January 23, 2021
No Comment: the Israeli Case
NO COMMENT: “Dr Tehila Schwartz-Altshuler, a lawyer of the Israel Democracy Institute, told Calcalist: ‘Anyone who could claim that this is not a clinical trial is simply a liar. This is the largest study of human beings of the 21st century.’”
The full article:
“The Helsinki Committee will declare that Pfizer is conducting an unauthorised human experiment in Israel
The committee charged with overseeing human trials is expected to declare that the vaccination campaign is a clinical trial and required prior approval.
Calcalist reports that the Helsinki Committee for Human Rights is expected to announce that Pfizer is conducting unauthorised human experiments in Israel.
The committee charged with overseeing human trials is expected to submit an opinion to the Ministry of Health, stating that the state-run immunisation process with Pfizer is a clinical trial and must therefore be approved in advance.
The supreme Helsinki Commission — charged with overseeing human trials in Israel — is expected to submit an opinion to the Ministry of Health, stating that the vaccination campaign conducted by the Israeli government together with Pfizer is fundamentally clinical research, a code name for human trials, and therefore requires the explicit authorisation of the Committee. The opinion has already been drawn up and it is expected that in the coming days it will be handed to the director of the Ministry of Health, Hezi Levy, possibly even today.
“Reading the contract signed between the Israeli government and Pfizer, it is clear, unequivocal and unequivocal that this is a clinical trial in every respect and therefore had to be approved by the Helsinki Committee”, a senior official explained to Calcalist, adding: “And this is what will be written in the Committee’s opinion: ‘There is nothing wrong with clinical trials, on the contrary, but clinical trials (human trials) must obtain the approval of the committee and, of course, of the persons on whom the trial is carried out, while at the same time giving the right to refuse to be part of the trial. These are basic matters’”, he concluded.
The chairman of the Helsinki Committee, Prof. Eitan Friedman, declined to comment to the publication and told Calcalist that the Committee will present its position in an orderly and customary manner, not through the media. Since the Committee is a statutory committee (established by law), the practical implication is that it will determine whether the human experiment Pfizer is currently conducting in Israel is unlawful.
The letter expected from the Helsinki Committee is of far-reaching significance. First, the Committee may establish that the Israeli government must stop transmitting information to Pfizer, which could cause Israel to breach the contract. If the government decides to ignore the Committee’s directive, every Israeli citizen will be able to appeal to the Supreme Court on the matter.
The Committee may also require that all Israeli citizens be informed that the results of the vaccine will be transmitted to a third party, and may also oblige the Ministry of Health to seek the consent of those vaccinated to being a subject of the experiment.
In addition, neither the Committee nor the citizens of Israel need use legal instruments: a short letter from the Committee announcing that it does not approve the experiment could greatly complicate matters for Pfizer and the Israeli government, since, following such a letter, Pfizer cannot approach the FDA and request final approval for the vaccine. “It is inconceivable that the FDA should grant final approval to a vaccine on the basis of a clinical trial rejected by the Israeli Helsinki Committee”, the paper says.
A lecturer in health communication at the IDC Herzliya International School, Dr Yaffa Shir Raz, responded to the Helsinki development, saying: “The question of questions: where does this scandal leave the Green Passport? Can the government go on promoting the coercion of the experiment upon us? The road to the court has never looked more paved, and this time it is hard to see how they will ignore it.”
Update: After the publication of the Calcalist report, the chairman of the Helsinki Committee, Prof. Eitan Friedman, issued a denial, saying that he and the whole Helsinki Committee continue to recommend the vaccine to those for whom it is not contraindicated, going on to say that “the vaccine is not a clinical trial. It is based on a clinical trial, it is based on experimentation. There is no connection between the vaccine and a clinical test.”
He says that the “commotion” centres on a single matter and that “as a supreme committee, some of its members are jurists and read parts of the agreement between the Ministry of Health and Pfizer, and we, as an ethics committee, wish to make sure that the rights and the privacy of Israeli citizens are guarded.”
He continued: “Also, when a clinical trial is carried out, which is a worthy study, we want to know from the scientific point of view what is happening, what the effects of the vaccine are, what the adverse effects are; yes, we very much want to know and to learn. But we want to know whether, within the contract with Pfizer, these rights are protected.”
Dr Tehila Schwartz-Altshuler, a lawyer of the Israel Democracy Institute, told Calcalist: “Anyone who could claim that this is not a clinical trial is simply a liar. This is the largest study of human beings of the 21st century. Israel is becoming the experimental field, not to say the backyard, for the whole world. It may be a fine and altruistic thing, but this should have been shared with the citizens of Israel.”
She says: “There is no clearer research hypothesis than in section 2.1 of the contract between the State of Israel and Pfizer, which provides that the purpose of the ‘experiment’ is ‘to measure and to analyse’. To say that it is not research is a lie. In section 2.2 the word ‘data’ appears again and again, and the point is that this is information from which you want to learn something other than transferring it into the medical file of the patient you have treated. This is a collaboration for research, and therefore there are also ‘Principles of collaboration’.”
Moreover, Schwartz-Altschuler explains that “article 4 — as in any medical research agreement — has terms and terminations, and there are agreements on the safety of the project. This further strengthens the fact that this is a study. For example, under the clause, the agreement will be revoked if one of the parties decides that it is ‘scientifically insignificant’.”
The English original at: https://www.israelnationalnews.com/News/News.aspx/295134
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