{"id":14464,"date":"2011-10-07T12:07:11","date_gmt":"2011-10-07T16:07:11","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=14464"},"modified":"2011-10-07T12:29:50","modified_gmt":"2011-10-07T16:29:50","slug":"robust-results-before","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2011\/10\/07\/robust-results-before\/","title":{"rendered":"ro&middot;bust results <u>before<\/u>&#8230;"},"content":{"rendered":"\n<ul>\n<div><strong><font color=\"#200020\">ro&middot;bust&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/font><\/strong><font color=\"#200020\">\/r\u00c5\u008d\u00cb\u02c6b\u00c9\u2122st\/<\/font><\/div>\n<div>&nbsp;&nbsp;<font color=\"#200020\"><em>adjective<\/em>:<\/font><\/div>\n<ol>\n<li>\n<div><font color=\"#200020\">(of a person, animal, or plant) Strong and healthy; vigorous.<\/font><\/div>\n<\/li>\n<li>\n<div><font color=\"#200020\">(of an object) Sturdy in construction.<\/font><\/div>\n<\/li>\n<\/ol>\n<\/ul>\n<p align=\"justify\"><img loading=\"lazy\" decoding=\"async\" width=\"101\" vspace=\"4\" border=\"0\" align=\"right\" hspace=\"4\" height=\"77\" src=\"http:\/\/1boringoldman.com\/images\/coffee_cup.gif\" \/>Why have so many lightweight scientific studies of the efficacy of psychiatric drugs had such a profound impact on prescribing habits of the last several decades? From the present vantage, the second round Anti-depressants [SSRIs] and Antipsychotics [Atypicals] are turning out to be anything but <strong><font color=\"#200020\">ro&middot;bust<\/font><\/strong>, yet they largely replaced their predecessors as the drugs of choice. More than that, they&#8217;ve become &quot;blockbusters&quot; in the marketplace, topping the charts in overall pharmaceutical sales &#8211; so much so that the specialty of psychiatry has been largely redefined as &#8216;clinical neuroscience&#8217; [meaning psychopharmacology]. One thing guaranteed. When the definitive history is written, the answer to the &quot;why&quot; of all this is going to turn out to be a lot more complex than the unidimensional and often demonic explanations we hear in our current period of disillusionment. But that&#8217;s for our children to figure out.<\/p>\n<p align=\"justify\">Speaking strictly for me, I had no idea that the studies were so &#8216;lightweight.&quot; One thing about thinking out loud [blogging], you can look back at what you were thinking about in the past. Two years ago today, I was drawing graphs of the US Income Tax structure trying to understand our financial predicament [<strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2009\/10\/06\/taxing-thoughts\/\"><font color=\"#200020\">taxing thoughts&hellip;<\/font><\/a><\/strong>]. One year ago, I was still at it, trying to understand how Alan Greenspan&#8217;s earlier associations with author and polemicist Ayn Rand had affected his sometimes disastrous economic decisions [<strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/wp-admin\/..\/index.php\/2010\/10\/09\/no-freedom-without-walls\/\"><font color=\"#200020\">no freedom without walls&hellip;<\/font><\/a><\/strong>], but I was just beginning to look at modern psychiatry [<u><strong><a target=\"_blank\" href=\"http:\/\/1boringoldman.com\/index.php\/2010\/10\/06\/4392\/\"><font color=\"#200020\">consequences&hellip;<\/font><\/a><\/strong><\/u>] in the wake of the chairman of the department I had been a member of for over thirty years being dethroned in scandal [Dr. Charles Nemeroff]. I suppose that it&#8217;s the<em> inertia of motion <\/em>of a career as a psychoanalyst and psychotherapist. If you spend your every working day poring over the details of patient&#8217;s histories trying to parse out the roots of the contemporary problems, it&#8217;s how you approach everything else.<\/p>\n<p align=\"justify\"><img decoding=\"async\" width=\"144\" vspace=\"4\" border=\"1\" align=\"left\" hspace=\"4\" src=\"http:\/\/graphics8.nytimes.com\/images\/2010\/10\/03\/business\/03pysch-graphic\/03pysch-graphic-articleInline-v2.jpg\" \/>So, one year ago, I was just learning that the Atypical Antipsychotics were the top-selling drugs. I didn&#8217;t know that LOCF stood for Last Observation Carried Forward, a method of correcting for the fact that people regularly quit clinical drug trials in droves. I had no clue that CRO meant Clinical Research Organization or that they existed. I didn&#8217;t know about ghost authors or guest authors. I knew to look for industry funding, but it never occurred to me that the authors didn&#8217;t do the study and were often picked after it was done. I didn&#8217;t know to go to the acknowledgements to read the Conflict of Interest declarations. Speaker&#8217;s Bureaus with industry prepared slides? You&#8217;ve got to be kidding. I didn&#8217;t know Harvard meant Joseph Biederman, Stanford meant Alan Schatzberg, or Brown meant Martin Keller. I knew that Charlie Nemeroff meant Emory, but I didn&#8217;t even know what that really meant. Since last year, I&#8217;ve gotten to know <u><strong><a target=\"_blank\" href=\"http:\/\/clinicaltrials.gov\/ct2\/search\"><font color=\"#200020\">clinicaltrials.gov<\/font><\/a><\/strong><\/u>, <a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/\"><u><strong><font color=\"#200020\">PubMed<\/font><\/strong><\/u><\/a>, the NIH <u><a target=\"_blank\" href=\"http:\/\/projectreporter.nih.gov\/reporter.cfm\"><strong><font color=\"#200020\">RePORTER<\/font><\/strong><\/a><\/u>, <strong><font color=\"#200020\">Ovid<\/font><\/strong>, <a target=\"_blank\" href=\"http:\/\/projects.propublica.org\/docdollars\/\"><u><strong><font color=\"#200020\">ProPublica<\/font><\/strong><\/u><\/a>, <a target=\"_blank\" href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cder\/drugsatfda\/\"><u><strong><font color=\"#200020\">Drugs@FDA<\/font><\/strong><\/u><\/a>, the sites where <strong><font color=\"#200020\">discovery court documents<\/font><\/strong> are archived, and I see <strong><font color=\"#200020\">Google<\/font><\/strong> searches in my dreams. But a year ago, I knew none of that. I&#8217;ve had a lot of help along the way [for which I&#8217;m eternally grateful]. And I&#8217;m a retired old guy with lots of time with a hard science background who is chronically curious. But my point is that a year ago, I was an average expectable psychiatrist, and I was in the dark &#8211; even about the chairman of a department I was a peripheral part of. I had no clue that the studies backing up these drugs were so <em><strong><font color=\"#200020\"><u>not<\/u>&nbsp; <\/font><\/strong><\/em><strong><font color=\"#200020\">ro&middot;bust<\/font><\/strong>. I knew the ads were malarky [they always were]. I knew Dr. Nemeroff was full of hot air [he always was]. But I didn&#8217;t know about the widespread deceit and <strong><font color=\"#200020\">deliberate scientific misinformation<\/font><\/strong> [that hasn&#8217;t always been].<\/p>\n<p align=\"justify\">So this year, I&#8217;ve learned a lot of things that I shouldn&#8217;t have to know. No practicing physician has the time to chase down the FDA reports on drugs, review the appropriateness of statistical tests, learn to calculate effect sizes or NNT [number needed to treat] values, check dropout rates and look to see if they used LOCF or Mixed Model corrections. That&#8217;s what Journal editors do [did]. That&#8217;s what experts are [were] for, &quot;thought leaders&quot; are [were] to think about. And there&#8217;s a limit to what can be done in their absence. I can maybe do a decent job of evaluating a Clinical Trial article now using all those tools mentioned. But I doubt that I could ever evaluate a genomic study with a gajillion SNPs using the statistics involving super-nova sized matrices &#8211; not sitting up here in the woods looking at the Internet.<\/p>\n<p align=\"justify\"><img decoding=\"async\" width=\"160\" vspace=\"4\" border=\"0\" align=\"right\" src=\"http:\/\/1boringoldman.com\/images\/traffic.gif\" \/>So that&#8217;s my message. I shouldn&#8217;t have to learn these finer details to know about the drugs, but it&#8217;s possible with time and effort. But I&#8217;m not even sure that I <u>could<\/u> learn to evaluate the masses of data generated in a genomic study, even if I gave it my best shot.&nbsp; That&#8217;s why I&#8217;ve been so obsessed with this &quot;personalized medicine&quot; business. If our researchers are as corrupt and deceitful as they have been with the drug trials, we&#8217;re up a creek with no paddle, because of the volume and complexity of the information. And it matters to our patients because there&#8217;s a powerful move afoot to treat people with drugs based on some commercial lab&#8217;s printout on their cheek swabs [maybe done at the same time as the waiting room depression screening questionnaire]. That&#8217;s no good in my book. We need <strong><font color=\"#200020\">ro&middot;bust<\/font><\/strong> results before any piece of that scenario comes close to happening&#8230;<\/p>\n<div align=\"justify\">I started to write about an article in the new <a target=\"_blank\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/21890791\"><strong><font color=\"#004400\">American Journal of Psychiatry<\/font><\/strong><\/a> that I was really glad to see, but decided that it needed a prequel rant. That article&#8217;s coming up next&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>ro&middot;bust&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;\/r\u00c5\u008d\u00cb\u02c6b\u00c9\u2122st\/ &nbsp;&nbsp;adjective: (of a person, animal, or plant) Strong and healthy; vigorous. (of an object) Sturdy in construction. Why have so many lightweight scientific studies of the efficacy of psychiatric drugs had such a profound impact on prescribing habits of the last several decades? From the present vantage, the second round Anti-depressants [SSRIs] and Antipsychotics [&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_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-14464","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/14464","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=14464"}],"version-history":[{"count":56,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/14464\/revisions"}],"predecessor-version":[{"id":14520,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/14464\/revisions\/14520"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=14464"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=14464"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=14464"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}