How did Israel's Ministry of Health become Pfizer's Agent?

By Dr. Guy Shinar

✍️ Dr Shinar is a physicist with 20 years of experience in the development, clinical research and regulation of medical devices, and a member of the Israeli Public Emergency Council for the COVID-19 Crisis.

The article the mainstream media refuses to publish. Read now:

🚨 The research collaboration agreement between Israel’s Ministry of Health and Pfizer [1] is a fascinating document, which shows line after line how a country voluntarily dissolved its sovereign powers and turned into a marketing and distribution agency on behalf of a commercial enterprise overnight. All of this within a narrow tunnel vision of the country’s responsibility to public health that it is supposed to serve.

🚨 A bit of background: at the end of 2020 Israel was facing an empty trough. None of the aggressive measures taken by Israel against COVID - lockdowns, social distancing, school closures and attempts to cut off the chain of infection by means of quarantine - had succeeded in preventing the spread of the virus. In addition, then Prime Minister Benjamin Netanyahu faced the threat of the disbanding of his government and replacing his rule in the elections, in the shadow of indictments pending against him. Netanyahu decided to bet on Pfizer's vaccine as a strategy that would allow him to solve both the COVID problem and the change of government problem at the same time. In this way, in exchange for the privilege to be the first country in the world to rollout the vaccine among its population, Israel entered into two agreements with Pfizer: a production and supply agreement that was not made public at all; and “The Real World Epidemiological Evidence Collaboration Agreement” [1] which is discussed in this article.

🚨 “The Real World Epidemiological Evidence Collaboration Agreement” was signed on January 6th, 2021. Its declared purpose was to measure and analyze epidemiological data arising from the vaccination of the population in Israel, and to determine if herd immunity is achieved as a result of the vaccine. In the framework of this agreement, research collaboration results were defined. All explicitly defined results were efficacy results, such as number of infected with COVID, number of hospitalizations with COVID, and death from COVID, or indices on the speed of the vaccine rollout in Israel, such as the number of vaccinated by age and demographic characteristics. None of the results that were explicitly agreed upon in advance were safety outcomes, such as overall mortality, hospitalizations from any cause or the known side effects of vaccines, whatever they may be.

🚨 The agreement included a declaration, according to which the two parties recognize that the success of the cooperation depends on the rate and extent of the vaccine rollout to the population in Israel. Israel’s Ministry of Health promised that the distribution, deployment, and provision of the vaccine to the population would be carried out in a timely manner. All of this without any condition on the matter of the safety of the vaccine, excluding a “catastrophe” which would bring about the vaccine being taken off the shelves. It isn’t clear from the agreement which of the parties would define what is defined as a “catastrophe” and what steps would be taken in order to identify that “catastrophe” before or at the beginning of its occurrence.

🚨 The agreement defines that Pfizer will collaborate with Israel’s Ministry of Health by providing, according to their own discretion, experts in the fields of: infectious and respiratory diseases, vaccines, epidemiology, mathematical modeling, data analysis and public health. The parties agreed to provide each other with documentation and computer programs from statistical data analysis. In other words, the agreement defines that Pfizer’s role not only amounts to providing vaccines and setting research goals, but also provision of experts in data analysis and data analytics programs. As such, Israel’s Ministry of Health gave up its scientific independence, not only in determining the research goals, but also in its execution.

🚨 One clause in the agreement discusses publications as a result of the collaborative research. The parties agreed to publish together in the scientific and medical literature, while marking the contribution of each of them. However - and this is a big however - each of the parties maintains the right to prevent the other party, in case the other party decides to publish separately, to mention the first party in the publication. In other words, Pfizer has the power under the agreement to omit any reference to its contribution to research, so its involvement in setting research goals, methods or even in writing it is not mentioned at all. The study can be portrayed as independent of Pfizer, although it is not necessarily so. In addition, if either party wishes to publish without the other party, then it is the duty of the party wishing to publish to submit the publication for review and feedback from the other party (the time allotted for the review is blacked out and we do not know how long it is). This is how the party who is not interested in the publication can suspend it - which may render the publication meaningless in a dynamic event such as COVID. In other words, the agreement gives Pfizer considerable control over the content and timing of the publications.

It should be noted that entire clauses in the agreement - such as legal liability and indemnification - are blacked out. So are whole sentences or key numbers from other sections.

Finally, under the agreement, the Ministry of Health gives Pfizer the right to use data collected as part of the collaboration, for purposes such as research and development, submission to regulatory authorities, scientific publication and other business objectives.

🚨 Why is the agreement with Pfizer so significant? Because it turns the state from a sovereign entity to an agent of a commercial pharmaceutical company seeking to operate in its territory.

The role of the state is to continually improve the health of its citizens and residents. As a result, it imposes safety, efficacy and quality requirements on pharmaceutical companies, and operates a regulatory system with legal authority to determine whether or not the drugs meet these requirements. The role of the pharmaceutical company is to test the efficacy and safety and ensure the quality, to the full satisfaction of the state. The one who markets and distributes the drugs is of course the drug company and not the state. This is not the case under the agreement with Pfizer, in which the Ministry of Health takes on some of the roles of the supervised, and in fact puts itself in a conflict of interest with its own role as the supervisor: it follows from the agreement that the Ministry of Health turns into: (1) the vaccine distributor and marketer for the population; (2) a research and data collection contractor on results aimed at evaluating the efficacy of vaccines alone, and not their safety; (3) the “publisher” of the study’s results, under the academic guise of its own health authorities (such as the major health funds or the Ministry of Health itself) in which articles are written whose publication actually requires Pfizer's approval.

🚨 It is worth noting here that all the Israeli studies signed by senior Ministry of Health officials, which appear to have been produced under the collaboration agreement, were carried out in the agreement’s spirit. None of them examined the two main results required for a reliable assessment of the vaccine’s efficacy-safety ratio: a valid comparison of overall mortality and hospitalizations for any reason between the vaccinated and the unvaccinated. Only one article [2] (and a letter to the editor that followed it [3]) examined any safety outcome - myocarditis - and concluded that it appears infrequently and is usually mild. The rest [4-7] tested only efficacy results, exactly as explicitly defined in the agreement.

🚨 Why did Ministry of Health officials enter into this agreement? Why did they not maintain their role as regulators, and volunteer to serve as Pfizer's marketing, distribution, research and publication branch? It’s almost certain that they believed with all their hearts - though they did not know at a sufficient level of certainty - that the vaccine was safe enough to use, especially since they overestimated the danger of COVID. In addition, it can be assumed that the pressure from Netanyahu and his bureau contributed to the matter. But the personal aspect cannot be ignored: many of the articles, which appear to have been written as a result of the collaboration agreement, were published in an expedited procedure in the best medical journals, and in particular the prestigious New England Journal of Medicine (NEJM). Publication in the NEJM is of the utmost prestige, and may have a lot of weight in terms of promotion in academia. Some of the articles are signed by the head of the public health services, Dr. Sharon Alroy-Preis (six publications in NEJM) and the director general of the Ministry of Health, Prof. Nachman Ash (three publications in NEJM) [2-7]. Here it is worth noting that according to the PubMed database, Dr. Alroy-Preis published only three articles before her appointment as head of public health services in 2020, and since her appointment about a year and a half ago, she has published no less than 16 articles.

🚨 So what exactly did we have here? The research collaboration agreement between the Ministry of Health and Pfizer reflects a preconceived notion according to which the vaccine is safe to use and all that remains to be researched about it are various indicators that are supposed to demonstrate its effectiveness. This is despite the fact that at the time of entering into the agreement there wasn’t (and in my opinion, there still isn’t!) any reliable information regarding its safety: Pfizer's randomized trial [8] was too small and short to allow sufficient characterization of safety, and to the best of my knowledge no subsequent trial examined differences in overall mortality or hospitalizations for any reason between randomly assigned or paired groups of vaccinated and unvaccinated. Leaving this preconceived notion became almost impossible once the agreement was signed, due to a confluence, not only between Netanyahu's political agenda and Pfizer's commercial interests, but also between them and the academic prestige of senior Ministry of Health officials. Israel would have done well if it had refrained from entering into the agreement. In this way, Israel could have rolled out its vaccination program in a measured way among the at-risk populations, without having to do so hastily as a result of a contractual obligation, and without forcing it in practice, through the Green Pass, on the entire population, and on children, in particular.

Sources:

https://govextra.gov.il/media/30806/11221-moh-pfizer-collaboration-agreement-redacted.pdf

https://www.nejm.org/doi/full/10.1056/NEJMoa2109730

https://www.nejm.org/doi/full/10.1056/NEJMc2116999

https://www.nejm.org/doi/full/10.1056/nejmoa2114228

https://www.nejm.org/doi/10.1056/NEJMoa2114255

https://www.nejm.org/doi/full/10.1056/NEJMc2104036

https://www.nejm.org/doi/pdf/10.1056/NEJMc2119358

https://www.nejm.org/doi/full/10.1056/nejmoa2034577

11221 Moh Pfizer Collaboration Agreement Redacted

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