Thomas Laughren M.D.: FDA and Zyprexa Pediatric bipolar and schizophrenia

M E M O R A N D U M

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH

DATE: April 29, 2007

FROM: Thomas P. Laughren, M.D. Director, Division of Psychiatry Products HFD-130

SUBJECT: Recommendation for approvable actions for Zyprexa Pediatric Supplements for bipolar disorder (acute mania) and schizophrenia TO: File NDA 20-592 (S-040 [bipolar] and S-041 [schizophrenia])

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10.0 CONCLUSIONS AND RECOMMENDATIONS I believe that Lilly has submitted sufficient data to support the conclusion that olanzapine is effective and acceptably safe in the treatment of adolescents with schizophrenia and acute mania/mixed episodes in bipolar disorder. However, before we can take an approval action, the sponsor needs to respond to various requests we have made and we need to reach agreement on labeling. Thus, we will issue the attached approvable letter along with our proposal for labeling.

cc: Orig NDA 20-592/S-040 and 041 HFD-130/TLaughren/MMathis/NKhin/CAlfaro/KKiedrow/DBates/SHardeman DOC: Zyprexa_Peds_Laughren_AE_Memo.doc

Thomas Laughren
4/29/2007 10:55:29 AM
MEDICAL OFFICER

FDA-Thomas Laughren.


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Thomas Laughren, M.D. and the Director of Psychiatry of Products for the FDA in the U.S. believes that Eli Lilly has produced sufficient evidence in 2007 that Zyprexa is safe for teens. Though Lilly has lied and held skewed data which is documented in the Zyprexa documents, and has a black box warning for diabetes, apparently all is well with the FDA, or at least with Thomas Laughren, who is associated with pharma-funded projects.

Thomas Laughren has not returned my request for an answer regarding the FDA stating that pediatric bipolar disorder is valid, and he has not given an interview requested by journalist and blog author Philip Dawdy at Furious Seasons.

Who is truly watching out for children in the FDA?

Risperdal and Abilify are antipsychotics that have been approved by the FDA for use in children, and my daughter was rx'd those as well as Zyprexa in 1999, at age 11. I can tell you what happened to her on those meds, in the order given.

Risperdal caused her eyes rolled straight up in her head, she was paste white, sweating and her blood pressure dropped. Inside a psych ward for "OCD" they changed her dx to Pediatric Bipolar Disorder. (in 1999!) then switched her from Risperdal to Zyprexa which caused her to gain 100 lbs in one year, and Abilify left her unable to sleep for 10 days.After those drugs "failed" here came Seroquel.

The only thing I can do is attempt to warn parents of a possible hideous outcome if their children are placed on these meds. Extreme medications should be last resort for extreme illness, not a theory based on Joseph Biederman's idea, while he counts his unreported pharma (million dollars) money to Senator Charles Grassley.

The DSM-IV that is currently in place has no diagnostic criteria in place for pediatric bipolar disorder. Why does the FDA approve medications for an illness/disorder that does not exist except by KOL's (Key Opinion Leader)beliefs?

Would we put a chemical restraint on a toddler having a meltdown at bedtime? apparently.