Questioning Offit. Part 5. SIDS

Previous parts:
Part 1: Introduction
Part 2: DTP
Part 3: Encephalopathy
Part 4: Dravet syndrome

It is hard to imagine a more stupid or more dangerous way of making decisions
than by putting those decisions in the hands of people who pay no price for being wrong.

Thomas Sowell

Offit's chapter 4. Roulette Redux

In Chapter Four, Offit continues his critique of the film "DPT: Vaccine Roulette". For example, the film claims that “The Physicians’ Desk Reference, published by drug manufacturers, says that the pertussis component of the DPT vaccine is probably linked to sudden infant death syndrome (SIDS).” However, Offit writes that the reference book goes on to state that DPT is typically administered to infants between 2 and 6 months of age — the very age range in which 85% of SIDS cases occur. Therefore, he concludes, “the association is likely coincidental.”

Offit points out several inaccuracies in the film. For instance, “the film claims that some children went into shock, but the study cited contains no such term — it only mentions hypotonic-hyporesponsive episodes.” (In fact, hypotonic-hyporesponsive episodes are described in the scientific literature as shock-like states.) Or, “the film states that DPT causes infantile spasms, but the spasms in question were not infantile, since a Danish study published five years before the show aired found no link between DPT and infantile spasms.”

Offit also argues that the film downplays the danger of pertussis infection, as it shows numerous children allegedly harmed by the DPT vaccine, but only a single child suffering from pertussis. In response, Lea Thompson stated that she was unable to find any data suggesting that pertussis posed a serious threat in the United States. Offit counters that in 1982, the year the film was released, ten children died of pertussis. To support this claim, he cites his own book. Conveniently, however, he does not provide a page number — and with the book spanning 3,700 pages and containing 2,560 mentions of the word “pertussis,” locating that statistic is no simple task.

Meanwhile, according to official CDC data, only four people died of pertussis in the U.S. in 1982 — and that includes all age groups. For comparison, 1,807 people died of tuberculosis that same year, yet no one was advocating for tuberculosis vaccination in the U.S. then — or now.

Offit then moves on to criticize the experts featured in the film, such as Robert Mendelsohn, Bobby Young, and Gordon Stewart.

Mendelsohn is faulted not only for opposing the pertussis vaccine, but for being against all vaccines in general. He also opposes mammography, water fluoridation, and the licensing of dietitians. Offit is especially appalled by Mendelsohn’s dismissive attitude toward physicians and mainstream medicine. Mendelsohn, for example, claims that “Doctors turn out to be dishonest, corrupt, unethical, sick, poorly educated, and downright stupid more often than the rest of society.”

Bobby Young, a microbiologist who worked on vaccines at the FDA, stated that in his opinion, the FDA had no interest in learning about side effects. Offit criticizes him on the grounds that he is neither a pediatrician nor a neurologist, and therefore, in Offit’s view, has no authority to speak about a possible link between high-pitched crying in infants and brain damage.

Gordon Stewart claims in the film that, in his opinion, the risk of vaccine complications is now higher than the risk of complications from the disease itself. Offit criticizes him for disparaging his colleagues, and he faults the film for failing to mention that Stewart had published a study claiming the vaccine was not only unsafe but also ineffective — which, according to Offit, is simply beyond the pale.

Offit:

In 1977, Stewart had published an article claiming not only that the pertussis vaccine was unsafe but that it didn’t work [179].

Offit is, to put it mildly, being disingenuous. In the article he cites, Stewart says nothing of the sort. What Stewart actually argues is that the introduction of the vaccine had little impact on the decline in pertussis mortality, which had already been falling before vaccination began and continued to decrease at roughly the same rate afterward. He includes mortality charts to support his position.

Stewart notes that the vaccine is effective in children over one year old but not in infants. This is acknowledged today — which is precisely why the vaccine is now administered to pregnant women, and then infants receive six or seven doses. He also writes that vaccinating infants might be justifiable if it could be shown that the protection lasted long enough for older children to shield infants from infection. However, that is not the case, since the vaccine's effectiveness wanes quickly. Among those who infected infants, 70% were fully vaccinated. (This, incidentally, has been confirmed by later studies. For example, a 2014 study found that most infants catch pertussis from their vaccinated siblings.)

Stewart concludes that since the vaccine can, in rare cases, lead to encephalopathy, vaccination is not justified — as the risk of the vaccine exceeds the risk of death or permanent harm from pertussis. In some parts of the country where pertussis has become rare, that risk even outweighs the chance of contracting the disease at all.

Offit then writes that crying and seizures after vaccination do not, in and of themselves, lead to brain damage. Yet in the previous chapter, he himself stated that Dravet syndrome causes brain damage and that vaccination can act as a trigger. Logically, this implies that a vaccine can cause seizures that result in brain damage — but Offit seems not to notice this contradiction.

In concluding the chapter, Offit writes that it’s no surprise this film sparked the anti-vaccine movement in the U.S. What’s surprising, he says, is that it didn’t happen earlier. After all, the history of vaccination is full of tragedies.

For example, in the early 1940s, all American soldiers were vaccinated against yellow fever. This vaccine included human serum, and some donors were infected with hepatitis. As a result, 300,000 soldiers contracted hepatitis, and 62 died.
In the early 1950s, 120,000 children were vaccinated with a polio vaccine that contained live virus. As a result, 70,000 developed poliomyelitis, 200 were left paralyzed, and 10 died.
And in 1929, in Lübeck, 250 infants were vaccinated with BCG containing unattenuated bacteria, leading to the deaths of 72 newborns.

***

Chapter Four includes 35 footnotes, but only 3 of them are used by Offit to support the safety and effectiveness of vaccines. I will examine these articles in more detail.

SIDS

Offit:

It should be kept in mind that the three preliminary immunizing doses of DTP are usually administered to infants between the ages of 2 and 6 months, and that about 85 percent of SIDS cases occur in the period 1 to 6 months of age.” In other words, the association is likely to be coincidental. Indeed, a study published in 1982 showed that pertussis vaccine didn’t cause SIDS [164].

Offit cites a report by the Institute of Medicine investigating the link between the DPT vaccine and SIDS. (He makes an error here: the report was published in 1992, not in 1982.) The report states that SIDS, as a phenomenon, was not mentioned in the medical literature until the 1960s — which coincidentally aligns with the start of mass infant vaccination campaigns. The peak incidence of SIDS occurs at 2 to 3 months of age, which also coincides — coincidentally, according to the report — with the routine vaccination schedule for infants.

The first recorded case of death following DPT vaccination was in 1933, when two infants vaccinated within a few days of birth died two hours after receiving the shot. In 1979, four children in Tennessee died within 24 hours of receiving the DPT vaccine. All of them had been given doses from the same batch. Despite this, no causal link between the vaccination and the deaths was officially established.

A 1986 study reviewed over 150 cases of fatal outcomes occurring shortly after DPT vaccination. Half of these deaths occurred within 24 hours of the shot.

Since SIDS occurs primarily in the first year of life, and most children receive three doses of DPT during that year, some overlap between SIDS and vaccination is statistically to be expected. However, a 1983 study found that SIDS deaths tended to occur on the first day and during the first week after vaccination, and were not evenly distributed over time. The authors of the report argued that this kind of analysis is flawed, because it does not account for the fact that the risk of SIDS peaks at around two months of age and then drops sharply. Therefore, in their view, a higher number of deaths near the vaccination period is to be expected, even without any causal link to the vaccine itself. Based on this reasoning, they conclude that temporal coincidence alone cannot serve as evidence of a causal relationship between vaccination and SIDS.

The report then reviews seven epidemiological studies. In one of them, children who received DT (diphtheria-tetanus) instead of DPT (diphtheria-pertussis-tetanus) were used as the control group. The rest were case-control studies. Of course, there are no randomized controlled trials. As a result, in all these studies, the control groups typically also consisted of vaccinated children. Most of these studies not only failed to find an increased risk of SIDS following DPT vaccination but even showed a protective effect — as if the vaccine reduced the risk of sudden death. The authors of the report acknowledge that this is implausible and explain it by invoking the “healthy vaccinee effect” — the idea that vaccinations are typically postponed when a child is ill. However, they do not adjust their calculations to account for this explanation and still conclude that the association between DPT and SIDS is merely coincidental.

As I’ve already mentioned, case-control studies are the weakest type of epidemiological evidence and are easy to manipulate. They can be useful for detecting signals, but the absence of a detected signal does not mean the signal doesn’t exist.

All the studies cited in the Institute of Medicine report rest on the assumption that sudden infant deaths are something that naturally occur with a certain statistical distribution — one that just happens to coincide with the vaccination schedule — and that, purely by coincidence, no one had noticed these deaths happening before the era of mass vaccination. A certain percentage of completely healthy babies, for reasons unknown, are simply destined to die suddenly. That’s just the way nature works, apparently. So, by presuming that a set percentage of infants are bound to die and that their deaths happen to follow a statistical curve that aligns with vaccination timing, the studies conclude everything is fine — that’s how it’s supposed to be. Case closed. Checkmate, anti-vaxxers!

***

Are there any studies suggesting that the DPT vaccine might contribute to sudden death? In Part Two, I already mentioned a series of studies by Peter Aaby’s group in Africa. These studies, conducted in different countries and at different times, consistently showed that DPT vaccination was associated with at least a twofold increase in infant mortality. In some communities, the risk was up to ten times higher. The introduction of DPT was accompanied by a rise in infant deaths.

Earlier, I mentioned the Tennessee case as summarized in the Institute of Medicine report — four infants who died within 24 hours of receiving the DPT vaccine. But in fact, in 1979 in Tennessee, eleven infants died within eight days of being vaccinated, five of them within the first 24 hours. Nine of these children had received vaccine doses from the same batch. The CDC conducted an investigation and concluded that this was merely a coincidence. The Institute of Medicine report also fails to mention that, following this incident, vaccine manufacturers stopped distributing entire batches to a single region and began dispersing each batch nationwide.

In Japan, between 1970 and 1974, the government paid compensation for 37 deaths linked to vaccination, including 11 cases of SIDS. After two infants died within 24 hours of receiving the vaccine, Japan raised the age for the first dose from 3 months to 2 years. As a result, over the next 6.5 years, compensation was awarded for only three deaths.

A special commission, headed by “the world’s leading expert on pertussis,” James Cherry, analyzed the Japanese data. In the published report, the commission wrote that “sudden deaths following vaccination disappeared when the vaccine schedule was delayed until children were 24 months old.” The commission concluded: “It is clear that delaying the first dose of the vaccine until 24 months of age, regardless of the vaccine type, reduces the number of serious adverse reactions temporarily associated with vaccination.”

In a 1997 Texas study, premature infants showed an increased risk of apnea (temporary cessation of breathing) and bradycardia (slowed heart rate) after receiving the DPT and Hib vaccines—conditions that may act as precursors to, or mechanisms behind, sudden death.

In a 1991 Australian study, breathing monitors were placed under infants’ mattresses to record precise changes in respiratory patterns before and after vaccination. The study showed that after DPT vaccination, the number of episodes involving sharply slowed or stopped breathing increased—not evenly, but in spikes that lasted for several weeks (see chart).

In March 1992, eight infants in Taiwan died within 36 hours of receiving the DPT vaccine. Seven of them had received vaccines from the same batch, prompting authorities to suspend its use. After analyzing SIDS cases in Taiwan from 1996 to 2013, researchers concluded that the risk of sudden death was increased by 60% among girls during the two days following DPT vaccination. The authors concluded that the vaccine likely only slightly hastened an otherwise inevitable death in these girls, who were already destined to die from SIDS a bit later.

Studies like this, despite their more robust design, are simply ignored. Meanwhile, case-control studies that find no link between vaccination and death continue to be cited—despite the fact that they fail to account for a key variable: the “healthy vaccinee effect.”

In the next section, we’ll look at infantile spasms (West syndrome) and clinical trials of pertussis vaccines—after which we’ll conclude this topic.