Israel’s Health Ministry has released the findings of an investigation into an experimental cancer treatment administered at Mayanei Hayeshua Medical Center, concluding that the treatment was given unlawfully, without the required regulatory approvals, and in violation of established procedures.

The investigation centered on the case of an 84-year-old patient with advanced metastatic pancreatic cancer who, in February 2019, received an experimental drug known as Gammora under what was described as a “compassionate use” treatment.

According to the Health Ministry’s investigative committee, the treatment was administered without the ministry’s approval and did not qualify under any of the legally recognized frameworks for experimental treatment, including clinical trials, emergency treatment, or compassionate use.

During the course of treatment, the patient developed sudden neurological symptoms. At the request of the patient and his family, the treatment was discontinued. He died several weeks later.

The committee examined the conduct of the hospital’s Helsinki Committee, the approval process, the preparation and administration of the experimental drug, and the actions of those involved in authorizing the treatment.

The report found that the drug had never been approved for use in humans. It also revealed that permission to import the substance into Israel had been granted only after it was declared to be intended for laboratory research—not for human treatment.

Despite that restriction, the drug was reportedly prepared for human use by individuals who lacked the appropriate qualifications.

Investigators further found that misleading information had been provided to the committee that approved the treatment and that the approval process relied in part on a previous authorization granted for another patient at Ichilov Hospital.

The committee identified what it described as significant failures in the hospital’s approval, oversight, and supervisory processes, stating that the deficiencies were not the result of a systemic error or isolated mistake, but rather “failures that were carried out knowingly.”

At the same time, the committee stopped short of concluding that the experimental treatment caused the patient’s death. According to the report, it could neither rule out a connection between the treatment and the patient’s deterioration nor determine such a link with a high degree of certainty. It noted that the patient may have died as a result of the progression of his advanced cancer.

The Health Ministry said it will continue reviewing the conduct of the hospital and those involved. After receiving their responses to the findings, the ministry will consider enforcement measures while implementing additional safeguards and oversight for future experimental and compassionate-use treatments.

(YWN World Headquarters – NYC)