Vaccines cause SIDS? Not supported by Boatmon vs HHS case

This is about the case of little J. B. Boatman, who was born four weeks prematurely, at the 36th week.  However, he rebounded from his early start, and at his four-months, well baby pediatric visit, on September 2 was doing very well and found healthy.  At that visit, J.B. had the routine 4 months vaccines. Tragically, the next day (September 3) little J.B. was found lifeless in his crib. His death was ruled to be the result of Sudden Infant Death Syndrome (SIDS). But did vaccines cause SIDS in J.B.?

His parents filed suit under the National Vaccine Injury Compensation Program (NVICP). The case was decided on July 10, 2017. Special Master  Thomas L. Gowen with the National Vaccine Injury Compensation Program granted J.B’s parents compensation.

In August 2017 the Boatmon decision was shared on anti-vaccine sites as evidence that vaccines cause SIDS. The decision does not, however, support the claim because it is flawed internally in several ways. It misuses and discounts the epidemiological evidence, accepts a problematic theory over the objection of a more qualified expert, and ignores several of the important factors of the case. In addition to its internal flaws, the decision is in tension with many other decisions of NVICP – in fact, it seems an outlier – and it is interesting that the same sites that tout this problematic decision ignore other decisions that ruled otherwise.

The Case

On September 3, 2011, J.B. Boatman, a four months old infant, died tragically. J.B. was born four weeks prematurely, at the 36th week, by an emergency Caesarian section, because of his mother’s preeclampsia.  However J.B. was robust at birth and was developing well, and at a well baby check up on September 2 was doing very well and found healthy.

On that day he received his DTaP, IPV, PCV, rotavirus and hepatitis B vaccines. In the early hours of September 3, he developed a mild fever. His parents gave him Advil (Ibuprofen) at 4 am and again at 8 am, which reduced his fever, and according to his mother’s testimony, he played that morning.

In the early afternoon, his father put him down for a nap in a crib, on his back, on top of a small pillow, put a blanket across his midsection, and went out to get lunch. His mother remained at home. A short while later the mother came in to check on him and gave him a pacifier. The room was not overheated (76ºF or 24.4ºC).

A little later – she estimated about ten minutes later – she came in and, in what is one of the parents’ worst nightmares, found him on his right side, head turned slightly downwards, and unresponsive.  She phoned the father, then 911.  A police officer arrived 4 minutes after the 911 call and continued the mother’s efforts at CPR.  The baby was transported to the hospital 22 minutes after the 911 call, but was pronounced dead eighty-two minutes after the 911 call. An autopsy was performed, but it was not as complete as the experts on both sides – the petitioners (as claimants in NVICP are referred to) and the respondents (the state) – would wish.

Under NVICP’s standards, the Special Master hearing the case has extensive leeway in assessing the evidence. To examine causation, the court uses the Althen standard, under which petitioners must show:

(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a proximate temporal relationship between vaccination and injury. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).(Boatman).

What this means for practical purposes is first, epidemiological evidence alone is not sufficient for a Special Master to reject a case, and second, a plausible theory of injury causation is enough to be awarded compensation, even if there is no good scientific evidence supporting it the decision. The grey area is what is plausible. And again, the Special Masters have broad leeway here. The standard of evidence is low compared to a civil court, where a plausible theory would not be enough. Basically, an expert the Special Master finds convincing can lead to compensation for the petitioner even without scientific evidence supporting the medical theory.

In the case of J.B. Boatmon, the Special Master’s decision is deeply flawed in several ways. First, the use the Special Master made of the epidemiology was problematic: His analysis of the epidemiological literature on vaccines and SIDS was highly inaccurate, and he then used the inaccurate analysis to dismiss the value of the epidemiological evidence – while inconsistently using it to find for petitioners on another point. Second, the causation theory the Special Master accepted was not well supported. Third, the Special Master discounted other facts. With respect to the two latter points, the Special Master rejected strong points made by a well qualified expert, so I will discuss them together.

There was no controversy in the case on the basic model of SIDS, as accepted in the literature. The decision explains that it’s the:

Triple Risk Model.16 This model posits that SIDS occurs when: (1) an infant in a critical development period; (2) possessing an underlying vulnerability; (3) encounters an exogenous stressor.

Further information about SIDS can be found here.

There was no real debate that J.B. was in the critical development period, which is the first year, and especially for the first six months. The main causal question here was whether vaccines can serve as the external stressor that causes SIDS – can vaccines cause SIDS?

Epidemiology, SIDS and Vaccines:

The special master said that:

The Vaccine Program does not require epidemiological evidence and the studies presented contained multiple methodological flaws, and did not tend to shed much light on the question at issue, that is, whether the death of the child in this case was caused or triggered by the vaccinations received the day before. Thus the studies were read and considered and credited to show that vaccines are generally safe, but were specifically unpersuasive as to whether they are on rare occasions the exogenous factor resulting in the perfect storm in a child with a defective arcuate nucleus or other 5HT structure during the vulnerable period of life. They were also unpersuasive to reject causation as they frequently showed some temporal correlation to the receipt of vaccines even if those correlations were not found to be statistically significant.

The choice of the special master to, basically, not give epidemiological evidence here weight as unpersuasive was problematic. Because there is extensive epidemiological literature on whether vaccines cause SIDS, and powerful evidence that no, they do not. In fact, some studies show a protective effect, though claiming that vaccines prevent SIDS is tricky. There is at least a plausible argument that the protective effect seen is the result of the fact that parents are less likely to take their sick children to get vaccines, and therefore the sick children are not vaccinated at the time of death – though there are also arguments that the protective effect is real. However, the evidence against causation is extensive.

Multiple studies have found no evidence that vaccines cause SIDS. The decision quotes several of these, but discounts them. It quotes a case study by Venneman et al. from 2007 but discounts it as too small even though the study has comprises 1,278  subjects, 307 SIDS cases and 971 controls and is self-described as “large”.

Similarly, the decision quotes a study by Kuhnert et al (2012) that reanalyzed several studies from the past using many different statistical methods and found no link. The decision rejected this on the ground that

“Kuhnert noted that the small number of cases is a problem with the three case control studies he reviewed, particularly in view of the short time periods under investigation.”

But the Kuhnert study made clear and strong findings of no link after many, many examinations.

The decision appeared to completely ignore a meta-analysis by Venneman that looked at nine case-control studies and found a reduced risk of SIDS. It is unclear why the meta-analysis was not given weight – it was clearly considered as strong by, for example, the American Academy of Pediatrics, which in its policy statement said, clearly reflecting its findings:

Infants should be immunized. Evidence suggests that immunization reduces the risk of SIDS by 50 percent.”

Again, I would be cautious about claiming a strong protective effect. There is some evidence for it, but the studies may have not sufficiently controlled for the healthy vaccinee effect, as Kuhnert pointed out. But there is extensive evidence against a link, including the Venneman meta-analysis, Kuhnert, and this large-scale study from 2015 that found a protective effect.

All that is on the side arguing that recent immunization is a risk factor for SIDS are very small case studies showing temporal correlations. Or incredibly flawed studies, for example, the Goldman study, that used VAERS raw reports with no controls – and analyzed them in extremely flawed ways. The Special Master also mentioned studies that found temporal correlations that were not statistically significant as supporting a link. But that’s an error: correlations that are not statistically significant have not met the required standard for seeing them as non-coincidental. To remind readers, some SIDS cases will happen after vaccines just by coincidence. In other words, the correlations alone show little.

Ironcially, a study emphasized by Special Master Gowen was a single case study of one inant by Ottaviani (which apparently merited discussion even though the much larger Venneman study was dismissed as too small) of a child who died after vaccine (which can happen by coincidence), and which concluded with a maybe – maybe it was the vaccine.

In other words, the Special Master ignored large studies, and treated them as equivalent to small scale ones and very, very flawed ones. That is simply incorrect.

The correct conclusion should have been that extensive literature found no link between vaccines and SIDS, and that suggests strongly that there is no such link. While the epidemiological evidence is not sufficient to reject the petition, it should have been taken into consideration.

The Special Master mentioned the National Academy of Science, Engineering and Medicine report of 2012, which examined adverse events from vaccines, as finding the evidence insufficient to accept or reject a link between vaccines and SIDS. But that’s not quite accurate. The report reviewed a link between DTAP and SIDS, and on p. 582 did conclude the evidence was insufficient to accept or reject a causal connection. But that’s because, focused on DTaP vaccines, they could not use the other studies, that were broader. They looked at one Geier study and correctly dismissed it, and found that the mechanistic studies too were not strong evidence. Note that an earlier IOM review that focused on SIDS and vaccines more broadly rejected a causal connection:

In short, the report, because of its format, did not include a thorough review of the literature on SIDS and vaccines and does not constitute a good basis for rejecting it.

Even more strangely, Special Master’s rejection of epidemiology was inconsistent: he rejected the epidemiological literature on vaccines and SIDS, but then turned to it on another issue – to find that most infants who die from SIDS have brain abnormalities. He said:

…a significant proportion – up to 70% – of SIDS infants have abnormalities in the arcuate nuclei and other sections of the medulla.

She further observed, “according to the Triple Risk Model, only infants with an underlying brainstem disease process die of SIDS, which explains why all infants who are placed prone to sleep or who bed share do not die of SIDS. They do not have the underlying vulnerability.

In other words, the epidemiology led Special Master Gowen to conclude that J.B. had an underlying brain vulnerability, absent any direct evidence (which would have been problematic by itself, but since both experts agreed he likely had the brain abnormality, I won’t dwell on it in an already long post).

Cytokine hypothesis

After rejecting the epidemiological evidence, Special Master Gowen accepted the theory proposed by the petitioners’ expert that the vaccines may have triggered production of cytokines and that was the stressor that filled the third factor needed for the third prong of the triple risk model. To remind readers, a plausible theory supported by a credible expert can be enough to win in vaccine court – and what is plausible is flexible. But there are limits. NVICP consistently rejected this exact theory in many cases, because it’s very speculative and goes against other evidence.

Basically, the theory goes like this. A 2009 article by Kinney and Thach suggested that about half of the infants who succumb to SIDS have a mild infection at the time of death and just before, most usually a mild Upper Respiratory Infection (URI), like a cold.

Petitioner’s expert, Dr. Miller, suggested a theory under which the reasons URI are associated with SIDS is that they stimulate the production of immune inflammatory cytokines. Those, said Miller, interfere with the 5-HT system that among other things regulates the respiratory system, and can be the stressor that causes the child not to breathe enough, and to die from SIDS.

Dr. Miller than added on top of that the idea that vaccines cause a similar production of cytokines with similar effect, and hence, can also cause SIDS.

He brought several studies to support the cytokine storm argument.

There are several problems with the theory, and with its application here. First, on a general level, Special Master Gowen is preferring testimony here by a general pathologist – whose area is not vaccines – over that of an immunology expert. In another case, Copenhaver v. Secretary of Health and Human Services, 129 Fed.Cl. 176 (2016), the Court of Federal Claims cited the description of Special Master Moran of Dr. McCusker, who:  “practices pediatric immunology every day. She has conducted research on cytokines, and written several papers on cytokines.”

In other words, the court preferred Dr. Miller’s opinion on cytokines, based on reading of problematic literature I will discuss in a moment, over that of Dr. McCusker, who has actual expertise in the area.

Dr. McCusker pointed out that:

…cytokines serve a variety of positive functions in the healthy human brain… Dr. McCusker opined that cytokines play a protective role.

She explained that there is no real evidence that the presence of cytokines here is harmful.

Dr. McCusker suggested a different role for mild URIs – that because they lead to babies’ noses being congested, they make it harder for the infants to breathe, and leading to SIDS that way. Dr. Chris Johnson, an ICU doctor with decades of experience, agreed that the problem URIs cause is obstructing the airflow:

I think the association of upper respiratory infection with SIDS shown by case-control studies is related to the well-known propensity of such infections to cause apnea, stopping breathing. Any respiratory virus can been associated with apnea but the most common offending one by far is respiratory syncytial virus (RSV). Not uncommonly the first manifestation of RSV infection in an infant is apnea — you can see that before any other respiratory symptoms even appear. RSV is extremely common in the winter and is highly infectious.

The association between viral respiratory infection and SIDS parallels known risk factors for SIDS, especially prematurity. Premature infants often have apnea, which commonly is treated with caffeine. It resolves as the central nervous system of the child matures. Since the current research on SIDS suggests brain stem immaturity in the respiratory response to either high carbon dioxide or low oxygen in the blood (especially the former) as a common pathway, the association of upper respiratory infection with SIDS makes explanatory sense. There is a disordered control of respiration when stressed. Interestingly, in my experience the infants who get apnea with RSV or other viruses typically have it very early in their illness, often before they are obviously sick.

In other words, while the Cytokines claim exists in the literature, it’s not the only explanation for the role of Upper Respiratory Infections (URIs), and the alternative explanation would not apply to vaccines: vaccine-induced fever would not stop breathing in the same way a URI would.

The mechanical aspect of SIDS gains support from the fact that the largest reduction we have seen in SIDS is since the back-to-sleep campaign, which targeted baby’s sleep position and sleep environment and more than halved SIDS.

The fact that there is an alternative explanation would not automatically make compensation inappropriate. The program is designed to compensate in cases of doubt, and if the special master thinks there are two plausible theories that are pretty close, going with compensation is reasonable. In this case, however, aside from the fact that the cytokine theory was countered by an expert in the subject area and promoted by someone outside the subject area, there were problems with its content.

First, the literature on which the cytokines theory relies on is problematic, something that Dr. McCusker went into in detail. Much of it consists of animal studies that are not good parallels to infants. For example, for discussion of a study involving rat brain tissue:

the Brambilla study submerged rats’ brain tissue in “super-physiologic doses” of IL-1β for an extended period of time; and kept it isolated in petri dishes, which would not reflect what happens to a vulnerable infant in a “crisis situation.”

More important, the application to vaccines was very ill-supported. A main study used to suggest vaccines cause the same production of cytokines as mild infections, looked mostly at cells in the lab. Basically, it placed cells in a medium into which vaccines were then injected (or infused) to see what happens. The study exposed these in-vitro cell cultures to vaccines, to study the production of cytokines. But that’s not parallel to what would happen in a complex body, with many other systems and protections against a negative reaction.

Also, mild URIs don’t usually involve a fever – but what Dr. Miller, petitioners’ expert, emphasized as evidence of the production of cytokines was the fever (Dr. McCusker pointed out that several of the cytokine studies in SIDS found the same production of cytokines with or without a fever, again countering the extension Dr. Miller tried to propose to vaccines). In other words, the fact that many SIDS victims had previous URIs doesn’t directly support the claim that fever from vaccines would lead to the same result. I would add that if the issue is the interference with breathing (or even if it’s the infection itself), vaccines, which prevent diseases that can interfere with breathing (like pertussis) could reduce SIDS, which may explain the protective effect.

In other words, the literature behind the cytokine storm theory is weak at best. The person proposing it is not an expert in cytokines, and the person disagreeing with it is. And finally, there was another explanation proposed for the basis of the theory – the relatively high prevalence of mild URIs in children who die from SIDS – that would not apply to the vaccine, and thus, would fit what the epidemiological literature teaches us.

Further, in this case, there were other problems with the petitioners’ expert’s argument. The child had a fever – what Dr. Miller pointed to and Special Master Gowen emphasized as a source of cytokine production – the night before he died. But at the time of his death, the child had been given Advil to control the fever, which had decreased in the morning, and there was no indication of fever at the time of his death. That does not fit the theory very well. Further, there were other clear risk factors. This was a premature infant (a risk factor), lying on his side (a risk factor), on a pillow (a risk factor).

Other Decisions:

In many other decisions, NVICP rejected similar arguments and – interestingly – accepted Dr. McCusker’s views on SIDS. In fact, this case appears to be an outlier, with NVICP rejecting similar cases constantly. Examples include:

  • Copenhaver v. Secretary of Health and Human Services, 129 Fed.Cl. 176 (2016). a child with a fever, Dr. Miller testifying claiming the same theory, Dr. McClusker testifying against the claim, the claim denied.
  • Cozart v. Secretary of Health and Human Services, 126 Fed.Cl. 488 (2016), SIDS, fever, Drs. Miller and McCusker testifying, compensation denied.
  • Lord v. Secretary of Health and Human Services, 2 016 WL 806818 (2016), SIDS, claim of cytokines, Drs. Miller and McCusker testifying, claim denied.
  • Bigbee v. Secretary of Dept. of Health and Human Services, 2012 WL 1237759 (2012), SIDS, claim based on cytokines, Dr. Levin for petitioners,  Dr. McCusker testifies, claim denied.
  • Doe v. Secretary of Health and Human Services, 601 F.3d 1349 (2010), SIDS, claim based on cytokines, Dr. Levin for petitioners, Dr. McCusker testifies, claim denied.

In other words, the VICP repeatedly denied the cytokine storm theory in cases of compensation for SIDS. It did so mostly because of the problems in the theory, as highlighted by expert witness Dr. McCusker. Special Master Gowen, in this case, ignored these problems and compensated on a very, very weak basis.

Conclusions

There is extensive epidemiological literature showing that there is no evidence that vaccines cause SIDS, and vaccines may even be protective against it (though the latter is not as clear). Generally, NVICP follows that literature and does not compensate for SIDS. In this outlier case a special master did a bad job working through the epidemiological literature, rejected it as evidence, and accepted a weak, ill supported theory to compensate a vaccinated child who died from SIDS, even though the child had several risk factors for SIDS and the facts of the case were tricky at best.

It’s horrible to lose a child. But NVICP is not a charity program: it’s not there to fix tragedies. Our system certainly needs better mechanisms to help those in need, but that’s not what NVICP was created for. Here, there was no good basis to find for the petitioner in this case, and this decision is ill-supported.

Update – 14 January 2019

This case was appealed to the Court of Federal Claims, and it reversed the decision of the Special Master. This appeal is discussed in detail in a new article.

Citations



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Dorit Rubinstein Reiss
This article is by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), 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 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.