The director of the mental asylum in Brassó (Brașov), Nicuşor Bîgiu, revealed last September that several drugs might have been tested on patients with chronic illnesses at the institute. Now it seems that it actually happened in the 21st century Romania: The Commissioner for Human Rights, Renate Weber, has been investigating the case since last year and has now announced that 20-30 patients were involved in drug trials at the Szászvolkány (Vulcan) branch office of the Brassó Neurological and Psychiatric Clinic Hospital between 2005 and 2015, without their consent.
A committee set up earlier by the hospital director to investigate the possible drug trials came to the same conclusion. During the investigation, the committee asked the head of the research to provide some information, but he refused to hand over the list of patients involved in the trials and their consent forms. The ombudsman also requested the medical documents, but they then mysteriously disappeared from the hospital archives. However, the ombudsman also concluded that the hospital never was licensed to conduct clinical researches on patients in the first place.
“Adevărul newspaper published on October 7, 2019, an article presenting the fact that drug testing trials were performed on patients under the terms of legislation that does not protect vulnerable groups, especially children. As a result of the facts presented by the press, the Ombudsman Institution conducted an investigation at the Brassó Neurological and Psychiatric Clinic Hospital (SPCN Brassó), on October 15, 2019, and at the Ministry of Health, on October 16, 2019.
For the validation of information gathered from both investigations, it became necessary to obtain additional information from SPCN Brassó. As a result, the Ministry of Health and the National Agency for Medicines and Medical Devices of Romania (ANMDMR) conducted a control study to verify the condition under which patients hospitalized at the Szászvolkány Department of the same hospital were involved in drug trials. Following the request for additional information on the clinical trials in question, SCPN Brașov presented to the Ombudsman Institution several documents and information regarding clinical trials conducted between 2001-2015, as an internal commission at the hospital was set up to investigate the same issues from the same time. However, medical documents of patients involved in the study have disappeared from the hospital archives,” the press release of the Ombudsman reads.
The Ombudsman continued the investigation at the Ministry of Health, ANliceMDMR and the National Commission of Bioethics at the Academy of Medical Sciences, but no institute had the documents. However, as a result, the Ombudsman found out that the hospital was never authorized to conduct clinical researches, even though several trials took place in the hospital, according to personnel. A single record of one patient was found, but his consent form was also lost.
The Ombudsman Institute informed the Prosecutor’s Office to the High Court of Cassation and Justice about the case. The office informed the ombudsman that the doctors who coordinated the trials were never the subject of a criminal investigation, but several home searches were conducted and the medical documents of the clinical trials were also analyzed. These documents have, however, disappeared despite the fact that they were returned to the Prosecutors Office after the investigation, the press release states.
According to the hospital director, a drug for schizophrenia was tested on the patients.
Title image (illustration): 20-30 patients were involved without their consent in drug trials at the Brassó Neurological and Psychiatric Clinic Hospital between 2005 and 2015. Photo: fájdalomközpont.hu