In the early 1980s in the wake of reports, publicized by a news report and later a book by Harris Coulter and Barbara Loe Fisher (DPT: A Shot in the Dark), that the whole cell DPT vaccine was linked to encephalitis and brain damage, a flood of product liability lawsuits was on the verge of bringing the US vaccine program to its knees. Later studies exonerated the DPT, especially a large case-control study, but those studies did not come until the 1990s. Even though existing evidence at the time did not clearly support a link, it did not clearly rule one out. As a result vaccine manufacturers had increasing difficulty obtaining liability insurance. More and more of them stopped making whole cell DPT. Congress ultimately was forced to intervene and passed the National Childhood Vaccine Injury Act (NCVIA) of 1986, which established a federal no-fault system to compensate victims of injury caused by mandated vaccines.

As part of the law, the Vaccine Court was established. The Vaccine Court has been discussed here on many occasions, but basically all claims of injury due to vaccines have to go through the Vaccine Court first. The court is different from other courts in several ways. First, win or lose, the government pays the complainants’ court costs. Second, there is a list of “table injuries” for which compensation is automatic. Third, the Vaccine Court doesn’t follow the Daubert standard, which for regular court cases sets fairly strong standards on the allowability of expert testimony and the qualification of experts who testify. That last difference sometimes results in the admission of “expert” testimony of a dubious nature. Also, legal standards, while informed by science (we hope), are not scientific standards. The reasoning that judges use to decide cases based in medicine often are not the reasoning that scientists or physicians would use, because, again, the law is not a system of science.

Despite its shortcomings, the Vaccine Court has generally worked well. Cases such as the Autism Omnibus were correctly adjudicated from a scientific standpoint. It’s because the Vaccine Court has generally worked well that antivaxers hate it and regularly attack its legitimacy. I’ve never really been able to figure this out, as the Vaccine Court basically eliminates a lot of the risk of legal action and provides more consistent rules and compensation in the case of real vaccine injuries. Of course, trial lawyers hate it. Yes, they get paid, win or lose, but there are no enormous payouts for them to get their 30% cut from.

Still, the Vaccine Court is not perfect, and a ruling that I heard about over the weekend demonstrates that. The antivaccine movement will be using this ruling as propaganda for years to come to frighten parents into thinking that vaccines can cause sudden infant death syndrome (SID). In considering this ruling, one has to remember that this is not a scientific ruling. Courts do not determine science. The difference between antivaxers and proponents of science-based medicine is that antivaxers recognize that courts do not determine science when a court rules against them but are eager to paint a court decision that supports their pseudoscience as “proof” that science does support them. In contrast, we recognize that, even when the court rules according to science, it is not a scientific ruling, but a legal ruling that happened to get the science right. This makes it easier for us to point out the same thing when the court gets the science wrong.

The antivaccine movement rejoices over a ruling

Surprisingly, as of this writing, there hasn’t been much about this ruling on the major antivaccine sites, but it is popping up on Facebook on the VAXXED page:

And VacTruth:

The quotes that antivaxers are pulling from the ruling include:

In this case, I have concluded, after review of the evidence, that it is more likely than not that the vaccines played a substantial causal role in the death of J.B. without the effect of which he would not have died. The role of inflammatory cytokines as neuro-modulators in the infant medulla has been well described and is likely the reason for a significant number of SIDS deaths occurring in conjunction with mild infection. I have concluded that it is more likely than not that the vaccine-stimulated cytokines had the same effect in this vulnerable infant during sleep.

And:

After carefully analyzing and weighing all of the evidence and testimony presented in this case in accordance with the applicable legal standards, the undersigned finds that petitioners have met their legal burden. Petitioners have put forth preponderant evidence that the vaccines J.B. received on September 2, 2011 actually caused or substantially contributed to his death from Sudden Infant Death Syndrome. Furthermore, respondent has failed to put forth preponderant evidence that J.B.’s death was in fact caused by factors unrelated to the vaccines. Accordingly, petitioners are entitled to compensation.

It sounds pretty damning, right? I doubt that you’ll be seeing this quote from the complete ruling anywhere:

In this case, I have concluded that petitioners have presented sufficient evidence and testimony to entitle them to compensation in the Vaccine Program. I have not concluded that vaccines present a substantial risk of SIDS. In fact, the evidence is to the contrary. The vast majority of vaccine recipients do not succumb to SIDS.

The vast majority? More like nearly all, and SIDS is not related to vaccines. As I said, this is a very confused and contradictory ruling. Reading all 55 tedious pages of it, I got the feeling that the Special Master was bending over backward to try to compensate the family despite a weak case based on a lot of speculation rooted mainly on basic science and a preponderance of evidence that, as admitted in the ruling, does not support a causative role for vaccines in SIDS (indeed, if anything, quite the contrary). Basically, Special Master Gowen misinterpreted the epidemiological data, and then used that misinterpretation to justify considering the petitioner’s “theories” to be plausible, even though the “theory” (wild-ass speculation, actually) is not well-supported by science.

The case

Before we get to the arguments, I will summarize sequence of events leading up to the death of J.B. Boatmon, as related in 13-611V Boatmon vs HHS, the case brought by J.B.’s parents Chase Boatmon and Maurina Cupid. I can’t even imagine what the parents went through losing a child and feel nothing but sympathy for their lost. SIDS is a horrible thing. To find your baby dead in his crib, as they did, is unimaginable. The human need to blame something is very understandable, particularly given the mysterious nature of SIDs. Unfortunately, this case shows how a combination of human nature, the need to see a correlation, can conspire with scientific speculation to produce a ruling that contradicts accepted clinical science. Before I delve into that, here is the background.

J.B. was born on April 7, 2011 four weeks prematurely at 36 weeks gestation. Because his mother had become pre-eclamptic, she underwent an urgent Caesarean section. At birth, J.B. was noted to be “well appearing, non-dysmorphic[,] alert and in no acute distress,” with Apgar scores of 8 at one minute and 9 at 5 minutes. One week after birth, J.B. received his first dose of hepatitis B vaccine, and at a two-week well baby visit J.B. was described as a “well appearing, alert…a healthy appearing 2 [week] old with normal growth and development.” On June 7, 2011, J.B. was brought to the emergency room for a cough and runny nose, where he underwent a chest x-ray that revealed “no radiographic evidence of acute cardiopulmonary disease.”

On September 2, 2011, nearly five months post-delivery but with a gestational age of four months given his early delivery, J.B. was taken to the pediatrician for a well-baby visit where he received multiple vaccines. The court documents describe this visit thusly (lightly edited for clarity):

J.B. was sleeping up to seven hours at a time, on his back, in a crib in his own room. He was described as “healthy appearing and cooperative . . . well-nourished and well developed.” His chest and lungs were normal with no adventitious sounds.

J.B.’s heart rate was regular with normal heart sounds and no pericardial friction rubs…His reflexes were all 2/2 and his red reflex was normal. His weight was 16 pounds, 8 ounces… For infants of his age, his weight was stable at the 50th percentile, his height was up at the 50th percentile, and his head circumference was at the 75th percentile. Nasal mucosa was normal, turbinates were normal, and nares were patent. Oropharynx was normal. He was recorded as not having a fever, nasal congestion, or cough and history of wheezing. He met numerous 4-month developmental milestones, including “head up 45 degrees, head up 90 degrees, sits – head steady.” During this visit, J.B. received DTaP, IPV, PCV, rotavirus, and Hep B vaccinations. Dr. Wright completed her records from this visit on September 2, 2011, at 10:45 a.m., suggesting that the appointment had concluded by that time…

J.B.’s father attested that during the well-baby visit, J.B. was “smiling and cooing like normal.” However, later that day after J.B. received the vaccinations, he “was not laughing or cooing like he normally did[,] he was not moving as much[, and] he seemed quiet and withdrawn.” That night, J.B. had a fever and he did not sleep well.

So thus far we have a fairly typical well baby visit, with standard vaccines administered. On the night after the visit, J.B. appeared to have had a mild typical reaction to vaccines, in which he didn’t feel well and had a fever. His parents gave him two doses of Advil overnight, one at 4 AM and one at 8 AM. J.B.’s mother reported that J.B. had sat up and played with her nephews during the morning.

In the early afternoon, J.B. became fussy. So his father put him in his crib for a nap in his room on the second floor of the house. His father stated that he placed J.B. supine with his head to the right on his back in the middle of the crib with a blanket across his midsection. The crib also contained a “little crib pillow – very flat” and no toys. It was noted that J.B. slept on his back and that he could roll over on his own, lift his head, and pull or push himself up. Here’s what happened next (again, lightly edited):

After putting J.B. down for his nap, his father left the home to get lunch. His mother remained in the home, but “heard [J.B.] fussing in crib” while she was cleaning and on the phone. After some period of time, J.B.’s mother went upstairs and put the pacifier in J.B.’s mouth. (noting that J.B. “tend[ed] to cry when he spit the pacifier out”). When she returned, she found J.B. on his right side, with his head turned slightly, and unresponsive. She called J.B.’s father and said that J.B. was not breathing. The father told her to call 911 and he headed home.

J.B.’s mother said that “approximately 50 minutes passed” between his father placing J.B. down for a nap and when she found J.B. unresponsive. There was a “10-minute window” between when his mother checked on J.B. and replaced his pacifier, and when she returned to find him unresponsive. She informed the police that his nose and mouth were not covered.

J.B.’s mother called 911 at 2:39 p.m. She then attempted CPR. It appears that she removed him from the crib and placed him on his back on the floor. Officer Anderson was the first to arrive, at 2:42 p.m. – just 3 minutes and 21 seconds after the call. Upon entering the home and going upstairs, the officer found J.B. lying on the bedroom floor, perpendicular to his crib. J.B. was face up, with his eyes closed, and unresponsive. He was still warm, but had no pulse or breath. Id. J.B.’s mother was kneeling over him. The officer performed chest compressions until EMS arrived.

The first responders left with J.B. at 3:02 p.m. and arrived at the emergency department of Harborview Medical Center at 3:08 p.m. J.B. was given oxygen under pressure during transport, but PEA (pulseless electrical activity) was noted on the monitor. Efforts at resuscitation were unsuccessful and J.B. was pronounced dead at the hospital, on September 3, 2011, at 4:01 p.m.

On September 5, medical examiner, Dr. Jeffrey Gofton, completed an autopsy report on J.B. He noted that the scene reenactment showed that J.B. was placed to sleep on his back but was later found on his right side. Scene photographs showed a crib with soft blankets and a flat, soft pillow, and no clutter or toys. He also noted that the baby had been fussy and had had an intermittent temperature that appeared to be controlled with Tylenol. He concluded that the death was due to SIDS:

The medical examiner stated that J.B.’s lungs exhibited congestion and pulmonary edema. However, J.B. had no traumatic injury, congenital abnormalities, or viruses such as influenza. Both a cerebral spinal fluid culture and a nasopharyngeal swab for viruses were negative. J.B.’s brain weighed 876 grams (normal is 620 plus or minus 71 grams). There was no evidence of epidural, subdural, or subarachnoid hemorrhage. Serial sectioning showed normal configuration and infantile myelination of the cerebrum. The brainstem was normally formed with no focal lesions. Extensive drug testing was performed and was negative. The medical examiner, based on the “absence of findings and the reported sleeping position in a child with no anatomic or microscopic significant findings,” stated that “the cause of death was SIDS and the manner was “natural.” The parties agree that the characterization of J.B.’s cause of death as SIDS is appropriate…

So here we have a tragic death, a little more than a day after a baby received his normal four month vaccinations.

Before I can discuss the evidence, it is important to understand the legal framework under which the decision had to be made.

The Althen test

As noted in the decision, there are two avenues to compensation under the National Vaccine Injury Compensation Program (NVICP). The first I’ve already mentioned, and that is proving a Table Injury; i.e., a specific injury in a specified period of time after vaccination. Table Injuries are almost automatically compensated, as legally they create the presumption of causation and the respondent has a high bar to show that the injury was due to something other than vaccines. SIDS is not a Table injury, nor should it be. The second avenue for compensation is to establish an “off-Table” injury, meaning that vaccines caused an injury not listed in the Table. In Althen v. Secretary of Health and Human Services, 04-5146 (U.S.Ct.App, Fed. Cir. 2005) the Federal Circuit Court established a three prong test for off-Table injuries. Specifically, petitioners must establish “(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.” Note that this is not a scientific standard. It’s worth reading the part of the decision describing the Althen test in full. There are several important points that will show you how a ruling as unscientific as this one could come about and be correct from a legal standpoint while still being utterly indefensible from a scientific standpoint:

  • The legal standard is “preponderance of evidence,” which has been interpreted to mean “more likely than not.” This is where we get the phrase “50% and a feather” to describe the evidence standard from.
  • Each Althen prong may be satisfied by medical records or a medical opinion. Petitioners are not required to provide “objective confirmation” by way of “medical documentation.”
  • Epidemiological studies, or the lack thereof, are not definitive. The Special Master can consider them if they exist to determine if they apply to the case at hand, but, as Special Master Gowen notes, “petitioners are not required to present medical literature or epidemiological evidence to establish any Althen prong” and medical literature and epidemiological evidence must be “viewed… not through the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant evidence standard.”
  • Petitioners do not have to show that the vaccine was the only cause of injury or even the predominant cause.
  • A petitioner is not required to eliminate all other possible causes of injury. According to Althen, this standard permits the use of “circumstantial evidence” and accomplishes Congress’s goal that “close calls regarding causation are resolved in favor of injured claimants.”
  • Once a petitioner fulfils the Althen test, the burden of proof shifts to the respondent to show that the injury was caused by something other than vaccination, and Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d 1363, 1369 (Fed. Cir. 2013). Section 13(a)(2) specifies that factors unrelated “[do]not include any idiopathic, unexplained, unknown, hypothetical, or undocumented causal factor, injury, illness, or condition.” In other words, “we don’t know” the cause of this injury is not good enough even if, in the case of SIDS, that is usually the case even in babies who die of SIDS weeks after a vaccination.

The science-minded among you are probably scratching your heads, and saying, “WTF?” You’re probably seeing the obvious, namely that these standards put scientists and science-based physicians arguing against vaccines causing an injury in any given Vaccine Court case at a huge disadvantage, particularly for conditions like SIDS whose causes remain mysterious, and give petitioners seeking compensation a huge advantage. This is undoubtedly true. However, you must realize that this is a feature, not a bug, of the NVICP. It was designed that way on purpose. The reason was that the entire function of the NVICP was to restore confidence in the vaccination schedule and to make it easy for those rare individuals with real vaccine-induced injuries to obtain compensation. Basically, the system is indeed rigged, just not in the way antivaccine activists frequently claim. Rather, it’s rigged in favor of the petitioners by design.

Now, on to the case.

The arguments: Speculative science beats epidemiology and known science

What makes this case rather interesting to me, despite its confused and frustrating outcome, is that it is one where the Daubert standard wouldn’t have excluded the expert witness for the petitioners. I’m referring to Douglas C. Miller, MD, PhD, a Clinical Professor of Pathology and Anatomical Sciences and director of the pathology residency program at the University of Missouri School of Medicine. He is not, however, as far as I can tell, what I would call a “heavy hitter” in the world of SIDS, at least not judging by his publication record. The only publication I could find by him related to SIDS was this one in 2007, and it wasn’t even about classical SIDS, as the deaths studied were in toddlers, who are way older than the age at which SIDS most commonly occurs.

One thing I did notice, though, is that Dr. Miller’s name does pop up in other Vaccine Court decisions, always (at least as far as I’ve been able to find) on the side of the petitioner. For instance, in Copenhaver v. HHS 13-1002V, he made basically the same arguments he made in this case, namely that vaccine-induced cytokine production kept the baby from waking up after he became hypoxic. The case was eerily similar to the Boatmon case in that the child received his four month vaccinations and then died suddenly three days later. There aren’t a lot of them (Dr. Miller doesn’t appear to be a frequent expert for the petitioner in Vaccine Court cases), but at least one of these cases goes back to 2000.

Even allowing for my usual logorrhea, it’s a bit hard to boil down the arguments made by the petitioners using Dr. Miller as their expert witness. It’s all very speculative. First, one has to be aware that SIDS is the leading cause of infant mortality in the US, with an incidence of 0.53 per 1,000 infants. That means one in two thousand infants dies of SIDS, which is a pretty large number. It’s been well studied that a major risk factor is infants sleeping in the prone position, with the head facing downward, which doubles the risk of SIDS. Other risk factors include covering the head, sleeping on an adult mattress, couch, or playpen, soft bedding, and bed sharing. Also, J.B. was African-American, preterm, and male, all groups overrepresented in SIDS deaths. The most commonly used model for how SIDS occurs is the Triple Risk Model of Dr. Hannah C. Kinney and colleagues, which posits that SIDS can occur when (1) an infant in a critical developmental period (2) possessing an underlying vulnerability (3) encounters an exogenous stressor. In this case, the critical developmental period is often between 2-4 months, which is the peak age range for SIDS.

Basically, the petitioners, through Dr. Miller, argued that a high percentage of SIDS infants, almost 50%, have no history of serious illness before death but do have a mild infection, often an upper respiratory infection. Under the first leg of the Triple Risk Model, the petitioners argued that J.B. likely had a defective or under-developed serotonin system in the arcuate nucleus or other area in the medulla oblongata of the brain, which is an area that is, conveniently enough, usually not sectioned during routine autopsy. Underdevelopment of the arcuate nucleus has been noted in SIDS infants and is thought to be important in the pathogenesis of SIDS by causing insensitivity to carbon dioxide and decreased respiratory drive. In more general terms, moving away from Dr. Miller’s argument, it is thought that SIDS might result from immature development of centers responsible for arousal, cardiovascular, and respiratory functions. When the cardiorespiratory system becomes compromised due to noxious environmental conditions (e.g., lower oxygen levels, higher carbon dioxide levels) during sleep, SIDS infants may not become aroused to defend against these conditions and breathe, resulting in cardiac arrest and death. It is generally well accepted that babies who die of SIDS must have an abnormality in the medulla, meeting test #2 of the Triple Test.

The next part of the argument is that cytokines released during a mild fever (as from a mild upper respiratory infection or after vaccines) can be enough of a stressor to suppress respiration in infants with predisposing factors, like an underdeveloped arcuate nucleus. (Cytokines are molecules released by various cells, especially in the immune system, that mediate the inflammatory response.) Again, even with my tendency towards logorrhea, it would take more space than I have available to summarize all the intricacies, but there is actually some evidence summarized in the discussion that increased production of specific cytokines due to mild infections could have a role in SIDS:

Dr. Miller, relying on multiple pieces of research described in the SIDS literature, opined that it is likely that the cytokine signaling triggered in the immune system by mild infection interacts with the underdeveloped 5-HT system in the brainstem, during sleep when the excitatory function of serotonin is reduced, to further suppress the function of the brainstem to cause a cardio-respiratory crisis. The further issue raised is whether, in the absence of a mild infection, can the multiple vaccines administered together – in this case the day before – trigger the same cytokines as does a mild infection with the same fatal result? Dr. Miller concluded that they do.

That’s nice, but it’s all theoretical. Again, the epidemiological evidence very much goes against a causative role of vaccination in SIDS. I like to point out that SIDS incidence declined dramatically (by 50%, actually) in the 1990s, largely due to the success of campaigns to educate parents about not putting infants on their stomachs to sleep, a point that is mentioned in this decision. I then like to point out that this is the same time period that (as antivaxers love to point out when claiming that vaccines cause autism) encompassed a large expansion of the US vaccination schedule. If vaccines caused SIDS, then we would expect the incidence of SIDS to increase, or at the very least antivaxers would have to argue that the incidence of SIDS would have declined even farther than it has if the vaccine schedule hadn’t been expanded—a rather tricky argument to make and one I’ve never seen made.

Of course, that’s just a general snarky observation on my part. It’s not as though we don’t have studies. Unfortunately, one of the studies cited was by Gary S. Goldman and Neil Z. Miller, specifically this one, “Relative Trends in Hospitalizations and Mortality Among Infants by the Number of Vaccine Doses and Age, based on the Vaccine Adverse Event Reporting System (VAERS): 1990-2010.” We’ve met these two before when they produced some awful science trying to “prove” a link between vaccination and infant mortality. This paper was similarly awful science. Yet in the decision, Special Master Gowen stated, “Goldman reported a statistically significant increase in deaths when 5 to 8 vaccines were administered simultaneously as opposed to 1 to 4.”

No. He. Did. Not. His paper was way too crappy to conclude anything. I mean, seriously. If you’re going to consider Goldman and Miller credible, listing it along with real epidemiological studies (Goldman and Miller do fake studies), and accept that the shortcomings in epidemiological studies of vaccines and SIDS are sufficient to make Dr. Miller’s handwaving speculation plausible, you have no business adjudicating science!

Studies showing no increased risk of SIDS due to vaccines were, in fact, discussed, particularly studies by Venneman, including a case control study and a meta-analysis, both of which found a decreased risk of SIDS associated with vaccination. Oddly enough, Special Master Gowen ignored the Venneman meta-analysis, not even citing it, and only concentrated on the case-control study. I note that both found a decreased risk of SIDS in the vaccinated, although neither could conclude that vaccination is causative in terms of decreased risk. I must say that I found Dr. Miller’s criticisms of the study rather unconvincing. Yes, like all epidemiological studies, they have flaws, but to go from finding a two-fold decreased risk of SIDS in the vaccinated to an increased risk would require some pretty amazing flaws in the studies.

There are also several other studies finding no effect on SIDS risk attributable to vaccination. One nice summary and reanalysis (with a different methodology) of three major case control studies was published by Kuhnert et al in 2012. One part of the ruling that really annoyed me was how Special Master Gowen honed in on just one statement from this study, “The small number of cases is a problem with the three case-control studies, particularly in view of the short time periods under investigation. This problem is illustrated by the very broad confidence intervals of estimates that are only related to the events of the first few days.” Yes, that’s a shortcoming of the studies, but these are among the largest. Also, consider the conclusion:

The detailed re-analyses show that the risk of SIDS in vaccinated cases and controls is neither increased nor reduced during the early post-vaccination period. This result of case-control analyses restricted to vaccinated cases and controls is similar to the results of the SCCS method. The risk of SIDS in unvaccinated cases and controls is higher than the risk to infants in the late post-vaccination period. An additional protective effect of vaccinations in the early post-vaccination period (as indicated by conventional case-control analyses) is derived from differences between vaccinated and not vaccinated subjects.

Yes, epidemiological studies of SIDS are difficult, but instead of looking at the totality of evidence and asking, “How likely is it that vaccines contribute to SIDS?” (answer based on existing literature: not very likely—far, far less likely than likely), Special Master Gowen seemed to be looking at the studies and asking if there were enough defects in the body of evidence to be able to accept the petitioners’ hypothesis of causation in this one case. Unfortunately for science, his answer was yes. Handwaving speculation like this won over science:

Dr. Miller’s theory, consistent with many of the articles in the literature, is that SIDS is multifactorial. Multiple factors come together at the fatal moment that causes the perfect storm leading to death. He theorizes that the cytokines triggered by the vaccines in the initial innate immune response to the vaccines travel to their receptors in the arcuate nucleus and suppress the serotonin function in a child whose functionality in that area is already impaired by an underdeveloped or defective 5-HT system while he is asleep, which further reduces 5-HT function. The input of the cytokines stimulated by the vaccines causes the lack of response to elevation of carbon dioxide that converts a recoverable event to a fatal one. Whether the vaccine generated cytokines cause additional metabolic activity generating fever and additional production of carbon dioxide, or whether they caused the neurons in the brainstem to be unable to respond to rebreathed or accumulated carbon dioxide, it is probable that they played an important role in causing the death of this infant.

The use of the word “theory” irritated the hell out of me, because none of what Dr. Miller put together is a scientific theory. At best, it’s a hypothesis, and a vague and difficult to falsify one, too. (I realize Special Master Gowen is using “theory” in the colloquial and legal sense, but it irritated me nonetheless.) Unfortunately, because the “theory” sounded plausible based on the literature, the best that the respondents could come up with was:

Dr. McCusker disagreed. She argued that the presence of the various intrinsic risk factors together with a flat pillow in the bed and side-sleeping to which the child turned after being placed supine was sufficient to explain the death. She argued that the role of mild infection was that it caused obstruction in the nasal passages in infants who are “obligate nose breathers” (Tr. 138) and mucous in the nose would obstruct the breathing of the child sufficient to cause death. She referred to infants she sees in the emergency room with upper respiratory tract infections who need to be suctioned which then brings down their carbon dioxide level.

Which is all almost certainly true, but, according to the law, doesn’t stand up against a seemingly plausible “theory” coupled with close temporal proximity between vaccination and sudden death.

Conclusions: How not to science

Never forget that Special Master Gowen’s ruling in the case of Boatmon vs HHS is a legal, not a scientific, ruling. Once you accept that, you can understand how it happened. In fact, the ruling is profoundly unscientific in that it turns the methodology used in science-based medicine to determine causation of disease on its head by valuing a plausible-sounding “theory” of how causation might occur over actual existing clinical and epidemiological evidence showing that causation very likely does not occur. Again, this possible under the law as cited by Special Master Gowen. However, it is not necessarily the only—or even the best—way the law and precedents need to be interpreted.

For a better way, one need only look at Special Master Christian Moran’s ruling in the case of Copenhaver v. HHS 13-1002V to see how, even under the constraints of Althen, arguments like Dr. Miller’s can be rejected. One of his reasons was:

Dr. McCusker’s testimony was largely, but not exclusively, about immunology generally, and cytokines specifically.21 As discussed in section 1.B, below, immunology is where Dr. Axelrod and Dr. Miller fell well short of being persuasive. In sum, Dr. McCusker possesses a background in pediatric immunology that is superior to either Dr. Axelrod or Dr. Miller. She practices pediatric immunology every day. [Emphasis mine.] She has conducted research on cytokines, and written several papers on cytokines.

I note that Dr. McCusker was also the respondent’s expert witness in the Boatmon case and that Dr. Axelrod, the immunologist, was not one of the Boatmun’s expert witnesses, which just left Dr. Miller discussing immunology, despite no specific expertise in it. Then there was this:

After considering all the evidence, the undersigned finds that the petitioners have failed to meet their burden of presenting a persuasive case that the vaccinations contributed to Nicholas’s unfortunate death. Three reasons support this overall conclusion. First, the Secretary’s expert, Dr. McCusker, was much better qualified to discuss cytokines. Second, the articles do not support the opinions Dr. Miller and Dr. Axelrod expressed. Third, there are gaps in the medical record for Nicholas that Dr. Miller fills with assumptions. Of these three reasons, the most significant are the first and second.

Perusing the ruling, I see the same arguments and many of the same journal articles cited. Somehow Special Master Moran saw that the same articles didn’t support Dr. Miller’s speculation, while Special Master Gowen did not. Obviously, these are different cases; so there could be differences other than the Special Master determining the different outcomes. Perhaps Dr. Miller upped his game in the interim between cases. Perhaps Dr. McCusker had an off day. Perhaps the cases were sufficiently different on the facts (e.g., Nicholas Copenhaver died three days after vaccination, while J. B. died only one day after).

Also, this is not the only example. There are several cases in which the Vaccine Court rejected the “cytokine storm” hypothesis — and correctly so, again, some of them in which Dr. Miller was the petitioner’s expert witness.

I don’t know what the difference was that resulted in a negative ruling for the Copenhavers and a positive ruling for Boatmon. Whatever the reason for it, the ruling in Boatmon v. HHS, while defensible legally, is indefensible on a scientific basis, even though Special Master Gowen specifically said that the evidence existing is that vaccines don’t cause SIDS. (If that’s the case, then how can you say they did in this specific case?) It’s also an outlier that ignores all the other previous NVICP rulings that have rejected the very same hypothesis of “cytokine storm” as a mechanism for vaccines causing SIDS. Yes, I am aware that Special Masters are not bound by precedent, but this ruling is still a jarring outlier.

Worse, this ruling will cause real problems. I can already see antivaxers gleefully getting ready to use it as “proof” that vaccines cause SIDS. Indeed, the only thing that surprises me is that they haven’t done so already in a big way.

Posted by David Gorski

Dr. Gorski's full information can be found here, along with information for patients. David H. Gorski, MD, PhD, FACS is a surgical oncologist at the Barbara Ann Karmanos Cancer Institute specializing in breast cancer surgery, where he also serves as the American College of Surgeons Committee on Cancer Liaison Physician as well as an Associate Professor of Surgery and member of the faculty of the Graduate Program in Cancer Biology at Wayne State University. If you are a potential patient and found this page through a Google search, please check out Dr. Gorski's biographical information, disclaimers regarding his writings, and notice to patients here.