{"id":50132,"date":"2014-09-22T11:17:31","date_gmt":"2014-09-22T15:17:31","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=50132"},"modified":"2014-09-23T23:42:13","modified_gmt":"2014-09-24T03:42:13","slug":"50132","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/09\/22\/50132\/","title":{"rendered":"monotonous and trivial…"},"content":{"rendered":"
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Adverse Events Caused by a Drug Warning?<\/a><\/div>\n
Medscape Psychiatry <\/font><\/strong><\/div>\n
by Robert L. Findling, MD<\/div>\n
July 31, 2014 <\/div>\n

"Hello. I’m Dr. Robert Findling, Director of the Division of Child and Adolescent Psychiatry at Johns Hopkins University and a vice president at the Kennedy Krieger Institute in Baltimore. The US Food and Drug Administration [FDA] issued a warning in 2004 that treatment with antidepressants could lead to an increased risk for suicidality in young people. Today I will talk about a new study that examined the impact of this FDA warning. This article was published in BMJ<\/em>, and the first author is Christine Lu."<\/p>\n

"Suicide in teens is not only tragic but is a leading cause of death in youngsters. A major risk factor for suicide is depression, so safe and effective treatments for depression are needed. <\/font><\/strong>Among high school students, 8% say that they have attempted suicide, and 30% of those youngsters have made a suicide attempt that required medical attention. Suicidality in teenagers is all too common. Moreover, it is associated with a reasonably high rate of morbidity and a real risk for mortality. For that reason, it’s important to consider events that could alter the rates of suicidality. The impact of the FDA warnings has already been examined. This paper asks more and different questions…"<\/p>\n

 <\/p>\n

"What did the study find? First, there was a 31% reduction in the rate of antidepressant prescriptions. Second, there was an increase of 21% in the rate of psychotropic drug poisonings in adolescents. Finally, the study did not find an increased rate of completed suicides. An accompanying editorial commented that the net effect was that the FDA warning led to more harm. The data from this study suggest that adverse events not only can occur from medicines but also as a result of warnings. This leads to the unanswered question: How do we communicate treatment-related outcomes and treatment-related concerns effectively and openly to ensure improved patient outcomes without unwanted consequences? I’m Dr. Robert Findling. Thank you for watching."<\/div>\n<\/blockquote>\n
At times, I fantacize that there’s some Fu Manchu<\/font><\/strong>, Keyser Söze<\/a>, Professor Moriarty<\/font><\/strong>, Karl Rove<\/font><\/strong>, some evil puppet-master in the background that orchestrates articles like this one, diabolically undermining the wisdom of the FDA’s Black Box warning about akathisia and suicidality as a potential adverse experience from the antidepressants, particularly in adolescence. For the decade since the warning was issued, articles debunking it come at regular intervals from many directions – the most recent being the one by Lu mentioned here. <\/div>\n

They’re all similar, the studies purporting  to either refute the warning or to say that it has caused harm. They seem to all rely on some large population study with a proprietary database showing that suicidality hasn’t fallen or has actually risen in the aftermath of the warning. They all document that the prescription of antidepressants to adolescents has fallen since it was issued [or at least not continued to rise]. The authors are an odd lot: adult psychiatrists<\/a>, statisticians<\/a>, bio-mathematicians<\/a>, a conservative think-tank<\/a>, etc. They imply that the Black Box warning resulted in withholding needed treatment from depressed kids. Like the Medscape<\/font><\/strong> presentation above, they leave out the fact that any literature that suggests that these drugs are effective in adolescents show minimal effects [if any] and are notorious examples of the experimercials <\/em>of the era [eg Paxil Study 329]. They have resulted in multiple settlements against pharmaceutical companies for damages and false advertising. <\/p>\n

So is there some evil genius in the background pulling the strings trying to dampen the impact of the warning? or maybe have it removed? Some of it has been PHARMA driven, at least early on, but it’s still coming even after all the antidepressant patents have expired. Dr. Findling may or may not be PHARMA friendly, but there’s no point any more. PHARMA may have started this mess, but they’re long gone now. So my hypothetical evil manipulator isn’t likely in that camp anymore. How about some other source – maybe among the ranks of Managed Care? They certainly stand to gain if people give antidepressants to kids rather than something else that costs the insurers more money [particularly now that the generic antidepressants are widely available and cost very little]. They’re a good candidate and the studies often use their databases. Actually, that’s who the author of the study discussed by Dr. Findling above [Dr. Lu] works for studying cost containment.<\/p>\n

But there’s another factor, one suggested by a lot of activists and critics of psychiatry – that psychiatrists just like to give out pills.  Yet another possibility – maybe they really think that antidepressants help depressed kids. I personally think there’s a simpler explanation that doesn’t postulate an arch-fiend in the background or even demonize<\/em> or dumbify<\/em> child psychiatrists. They don’t know anything else to do. Seeing the kid frequently and getting to the bottom of the problem isn’t in vogue, nor is it reimbursed. There’s no hospital for the really sick, at risk kids. In the modern world that focuses on diagnostic groups [as in the unitary domain – Adolescents with MDD<\/em>], evidence-based medicine has no place for the kind of single-case model that asks "What’s wrong in the world of this unique<\/em> adolescent who is floundering at a time in life when floundering is more rule than exception?<\/font>" Most of the kids survive, but the consequences can and do play out in problems that persist for a lifetime in the enduring identity formed in the teen years. Dramatic? That’s intentional.<\/em><\/p>\n

I expect that many prescribers have benevolent and therapeutic intent, but ignore the relative ineffectiveness of the drugs and the rare adverse side effects that can be fatal because they don’t know anything else to do; because they can feel that something needs doing that they either don’t know how to do or isn’t "allowed"; and they hide from those uncomfortable twinges behind the kind of rationalizing and uncritical thought we hear in this monotonous and trivial Medscape <\/font><\/strong>presentation that parrots a widely discredited article [read from a teleprompter]…<\/div>\n","protected":false},"excerpt":{"rendered":"

Adverse Events Caused by a Drug Warning? Medscape Psychiatry by Robert L. Findling, MD July 31, 2014 "Hello. I’m Dr. Robert Findling, Director of the Division of Child and Adolescent Psychiatry at Johns Hopkins University and a vice president at the Kennedy Krieger Institute in Baltimore. The US Food and Drug Administration [FDA] issued a warning in […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","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":[5],"tags":[],"class_list":["post-50132","post","type-post","status-publish","format-standard","hentry","category-opinion"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/50132","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=50132"}],"version-history":[{"count":32,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/50132\/revisions"}],"predecessor-version":[{"id":50200,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/50132\/revisions\/50200"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=50132"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=50132"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=50132"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}