A high-profile pediatric oncologist in Belgium, who has been developing a cancer vaccine for brain tumors, is being investigated for possible misconduct and ethical violations.
While information on the case continues to emerge, it appears that Stefaan Van Gool, MD, left his appointments at both the University of Leuven and the University Hospital Leuven in Belgium, under unclear circumstances.
The case was highlighted recently on the Retraction Watch website, which says it is “still hazy on details.”
The CEO of University Hospitals Leuven (UZLeuven) had initially told Retraction Watch that Dr Van Gool left his position at the hospital in 2015 as a result of administrative problems but offered no further information about their specific nature.
However, late last month, the Belgian daily newspaper De Standaard reported that the reason for Dr Van Gool’s departure stemmed from “significant ethical and scientific problems in his clinical trials on patients.”
The investigation revolves around a cancer vaccine that Dr Van Gool has been developing, initially at UZLeuven and, after his departure, at a private clinic (IOZK) in Cologne, Germany, where he practices today.
His work has attracted patients come from all over the world, who come to the clinic with high hopes that his vaccine will cure their life-threatening brain tumors and are willing to pay thousands out of their own pockets for the chance. Many of his patients have been children with a rare form of pediatric brain cancer known as diffuse intrinsic pontine glioma, which is invariably fatal and lacks any effective treatment.
However, according to De Standaard, a committee composed of professors from Leuven and other universities severely reprimanded him for recommending this experimental treatment when there was no proof that it worked. To date, the effectiveness of the vaccine remains 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,” the Belgian newspaper reports.
The newspaper went on to note that in several cases, Dr Van Gool may have been violating Belgian law by treating patients before the clinical trials had been officially approved by an ethics committee and/or the Federal Agency for Medicines and Health Products.
There was also a question about the scientific viability of his trials. One source close to the case said 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,” the newspaper reports.
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