Should "anti-vaxxers" cite VSD, PRISM or CISA instead of VAERS?
The Case for Vaccine Data Science - Part 8
This is Part 8 of my Case for Vaccine Data Science series.
Are all mRNA vaccine skeptics automatically also anti-vaxxers?
First of all, not all mRNA vaccine skeptics are actual anti-vaxxers. But apparently, David Gorski approves of this rule where anyone who says “We are pro-vaccine, but <whatever>” is actually anti-vaccine!
Never mind that Gorski himself was very concerned that he might have to give up his primary vocation - ridiculing vaccine skeptics - if Trump got re-elected. (Emphasis mine)
Can we still trust the CDC and FDA (and other federal agencies, like the NIH, ostensibly dedicated to upholding policy based on good science)? Although the answer is still yes for most topics, for COVID-19 increasingly the answer is no. I fear that the list of topics on which the CDC and FDA can no longer be trusted will only grow if Donald Trump is reelected and that, even if he isn’t, some of the changes weakening the firewall between political appointees and the career scientific personnel of these agencies might be permanent and difficult for a President Biden to reverse.
So Gorski is pro-vaccine, but if Trump was re-elected then…?
No need to guess. He answers it himself:
That doesn’t mean using an EUA to authorize the use of a COVID-19 vaccine might not be reasonable under certain circumstances. It’s also true that it is not unreasonable not to trust the current FDA leadership to make a science- and ethics-based decision in the face of unrelenting pressure from the White House.
Well, oops! So David Gorski nearly turned in his pro-vaccine card because of a politician!
Why “anti-vaxxers” cite VAERS
Now, with this super broad definition of anti-vaxxer in mind, let us get back to the main topic of the current article.
From the same article, I see another very interesting comment which reflects the thought process of David Gorski and likely others who promote vaccines.
Let’s just say that there’s a reason that you almost never see antivaxxers like Jessica Rose and Joe Mercola citing the VSD, PRISM, and CISA results to promote their conspiracy theories. They’re active surveillance systems, and, far more often than not, analysis of their data fail to support the hypotheses generated by analyses of VAERS with respect to causation.
But this completely misses the point!
Only VAERS provides a transparent way to cross-verify what the other safety monitoring systems are claiming.
An example: Verification of CDC’s v-safe text mining
Once enough information was available (but don’t forget - only after a long delay to respond to the FOIA request, by which time every age group vaccine had been approved), I could actually cross verify the CDC paper published in Oct 2021!
Only to find out that the paper which was claiming that the vaccine was “safe and effective” based on “Findings from the CDC v-safe surveillance system” was actually a classic case of “Absence of Evidence” presented as “Evidence of Absence” (of vaccine danger).
1 In the paper, the CDC never mentioned that 7.7% of v-safe participants had “sought medical care”. This means they also did not mention that these people got a call from the v-safe call center to help them report the issue to VAERS
2 In turn, there was no effort to even check the v-safe data which had already entered VAERS
The problem with a protocol approved by an Institutional Review Board
Moreover, David Gorski is also quite upset that people are doing analyses “even without a protocol approved by an institutional review board”.
In the age of COVID-19, VAERS has become a weapon because of its very nature that makes it perfect for this purpose to antivaxxers. It is a completely open database. Anyone can submit a report of an AE after vaccination to it. The complete VAERS dataset (scrubbed of personally identifiable information, such as names) can be downloaded and analyzed by anyone, even without a protocol approved by an institutional review board.
But the CDC took over 12 months to respond to the FOIA request sent in by ICAN.
Should we really expect institutional review boards to behave any differently?
Are institutional review boards actually unbiased?
For example, here is someone who wanted to study blood work after mRNA vaccines and created a research proposal for an institutional review board.
So what is an institutional review board (IRB)?
From the article:
An IRB is an FDA-regulated committee that reviews research protocols. From the FDA website: “Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.“
Also from the same article:
Six months ago, I started collaborating with Dr. Aaron Williams and Dr. Jeff Jones to design a study looking at three potential biomarkers in patients who have had the COVID shots: troponin, testosterone, and ferritin. These markers - easily available to the general public and inexpensive - were chosen based on what we and others are seeing clinically in the vaccine-injured. We decided to study patients before and after receiving the latest bivalent COVID shots and submitted our protocol… outlined below… to the WCG IRB.
But the research proposal was rejected without an explanation:
Our efforts came to a screeching halt on November 7th when we received an abrupt email stating that WCG IRB would not be reviewing our study. I sent two follow-up emails asking why they were declining to review our research, but they did not respond.
Well, so much for IRBs and their protocols!
Summary
Too bad, Mr Gorski!
Us mRNA vaccine skeptics will just keep doing whatever we like, because we don’t trust the gatekeepers any more.