Sunday, July 10, 2011

Discontinuation of Quetiapine (SEROQUEL) From an NIMH-Funded Trial Due to Serious Adverse Events

 Do the benefits outweigh the risk? The Grim Sleeper above wants you to believe they do!

I happened to come across this study of quetiapine (seroquel) copy & pasted below. This information should be sounding off alarm bells and raising grave concerns over a drug that has been continually approved for ever expanding indications by the FDA. It should be stated that we (the citizens of America) have stood idol & watched as a drug assault upon America has transpired based on at best questionable clinical trial study data that in many cases is not only skewed; but controlled, manipulated, & directly funded by AstraZeneca.

  This all has the evidenced appearance to be nothing short of a colossal marketing campaign masked as legitimate scientific data/endeavors. Please check out what AstraZeneca has in the pipeline for Seroquel as that patent clock continues to tick down -->U.S.National Institutes of Health:Clinical trials:quetiapine (Seroquel); and then take a moment to ask yourself how a dangerous and powerful anti-psychotic drug has become one of the most prescribed and profitable drugs in America (worth multiple billions of dollars in sales and profit each year) ? 

It is definitely not because we have had an explosive epidemic of psychosis or that some unknown pathogen is causing a massive schizophrenia outbreak. 

It is no mistake many tens of thousands of users have been stricken with serious and debilitating preventable conditions from ingesting Seroquel. No expense has been spared by AstraZeneca in the marketing of this drug at every level possible; from the Representative offices of Washington DC, to your main street doctors office & and virtually every place in-between.  

As you read this study below conducted by the National Institute of Mental Health, you should ask yourself how this same government could be approving the use of this drug in younger & younger children & in many more less serious health conditions (yes, they are even now trialing this drug on toddlers and it's being used regularly off label in children as young as 2 years old).  

You may come to the conclusion from reading this article, other posting on this blog, or by doing your own research, that this madness must stop! If you are that person; I can only say that it will not stop until you stand up and make it stop. Please make your voice heard!


Discontinuation of Quetiapine From an NIMH-Funded Trial Due to Serious Adverse Events

La Jolla, Calif., HELENA KRAEMER, Ph.D.
Stanford, Calif., and STEPHAN ARNDT, Ph.D.
Iowa City, Iowa

To the Editor: We have been conducting a 5-year study, funded by the National Institute of Mental Health, to compare four commonly used atypical antipsychotics (aripiprazole, olanzapine, quetiapine, and risperidone) in middle-aged and older patients with psychotic symptoms for whom a treating clinician has recommended an atypical antipsychotic. In this Institutional Review Board-approved protocol, we use equipoise-stratified randomization which allows the patients and their physicians to exclude up to two of these antipsychotic agents that are not acceptable to them. The treating physician chooses the dosage and duration of treatment. The detailed study design is described elsewhere (2). We report the results of an unplanned interim analysis recommended by our Data and Safety Monitoring Board, which led to the discontinuation of quetiapine from the study. It includes the first 294 of the proposed 450 subjects to be enrolled. Sixty-one subjects dropped out prior to data collection and were excluded from analysis. Diagnoses for the remaining 233 patients were as follows: schizophrenia (32%); bipolar disorder (11%); and psychosis associated with dementia (24%), with depression (11%), with posttraumatic stress disorder (16%), or not otherwise specified (6%).
There were 79 Food and Drug Administration-defined serious adverse events (3) that occurred in 57 of the 233 study subjects while they were taking their randomly assigned drugs (Table 1). Among the patients taking quetiapine, 38.5% had serious adverse events relative to 19.0% in other groups ({chi}2=9.56, df=1, p=0.002), providing a relative risk of 2.0 (confidence interval=1.3–3.1). All pairwise differences involving quetiapine were significant. Using Mantel-Haenszel tests to account for the equipoise-stratified randomization and pooling the other drug groups, the quetiapine group exhibited higher rates of serious adverse events ({chi}2=5.63, df=1, p=0.022). (Pairwise differences using Mantel-Haenszel analysis did not reach significance.) Of the serious adverse events with quetiapine, 29.7% (11/37) were rated as "probably" or "possibly" related to the medication. For other drugs, 21.1% (9/42) of the serious adverse events were rated as "probably" or "possibly" related to the medication. Of the individual types of medical serious adverse events, rates of pneumonia were higher with quetiapine than with other drugs combined (p=0.011, Fisher’s exact).

View this table:[in this window]
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A multivariate logistic regression analysis for all serious adverse events was performed, 

covarying for age, prior antipsychotic treatment, and medical burden. 
The overall difference in the proportion of serious adverse events among the four drug groups 
remained similar in all analyses. 
Likewise, differences in length of treatment did not seem to be responsible for differential rates 
of serious adverse events, since there was no significant difference between quetiapine and other 
drugs regarding the duration the subjects continued to take their randomly assigned medication.

Dr. Jeste reports that AstraZeneca, Bristol-Myers Squibb, Eli Lilly, and Janssen donated quetiapine, aripiprazole, olanzapine, and risperidone, respectively, for this NIMH-funded study.
Drs. Jin, Golshan, Mudaliar, Kraemer, and Arndt and Ms. Glorioso and Mr. Fellows report no competing interests.
Supported in part by grants from NIMH (R01 MH64722, T32 MH019934, and P30 MH080002) and the Department of Veterans Affairs.

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