I wrote last year about how 2020 had been a year of physicians behaving badly, and I think I should have said more badly than before. The arrival of the COVID-19 Pandemic gave a golden opportunity for quackery, as we documented on this blog, but doctors and scientists behaved badly, be they quacks, antivaxxers, grifters, or cranks. As I sat down yesterday to think about what to write about, I quickly came across a piece of misinformation about vaccines that has dominated 2021, and looks to continue to be a major antivaccine technique to spread fear, uncertainty, and doubt. I thought I would discuss it now. I was going to save this topic for a year-end post next week, but it is on Joe Mercola's website and will disappear by tomorrow. The reason is that a few months ago, in a dispute aboutcensorship, ber-quack Dr. After 48 hours, all new articles on Mercola's website will disappear. The Wayback Machine archives all of the articles that Mercola set his robots.txt file to exclude. Jessica Rose appears in an article on Sunday entitled What the VAERS Data Tell Us About COVID Jab Safety, so I thought I should write about her.
VAERS is a vaccine adverse events reporting system. Misuse of VAERS by antivaxxers and those who claim not to be antivaccine but frequently repeat the same sorts of tropes that antivaxxers do about COVID-19 vaccines has been a frequent topic on this blog in 2021.
Who is Jessica Rose?
I thought it would be worthwhile to look into her background before I looked into the VAERS misuse and conspiracy theories that she is peddling. He describes Rose in Mercola's article.
Jessica Rose, a research fellow at the Institute for Pure and Applied Knowledge in Israel, talks about her research into the U.S. Vaccine Adverse Events Reporting System.
Mercola is effusive in the transcript.
We are going to be talking to Jessica Rose, who has an amazing serendipities. She has accumulated a skill set that is close to optimal for helping us understand what is going on. She is a Biologist. It sounds cool, but I don't know what it means. She has degrees in two of my favorite fields. If I had to get a PhD, it would be in biology. She is also a surfer. She caught the bug while studying in Israel and was going to go to Australia to surf, but she didn't make it. She couldn't go after the COVID hit. She had to come up with something else. She decided that she was going to code. She picked an obscure program that I have never heard of before. I think it's called R and it's used for statistics and graphics. She used that. She said she was going to work on the VAERS database and had been working on it. She came up with the most amazing pieces of information. If you listen to the conversation, you will be grateful for what she has done. Thank you for joining us, we have a lot of history.
Talk about the introduction. Rose doesn't have a "skill set almost optimal for helping us to understand what's going on." This is the way it should be. Computational biology alone is not enough to deal with the VAERS database. Training in epidemiology, infectious disease, pharmacosurveillance, and a deep knowledge of how VAERS works would be required. Rose describes her skills on her profile.
A PhD researcher with a history of working in the higher education industry. A strong research professional is skilled in a lot of things.
It is all good, but it is as I expected. Her background is more in Computational biology that looks at the structure of genes and the way they are related to each other than it is in the sort of mathematical and statistical skill needed to get into VAERS. A look at her curriculum vitae shows that she has a lot of biology, but not epidemiology.
Rose is now employed by IPAK. IPAK is a cringeworthy name that makes one suspicious of its science. James Lyons-Weiler is an antivaxxer who I have written about a number of times here and elsewhere. Lyons-Weiler and Paul Thomas were trying to argue that the MMR vaccine causes autism by publishing bad studies about aluminum adjuvants. Lyons-Weiler and Thomas did a study that claimed that unvaccinated children are healthier. Lyons-Weiler shifted quickly to COVID-19, claiming in January 2020 that the novel coronaviruses that was raging through Wuhan at the time had been the result of a failed SARS vaccine, thus presaging the "lab leak" conspiracy theory by many months. If you are a good scientist, you would not be able to work for an institute like IPAK.
It is not enough to show that Jessica Rose lacks the qualifications to do the analyses she has done and that she works for a group that is spreading misinformation about vaccines. The most famous of her claims is that the government is covering up the deaths of tens of thousands of people because of the COVID-19 vaccine.
There are antivaxxers and veterans.
Mercola starts his article by talking about VAERS as the best vaccine safety monitoring system there is, as though it were the only thing that mattered.
VAERS is one of the best tools for evaluating vaccine safety. The 1986 National Childhood Vaccine Injury Act was the reason for it. The VAERS was created to collect injury reports in a centralized database so that the post-marketing safety of childhood vaccines could be monitored.
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We have three decades of data to compare trends against, because the system was launched in 1990. Vaccine injuries are under reported. Only 10% to as little as 1% of injuries have been reported.
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Steve Kirsch, executive director of the COVID-19 Early Treatment Fund, suggests that injuries are under reported when it comes to the COVID jab. VAERS can still give valuable information about a vaccine.
I always like to mention something about the discussions of VAERS by antivaxxers when I talk about why VAERS is the be-all and end-all of vaccine safety monitoring. The Vaccine Safety Datalink (VSD), the Clinical Immunization Safety Assessment (CISA) project, or the FDA's Post- is a vaccine safety monitoring database that antivaxxers rarely cite.
VAERS is a passive reporting system that relies on doctors, nurses, healthcare workers, and people receiving vaccines to report adverse reactions. The system was never intended to give an accurate estimate of the vaccine's effectiveness, but rather to serve as an early warning system for new vaccine-related injuries. VAERS is a hypothesis-generating system, not a hypothesis testing system, and its hypotheses are tested using better systems, like VSD, CISA, and PRISM. These systems are active in reporting their health records in order to identify potential signals and there is less bias that way than VAERS.
Back to VAERS. The main problem with using VAERS to estimate the number of adverse events after vaccination is that anyone with access to the internet, mail, or the telephone can report anything to VAERS. The reports were accepted. VAERS contacted these people to ask about the reports, but they did not remove them because they refused to allow reports that vaccines might turn one into the Wonder Woman or the Incredible Hulk.
Mercola goes on to write that anyone can enter anything into VAERS, which is clearly antivaxxers.
The VAERS data is unreliable because anyone can file a report, which is why so-called fact checkers try to explain away the data. This is hogwash. There are penalties for filing a false report, but anyone can file a report. We can be certain that there is no over- reporting.
The man is implied to be a straw man. No one is saying that VAERS is unreliable because a lot of people are reporting fakeAEs such as being turned into fictional monsters and superheroes. We point out these examples as part of the discussion of how VAERS reports represent raw, unadjudicated data. Antivaxxers assume that any injuries entered into VAERS must have been caused by the vaccine, but that is not the case. VAERS data cannot establish causality, as it cannot establish reliable estimates for the incidence of a given event.
We can be certain that VAERS has been gamed multiple times in its 30 year history, despite Mercola's claim that we can be "quite certain there's no over-reporting going on". One of the earliest times I wrote about VAERS was in 2006 when I talked about a study that looked at vaccine litigation. The study found that most VAERS case reports that were related to overdose, neuropathy, and thimerosal were related to litigation. With a great deal of confidence, we know that these reports were false because we know that vaccination is unrelated to mental retardation and other disorders. There has been a previously undisclosed rise in the number of reports to the VAERS related to pending litigation for vaccine injury. This is not a new problem for VAERS.
The authors noted in the discussion.
There is a question about the misuse of VAERS in the litigation process. When a study is being used to influence public health decisions, it is important that reviewers and editors understand how the data were constructed and their source. No one has described the magnitude of litigation-related reporting and how it might affect the results of studies using VAERS data. Changes in reporting sources should be taken into account when using VAERS data.
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It is not possible to determine the effect of these reports on existing analyses because the existing literature does not describe carefully inclusion and exclusion criteria. It is apparent that a large amount of reports are being made related to litigation that should be excluded. This is important for vaccines that contain the substance, and for the vaccine that protects against the disease, because of the controversy surrounding it. It is incumbent on the authors who use VAERS data to provide detailed methods sections that describe their inclusion and exclusion criteria. We are making the SAS code available to interested parties. The VAERS data set needs more than just reference extracts.
The authors concluded that their estimates of how many VAERS reports were related to litigation were likely conservative and underestimates, because theKeywords used in their analysis to identify litigation-related cases were insufficient to the task. The authors were probably under assasinated by the cases they were looking for. This is how it should be. There is a reason why I used to call studies that used unadjudicated VAERS reports to estimate changes in prevalence of AEs after vaccine "dumpster diving." The study concluded that the changes in reports to the VAERS database from California were caused by the passage of the law that eliminated nonmedical "personal belief exemptions" to school vaccine mandates. Mercola and Rose want you to believe that VAERS reports are reliable.
Does any of this sound familiar to you? The mistake that Tracy Heg, John Mandrola, and Allison Krug made was to rely on just raw VAERS reports from the database.
Under reporting to VAERS is not rampant, at least not in the way they make it seem. It is often said that only 1% of the cases are reported to VAERS. There is a lot of under reporting for minor injuries, such as pain at the injection site. Absolutely, there is! If your child has a high temperature a day after getting a vaccine, are you going to report it to VAERS? Probably not. If someone dies soon after a vaccine, you can be sure that it will be reported, because the government has implemented a system that asks if you have had any symptoms after vaccination. The more serious the AE, the more likely it is to be reported to VAERS, particularly with the reminders people who opted into V-Safe have been receiving.
This doesn't take into account the fact that Mercola and Rose have no plausibility behind their claims. According to Mercola, the actual death toll in the US could be anywhere from 278,500 to 898,600 due to under reporting of deaths.
Jessica Rose has made some claims.
Just use R and excel to play with VAERS.
During the interview, Mercola asked Rose what she found. She encourages people to do their own research.
I urge everyone to do this. Go to their website and download the files. You can use whatever you want with it, it's compatible with the file. The OpenVAERS system is easy to use.
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There are three separate files that you can download for the domestic data set, which include the individual's data, the symptoms or adverse events that they reported, and the injection data.
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I merged them so that I could get a lot more information. You can count the number of adverse events that have happened in the year. In the context of the COVID-19 products, exclude all the other vaccines and compare the number of adverse events to the total number of adverse events reported over the course of 30 years.
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There is no comparison. The adverse event report data for all of the vaccines combined is an average of 39,000 over the past 10 years. There are many of them.
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We are looking at about 39,000 adverse events per year for all vaccines, as opposed to the domestic dataset which has over 650,000 adverse events. The under reporting factor is not included.
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We see the same trend when we separate adverse events. In the previous 10 years, the average number of deaths for all the products combined was 155, not including the under reporting factor. The increase in reporting for deaths is over 6,000%.
You want a bunch of people with no knowledge of epidemiology or the limitations of VAERS to play with the whole VAERS dataset in R. Learning to use R involves a bit of a learning curve that is more difficult than using excel.
If you don't know how VAERS works and what its raw data can be used for, you will fall victim to GIGO or "garbage in, garbage out."
Weaponizing vets.
Those of us who have been deconstructing antivaccine misinformation for a long time knew that VAERS would be a problem before any of the COVID-19 vaccines started rolling out in the US. The misuse of VAERS to link vaccines to a number of health outcomes, including infertility, death, and sudden infant death syndrome, was premature. Why wouldn't they do it with the COVID-19 vaccines? In terms of antivaccine misinformation in the year 2021, it was the year when the public, news media, and public health officials had their faces rubbed in as they warned about the vaccine.
The misuse of VAERS reports was the first thing I noticed. Before the Pfizer vaccine was issued an EUA, I was pointing out how lawyers game VAERS for their litigation and noted the bad scientific studies published by antivaccine physicians and scientists that use VAERS as their data source. One year ago tomorrow, I was discussing reports of Bell's palsy and syncope from the Moderna clinical trial and how VAERS would likely be used to amplify claims that these are caused by the vaccine.
It must be the chip.
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David Gorski, MD, PhD, is on December 17, 2020.
By February 1, 2021, the first serious attempts by antivaxxers to make false statements about VAERS reports showing that COVID-19 vaccines are deadly were already happening, and I discussed why they did not show this and were not evidence that COVID-19 vaccines were causing heart attacks and sudden death There had been only 323 deaths and 9,845 deaths reported to VAERS. By May of 2021, conspiracy theorists were helping Mercola use VAERS to spread the conspiracy theory that the vaccines were part of the global depopulation agenda, and by July a "holistic cardiologist" from my part of the country was joining in the misinformation.
The conspiracy theories have been entered.
I have said many times that all science denial, especially antivaccine pseudoscience, is based on conspiracy theory. The central conspiracy theory of the antivaccine movement is that the CDC, FDA, and big pharma are trying to hide the truth about vaccines. There must be a conspiracy theory to explain why people like Jessica Rose are not being taken seriously. The CDC is covering it up.
And:
The US Food and Drug Administration and Centers for Disease Control and Prevention deny that a single death can be attributed to the COVID jabs. As noted by Rose.
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It is not possible to say that no one death was caused by the shot. It isn't scientific to say that those people wouldn't have died anyway. That isn't how life works.
Actually, it is. Rose doesn't understand or refuses to discuss the baseline rate. Mark Hoofnagle said, "Let's go all the way back to January to see what I mean, where I will, as I am wont to do."
3.3 million deaths/year, about 275k/month, is my rough math. I get about 4% of my population vaccined this month, so I get about 4% of deaths.
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Mark Hoofnagle wrote on January 30, 2021.
Mark was estimating over 4K deaths by random chance near the time of COVID-19 vaccine.
We can redo the estimates that I did in July because it has been over a year since the COVID-19 vaccines were released. In the US, 202 million people have been fully vaccined, or 61 dollars of the population, according to our World In Data. I realize that the question of boosters complicates the definition of fully vaccineed, but this is a back-of-the-envelope calculation designed to give a rough estimate. For a population of 202 million, we would expect to see an average of 4,848 deaths per day by random chance, based on the baseline death rate that I used back then. We would expect to have seen over one million deaths in this time period by random chance alone, and that doesn't include the increase in the baseline death rate due to deaths from actual COVID-19.
Rose's appeal to incredulity is silly because of the sheer size of those numbers.
Jessica Rose: Nope. They claim that there are no adverse event reports of death in VAERS because of the products. They are holding fast. There are doctors who are spouting this garbage. It is not plausible to say that. It is not scientific to say that there was not one death caused by something. I am happy when people say that because it is going to be easy to disprove. I think I have. Data is notoriously difficult to show causality with.
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Dr. Mercola: Yeah, right. I didn't know it was possible. You know, it probably will.
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The Bradford Hill criteria is a set of 10 criteria that you should satisfy in order to show very strong evidence of a relationship. One thing has to come before the other in order for temporality to be important. The shorter the duration between those two, the more likely there is a cause. When you talk about percentages of people who died, having died within 24 hours of one of their jabs, let's say you're talking 50%. That is kind of odd to me. Yeah. It is funny and they completely deny the effect. I mean, it is.
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Dr. Mercola said it was a coincidence.
It's almost certainly a coincidence, as many of the problems attributed to vaccines by antivaxxers misusing VAERs were long before the pandemic. The Logic of Science did a calculation five years ago that concluded that even if there is no correlation between vaccines and autism, there will still be new diagnoses. The principle works here, but the numbers are much larger.
The large baseline rate of deaths that occur every day, day in and day out, just because a small percentage of a large population will die of multiple causes every day one expects large numbers of deaths to occur after vaccination by random chance, is the reason for this large receiving vaccines. Mercola, Kirsch, and Rose claim that VAERs do not underreport deaths, given the long term findings of V-Safe and the fact that death is the most serious after vaccination.
Mercola and Rose ignore the other criteria, such as plausibility, consistency, coherence between epidemiological and laboratory findings, biological gradient, and others, and cite temporality ber alles. The CDC uses other databases, such as VSD, to test the safety signals identified in VAERS, before using them in analyses, because raw VAERS reports are investigated and adjudicated before the CDC uses them in analyses.
Rose gets worse. She points to an estimate by tech millionaire turned ivermectin pusher Steve Kirsch, who claims that COVID-19 vaccines kill twice as many people as they save. Jeffrey Morris destroyed the methodology used to arrive at his estimate of a 41-fold under reporting rate. Let's say that Kirsch cherry picked studies and used inappropriate analyses and comparisons to come up with this estimate.
It is difficult to see how a 41x estimate of URR can be believable given the results of 3 studies. He would need more convincing evidence to justify the high 41x level, as he has stated in the past that the URR would be higher than in previous years.
We would expect the URR to be lower for COVID-19 vaccines than for vaccines in previous years, not higher, especially for the most severe AEs, because of the V-Safe system and the huge publicity surrounding them.
Rose claims that the CDC is "deleting" VAERS reports for children. There are a number of reasons why VAERS ID entries are deleted. Rose admits that it could be because more than one report was filed for the same vaccine recipient. A version of this conspiracy theory was going around a few months ago, and the CDC responded by explaining that some 6,000 VAERS reports had been removed from the database because they came from outside the US
The CDC is aware of an error that took place while data was being uploaded to the page, according to a CDC representative.
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The number of deaths reported to the Vaccine Adverse event Reporting System (VAERS) appeared to have spiked after the COVID-19 vaccine. It happened because of combining foreign and domestic reports.
I wish the CDC would be more alert about such incidents. The CDC should announce when it corrects the anomalies in VAERS data instead of waiting until questions are asked. It wouldn't stop conspiracy theories like Mercola and Rose, but it could help. If the CDC isn't aware that VAERS is being monitored for anomalies by antivaxers, there are other legitimate reasons for reports to be removed. The removal which was just part of the normal maintenance of VAERS is now being used as a basis for a conspiracy. Rose will deny that she was looking at something like this, but there is no doubt that the CDC can no longer do routine quality control of the VAERS database without a lot more transparency, as conspiracy mongers like her are watching for any anomalies that they can weaponize.
The best and worst system.
Jessica Rose would be engaging in dumpster diving of the VAERS database. The antivaccine movement has been weaponized to the point that I have spent a lot of time and effort dealing with antivaccine propaganda and conspiracy mongering related to VAERS. VAERS has become a weapon in the age of COVID-19 because of its very nature, which makes it perfect for antivaxxers. The database is completely open. Anyone can submit a report of an injury. The VAERS dataset can be downloaded and analyzed by anyone, even without a protocol approved by an institutional review board.
There is a reason that antivaxxers like Jessica Rose and Joe Mercola never mention the results of the VSD, PRISM, and CISA. Analysis of their data fails to support the hypotheses generated by analyses of VAERS.
There is nothing new under the sun when it comes to the antivaccine movement, nor are there any new antivaccine arguments or techniques of misinformation. The same old things have been changed for COVID-19, but they are still the same things that antivaxxers have been using for years. The VAERS database has been weaponized to spread FUD about COVID-19 vaccines, and it is hard to think of a better example. I don't think the media or public health officials are any better at addressing this technique of misinformation than they were a year ago.
