The chairman and other members of the higher committee responsible for approving and supervising experiments on people resigned in protest against a decision by the Health Ministry director general.
Moshe Bar Siman Tov decided to strip the committee of most of its authority and pursue a policy benefitting pharmaceutical companies seeking to conduct clinical trials in Israel.
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The group is formulating a joint letter of resignation, including a long list of other members wishing to terminate their roles. Committee members assert that most of the 21-person committee will resign soon.
Bar Siman Tov held a discussion last Thursday with committee members in which he presented the ministry’s policy change, including the removal of “obstacles” to pharmaceutical companies seeking to conduct clinical trials in Israel. According to members who attended the meeting, Bar Siman Tov claimed Israel should be “less Bolshevik” and rely more on market forces rather than on regulation.
Prior to the meeting, a one-page letter was sent to the committee chairperson, Prof. Stavit Shalev, in which the director general informed her of the dramatic change regarding approvals and supervision of clinical trials in Israel. In the new plan, Bar Siman Tov is canceling the exiting two-stage process of approving clinical trials and authorizing the local hospital committee, known as Helsinki committees, to approve human clinical trials. In doing so, he is vacating most of the higher committee’s authority. The plan is also to create a so-called central committee, to be headed by Prof. Jonathan Halevy, the former director of Shaare Zedek Medical Center, which will approve multicenter studies being conducted by several hospitals.
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The move, dropped on committee members without prior discussion of its consequences, drew harsh criticism. “The director general is stripping the committee of its authority and caving into big pharma and local hospitals with this move,” said Rabbi Yuval Cherlow, a longtime committee member. “He is removing the obstacle of the ethics board and allowing them to do everything. He says the consequences could cost patients in Israel dearly, hurting the quality of trials and even the researchers themselves.
The Higher Helsinki Committee consists of 22 members, including doctors and researchers from various fields with an emphasis on genetics and fertility, legal and ethics experts, and representatives from the public and health system. The voluntary committee meets monthly. Members discuss and issue opinions on trials, mainly in sensitive fields like genetics, fertility-related trials and any clinical trial requiring special attention. The committee examines the medical logic of a trial, how it is conducted and ethical aspects.
Genetics have been the most relevant concern lately, such as discussions on the importance and approval process of the Health Ministry’s Mosaic Project for creating a database of biological and genetic samples in Israel.
According to a committee report, the committee discussed 159 study proposals and 81 requests for supervising existing studies. The studies discussed including among others pharmacogenetics, genetic testing for medical purposes, embryonic stem cell research, fertility and studies with participants who cannot grant consent.
Only 55 of the 159 study proposals were approved without requiring adjustments. 41 required changes before approval at the hospital committee level. 30 percent required changes and further review by the higher committee. Just 2 percent were rejected. “The higher committee gets proposals that are disgracefully regarding the methodology and meeting demands of the law, and that’s after passing the institutional Helsinki Committee,” said Cherlow.
He sees Bar Siman Tov’s move as dangerous, dismantling a vital defense and control mechanism regarding human clinical trials. “Israel is starting to fall behind other countries with higher ethical demands.”
Other committee members criticize the move in the belief that the local committees are fell less able to analyze and supervise clinical trials. “These committees have five members, mostly doctors and a member of the hospital’s legal team,” said one member. “The hospital has an interest to conduct tests, be it to have a reputation as an innovator or economic reasons. The higher committee has sent back many proposals for corrections and clarifications. Now there’s no one to supervise the hospitals.”