Greek authorities probe illegal clinical studies on elderly peopleBMJ 2004; 328 doi: http://dx.doi.org/10.1136/bmj.328.7453.1398-c (Published 10 June 2004) Cite this as: BMJ 2004;328:1398
Prosecutors in Greece are investigating claims that elderly people have been used for clinical studies without their knowledge.
According to a leaked report by health inspectors, residents of an old people's home in Athens were allegedly used in a clinical study on their cholesterol and triglyceride concentrations without their written consent.
It alleged that other clinical trials, including a study on the resistance of pneumococcus to penicillin, were also carried out on dozens of residents, again without their knowledge.
The studies were allegedly funded by a drug company.
The deputy minister for health and social affairs, Giorgos Constantopoulos, accused the pharmaceutical company, which has not been named, of opening a “department” in the old people's home in Ambelokipi.
“There are 400 elderly people from all social strata in the retirement home, which is of great interest to researchers. But the point at which research ends and experiments start will be investigated by the judiciary, as well as whether there was a breach of the medical code of ethics,” he said in an interview with Kathimerini, a Greek daily newspaper (2 June).
Health inspectors took action in June 2003 after the daughter of one of the women living in the home complained that “strange” drugs were being given to the residents.
In the course of the year long probe, managers of Gerokomeion, the company that runs the private home, as well as the university doctors who were conducting the trials and staff from the company involved, were questioned.
A leaked version of the health inspector's 162 page report—which was handed over to the Athens chief prosecutor, Dimitris Papangelopoulos, last week—said that clinical trials had been approved by the country's drugs watchdog, the National Drug Organisation, but that doctors had not obtained the residents' consent. Doctors at the home are alleged to have set up a special non-profit company to run the trials.
The inspector's investigation into the 150 year old home also showed shortcomings in financial accounting, security, and hygiene.
Mr Constantopoulos said that the inspectors have widened their investigation to include another 14 old people's homes in Athens.
The revelation that elderly people have been used in clinical trials has sparked fresh concern over the lack of checks on homes across the country.
The Ambelokipi home did not have a licence, and health inspectors found that it also did not comply with regulations passed in 1995.
“There are retirement homes that operate without even signs outside and which switch off their lights when we approach. But people who shut up elderly people in such homes are also to blame,” Mr Constantopoulos said.