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First session of the case for the clinical trials |
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Today the first session of Sofia city court on the case of the clinical trials will be held. The case was constituted on the claim of G.K., a cancer patient. The patient is included in a clinical trial for a new medicine product Epotilon produced by the German company Bayer-Schering. During the trial G.K. and three other patients began suffering form polyneuropathy as a side effect and therefore the trial was terminated. Polyneuropathy is not described as a possible side effect in the informed consent of the patients. Even though all patients have been insured the insurer Allianz Bulgaria has not paid out the due compensation. After a signal from CZPZ the Executive agency of medicines has made an inspection and has found out a series of violations in carrying out the clinical trial including that against its lawful obligations the researchers ( the French company ICN research) did not announce the appearance of the side effects of the medication.
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