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Health12:57 · Jun 14

Health Ministry Finds Deliberate Breaches in Experimental Cancer Treatment Case

YnetCenter
Translated & summarized from Ynet by baba
The story · English

A Health Ministry inquiry has concluded that serious violations occurred seven years after an experimental treatment was given to a cancer patient under compassionate use at Mayanei HaYeshua Hospital in Bnei Brak. The ministry said it is now considering action against those involved. The patient died several weeks after the treatment was stopped, but the committee said it could not determine that the procedure caused his death because he had advanced pancreatic cancer.

The review was opened by the Public Complaints Commissioner for Medical Professions after a complaint alleged the treatment had been given against accepted medical guidance and without the required regulatory approvals. The patient, about 84, had metastatic pancreatic cancer and sought treatment with the experimental drug Gammora from a pharmaceutical company. It was administered in February 2019 as compassionate use, without Health Ministry approval. During the treatment he developed sudden neurological symptoms, the family asked for it to be stopped, and he died a few weeks later.

The committee examined the hospital’s Helsinki Committee process and the approval route used at Mayanei HaYeshua, including how the request was assessed, regulatory aspects of preparing and authorizing the treatment, and whether staff complied with ministry rules. Its findings said the treatment was unlawful and contained major failures. It was not eligible under any legal pathway, including a clinical trial, emergency treatment, or compassionate use. The ministry had not approved it, and the committee said misleading information was given to reviewers.

The report also found that the drug had not been approved for human use. Its import permit was granted on the stated basis that it was for laboratory use only, as the manufacturer’s materials also said. Converting it for human treatment was therefore unlawful, and it was prepared by people without suitable training. The committee said the hospital’s approval, oversight, and supervision processes were seriously flawed, and that the approval relied on authorization previously given to another patient at Ichilov Hospital. It concluded these were deliberate failures, not a systemic flaw. The ministry said it will continue reviewing the institutions and individuals involved, seek lessons to protect patient safety, and then decide on further steps after receiving their responses.

Read the original at Ynet
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