Strattera - From Failed Antidepressant to New Drug for ADHD
An investigative journalist has been chasing up some rather worrying matters about Strattera, which proved to be a 'failed' antidepressant and so was repackaged as a new drug for ADHD to recover profits at the risks of children.
http://www.24-7pressrelease.com/view_press_release.php?rID=12752
"Eli Lilly withheld disastrous effects of Strattera from parents and children
The wording of the parent and children information in an ongoing clinical trial of Strattera has been revealed. Eli Lilly withheld the drug's disastrous effects in order to get children to participate in the study.
/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. "
http://www.24-7pressrelease.com/view_press_release.php?rID=11901
MHRA forbids Sweden to reveal Strattera suicide data
The British Medicines and Healthcare products Regulatory Agency (MHRA) has forbidden Swedish authorities to reveal Strattera suicide data. A release in Sweden of data about suicides and suicide attempts from Eli Lilly's Strattera is said to hurt the relations between the two countries.
/24-7PressRelease/ - SWEDEN - March 10, 2006 - Data about the harmful effects from the ADHD drug Strattera were revealed in a document from 9 December 2005, written by the British MHRA and sent to the Swedish MPA (Medical Products Agency). The information was gotten as a result of FOIA-requests, and released by court order.
The document told about 130 reports of suicidality in one month from treatment with Strattera. It told about 766 spontaneous reports of cardiac disorders and 172 of liver injury, and about 20 completed suicides. The 130 cases of suicidal and self-injurious behaviour were reported September 23 - October 25, 2005.
The main part of the information was classified and not released. So was, for example, the full assessment of all data about suicidality withheld from the public. That review - on which MHRA based their conclusions - was made by the manufacturer, Eli Lilly, and was named Annex 4 to the report. It would of course be of tremendous value for independent researchers to read how Lilly has treated the statistical data, but this has not been possible.
And now MHRA has forbidden Sweden to release Lilly's review. In a decision made by the Swedish MPA, as a result of a new FOIA-request, it is written that contact has been taken with the British authority MHRA and that the release of Lilly's suicide review would hurt the relations between the two countries! Thus the review cannot be released.
The MHRA, as well as FDA and other national medical agencies are supposed to be "watchdogs", supposed to protect the public from harmful effects of dangerous drugs. That the MHRA now gives directive to other countries to hide the information about Strattera suicide data is a big medical scandal.
All information about the harmful effects of this psychiatric drug should now be made public by the medical authorities and an impartial evaluation of the data should be done. Psychiatrist should no longer be allowed to prescribe poisonous drugs to normal children; children who do not have any objective abnormality but whose behaviour are deemed inappropriate."
http://www.24-7pressrelease.com/view_press_release.php?rID=16662
Strattera - 10,988 adverse "psychiatric reactions" reported in less than three years
In less than three years 10,988 adverse "psychiatric reactions" have been reported to Eli Lilly for the ADHD drug Strattera. This is revealed in a document treated as a "state secret" by the British and Swedish medical agencies.
/24-7PressRelease/ - HAGERSTEN, SWEDEN, August 01, 2006 - The document, Psychiatric Adverse Events including Cumulative review of spontaneous reports of suicidal and self-injurious behaviour, is an attachment to an unpublished report about Strattera from the British Medicines and Healthcare products Regulatory Agency (MHRA), January 2006.
The attachment, mentioning the 10,988 "psychiatric reactions", also gives a good insight into how psychiatric drugs and drug cocktails are killing children and adults, and how psychiatric diagnoses are used to hide the harmful effects of drugs.
A court in Sweden has recently ordered the document to be made public.
This was done after the Swedish Medical Products Agency (MPA) and the British MHRA in their response to FOIA [FREEDOM OF INFORMATION ACT] requests had treated this document as if it was a "state secret".
In its arguments to the court the Swedish MPA even said that issuance of it would hurt the relations between Sweden and UK. Neither the British National Institute for Health and Clinical Excellence (NICE), responsible for "guidance on the appropriate treatment", being in possession of the document, was willing to reveal the data in it. NICE said in an answer to a FOIA-request that the document was "received in confidence and disclosure of that information would amount to an actionable breach of confidence".
These agencies, responsible for protecting the public from harmful drugs and for "appropriate treatment", consider a document reviewing the "suicidal and self-injurious behaviour" caused by a psychiatric drug in the category of state secrets, and that it would be "an actionable breach of confidence" to let the public know about these data.
But a court in Sweden has made the document public. The document consists mainly of Eli Lilly's review of the 431 cases of suicidal and self-injurious behaviour reported for Strattera from November 2002 up to October 2005. 130 of these reports were submitted in one month (October 2005), after the warnings were issued in September that Strattera increased the risk for suicidality.
Lilly's review is an excellent example of how to explain away suicides, suicide attempts and suicide ideation caused by psychiatric drugs - and of how the assessing medical agency then buys these explanations.
It can be seen in the review that children and adolescents in many cases are getting psychiatric drug cocktails - Strattera together with antidepressant SSRI drugs (as Zoloft and Prozac) and antipsychotic drugs (as Risperidone and Zyprexa). The reason for the adding of more drugs to the first one, is that one psychiatric drug's harmful effect - according to the psychiatric ideology - is seen as yet another "psychiatric disorder", to be treated with yet another mind altering (poisonous) drug. And so on.
The alleged psychiatric brain disorder ADHD (without any objective abnormality) is NOT associated with suicidal thoughts in its list of "symptoms". However as the reports of suicidal behaviour from "treatment" with Strattera kept coming in, Eli Lilly had to connect depression and suicidal behaviour with ADHD, to exonerate the drug and blame it on the children's "underlying condition". For this purpose Eli Lilly claimed in its submission to the FDA in September 2005: "Depression is present in up to 40% ...of ADHD adolescents and children."
It is very convenient for drug companies that psychiatrists are adding more poisonous drugs to the first one when its harmful effects are showing up. No single drug can then be blamed for the death of children.
It is even more convenient to blame the harmful effects of a drug on a (presumed) "underlying condition". This is what Eli Lilly and the psychiatric experts at the MHRA are doing when they in cases of suicidal behaviour in connection with Strattera find "confounding factors" present. No matter how obvious the case of poisoning the conclusions from the medical agency become (at best): "the possibility that atomoxetine [Strattera] may have exacerbated the individuals underlying condition in these cases cannot be excluded."
In its report about Strattera (January 2006) the MHRA talks about "the large number of psychiatric reactions". It says the agency in September 2005, due to this large number of harmful effects, had requested Eli Lilly "to perform a cumulative review of all psychiatric disorders reported for atomoxetine [Strattera]".
In the attachment, containing the review by Eli Lilly of suicidal behaviour, no review of "the large number of psychiatric reactions" can be found. What can be found is the number of reported reactions (up to September 2005): 10,988 adverse "psychiatric reactions" described in 6,751 reports. Example of reactions: The two categories aggression and anger are reported in 1117 cases, abnormal behaviour in 989 cases, and homicidal ideation in 19 cases.
The MHRA has still not let the public know any details about this "large number of psychiatric reactions". Neither has the agency let the public know the updated figures for suicidal behaviour in connection with Strattera.
Janne Larsson
writer from Sweden - investigating psychiatry
http://www.24-7pressrelease.com/view_press_release.php?rID=12752
"Eli Lilly withheld disastrous effects of Strattera from parents and children
The wording of the parent and children information in an ongoing clinical trial of Strattera has been revealed. Eli Lilly withheld the drug's disastrous effects in order to get children to participate in the study.
/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. "
http://www.24-7pressrelease.com/view_press_release.php?rID=11901
MHRA forbids Sweden to reveal Strattera suicide data
The British Medicines and Healthcare products Regulatory Agency (MHRA) has forbidden Swedish authorities to reveal Strattera suicide data. A release in Sweden of data about suicides and suicide attempts from Eli Lilly's Strattera is said to hurt the relations between the two countries.
/24-7PressRelease/ - SWEDEN - March 10, 2006 - Data about the harmful effects from the ADHD drug Strattera were revealed in a document from 9 December 2005, written by the British MHRA and sent to the Swedish MPA (Medical Products Agency). The information was gotten as a result of FOIA-requests, and released by court order.
The document told about 130 reports of suicidality in one month from treatment with Strattera. It told about 766 spontaneous reports of cardiac disorders and 172 of liver injury, and about 20 completed suicides. The 130 cases of suicidal and self-injurious behaviour were reported September 23 - October 25, 2005.
The main part of the information was classified and not released. So was, for example, the full assessment of all data about suicidality withheld from the public. That review - on which MHRA based their conclusions - was made by the manufacturer, Eli Lilly, and was named Annex 4 to the report. It would of course be of tremendous value for independent researchers to read how Lilly has treated the statistical data, but this has not been possible.
And now MHRA has forbidden Sweden to release Lilly's review. In a decision made by the Swedish MPA, as a result of a new FOIA-request, it is written that contact has been taken with the British authority MHRA and that the release of Lilly's suicide review would hurt the relations between the two countries! Thus the review cannot be released.
The MHRA, as well as FDA and other national medical agencies are supposed to be "watchdogs", supposed to protect the public from harmful effects of dangerous drugs. That the MHRA now gives directive to other countries to hide the information about Strattera suicide data is a big medical scandal.
All information about the harmful effects of this psychiatric drug should now be made public by the medical authorities and an impartial evaluation of the data should be done. Psychiatrist should no longer be allowed to prescribe poisonous drugs to normal children; children who do not have any objective abnormality but whose behaviour are deemed inappropriate."
http://www.24-7pressrelease.com/view_press_release.php?rID=16662
Strattera - 10,988 adverse "psychiatric reactions" reported in less than three years
In less than three years 10,988 adverse "psychiatric reactions" have been reported to Eli Lilly for the ADHD drug Strattera. This is revealed in a document treated as a "state secret" by the British and Swedish medical agencies.
/24-7PressRelease/ - HAGERSTEN, SWEDEN, August 01, 2006 - The document, Psychiatric Adverse Events including Cumulative review of spontaneous reports of suicidal and self-injurious behaviour, is an attachment to an unpublished report about Strattera from the British Medicines and Healthcare products Regulatory Agency (MHRA), January 2006.
The attachment, mentioning the 10,988 "psychiatric reactions", also gives a good insight into how psychiatric drugs and drug cocktails are killing children and adults, and how psychiatric diagnoses are used to hide the harmful effects of drugs.
A court in Sweden has recently ordered the document to be made public.
This was done after the Swedish Medical Products Agency (MPA) and the British MHRA in their response to FOIA [FREEDOM OF INFORMATION ACT] requests had treated this document as if it was a "state secret".
In its arguments to the court the Swedish MPA even said that issuance of it would hurt the relations between Sweden and UK. Neither the British National Institute for Health and Clinical Excellence (NICE), responsible for "guidance on the appropriate treatment", being in possession of the document, was willing to reveal the data in it. NICE said in an answer to a FOIA-request that the document was "received in confidence and disclosure of that information would amount to an actionable breach of confidence".
These agencies, responsible for protecting the public from harmful drugs and for "appropriate treatment", consider a document reviewing the "suicidal and self-injurious behaviour" caused by a psychiatric drug in the category of state secrets, and that it would be "an actionable breach of confidence" to let the public know about these data.
But a court in Sweden has made the document public. The document consists mainly of Eli Lilly's review of the 431 cases of suicidal and self-injurious behaviour reported for Strattera from November 2002 up to October 2005. 130 of these reports were submitted in one month (October 2005), after the warnings were issued in September that Strattera increased the risk for suicidality.
Lilly's review is an excellent example of how to explain away suicides, suicide attempts and suicide ideation caused by psychiatric drugs - and of how the assessing medical agency then buys these explanations.
It can be seen in the review that children and adolescents in many cases are getting psychiatric drug cocktails - Strattera together with antidepressant SSRI drugs (as Zoloft and Prozac) and antipsychotic drugs (as Risperidone and Zyprexa). The reason for the adding of more drugs to the first one, is that one psychiatric drug's harmful effect - according to the psychiatric ideology - is seen as yet another "psychiatric disorder", to be treated with yet another mind altering (poisonous) drug. And so on.
The alleged psychiatric brain disorder ADHD (without any objective abnormality) is NOT associated with suicidal thoughts in its list of "symptoms". However as the reports of suicidal behaviour from "treatment" with Strattera kept coming in, Eli Lilly had to connect depression and suicidal behaviour with ADHD, to exonerate the drug and blame it on the children's "underlying condition". For this purpose Eli Lilly claimed in its submission to the FDA in September 2005: "Depression is present in up to 40% ...of ADHD adolescents and children."
It is very convenient for drug companies that psychiatrists are adding more poisonous drugs to the first one when its harmful effects are showing up. No single drug can then be blamed for the death of children.
It is even more convenient to blame the harmful effects of a drug on a (presumed) "underlying condition". This is what Eli Lilly and the psychiatric experts at the MHRA are doing when they in cases of suicidal behaviour in connection with Strattera find "confounding factors" present. No matter how obvious the case of poisoning the conclusions from the medical agency become (at best): "the possibility that atomoxetine [Strattera] may have exacerbated the individuals underlying condition in these cases cannot be excluded."
In its report about Strattera (January 2006) the MHRA talks about "the large number of psychiatric reactions". It says the agency in September 2005, due to this large number of harmful effects, had requested Eli Lilly "to perform a cumulative review of all psychiatric disorders reported for atomoxetine [Strattera]".
In the attachment, containing the review by Eli Lilly of suicidal behaviour, no review of "the large number of psychiatric reactions" can be found. What can be found is the number of reported reactions (up to September 2005): 10,988 adverse "psychiatric reactions" described in 6,751 reports. Example of reactions: The two categories aggression and anger are reported in 1117 cases, abnormal behaviour in 989 cases, and homicidal ideation in 19 cases.
The MHRA has still not let the public know any details about this "large number of psychiatric reactions". Neither has the agency let the public know the updated figures for suicidal behaviour in connection with Strattera.
Janne Larsson
writer from Sweden - investigating psychiatry
posted by Small Voice | 4:47 pm
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