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does it not make one wonder the extent to which psychiatric drug research is based on sloppy and or fraudulent data i m not throwing out a number here i really have no idea perhaps these are rare occurrences but given that fda oversight of research is close to nonexistent much of what happens in research is essentially done on the honor system unfortunately it appears that there is enough dishonor in the current honor system to strongly suggest that we need a lot more oversight posted by cl psych at 11 19 2007 04 55 00 am 2 comments labels misconduct thursday november 15 2007 upcoming features two upcoming stories will both titillate and enrage 1 how a certain company hid risks of a medication and i have the documentation to prove it of course independent academics make a special appearance 2 a researcher with an impressive record it is unlikely that any researcher has given sexually transmitted diseases to more patients than this person holding patients captive yes running clinical trial sites that provide strange data yes and more all coming hopefully soon from your humble correspondent readers please continue to send tips in the meantime several blogs have been absolutely ablaze lately including the following do yourself a favor and check them out scientific misconduct blog health care renewal furious seasons posted by cl psych at 11 15 2007 04 34 00 pm 0 comments absolutely smashing indictment of big pharma okay we all know by now that pharma giles is the premier site for cutting parody on the pharma industry bar none on occasion he steps away from vicious satire and issues a dead on incisive rant one such rant was recently posted and i think everyone should read it teaser follows drugs like vioxx oxycontin and possibly avandia have all recently been launched onto an unsuspecting public in the quest for billion dollar profits and have gone on to harm tens of thousands even though there is evidence to suggest that the companies behind them had a pretty good inkling of the potentially lethal hazards and side effects from data they chose to selectively ignore during trials people have needlessly suffered or died at best because of complacency and at worst because of corporate greed and as a result public trust in the pharmaceutical industry has never been lower and because of public mistrust the regulatory environment has become so tight that it is now much harder to launch new medicines of any sort a situation which is a constant cause of whining by the pharma ceos who are ironically ultimately responsible for creating the hostile regulatory climate in the first place pharma industry wonks talk about the risk benefit of new drugs and yet it seems that these days it s the public who take the risks and the ceos and shareholders who get the most benefit executives hide behind the line that they cannot be aware of every little thing that goes on their companies and therefore cannot be responsible for any illegal actions of their underlings sorry guys but just what do you get paid six seven or even eight figure compensation packages for by and large it certainly isn t for your personalities or good looks is it howard udell is certainly now trying to suggest that well sure he pleaded guilty but only because he was the boss and not because he was actually personally responsible for any wrong doing sorry pal that may well be true but i think the buck stops with you if you or your fellow execs weren t aware of any wrong doing then you damn well should have been mr udell is still employed in his capacity as chief counsel for purdue ms skolek points out to me slam dunk i d also add the atypical antipsychotics into the mix as well take a look at recent data regarding their performance in dementia for example 1 2 shockingly poor and who is accountable when these medications are marketed to bury risks and make false statements regarding a drug s efficacy apparently nobody sure a fine may be levied but that s just a drop in the bucket you don t think accountants and lawyers are busy figuring out as i type how much money can be lost in lawsuits versus how much can be made from b s marketing campaigns that overstate benefits and hide risks it s all a risk benefit calculation how much financial risk do we take by hiding data versus how much can we benefit from aggressively marketing the product posted by cl psych at 11 15 2007 04 23 00 pm 5 comments labels pharmagiles monday november 12 2007 latest abilify for alzheimer s study is a complete joke here s why a trial has recently appeared in the american journal of geriatric psychiatry this study claims that aripiprazole abilify is safe and effective in treating alzheimer s patients who presented signs of psychosis as i will demonstrate anyone with an ounce of common sense and certainly anyone who passed a basic statistics course can see these claims especially the claims regarding efficacy are bordering on hilarious efficacy here s what the authors said apripiprazole 10 mg day was efficacious and safe for psychosis associated with ad significantly improving psychotic symptoms agitation and clinical global impression quickie stats lesson in determining if there is a statistically significant difference between two groups a large factor is the size of the sample just because a difference is statistically significant does not imply that the difference actually means anything of value with a large sample size as was seen in the present study very small effects can become statistically significant next let s discuss the size of these treatment effects how helpful was abilify mean change on the neuopsychiatric inventory nursing home version was 17 6 points for the 10 mg day abilify group and 13 0 points for the placebo group with the knowledge of the mean change and the standard deviations from both groups one can easily calculate the effect size which indicates the magnitude of the treatment effect i e did people get a little better or a lot better the effect size using cohen s d was 14 the general guideline is that d 20 is a small effect so less than small i guess you could call it miniscule how about other measures used in the study here are a few neuropsychiatric inventory nursing home version psychosis subscale effect size 19 clinical global impressions severity effect size 12 clinical global impressions improvement effect size 10 brief psychiatric rating scale effect size 15 cohen mansfield agitation inventory effect size 17 no matter how you slice it the effects were all very small let s also do a common sense test the clinical global impressions improvement scale asks one question the wording may vary slightly across studies but one example is rate total improvement whether or not in your judgment it is due entirely to drug treatment compared to his her condition at admission to the project how much has he she changed in the current abilify study the average advantage for people taking abilify 10 mg day versus placebo was 0 3 points there are seven points on the rating scale for example at one point on the rating scale is minimally improved and the next point is moderately improved so the average patient on abilify was 0 3 points closer to moderately improved compared to minimally improved relative to someone on a placebo can you say ooooh big deal anyone who has taken a basic course in statistics should be either laughing or crying your choice at this point what makes this particularly egregious is that the first two authors are academic researchers who absolutely must have received this lesson dozens of times during their research training so there is no pleading ignorance on their part statistical significance okay maybe this is a smaller point but when i plug their numbers means sd n into a t test i find that some of the differences they labeled as statistically significant are no longer statistically significant yes they used a different statistic which was apparently useful to them but i thought i d at least mention that if someone chose to use a different analysis the data may have turned out as not statistically significant in any case the benefits of abilify as shown in this study are minimal at best safety okay so abilify does not work very well but at least it won t kill you right 18 people died across the course of the study including 3 of the placebo group and 7 of the abilify 10 mg day group cerebrovascular adverse events were reported for four patients in the 10 mg abilify group and zero people in the placebo group as has become nearly an essential disclaimer in studies these days the authors write eighteen deaths occurred during the study none of which were considered to be related to study medication my emphasis of course not the study is funded by a bristol myers squibb and the company and its independent academic investigators determine if the drug could have caused any deaths the fox is policing the henhouse discussion the best part of any article is the discussion because it is a marketing exhibit the results of this placebo controlled fixed dose study indicate that aripiprazole impacts beneficially on psychotic symptoms in institutionalized patients suffering from psychosis associated with ad this is the first such study to report improvement in both primary and secondary outcome measures in this patient population aripiprazole also produced significant improvement in other aspects of psychological and behavioral symptoms as evident from changes in secondary outcome scores thus the results indicate that the use of aripiprazole cannot only alleviate the specific symptoms of psychosis but can also reduce the overall psychological and behavioral burden of ad interestingly the 5 and 10 mg day doses of aripiprazole show robust efficacy to improve the cmai scores from baseline to endpoint reinforcing the evidence that atypical antipsychotics are efficacious in the treatment of agitation apparently robust efficacy means having a miniscule impact relative to placebo again see above commentary about the extremely small extent to which abilify impacts beneficially upon participants in this study to the authors credit they mention that elderly patients with dementia related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo right kind of like what happened in this study at least for the patients who took 10 mg of abilify i realize it may have been a chance occurrence that the abilify 10 mg patients died at a higher rate but when you combine minimal treatment benefit with doubling the risk of death why the hell would anyone choose to prescribe abilify based on results from this study believe it or not there are a couple of other points about the study that i could prattle on about but i think the point has been made journal policies if you wander over to the american journal of geriatric psychiatry s instructions for authors you can see the following provide measures of effect size liberally give cautions when statistical significance has doubtful clinical or practical significance what i have done in this post is provide the measures of effect size since the authors did not provide a single measure of effect size not a single one but wait if this paper clearly violates one of the main principles listed under statistic guidelines for the instructions to authors how did it get published good question and that takes me right back to my earlier posts on peer review and how the experts who review papers sometimes do so in a slipshod lazy biased and or incompetent fashion 1 2 3 4 and the editor did he even skim this manuscript to see if it conformed to the guidelines of the journal so a paper that flouts the journal s own policies is published a paper in which statements regarding a product s efficacy are far overblown perhaps drug reps will be disseminating this wonderful piece of science nationwide or even internationally to help get patients onto abilify because now their marketing is based on science will physicians see through this sort of ruse and laugh the reps out of the office or will they briefly scan the abstract conclude the drug is effective and then whip out their prescription pads you tell me last but not least i present a golden goblet award to the academic authors of the study as well as to the coauthors at bristol myers squibb your ability to present teeny treatment effects as robust and get away with it is notable great work you deserve a good cut of however many are added to bms s coffers from unneeded prescriptions of abilify for dementia posted by cl psych at 11 12 2007 09 04 00 am 10 comments labels abilify dementia off label marketing stealth marketing friday november 09 2007 ari pimp razole science and marketing collide wow i ve recently seen a study on aripiprazole abilify that boggled my mind it was in the category of godawful i ll be writing more about it likely within the next few days stay tuned it goes to show that bristol myers squibb will stop at nothing to market their product but i suppose their recent large settlement for naughty marketing of abilify already indicated they had no qualms in how they pimped their product the atypical antipsychotics keep taking a beating on this site 1 2 lots of hype for these medications treating um everything yet little supporting data posted by cl psych at 11 09 2007 02 47 00 pm 2 comments labels abilify thursday november 08 2007 nimh gets dunce journalism award i have pilloried the study published in the american journal of psychiatry in september 2007 that purported to show that fewer ssri prescriptions for kids in the usa was associated with an increase in the youth suicide rate for american youth i quote from my earlier post below look closely at the above graphs click to enlarge from the article note that the decrease in ssri prescriptions from 2003 to 2004 was very slight across the 0 10 11 14 and 15 19 age groups which is the timeframe in which suicide rates for those aged 5 19 increased notably the larger declines in ssri prescribing for youth occurred from 2004 2005 which happens to be when the suicide rate for those aged 15 24 appears to have decreased from 10 3 per 100 000 see table 9 page 28 here to 9 8 per 100 000 see table 7 here yes i know i am comparing data for ages 15 24 to data on ages 5 19 but i think this makes sense when one considers that the suicide rate for those 14 and under is much lower than for those aged 15 24 actually grouping suicide data for ages 5 19 makes little sense to me given the vast differences in suicide rate within this age group it is important to note that the authors of the paper did not have data from 2005 but there is nothing from the 2003 2004 u s ssri prescription data cited in their paper that even suggests a relationship between decreased ssri use in youth and an increased suicide rate as the decrease in prescriptions was minimal pay close attention the authors ran a total of zero statistical ana...
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