Questioning Offit. Part 3. Encephalopathy

Previous entries:
Chapter 1: Introduction
Chapter 2: DTP

There’s simply no polite way to tell people they’ve dedicated their lives to an illusion.

― Daniel C. Dennett

Offit's Chapter 3. A Crude Brew

In Chapter Three, continuing his criticism of the film DPT: Vaccine Roulette, Offit describes how the pertussis vaccine was created in the 1930s: by simply killing pertussis bacteria with carbolic acid, an antiseptic and this mixture was injected into children. It turned out to be fairly effective, but apparently not very safe. Then, in 1948, the pertussis vaccine was combined with the diphtheria and tetanus vaccines to create the DPT shot. This combined vaccine was used in the U.S. and other developed countries until the mid-1990s, and it is still used in many other countries today.

By the early 1980s, only one study in the United States had carefully examined the side effects of pertussis vaccine. It was carried out by Larry Baraff, and as Offit writes, Baraff’s findings were striking. Baraff explained that these side effects were the result of the archaic technology used to make the vaccine. “I don’t think that this is the type of vaccine that would be produced today,” he said. “If this vaccine were produced in 1980, instead of in the 1930s and ‘40s, there would be a different type of technology available and we would make a more purified vaccine.”

Offit counters this by claiming that these are merely coincidences:

every year in the United States, in England, and throughout the world, children suffer epilepsy and mental retardation; this has been true for centuries, well before the pertussis vaccine was invented. Also, symptoms of epilepsy and retardation often occur in the first year of life, the same time that children are receiving three doses of vaccine. Given the widespread use of pertussis vaccine, most children destined to develop seizures or mental retardation anyway would likely have received it, some within the previous twenty-four or forty-eight hours.

Offit goes on to write that "the first flaw with the notion that pertussis vaccine caused brain damage was that it didn’t make biological sense." The common theory is that the brain damage is caused by endotoxin contained in the vaccine. (Incidentally, the person who first discovered endotoxins in vaccines back in 1978 was not a regulatory agency like the FDA or CDC, nor a pharmaceutical company that produces vaccines, but Mark Geier — the father of David Geier, recently appointed by Robert F. Kennedy Jr. to investigate the causes of autism. He found endotoxins not only in pertussis vaccines, but also in flu, mumps, and several other vaccines. Out of 20 vaccines tested, 17 contained endotoxin.) Offit doesn’t dispute that endotoxin can cause brain damage. But, he writes, the problem with this theory is that administering endotoxin always causes a fever, but many children with seizures and retardation following pertussis vaccine never had fever. Therefore, Offit concludes, it couldn’t have been the endotoxin.
Offit does not mention that nearly all pertussis vaccines also contain aluminum — a known neurotoxin.

***

Chapter Three includes 54 footnotes, 16 of which cite studies intended to support the safety and effectiveness of vaccination. Let’s take a closer look at them.

Offit writes:

In the 1930s, Pearl Kendrick and Grace Eldering made a vaccine by simply killing pertussis bacteria with carbolic acid, an antiseptic. In 1939, they tested it. Kendrick and Eldering studied more than 4,000 children, giving their vaccine to half; during the next four years, they watched to see who got sick and who didn’t. The results were clear: whereas 348 unvaccinated children got whooping cough, only 52 vaccinated children suffered the disease. [109].

I have no objection to the claim that the pertussis vaccine is effective during the first couple of years. What’s worth noting from this study is that the vaccine in question did not contain aluminum, and yet it was quite effective. Aluminum was added to vaccines starting in the 1940s, primarily because it allowed manufacturers to reduce the amount of antigen, making vaccines cheaper to produce.

Refuting Miller

Offit then cites studies that, in his view, refute the findings of David Miller’s study, which we discussed in the previous section. To recap, the British Ministry of Health commissioned a large-scale study by Professor David Miller, which found a link between the DTP vaccine and severe neurological disorders.

Offit:

Epidemiological studies didn’t support Miller’s study, either. In 1956, the Medical Research Council in England studied more than thirty thousand children for two years. It couldn’t find even one who had suffered brain damage as a result of the pertussis vaccine [117].

This is a rather strong claim. When reading these lines, a parent is left with the impression that the DTP vaccine is safe. But did the study really establish that?

First, the study did not include unvaccinated children, nor did it include children vaccinated with the DTP vaccine. All the children received one of 14 monovalent pertussis vaccines. These vaccines varied in composition: six contained aluminum, the rest did not; some used thimerosal as a preservative, others used phenol. Some were cultured on bovine blood, others on sheep, horse, or human blood. Some children received intramuscular injections, others subcutaneous ones. Of the 14 vaccines, nine turned out to be ineffective, and five were effective. All five effective vaccines did not contain aluminum. The majority of the children in this study received vaccines without aluminum.

Within 72 hours of vaccination, eight children experienced seizures. The authors stated that it was not possible to determine whether these cases were coincidental or caused by the vaccine. Another 34 children had seizures between 4 and 28 days after vaccination. Regarding these episodes, the authors wrote: "There is no reason to believe that these seizures were caused by the vaccine."

The study indeed did not identify any cases of permanent brain damage. But the authors found this surprising, since such cases had been observed in previous studies. They explained this by noting that children with a personal or family history of seizures, epilepsy, hydrocephalus, intellectual disabilities, or similar conditions were excluded from the study. Moreover, vaccination was postponed for a month after any recent infections or smallpox vaccination.

During the study, 24 children developed paralytic poliomyelitis. Three fell ill within a month after vaccination, and all three developed paralysis in the limb that had received the injection. The authors noted: "The fact that the three children who developed poliomyelitis within a month after injection had paralysis only in the injected limb suggests, in view of the published evidence, that there was a causal relationship between the injection and the site of paralysis.

To summarize:
- The children in the study were between 6 months and 3 years old. Today, the first dose of DTP is administered at 2 months.
- Only completely healthy children were included in the study.
- Some children received subcutaneous injections. Other studies have shown that subcutaneous administration causes significantly fewer side effects. Today, DTP and other pertussis vaccines are given intramuscularly.
- Most importantly: this study did not use DTP, but various monovalent pertussis vaccines. Most children received a vaccine without aluminum. Such vaccines are no longer produced today.
This study cannot be used to draw conclusions about the safety of the DTP vaccine. Offit’s use of it as evidence for DTP’s safety is misleading.

Offit:

In 1962, Bo Hellström at the Karolinska Institute in Stockholm studied eighty-four healthy infants who had received DTP and later suffered high fever or decreased responsiveness. Hellström performed electroencephalograms on children six and twenty-four hours after vaccination, reasoning that if the vaccine was affecting the brain, then the EEGs, which can detect even slight alterations in brain wave activity, should be abnormal. But they weren’t. All the children had perfectly normal EEGs [118].

First, this is quite a small study to draw any definitive conclusions. No one is claiming that DTP causes encephalopathy in every vaccinated child.

Second, Offit engages in cherry-picking here, omitting another similar study from 1955, in which EEG abnormalities were found in two out of 83 children after vaccination, as well as a 1961 study that observed EEG changes following smallpox vaccination. Both of these studies are actually mentioned in the very article Offit cites.

Third, in this study, the vaccine was administered subcutaneously—again, a method known to cause fewer side effects. In the previous study that prompted this one, the vaccine was given intramuscularly.

Fourth, the authors of both EEG studies examined only healthy children receiving their very first vaccination. However, it is well known that later doses are more likely to cause adverse reactions (this is explicitly stated in the next study we’ll examine). For example, in that same 1955 study that preceded the one Offit refers to, there is a case of a girl who received her first dose intramuscularly. Twelve hours later, she had a brief seizure episode that her mother didn’t consider serious and did not mention to the doctor at the next appointment. Twelve hours after the second dose, the girl experienced severe seizures. She was taken to the hospital, but despite treatment, the seizures continued, and twelve hours later, she died.
But all of this is far from the most important point—we’ll return to this article later.

Offit writes:

In 1983, two years after David Miller’s study was published, T. M. Pollack and Jean Morris, researchers at the Public Health Laboratory and Department of Community Medicine in London, published their own study. They analyzed 134,700 children in the North West Thames Region of England who had received three doses of DTP and compared them to 133,500 children who had received DT alone. Their study enabled them to isolate the effect of the pertussis component of the vaccine. They, too, couldn’t find what David Miller had found [119].

This study was conducted in response to data from the Committee on Safety of Medicines, which indicated that DTP caused significantly more adverse effects compared to DT. Scientists from the Public Health Laboratory Service (the British equivalent of the CDC) hypothesized that the reason was a negative media campaign against DTP that had emerged in the mid-1970s. Based on this assumption, they carried out their own study, relying exclusively on hospitalization data following vaccination, and concluded that there was no significant difference in neurological reactions between DTP and DT.

At first glance—if you only read the abstract—it may appear to be a classic retrospective vaccine safety study: children vaccinated with one aluminum-containing vaccine are compared with children vaccinated with another aluminum-containing vaccine, no significant differences are found, and both vaccines are deemed safe.

However, on closer inspection—after reading the entire paper—a completely different picture emerges. In reality, the authors found twice as many deaths among those who received DTP; four times as many neurological disorders; and three times as many seizures compared to DT. So how did they manage to conclude that there was no difference? Very simply: they excluded all children with a family history of seizures from their analysis.

Of course, this is not mentioned in the abstract. At the very least, the conclusion should have been that children with a family history of seizures should not receive DTP. But that’s not in the abstract. Doctors, who rarely read papers beyond abstracts, are unaware of all this information. Offit, most likely, also only read the abstract.

Offit:

Also in 1983, three neuropathologists in England studied the brains of twenty-nine children whose deaths had been blamed on pertussis vaccine. Some had died within a week of getting the vaccine; others had suffered epilepsy, mental retardation, or physical disabilities. The investigators were looking for anything that tied these cases together—some indication that the vaccine had caused the problem. But no distinct pathological finding linked the cases [120].

Offit clearly didn’t read this study. In reality, the authors did not examine the brains of twenty-nine children themselves — they didn’t perform any autopsies. What they did was review published autopsy reports conducted by other pathologists and described in the medical literature. These descriptions were “difficult to interpret” due to imprecise terminology and incomplete documentation of neuropathological findings. The only material the authors were able to study directly were histological brain sections from some of these children. Even then, the samples were taken from different parts of the brain in each case, without any standardized methodology. In other words, this was not a systematic investigation, but rather an analysis of fragmented data. The amount of available data was very limited — which is why the authors were unable to reach any clear conclusions.

Offit:

In 1988, researchers in Denmark took advantage of a natural experiment. Before April 1970 children in Denmark were vaccinated with the DTP vaccine at five, six, seven, and eighteen months of age. But after April 1970 they were given the pertussis vaccine at five and nine weeks and again at ten months of age. Investigators reasoned that if epilepsy were a consequence of receiving pertussis vaccine, then the onset of seizures should change with the changing schedule. But it didn’t [121].

What Offit fails to emphasize is that the vaccines being compared were not the same. In 1970, when changes were made to Denmark’s vaccination schedule, the pertussis vaccine itself was also modified: its potency was reduced by 20%, and the aluminum adjuvant was removed from its formulation. Moreover, at the same time, the inactivated polio vaccine — which also contained aluminum — was removed from the schedule.

So, if this study proved the safety of the pertussis vaccine at all, it only demonstrated the safety of a monovalent, aluminum-free pertussis vaccine — a type of vaccine that is no longer produced or used anywhere today. All current pertussis vaccines are combination vaccines and all contain aluminum as an adjuvant.

The authors also mention two other studies that found an association between pertussis vaccination and meningitis:
- In a large Swedish study, three children vaccinated against pertussis died of fulminant bacterial infections, while no such deaths occurred in the control group.
- In a case-control study in Minnesota, children with purulent meningitis were more likely to have been recently vaccinated compared to age-matched children without meningitis.
In this particular study, they didn’t find a link between pertussis vaccination and meningitis — likely because it’s difficult to detect any clear signal when there are such massive simultaneous changes to the vaccination schedule.

Offit:

Six years after the airing of Vaccine Roulette, a study was finally performed on American children. In 1988, researchers from the department of epidemiology at Harvard’s School of Public Health and the Group Health Cooperative of Puget Sound in Seattle examined the records of more than thirty-five thousand children. They wanted to determine whether epilepsy was more common in those recently vaccinated. It wasn’t [122].

Let’s take a closer look at what stands behind this “It wasn't”.
First, 25% of children were excluded from the study. The authors excluded all those born weighing less than 2.5 kg, as well as children who might have had neurological risk factors. In other words, they excluded precisely those who would have been the most vulnerable to post-vaccination complications.
Second, they excluded all seizure cases that did not result in hospitalization or the prescription of antiepileptic medication — despite acknowledging that not all seizures require medical treatment.
Third, they excluded all cases in which seizures began more than 72 hours after vaccination.

In the end, the authors were left with just one girl who, at 11 months old, began having seizures lasting 2.5 hours on the very day she received the DTP vaccine. At age six, she was still taking antiepileptic medication, continued to have seizures, and had abnormal EEG readings. The authors dismissed this case as a mere coincidence. They concluded that serious neurological disorders following vaccination are very rare in healthy children.
However, the researchers still recorded a 3.7-fold increase in the risk of febrile seizures shortly after vaccination.
Why did the researchers go to such lengths to exclude children who were more likely to suffer complications from vaccination? Most likely because the study was funded by the FDA and pharmaceutical companies.

Offit writes:

Two years later, Marie Griffin and colleagues from Vanderbilt University published a study of more than thirty-eight thousand children in Tennessee, looking for a relationship between DTP and brain damage. Again, they were unable to find what David Miller had found [123].

This is an example of a so-called self-controlled study. In such studies, the control group consists of the same vaccinated children, but not immediately after vaccination — rather, a month later. That is, all children are vaccinated, and then the 0–30 days post-vaccination period is compared to the period starting 30 days after vaccination. There’s a veiled assumption here that anything occurring more than a month after vaccination can no longer be related to it. It’s important to note that studies of this type almost never compare the 30-day period before vaccination with the period after — which would be far more logical. Why do the authors make such a strange choice? Possibly because this study was also funded by the CDC and the FDA.

In the end, the study authors did not find that epilepsy occurred more often in the first month after vaccination than in the period after that. Well — technically they did find it, but the association was not statistically significant. Of course, to achieve this “non-significance,” they excluded two children with encephalopathy that began two weeks after vaccination. The authors did not explain why those children were excluded.

For identifying links between vaccination and chronic illnesses, such studies are scientific garbage. Regardless of their results, nothing meaningful about the long-term effects of vaccines can be concluded from self-controlled studies. These studies are only suitable for examining acute reactions. But for conditions like encephalopathy, this approach is unsuitable — encephalopathy can appear a month later or even beyond that.

For example, it is known that intracerebral injections of aluminum hydroxide cause epilepsy in monkeys. But the condition doesn’t develop immediately — the first signs appear 3–4 weeks after injection and worsen over time. Now suppose we conduct a self-controlled study with the aforementioned design in monkeys. We inject aluminum into all their brains, then compare how many develop epilepsy in the first 30 days versus how many develop it later. It might turn out that half of the monkeys develop epilepsy in the first 30 days, and half later. Then we could conclude that intracerebral aluminum injections are not associated with epilepsy. Moreover, it might turn out that fewer than half of the monkeys develop epilepsy in the first 30 days, while the majority do so during the second month after the injection. In that case, the study’s conclusion would be unequivocal: intracerebral aluminum injections protect monkeys from epilepsy.
Sounds insane? That’s exactly how modern science proves vaccine safety.

Aluminum spreads through the body very slowly. If it takes several weeks to reach key parts of the brain after an intracerebral injection, then after an intramuscular injection, the process could take months or even years. Sometimes it happens quickly — within a few hours. Perhaps in such cases, the vaccine accidentally enters a blood vessel rather than muscle, allowing aluminum to reach the brain within hours and cause an immediate reaction, which researchers do associate with the vaccine.
By the way, in patients undergoing dialysis with aluminum-containing solutions, encephalopathy developed on average four years after starting dialysis.

Now let’s return to the Swedish study, in which the authors performed EEGs on infants within 24 hours after vaccination and found no changes in brain activity. In the previously mentioned monkey study, EEGs were also conducted—but not 24 hours after the injection. Instead, they were done four weeks after aluminum was injected into the brain, and the results differed significantly from the pre-injection EEGs.

Aluminum injected into muscle crosses the blood–brain barrier, but it doesn’t reach the brain immediately. For example, in one out of every 250 sheep vaccinated against the bluetongue virus with an aluminum-containing vaccine, cognitive impairments developed. However, these impairments didn’t appear right away—they only became noticeable several days after the second injection. [1] This implies that a completely normal EEG one day after vaccination cannot be taken as proof of a vaccine’s safety. To draw well-founded conclusions, EEG studies need to be conducted several weeks or even months after vaccination.

Then Offit cites several articles and reports claiming that pertussis vaccination is not associated with encephalopathy. These reports reference the previously mentioned studies, and most of them conclude that yes, neurological disorders are often observed after vaccination, but correlation does not imply causation, and these are merely coincidental.

For example, a report by the Child Neurology Society states that it is known that rabies vaccines can cause neurological disorders, and the 1976 flu vaccine did as well. The authors write that, in theory, it is possible that the endotoxin in the pertussis vaccine could cause encephalopathy—but there is no evidence for this. As usual, aluminum isn’t even mentioned [129].

In another 1990 article, James Cherry, whom we've encountered before, writes that “it is known that, in the past, smallpox, rabies, and tetanus vaccines caused encephalitis, anaphylaxis, and immunologic neurological illness. Early pertussis vaccines were also associated with similar reactions, but at that time they were not standardized… Unfortunately, over the last 8 years the vaccine has been under attack because of the historical medical belief that it can cause brain damage. This belief was never a major medical concern because the benefit of the vaccine was clearly much greater than even the perceived risk. Nonetheless, due to the sensationalistic media and parents who attribute their children’s illnesses and deaths to pertussis vaccine, we now have a national problem that shouldn't be.”

Cherry considers the National Vaccine Injury Compensation Program, introduced in 1986, to be a new national tragedy because it legitimized the idea of a causal connection between vaccination and complications, created unscientific precedents in defining what counts as a vaccine-related injury, and encouraged increased litigation against physicians. “We need to end this national nonsense,” he urges. Moreover, new vaccines are needed not to prevent nonexistent problems such as "pertussis vaccine encephalopathy," but to decrease the many disquieting reactions of the pertussis vaccine such as persistent uncontrollable crying, and hypotonic hyporesponsive state” [127].

A third report acknowledges that there are indeed many case reports of severe neurological disorders following pertussis vaccination, and that the authors of those studies concluded there was a causal connection. But the authors of the report explain them away as mere coincidences [126].

The reports also state that there is no animal model of encephalopathy or other neurological disorders that might be caused by vaccination. Meanwhile, the fact that aluminum hydroxide—used as an adjuvant in pertussis vaccines—causes epilepsy, seizures, and cognitive impairment in monkeys has been known since the 1940s [1] [2] [3].

The fourth report, by the Institute of Medicine—the most comprehensive of those cited—does at least mention in the appendix that aluminum salts may play a role in the development of encephalopathy following pertussis vaccination, and that patients with kidney failure who underwent dialysis with aluminum-containing solutions developed severe and often fatal encephalopathy. Nevertheless, the authors of the report conclude that there is no evidence that aluminum in vaccines can cause encephalopathy [128].

Offit writes about this report:

In 1991, the Institute of Medicine—an independent research institute within the U.S. National Academies of Science—concluded that the association between pertussis vaccine and brain damage remained unproved.

In fact, the report clearly states: "the evidence is consistent with a causal relation between DPT vaccine and acute encephalopathy and shock and "unusual shock-like state," (p. 23). But for some reason, Offit neglects to mention this.

Then Offit cites more recent studies:

In 1994, researchers from the University of Washington and the Centers for Disease Control and Prevention teamed up to do yet another study. They evaluated more than two hundred thousand children in Washington and Oregon and concluded: “This study did not find any statistically significant increased risk of onset of serious acute neurological illness in the seven days after DTP vaccine [130].

This study was conducted in response to Miller’s work and followed the same design: a case-control study comparing children with neurological disorders to a control group of children without such conditions. Both groups included vaccinated children. Offit omits the fact that the study actually showed a fourfold increase in the risk of encephalopathy or complicated seizures. However, this result was not statistically significant due to the insufficient sample size. In other words, the study confirmed Miller’s findings, but because of the smaller sample size, the observed risk did not reach statistical significance.

This kind of situation often recurs in research related to vaccines. When a large study is published that points to possible vaccination risks, the CDC responds by funding smaller studies. Even if these studies detect an increased risk, it doesn’t reach statistical significance due to the small sample size. As a result, the CDC-funded study becomes the primary source cited, while the original, larger and more carefully conducted study is forgotten.

Offit writes that as a result of these studies "on March 10, 1995, seizure disorder following DTP vaccine was removed from the Vaccine Injury Compensation Program’s list of compensable injuries because “no medical evidence” existed to support the presumption—ironic, given that the program was born of this specific concern."

By the way, this was actually one of the key goals of all those studies funded by the CDC. In the early 1990s, after the passage of the National Childhood Vaccine Injury Act of 1986, the courts of the Vaccine Injury Compensation Program were flooded with thousands of claims. This surge threatened to bankrupt the compensation fund, and so it became necessary to reduce the list of conditions eligible for compensation.

Offit:

Finally, in 2001, researchers working with a group of health-maintenance organizations performed the clearest, most definitive study to date. Using computerized records, investigators analyzed the occurrence of seizures in three hundred and forty thousand children given DTP compared with two hundred thousand children who received no vaccine. They concluded: “There are significantly elevated risks of febrile seizures after receipt of DTP vaccine, but these risks do not appear to be associated with any long-term, adverse consequences [132].

As in the previous studies, the control group consisted of vaccinated children who had not received any vaccines in the preceding 30 days. In other words, just like in the self-controlled study discussed earlier, this study operated on the assumption that seizures can only occur within 30 days of vaccination. As we know from experiments on monkeys—and considering the slow distribution of aluminum in the body—this assumption is not accurate.

Nevertheless, this CDC-funded study found a sixfold increase in the risk of febrile seizures on the day of vaccination. In fact, it also showed a twofold increase in the risk of non-febrile seizures. But once again, due to the small sample size, this result was deemed statistically insignificant. And in this case, the authors actually had a large enough dataset available. Yet for some reason, they chose to randomly select 1,094 cases out of the 2,281 available to them—and analyzed only those.

The Trial of the Miller Study

After this, Offit poses the question: how could it be that Miller’s rigorous study found a statistically significant link between the pertussis vaccine and neurological disorders, while later studies failed to find any such connection? The most obvious answer—that Miller’s study was more rigorous, significantly larger, and, crucially, independent, unlike all the subsequent studies funded by the CDC, FDA, and pharmaceutical companies—is not even considered by Offit. Instead, he devotes several dozen pages to describing lawsuits against DPT manufacturers, including one particular case in which Miller’s study allegedly “fell to pieces.”

Why did it fall to pieces? According to Offit, it was published prematurely under political pressure and therefore included only 1,000 out of the intended 1,182 cases of encephalopathy. Once the full dataset was gathered, the picture changed. Additionally, three children were reportedly misdiagnosed, while others had viral infections that could have explained their encephalopathy. As a result, Offit claims, Miller’s conclusions were completely dismantled.

But Miller’s study was a standard case-control study—one of the weakest types of studies. Like the others, it only assumed a link if encephalopathy occurred within the first week after vaccination. By design, case-control studies cannot prove causality. They can only detect a signal, no more. And even if no signal is detected, that still doesn’t prove the absence of a link.

These types of studies are easy to manipulate. For example, you can select your control group not from unvaccinated children, but from children who hadn’t received a vaccine in the preceding week. That’s exactly what Miller’s study did. So, if a child received a vaccine and developed encephalopathy symptoms eight days later, they could still end up in the control group. In such a case, an encephalopathy on day eight actually lowers the apparent risk from the vaccine—"proving" the vaccine was not responsible. (As we saw in the monkey studies, epilepsy usually developed during the second month after aluminum injection.) And even under these limiting conditions, Miller’s study still found a threefold increase in the risk of encephalopathy within 72 hours of vaccination—simply because it was large enough to detect the signal.

Later studies (also case-control in design) were significantly smaller and therefore failed to reach statistical significance. Still, as mentioned, these studies are highly susceptible to manipulation. Since encephalopathy is a rare outcome, all it takes is the exclusion of a few cases—moving them from one group to another—to wipe out statistical significance.

So how was this done in Miller’s case? The judge overseeing the lawsuit decided that infantile spasms were unrelated to vaccination and excluded them from the analysis [149]. (We’ll discuss infantile spasms in Part Five.) He also reassigned a number of children between the case and control groups, and in doing so, the statistical significance disappeared. Then the judge concluded that some children’s encephalopathy was caused by a virus—which led to the astounding result that no encephalopathy cases remained in the vaccinated group at all (!). From this, the conclusion was drawn that the vaccine actually protects against encephalopathy rather than causing it (sic!). The study’s authors tried to object, pointing out that such an approach was, to put it mildly, unscientific—but their concerns were ignored.

Since then, Offit writes, there have been no further lawsuits over the pertussis vaccine in British courts.

Conclusions

In this chapter, we reviewed nine studies that were supposedly conducted to refute the conclusions of Miller’s research. In reality, five of them actually supported his findings—only the observed risk either failed to reach statistical significance due to small sample sizes, or the authors were compelled to exclude certain children from the analysis in order to eliminate the apparent risk and erase statistical significance.

Two other studies focused not on the DPT vaccine but on monovalent pertussis vaccines that did not contain aluminum. Their results cannot be extrapolated to the DPT formulation. The design of the remaining studies (such as EEGs taken 24 hours after vaccination and analyses of autopsy reports) simply did not allow for a meaningful refutation of Miller’s conclusions.

Moreover, the report from the Institute of Medicine explicitly acknowledged a causal relationship between the DPT vaccine and acute encephalopathy—a fact Offit conveniently omits.

It’s also important to note that not one of these studies compared vaccinated children to unvaccinated children. In essence, all of them were variations of the same kind of “study” that would have us believe intracerebral injections of aluminum somehow protect monkeys from epilepsy.

Speaking of epilepsy and Dravet syndrome—we’ll turn to that topic in the next chapter.