Eli Lilly withheld disastrous effects of Strattera from parents and children

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[sSRI-Research] Larsson - [Press Release] Eli Lilly withheld

disastrous effects of Strattera fr

 

 

 

 

April 5, 2006

 

Press Release Contact Information:

 

Janne Larsson

writer

Snöbollsgränd 22

Hägersten

Sweden 129 45

E-Mail: janne.olov.larsson

 

 

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.

 

Janne Larsson

 

writer from Sweden - investigating psychiatry

 

Read more Press Releases from Janne Larsson:

 

 

MHRA forbids Sweden to reveal Strattera suicide data

Eli Lilly's Strattera - 130 reports of suicidality in one month

Eli Lilly's and Christopher Gillberg's failed experiment with

Strattera

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