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on is that this story has a lot of traction posted by cl psych at 12 29 2006 08 07 00 pm 0 comments wednesday december 20 2006 taking a break i have several other pressing matters to which i must attend for the next little while i will likely not be posting until the end of december or perhaps early january however i will likely be doing some writing on at least some of the following topics in the interim so that i am ready to hit the ground running upon my return texas medication algorithm project ssris and suicide troubles associated with having children when older reply to herb on vns corcept and mifepristone posted by cl psych at 12 20 2006 02 04 00 pm 3 comments more on fda and ssri suicide link look at the above table on the left are data from the fda showing an increased risk of suicide on active treatment on the right are the current data that the fda upon which the recent fda panel made its recommendations about the risks of ssri treatment david healy presented the above slide in his testimony to the fda about a week ago below i present some excerpts from his speech made that same day this study presented by fda over 3 years ago shows a clearly increased rate of suicides on active treatment there were more patients suicides and trials in this study than in the material fda have presented to this meeting and this study included withdrawal suicides fda got their 2003 problem to vanish by controlling for age sex and the location of the trial giving the results you see on the right but if age and sex were substantially imbalanced in these trials then the studies must have been invalid regarding study location this year fda cited lower rates of suicide in us placebo controlled trials but didn t explain the finding are you aware us investigators have been jailed for entering fake patients into trials bogus patients get better on treatment but there is one thing a bogus patient does not do he does not commit suicide does this explain fda s findings or is the real answer even darker at the 2004 pdac meeting fda did not have all the pediatric trials i bet they don t have all the adult studies i ve seen we know for certain that all of the 2003 material is not included today do you know why not i know fda do have the placebo suicide who was taking an antipsychotic antidepressant and 2 benzodiazepines but don t know what they ve done with him do you healy apparently concluded his remarks with this so truth of fiction well the fda document and presentation are exceedingly strange and this might following mark twain suggest truth but there is too much blatant manipulation of the data for that we are left with fiction perhaps the strangeness derives from the fact that we are missing a key element of a good fiction namely the final line as to who is doing what to whom for more on the magically changing fda data on ssris and suicide see my earlier post always keep in mind that sponsors were responsible for providing the data and the sponsors have a history of manipulating the placebo suicide data to make placebo appear more risky not that one can entirely blame the sponsors as fda has been fully compliant with this manipulation of data to see how rose colored glasses have been worn when interpreting the ssri suicide data see another earlier post which also discusses some of healy s work there s more to be said about the fda s handling of this data thanks to an anonymous reader for providing me with the chart and speech excerpts posted by cl psych at 12 20 2006 01 56 00 pm 1 comments tmap part 2 i ll be quoting a few pieces from the actual legal document stating claims against johnson johnson in the tmap case the lawsuit alleges that j j i ll just generically refer to the defendants as j j aka johnson johnson throughout this post unduly influenced at least one mental health program decision maker to become a chief proponent of risperdal s inclusion in the tmap protocol and to help secure tmap s adoption and implementation additionally after tmap s initial adoption by texas mental health program decision makers an implementation project was developed to facilitate the expansion of tmap throughout texas the defendants continued their financial support of and improper influence in the tmap project through this implementation plan also know sic as the texas medication of medication algorithms or tima as a result of the continuing improper relationship between defendants and at least one texas mental health program decision maker defendant s product risperdal received a preferential recommendation as a medication of choice for children on the tcmap algorithms used to treat children and adolescents defendants product did not have an fda indication for use in children and adolescents when it was placed on the tcmap algorithms one more defendants bypassed governmental safeguards and scientific review by promoting tmap and the related child and adolescent algorithms tcmap as treatment models developed by panels of experts defendants relied upon paid consultants on their expert consensus panels peer to peer or viral marketing strategies and administrative decisions made by a select few public officials to facilitate the adoption of tmap like programs in other states to date at least seventeen states including texas have implemented tmap or are in the process of doing so in effect tmap became the standard bearer for defendants risperdal marketing plan here s the lowdown tmap is allegedly based on expert consensus but the lawsuit is essentially saying that these experts were in some cases acting as paid j j shills these folks were wined dined and received payments from j j while putting the tmap related materials together how many of the experts and government officials were in on this that will hopefully come out during the legal proceedings as lilly learned earlier this week release of company documents often makes for some pretty bad pr i am by no means stating that more than a few of these experts or governmental officials were on the take if the correct wheels are greased one needs not bother to bribe everyone you can bet there will be more on this posted by cl psych at 12 20 2006 01 03 00 pm 2 comments tmap part 1 janssen owned by johnson johnson and a few other companies are being sued for defrauding the texas public mental health system how could a company do a thing like that well let s start with a quote from a texas newspaper jones lawsuit alleges that the companies launched a drug named risperdal in 1994 to treat schizophrenia about the same time the state was developing a protocol or treatment guidelines for which drugs should be used in public mental health programs this is the texas medication algorithm project the defendants provided substantial financial contributions to and improperly influenced the development of the protocols the lawsuit said and risperdal took precedence in the protocols over cheaper equally effective medicines the drug later received recommendations as the medicine of choice in the state s mental health protocol for treating children and adolescents even though it lacked a food and drug administration indication for those age groups the lawsuit says it says side effects and health risks include increased chance of stroke renal failure and hyperglycemia the companies pushed risperdal in other states through paid consultants on expert panels peer to peer marketing strategies and administrative decisions made by a select few public officials the lawsuit says the companies sent an unnamed texas official around the country as a spokesman for the drug and they hired third party contractors to conceal their control and funding of medical education programs speakers bureaus and clinical research that promoted the benefits and safety of risperdal the lawsuit says the lawsuit says at least 17 states including texas have implemented the protocol or are doing so snip a commission spokesman did say texas paid 308 000 claims totaling 73 5 million for risperdal in 2005 that hopefully piqued your interest essentially texas and several other states developed guidelines which laid out a prescribing algorithm for patients in public mental health programs the catch is that the recommended first line medications are nearly all in the newest most expensive classes take a look for yourself at the tmap algorithms while this is allegedly based on research there was no research conducted at least not to my knowledge that directly tested the recommended line of medications i e ssris before tricyclics for depression or atypical antipsychotics before conventional antipsychotics for schizophrenia in any systematic manner we are certain that tmap recommends expensive meds but are they the most effective hmmm the plot thickens in pennsylvania a state official steven fiorello who was on a committee that helped decide which meds would get used for mental health treatment in state hospitals was charged criminally why because he had received honoraria and other income from drug companies and failed to disclose these conflicts of interest my earlier post bribery pays tells a little more about his story why is this relevant because the program in pennsylvania was similar to tmap it was an algorithm based program that allegedly placed a higher priority on newer more expensive meds for people receiving state mental health care so what about tmap and money oh right the lawsuit that s coming in my next post posted by cl psych at 12 20 2006 12 58 00 pm 0 comments tuesday december 19 2006 a vns debate a reader sent in a comment earlier taking exception to my comments about vagus nerve stimulation therapy i have responded and am opening this one up to anyone else with an opinion i m reposting his comment followed by mine note that any highlighting is added by myself i happened upon your blog and i d like to take a moment to share my perspective as it relates to several of your postings relating to the vns therapy for trd unlike you i do not hold any academic degrees in psychology or psychiatry but i do have hands on experiences research and knowledge of 43 years as a support person to my spouse and as a mental health advocate and activist amongst the many hats i ve worn through the years i m a retired business executive and entrepreneur as well as a former dbsa depression bipolar support alliance facilitator president and board member of a local chapter and a state appointment as a guardian advocate while you may be an academic with a respectable amount of clinical experience and no drug industry funding you don t indicate if you re an m d or phd nor do you elaborate on what a respectable amount of clinical experience represents or the fact that you receive no drug funding is the fact you receive no drug funding a shortcoming and or reflection upon your lack of expertise or abilities there s something to making innuendos when reading from a couple of lines of text without really researching and digging deep as i ve found from some of your commentary the fact that researchers and other medical professionals receive funding from sponsors is not an indictment of their research ethics integrity or honesty or in the case of dr nemeroff an admission of guilt that his research is incorrect or that his peers think any the less of the man s work it certainly is an impropriety and rightfully cited but is not necessarily a cause for indictment as to the information nor do you explain to your readership the nature of funding for research and without sponsor funding most research would be non existent i shall also add to the other hats that i ve worn i am also intimately involved in researching the vns therapy for trd simply because my spouse was one of the earliest research study subjects for this treatment option unlike you reading the public citizen and the comments of drs lurie and wolfe both of whom are not trained in the field of psychology or psychiatry and both questioning the safety and efficacy when in fact the therapy has safely been used for over 10 years and longer term study results 2 years are establishing long term remissions and efficacy for trd when compared to the failures of other treatment options for this extremely difficult to treat and disenfranchised group of patients i also wrote to dr lurie regarding his assertions of a placebo effect i asked him to please cite for me any medical literature relating to a placebo effect lasting 3 or more years which many of these patients are experiencing contrary to public citizen s letter s i still have not received a response from him maybe you d care to respond as you seem impressed with their writings obviously you ve not read nor have you commented upon the 300 or more medical professionals and leading researchers who also take exception to many of your comments some of whom have correctly divulged their relationships to the sponsor then too so has the membership about 36 000 of the apa having no relationship to the sponsor responded contradicting your position which you ve omitted from your commentaries to your readership the facts are the d 02 double blind study was an acknowledged blunder from the standpoint of the protocol being based upon the protocols of drug studies but then again i m sure you had an understanding of that fact this is a medical device and not a drug and the requirements are different you also omitted in your commentaries that the independent device panel of experts favorably approved the therapy too while you seem to arrive at the conclusion that the study was a failure it appears many of your colleagues do not see it as such but as i ve previously stated you haven t read their commentaries as it is not apart of the news media s sensationalistic forms of reporting that you appear to be reading without getting to the nitty gritty of the story i happen to have a website which i utilize as a repository of information that i ve garnered through the years and a means to share my unbiased thoughts and information relating to the therapy it is called vnsdepression com the link to the site is http www vnsdepression com more importantly from a real life and real time standpoint after 37 years of failed psychotherapy medications holistic approaches and other alternative as well as adjunctive therapies my spouse has achieved almost 6 years of continuous remission with little or no medications then too so are many others who have had similar experiences to my spouse while the therapy is not a panacea it does afford a new an innovative approach to a percentage of the most difficult patients to treat with varying degrees of efficacy not obtainable elsewhere and therefore the need for this therapy and the continued research into other new an innovative approaches to treat this unique population of patients i ll add that my spouse s psychiatrist maintained an attitude similar to yours as it pertained to the initial data but he was willing to listen and be educated of his clinic...
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