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ay december 17 2006 zyprexa coverup exposed lilly s attempt to cover up data on the risks posed by olanzapine zyprexa treatment has been exposed by an article in the new york times lilly s own published data which it told its sales representatives to play down in conversations with doctors has shown that 30 percent of patients taking zyprexa gain 22 pounds or more after a year on the drug and some patients have reported gaining 100 pounds or more but lilly was concerned that zyprexa s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes according to the documents which cover the period 1995 to 2004 snip to reassure doctors lilly also publicly said that when it followed up with patients who had taken zyprexa in a clinical trial for three years it found that weight gain appeared to plateau after about nine months but the company did not discuss a far less reassuring finding in early 1999 disclosed in the documents that blood sugar levels in the patients increased steadily for three years in 2000 and 2001 more warning signs emerged the documents show in four surveys conducted by lilly s marketing department the company found that 70 percent of psychiatrists polled had seen at least one of their patients develop high blood sugar or diabetes while taking zyprexa compared with about 20 percent for risperdal or seroquel lilly never disclosed those findings lilly also instructed its sales reps to downplay the medication s risks lilly s written response to these documents in summary there is no scientific evidence establishing that zyprexa causes diabetes it also said that the release of the documents was illegal nice defense deny it and then say that the documents are not valid because they were obtained illegally this ought to make for quite a legal spectacle another apt quote from the nyt in some ways the zyprexa documents are reminiscent of those produced in litigation over vioxx which merck stopped selling in 2004 after a clinical trial proved it caused heart problems they treat very different conditions but zyprexa and vioxx are not entirely dissimilar both were thought to be safer than older and cheaper drugs becoming bestsellers as a result but turned out to have serious side effects you really should read the full article since i have only covered some of the evidence here the only surprise is that the company documents were made public thank you james gottstein as the evidence has been mounting for some time that olanzapine was a risky drug whose small at best efficacy advantages were offset by its nasty tendency to produce diabetes hat tip furious seasons posted by cl psych at 12 17 2006 08 04 00 am 3 comments friday december 15 2006 could agomelatine be the ideal antidepressant the above title is from a journal article pandi perumal et al 2006 i ve not been able to track down the actual article yet but even asking if something could be the ideal antidepressant in a journal article title is patently ridiculous if a medication caused remission of symptoms in 100 of patients with minimal side effects it would be ideal but maybe we ve finally cured depression perhaps agomelatine really does magically cure depression let s take a look the data i found one study from which i could estimate the treatment estimate based on the abstract kennedy and emsley 2006 here s what the abstract said in part the efficacy and safety of flexible dosing with the antidepressant agomelatine 25 50 mg day was evaluated in a 6 week double blind randomized placebo controlled study involving 212 patients who met diagnostic and statistical manual of mental disorders fourth edition dsm iv criteria for major depressive disorder current major depressive episode patients receiving agomelatine 25 mg and 50 mg day had a significantly lower mean hamilton rating scale for depression ham d score at endpoint compared with those who received placebo 14 1 7 7 vs 16 5 7 4 p 0 026 based on these means and standard deviations i come up with an effect size of 31 which is considered small a small effect does not make for the ideal antidepressant duplicate publication watch read the abstracts from these two articles montgomery 2006 and kennedy and emsley 2006 i reproduced a segment from the kennedy emsley abstract above and here s a piece from montgomery s writing below in a recent placebo controlled study 212 mdd patients were randomly assigned double blind to receive placebo or agomelatine 25 and 50 mg day there was a significant advantage for agomelatine after 6 weeks according to scores on the hamilton depression rating scale ham d p 0 026 and the clinical global impression severity p 0 017 with an improved response rate p 0 03 look familiar more hype montgomery s abstract closes with agomelatine may fill the gap in the current therapeutic armamentarium by combining efficacy with a favorable tolerability profile and additional clinical benefits i have not seen the tolerability related data but i see not one shred of data to support additional clinical benefits unless he s referring to potential improvement in sleep but if we re thinking of clinical benefits in the manner of better reduction of patient symptoms there is simply no data to support that assertion the gap in the current therapeutic armamentarium is that current treatments are not much more effective than placebo as demonstrated by agomelatine and they have notable side effects when ssris and atypical antipsychotics emerged they were considered to be much safer and better tolerated treatments than their predecessors and we now know that is not the case does this new ideal drug have a better safety profile we had better wait and see before jumping on yet another bandwagon for a treatment that is overly hyped by the way i tried to find more clinical trial data on this drug from the novartis website but their clinical trial register was not functional at the time posted by cl psych at 12 15 2006 08 36 00 am 12 comments experimercials i have pointed out on many occasions that psychiatric research showing minimal to modest effects gets overhyped heavily by both drug companies and academic researchers for example see my post on injectable abilify from a couple days ago it made me think about a somewhat snarky letter to the editor by bernard carroll published in the american journal of psychiatry a couple years ago it s worth reading both his letter page 4 and the authors response page 5 go here to check it out remember folks if a trial has a huge number of participants a trivial difference between the drug and placebo will be labeled as statistically significant but don t be fooled we must also know the magnitude of the effect and as i ve noted on many occasions such as here here and here the size of the treatment effect is often fairly unimpressive i must include one quote from carroll s letter the study has all the hallmarks of an experimercial a cost is no object exercise driven by a corporate sponsor to create positive publicity for its product in a market niche this is reminiscent of the arise rd risperdal as an add on treatment for depression study that i have written much about recently here here and here in which relatively minimal treatment effects were seen yet the accompanying press release and indeed much of the discussion in the article itself is overly optimistic regarding the treatment posted by cl psych at 12 15 2006 05 20 00 am 2 comments thursday december 14 2006 more on fda conflicts of interest i mentioned yesterday that dr bruce pollock received a waiver to sit on the advisory committee although he was not given a vote even without a vote he was obviously there to share his expert opinion with other members of the committee as carl elliott mentioned in a piece two days ago in the late 1990s worries had emerged that patients might become dependent on the ssris to combat the perception that people who stopped using paxil might experience withdrawal symptoms or discontinuation symptoms as they were often called glaxosmithkline then still known as smithkline beecham hired a public relations agency called ruder finn ruder finn drafted letters that they planned to submit to scientific journals and that downplayed the idea that paxil was associated with discontinuation symptoms according to internal memos pollock was one of four psychiatrists whom they planned to invite to author the letters a letter from pollock eventually appeared in the journal of clinical psychiatry although the wording of pollock s letter was somewhat different from the draft written by ruder finn it made all the same points it even made them in the same order but there was no disclosure no mention of industry funding no mention of editorial assistance and no mention of ruder finn pollock concluded his letter by saying rather than directing our efforts towards the relatively infrequent minor and transient discontinuation symptoms associated with ssri therapy clinicians may be well advised to focus their energies on the greater issues of efficacy safety and patient outcome the bottom line concerns about discontinuation symptoms were overblown it gets even better although pollock was on the glaxosmithkline advisory board he claimed he wrote the letter to the journal of clinical psychiatry himself without seeing the marketing memo that made the same points as his letter hey it scertainly possible that pollock is being absolutely honest but one must admit that it is odd that his letter so closely follows a pr document it then gets yet more better pardon the grammar but you ll have to read elliott s piece to get the full story and people wonder why i was concerned that the fda panel would avoid making any recommendations that would make a pharmaceutical product appear in a bad light one final note if you go through the documents related to the pr firm and the letter sent to jcp then you ll also notice that charles nemeroff was apparently slated to have his name on a letter regarding this issue a pubmed search did not find any such letter so i assume that he did not participate if he was asked to stick his name on a paper he did not write and he refused then good for him of course it is possible that ruder finn never contacted him i don t know nemeroff s behavior has been called into question on numerous occasions on this site here and here for a small sample and i hope that paroxetine was a case where he got it right posted by cl psych at 12 14 2006 06 03 00 am 1 comments fda to issue stronger warning on antidepressants according to the la times a food and drug administration federal panel wednesday recommended the agency issue its strongest possible warning to alert patients and doctors that antidepressants can increase the risk of suicidal thoughts and behavior in young adults the panel called for placing the so called black box warning on product labels and in medication guides distributed to patients following the vote fda officials said they intended to expand the warning to include young adults i will need more time to think this one over but it is certainly more than i expected i thought nothing would happen i am sticking with my earlier comments that the fda review was selective in the data it included and its trust of industry to release all relevant data was likely naive at best since i have not seen data that has done more than break age down into adult versus child adolescent prior to the release of the fda data i really don t know what to make of it if the data are accurate it s certainly interesting that age has such an impact upon the drugs propensity to sometimes cause suicidality my final point for now is that the whole panic over black box warnings is overblown dr carol rabinowitz president of the american psychiatric association has been quoted on a few occasions saying that black box warnings will lead to less people receiving treatment and this will increase rates of suicide my response is that people have a right to know the risks of treatment for example suppose a patient named bill is prescribed an antidepressant within two weeks he becomes agitated and suicidal if his physician does not warn him at the time of prescription that there is a small chance that the drug will cause him to feel agitated and or suicidal then he may believe that the new feelings of suicidality are due to his depression getting worse now bill is thinking wow even with treatment my depression is getting worse this is hopeless on the other hand if bill is warned he may think ok this drug is not helping it might be making me feel worse maybe i should call my doctor and see what s happening here which line of thinking do you think is more apt to induce suicide if you ve read my site with any regularity you know what is coming next we could sidestep the issue of suicidality sexual side effects and the like entirely we could even have better long term treatment outcomes it s called psychotherapy instead of medication for depression some patients might consider trying it out posted by cl psych at 12 14 2006 05 34 00 am 0 comments wednesday december 13 2006 dumbest thing ever i try to avoid anything political on this blog except as it relates to the mental health treatment but every once in a while something so amazingly stupid comes along that it simply must be passed along among the 1 000 people who work in the u s embassy in iraq only 33 are arabic speakers and only six speak the language fluently according to the iraq study group report released on wednesday add this to the litany of reasons why things aren t going so hot in iraq reuters posted by cl psych at 12 13 2006 09 39 00 am 0 comments fda ssri panel and conflicts of interest according to merrill goozner there are conflicts of interest on the fda panel which will review the link between ssris and suicide andrew leon is one member whose links to big pharma seem significant yet fda issued him a waiver so that he can stay on the panel bruce pollock will not vote but will be on the committee and goozner documents that he also has significant conflicts of interest even the consumer advocate is reported as having significant conflicts of interest in terms of her holding stock in drug companies apparently the fda could not locate a consumer advocate without a significant conflict of interest this is well past strange for the details check out goozner s post give the highly controversial nature of the topic one would think that the fda would want the committee to appear as clean as possible the conflicts of interest do not necessarily mean that the fix is in but at the very least it makes for very bad pr posted by cl psych at 12 13 2006 09 12 00 am 0 comments agitating research aripiprazole abilify is now available in injectable form and is allegedly a great way to calm down patients quickly here s a piece from the press release touting the release of this medication abilify injection provides r...
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