Bnei Brak hospital probe finds illegal experimental treatment was given without approval

Israel’s Health Ministry on Sunday published key findings from an inquiry into treatment given at Mayanei HaYeshua Hospital in Bnei Brak under what was presented as a “compassionate use” case. The investigation was opened by the ministry’s Public Complaints Commissioner for the Medical Professions after a formal complaint, and the ministry said it will keep reviewing the conduct of the institutions and people involved and take further steps after receiving their responses.

The case involved an 84-year-old man with advanced pancreatic cancer and metastases who sought access to the experimental drug Gammora. According to the ministry, the treatment was administered in February 2019 as compassionate use, but without Health Ministry approval. During the treatment, the patient developed sudden neurological symptoms, the family asked for the treatment to stop, and he died several weeks later.

The committee reviewed the hospital’s Helsinki Committee process, the approval chain, the regulatory handling of the request, and the preparation and use of the drug. It concluded that the treatment was unlawful and contained major failures: it did not meet the legal requirements for any available pathway, including a clinical trial, urgent treatment, or compassionate use; it was not approved by the Health Ministry; and false information was presented to the committee.

The inquiry also found that Gammora was not approved for use in humans. Its import authorization to Israel was issued on the basis that it was for laboratory use only, as stated in the manufacturer’s materials, and converting it into a treatment for humans was done illegally and prepared by unqualified personnel. The committee said the approval and oversight failures were significant, that the approval relied on authorization previously granted to another patient at Ichilov Hospital, and that the breaches were deliberate rather than systemic. However, it said it could not determine with high certainty whether the failures worsened the patient’s condition, since he may have died from the progression of his underlying disease. The report stressed the need to follow regulatory procedures even when families of gravely ill patients are seeking treatment options.