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Home » BMJ posts an opinion piece about VAERS — getting it wrong again

BMJ posts an opinion piece about VAERS — getting it wrong again


The BMJ, once known as the British Medical Journal, is generally a well-respected, peer-reviewed medical journal. The BMJ published the definitive takedown of the cunning fraud, Andrew Wakefield, by Brian Deer, which can be read herehere, and here. But now the BMJ seems to have moved from exposing the lies of anti-vaxxers to now allowing anti-vaccine opinion pieces and editorials, with a recent one about the VAERS system.

The BMJ seems to have gone off the rails on vaccines when they hired the notorious anti-vaccine disinformation specialist, Peter Doshi, to pen a few editorials and opinion pieces that broadcast anti-vaccine propaganda that makes it appear that the BMJ is supporting anti-vaccine nonsense. Doshi, who is NOT a vaccine scientist and lacks any scientific credibility in vaccine science, really went hard after the COVID-19 vaccines.

The new anti-vaccine opinion piece from the BMJ about the VAERS system made me laugh, but the humor was mitigated by the fact that it was just more anti-vaccine propaganda. And I had to deal with it.

person in blue long sleeve suit sitting by the wooden table holding black and silver pen
Photo by Tiger Lily on Pexels.com

First, what is VAERS?

Before I get to the BMJ article, I think I need to explain what is VAERS to the first-time reader.

The Vaccine Adverse Event Reporting System (VAERS) is one of the systems employed by the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) to monitor vaccine safety. VAERS is a post-marketing surveillance program, collecting information about adverse events (including death) that occur after the administration of vaccines to ascertain whether the risk-benefit ratio is high enough to justify the continued use of any particular vaccine.

VAERS, the Vaccine Safety Datalink (VSD), and the Clinical Immunization Safety Assessment Network (CISA) are the major tools used by the CDC and FDA to monitor vaccine safety. These are powerful tools that provide full information about each patient so that correlation and causation may be determined through powerful case-control or cohort analyses of the data.

However, there are no analyses that can establish any type of causation between the vaccination and the claimed adverse event that is reported to the VAERS database. Frankly, it can be gamed by those with nefarious intentions, which can limit the value of the VAERS data.

To be honest, VAERS is a feel-good system for those who think that there’s a link between vaccines and something terrible, but without an active investigation, the data is just above the level of totally meaningless. Most epidemiologists know it is valueless as a database to determine correlation and/or causation. Even the VAERS system itself says that the data cannot be used to ascertain the difference between coincidence and true causality.

According to the CDC:

Established in 1990, the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.

VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.

The VAERS website adds the following information about the database:

VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.

The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.”

If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.

In essence, VAERS is nothing more than anecdotes that have limited value, so they cannot show correlation or causation. But, it is not valueless. It can be used as a safety signal – if researchers observe a large number of reports for something, say myocarditis, then the scientific method should be employed to determine if the signal is something more than coincidence.

Here’s how real researchers use VAERS:

  1. Observation. Note the number of reports of a particular adverse event observed after a particular vaccine.
  2. Hypothesis. Ask the question, “Is the vaccine linked to a particular adverse event?”
  3. Test the hypothesis. Researchers could use the VSD, which contains full medical histories of patients who received and did not receive a particular vaccine. In other words, it’s real-world data that includes a “control group.” So, researchers could search for all cases of a particular adverse event in the database, and then they look at how many were vaccinated or unvaccinated. Or they could look at all patients in the database, split them into vaccinated and unvaccinated, and see if there’s a difference in the risk of a particular adverse event.
  4. Publish the results in a peer-reviewed journal. Then we can see the actual data and statistical analyses.

Let me try to summarize this information into a simple point — scientists use VAERS as a safety signal. If they detect a signal, then they use other, more powerful, and robust tools, to determine if the signal is just noise or if the signal is a signal for a serious set of adverse events.

The BMJ and VAERS

In a paper published on 9 November 2023 in the BMJ, Jennifer Block wrote a scathing indictment of the VAERS system in the USA. As I usually do, I’ll critique this article from several different directions, but those critiques will be based on the facts.

  • Author. Jennifer Block seems like a competent writer who can spell English words correctly. However, she is not a scientist, let alone a vaccine scientist, which is someone who has extensive education and experience in the fields of epidemiology, microbiology, immunology, public health, and other areas of science. Moreover, according to her list of articles on BMJ, Ms. Block has an almost singular focus on anti-vaccine topics, including VAERS. And she really has shown an intense dislike for COVID-19 vaccines, despite lacking any evidence supporting her claims. She is simply not credible on any scientific aspect of vaccines.
  • Peer review. This article, despite being published in the peer-reviewed BMJ, is not peer-reviewed. It is an opinion piece that was probably reviewed by other anti-vaccine editors at the BMJ. I think certain groups of people will see this paper, published in a formerly respected journal, and say “This proves that VAERS doesn’t work.” In journals like BMJ, the editorial section is separate from the science section. The science requires actual research and peer review by other scientists. The editorial section is not rigorously critiqued like science and almost anything that is penned by anyone with an agenda will get published. And let’s not forget that the aforementioned Peter Doshi, the head of anti-vaccine nonsense at the BMJ, is one of the editors who approves these editorial pieces.
  • Anecdotes. As I wrote above, VAERS is nothing more than a safety signal system that relies upon anecdotes from people who submit information to it despite what was written in the BMJ. And I need to remind the reader that anecdotes ≠ data. And more anecdotes are not equal to more data. Ms. Block tries to critique the anecdotal VAERS system with anecdotes of her own. It breaks my irony meter. The article starts with the story of an anesthesiologist who collapsed from pulmonary hypertension, a rare condition, after receiving a COVID-19 vaccination. She tries to claim that it was caused by the vaccine, despite any evidence supporting that claim. It is entirely possible that he had the underlying condition and the vaccine had nothing to do with it. Furthermore, I am at a loss as to a biologically plausible mechanism whereby a COVID-19 vaccine is linked to pulmonary hypertension.
  • VAERS is broken. It’s ironic that I might agree with Ms. Block on this point. It is broken in that it is misused by too many people, usually by anti-vaccine “scientists.” It’s a feel-good system for anti-vaxxers, but real vaccine scientists use it as an observational tool, as I wrote above.
  • Ignoring other tools. As I wrote above, there are two other, more powerful, tools that are used to find links between vaccines and serious adverse events — the Vaccine Safety Datalink (VSD) and the Clinical Immunization Safety Assessment Network (CISA). Ms. Block completely ignores those two systems that are used by epidemiologists and public health experts to drill down to the medical records of vaccinated individuals to determine if there is a link between a vaccine and a particular adverse event. The systems are complicated, you would have to have a fairly advanced expertise in statistics and other research tools to use them, but anyone can use them. If I saw “pulmonary hypertension” events on VAERS, I could use VSD to determine if there were other cases of it post-vaccination, and what was the incidence rate compared to the general population. THAT is the information a real scientist needs.
  • VAERS is understaffed. Ms. Block claims that VAERS is woefully understaffed because it cannot handle the hundreds of thousands of reports made to the system every year. To be clear, the VAERS reports skyrocketed after COVID-19 vaccinations started, mostly because false claims about the vaccine were made widely all over the internet. Nevertheless, she seems to not understand how VAERS works. CDC and FDA scientists monitor it for those “safety signals,” and then become detectives. Now, I will agree that with hundreds of thousands of reports, it may be difficult for every safety signal to be found, but most are. Plus, scientists use the VSD and CISA systems to find a correlation between vaccines and adverse events.

Summary

Once again, the BMJ has published an anti-vaccine opinion piece about the US Vaccine Adverse Events Reporting System. Jennifer Block wants to make it appear that because VAERS is broken, it’s missing key safety signals. On the other hand, I think it’s broken because it is not a scientific database. Lucky for those of us concerned about vaccine safety, there are better databases that Ms. Block conveniently ignores.

Vaccines are safe and effective. Scientific data, not the opinions of an anti-vaxxer, supports that claim. VAERS should be fixed so that it’s more accurate instead of being a database that is misused and misunderstood by anti-vaccine activists.

Citations

Michael Simpson

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