Dear Mr. Herxheimer,
you may remember that 3 years ago you accompanied me and Prof. Müller-Oerlinghausen when we visited the Europeam Medical Agency EMEA to read some documents on SSRI antidepressants.
After more than three years I succeeded to get access to the files regarding the registration of Zoloft in Germany at the german regulatory agency BfArM.
My lawyer, Prof. Müller-Oerlinghausen from the Drug Commission of the German Medical Association and I have looked into the files of the german medical authorities and have found documents proving my claim, that the increased risk of suicide was evident when ZOLOFT was registered in Germany in 1996. The data from all clinical trials show that the rate of suicide among the patients taking sertraline was statistically significant higher than among the patients getting placebos or a different antidepressant. Also the death rate in the sertraline group was significantly higher. But the german expert ignored the data and claimed instead that sertraline even reduces the risk of suicide.
I hesitated for some time to give the documents to the press and to the public because the german authorites did not allow me to give them to anybody. But the public has a right to know the facts! The crucial pages are page 50 to 53 of the expert report (page 1-3 of the file Gutachten_1995_03.pdf) and the tables of the listing of all deaths. They show that until 1.sept. 1993 16940 patients taking part in medical studies took sertraline and 0.09% (=15 patients) were suicidal. In the control group of 9016 patients only 0.02% were suicidal (=2 patients). This diffenence ist statistically significant with more than 99 percent probability!
The tables show that among the 46 deaths of all clinical trials 34 patients had taken sertraline and among them 10 committed suicide (9 official suicides and one patients poisioned himself with carbon-monoxide). In the control group only one patient committed suicide.
All these data were ignored by the german expert, a very prominent german psychiatrist, who has written the report. Instead he claimed that Zoloft even reduces the risk of suicide. This report was the medical basis for the german medical agency to approve Zoloft in germany in 1996.
I will keep you informed.
best regards,
Lothar Schröder
2 Kommentare:
lothar,
regarding the data you acquired, it seems identical to what i did in sweden when prozac was submitted. my professor who took a bribe had declared that the product was useless.they also knew of the dangerous side-effects but choose to ignore it. i suspect that your professor was as criminal as mine.
dont let them off the hook.
Dear Lothar,
My name is Alla and I`m working in Russian company which makes documentaries for Channel One (Russia). We are now making a film regarding cynicism of pharmaceutecal companies. We think that your story can show a lot about the pharmaceuticals and that is why we would like to ask you whether it is possible to meet with you to speak about it and take an interview for our film.
I can write you more concretely about the themes we would like to mention in this film and all that but I couldn`t reach you by e-mail. I found one in the internet and wrote you already twice and didn`t get any reply. Could you please advise how is it possible to contact you?
My e-mail is: malena22@mail.ru
We would very much appreciate your help and participation in the film.
Thanks in advance!
Alla
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