Experimental Treatment Given Without Approval at Bnei Brak Hospital; Patient Later Died, Investigation Finds
Israel’s Health Ministry on Sunday released the findings of an investigative committee that examined the circumstances surrounding an experimental treatment administered several years ago at Bnei Brak’s Mayanei Hayeshua Medical Center under what was described as a “compassionate use” arrangement.
According to the ministry, the committee concluded that the treatment was administered unlawfully and that several of the violations were committed knowingly by those involved.
The panel was established by the Health Ministry’s Public Complaints Commission for Medical Professions following a complaint filed regarding the case. The ministry said it will continue reviewing the conduct of the institutions and individuals involved and will determine what enforcement and disciplinary measures may be warranted after receiving responses to the report’s findings.
According to the investigation, the case involved an 84-year-old patient suffering from advanced pancreatic cancer with metastases. In February 2019, the patient sought treatment with an experimental drug known as Gammora, developed by a pharmaceutical company. The treatment was administered under the designation of “compassionate use” despite lacking approval from the Health Ministry.
During the course of treatment, the patient reportedly developed sudden neurological symptoms. The treatment was subsequently halted at the family’s request, and the patient died several weeks later.
As part of its review, the committee examined the conduct of the hospital’s Helsinki Committee and the approval procedures that were followed, including the evaluation of the request, regulatory aspects surrounding preparation and administration of the drug, the actions of the individuals involved, and compliance with Health Ministry regulations and guidelines.
The committee found that the treatment was carried out improperly and suffered from significant procedural failures. According to the report, the treatment did not qualify under any of the legally recognized pathways for administering such care, including clinical trials, emergency treatment, or compassionate-use treatment. It was not approved by the Health Ministry and was carried out in violation of both legal requirements and ministry regulations. Investigators also found that misleading information had been provided to the reviewing committee.
The report further determined that the drug had never been approved for use in humans. Import authorization had been granted based on declarations that the substance was intended solely for laboratory use, a designation that was explicitly stated in the manufacturer’s documentation. The committee concluded that converting the substance for human treatment was unlawful and that the preparation of the drug was performed by individuals who lacked the appropriate qualifications.
Investigators also identified major deficiencies in the hospital’s approval, oversight, and supervision procedures. According to the findings, authorization for the treatment relied in part on approval previously granted for a different patient at Ichilov Hospital. The committee concluded that the failures were not the result of a systemic breakdown but rather represented conscious decisions made by those involved.
At the same time, the committee emphasized that despite the seriousness of its findings, it could not determine with a high degree of certainty whether the irregularities directly contributed to the patient’s deterioration or death. Investigators noted that the patient may have died as a result of the progression of his underlying illness and worsening medical condition.
The report concludes by stressing the importance of adhering to regulatory safeguards designed to protect patients, even in cases involving severe illnesses where families are searching for additional treatment options.
{Matzav.com}
