Clinical trials lawyer Gene Matthews, is troubled by revelations that drug trials on vulnerable children were approved in the 1960s. Mr Matthews said: “It is deeply troubling that the government in the 1960s supported experimental drugs trials on exceptionally vulnerable children without any awareness or involvement of their parents or the children themselves”.
Files released from the National Archives have revealed that Home Office doctors supported two experimental drug trials on children in Approved Schools in the 1960s.
A trial of anticonvulsant drug Beclamide, formerly prescribed for epilepsy and a drug with sedative side-effects, was approved at Richard Hill Approved School in North Yorkshire.
The school accommodated pupils aged 15 or over, and the drug was given to the most disruptive boys to attempt to improve their behaviour.
A psychiatrist attached to the school described the boys as “impulsive, explosive, irritable, restless and aggressive”. The “double blind” trial, which documents indicate proceeded in 1968 and lasted six months, saw one group of boys given the drug, and a second control group given a placebo. The results were not reported.
A second trial was proposed by a school psychiatrist at Springhead Park Approved School in Rothwell, a school for 14 and 15 year old girls.
The drug, Haloperidol, a powerful sedative, is now used as an anti-psychotic drug.
The psychiatrist proposed “some form of drug trial to see if, by allaying the anxiety of the girls chemically, we might perhaps settle the school a little bit more”. Whilst the Home Office backed the trial, it did not proceed due to objections raised by the School’s headmistress and managers.
Approved Schools were residential institutions which housed young children considered to be beyond parental control. Children were usually sent there by Juvenile Courts; however the schools were not classified as prisons. The Home Office inspected and funded the Schools which were usually run by voluntary organisations.
In neither of these trials were the children’s parents consulted, nor their consent obtained.
Files show that the Richmond Hill headmaster informed the Home Office “in view of assurances from the school [and manufacturers] doctor.. the managers had decided that there was no need to consult the parents”.
It seems the trial was not discussed or explained to the children and/ or their parents and consent was not obtained.
Clinical trials lawyer Gene Matthews, partner at Leigh Day, who acted for volunteers who suffered life-threatening injuries in the Northwick Park drug trial, said:
“Clearly, the administration of drugs in an attempt to control behaviours of perceived ‘disruptive children’, without their consent was plainly wrong and unacceptable.
“Whilst it seems we are now, thankfully, far away from this paternalistic approach, informed consent remains a real issue in clinical trials.
“Drug trials in children remain relatively rare. To stand a chance of fighting life threatening disease, paediatric trials are crucial, but children taking part in such clinical trials must be properly consented with appropriate safety, ethical and insurance safeguards”.