The European commissioner of Health urges to investigate the AstraZeneca laboratory for a death in a clinical trial. The EMP Lidia Senra (Group of the European United Left/, United Left/Nordic Green Left, GUE-NGL), has realized several questions in the European Parliament which have promoted that the commissioner of Health of the European Commission, Vytenis Andriukaitis, urges that it is investigated in Spain the death of a person in a clinical trial of the AstraZeneca pharmaceutical. The fundamental rights of the citizens who take part in a clinical trial are damaged when one of these citizens suffers a serious damage or dies. Juan Santos Sierra died in April, 2013 in the Hospital of Merida (Spain) when he was taking part in the clinical trial of a new medicine of the pharmaceutical laboratory AstraZeneca (“Sifalimumab”, for the lupus). During all this time, his family could not have acceded to the mandatory insurances policy. They have not been able to manage to advance in the indemnification for the damages and prejudices caused by the death of the patient, although they have signed all the necessary legal agreements to take part in the trial, because AstraZeneca and the insurance refuse to provide it. AstraZeneca also refuses to offer the personal information generated in the test. Hence, Senra asks Andriukaitis: 1. Does the Commission understand that it is coherent that the promoter of this clinical trial can accede to the information chain of the clinical trial and can “open the test” in such a way that it could manipulate the information? In case of death or serious damages: 2. Does the Commission not think that the personal information generated in the trial should be guarded by judges or independent entities? 3. Don’t you think that it is necessary to allow the family access in order to be able to request second opinions and to investigate the real reason of the death? Response of Mr. Andriukaitis in name of the Commission: Clinical trials must be authorized before they begin. It concerns the ethical corresponding committee to examine, before they could begin the trials, if the written information facilitated to the subject of the test to obtain his informed assent is adapted and complete. The matter which you, Honorable Member, talk about will have to be investigated in accordance with the civil and criminal legislation of the affected country . In the case of Sierra, the investigator and the promoter have taken more than one year to facilitate the informed consents to the family, in spite of the fact that they have requested it even taking it to a judge. In addition, these consents presented big failures (unjustified increases of dose with different signatures in each informed consent from the patient, absence of information about the action methodology in case of serious damages or death, etc.). Likewise, the promoter and the investigator try to conceal information to feign that the death was not due to the trial. Senra asks again for an official response: 1. Does the Commission not think that the informed consent should indicate the action methodology in case of serious damage or death? 2. Does the Commission not think that it should be opened an investigation on the way of acting of AstraZeneca AB in the clinical trials in general and also especially in the case of Juan Santos Sierra? 3. Don’t you think that it is been damaged the right of the patients and their families, on being unprotected against the power of the pharmacists? The Commissioner insists: The investigation and the subsequent inquiries on the matter mentioned, including the possibility of acceding to the information of the patient, must be in accordance with the civil and criminal legislation of the country which we talk about and, if it proceeds, by a national court .
Posted on: Thu, 11 Dec 2014 08:18:11 +0000
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