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o 1 2 billion public citizen among others such as merrill goozner have criticized these figures as a major overestimate many others have been chiming in as well feel free to join the discussion in addition there has been much discussion of pfizer peter rost as i posted last week has been writing some fascinating pieces on pfizer and john mack at the pharma marketing blog is also getting his two cents in it s well worth a read here s the link to the pharma marketing blog enjoy posted by cl psych at 12 11 2006 12 00 00 pm 0 comments thank you mr dawdy for your reporting on the latest news on abilify i saw the press release for the study of aripiprazole abilify last week and thought that i should write about it but the furious seasons site beat me to the punch discussing the sponsor s rather funny interpretation of the study s results i need to track down the actual study and see what more can be said about it but my guess is that dawdy has nailed it posted by cl psych at 12 11 2006 11 45 00 am 0 comments saturday december 09 2006 uh oh chuck they out to get us man authorship again you may have thought i had nothing more to say about the arise rd study in which risperidone risperdal was used as an adjunctive add on treatment for depression but incredibly there is more information pertinent to its discussion if you are already familiar with the issues surrounding the authorship of the paper please skip ahead two paragraphs you may recall the authorship being altered from when this study was presented in abstract form presented at the american college of neuropsychopharmacology conference to when it was published in final form in neuropsychopharmacology i took exception to keller a big name in psychiatry being added to the paper as an author as he did not appear on the previous abstract as an author i hypothesized that keller was added because his big name gives the study an air of scientific credibility especially given the study s unimpressive results and clear use of statistical legerdemain adding a big name was an excellent marketing ploy by janssen to quote from my earlier piece on the authorship of this paper what did he keller do to get on the study k eller is credited with study concept and design which i would deem impossible since if he really conceived and designed the study he would have appeared as an author on the earlier abstract yet he is listed fourth on the list of people who designed the study he is also credited along with all of the authors with analysis and interpretation of the data and critical revision of the manuscript for important intellectual content is it possible that he did a great job of helping to revise the manuscript i suppose but it seems there were plenty of other people who were also involved with the writing of the paper note that keller was not credited with drafting of the manuscript so keller did not recruit participants provided no administrative support did not provide statistical expertise and did not draft the manuscript but apparently helped design the study after it was completed very impressive indeed so now to the point of this post i tracked down that this study was presented previously on two or three other occasions outside of at the acnp conference it was presented at the 2003 american psychiatric association conference possibly in two different forms though i am not sure on this point as well as at the 2004 american psychiatric association conference and the ncdeu 2003 conference see here on page 138 for the ncdeu reference and here for the 2003 and 2004 american psychiatric association references both keller and nemeroff are conspicuously absent from the 2003 and 2004 apa and ncdeu presentations yet both appear on the final manuscript as authors nemeroff appears as the lead author on the 2004 acnp abstract for the study despite not appearing at all on prior presentations keller who allegedly helped design the study only appears on the final manuscript he appears on not a single presentation of the study data to top it off a press release touted keller and nemeroff as co principal investigators on the study obviously if they were really principal investigators in any meaningful sense of the term their names would have appeared on all earlier presentations of the data before doing this additional research it seemed keller s contributions were minimal at best and now it appears that nemeroff s work can now also be called into question as he appears nowhere on earlier presentations prior to the acnp presentation at this point i would say the evidence is quite clear that the changing authorship of the paper had little to do with which authors were responsible for conducting the study running analyses and writing the paper but it sure makes for excellent marketing when big names like nemeroff and keller stick their names in the authorship line please feel free to read the entire story starting with a more detailed description of the authorship saga followed by the covered up conflicts of interest and finally the tricky use of statistics posted by cl psych at 12 09 2006 09 51 00 am 2 comments labels arise rd study risperdal sunderland admits guilt from the washington post a senior government scientist who was a focus of a congressional probe into conflicts of interest in medical research admitted in federal court yesterday that he improperly failed to disclose payments of 285 000 he received as a consultant for the pharmaceutical manufacturer pfizer inc pearson trey sunderland iii who was chief of the geriatric psychiatry branch of the national institute of mental health pleaded guilty in baltimore to a misdemeanor charge of violating conflict of interest rules the criminal prosecution of a researcher for violating conflict of interest rules is a rarity but sunderland s consulting arrangements which first surfaced in 2004 were among the most egregious of the possible conflicts detailed during the probe by a congressional subcommittee but members of congress said yesterday that they found it disturbing that even after his guilty plea sunderland remains in his federal job where he is a member of the public health service commissioned corps the question now becomes will the national institutes of health and the commissioned corps finally move to terminate dr sunderland s assignment rep bart stupak d mich asked in a statement is a criminal guilty plea enough to at long last remove dr sunderland from nih gee bart asking for accountability that seems a bit harsh a slap on the wrist should do just fine of course sunderland had to be involved in psychiatry at least he is not alone as i ve documents several other instances of ethically strange and or scientifically dubious behavior occurring in the mental health profession over the past few months posted by cl psych at 12 09 2006 08 17 00 am 0 comments friday december 08 2006 new york says no to vns i noticed someone was looking under medicare determination vns and stumbled upon my site i did a little and i mean very little sorry research on the topic i noticed that public citizen recommends wisely that vagus nerve stimulation not be covered by medicare as a depression treatment due to the meager evidence in its support i suspect that dr charles nemeroff disagrees i could not find any national medicare policy on vns but i found that the state of new york had the following to say in 2005 the fda approved this device for the adjunctive long term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments however based on review of the available scientific literature and other pertinent sources this local coverage determination lcd finds there is not sufficient evidence or support to pay for vns therapy as reasonable and necessary treatment for depression with this sort of evidence based decision making i have to say i heart new york posted by cl psych at 12 08 2006 06 22 00 pm 5 comments email problems my email is behaving strangely today so i am fairly sure i m not receiving all emails that are sent my way so if i fail to respond to something you ve sent today i d suggest that you resend it thanks posted by cl psych at 12 08 2006 01 52 00 pm 0 comments the bad psychiatrist blog i noticed that somebody recently came to my site from a google search using the terms bad psychiatrist blog that does seem apt in a few ways i d like to give a public thanks to google s magic little indexing system for sticking me at the top of the bad psychiatrist blog search you will indeed find posts about bad psychiatrist behavior you can start here or here if that s what you re looking for posted by cl psych at 12 08 2006 01 44 00 pm 0 comments sexual side effects of ssris even more troubling i just bumped into a very interesting gem of an article by dr audrey bahrick a psychologist at the university of iowa university counseling service which deals with ssri induced sexual side effects while we are all aware that sexual side effects are common with ssris the general assumption that these side effects are transient and that they vanish within a few weeks or when medication is terminated indeed that the ssris cause a decrease in males perception of sexual pleasure has led some to believe that ssris should be used to treat premature ejaculation as dr bahrick aptly points out there is no evidence that ssri side effects disappear indeed sexual side effects can be long lasting she starts out by noting depending on definitions of sexual dysfunction and methodology post market prevalence studies have found rates between 36 and 98 the 5 to 15 rates of ssri and snri induced sexual side effects listed in the current drug insert literature are based on information obtained in the initial trials via spontaneous reports of individuals who had been on the medications for a short time the differences in reported rates between the pre market trials and post market prevalence studies are an artifact of methodology we now know that when individuals are directly asked about their experience of sexual side effects via either a structured clinical interview or a self report inventory we obtain vastly different rate information than if we rely on individuals to spontaneously volunteer personally sensitive information about changes in sexual functioning it was easy to not find sexual side effects by making sure to not look for them likewise she notes that although researchers have now noted that sexual side effects occur they have avoided asking if they persist upon treatment discontinuation to top if off researchers have designed measures of sexual side effects that may miss some of the most common and impairing sexual side effects note what bahrick has to say about these effects which include erections that may be easily achieved and maintained yet are numb or nearly numb orgasms that are preceded by little sense of building arousal and are experienced as pleasureless or nearly so and genitals that respond to touch by erection or lubrication but without attendant subjective feelings of arousal aspects of normal sexual functioning seem to be mimicked without the attendant capacity to experience pleasure while ssri snri related decreased genital sensation or genital anesthesia and decreased orgasmic intensity or ejaculatory anhedonia are reported to be uncommon it is more accurate to say that they are uncommonly assessed our literature appears to be building upon the assumption that the symptoms are rare by failing to systematically include such symptoms in our instruments and by failing to transparently report them when they are included she points out that the most common measure of sexual side effects does not include an item on genital anesthesia additionally the instrument does include an item related to reduced pleasure of orgasm and its severity however the item is not separately scored but rather folded in with two other items related to frequency and timing of orgasm zajecka and colleagues examined these symptoms in a 1997 publication yet the data were apparently not reported fully according to bahrick there is only one study montejo et al 1999 that has examined the emergence of sexual side effects after cessation of ssri medication in this study patients who had experienced significant reductions in depressive symptoms in response to an ssri were switched to amineptine which impacts the dopaminergic system and noradrenergic systems to a much greater extent than it impacts serotonin or to paxil a third group received amineptine only they were not switched from an ssri amineptine only treatment resulted in 4 incidence of sexual dysfunction whereas the switched to paxil group had an 89 incidence of sexual dysfunction and the switched to amineptine group decreased from a 100 to a 55 incidence of sexual side effects mind you these treatments lasted for six months so those who switched to amineptine a drug that rarely induces sexual side effects still had a high rate of sexual side effects six months after ssri treatment discontinuation in bahrick s article an internet community known as ssrisex is described in which discussion of post ssri discontinuation sexual side effects is prominent indeed the group is reported to have coined the term post ssri sexual dysfunction pssd in addition two case reports here and here have been published in 2006 regarding pssd in sum there is emerging evidence from case reports an internet discussion group and at least one empirical study that ssri induced sexual dysfunction may last longer than previously thought and is causative of genital anesthesia ejaculatory anhedonia and decreased orgasmic intensity here s hoping that more thorough investigation of this topic will be done i have a feeling the investigation will occur at about the same time a new antidepressant emerges that does not cause sexual side effects wellbutrin has gone generic so there is no incentive for its manufacturer glaxo wellcome to demonstrate the prevalence of long term ssri side effects or of the other treatment emergent side effects mentioned above in fact i ll lay down an idea here a drug company could make a me too ripoff of bupropion wellbutrin and then conduct these very studies on the sexual side effects of ssris wellbutrin tried to market their drug in such a fashion indeed i ll not soon forget the wellbutrin commercial with the man getting on the horse while talking about a lack of sexual side effects freud must have been rolling over in his grave maybe wellbutrin s campaign did not go far enough they should have sponsored more research on the topic or maybe reboxetine can be pulled off the shelf are you listening pfizer and run through trials for fda approval though one should read the following case study regarding reboxetine due to its bizarre nature in any case if we assume that further resea...
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