Antivax lawyer Aaron Siri misrepresents vaccine safety testing

If there’s one thing that antivaxxers do, particularly antivax shill lawyers like Aaron Siri, it’s to spin and dissemble, often misrepresenting what vaccine advocates say in order to produce a false “gotcha” moment that, if you don’t know the background, can make them seem either to have changed their views or to have been deceptive. Other times, they just invent new definitions for what “real science” looks like, as Aaron Siri did when he tried to argue that the entire childhood vaccine schedule is unsafe because not every vaccine has been tested in a randomized controlled clinical trial (RCT) versus the only true placebo control that he declares to be valid: A saline placebo. It’s utter nonsense, of course, although it’s oft-repeated by Robert F. Kennedy, Jr. It also ignores the history of vaccine development, the ethics of clinical trials (particularly clinical equipoise), and that saline placebos are not the be-all and end-all of “correct” controls for RCTs of vaccines. It is scientifically and ethically acceptable to use other controls besides normal saline.

This time around, Aaron Siri posted an article on his Substack entitled, AND LIKE THAT, THE CLAIM VACCINES ARE THE WORLD’S BEST STUDIED PRODUCT DIES. (I like the all caps. Quite unhinged. Also, “Just like that”? I have to wonder if Siri is secretly a big Sex and the City fan.) Right after the all caps proclamation, Siri boasts: “The world’s leading vaccinologist, Dr. Stanley Plotkin, and company have just capitulated…” But did he, though? Did he really?

It turns out that what Siri is spinning is a Perspective article published this month in the New England Journal of Medicine by Daniel A. Salmon, Ph.D., M.P.H., Walter A. Orenstein, M.D., Stanley A. Plotkin, M.D., and Robert T. Chen, M.D. entitled Funding Postauthorization Vaccine-Safety Science. By itself, the article is nothing radical. In brief, Salmon et al make a fairly reasonable proposal, namely to use some of the Vaccine Injury Compensation Program (VICP) trust fund to pay for post-licensure vaccine safety studies. The VICP, you’ll recall, was set up in 1988 as mandated by the National Childhood Vaccine Injury Act of 1986 and is funded by an excise tax on each dose of vaccine. It funds the Vaccine Court and pays for any judgments in which compensation is awarded to complainants for vaccine injury. I will admit that I was unaware that the VICP trust fund had built up quite a surplus; so it isn’t unreasonable at all to suggest:

Postauthorization vaccine-safety research requires adequate and timely funding directly linked to the introduction of new vaccines, just as VFC and VICP funding is. The VICP is funded by an excise tax on each dose of routinely recommended vaccines ($0.75 per case of disease prevented), which goes to the VICP Trust Fund. Trust fund income has exceeded expenditures by about $120 million per year since 1991, and there was a balance of $4.3 billion as of April 30, 2023. Using this balance for vaccine-safety science and reduction of vaccine reactions would benefit immunization programs and the public, in keeping with the VICP’s intent.

During the 5 years of legislative hearings that led to the VICP, Senator Paula Hawkins (R-FL), its sponsor, noted, “Although compensation of the injured children is a key component…other provisions of this bill are of equal importance, perhaps more important, because they are designed to improve the entire immunization program to prevent the injuries in the first place.”⁴

Note that “VFC” = the Vaccines for Children program.

Now here’s where the spin comes in. Siri, being antivaccine, views any proposals to improve vaccine safety monitoring not as just proposals to improve an already strong system that, like any other system, has weaknesses that can be addressed, but rather as an abject admission that the current system is slipshod to the point of missing horrific “vaccine injuries,” such as the autism, which vaccines don’t cause. You’ll also notice that he focuses like a laser on Stanley Plotkin, rather than any of the other coauthors, even though Plotkin is not the first author or corresponding author. (In, medical publishing, those are the two most important authors in any list longer than two authors.) The reason for this, of course, is that Plotkin is one of the greatest vaccine scientists who ever lived, who literally wrote the book on the subject. (Plotkin’s book Vaccines is still a standard textbook on vaccinology.) He’s 92 years old and not only still kicking, but still consulting on vaccine development. During his time at the Wistar Institute, he During his time at Wistar, he was heavily involved in the development of several vaccines, including vaccines for rubella, rabies, rotavirus, and cytomegalovirus (CMV). 

So it shouldn’t be surprising to see Siri start his Substack entry thusly:

Wow. After decades of Dr. Stanley Plotkin and his vaccinologist disciples insisting vaccines are the most well studied products on the planet, they just penned an article admitting precisely the opposite.

They just admitted vaccines are not properly studied—neither pre-licensure nor post-licensure. They admitted, for example, “prelicensure clinical trials have limited sample sizes [and] follow-up durations” and that “there are not resources earmarked for postauthorization safety studies.”

That is an incredible reversal. But let me provide context so nobody is fooled at what they are clearly up to:

For decades, the medical community insisted vaccines are the most thoroughly studied product ever; for example, Dr. Paul Offit said, “I think we should be proud of vaccines as arguably the safest, best tested things we put in our body.”

For decades, parents of vaccine injured children, vaccine injured adults, and other stakeholders contested these claims only to be shunned and attacked by the medical community and health agencies.

No, the NEJM article did not “admit precisely the opposite” of vaccines being the “most well-studied products on the planet.” Also note the persecution complex, a common refrain among antivaxxers in which it is claimed that we attack those who think they were injured by vaccines. That’s not usually the case; rather, we criticize the pseudoscience and conspiracy mongering by leaders of the antivax movement, such as RFK Jr. and, yes, Aaron Siri, who has long served as one of the go-to lawyers enlisted by antivax activists to try to weaponize the courts against science to sow fear, uncertainty, and doubt about vaccines.

Moreover, Siri, being the smart lawyer that he is, knows very well that it’s quite possible for something to be the “best studied” even if there are gaps in those studies, the addressing of which would improve how well studied those products are. In other words, even the best can improve! Moreover, he deceives by cherry picking. Here’s what Salmon et al wrote in context:

Postauthorization studies are needed to fully characterize the safety profile of a new vaccine, since prelicensure clinical trials have limited sample sizes, follow-up durations, and population heterogeneity.¹ It is critical to examine adverse events following immunization (AEFIs) that have not been detected in clinical trials, to ascertain whether they are causally or coincidentally related to vaccination. When they are caused by vaccines (vaccine adverse reactions), the risk attributable to vaccination and the biologic mechanism must be ascertained. That science becomes the basis for developing safer vaccines, if possible, and for determining contraindications to vaccination and the compensation that should be offered for AEFIs. Currently in the United States, when the Advisory Committee on Immunization Practices (ACIP) recommends a new routine vaccine, the only automatic statutory resource allocations that follow are for vaccine procurement by Vaccines for Children (VFC) and for the Vaccine Injury Compensation Program (VICP). Although the ACIP acknowledges the need,²there are currently no resources earmarked for postauthorization safety studies beyond annual appropriations, which must be approved by Congress each year.

See the deception? Siri tries to make you think that Salmon et al “admitted” that there are “no resources earmarked for postauthorization safety studies,” not what the article actually said, “no resources earmarked for postauthorization safety studies beyond annual appropriations, which must be approved by Congress each year.” It is true that later in his rant Siri does quote the full sentence that includes “beyond annual appropriations,” but by then the impression has been made and his response is:

Again, no shit! But nice of you to finally admit it after decades of gaslighting.

The only gaslighting going on here is by Siri and his fellow antivaxxers. Later in the article, Salmon et al add more context:

Over the past two decades, many new vaccines have been introduced for children and for vulnerable populations such as pregnant women and older adults. However, aside from emergency appropriations for the H1N1 influenza and Covid-19 pandemics, the budget for vaccine-safety monitoring at the CDC (which is responsible for the majority of U.S. federal efforts) has remained stagnant during this period, at about $20 million per year. Although these resources have been used efficiently, this inadequate level of funding has adversely affected the speed and completeness of the science.

This is, of course, a conversation worth having. One might very easily propose increasing funding by increasing the annual appropriation to the CDC for vaccine safety monitoring. One might also propose, as Salmon et al do in this article, increasing funding by uncoupling it from yearly Congressional appropriations by tapping into the VICP trust fund. Of course, there are pros and cons to each approach. The obvious downside of relying on Congressional appropriations every year is known. Congress can be fickle and might cut the budget in years when the deficit is higher than usual. Given the current composition of Congress, one could also imagine Congress saddling the CDC with mandates to “investigate” vaccine “injuries” that have long been debunked, such as the claimed link between vaccines and autism. One potential downside of tapping into the VICP trust fund is that spending too much could jeopardize the fund if it is ever needed for large payouts for vaccine injuries determined by the Vaccine Court. In any event, this is a discussion that is useful regarding the science and public policy involved in post-licensure surveillance for vaccine injuries.

I also note, as I always do during these discussions, that our existing vaccine safety monitoring system is actually quite robust and consists of multiple systems. For example, there is the passive system, the Vaccine Adverse Events Reporting System (VAERS), to which anyone can report anything as a vaccine injury, and then the CDC has to sort it out. (VAERS serves as a “canary in the coal mine” early warning system that is more hypothesis-generating than hypothesis testing.) In addition, there are multiple active surveillance systems, chief of which is the Vaccine Safety Datalink (VSD), which actively monitors the medical records of millions of people, looking for anomalies suggestive of a link to specific vaccines. Indeed, Salmon et al describe these systems:

Historically, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have led postauthorization vaccine-safety surveillance and research in that they comanage the Vaccine Adverse Event Reporting System (VAERS) passive-surveillance system, which is used to detect signals that require further investigation. But though VAERS is large and events may be reported to it in a timely fashion, few VAERS reports include the specific laboratory or clinical findings required for determining causality. In most VAERS cases, establishing a causal link would require rate calculations showing that there is a higher rate of AEFIs in vaccinated groups than in unvaccinated control groups, but VAERS reports lack much of the information needed for such calculations. Active surveillance using health care databases such as the Vaccine Safety Datalink and the FDA’s Biologics Effectiveness and Safety (BEST) System managed by the CDC and the FDA has this capacity to ascertain or rule out associations between vaccines and AEFIs. Other government databases (e.g., the Medicare database) have also been used for active surveillance, and the CDC conducts clinical assessment of AEFIs by means of the Clinical Immunization Safety Assessment Network.

That sounds like quite a few resources devoted to post-licensure vaccine safety monitoring, very much contrary to Siri’s mischaracterization that Plotkin had just “admitted” that there are “no resources earmarked for postauthorization safety studies.”

Another reason that Siri uses Plotkin as the primary author (even though he isn’t) is because there’s…history. Several years ago, Plotkin was deposed by Siri, and antivaxxers have been cherry picking quotes from that deposition ever since antivax activist Del Bigtree posted it to his Highwire website:

In 2018, I had the unprecedented opportunity to depose the architect of our vaccination program and the Godfather of Vaccinology, Dr. Plotkin, and lay bare the evidence that showed what these authors are now finally admitting about the utter lack of vaccine safety trials and studies. See https://thehighwire.com/ark-videos/the-deposition-of-stanley-plotkin/.

After this deposition is made public, Dr. Plotkin goes on a tirade, making demands that FDA add “missing information on safety and efficacy” in vaccine package inserts and that CDC exclude harms from its Vaccine Information Sheets, “lobbying the Gates Foundation to support pro-vaccine organizations,” working to have WHO list vaccine hesitancy as a global threat, lobbying AAP, IDSA and PIDS to “support training of witnesses” to support vaccine safety, etc. See https://icandecide.org/article/dr-stanley-plotkin-the-godfather-of-vaccines-reaction-to-being-questioned/.

Fortunately, Dr. Vincent Iannelli has the goods putting this deception into context:

If you watch this week’s Plotkin on Vaccines, despite Del saying the video wasn’t edited, you will miss some stuff from the transcript of Plotkin’s deposition.

So my comments are, one, that my estimate was pretty much correct. Second, that, unfortunately, Dr. Shaw has been associated with the party that I mentioned before, Tomljenovic, who, in my view, is completely untrustworthy as far as scientific data are concerned. So I’m concerned about Dr. Shaw being influenced by that individual.

And I’m not aware that there is evidence that aluminum disrupts the developmental processes in susceptible children.

-Stanley Plotkin

And Plotkin never says that he considers the French group or Romain K Gherardi a respected researcher, as Del claims. At one point, he does say that he considers the Journal of Neuroscience a respectable journal, but they weren’t talking about Gherardi’s study or aluminum.

You might recognize Drs. Christopher Shaw and Lucija Tomljenovic, both of whom have been the topics of posts on this blog about their awful vaccine pseudoscience going back nearly ten years. Truth be told, there is one thing that I disagree with Dr. Plotkin about. He’s far too kind in his assessment of Christopher Shaw as a halfway decent scientist. From my perspective, Shaw is as antivax as Tomljenovic. Indeed, he’s almost certainly the leader of that antivax “research” clown car.

In addition, antivaxxers like Siri jumped on Plotkin saying that he cannot absolutely prove that vaccines cause autism, as though saying that was slam dunk “evidence” that Plotkin was admitting that antivaxxers had a point. As Dr. Iannelli points out, it wasn’t and isn’t. For example:

What do anti-vaccine folks think he said?

I would say it is logically true that you cannot say, you cannot point to proof that it doesn’t cause autism.

-Stanley Plotkin, M.D

No, he isn’t saying that vaccines are associated with autism.

I could not say that as a, as a scientist or a logician. But I can say as a physician that, no, they do not cause autism, because as a physician, I have to take the whole body of scientific information into consideration when I make a recommendation for a child.

-Stanley Plotkin, M.D.

All he is saying is that you can’t definitively prove a negative.

What a surprise. Siri is being deceptive. Knock me over with a feather.

I like to put it this way. I can’t absolutely prove that homeopathy doesn’t work. I can, however, say that for all practical purposes it doesn’t work because (1) the overwhelming body of scientific evidence fails to show any effect beyond placebo and (2) for homeopathy to work, not only would much of what is now well-established science regarding chemistry, biochemistry, and physics have to be wrong, but it would have to be spectacularly wrong. I always leave a slight bit of wiggle room that maybe it’s possible that someday we’d find all that inconvenient science wrong, but it’s incredibly unlikely. Plotkin’s doing a similar thing, although the antivax-proposed vaccine-autism link is not quite as implausible as homeopathy. (Not quite, but it’s getting close.)

As is the case with antivaxxers, Siri treats any discussion of gaps in our knowledge base as evidence that he’s right, vaccines cause autism and all the other complications that antivaxxers blame on vaccines, and “they” are covering it up. For example, Salmon et al write:

In 234 reviews of various vaccines and health outcomes conducted from 1991 to 2012, the IOM found inadequate evidence to prove or disprove causation in 179 (76%) of the relationships it explored, illustrating the need for more rigorous science. In 2024, the National Academies of Sciences, Engineering, and Medicine issued a report on potential harms from Covid-19 vaccines and was unable to find sufficient evidence of a causal relationship in 65 conclusions (76%) (there was sufficient evidence in only 20 conclusions). The growing capacity of large health care databases affords new opportunities to obtain real-world data and conduct rigorous studies to quickly investigate AEFIs. The biologic mechanism remains unelucidated for most vaccine adverse reactions — notably, Guillain–Barré syndrome after administration of the 1976–1977 influenza vaccine and several other vaccines thereafter, myocarditis after mRNA-based Covid-19 vaccines, and intussusception after the first rotavirus vaccine (see table).¹ Identifying the biologic mechanisms of adverse reactions — how and in whom they occur — is critical for developing safer vaccines, preventing adverse reactions by expanding contraindications, and equitably compensating vaccinees for true adverse reactions. Recent advances in genomics, “adversomics,” and understanding of the biology of adverse health outcomes have created unprecedented opportunities to elucidate the biologic mechanisms of vaccine adverse reactions.³

Look! Salmon et al even included a handy-dandy table!

We’ve even discussed some of these here on this very blog. Clearly we SBM advocates do a very poor job of “covering up vaccine injuries”!

Siri’s responses are hilarious projection. For instance, he claims about the part about needing more rigorous science:

Again, no shit, and I would appreciate if you would please properly cite to the ICAN white paper from 2017 from which you have plainly lifted this point https://icandecide.org/wp-content/uploads/2019/09/VaccineSafety-Version-1.0-October-2-2017-1.pdf.

Seriously, Mr. Siri. Calm your jets. There’s no need to cite ICAN’s ideological and pseudoscientific nonsense when real scientists have been discussing vaccines, vaccine efficacy, and vaccine safety using actual science, data, and epidemiology for decades, without any need to refer to the likes of you.

Other responses from Siri are similar:

• “Shameless to pretend you have not for decades ignored or attacked those calling for these studies while pretending a mountain of such studies showing the foregoing don’t already exist.”
• “Again, shameless to pretend parent groups have not been yelling about this issue for decades only to be ignored and attacked.”

Again, the “parents’ groups” to which Siri is referring are antivax to the core, groups like, yes, ICAN and Children’s Health Defense, both of which, I seem to recall, he has worked with at one time or another to use the legal system to demonize vaccines.

Finally, projection is the name of the game whenever someone like Aaron Siri seeks to spin:

Plotkin and company should welcome studies which can show vaccines have not contributed to the rise in chronic childhood disease (many of which are immune mediated diseases) from 12% of children in the early 1980s (when CDC recommended 7 routine childhood injections) to over 50% of children now (when CDC recommends over 90 routine childhood injections). 

And I think they do welcome such studies if they can assure that the outcome would show vaccines do not cause these harms. Alas, the reality is that (as they know) studies showing vaccines contribute to this rise already exist. But their goal, in any event, is not to really study safety. Rather it is to prove their prior assumption that vaccines are safe and harms are “rare.” This approach is how they designed VAERS, V-SAFE, VSD, and every other “safety” system.

Oh, look. Siri is admitting that there are several vaccine safety systems designed to find evidence of complications and adverse events attributable to vaccines. Of course, this is weapons-grade projection. Let me take the liberty of rephrasing Siri’s last paragraph above, but this time applying it to antivaxxers like him:

And I think they do welcome such studies if they can assure that the outcome would show vaccines do cause these harms. Alas, the reality is that (as they know) studies showing vaccines do not contribute to this rise already exist. But their goal, in any event, is not to really study safety. Rather it is to prove their prior assumption that vaccines are unsafe and harms are severe and very common. This approach is how they design all their “alternative” studies and monitoring systems.

There, fixed that for ya, Mr. Siri. After all, it really isn’t about “vaccine safety.” It’s about suing pharmaceutical companies and the government to win big fat settlements (and, of course, huge 30% contingency fees from those settlements for Mr. Siri and his fellow antivax lawyers), regardless of whether there is good scientific evidence that vaccines caused the “harms” attributed to them. I have pointed out many times that the Vaccine Court actually is quite accommodating to complainants, bending over backwards to the point of paying their legal fees and reasonable expenses incurred bringing cases before it (e.g., expert witness testimony), win or lose. It uses the civil litigation standard of “50% and a feather” to determine who wins, and it’s notoriously open to even fairly dubious “scientific evidence” and “models of causation,” to the point of sometimes ruling quite badly, at least from a scientific standpoint. Yet antivax lawyers hate the Vaccine Court. Why? I’ve long suspected that it’s because these lawyers aren’t satisfied with the hourly rates they can collect bringing cases before the court, even if those hourly rates are guaranteed. No, they want the big bucks and the big splash in the media that those big judgments would garner.

Finally, I laughed when I read this passage:

That all said, if they are really well-meaning, I would welcome collaborating. To be fair, I will email all four of them to request a meeting to review existing science and design studies mutually agreed upon. If they are really interested in vaccine safety, they should welcome that (I have no hard feelings despite their attacks on me and I hope they can rise above any hard feelings they have for the sake of protecting children). Most importantly, I’m willing to live with the results of those studies. Are they?

Mr. Siri will excuse my…skepticism…regarding his claim that he would “live with the results of those studies.” After all, he has a long history of doing just the opposite. As for “collaborating” with an antivax lawyer to design and conducts studies of vaccine safety, I’m sure that Plotkin and his co-authors are too savvy to fall for that old trap. Generally, what happens when hapless and naive scientists fall for this particular trap is that it’s impossible to agree on a protocol because antivaxxers are not about science.

Siri framing his offer as wanting to invite the four authors of the NEJM Perspective piece to “review existing science and design studies mutually agreed upon” might seem reasonable, the key word being “seem.” It’s only “reasonable,” though, if you’re an antivax activist like Siri. There are not “two sides” to the issue of whether vaccines cause autism, for example, at least not two equally scientifically valid sides—or even sides that are roughly equal (or, come to think of it, are somewhere in the same order of magnitude). Such an offer to bring together adherents to rival scientific hypotheses to “collaborate” might make sense when both of the two hypotheses have a lot of evidence to support them and it’s still unclear which hypothesis best explains existing evidence, but that’s not what Siri is proposing. Rather, whether Siri realizes it or not or will admit it or not, what he is proposing is very much akin to “bringing together” flat earthers to collaborate with geologists and astronomers to design experiments to determine once and for all if the earth is round or flat.

In this, Mr. Siri is very much like an even more bonkers antivax crank, Steve Kirsch, who a year ago basically proposed a similar “collaboration” between vaccine scientists—he even included Stanley Plotkin in his list!—and antivaxxers, all to the same end, although Kirsch limited the collaboration to the question of whether vaccines cause autism. Then, of course, when Plotkin and his coauthors either ignore or refuse his offer, Siri is guaranteed to portray that as “proof” that they are “afraid” of him and his “science.” Same as it ever was.