This article about another ICAN FOIA lawsuit was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.
The Informed Consent Action Network (ICAN) is an anti-vaccine organization, founded in 2016 by Del Bigtree, largely funded by a New York couple, Bernard and Lisa Selz.
On March 4 and March 5, 2020, ICAN claimed a “win” against the CDC that, they said, prevented CDC from claiming vaccines don’t cause autism. In reality, the ICAN Freedom of Information Act (FOIA) lawsuit was settled, and the settlement doesn’t counter the existing scientific consensus that vaccines do not cause autism.
The ICAN FOIA lawsuit is legally incorrect
On December 31, 2019, ICAN and another organization, “the Institute for Autism Science” (ISA) filed a 36-page complaint against the Centers for Disease Control and Prevention (CDC). In the complaint, the plaintiffs claim to be “nonprofit groups involved in supporting families with autism spectrum disorder (“autism”), as well as supporting research into identifying the potential causes of autism in order to better understand how to treat and prevent autism (the “Autism Groups”).
There is no evidence online that “the Institute for Autism Science” ever provided support for autism families, or supported autism research. The Institute for Autism Science has a shell website along with a very limited Facebook page ran by Patrick Layton. Layton was employed by the Vaxxed team as a bus driver and is now employed by ICAN.
The complaint can, therefore, be fairly attributed to ICAN.
The ICAN FOIA lawsuit requested one of two things – studies showing that DTaP (for Diptheria, tetanus, and whooping cough), Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcal conjugate (PCV13), and inactivated polio vaccine (IPV) vaccines are not linked to autism, or that the CDC admits that “no such studies exist.”
The complaint is somewhat strange as an FOIA lawsuit. It clearly tries to make the claim that there is no basis to assert that vaccines do not cause autism, and does so in a problematic manner. For example, to support their claim of no financial consequences for vaccine harms, the authors of the claim quote the part of s. 42 U.S.C. § 300aa-11 that says that no person may bring a claim for vaccine injury or death, but omit the second part, which states:
unless a petition has been filed, in accordance with section 300aa–16 of this title, for compensation under the Program for such injury or death and—
the United States Court of Federal Claims has issued a judgment under section 300aa–12 of this title on such petition, and
such person elects under section 300aa–21(a) of this title to file such an action, or
such person elects to withdraw such petition under section 300aa–21(b) of this title or such petition is considered withdrawn under such section.
In other words, they omit the part of the section that allows bringing suit for a variety of claims (not including design defects) after going through the program. The complaint claims that “HHS has not prepared or filed a single biennial vaccine safety report for Congress as required by part “c” of the Mandate,” something we now know – and ICAN no doubt knows – is not true since Congress has received two reports and considers that to fill the obligations under the act.
I mention this to alert readers that, going in, the complaint suffered from severe inaccuracies. The bulk of the complaint attempts to marshal out the evidence the anti-vaccine activists think the pertussis-containing vaccine and other vaccines cause autism. I will address some of this in the second part, but I won’t spend time going over the entire thing because, well, it’s legally irrelevant and these are not new claims.
The vast majority of this complaint is legally irrelevant to the ICAN FOIA lawsuit. The question the court needed to address in the ICAN FOIA lawsuit was not whether the vaccines cause autism. That’s not an FOIA question and not something the court will need to reach to address whether the plaintiffs are entitled to the materials.
The Freedom of Information Act was created to allow citizens to obtain existing records from the government, to increase transparency. It is not a basis to request agency action to change policy, though records obtained can be used in such lawsuits – if there is an independent basis – later.
To win their FOIA lawsuit, the complaint had to show that there is a basis to think obtainable records exist, and the government is not handing them over. There is not much of that in the complaint.
There is no way, shape or form that the court addressing this ICAN FOIA lawsuit would rule on whether vaccines cause autism because that’s not what FOIA is about. Including that lengthy discussion suggests strongly that the complaint was not filed with a view to achieving a meaningful legal victory on the requests, but to use as talking points when the result – whatever it is – is presented to ICAN’s followers, and maybe others. In other words, this was not an honest lawsuit.
The lawsuit ended with a settlement. In the settlement, the CDC submitted 20 studies as “responsive to the FOIA requests”, and the parties agreed that “the above-captioned action is voluntarily dismissed, with prejudice.
What does this mean legally? It means the parties agree that what CDC submitted fills the FOIA requests, the lawsuit is dismissed, and cannot be filed again as it was (“with prejudice”). That is all it legally means.
Can this be fairly presented as a legal win? Well, the CDC did provide a list of studies in response to requests. So they got something. But honestly, it’s not as if they could not find these studies themselves. The CDC’s website states “vaccines do not cause autism” and links to many of these studies.
Further, government delays in filling lawsuits that lead to litigation are very, very common – in part because of resource constraints, and the fact that agencies have other requirements and often backlogs of requests.
Although not all of these FOIA lawsuits are settled, as with other cases, parties may have good grounds to settle for ease, regardless of merits: the agency wants the case to go away, and that’s it. So it is not particularly meaningful that the CDC took time to respond before litigation – especially given the nature of the request that actually asked for new information – or that it settled the case. So maybe it’s some win – they got a list – but it’s hardly anything to write home about.
All indications are, however, that the goal of the lawsuit was never to obtain information plaintiffs lacked but to create a foundation to claim a win against the CDC towards ICAN’s supporters. The FOIA requests were designed for that, and the way Mr. Bigtree, ICAN’s founder, used the result shows that very clearly.
What does this mean scientifically?
On March 5, 2020, anti-vaccine activist Del Bigtree spent about 40 minutes of his online show claiming that the settling of the FOIA lawsuit shows there is no good evidence behind the claim that vaccines don’t cause autism. But that’s not true. Mr. Bigtree’s claim fails in three ways:
- The requests could not show the conclusion Mr. Bigtree wants to draw from them, and were intentionally phrased to misrepresent the totality of the data;
- even so, some of the studies in question do cover the vaccines discussed; and
- the nature of FOIA requests is such that Mr. Bigtree could not fairly draw such a conclusion from them even if that was not the case.
The ICAN FOIA lawsuit asked for very specific studies. They asked specifically for studies showing individual vaccines on the schedule do not cause autism. But the CDC does not actually need a study on each vaccine to conclude that.
That’s not what the conclusion depends on, in two ways:
- studies would not be done for things without a plausible basis;
- and the CDC, as an expert agency, will look at the whole body of evidence in drawing conclusions, as it did here.
Studies on vaccines and autism would naturally focus on areas where there is a plausible claim for a link between vaccines and autism, in other words, where there is a viable hypothesis connecting the two. Those areas were, in fact, thoroughly examined.
Studies covered whether thimerosal-containing vaccines caused autism, and conclusively showed they do not.
In addition, there is a growing body of research on what actually causes autism that goes against the claim that vaccines cause it, suggesting that autism starts in the womb and that genetics plays a major role. In addition, some environmental factors are related to autism – such as parental age, obesity, illness or infection in pregnancy. There is evidence on those, but not for vaccines.
Looking at the entirety of the evidence, not just the CDC but many other expert bodies concluded that vaccines do not cause autism. For example, the Institute of Medicine – now the National Academies of Science, Engineering, and Medicine – has a page stating “Vaccines do not Cause Autism”, listing the evidence on which it bases that conclusion.
This is especially relevant since the complaint takes some specific paragraphs out of IOM reports in support of its claim – but the IOM is clear that when it looks at the totality of the evidence, vaccines do not cause autism.
Similarly, Johns Hopkins’ expert concludes vaccines do not cause autism. The American Academy of Pediatrics concludes the same, with its own list of studies. So did the Autism Science Foundation and Autism Speaks. The CDC’s conclusion is in line with other experts and expert bodies that examined it.
Further, as summarized by pediatrician Vince Iannelli on Vaxopedia, the studies ICAN was given also covered their specific vaccines, though they appeared not to understand that (screenshots omitted):
“Also, if it is vaccines in the first six months of life, then why wasn’t that found in this study that was submitted by the CDC to ICAN, which they either didn’t read or didn’t understand?
“We found no evidence indicating an association between exposure to antibody-stimulating proteins and polysaccharides contained in vaccines during the first 2 years of life and the risk of acquiring ASD, AD, or ASD with regression. We also detected no associations when exposures were evaluated as cumulative exposure from birth to 3 months, from birth to 7 months, or from birth to 2 years, or as maximum exposure on a single day during those 3 time periods. These results indicate that parental concerns that their children are receiving too many vaccines in the first 2 years of life or too many vaccines at a single doctor visit are not supported in terms of an increased risk of autism.”
DeStafano on Increasing Exposure to Antibody-Stimulating Proteins and Polysaccharides in Vaccines Is Not Associated with Risk of Autism
Although ICAN complains that this study is just about antigen exposure, most folks will understand that those antigens come from vaccines!!!
And it isn’t even the only study to prove that there is no association between “general vaccinations” and autism.
“In this study, we could not find the evidence that MMR vaccination increases the risk of ASD onset. The present results support the findings from the previous case–control studies conducted in Caucasian populations. Furthermore, we could not find any evidences that other types of vaccines or a combined effect of multiple vaccines was associated with ASD onset. Therefore, this study did not support the theory that vaccinations should be avoided to reduce the risk of ASD onset. We should be more concerned about acquiring infectious diseases by avoiding vaccinations.”
Uno on The Combined Measles, Mumps, and Rubella Vaccines and the Total Number of Vaccines Are Not Associated With Development of Autism Spectrum Disorder: The First Case-Control Study in Asia
The 2012 study, The Combined Measles, Mumps, and Rubella Vaccines and the Total Number of Vaccines Are Not Associated With Development of Autism Spectrum Disorder: The First Case-Control Study in Asia, looked at MMR, measles, mumps, rubella, DPT, polio, B-encephalitis, and BCG vaccines and found no association with autism.”
While it’s a bit more speculative, because that was not the focus of these studies, I would add that several of the studies on thimerosal also address individual vaccines. For example, this study looks at DTP and dose/response – in other words, it asks if more doses of DTP increased the risk of autism.
While these were thimerosal-containing vaccines, they did look at the number of doses of these vaccines – and if these vaccines are related to autism, you would expect more doses to increase the risk (a dose-response study, a fundamental aspect of establishing causation).
In reality, while more doses were associated with an increase in the risk of tics, they were negatively associated with the risk of developmental disorders and ADD – in other words, more doses appeared to decrease the risk (likely, this is not a real causal connection).
This study of thimerosal also looked at cumulative exposure and autism, and though it focused on thimerosal, these vaccines would also, mostly, contain aluminum adjuvants – and there was no link there, either.
Further, the more recent study by Hviid et al. had a completely unvaccinated group of over 4,000 children and examined the risk in that group. It found no increased risk of autism in vaccinated children compared to them.
When ICAN rejects the CDC’s conclusions based on the entirety of the data, it is as if ICAN were saying:
CDC can’t claim that ‘horse feed doesn’t turn horses into unicorns’ because all types of horse feed haven’t been studied.
The original claim was that oats could turn horses into unicorns, but through extensive study, this was shown to be false. There are also studies on what does lead to the development of horns on other animals, which does not include horsefeed, and evidence that routinely used horsefeed is generally safe. There is also a lack of evidence to suggest that any other type of horse food is able to turn horses into unicorns.
ICAN is trying to imply that since alfalfa, hay, grass, beets, and soybeans haven’t been studied, the CDC can’t claim horse feed doesn’t turn horses into unicorns, even though there is no evidence to suggest that any horse food is will turn a horse into a unicorn.
Finally, I want to remind people that this list was given as a response to the ICAN FOIA lawsuit. FOIA lawsuits are designed to provide citizens with existing records.
The CDC does not have to compile a record for it. But in essence, this lawsuit asked the CDC to compile a record for the expert-based and referenced conclusion on its website, beyond the studies on the website. The CDC could have fought for dismissing the lawsuit based on that, but it’s likely not worth their time, and they probably settled it because they have a lot of other things on their plate (like coronavirus).
Instead, the CDC provided a list of studies – but in a context like this, it likely did not – and in the middle of dealing with a global pandemic likely should not have – sit down to write a detailed report on an issue discussed repeatedly.
It likely just put together a list of the most easily available. Does that mean the experts who wrote – and referenced – the page only had those studies in mind? Probably not.
In stark terms, creating a new record to settle an FOIA lawsuit isn’t going to be the first priority for an agency; they will do the minimum. Addressing the content of the studies provided is fair, in those circumstances, but needs to be done correctly (and see above on ICAN and the antigen study). Trying to claim these studies are the entirety of the evidence on the topic is unconvincing.
ICAN settled another FOIA lawsuit. In settling it, it did not add to our body of knowledge on government conduct, or the scientific evidence on vaccines and autism. It got very little.
ICAN tried to demand that the CDC prove a negative – that vaccines don’t cause autism – by doing specific studies they think it should do. In reality, expert authorities are justified in saying:
We have looked hard for any evidence that vaccines cause ASD and we have found NONE. Therefore, we feel justified in asserting that we have found no evidence that vaccines cause autism, and we have confidence that we could do a hundred more studies and none of them would provide evidence that vaccines cause autism. Translating that into lay terms, we can say that vaccines don’t cause autism.
When ICAN uses this non-win to claim a major win, and when it tries to present it as showing something meaningful about vaccines and autism, ICAN is misleading its followers and trying to mislead others.
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