Leading brain cancer specialist fudged cancer trials
Stefaan Van Gool. Foto: BELGAIMAGE

Two years ago, well known paediatric cancer specialist Stefaan Van Gool made a quiet exit from the University Hospital in Leuven. There was a reason for his departure, De Standaard has discovered. There were significant ethical and scientific problems in his clinical trials on patients.

Eleven-year-old Maithili from Bruges in Belgium has an inoperable brain tumour. Eight-year-old Elijah, who lives nearly four thousand miles away, in Maryland (USA), suffers from the same incurable disease as Maithili. Newspapers in Belgium and in the US recently carried stories about the children. They all had the same goal – to raise between forty and seventy thousand euros to pay for tumour vaccinations by the Belgian paediatric neuro-oncologist Stefaan Van Gool.

Up until a couple of years ago, Van Gool was on the staff of the University Hospital in Leuven, though he was probably better known to most Belgians for the reality TV series ‘Topdokters’. Today he works in a private clinic in Germany.

De Standaard has learned that Van Gool left Leuven University Hospital after it appeared that there were serious ethical, legal and scientific problems with the clinical trials he carried out. Children and adults with life-threatening brain tumours were treated with experimental tumour vaccines. Today Maithili and Elijah are hoping that a similar treatment by Van Gool will save their lives.

But Van Gool’s experimental treatments in Leuven University Hospital may have given his patients – or in the case of children, their parents – false hope. A committee of enquiry made up of professors from Leuven and other universities mauled him for recommending his experimental tumour vaccinations to patients when it was by no means certain that they would work. To date, their effectiveness is still unproven.

Moreover, there is at least a doubt whether every adult patient or sick child’s parent had actually agreed to the experimental treatment for the life-threatening brain tumour or had received all the requisite and objective information about it.

In addition, several cases show Van Gool breaking the law by treating patients even before the trials were officially approved by an ethics committee and / or the Federal Agency for Medicines and Health Products (FAMHP). This left the patients uninsured if something serious happened – such as an epileptic fit – during the trial.

The trials were also scientifically unsound. A source close to the case says that the litany of problems in Van Gool’s trials is more reminiscent of malpractice by pharmaceutical companies in developing countries than of solid research in Belgium.

After all these problems had come to light, Van Gool left Leuven University Hospital in February 2015. He has been still attached to the University. Meanwhile, what happened in his trials was to remain within the hospitals walls – although before his appointment as the university’s rector, Rik Torfs had announced his intention to put an end to the culture of silence surrounding research integrity or the lack thereof. Sources very familiar with the case make a connection with the research grants that Van Gool brought in.

Rector Torfs declined to comment about the case. The Leuven University Hospital and Stefaan Van Gool prefer not to comment, referring to the confidentiality clause in the contract they agreed upon.

Nota Verzekeringscomite by De Standaard on Scribd

Letterlijk onderzoekscommissie by De Standaard on Scribd

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