Cloud Over Pediatric Oncologist and Brain Cancer Vaccine

Roxanne Nelson, BSN, RN

April 19, 2017

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.

According to Marc Decramer, MD, the CEO of UZLeuven, Dr Van Gool left the hospital in 2015 because "significant administrative problems with his trials were revealed."

However, he emphasized that there were no signs that the data had been fudged or misrepresented in any way, or that there were false reports of data that had not actually been collected.  Dr Decramer noted that "we stopped his contract with the hospital in 2015 and also halted his university appointment. His clinical studies were stopped in 2014, and Dr Van Gool was no longer allowed to see patients as of 2015."

From 2015 till 2016, Dr Van Gool maintained a minimal academic position that was meant to provide the opportunity to promote two PhD theses that were nearly finished, and he left the university in the summer of 2016. The authorities and all patients involved in his vaccination studies were notified that the trials had been stopped.

Retraction Watch notes that journalist Maxie Eckert was able to obtain official documents from multiple confidential sources, which provided details of the investigations and Dr Van Gool's research practices, but she declined to share this information because of the arrangements that she made with the sources. But in brief, UZLeuven began an investigation into Dr Van Gool's research back in 2013, with an internal audit. The following year, a committee met to examine the evidence and found significant problems with the clinical trials.

De Standaard also reported that "there were significant problems with three of Van Gool's studies: there was no approval by the ethics committee, informed consent forms were missing, and research results were not fully written up, so that data cannot be checked or verified."

Dr Van Gool continues to see patients in the private clinic in Germany and to treat them with his experimental vaccine. He also is receiving research funding from multiple sources, including the Olivia Hendrickx Research Fund, Herman Memorial Research Fund, and James E. Kearney Foundation, as well as gifts from private families, service clubs, and organizations, according to Retraction Watch.

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