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Text of the page (random words):
but now it s in jama so a wider audience may now pay attention or ignore it good marketing usually beats science so maybe this won t make any difference antidepressants for all but very severe depression all the benefits of placebo plus the added bonus of side effects sign me up to quote the authors what makes our findings surprising is the high level of depression symptom severity that appears to be required for clinically meaningful drug placebo differences to emerge particularly given the evidence that the majority of patients receiving adm in clinical practice present with scores below these levels in other words most people who receive antidepressants would likely have done just as well on placebo without the side effects a few other posts on the topic the long lasting placebo effect sexual side effects of ssris paxil how to lie the much vaunted public health benefits of antidepressants antidepressants offer weak efficacy for all but most severe depression hiding negative data on antidepressants suicidal tendencies nah not here i ve linked the abstract of the latest jama study here enjoy posted by cl psych at 1 05 2010 03 08 00 pm 22 comments labels antidepressants wednesday december 16 2009 atypical antipsychotics for depression now with considerable evidence i ve been wanting to write about this for months here goes we know that antipsychotics are the new panacea for all things mental health related including depression 1 2 3 but critics kept pointing to a pesky lack of evidence that such treatments actually worked bristol myers squibb manufacturer of abilify has been running a disinformation campaign in medical journals to tout its drug as an antidepressant their attempts to paint a positive picture of abilify s antidepressant properties and its allegedly fantastic safety tolerability profile have been simultaneously tragic and amusing 1 2 3 we re now moving on to something bigger it ain t just abilify folks it s all the atypicals they are all antidepressants according to the authors of a recent meta analysis for atypical antipsychotics at present this body of evidence is considerably larger than that for any other augmentation strategy in the treatment of major depressive disorder in other words if you are not prescribing atypicals for your patients who don t show adequate response to antidepressants you are not practicing evidence based medicine you are a bleeping cowboy who is willfully disregarding science you are denying your patients the best possible treatment the authors don t actually say any of those things but those are the implications if the evidence for using antipsychotics is considerably larger than the evidence for anything else then the implications are clear cut and this is exactly how this study will be cited salespeople from drug reps to academic psychiatrists to practitioners looking to earn a few thousand extra bucks on the side through pharma speaking gigs will discuss this study as if it were a landmark finding response and remission but the evidence is not all that convincing here s why the authors pooled together the results of 16 randomized controlled trials in these studies patients had failed to respond adequately using various definitions to an antidepressant patients were then assigned to receive either an atypical antipsychotic or a placebo in addition to their antidepressant outcomes were then tabulated somewhere between 4 and 12 weeks later the results seem clear cut if your brain is turned to off the response rates for atypicals was 44 compared to 30 for placebo the remission rates were 31 for atypicals and 17 for placebo the advantage for atypicals is statistically significant well there you have it done deal ask your doctor about abilify zyprexa seroquel today but the most important thing in a treatment outcome study is the outcomes the authors of the meta analysis did not bother to actually measure change in scores on rating scales instead they only used response and remission rates there is absolutely no good reason for doing this it s potentially quite misleading doctors like remission and response rates because they provide the illusion that we are measuring depression exactly a responder got a lot better and is functioning reasonably well whereas a non responder is in bed 12 hours a day while spending the rest of her time watching the e network eating bon bons and sobbing constantly but it s not nearly that scientific a responder is usually defined as someone who got 50 better on his or her depression rating score during the study period so bob s depression rating score improved by 52 he s a responder but amy s score only improved by 48 so she s a nonresponder is this 4 difference really meaningful let s look at the following dataset for 20 participants in a fictional study improvements in depression over course of 10 week study drug placebo 40 30 55 60 50 45 55 48 52 48 60 55 60 55 10 25 20 10 25 30 using a 50 improvement to determine if a patient is a responder we get a 60 response rate on drug and a 30 response rate on placebo lazy logic says oooh the drug is twice as effective as placebo but is we take the average for each group we get an average improvement of 42 7 on the drug compared to 40 6 on placebo see the problem with response and remission rates similar arguments have been made by smarter people than myself putting outcomes into convenient little categories makes good sense when the categories themselves make sense events like having a heart attack getting pregnant or dying if the death rate on a drug is 4 compared to 2 on a placebo then the drug really reduced death by 50 but if the remission rate or response rate for depression is 40 on drug compared to 20 on placebo that does not mean the drug is twice as effective as placebo in treating depression if you need to score a 7 or below on a depression rating scale to be in remission but you score an 8 are you really much worse off than the person who scored a 7 am i saying that the drugs really just squeaked by placebo in these studies well i ve read the abilify studies and posted on them previously in those studies abilify barely beat the placebo and in the opinion of the patients themselves abilify didn t beat placebo at all and the studies were designed to benefit abilify not to actually see if the drug worked as i noted previously patients were initially assigned to receive an antidepressant plus a placebo for eight weeks those who failed to respond to treatment were assigned to abilify antidepressant or placebo antidepressant those who responded during the initial 8 weeks were then eliminated from the study so we ve already established that antidepressant placebo didn t work for these people yet they were then assigned to treatment for 6 weeks with the same treatment and compared to those who were assigned antidepressant abilify so the antidepressant placebo group started at a huge disadvantage because it was already established that they did not respond well to such a treatment regimen no wonder abilify came out on top albeit by a modest margin here s an analogy a group of 100 students is assigned to be tutored by tutor a regarding math the students are all tutored for 8 weeks the 50 students whose math skills improve are sent on their merry way that leaves 50 students who did not improve under tutor a s tutelage so tutor b comes along to tutor 25 of these students while tutor a sticks with 25 of them tutor b s students do somewhat better than tutor a s students on a math test 6 weeks later is tutor b better than tutor a not really a fair comparison between tutor a and tutor b is it i ve not read the other antipsychotics for depression studies i ll even give them the benefit of the doubt and assume they were not designed in the same biased manner as the abilify trials it is however worth noting that the benefit of abilify in terms of response and remission rates compared to placebo was about the same as for the other atypicals which leads me to think that the other atypicals probably show similar marginal benefits for depression but now based solely on potentially quite misleading response and remission rates an article appears in the american journal of psychiatry a piece that has the potential to ramp up the prescribing of antipsychotics for depression to an even more ridiculous level let the good times roll source of ironclad evidence that atypical antipsychotics are antidepressants until you actually read the paper nelson j papakostas g 2009 atypical antipsychotic augmentation in major depressive disorder a meta analysis of placebo controlled randomized trials american journal of psychiatry 166 9 980 991 doi 10 1176 appi ajp 2009 09030312 posted by cl psych at 12 16 2009 12 46 00 pm 11 comments labels abilify antidepressants antipsychotic depression evidence friday october 30 2009 transcranial magnetic stimulation for depression not so effective but fda approved apparently the fda will approve just about anything as an antidepressant despite patients indicating that they don t perceive abilify to work as an antidepressant the fda approved it likely leading to tens of thousands of americans being able to enjoy a taste of akathisia while getting all the psychological benefits of a placebo good work fda the shift of antipsychotics into antidepressants has been documented in many places and is ironically very depressing 1 2 3 4 the fda s anything goes attitude regarding antidepressants apparently extends to mediocre medical devices in 2007 a paper in biological psychiatry presented results from a large trial comparing tms to sham tms the article concluded that the treatment was a fantastic option for depression well close to that anyway that actually wrote that transcranial magnetic stimulation was effective in treating major depression with minimal side effects reported it offers clinicians a novel alternative for the treatment of this disorder before all of us poor depressed souls get in line for some sweet magnetic stimulation maybe we should like look at the evidence on the primary measure of outcome the montgomery asberg depression rating scale the results weren t quite statistically significant so the sponsor tried to convince the fda neurological devices panel that the secondary measures showed super impressive results the problem they didn t the fda review panel thought a few things as can be seen in its entirety here the panel s consensus was that the efficacy was not established some stated that the device s effectiveness was small borderline marginal and of questionable clinical significance the study 01 endpoint with a p value of 0 057 per se was not considered a fatal flaw in the study analysis the panel did not believe that clinical significance was demonstrated with these results in general the panel believed that the analyses of the secondary effectiveness endpoints did not contribute significant information to help establish the effectiveness of the device the panel agreed that unblinding was greater in the active group and considering the magnitude of the effect size it may have influenced the study results 35 8 of people receiving tms reported pain at the application site compared to only 3 8 in the sham tms group this is a quick way to make a study unblind as people experiencing pain could logically surmise that they were receiving tms the panel stated that there were too many non random dropouts to reliably interpret these results the panel s consensus was that the week 6 data was of limited value and did not provide supportive data for establishing effectiveness after week 4 patients who did not show adequate improvement were given the option to quit the double blind study over half of patients departed the study after week 4 one more doozy a quote follows from a letter to the editor in biological psychiatry in which tms is taken to task the authors note that some patient outcome measures were collected in the trial but omitted from the article of the 15 secondary end points the authors included in the paper 11 were statistically significant of 11 secondary end points not included 2 were statistically significant thus the published end points were three times more likely to be statistically significant than the unpublished ones tms was denied fda approval in january 2007 but in october 2008 the fda had a change of heart approving the device i m not quite sure what changed the mind of the fda the following disclaimer on the device s website is a bit funny neurostar tms therapy has not been studied in patients who have not received prior antidepressant treatment its effectiveness has also not been established in patients who have failed to receive benefit from two or more prior antidepressant medications at minimal effective dose and duration in the current episode so it s only demonstrated weak efficacy in people who have failed one not zero not more than one antidepressant trial impressive eh to summarize the sponsor and its affiliated academics wrote a paper in a major psychiatry journal in which positive outcomes were three times as likely to be reported as negative outcomes the efficacy data were unimpressive according to an fda panel and these panels are not known for being particularly choosy about efficacy data it seemed that tms was dead in the water only to be resurrected in the form of a surprising fda approval and if being resurrected from the grave doesn t make for a great halloween post then what does offending study o reardon j solvason h janicak p sampson s isenberg k nahas z mcdonald w avery d fitzgerald p loo c 2007 efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression a multisite randomized controlled trial biological psychiatry 62 11 1208 1216 doi 10 1016 j biopsych 2007 01 018 letter to editor yu e lurie p 2009 transcranial magnetic stimulation not proven effective biological psychiatry doi 10 1016 j biopsych 2009 03 026 posted by cl psych at 10 30 2009 06 39 00 am 15 comments labels depression neuronetics transcranial magnetic stimulation older posts home subscribe to posts atom email email me blog archive 2011 1 february 1 alive but inactive 2010 8 october 1 may 1 april 1 march 3 february 1 january 1 2009 33 december 1 october 1 september 2 august 1 july 4 june 4 may 2 april 5 march 5 february 2 january 6 2008 103 december 3 november 2 october 7 september 9 august 8 july 5 june 6 may 8 april 14 march 11 february 13 january 17 2007 328 december 11 november 16 october 14 september 24 august 8 july 11 june 23 may 31 april 31 march 37 february 59 january 63 2006 219 december 59 november 69 october 48 september 43 academia bitch ph d crooked timber inside higher ed pharma general brandweeknrx edrugsearch gooznews health care renewal jim edwards nrx dr peter rost pharma blogosphere pharma giles pharmagossip pharmalot pharma marketing blog world pharma news 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