German Documentary on SSRIs To Be Broadcast

ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

FYI On Tuesday, December 9, German TV ZDF will broadcast a hard hitting documentary about corrupt pharmaceutical company practices. One issue that will be addressed for the first time is: Why did the German drug regulatory agency (BGA) approve Prozac in 1991 after denying Eli Lilly the license to market the drug in Germany in 1984 without explicit label warnings about the increased suicide risk the drug poses?

May 25, 1984 Internal memorandum from Eli Lilly regarding the company’s efforts to obtain a marketing license for Prozac in Germany states: “During the treatment with the preparation [fluoxetine] 16 suicide attempts were made, 2 of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation in the sence (sic) of an deterioration of the clinical condition, which reached its lowest point.” [PZ281]

Furthermore, Lilly’s own documents reveal that a 1988 review of clinical trials found that 38% of patients taking Prozac compared to 19% of patients on placebo experienced “activation,” which is linked by the FDA in current labeling to violent and suicidal behavior. [PZ-477].

See: Eli Lilly internal documents: What do They Reveal? http://www.ahrp.org/infomail/05/01/27.php

BZ281: Lilly Memo, Keitz; Bad Homburg to Corporate Headquarters, May 25, 1984, with Comment on Clinical Documentation Fluoxetine from BGA (Germany) rejecting Prozac for marketing.

PZ-477: Lilly Memo. Activation and Sedation in Fluoxetine Clinical Trials, 1988

See: Lenzer, J. FDA to Review “Missing” Drug Company Documents, BMJ (formerly British Medical Journal), January 1, 2005. http://bmj.bmjjournals.com/cgi/content/full/330/7481/7

Contact: Vera Hassner Sharav

veracare@ahrp.org

212-595-8974

 

From: Lothar Schröder [mailto:lothar1962@googlemail.com]

Sent: Saturday, December 06, 2008 6:32 AM

To: veracare@ahrp.org

Subject: German TV-Documentary on SSRI and psychotopic Drugs

Dear Vera, since the death of my wife I am trying to inform the German public about the risk and dangers of SSRI-antidepressants. My wife took ZOLOFT 3 years ago for only 11 days. Two days before her death the medication was stopped abruptly. A few months after her death the European Commission made it mandatory for European license holder of SSRI- antidepressants to include a warning about the risk of suicide for children and adolescents in the product information and package insert. Before it, the risk of suicide was not even listed in the product information and package insert.

I have tried to press criminal charges against Pfizer but the German courts have put it down. I have also informed the media about it. Now next Tuesday (09. December 2008, 21:00 hour German time on ZDF) the German TV ZDF will broadcast a documentary about the criminal practices by the big pharmacy companies to press the SSRI antidepressant to the European market. The German regulatory agency BGA (Bundesgesundheitsamt) knew about the risk of suicide of the SSRI Prozac and refused to admit it to the German market: first in 1985 and then 3 years later in 1988. But finally Prozac was admitted to the German market in 1991. Zoloft and the other SSRI antidepressants followed.

Last Tuesday, Frontal 21 has broadcast a 6-minute long report about Prozac and Zoloft (see: http://frontal21.zdf.de/ZDFde/inhalt/19/0,1872,7486227,00.html).

I hope that this report and the documentary will put real pressure on our politicians and on our regulatory agency. Why was Prozac approved in 1991 although the german BGA knew about the risk of suicide since 1984? Maybe you want to inform the readers of your infomail – I am one of them for many years- and in your blog about the documentary. It will be seen in all German speaking countries in Europe. Thank you very much.

Best regards,

Lothar Schröder 

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