The Ministry of Health today publishes the main findings of the inspection committee appointed to examine the circumstances of the treatment provided as part of a procedure presented as "compassionate care" at the Einei Hayeshua Hospital.
The committee was established by the Public Acceptance Commission for Medical Professions at the Ministry of Health, after a complaint was filed with the commission on the subject.
In accordance with the report, the Ministry of Health will continue to examine the conduct of the institutions and parties involved, to draw the necessary lessons for maintaining patient safety and enforcing the guidelines regarding medical treatments. After receiving the parties' comments on the report's findings, the Ministry will take the steps available to it on the matter.
The committee was appointed following a case in which a patient was given treatment with an experimental drug as part of "compassionate care," when the treatment was carried out in violation of accepted medical guidelines and without meeting the required regulatory requirements.
The patient, aged 84, was diagnosed with advanced pancreatic cancer with metastases, and sought treatment with an experimental drug, Gammora, from a pharmaceutical company. The treatment was administered in February 2019 as "compassionate care" without approval from the Ministry of Health. During the treatment, the patient developed sudden neurological symptoms. The treatment was discontinued at the family's request, and the patient died several weeks later.
As part of the examination of the incident, the conduct of the Helsinki Committee and the approval procedures taken at Mayanei Hayeshua Hospital were examined, including the manner in which the request was reviewed, regulatory aspects of the preparation, approval of the treatment and use of the preparation, the conduct of the parties involved and their compliance with the procedures and guidelines of the Ministry of Health.
The committee's conclusions revealed that the treatment was carried out illegally with significant deficiencies. The committee determined that the treatment did not meet the conditions of any of the existing legal pathways, including medical trials, emergency treatment or compassionate care, was not approved by the Ministry of Health and was carried out in violation of the provisions of the law and the ministry's procedures and provided misleading information to the committee. It was also found that the preparation was not approved for use in humans and the import permit to Israel was granted in accordance with a declaration that it was intended for laboratory use only, as also explicitly stated in the manufacturer's information sheets, so that its conversion to human treatment was done illegally, and its preparation was done by persons without appropriate training.
In addition, the committee found that there were significant deficiencies in the approval, control and supervision processes required by the hospital, as the approval given there was based on approval given to another patient at Ichilov Hospital.
The committee determined that these were deliberate failures and not a systemic deficiency.
However, the committee's conclusions emphasize that despite the seriousness of the findings, it is not possible to rule out or determine with high certainty whether these failures caused the patient's condition to worsen. As there is a likelihood that the patient died due to the worsening of his medical condition and the progression of his illness.
The committee's report emphasizes the importance of complying with regulatory procedures designed to ensure patient safety, even in situations of serious illness where families are seeking therapeutic solutions.
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