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 claim a 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
I first learned of a ruling in which the Vaccine Court screwed up on (where else?) Facebook:
The quotes that antivaxers cherry pick 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.
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.
To be honest, I'm surprised antivaxers haven't made a much bigger deal out of this ruling than they have thus far, given that the ruling was first publicized over a week ago, but I guess I should be grateful for small favors. Who knows how long they will continue to refrain?
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.
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To me that looks like a loophole big enough to build a six-lane highway through. In a normal court of law, defendants can and would challenge Dr. Miller's expertise in the subject. I was a juror on a case--admittedly not a medical-related case, and in state rather than federal court--that was dismissed because plaintiff's witness was not an expert on the specific matter before the court. But apparently in Vaccine Court, Miller's M.D. is sufficient to prove his expertise.
Regarding the theory of SIDS considered in this case: routine autopsy tissue sampling does include the medulla, but not necessarily the arcuate nucleus. "Underdevelopment" of this area sounds like an imprecise and subjective judgment, while actually measuring serotonin levels as part of a "biochemical autopsy" might be more useful. Was biochemical screening for other possible disorders undertaken in this case, as detailed here?:
I would hope that the judge/master in this vaccine court case acquaints himself with the quality of work by Goldman and Neil Z. Miller (who is notorious for claiming that he communicates with extraterrestrials) before citing them again.
The Special Masters are also human, with human failings and emotions as well....I'm sure, having to hear the cases they hear - in which a substantial number involve things like SIDS, that it is a very difficult position to find oneself.
I still respect them for their service.
This evaluation falls to the special master; there are plenty of cases, for example, in which Mark Geier is noted to be a lousy expert witness.
I'm deeply concerned that antiquated methods to determine an infant's cause-of-death (e.g., SIDS) continue to be state-of-the-art.
As an example, it's time to stop fixating on a child's sleeping position and pillow dimensions as causation.
In my opinion, a proteomic analysis of neurotrophins (e.g., NGF, BDNF) should be used to determine the "sudden" and catastrophic events associated with SIDS.
Most importantly, an atypical immune response to vaccine components and/or contaminants should be considered in that mast-cell degranulation and a release of neurotrophin often occur after said response.
Do vaccines cause SIDS?
No one is certain, but, let's use state-of-the-art methods to determine if forced immunity is a potential etiology.
@ Julian Frost:
You've made a valiant effort arguing with MJD; you're articulate and knowledgeable and I'll venture that your heart is probably in the right place
you're not going to get anywhere with him**-
to quote Barney Frank ( see YouTube) - it's like arguing with a " dining room table".
** I know, I know it's for the others who may read this post
@ #5 MJD
You're welcome for my fixing that typographical mistake. You must have missed the correct macro key that inserts your usual monomaniacal subject. No need to thank me.
What, pray tell, would 'force immunity' be, if there were such a thing? Further, how would vaccines be implicated in such an imagining—how would/could a vaccine force any blooming thing?
Se Habla Espol writes,
...how would/could a vaccine force any blooming thing?
Briefly, adaptive immunity can be unpredictable based on several factors including genetics and environmental insult.
Some infants may have increased immune-system maturity based on said factors and therefore be more susceptible to vaccine contraindications.
When a tragedy like SIDS occurs, especially when vaccines (i.e., forced immunity) are in question, it would behoove medical investigators to use state-of-the-art analytics to quantify the biomarkers associated with atypical adaptive-immunity.
The placement of toys, blankets, and pillows in a crib are important, but, biological factors must continue to be investigated to reduce the incidence of SIDS.
SHE@9: Pardon me, I speak alt-med.
"Forced immunity" is the favored term of people who oppose all kinds of vaccine mandates--even the law recently passed in California that requires documentation of all medical exemptions and does not allow non-medical exemptions for children enrolling in school. There is a way around the rule: the parents can home school the kids.
As I have said before, allowing your kids to be vulnerable to vaccine-preventable diseases (other than for medical contraindications to vaccinating) is wrong, but it is not as wrong as allowing your kids to endanger other people's kids who are depending on herd immunity to avoid contracting vaccine-preventable diseases.
There's another way: buy a medical exemption from a crooked doctor. It's easier than having to put up with the kid during prime housewife social hours.
At least 8 similar Vaccines-SIDS-cases happened in Namibia from the beginning of this year. The same scenario, deaths within 24 hours. Most of the fatalities are 6 weeks infants. Local and WHO health authorities are adamant to stick to - "coincidental, and not vaccine related". Nobody ever was held responsible for an apparent mishaps of the system.
My two thumbs up to Special Masters Court ruling. It will serve us as proper guideline on a long way to justice.
We neither have Vaccine Court nor Vaccine Injury compensation program here.
Is there any evidence, other than temporal coincidence, that any vaccination was connected with any death? Propaganda from the anti-vax industry does not qualify as evidence (except in the singular VICP Court case described in the article).
“Forced immunity” is the favored term of people who oppose all kinds of vaccine mandates
It is almost as if they stole it from the "forced-birth" term often applied to the women-are-incubators fetus-fondling anti-abortionists.
This kind of thing is a little more my speed - but only a bit - so I'm curious if the decisions from this "vaccine court" are appealable. My guess would be yes, based on other special masters decisions that I've seen. Hopefully this decision won't survive appeal.
Eric Lund (#11) writes,
“Forced immunity” is the favored term of people who oppose all kinds of vaccine mandates–
I disagree with your use of the words "people" and "all", they're to vague and encompassing .
In my opinion, "Forced immunity" is a favored term to describe a process wherein immunologic adjuvants are used to increase an immune response (i.e., adjuvants are used to force an outcome).
In other words, the phrase "adjuvant/antigen induced immunity" is simplified to "Forced immunity".
In other words, your "forced immunity" term is nonsense. I understand.
They are, but the standard is the "arbitrary and capricious" test, which I'm not seeing here.
MJD, wouldn't "forced immunity" begin at birth, the moment a person is exposed to this filthy, antigen-filled world we live in? Viruses and bacteria and fungi and parasites attacking every millimeter of the body, trying to find a way in?
As to things like body position and pillows, if the rate of SIDS dropped by 50% after educational campaigns to teach parents and caregivers to put babies to sleep on their back in an empty crib, wouldn't that indicate that those things are very important?
@ Justa Tech (#17),
If viruses and bacteria and fungi and parasites used an immunologic adjuvant as a means of transport into the body it would be "Forced suicide".
Harmful microorganism evolve to avoid the immune system not attract it.
I agree, all initiatives that are shown to reduce SIDS are very important. You and I think alike sometimes, Justa Tech.
MJD @18; No, we do not think alike. Not at all.
First, you said things like body position and crib contents didn't matter. Now you're saying they do matter. Pick one and stick with it.
Second, you wouldn't understand adjuvants if you took a graduate class. Seriously, where do you think some of the most effective adjuvants come from? How about LPS? It comes from bacteria! It's not used in vaccines because it's too strong (and not approved in humans), but boy howdy is it used by bacteria!
Also, on what planet is an adjuvant a means to get into the body? That's just fractally wrong.
Your intellectual balloon must be tiny. Please consider expanding it.
So let me get this straight.
Parents take their healthy infant in for a well-child visit, they give the child vaccines for 7 diseases, and the child almost immediately exhibits symptoms of at first mild but then moderate adverse reactions. Then the child is found dead in his crib the very next day. Yet your take on this is that the parents' act of seeking compensation for a possible vaccine injury is simply due to the "human need to blame something"?
Do I have that right?
You are correct that the judge did in fact say the following (and for what it's worth it frustrates me as well when anyone reporting on this case fails to mention and address this):
"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."
I have two thoughts about this. The "vast majority of vaccine recipients do not succumb to SIDS". How reassuring! But don't we then need to determine what percentage of vaccine recipients *do* succumb to SIDS? I would hazard the guess that the "vast majority" of VIOXX recipients didn't croak...does that mean VIOXX doesn't cause people to die?
My second thought is that both the Special Master and yourself have such a biased perspective on this issue. The Special Master does not have a problem linking cytokine storms caused by "mild infection" with SIDS, saying:
"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."
Ok so we can agree that a cytokine storm caused by mild infection could likely cause a "significant number of SIDS deaths", correct?
Are you unaware that it has been well documented that the administration of vaccines can and does cause an increase in inflammatory cytokines?
Pro-inflammatory cytokine responses correspond with subjective side effects after influenza virus vaccination.
Furthermore, this particular study found that the level of inflammatory cytokine response and subjective reported side effects were correlated. So the fact that the child in this case almost immediately exhibited signs of vaccine adverse reactions is significant, is it not?
So please explain to me why it is that the Special Masters can conclude that "mild infection" is likely a cause of a significant number of SIDS cases, but is somehow confident that similar cytokine storms caused by vaccinations definitely do not contribute to SIDS cases.
The reality here is that vaccination has been shown to cause large increases in inflammatory cytokines, and there is a biologically plausible explanation for how such cytokines could contribute to causing SIDS (the Special Masters just admitted that). What you and the Special Masters and the CDC and all the others who deny vaccine injury are basically saying here is that we cannot consider this scientific information because we have previous information from epidemiological studies which definitively tells us that vaccines do not cause SIDS.
"Cytokine storms." You keep using that phrase. I do not think it means what you think it means.
David Foster seems to be equating systemic infection with a pathogens capable of producing a large quantity of viral or bacterial toxins, with vaccination that induces an immune response under much more benign conditions,
It does not follow that cytokine production (in quantity or quality) is the same in both settings.
It is also not established that SIDS is simply a matter of cytokine overload.
*hint to David: shouting VIOXX in ALL CAPS is a hallmark of a very weak argument.
@ Justa Tech (#21),
Thanks for your attention!
Please tell me more...
I think David Foster should go back and re-read Orac's entire post since he clearly has missed the entire point, to wit: coming to a conclusion as a matter of law is very different than coming to a conclusion as a matter of science because they use two completely different methods of evaluating evidence. It is not apples vs apples.
A legal conclusion can be correct in terms of how the law is written and interpreted based on precedent and still be completely wrong when it comes to the actual science. That's because coming to the correct scientific conclusion isn't always the point of a legal proceeding. That point is justice; Congress felt it was more just to make it easier for parents/patients to get compensation for a real vaccine injury than harder as a matter of justice. Thus, the system is rigged in favor of the plaintiff.
CJX: We'll see if Dorit opines; she's much more informed on this than I, but if I understand the law correctly, you can't appeal the ruling of the Special Masters, BUT you can then sue in state court. However, I do believe you forfeit the benefits of the NVIC, meaning government pays for the proceedings, and whatever compensation the Special Master awards.
In this case the government lost. They usually can't appeal which means that the program will pay damages to the family.
Any claim made by David Foster is a very weak argument.
The appeals path is from the Office of Special Masters to the Court of Federal Claims, then the Federal Circuit, and then SCOTUS. Design defect claims are preempted and cannot be taken to state court. Note, however, that CJTX was talking about an appeal by the Respondent, not the claimants. These I've only seen from COFC to the circuit court.
Dorit has already written an article about this at Skeptical Raptor. If I have got her position correct on this, the ruling can be appealed, but the likelihood of a successful appeal in this example is low.
What we seem to have is an example of a Special Master who took the unproven theory of the plaintiff's expert at face value and discounted the evidence provided in contrary. There is the strange event of the Special Master discounting the results of a large study (hundreds of individuals) as being too small, but then accepting the results of a single case study.
The Special Master has made a mistake. Given the role of the court, it is probably best to just let that lie, rather than put the family through further grief. However, Miller's lack of expertise should be highlighted loudly so everyone knows.
Narad (#24), Icytokine storm means just what I thought it meant.
Dangerous Bacon (#25), why don't you do a bit of research before posting your own theories?
@ David Foster #23--So you're going to ignore the Venneman meta-analysis same as Special Master Gowen did?
Would you care to tell us why you think it can be ignored?
In other anti-vax wingnut news, John C Stone has an "Open Letter To The Editor Of The Guardian", complete with references, 90% of which are links to... articles and letters written in green ink by John C Stone.
@David Foster: Now, find us ANY peer-reviewed journal article that shows that vaccines cause SIDS. I see your articles range from 1993 (!) to 2014.
The 2014 article actually states this in the review: No significant difference was observed in cytokine levels of IL-1β, IL-4, IL-6, IL-10, IL-12, IFN-γ, MIP-1, TNF-α, and prostaglandin E2 (PGE2) in sera between the two groups. However, significantly higher levels of human
G-CSF were observed in recipients with febrile illness than in those without febrile reactions. Further investigations of the
significance of elevated serum G-CSF levels are required in vaccine recipients with febrile illness.
So infants with febrile illnesses have elevated serum G-CSF, but there is no linking with any significant issues.
Yes, you should remember if you post links, we WILL look at the articles. Flu vaccines in adults, an article from 1993, an article from 2004? They are not at all related to the subject at hand.
In that case, I have to question both your reading and thinking ability:
"Inflammation associated with a cytokine storm begins at a local site and spreads throughout the body via the systemic circulation. Rubor (redness), tumor (swelling or edema), calor (heat), dolor (pain), and “functio laesa” (loss of function) are the hallmarks of acute inflammation. When localized in skin or other tissue, these responses increase blood flow, enable vascular leukocytes and plasma proteins to reach extravascular sites of injury, increase local temperatures (which is advantageous for host defense against bacterial infections), and generate pain, thereby warning the host of the local responses. These responses often occur at the expense of local organ function, particularly when tissue edema causes a rise in extravascular pressures and a reduction in tissue perfusion."
Yah. Fits the description of SIDS perfectly.
On a similar note, in other anti-vax news...
We learn how Jake's brilliant career is progressing-
( see Autism Investigated today)
- he is again writing for the Epoch Times
- he is editor of Autism Investigated
- he served as a " campaign field representative"/ volunteer for the Donald and for other GOP candidates
-he made freelance contributions to the Autism Media Channel and the Children's Medical Safety Research Institute
He's on a roll!
If he keeps this up, soon he'll be featured at Natural News, PRN or the Bolen Report
@Denice, difficult to see this as a worthy life goal for gnat.
DW: It's easy to be the editor of your own internet spot. However, Jake knows about as much about editing and writing as he does about how vaccine and the immune system work. Which is to say, not much; if he was writing for an actual internet news source, he wouldn't last there long. I wonder if his mother's ever taken a look at his 'writing.'
Try to apply to the court ruling this algorithm:
1) Vaccines are active biological substances, far from being regarded as a product of mother nature
2) Vacination is a medical procedure
3) Any medical procedure has its share of adverse events, deaths are included
4) Vaccination with polivalent antigens is an immense stress, shock like event for the innate immune system of infant, especially for pematurely born ones
5) Any human individual has his/her special way of vaccines' handling
6) Wrap all stated above and apply a little share of common sense without any bias
7) Apply the basic rule in forensic pathology "seldom say never"
PS The question is: WHO is going to be responsible for the consequences? .....It's where is the major f...up.
Vaccines are modified natural organisms. What's the problem? How is "mother nature" involved, and who is she?
Yes, vaccination is a minor but safe and efficacious medical procedure.
The adverse events are strongly dependent on (a) the patient's condition and (b) the procedure involved. Some procedures, like vaccination, are inherently safer than others like abdominal surgery; some patients can handle a given procedure better than others.
Are any polyvalent vaccines given to newborn premies? How many pathogens are recognized from the vacccine given to newborn premies? How many microörganisms enter an infants system from nursing?
It's not clear what, if anything, this means. Are you referring to the occasional idiosyncratic variation in a person's immune system, or maybe something elde?
Especially without anti-vax bias, which is often based on "purity of bodily fluids" considerations.
Yes, and likewise, "never say always".
@Yury Vasin #40:
No. The number of antigens in modern vaccines is very low. As human beings, we get hit with more antigens in an hour than there is in the entire vaccine schedule.
Special snowflake argument.
One huge problem with this argument: if a child is really that vulnerable to vaccines, how much worse will the antigen load from a full blown infection be?
Looking at your above statement:
1. Very few vaccines carry active (live & attenuated) biologics
2. Is correct but it is a very minor procedure with limited (as in very) adverse reactions,
3. True but again see answer to #2.
4. This is a face palm statement. Vaccines do not cause immense stress and are not given to any group such as premies.
5. No, no, no; vaccines work because the vast majority of humans immune systems react the same way.
6. Common sense has seldom actually answered a question. Especially in science it only becomes common sense after the question has been answered. The best example is hand washing and childbirth.
7. Outliers occur, no one has ever said they don't.
Your PS makes as little sense as the rest of your statements.
Yury, can you tell us why special snowflakes have a worse reaction to vaccines than getting the full blown disease?
Yury, can you tell us why special snowflakes have a worse reaction to vaccines than getting the full blown disease?
With full blown infectious disease we play by the rules of nature vs modern days medicine abilities- the rules of ethiology, pathogenesis, pathology, clinical manifestations and applicable treatment.
With vacinnes, especially when it comes to death, there are no rules. Instead of rules we have dogmas like it just not possible. This is scary and in my opinion is not right at all. It is a kind of one way traffic in favor of immunisation services provider. The absence of balance is my concern.
P.S And special snowflakes are in fact the lives of innocent infants with attached parents.
So, what was the alleged cause of SIDS before vaccines? Or, at least before we had as many vaccines as we have today? A family member lost a child to SIDS 46 years ago. She was told it was because both she and her husband were deaf. If only she'd known that she could have blamed it on a measles vaccine. No, I'm not being serious...about the vaccine. Perfectly serious about what she was told. She did not have another child.
4. This is a face palm statement. Vaccines do not cause immense stress and are not given to any group such as premies
Rich, just apply to yourself the Polio component only of the cocktail, given to 6 weeks babies, if that not enough try the rest.
Believe me, I went through that type of experience as an adult.
5. No, no, no; vaccines work because the vast majority of humans immune systems react the same way.
Instead of the same way more appropriate would be - in a similar way with a huge number of exeptions.
#45 Ellie, The Triple Risk model for SIDS accommodates a lot.
SIDS isn't a 'cause of death' its a description of death, claiming the cause 'unknown'. Vaccine can play role as a triggering for SIDS.
A little background (you may have to C&P the link)
Yury: "With full blown infectious disease we play by the rules of nature vs modern days medicine abilities- the rules of ethiology, pathogenesis, pathology, clinical manifestations and applicable treatment."
What is the proven treatment for viral pneumonia due to measles? Or for this particular heinous measles complication:
Provide verifiable scientific documentation in the form of PubMed indexed papers by reputable qualified researchers. Because argument by blatant assertion gets you mocked.
Yury: "With vacinnes, especially when it comes to death, there are no rules."
By the way, provide the PubMed indexed studies by reputable qualified researchers that the MMR-II causes more death than measles, mumps and rubella.
When we are done with measles, we will then roll on with tetanus and diphtheria: Diphtheria in the former Soviet Union: reemergence of a pandemic disease.
Wow. The logical fail. It hurts.
You're trying to apply deductive reasoning to science, which uses inductive reasoning. For your logic to be true, every premise must be true. If even one is false, the whole thing falls apart.
Item 1. The word "active" is loaded language. Many vaccines are inactivated or acellular, not live. Even water is active biologically if you mean that simply by virtue of affecting the body something is "active biologically."
#2: Vaccination is not a procedure. It is the administration of a medication. Some vaccines aren't even injected (rotovirus is oral). Calling it a "procedure" magnifies what the practitioner is actually doing, and makes the langauge loaded (which of course is what you're going for). It's spin.
#3: Medication administration does have its risks, but I have never heard anti-vaxxers assert that an injection per se causes autism, SIDS, or the bogeyman of the week. Pain, irritation, and rare infection at the site is about it. Oh, you mean the vaccine itself. Also rare. Billions of doses, a few hundred adverse reactions.
#4: A facepalm statement indeed. Vaccination does not cause the immune system stress. It simply turns the immune system on to create antibodies without the person having to endure the actual disease.
#5: Citation needed.
#6: There is no common sense in your argument. It fails at each step of the deductive reasoning process, therefore your conclusion cannot be considered true.
As for who is responsible: that's what the NVIC is for.
You make a big deal about using the terminology of medicine, but you make it clear you haven't the foggiest idea what they really mean. I don't think you'd know etiology if it smacked you in the face. You certainly don't understand what medicine says about vaccines and what is and isn't possible.
When you evaluate a claim scientifically you have to show how it might be possible before you can even discuss it. If the claim doesn't fit the laws of science as we know them, then you can't prove something is even plausible before you try to prove it's even possible/probable.
Example: homeopathy. It's "rules" do not fit the laws of physics or chemistry, therefore any discussion of whether it can actually work is completely irrelevant because the idea behind it is not plausible. Hence the term, "Tooth Fairy Science."
Funny, the MMR vaccine is not given that early.
And an update from last month -
Johnny, so Dr. Vasin is not a very good pathologist when it comes to infectious diseases. Perhaps he should stick to assault cases.
Good Lord, this guy is an actual pathologist? Where'd he get his medical degree? A crackerjack box?
Guess the old joke really is true.
Not surprised at all that vaccines cause SIDS.
It's no surprise considering that these giant pharmaceutical corporations, such as Merck, lie through their teeth about the safety and efficacy of their vaccines all for the sake of increased profits over human health.
I know that right now Merck is embroiled in at least two federal court cases involving their omission and concealment of critical vaccine information. Furthermore, a U.S District judge threw out Merck's attempt at dismissal. Obviously, something sinister is going on here, and the truth is finally starting to spill out and be recognized!
All I know is what I read in the papers...
Draper, do you support parents who shake their babies to death and use the "vaccines cause SIDS" argument?
It has come up for discussion here before:
Because, unless you come up with something more substantial than you unsupported opinion then we will assume that you're cool with blaming shaken baby syndrome on vaccines.
I know that right now Merck is embroiled in at least two federal court cases involving their omission and concealment of critical vaccine information.
@herr doktor bimler:
The first case: United States v. Merck & Co
The second case: Chatom Primary Care v. Merck & Co
Both of your urls identify the same document.
One was probably Krahling vs Merck, but that concerns the effectiveness of the mumps vaccine, not its safety.
Not sure what the second would be.
Draper, should you decide to bring up the lie about Japan and pertussis vaccine, here is some food for thought:
Expert Rev Vaccines. 2005 Apr;4(2):173-84.
Acellular pertussis vaccines in Japan: past, present and future.
So Draper, what does that have do with with SIDS. Mumps vaccination happens only after the child's first birthday. SIDS is defined as a death before the child's first birthday.
Also, that is dated three years ago. So it is relevant now because...?
Not sure what the second would be.
Not entirely clear, because Draper has listed the same link twice. But Chatom vs. Merck and US vs. Merck are simply riding on the coat-tails of Krahling vs Merck, and are being handled together -- they're all the same case.
The accusation is that Merck exaggerated the efficacy of a vaccine, not "omission and concealment of critical vaccine information".
MI Dawn (#35):
You claim my studies are not relevant to this discussion. Here are the titles of the studies:
"Vaccination in Humans Generates Broad T Cell Cytokine Responses"
"Changes in cytokine production after measles virus vaccination: predominant production of IL-4 suggests induction of a Th2 response."
"Production of inflammatory cytokines in
response to diphtheria-pertussis-tetanus (DPT),
haemophilus influenzae type b (Hib), and 7-valent
pneumococcal (PCV7) vaccines"
The point of my post was to provide evidence that vaccines do in fact cause increases in cytokines, so how are these studies not relevant? I understand that it is SOP for pseudo-skeptics to use just about any excuse possible to dismiss information which doesn't fit with their argument (too old, too new, listed on website X, affiliated with person Y, etc), but your points are kinda silly.
Regarding the 2014 study, you might have missed this:
"All effective vaccines induce acquired immunity with the development of antigen-specific antibodies and/or cell-mediated immunity, and the stimulation of innate immunity is now considered essential. Innate immunity consists of two different patterns: pathogen-associated molecular patterns (PAMPs) and damage-associated molecular patterns (DAMPs), and controls the T and B cells to regulate acquired immune responses.10 The stimulation of innate immunity has been found to modulate the development of an acquired immune response through the production of cytokines.11-13"
And then this, which shows that it is the aluminum which is largely responsible for the increase of cytokines:
"Aluminum adjuvant induces inflammation at the injection site, and endogenous products released from damaged cells (damage or danger associated signals) stimulate DAMP, activating inflammasomes.17,18 These have been shown to induce the production of inflammatory cytokine IL-1β from proinflammatory molecules.19"
Again, these studies were intended to support the notion that vaccines do lead to increases in cytokines. They are certainly relevant.
So Draper, what does that have do with with SIDS.
The argument seems to be that people are suing a pharmaceutical company about one vaccine, therefore "something sinister is going on here"... therefore a different vaccine kills babies, while eerie theremin music plays in the background. Cut to a close-up of the Georgia Guidestones.
I would rather that Draper be more specific about what sinister things are going on; if it is the Depopulation Agenda, we expect details!
which means next to nothing.
levorotatory sugars? Is this another "blame the left" attack?
U.S District judge threw out Merck’s attempt at dismissal
"Threw out" is just wrong. "Defendant’s Motions [to dismiss] regarding all claims for both cases are granted in part and denied in part. "
I realize you are making a semantic argument in order to undermine my points. However, I shall include Sudden Unexplained Death in Childhood (SUDC) in addition to SIDS if that makes you happy.
And the agenda has always been the same. Make money. Screw the public. I don't know if you are shills, ignorant citizens, or even well-intentioned fools. Whatever the reason, you are defending unscrupulous corporations that do not care if your children die, just as long as they show good quarterly reports. For shame.
Your evidence for these conspiracy claims would be what, exactly? Oh, that's right: they're conspiracy claims, so the absence of evidence is deemed to be conclusive proof of any claim that can be made.
@Chris Hickie (#33)
Make you a deal. You answer my question first, then I'll answer yours.
So please explain to me why it is that the Special Masters can conclude that “mild infection” is likely a cause of a significant number of SIDS cases, but is somehow confident that similar cytokine storms caused by vaccinations definitely do not contribute to SIDS cases.
Draper: "And the agenda has always been the same. Make money. Screw the public"
Do tell. Why is it more profitable to a company to prevent diseases instead of treating them? Please tell us how withholding DTaP vaccines to prevent diphtheria, tetanus and pertussis is so much cheaper than treating those diseases.
In short, explain why these two papers are bogus by providing PubMed indexed studies by reputable qualified researchers:
Economic Evaluation of the Routine Childhood Immunization Program in the United States, 2009
Diphtheria in the former Soviet Union: reemergence of a pandemic disease.
"Whatever the reason, you are defending unscrupulous corporations that do not care if your children die, just as long as they show good quarterly reports. For shame."
You are good at making things up. We can do that too. Why do you want kids to get sick with pertussis, Hib, mumps, measles, chicken pox, etc. Do you enjoy seeing feverish kids in pain? Do you bask in the attention when they are admitted to the hospital? Does seeing a kid put on a ventilator make you happy? Come on! Confess your addiction to the love of watching very sick children suffer!
Note: this is sarcasm. I have a child who spent too much time in hospitals, including several bouts of croup (fortunately only a tent, and blowby tube) and later open heart surgery. This is something I would never wish on anyone, which is why I am baffled by those who think these severe diseases are okay dokay.
hdb: "The argument seems to be that people are suing a pharmaceutical company about one vaccine, therefore “something sinister is going on here”… therefore a different vaccine kills babies, while eerie theremin music plays in the background."
Also known as "poisoning of the well", which Draper is doing quite badly. As someone who is much too familiar with the emergency rooms of several local hospitals, experienced the terror of riding in the front seat of an ambulance, and has spent lots of reading in medical clinic waiting rooms....
... I do not understand the affection folks like Draper and Mr. Foster have for kids getting sick with some rather nasty diseases. It is obvious that they do not have a clue of the consequences. And have never spent a night sleeping next to a sick toddler in a hospital (I have done many).
If one really wanted to help if they have a child of autism, they would sign up for this program:
About half of the genetic sequences that cause autism have been discovered. Some of them come with actual medical interventions! If a family joins, sends in spit in a tube from the kid and both parents, they can help find more information.
Citation needed that vaccination can cause a cytokine storm as bad as one caused by a mild infection.
Citation needs to be provided by Orac that vaccination CANNOT cause a cytokine storm as bad as one caused by a mild infection. He is the one drawing conclusions based on assumptions.
@David Foster: nope, that's not how it works. You made the claim that vaccination can cause a cytokine storm as bad as (or worse than) one from a minor infection, so YOU stump up the evidence. We do not have to prove a negative.
I don’t know if you are shills, ignorant citizens, or even well-intentioned fools.
I'm here because of a childish delight in pointing and laughing at numpties. I don't know where that fits into the taxonomy.
HDB is correct on the coattails bit, BTW. The core case is the Krahling & Wlochowski qui tam False Claims Act suit.
I realize you are making a semantic argument in order to undermine my points.
"Asking for details of purported court cases" seems to work too.
^ But U.S. v. Merck is Krahling & Wlochowski. The government is always the plaintiff in a FCA suit; that's what the "ex rel." is about; the "whistleblowers" are the relators. The DOJ had two years to decide whether to prosecute the claim or leave it to K&W. The latter is the common, cost-effective choice.
K&W are in it for the potential payday, tinged with revenge, period, so complaints about Merck's imaginary lack of interest in anything but "the bottom line" are sorely misplaced.
Read this if you want a smile. Cracked article on why conspiracy theories don't work.
What happened to the "storms"?
@David Foster: I said they were irrelevant because they didn't prove that cytokine increase from vaccines leads to SIDS. And no, you made the assertion. ORAC doesn't have to prove you are wrong. You have to prove you are right. Which you haven't done so far.
Chris, you would probably be defending Toyota or Ford if they made cars that were prone to exploding and didn't want to recall them. There's no helping people like you. I see now what you are: you're just a pharmy fanboi, LOL. How pathetic. Enjoy your time wanking off the other fanbois here. It's probably all you're good for anyway.
Did I miss something?
I presume you have joined the dots and can demonstrate that vaccinations do induce a "cytokine storm" (as opposed to stimulating cytokine production), and that cytokine storms are directly causal for autism?
I'll take that last comment of yours as capitulation, and an acceptance that Chris has won the scientific debate.
Sorry, I meant "directly causal for SIDS" (not autism)
Draper, you are a laugh riot. You did not even understand the questions I posed to you.
Seriously, how does a money grubbing lawsuit by a pair of guys about the mumps vaccine show that SIDS is caused by vaccines? Especially since SIDS is defined as happening before a child's first birthday, and the MMR vaccine is only given after the first birthday. All you managed to do is a limp "poisoning the well" attempt.
Then the stuff about money is hilarious. One what universe is it cheaper to care for sick babies in a hospital than prevent three infant killers like diphtheria, tetanus and pertussis? I gave you an actual economic study!
Plus I showed you two very stark examples of what happened when anti-vaccine rhetoric causes pertussis to return to Japan, and diphtheria returns to the countries of the former Soviet Union. The result was lots of dead children, and is was not from SIDS.
Your response: limp worthless insults.
Pardon me if I prefer children actually staying healthy and not dying by suffocating due to bacterial toxins.
Oh, and here is another study of interest:
Neonatal Deaths After Hepatitis B VaccineThe Vaccine Adverse Event Reporting System, 1991-1998
Even though you cannot download the pdf, the tables are accessible. Here are some snippets, summarized because it is a picture file:
"slept with parents and sibling on sofa bed"
"co-slept with mother on couch, found on back on floor beside couch"
"co-slept with mom in bed, found on left side"
"mother heavy smoker; co-slept with mother in bed, found on left side"
Then there were several heart and other disorders discovered. But the main thing I get is why the "back to sleep" (not with parents) has reduced SIDS.
As to one one Special Master can come to one conclusion, and another Special Master to another: they are making legal conclusions, not scientific conclusions. They operate on a different set of standards and rules for evaluating evidence than scientists do. Sometimes, they tie the law and evidence in knots because they fell sorry for a family. It's not good law, or good science, though sometimes it's good for one suffering family.
You troll monkey spin doctor. What part of "I have not concluded that vaccines present a substantial risk of SIDS" you don't understand? Nobody is saying there is a substantial risk, but there is A risk. And that's all the acknowledgement we need. That's what the court case showed and you lacked to show any evidence against.
My name is Legion, for we are many.
"'World's number 1 anti-vaxxer' Kent Heckenlively denied entry to Australia"
Good for Australia.
That's all the acknowledgement the anti-vax industry needs: a single legal (non-scientific) case which it can misrepresent as being Scientific Proof™ of everything it's ever claimed, along with other weird claims it hasn't made yet.
As usual Heckenlively is over-selling his achievements.
@Don Mega (abusive):
Extremely smart people have investigated whether vaccination causes SIDS. The answer? It doesn't.
A) If this bogus conclusion is taken at face value, there will be an increase in unvaccinated children. For that there is a known risk much higher than the risk of SIDS.
B) The likelihood that this will remain as "not a substantial risk" in the loony dens is very small indeed.
but there is A risk.
There's a risk to everything, starting with getting out of bed in the morning.
Shay simmons (#101) writes,
There’s a risk to everything...
A risk there is, to everything.
The fear of loss is a path to the Dark Side.
- Yoda (a legendary Jedi Master)
1977 Star Wars Vaccination Poster:
Many responses to my original post, however no one (including Orac himeslf) has bothered to address the following question:
"So please explain to me why it is that the Special Masters can conclude that 'mild infection' is likely a cause of a significant number of SIDS cases, but is somehow confident that similar cytokine storms caused by vaccinations definitely do not contribute to SIDS cases."
The Special Masters in his decision even laid out the argument for biological plausibility that increases in cytokines could a "significant number of SIDS cases". I provided a few of the studies which make it very clear that vaccination does lead to increases in cytokines. And in this case the Special Masters ruled that this was a contributing factor in this particular SIDS case.
So why is everyone so willing to accept that mild infection could cause SIDS, but vaccines certainly do not?
Trivial. A Special Master is a judicial person, not a scientific or medical person. A judicial person is required by law to decide based strictly on the information presented in each specific case; a scientific person gets to look at all the information.
If the Special Master missed part of the evidence presented, whether because of a lawyer's omission, by sleeping through it, or by just failing to understand it, the missing information cannot legally be part of his decision. He must ignore everything he knows outside the case as presented, even if it results in a ridiculous judgment, as in this case.
Yoda wasn't in Star Wars in 1977.
Don: that might be good enough in court, but it's not good enough for science.
What part of legal evidence =/= scientific evidence are you failing to grasp here?
All of it, based on your postings.
that’s all the acknowledgement we need.
Are we sure that Don Mega isn't a parody? That message sounds so much like an admission -- or rather, a boast -- that the context and meaning of the court verdict don't matter to someone who intends to misuse it.
HDB, I would point out that Poe's Law applies to the anti-vax religion the same way it applies to more conventional religions. Given an outrageous statement by a religioso, it is undecidable whether it's a parody or it's for real.
You crept back out of the woodwork just to keep begging the question? What "cytokine storm"? There's no resemblance.
@David Foster #103, you are a liar. I addressed your question when I demanded supporting evidence that vaccination could cause a cytokine storm. I also dealt with your claim that we had to prove that it couldn't.
The fact that you don't like our answers and can't find evidence that vaccines can cause cytokine storms does not give you the right to lie and say your question hasn't been answered.
I find your questions very misleading. You have had the issue of cytokine storms and vaccines explained to you already, and you also ignored my question to you @ comment #89.
To say you have not been answered on this point is to either display incredible ignorance and inability to learn, or extreme deviousness by trying to continue to mislead readers of this blog that you have recived no answer.
Here is a hint - a cytokine storm is not merely an "increase in cytokines", it is a very specific, severe and potentially fatal massive release of damaging cytokines that may occur during some forms of infection, when the host is unable to control the positive feedback loop that triggers cytokine mediated influx of activated T-cells, which then release more cytokines.
It's descriptive value is trivialised by your insistence that it is merely a non-specific "increase" in cytokines (which is something every one of us has every day). Of course, it sounds "scary", so you'd like to think it can be triggered by vaccines, but that is not the case.
Infections may contribute to SIDS is not merely because of cytokine release (and their role has yet to be verified or clearly established), but other factors including the physiological consequenses of that infection, inducing subclinical changes within the upper respiratory tract.
The final clincher is that if you lot seem to think cytokine release causes SIDS, or autism or whatever, then you logically should be trying to minimise events that result in cytokine release. We know infections trigger more significant responses than vaccinations do, and vaccines also prevent infections.
So you would support vaccination, I presume?
@Dingo199, @Narad and @Julian Frost
What you don't seem to appreciate is that the Special Master in this case already determined that it was an increase in cytokines from vaccination which was a contributing factor in this case of SIDS. And he notes the science which has already established that such an increase in cytokines from even mild infections is likely a contributor in a significant number of SIDS cases.
To be honest, I never should have used the term "cytokine storm", but I'm not sure why all of you seem to think that it is incumbent on me to prove that vaccination causes a cytokine storm. I already cited studies showing that vaccination increased cytokines...this is kinda obvious stuff right?
I was simply pointing out the twisted logic where Orac and the rest of you can't seem to see the obvious, that if a mild infection could cause SIDS due to increased cytokines, it is very biologically plausible that vaccination, especially against 7 or 9 diseases at once, could do the very same thing.
One additional point regarding biological plausibility, more and more vaccines are being added to the schedule which contain an alum adjuvant, and alum is known to cause very large production of cytokines:
Alum induces innate immune responses through macrophage and mast cell sensors, but these are not required for alum to act as an adjuvant for specific immunity
"Our results show that many proinflammatory cytokines and chemokines are rapidly produced in vivo after exposure to alum."
I still want to know why a vaccine can create a worse "cytokine storm" than the actual disease. Just post the scientific data that compares the cytokine storms between the vaccine versus the disease.
Like the cytokine storm from the DTaP versus diphtheria, tetanus and pertussis... or the one caused by the Hib vaccine versus actually getting Hib with its resulting meningitis.
I’m not sure why all of you seem to think that it is incumbent on me to prove that vaccination causes a cytokine storm.
Your continued, emphatic, unambiguous insistence that "vaccination causes a cytokine storm" is surely reason enough.
@Chris are you learning impaired? I don't need to show that. A significant increase in cytokines is required for the vaccines to even work:
"our data suggest that following the first DTaP booster, children aged 16 to 19 months have a cytokine profile consistent with a Th1 response, which is known to be essential for clearance of pertussis infection."
We are talking biological plausibility at this point.
"Determined" is again the wrong word. The Special Master ruled that it may have been a contributing factor. In fact. if you read the ruling, the Special Master bent over backwards to find in favour of the claimant.
An "increase in cytokines" is not the same as a cytokine storm. And lots of things increase cytokine levels. We wanted you to show that vaccination increased cytokine levels to a point where damage was caused. And no, a highly dubious ruling by a Special Master does not count as proof.
@Julian Frost: Again, for probably the fourth time now, let me explain it to you again. Included in the Special Master's ruling is the explanation that an increase in cytokines from even a "mild infection" is known to directly impact the medulla and could therefore be a contributing factor in a significant number of cases of SIDS. Do you take issue with that? The research backs it up.
I simply asked, if you accept that this is true, then how do you justify disqualifying vaccines as a possible cause of SIDS when the research also shows that vaccination leads to increases in cytokines (indeed, this must be the case or vaccinations wouldn't work).
Research has already shown that increases in cytokines can cause damage, now it's just a matter of how much difference there is between natural infection and vaccination. This is where the number of diseases we vaccinate for on a given day might become a contributing factor.
@David Foster #117:
Operative word "could". Just remember, an asteroid large enough to cause an extinction level event could strike Earth in the next decade.
1) You have not yet provided convincing evidence that the increase in cytokines caused by vaccination is severe enough to cause damage. The Special Master bent over backwards to rule in favour of the plaintiff in the referred case.
2) The potential link between vaccination and SIDS has been investigated. There isn't one. I posted a link in this thread twice already. I now post it for a third (and hopefully final) time.
"Research has already shown that increases in cytokines can cause damage, now it’s just a matter of how much difference there is between natural infection and vaccination."
Do tell us all about that research. We would all like to about the magic "research" paper that tells the cytokines from a vaccine was worse than the disease. Seriously tell us the reaction to an MMR vaccine was worse than the one in a thousand chance of encephalitis from actually getting measles!
Argument by blatant assertion is not allowed. Provide actual factual scientific verification.
Suddenly on 09/10/2017, the son of Yury Vasin Winhoek, Namibia, died.
His comments are Nos. 10,13,45,47,48 under the text. I beg your colleagues and not indifferent to take due care of his position for the sake of children's lives. Inessa Vasina's mother
Mrs. Vasina: I'm a little confused about who's speaking here. My condolences for your loss.
However, Yuri's position is not improved by his untimely death, and it's not being disrespectful to decline to change our views on him or his position given that conversation ended weeks ago.