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/24-7PressRelease/ - HAGERSTEN, SWEDEN, April 05, 2006 - The "ADHD medication" Strattera is not approved in Sweden. Eli Lilly decided to do a one-year clinical trial of the drug on children. The purpose of the study was to get Strattera approved by the Medical Products Agency (MPA). The company hired the psychiatric authority Bjorn Kadesjö to lead the trial.
The 100 participating children and their parents needed information about the adverse effects of the drug in order to sign the consent form. They thought they got it. They did not.
Eli Lilly deliberately withheld information about disastrous effects of Strattera - information which could have made the parents and children want to withdraw from the study; information which could have made the Regional Ethical Review Board want to disapprove the application; information which could "disturb" the result of the trial.
The "updated" information given to parents and children about adverse effects was from January 31, 2005. The only serious adverse effect mentioned was liver injury in very rare cases.
But documents now made public show that Eli Lilly knew about several serious effects from Strattera at that time.
Take the FDA report Psychiatric Adverse Events Associated with Drug Treatment of ADHD: Review of Postmarketing Safety Data, released for the FDA Pediatric Advisory Committee meeting, March 22. It says that Eli Lilly (and other pharmaceutical companies) were asked to provide information about a) signs and/or symptoms of psychosis or mania; b) suicidal ideation and behavior; c) aggression and violent behavior, (for Strattera for the period November 2002 - June 2005). In that period Lilly had received 350 reports of psychosis or mania, 900 reports of aggression and violent behavior and 400 reports of suicidality. In a Preliminary Assessment Report from December 2005, written by the British medical regulatory agency MHRA, it is mentioned that Lilly from November 2002 to September 2005 had received 766 reports of heart disorders connected to the use of Strattera. (It should be noted that credible estimates of the percent of adverse reactions that are reported range from 1-10%.)
It is certainly not so that Eli Lilly had received these reports in the period February - June 2005. Almost all of reports had been received in the foregoing 26-month period and only a minor part in the 5 month up to June 2005.
This means that Eli Lilly deliberately withheld Strattera's disastrous effects of psychosis and mania, aggression and violent behavior, suicidality and heart disorder, in the information to parents and children in the clinical trial.
writer from Sweden - investigating psychiatry
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