Top Doc’s Fall from Grace
Stefaan Van Gool at the department of child neuro-oncology, UZ Leuven, where he was head of clinic.
It was a report that caused frowns in the medical world and beyond. That Stefaan Van Gool had left the University Hospital in Leuven was known a good eighteen months earlier. But why should a professor known nationally and internationally for his experimental brain tumour vaccine, and Leuven’s University Hospital, the flagship of groundbreaking medical research in Belgium, decide to part company? It was a long time before anyone got to the bottom of that well-kept secret. Now, however, a reconstruction by De Standaard shows that Van Gool’s departure was due to significant problems with the clinical trials he carried out on patients with a life-threatening brain tumour. Patients that include many children.


In 2015 it was reported in the media that Professor Stefaan Van Gool, best known to most people for his role in the television documentary series ‘Topdokters’ on the Vier channel, was no longer connected with Leuven’s University Hospital. Earlier that year he and the hospital had ended their association by ‘mutual agreement’. Or so it was said. The reason for that parting of the ways was never disclosed.

Even so, quite a few people are aware of what was behind Stefaan Van Gool’s departure. And not only in Leuven. Experts from the various health insurance companies, the National Institute for Health and Disability Insurance (INAMI-RIZIV), the Federal Agency for Medicines and Health Products (FAMHP), and from other universities were also involved in monitoring and scrutinizing his clinical trials. Six people were willing to talk about what went wrong in Van Gool’s trials. Some let De Standaard look at some of the documents in the case.

This all began to surface in late 2013. At the time the recordings for the Vier series ‘Topdokters’ were in full swing. The broadcasts introduced the TV audience in Flanders to Van Gool himself, his family, and the paediatric neuro-oncology unit in Leuven. And viewers also got to know his patients – children, teenagers and adults all suffering from brain tumours and all pinning their last hopes on Van Gool.

According to Van Gool himself at the time of ‘Topdokters’ he had already treated more than two hundred adults and forty children with his experimental tumour vaccines. One of his patients was Fran, a little girl who was given the vaccines to combat a malignant brain tumour. Over several episodes, ‘Topdokters’ followed Fran and her parents into the operating room or Van Gool’s consulting room. The child relapsed, however, and later died.

Van Gool is an authority. His patients came to Leuven from all over the world for his tumour vaccinations. Today, the parents of children who were being treated by Van Gool still say that they would always go back to him. They evidently had and still have complete faith in him.

Not given to modesty, Van Gool had no qualms about blowing his own trumpet. ‘If Marie-Rose Morel [a Flemish politician who died of cancer in 2011] and Steve Jobs had been treated by us they might still be alive,’ he stated in the members’ magazine of the SP.A, the Flemish socialist party, in late 2011.

In 2013 and 2014 respectively an internal audit and a committee of inquiry made up of internal and external professors concluded that Van Gool’s results were more fantasy than reality. Even today it still remains to be seen whether or not his experimental tumour vaccines have any effect on brain tumours. Yet years ago Van Gool was already loudly stressing the imaginary benefits and, according to him, the non-existent risks in several of his trials.

Study Not Approved, Patients Not Insured

The list of shortcomings in the way Van Gool’s trials were carried out is a long one. It highlights the chaos that reigned in his experiments with patients.

Van Gool had started experimental treatment with tumour vaccines even before he got the go-ahead for the trial from the Federal Agency for Medicines and Health Products. In another case there was no application at all either to the ethics committee or the FAMHP – in other words, there was no independent expert evaluation of what patients might gain from the trial or what the potential risks of the treatment might have been.

That lack of official approval from the Federal Agency for Medicines and Health Products and/or the ethics committee meant that patients were not insured against anything that might happen during the trial or as the result of a side effect. It is not known whether problems did arise or not.

In many cases Van Gool failed to mention what experts call ‘serious adverse events’ – incidents that can lead to permanent disability or even to the death of the test subject. Admittedly, a scientific paper on one of his trials does refer to epileptic seizures and dangerous anomalies in patients’ blood. But he neglected to inform the ethics committee about this, despite the clear obligation to do so.


The first internal investigation in the winter of 2013-2014 set alarm bells ringing in Leuven University Hospital. The hospital decided to call a halt to several trials.

Van Gool received an internal reprimand. A proposed visit by Herman Van Rompuy, then President of the European Council, to Van Gool’s laboratories in the middle of January 2014 was allowed to go ahead but was expanded to include research by Van Gool’s colleagues. It was no longer to be the one-man show that had been envisaged.

Despite the internal rumpus Van Gool continued to court the media. In February 2014 he took the initiative along with 160 other paediatricians to write an open letter to the Speaker of the House of Representatives in which they opposed the planned extension of euthanasia legislation to minors. Van Gool debated the issue with philosopher Walter Musch on the late-night VRT discussion programme ‘Reyers Laat’.

‘Smacks more of malpractice by pharmaceutical companies’

Meanwhile, Van Gool was closely monitored. In November 2014 a committee of internal and external experts was also appointed to examine the matter in detail.

The result was to bring to light even greater problems in Van Gool’s trials. Important documents relating to a significant number of patients involved in Van Gool’s vaccination trials were either not to be found or were not completely filled in. These were the ‘informed consent’ forms signed by patients (or the parents of minors) to confirm that the trial and the procedures it involved had been clearly explained to them; that they were aware that they could withdraw from the trial at any time (without having to give their reasons for doing so); and that they were willing to take part in the trial.

A doctor who knows the case confirms that some of those taking part in the trial had simply not understood that the vaccines’ effectiveness was not yet certain.

But a patient’s ‘informed consent’ is a crucial ethical precondition of any experiment on a human subject. That this was not in order in Van Gool’s studies, says one individual who has followed the case, smacks more of malpractice by pharmaceutical companies in developing countries than properly conducted research in Belgium.

Worthless Study Results

Apart from the ethical and legal failings, Van Gool seems to have taken a pretty slapdash attitude to the protocols that regulate clinical trials. ‘The infractions that have been established are serious, both in number and nature. They put the reliability of the research at risk,’ concluded the committee of inquiry made up of internal and external experts.

It was found that many of the patients who had received the experimental vaccines had not been followed up as protocol required. It was also shown that some of the patients taking part in Van Gool’s trials did not have the type of tumour that the trial was targeting. While others, in addition to the experimental tumour vaccinations, were also given medication that was banned in the trial. Those drugs make it more difficult to assess by brain scanning how the tumour is developing.

Thus Van Gool failed to observe the trial protocols that he himself had written. He made his own results worthless to science.

One of the trials in which Van Gool deviated from protocol was funded by the National Institute for Health and Disability Insurance (INAMI-RIZIV). Leuven University Hospital told the Institute that based on the data gathered in the study, administration of the tumour vaccine after surgery on the malignant brain tumour did not seem sensible.

The slipshod way of working is not only a shame for science. It also means that during the trials incurably ill patients underwent treatments and examinations that ultimately should not be used in scientific analyses. Including brain scans, for which children are fully anesthetized.

From Leuven to Cologne

In February 2015 Marc Decramer, CEO of Leuven University Hospital, informed the National Institute for Health and Disability Insurance (INAMI-RIZIV) that his hospital and Professor Van Gool had terminated their partnership by mutual agreement. The programme of tumour vaccine trials would remain at a standstill, he went on, but the hospital would look at how it could be restarted in the future.

And Van Gool himself? After his departure from the hospital he would still be allowed to remain at the university, reportedly to complete those projects that were already up running. Later that year, in September 2015, he started work at the Immunological Oncological Centre Cologne (IOZK), a private centre specializing in immunological oncology. ‘I'm glad I’m still working in the same direction,’ says Van Gool in a message posted on the IOZK website.

Today, in Cologne, Van Gool is still treating patients with similar tumour vaccinations, even Belgian patients. There have been stories in several newspapers recently about eleven-year-old Maithili from Bruges, who has a brain tumour that can’t be removed. Her parents are desperately trying to raise the money for her treatment by organizing charity brunches and tombolas. They’re helped out by local companies and groups. The bill for little Maithili’s treatment is between fifty and seventy thousand euros, none of which is covered by their health insurance.

Stefaan Van Gool’s fame has even reached America. In February this year The Washington Post published the story of Elijah, an eight-year-old boy with a brain stem tumour. His parents’ last hope is Van Gool’s tumour vaccination treatment in Cologne, which was started in October last year. In total they will have to raise around 45,000 dollars since in their case too there is no insurance cover for the treatment.

Belgian patients who go to Cologne for Van Gool’s tumour vaccinations sometimes ask for reimbursement from a Belgian health insurance company. But it’s always refused. So far there is simply not enough hard evidence that tumour vaccinations are any help at all when it comes to brain tumours.

So far, however, no one has given the patients or their relatives any kind of detailed explanation about the value of Van Gool’s clinical trials. He left Leuven’s University Hospital and the reason for his departure has remained a closely guarded secret.

Rector Rik Torfs prefers not to comment. The Leuven University Hospital refers to the confidentiality clause in the contract they agreed upon. However, a spokesperson of the hospital says that all persons who had to be informed about the case have been informed.

Van Gool says that the truth of why he left Leuven is different. ‘But I will not talk about that. I stick to the agreement with the Leuven University Hospital.’

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