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