In recent days there has been a big uproar regarding the Helsinki Committee, what it determined or did not determine, and what it means for the vaccine. So let's break down the issue, to understand what the Ministry of Health really did wrong, and what this means for Pfizer, the vaccine and also the Helsinki Committee
In recent days there has been a big uproar regarding the Helsinki Committee, what it determined or did not determine, and what it means for the vaccine. So let's break down the issue, to understand what the Ministry of Health really did wrong, and what this means for Pfizer, the vaccine and the Helsinki Committee.
Let's start with the Helsinki Committee.
The committee is an independent body - that is, it is not subordinate to any country - that tries to make sure that medical experiments will take place according to national (at the state level) and international ethical rules. In every case of a medical experiment, the committee accepts the planned experiment protocol and determines whether it is safe for the participants. It is not only about safety in terms of their health, but also that the rights of the participants are not compromised. That is, that the participants receive a clear explanation of the way the research will be conducted, and only then will they sign the agreement to participate in it.
I will add and point out that there is a very good reason for the existence of the Helsinki Committee. We have already seen that medical experiments supervised by internal national committees can disobey international rules of ethics and even basic morality. This is what happened in the medical experiments conducted by the Nazis (as an extreme example), but also in more 'light' cases such as an experiment conducted in the United States more than fifty years ago, in which hundreds of poor blacks did not receive proper treatment for syphilis.
And now to the Ministry of Health.
The Ministry of Health recently signed an agreement with Pfizer. In other words, the prime minister signed the law in practice, but let it go. Pfizer promised, as part of the agreement, to provide vaccinations to all residents of the country, with the exception of children and those who cannot be vaccinated. In exchange for this, the Israeli government will pay a handsome sum for each vaccine, and also - and here is the crux of the dispute - will provide Pfizer with information that will allow it to assess how effective the vaccine is[1].
Well, what information will Israel provide to Pfizer? There is no clear answer to that. The Ministry of Health claims that it will only provide Pfizer with "general epidemiological" information - that is, information about the spread of the epidemic, and probably about the effectiveness of the vaccine against it. Even in the agreement there is no clear explanation about the information. However, there is a clarification that the "goals of the research" (unfortunate wording in itself) are to understand how many confirmed cases have been discovered, how many are hospitalized, how many severe cases, how many are ventilated, how many die and how many symptomatic patients[2].
So far, so good. Almost all of this information can be found on the website of the Ministry of Health and in the media, and it does not harm anyone's privacy.
The problem begins with the destination according to which the vaccinators will be divided according to several different parameters. It is not clarified what type of segmentation the Ministry of Health agreed upon. Is it segmentation by gender, for example? Even in this case, it is not a real violation of privacy, since it is impossible to identify individual vaccinators only by their gender. But what if the division is "every male living in Rishon Lezion, with two moles on his right cheek and a broken leg from the year XNUMX?" In this case, it is easy to identify the vaccinator - and therefore there is a violation of his privacy.
It can be assumed that the segments that Pfizer will require will not be so detailed, but since they are not exactly defined, it is impossible to know for sure. And even segmentation by age, sex, place of residence and underlying diseases, for example, may betray the identity of some of the vaccinated.
Commitment to maintaining privacy
The positive side is that it does not appear that either party had malicious intent to harm the privacy of those getting vaccinated. It was officially and explicitly clarified in the document that the information must comply with information privacy laws - both in Israel and in the United States. Pfizer has also pledged not to use the information in a way that is not designed to protect public health, and will not disclose the details of individual patients. This is encouraging, although not enough. It is not clear, for example, whether the Ministry of Health has created a position for an information security person who will make sure that the data transferred to Pfizer does not allow it and others to identify individuals. In an operation of this magnitude, it is important to have a professional (or several) who will be responsible for the issue.
Not only the Ministry of Health will provide information to Pfizer. Pfizer has pledged to transfer to Israel all the information it has about the vaccine, and will allow the Ministry of Health to consult weekly with its experts to understand the impact and effectiveness of the vaccine.
The main problem I see in the document is that several parts of it were censored - that is, blacked out - before it was revealed to the public. We cannot know as a result, for example, what the legal liability of both parties is. If there is a malfunction in the vaccine, who takes responsibility? If the medical information is not collected as required by the contract, what exactly will happen? we do not know. This, in itself, is a reason for the defect.
The Helsinki Committee - which oversees experiments on humans in Israel - decided to review the agreement on vaccines, and rightly so. Before we continue, we will jump directly to the final opinion of the chairman of the committee, Prof. Eitan Friedman. I am quoting here from Globes -
"The vaccine itself passed all approvals. The vaccine is not a clinical trial, and we urge everyone who does not have a contraindication to go and get vaccinated. We want to make sure as the Helsinki Committee that the rights and privacy of the citizens of the State of Israel are preserved even when clinical research is conducted which is proper research."[3]
I repeat: the chairman of the Helsinki Committee announced that the vaccination "is not a clinical trial" and called on people to get vaccinated in a way that is not ambiguous.
What is the real concern of the Helsinki Committee? Well, first of all the committee wants to make sure that the information that is transferred to Pfizer does not violate the privacy of the vaccinated. The state did not turn to the Helsinki Committee to get approval for the agreement in this respect, but - and this is a big pity - there was no reason to think that the vaccination operation should be defined as a "clinical trial". Yes, data on the success of the vaccine is transferred to the Pfizer company, but the operation is not officially registered anywhere as a "clinical trial". In fact, Prof. Friedman himself clarified that this is not a clinical trial!
It is therefore understandable why the state did not even bother to contact the Helsinki Committee for approval for the experiment... simply because it is not an experiment.
Clinical trial or post marketing research?
So what's going on here? Has the committee determined that this is a clinical trial or not?
Now things get complicated. It seems that the members of the committee do not completely agree with each other. And again I return the microphone to Prof. Friedman who said -
"You don't need any ethical approval, you don't need any regulatory approval - you don't need any involvement of the Helsinki Committee. What's the fuss about? Some of the committee are lawyers, they read the agreement between the Ministry of Health and Pfizer. We want to make sure that the details and rights of the citizens of the State of Israel are preserved - even when research is carried out which is proper research."
What does Prof. Friedman actually say? that the jurists on the committee simply want to make sure that the details and rights of the citizens of Israel are preserved. The Helsinki Committee should really monitor every clinical trial in this regard. But if it is not a clinical trial, as the chairman of the committee himself said, then what does the Helsinki Committee have to do with the whole thing??
I think we can all agree that the requirement to protect citizens' privacy is very appropriate, regardless of whether it is a clinical trial or not. But it seems that the committee messed with the bureaucracy - and perhaps its own ego - and tried to dance on both weddings. It's not a clinical trial... or it is. And the committee has the authority to deal with it... or not. The conflicting messages come from the committee itself!
All this does not change two facts, and here we will summarize the record.
First, no one on the committee claims that the vaccine did not go through the proper procedures to ensure that it is effective and safe to use. If for a moment you were worried about this issue - you can relax.
Second, the Ministry of Health - and the state - did not conduct themselves completely well. Not because they didn't contact the Helsinki Committee - as I wrote, there was no reason to think it was a clinical trial - but because they hid details about the agreement with Pfizer. In fact, they are still hiding details instead of being completely transparent with the public. The completely predictable result of this conduct is that the public has lost faith in the Ministry of Health. Beyond that, we do not know how the Ministry of Health intends to transfer the information to Pfizer in a way that will be safe and will not reveal the identity of the vaccinators.
Does all this mean that it is not worth getting vaccinated? Definately not. If you care about your health - go get vaccinated. And if you care about your privacy... well, why the hell are you even reading this post on Facebook, browsing Google's browser, or using Instagram, WhatsApp, Tinder and all the rest? Privacy disappeared a long time ago.
Go get vaccinated.
[1] https://www.ynet.co.il/health/article/ByChKlmyd
[2] https://www.globes.co.il/news/article.aspx?did=1001357428
[3] http://www.ice.co.il/law/news/article/804591
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