Drugs tested on psych patients without informed consent: report
Psychiatric patients in a mental health institution in Heiloo were used in a drug test against the rules. This is according to the research program Zembla, based on documents and interviews with anonymous staff.
According to an internal whistle blower, 22 of the 52 patients in the facility participated in the medical experiment from August 2013 while suffering from severe psychosis. This means that the patients were unable to make an informed decision. The researcher was only authorized to do an experiment on mentally competent ambulatory patients, i.e. patients who function enough to live independently and to know what they are agreeing to. According to this protocol, only patients who are not living in the clinic may participate in the study.
The participating patients receive a lot of care within the clinic, some even 24 hours a day. According to the whistle blower and other employees, there are therefore great doubts about the mental competence of these patients. The patients' families were only informed about the test a year after the trial had begun.
In the experiment two medical drugs, clozapine and memantine, are combined. Clozapine is an anti-psychotic used in severely psychotic patients. Memantine is administered to patients with Alzheimer's disease to prevent memory loss. GGZ Noord-Holland-Noord hopes that the addition of memantine will show positive effects in people who have not benefited from the use of clozapine. The experiment also has to show whether the drug combination is safe to use.
Memantine is sold and marketed under the name Ebixa by Dutch company Lundbeck BV, among others. In the Transparency Register Lundbec BV is listed as having paid 2 thousand euros to GGZ Noord-Holland-Noord to sponsor a gathering in 2012, 2013 and 2014. Other drug companies paid similar amounts to the facility in those years.
The whistle blower was the personal caregiver of a patient suffering from paranoid schizophrenia. According to this caregiver, the patient is not mentally competent, but was persuaded to participate in the trial. The whistle blower wrote a letter to the Board of Directors of GGZ Noord-Holland. The whistle blower was dismissed and was ordered not to say anything further, under penalty of heavy fines.
The person performing the experiment, a psychiatrist who wants to get her doctorate on the subject, did not want to give a comment to Zembla. Her supervisor told the program that it "is only a misunderstanding".
Zembla also spoke to the families of two patients involved in the experiment. They are shocked that they were only informed a year later, because they have serious doubts about the mental competence of their relatives and do not believe that they could have made an informed decision.