Health Ministry Finds Serious Illegal Use of Experimental Treatment at Bnei Brak Hospital

Israel’s Health Ministry said on Sunday it is reviewing a hospital case in which an experimental drug was given as a so-called compassionate treatment at Mayanei HaYeshua Hospital in Bnei Brak, without ministry approval and in violation of accepted medical and regulatory rules. The inquiry was opened by the ministry’s public complaints commissioner for medical professions after a complaint was filed.

The patient was an 84-year-old man with advanced pancreatic cancer and metastases. In February 2019, he received the experimental product Gammora, from a pharmaceutical company, as a compassionate-use treatment that had not been authorized by the Health Ministry. During the course of treatment, he developed sudden neurological symptoms, the treatment was stopped at the family’s request, and he died several weeks later.

The committee examined the hospital’s Helsinki Committee process, the approval steps taken, the regulatory basis for preparing and using the drug, and the conduct of all involved parties. It found that the treatment was carried out unlawfully and with major failures: it did not fit any legal route, including a clinical trial, emergency treatment, or compassionate use, and the committee said misleading information had been given to it.

Investigators also found that the drug had not been approved for use in humans. Its import permit was issued on the understanding that it was for laboratory use only, as stated in the manufacturer’s materials, yet it was converted for human treatment unlawfully and prepared by people without proper training. The committee also said the hospital’s approval, control, and oversight processes were seriously flawed and had relied on approval given to another patient at Ichilov Hospital. It concluded the failures were deliberate, not merely systemic, but said it could not determine with high confidence whether they worsened the patient’s condition, since he may have died from the progression of his cancer. The ministry said it will continue examining the conduct of the institutions and people involved and, after receiving their responses, will decide on further steps.