Final report "unsupported" - out of respect for patients

Many of the patients in Haukeland who took part in the Norwait Cancer Study had metastasis. After that, there was a storm surrounding the study. Now the Regional Research Ethics Committee rejects the study’s final report.

The Norwegian Health Authority decided that the research conducted by the Haukland University Hospital in the Norwich cancer study could not be relied upon. However, the results were included in the final report. Photo: Marit Humedal/NTB

The Regional Committee for Medical and Healthcare Research Ethics (REK Vest) is not satisfied with the final report of the Norwait Cancer Study. The committee takes a very unusual step: sends a final report of a research project to the project manager.

A final report is sent to the regional committee upon completion of the research project.

– Out of respect for patients, researchers should conduct a comprehensive scientific analysis of Norwich’s study, the panel writes.

There has been a storm over Norwhite’s study. Gross errors were detected in the inclusion of patients in the Haukeland study. Many experienced tumor regrowth and cancer spread.

In the inspection case, the Norwegian Health Authority found a violation of the Health Research Act. This applies to the project manager as well as the University Hospital Stavanger and the Haukeland. The director of the Norwegian Health Authority, Fredrik Andersen, drew heavy criticism.

Serious and exceptional

But controversies surrounding the study have not subsided. The final report of the study was submitted to the Regional Ethics Committee (REK) at the end of January.

After that, several people who participated in the study wrote to REK. They point out that the report contains several factual errors, and that the analyzes are erroneous and misleading. Shows which emails Aftenposten has accessed.

“The real estate agency will confirm the seriousness and exceptional nature of the case,” the press release read.

The committee stresses that the patients in the study exposed themselves to personal risks. And that it is important to appreciate their important contribution to the new knowledge through participation in the study.

“Out of respect for their efforts, researchers should conduct a comprehensive scientific analysis, processing and publication of the data,” REK wrote.

The Committee believes that it is very important to make complete data visible in the final report. Refers to openness and transparency in research.

facts

This is Norwitt’s study:

All patients in Norway with rectal cancer who had previously received radiation therapy could join the study.

In the national project, one could study whether these patients could avoid major disease
The operation in which the rectum is removed.

Only patients who had complete tumor regression after prior treatment could participate in the wait-and-see scheme.

Classes began in the winter of 2018.

Patients had to be followed closely to see if the tumor returned. This regrowth was thought to occur in four out of ten. Regrowth does not result in a reduced prognosis if it is performed promptly.

Listing abruptly stopped in November 2020.

A review showed an unexpectedly high rate (33 per cent) of local regrowth with metastasis for patients at the University Hospital of Haukland.

Of the 31 people from Hokland, at least 16 are included who should not have been included. Several violations of the search protocol were detected.

It also included three times more than expected.

At least eight of them had additional tumor growth and spread of the cancer.

It is normal for the research projects that are being implemented to be published. Before publication, they are reviewed and critically analyzed – they receive what is called peer review, notes Nina Langland. She is the chair of a committee at REK Vest.

Patients were discontinued. Hospitals are following up on patients who are still in the waiting-and-see phase. It is not appropriate to post anything yet.

– Then our alternative is to demand a final report that has a format similar to a scientific publication, as you say.

Scientific analysis of data from participants will be in the interest of patients and the general public. REK’s mission is to ensure that ethics and patients’ rights are protected.

The final report of a research project is usually not very detailed. And it doesn’t have to be, because it’s usually associated with a scientific publication. But it is not in this case.

He does not take a stand on right or wrong

REK points out that the Health Research Act is clear: The final report must present the results of the study “in an objective and consistent manner.” It must ensure that both positive and negative results emerge.

– We did not take a position on right and wrong in the final report. Langland says there are many strong opinions on this subject from several parties.

And remember, it is the project manager’s responsibility to create a final report in the format that will be approved by the REK. He was given a six-month deadline.

– The project manager received strong criticism from the Norwegian Health Authority. Do you trust him to lead the work on the revised final report?

– He’s a scientifically qualified researcher who’s quite capable of revising this in a good way, you say.

Hans Wasmut, a gastric surgeon and retired physician from St Olav’s Hospital, is one of the whistleblowers in the Norwit case.

In the event of an oversight, the Norwegian Health Authority has ordered the research project in Haukeland to be halted. They didn’t trust the search there. Thus, they cannot be included in the reports and publications from the Norwich study, she says. But in the final report, all figures from the seven hospitals are treated equally.

Aftenposten asked the project manager for comment. Refers to University Hospital Stavanger (SUS) as Director of Research.

Communications director Helga Strand-Vestbo at SUS says they have just received feedback from REK and will review it well.

It covers more than it reveals

Hans Wasmuth, a gastric surgeon and retired physician from St Olav’s Hospital, is one of the whistleblowers in the Norwich study. He criticizes the final report.

There are two points in particular that are believed to be dangerous:

That Haukeland’s numbers are combined with those from other hospitals, despite an order from the Norwegian Health Authority.
The final report does not mention actual numbers, only percentages. He thinks this is unscientific and could give the wrong impression.

“The termination notice does not answer in any understandable way as to why the study failed, or what was critical to it now being terminated as a study,” he wrote in an email to REK.

And Wasmuth is pleased that it should now be rewritten. He believes that the final report is characterized by a violation of recognized standards of research ethics.

— it covers more than it reveals what went wrong in the study, he points out.