with a psychotic illness would be unnecessarily given drugs with  potentially dangerous side effects.<\/sup><\/p>\n<p align=\"justify\"><sup>Quetiapine, sold as Seroquel, has been linked to weight gain  and its manufacturer AstraZeneca, which was to fund the trial, last  month paid US$647 million [$622 million] to settle a lawsuit in the US,  alleging there was insufficient warning the drug may cause diabetes. Professor McGorry, one of the Prime Minister&#8217;s key mental  health advisers, 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.<\/sup><\/p>\n<p align=\"justify\"><sup>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 argued 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.<\/sup><\/p>\n<p align=\"justify\"><sup>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 &#8211; 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. Melbourne Health&#8217;s research ethics committee will still  consider the complaint   in September.<\/sup><\/p>\n<div align=\"justify\"><sup><em>The Sun-Herald<\/em> recently revealed a growing backlash  against the government&#8217;s mental health reforms, with Professor McGorry&#8217;s  peers claiming his youth early intervention model had been &quot;massively  oversold&quot;&#8230;<\/sup><\/div>\n<\/blockquote>\n<blockquote>\n<div align=\"center\"><a href=\"http:\/\/www.psychologytoday.com\/blog\/dsm5-in-distress\/201108\/seven-questions-professor-patrick-mcgorry?\" target=\"_blank\"><u><strong><font color=\"#200020\">Seven Questions For Professor Patrick McGorry<\/font><\/strong><\/u><\/a><br \/>    <strong><font color=\"#200020\"><sup>Psychiatry cannot promise more than it can deliver<\/sup><br \/>    Psychology Today<\/font><\/strong><br \/>    by Allen Frances M.D.<br \/>    August 18, 2011<\/div>\n<p align=\"justify\"><sup>The great news is that Professor McGorry has recently renounced the  relevance of psychosis risk syndrome in the current practice of clinical  psychiatry.  He has done so in two separate and dramatic ways: 1: by withdrawing his  support for the  inclusion of psychosis risk in DSM 5; and 2: by  promising not to include it as a target in Australia&#8217;s massive new  experiment in early intervention. Psychosis risk syndrome is an  extremely promising topic for ongoing research, but it is not nearly  ready for current clinical application and if introduced prematurely  could cause disastrous unintended consequences&#8230;<\/sup><\/p>\n<p align=\"justify\"><sup>But a dark cloud surrounds the silver lining of having one  psychiatrist in a position of almost unopposed influence.  Professor  McGorry has developed the messianic blind spot that is so common in  visionary prophets. His zeal has made him an unreliable evaluator of  scientific evidence, allowing him to defend absolutely indefensible  positions with the convincing, but inaccurate, force of a true believer&#8230;<\/sup><\/p>\n<div><sup>Below  are seven questions that beg for Dr McGorry&#8217;s immediate public response.  No evasion or questioning of my motivation is called for- just   straight answers to simple questions. It will be useful for Professor  McGorry to respond for the record now, before Australia&#8217;s makes final  the terms of its much needed and awaited investment in mental health.<\/sup><\/div>\n<ul>\n<div align=\"justify\"><sup> <u>Question  1:<\/u> Please spell out on what scientific basis you have dismissed the  findings of the Cochrane report and indicate why Australia should base  policy decisions on your personal interpretation of these data rather  than on Cochrane&#8217;s more objective and systematic approach<br \/>     <u>Question  2:<\/u> What will be your role in establishing the goals and in directing  the implementation of Australia&#8217;s early intervention programs and what  protections are in place to ensure that opposing voices and  interpretations get a fair hearing? Who else will be involved in the  governance of these programs and how will they be selected?&#8217;<br \/>     <u>Question 3:<\/u>  Can you now state with certainty that the newly funded  early psychosis intervention programs will be restricted exclusively to  those who are already diagnosed with definite psychosis and will  definitely not include individuals deemed to be only at some increased  risk for future psychosis?<br \/>     <u>Question 4:<\/u> Do you now agree that it is  inappropriate to prescribe   antipsychotic medication for psychosis  risk except under the close supervision of an approved research  protocol?<br \/>     <u>Question 5:<\/u> What protections will be in place to avoid  the premature and incorrect differential diagnosis of psychosis? The  distinction between prepsychotic and psychotic is much clearer on paper  than in practice and psychotic symptoms in teenagers are often  transient, caused by <span class=\"pt-basics-link\">substance abuse<\/span> or <span class=\"pt-basics-link\">mood disorder<\/span>.  Will strict diagnostic requirements, careful differential diagnosis,  and quality control  guard against incorrect, premature, and  stigmatizing diagnoses and also against unnecessary and potentially  harmful treatments?<br \/>     <u>Question 6:<\/u> Why not roll out the EPPIC programs in gradual steps?  This would ensure that the model translates well from the research  environment to day to day practice and would provide an opportunity to  demonstrate its efficacy and cost effectiveness before disproportionate  investments are made in it.<br \/>     <u>Question 7:<\/u> How do you justify the  funding shortfalls for other necessary continuity of care programs that  will likely be caused by the front ending of expenditures for EPPIC [especially given lack of convincing evidence that EPPIC confers   enduring benefits or any reduction in future need for, or cost of,  services]? Is it worth staking such a large proportion of the mental  health budget on such an uncertain roll of the dice?<\/sup><\/div>\n<\/ul>\n<div align=\"justify\"><sup>His track  record makes clear that Professor McGorry can not be relied upon as a  neutral reviewer of scientific evidence or a neutral advisor on the  question of which mental health investments will bring to Australians  the highest and safest returns. His countrymen should be very grateful  to Professor McGorry for having obtained desperately needed funding for  mental health, but should also be cautious in following his lead in  determining how to best to allocate it. The mental health situation in  Australia is without historic precedent. Never before has the future  direction of an entire country&#8217;s mental health program depended almost  solely on the unopposed opinions and actions of one charismatic  psychiatrist and his band of loyal followers. His inordinate power  places a huge responsibility on Professor McGorry to exercise  responsible and responsive leadership.  Direct answers to the questions raised above are needed to ensure that  public policy will follow the scientific evidence and not be unduly  influenced by the blinkered zeal of one man, however well meaning and  highly respected he may be.<\/sup><\/div>\n<\/blockquote>\n<div align=\"justify\">So Dr. McGorry backed down on his <strong><font color=\"#6600cc\">Seroquel<\/font><\/strong> trial. That was a good decision. And it remains to be seen what will come of <strong><font color=\"#200020\">EPPIC<\/font><\/strong>, Australia&#8217;s grand plan for early intervention in Schizophrenia. In the full version of his commentary, Dr. Frances talks about Dr. McGorry&#8217;s ad hominem responses to his critics along the way.  I have nothing much to add to Dr. Frances&#8217; excellent comments on future  directions &#8211; his questions are sound. I wish Dr. Frances had expressed a similar wisdom back when he  was in the &quot;guidelines&quot; business a decade ago [<strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/..\/index.php\/2011\/06\/15\/detestable\/\">detestable&hellip;<\/a><\/strong>, <strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/..\/index.php\/2011\/06\/16\/gpp\/\">gpp?&hellip;<\/a><\/strong>, <strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/..\/index.php\/2011\/06\/16\/a-long-awaited-corner\/\">a long awaited corner&hellip;<\/a><\/strong>, <strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/..\/index.php\/2011\/06\/16\/a-connection\/\">a connection&hellip;<\/a><\/strong>]. Likewise, at this point, I have nothing to say about whether Dr. McGorry belongs in the category of shady characters like Drs. Nemeroff, Schatzberg, and Biederman, or if he&#8217;s simply on a misguided path &#8211; falling prey to the shoals of therapeutic zeal. I just don&#8217;t know enough yet to speculate on that point, but I expect this story is far from over and we&#8217;ll know more in due time.<\/div>\n<p align=\"justify\">This particular story has an uncanny <strong>d\u00c3\u00a9j&agrave; vu<\/strong> feel to me. I came into psychiatry on the waning cusp of two paradigms &#8211; psychoanalysis and the community mental health movement. Both have survived, but have been eclipsed in the intervening years by the emphasis on psychopharmacology and neuroscience. At the time I started, the rhetoric of community health was alive and strong. Institutionalization of mental patients was detrimental. They needed to be treated in the community with an army of mental health workers and social support staff. The old hospitals were emptying [closing]. Hospitals were for short term stabilization only. While the rhetoric was put in terms of a social reform movement, the motor driving it was the coming of the neuroleptic medication &#8211; the antipsychotics &#8211; which made the change a possibility. By the time I arrived, the funding and the availability of even acute beds had fallen below the critical point, and we struggled to maintain chronic patients with limited staff and ever-falling resources. That struggle is ongoing. The &quot;street people&quot; [chronic mental patients] were beginning to appear in our cities on the streets and living under bridges. <\/p>\n<p align=\"justify\">When I read that the coming of the neuroleptics&nbsp; in the late 1950s heralded the dawn of a new age of neuroscience and psychopharmacology, I recall to other side of that coin as the director of a public crisis intervention service with a community support team overwhelmed by the task at hand. So I&#8217;ve always found that time being touted as the beginning of a golden age to be a dramatic rewriting of the history as I saw it on the streets of Atlanta Georgia. The neuroleptics may have been the driver, but they weren&#8217;t holding things in the road. And the side effects of the drugs were as apparent on Peachtree Street as they were in the Halls of Grady Hospital. That experience undoubtedly colors how I hear the story of Dr. McGorry&#8217;s <strong><font color=\"#200020\">EPPIC<\/font><\/strong> program and its massive government funding. Back then, the watchword was Preventive Medicine too &#8211; rapid treatment [Secondary Prevention] and Community Services that prevented deterioration [Tertiary Prevention]. The Community Mental Health Movement was easy to sell when it was young with high hopes for the future, but moved to the ranks of an albatross when it came to long term funding. So now, some places have somewhat functioning versions &#8211; but most don&#8217;t. Governments, like the most dedicated of Mental Health Professionals, burn out when success is measured by slowing the rate of decline rather than something like cure or at least regular improvement.<\/p>\n<p align=\"justify\">But there&#8217;s one point in this story that is undebatable from my perspective. It&#8217;s typified by the oft-used NIMH phrase &quot;<strong><font color=\"#200020\">Translational Science<\/font><\/strong>.&quot;&nbsp; It refers to the push to move research findings quickly from the &quot;bench to the bedside.&quot; There&#8217;s nothing wrong with the idea itself. Of course we&#8217;d want effective medical discovery made available to patients quickly &#8211; provided its safety and efficacy is assured. But I&#8217;m afraid that it has all too often been used when a better term would be &quot;the race to market.&quot; With appropriate warnings and safeguards, all of the neo-psychiatric drugs have a place in our armamentarium of therapeutic tools [neuroleptics, SSRIs, mood stabilizers, even atypical antipsychotics]. But that is certainly a much smaller place than in current practice, with a lot more monitoring for true efficacy, and a great deal more attention to the toxicity of the drugs &#8211; particularly long term. Even if Dr. McGorry does assure us that his program is <u>not<\/u> a conduit for medicating people with toxic drugs on the 30% chance that they <u>might<\/u> develop an illness that the medication <u>might<\/u> help, his plan still only reaches the level of a &quot;pilot project,&quot; not a national mental health initiative. He&#8217;s coming off the bench way too fast.<\/p>\n<div align=\"justify\">If you read my earlier <strong><em>n=1<\/em><\/strong> musings, you probably guessed that I actually don&#8217;t think he&#8217;s on the right track. My opinion rises no higher than just that, an opinion, but it&#8217;s actually based on a lot more <strong><em>n<\/em><\/strong>s than just the single case I mentioned. It&#8217;s based on ten years in the trenches of the chronic care of Schizophrenic patients during the nova of the Community Health Movement. In my view, psychosis is a cataclysmic complication of what we call Schizophrenia, but there&#8217;s a more basic problem in processing internal and external experience that antedates the first psychotic episode, even the trema, and is untouched by antipsychotic medication. Active psychosis isn&#8217;t good for people sure enough, and warrants prompt attention, but I don&#8217;t think psychosis is the only long term problem and I doubt that premedication will make a difference. I&#8217;d like to see Dr. McGorry and his EPPIC Project focus some attention on further refining our understanding of that underlying process in his &quot;Ultra High Risk&quot; group by looking carefully at how the patients who don&#8217;t develop psychosis and the ones that do differ. And in his ongoing treatment of the psychotic patients, I&#8217;d like to see him hone in systematically on what actually helps and what doesn&#8217;t &#8211; what &quot;treatment&quot; means. We&#8217;re still not sure about that. Schizophrenia is at the same time one of the most fascinating and the most tragic of human fates and it deserves all the attention we can give it, but Schizophrenic people have historically done their time as experimental subjects. Such programs need to be well thought out, genuinely &quot;evidence-based,&quot; and move in careful <strong>baby steps<\/strong>&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>McGorry aborts teen drug trial Sydney Morning Herald by Jill Stark August 21, 2011 THE FORMER Australian of the year Patrick McGorry has aborted a controversial trial of anti-psychotic drugs on children as young as 15 who are &#8221;at risk&#8221; of psychosis, amid complaints the study was unethical. The Sun-Herald can reveal 13 international health [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-12501","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/12501","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=12501"}],"version-history":[{"count":19,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/12501\/revisions"}],"predecessor-version":[{"id":12520,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/12501\/revisions\/12520"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=12501"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=12501"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=12501"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}