Health Ministry Finds Major Irregularities in Compassionate-Use Gammora Treatment

Israel’s Health Ministry said it has completed an inquiry into serious failures in the approval of a compassionate-use treatment involving Gammora, a drug developed by Zion Pharma, now known as Code Pharma. The treatment was given at Mayanei HaYeshua Hospital, and the ministry said the committee found the violations were committed knowingly by those involved. The ministry is now weighing its next steps, and its notice did not specify whether the hospital alone was responsible or whether the drug company was also implicated.

Compassionate-use treatment refers to using an unapproved product outside a clinical trial when a patient has very limited alternatives. The ministry said this case did not comply with accepted medical guidelines or regulatory requirements. The patient, a man in his 80s, had advanced pancreatic cancer with metastases and sought treatment with the experimental Gammora product. During the course of treatment he suddenly developed neurological symptoms, the treatment was stopped at the family’s request, and he died several weeks later.

The committee concluded the treatment was unlawful and involved major deficiencies. It found that none of the legal pathways for such use applied, including a clinical trial, emergency treatment, or compassionate use. The product had not been approved by the Health Ministry, and the committee said the procedure breached ministry rules and the law, while also involving misleading information provided to the committee.

According to the findings, the import permit for the drug was issued only on the basis that it was intended for laboratory use, as also stated in the manufacturer’s information sheets, so its conversion for human treatment was unlawful. The preparation was carried out by people without suitable training. The committee also found serious failures in the approval, oversight, and monitoring processes required by the hospital, and said the authorization relied on approval previously given to another patient at Ichilov Hospital. Even so, the committee said it could not determine with high certainty whether these failures caused the patient’s deterioration, since his death may have resulted from the progression of his illness. The hospital had not responded by publication time.