Star pediatric oncologist committed misconduct, ethical violations: reports

A high-profile pediatric oncologist quietly left his former institution in 2015 after it concluded his clinical trials had been affected by significant “administrative problems.” But now the results of the university’s investigations and what followed have become public, after a paper in Belgium published a series of news reports last month.

We’re still hazy on some details of the case. The recent news reports allege that Van Gool started some clinical trials without proper ethical approvals and informed consent, and may have misled patients and their families about the benefits and potential side effects of his experimental treatment. Meanwhile, the CEO University Hospitals Leuven (UZLeuven) told us that Stefaan Van Gool, who had appointments at both the hospital and the university (KULeuven), left the hospital in 2015 as a result of administrative problems, but did not disclose the specific nature of these issues.

For the past 15 years or so, Van Gool has been developing and studying a vaccine to treat various cancers, initially at UZLeuven and, after September 2015, at a private clinic in Germany. Today, patients travel to his private clinic from all over the world and pay tens of thousands of dollars to receive the vaccine. But according to Flemish daily newspaper De Standaard, several years ago, UZLeuven began investigating his research and patient care practices. The outcome of these investigations was kept private until last month, after De Standaard published its reports.

Marc Decramer, the CEO of UZLeuven, confirmed that Van Gool left the hospital in 2015 and the university in 2016, but did not provide the specific reasons for his exit:

Prof. Van Gool left us in 2015 because significant administrative problems with his trials were revealed. There was no fraudulous representation of data, nor reporting of data that had not been collected. 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 he retained a 5% academic position, meant to provide the opportunity to promote two PhD theses, that were nearly finished. These studies dealt with in vitro vaccine preparation, and did not require patient contact. He effectively left the university in the summer of 2016. We notified the authorities and all patients involved in his vaccination studies, that had been stopped.

We contacted many of Van Gool’s colleagues and co-authors, but have not received responses. When we reached out to Van Gool for further insights on the case, his response was brief:

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In Belgium, Van Gool is likely best known for being featured on the TV series Topdoktors. Parents across the globe have sought out his experimental treatment, often as a last resort for their children with a rare form of pediatric brain cancer known as diffuse intrinsic pontine glioma (DIPG). He administers the vaccine regimen at a private clinic in Cologne, Germany. (Most children with DIPG die within a year or two of being diagnosed).

According to journalist Maxie Eckert, De Standaard began asking questions about Van Gool back in May 2015, when news organizations in Belgium reported that he had left the hospital under unclear circumstances. Eckert, who co-authored the recent De Standaard pieces, told us she couldn’t get anywhere:

We couldn’t get through the wall. No one was willing to say anything. The hospital, university and Van Gool all said a non-disclosure agreement prevented them for speaking about the matter.

Eventually, Eckert obtained official documents from multiple confidential sources, which provided details of the investigations and Van Gool’s research practices, and which she declined to share (aside from the one published here) because she made certain agreements with sources. According to De Standaard, the hospital began investigating Van Gool’s research practices in 2013 with an internal audit. In 2014, a committee of inquiry—comprised of internal and experts—met to examine all the evidence and found significant problems with the clinical trials. Quoting from the committee of inquiry findings, De Standaard wrote:

The infractions that have been established are serious, both in number and nature. They put the reliability of the research at risk

More specifically, the committee found that Van Gool misled patients and their families about the benefits and potential risks of the vaccine. Eckert told us:

The commission of internal and external experts found that Van Gool emphasized the tumor vaccine was effective, although the clinical study was to determine whether or not that was indeed true. He claimed he didn’t expect serious side effects, and again, that is what the studies were set up to investigate.

De Standaard also questioned whether Van Gool had received approval from an ethics committee or the federal agency in Belgium that regulates the quality and safety of drugs before initiating clinical trials. Eckert said she found that in the 2010-HGG trial, described in this 2015 Frontiers in Oncology paper, Van Gool started treating some patients before receiving approval from the federal authority. Eckert told us:

The trials were eventually approved, but not before 25 patients had received treatment.

Additionally, according to the documents Eckert obtained, the investigation raised doubts as to whether all patients involved in the clinical studies had consented to treatment, as some informed consent forms were missing.

Decramer told us the investigation did not reveal any issues with the actual results or conclusions of Van Gool’s clinical studies (of which, according to Eckert, there are at least seven).

Although UZLeuven decided to take action to prevent Van Gool from seeing patients and performing clinical trials at the prestigious Belgium institution, it has not stopped Van Gool from continuing to conduct research and care for patients. Since September 2015, Van Gool has been practicing at a clinic in Cologne, Germany and is still giving his experimental vaccine to patients, who must pay $45,000 or more for the three-course treatment. Van Gool also continues to receive funding support from various sources, including the Olivia Hendrickx Research Fund, Herman Memorial Research Fund, the James E. Kearney Foundation as well as gifts from private families, service clubs and organizations, according to the acknowledgments in a 2015 paper.

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