Questioning Offit. Part 6. West syndrome

Previous parts:
Part 1: Introduction
Part 2: DTP
Part 3: Encephalopathy
Part 4: Dravet syndrome
Part 5. SIDS

“Not to speak is to speak. Not to act is to act.”
“Silence in the face of evil is itself evil.”
Dietrich Bonhoeffer

Infantile Spasms (West Syndrome)

Infantile spasms, also known as West syndrome, are a specific type of epilepsy that occurs exclusively in infants. Seizures in this syndrome do not resemble typical epileptic convulsions but rather appear as a series of brief jerks or sudden movements. West syndrome is usually accompanied by developmental delays.

West syndrome is a phenomenon that, like SIDS (sudden infant death syndrome), emerged around the same time as the introduction of vaccination. Although the first case was described in 1841 in the son of physician William West, over the next 100 years, the medical literature contained only sporadic mentions of similar symptoms. The syndrome was essentially rediscovered in the mid-20th century, which coincidentally aligned with the beginning of mass infant vaccination.<

The authors of the 1991 report from the Institute of Medicine, frequently cited by Offit, noted that in 1957, 24 cases of sudden-onset infantile spasms in previously healthy infants were reported, nine of which occurred within five days of receiving the DTP vaccine. Later, the medical literature included numerous additional reports of infantile spasms following DTP vaccination. The time interval between vaccination and the onset of spasms ranged from several minutes to several weeks.

For example, a 1987 study described six infants aged 2 to 9 months who developed infantile spasms between 6.5 hours and five days after vaccination. A 1977 study covering 185 cases of infantile spasms found that in 20% of cases, the infants had been vaccinated in the month preceding the onset of symptoms. Another study from 1970 reported that 13 out of 98 infants experienced spasms almost immediately after vaccination, despite being considered healthy beforehand.

Offit makes no mention of any of this. He merely writes the following:

Five years before Vaccine Roulette, a study from Denmark clearly showed that DTP didn’t cause infantile spasms [165]. This study was well known, having been included in review articles and book chapters for several years. Subsequent studies confirmed the Denmark study [166].

So what is this well-known study by the Danish researchers?
In Part Three, we already looked at a similar Danish study. In 1970, when Denmark made significant changes to its vaccination schedule, the DTP vaccine was replaced with a monovalent pertussis vaccine that did not contain aluminum and had a 20% lower potency. Based on that study, Offit concluded that the DTP vaccine was not associated with epilepsy.

An almost identical study using the same data was conducted to claim that DTP is not associated with infantile spasms. Of all the studies available, Paul Offit chose to cite this one in particular—even though, in this very study that supposedly proves the safety of DTP, the DTP vaccine was not used at all. Instead, a monovalent, aluminum-free pertussis vaccine was administered.

Thus, if this study proved anything at all, it was only the relative safety of an aluminum-free vaccine that is no longer produced today. But even that is questionable. The study itself states that after the pertussis vaccination was moved from five months to five weeks of age, the proportion of infantile spasms beginning before the age of three months increased from 12% to 23%—which in fact suggests a role of the vaccine in triggering West syndrome.

The second study that Offit cites to support his position that DTP is not associated with infantile spasms is a case-control study. But this study actually found that cases of infantile spasms occurred more frequently during the first week after vaccination. The authors explained it as follows: “It is suggested that these vaccines do not cause infantile spasms but may trigger their onset in those children in whom the disorder is destined to develop.”

In other words, yet again, a study that identified a link between vaccination and infantile spasms is presented as one that “clearly showed that DTP does not cause infantile spasms.”

The third source Offit cites isn’t actually a study at all—it’s simply a clinical case series describing instances of infantile spasms, some of which occurred shortly after vaccination. It seems Offit may have cited this reference by mistake, as it does not support his argument; in fact, it rather contradicts it.

The 1991 report from the Institute of Medicine acknowledges that cases of infantile spasms following DTP vaccination raise legitimate concerns about a possible link between the vaccine and seizures. However, as the authors note, the time interval between vaccination and the onset of spasms varies widely—from a few hours to several months.

This variation is, in fact, easy to explain. Aluminum, along with pertussis endotoxin—likely the agents responsible for triggering spasms—can take varying amounts of time to travel from the injection site to the brain. If accidentally injected into a blood vessel, they may reach the brain quickly, within minutes or hours. With a standard intramuscular injection into the shoulder, the process could take several days. And when injected into the thigh, the route through the lymphatic system could extend the journey to the brain over weeks or even months.

Nevertheless, the Institute of Medicine report concludes that pertussis vaccination is not associated with infantile spasms. This conclusion is based primarily on the aforementioned Danish study—the same one that used a monovalent, low-potency, aluminum-free vaccine. And yet, confidence in the “safety” of the DTP vaccine is built on this study, even though the DTP vaccine itself was never actually used in it.

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Clinical Trials

To conclude the discussion on pertussis and the DTP vaccine, let’s talk about the clinical trials of pertussis vaccines.

It was known from the very beginning that the whole-cell pertussis vaccine had relatively low efficacy and high reactogenicity—both as part of the DTP combination and in its monovalent form. As early as 1955, the authors of one study wrote:

None of the vaccines so far studied have been shown to be completely effective at any dose that is practical to give, and, indeed, there have been recent reports of severe systemic reactions following routine immunization. Possibly even more important than the appearance of these comparatively infrequent severe systemic reactions is the fact that virtually every child who receives pertussis immunization demonstrates some form of systemic toxicity within the 24 hours following injection. This may be manifested only by irritability, anorexia, or vomiting and these mild symptoms may or may not be accompanied by hyperpyrexia. This type of reaction has come to be considered “normal” and is even expected to occur after routine immunization. There is no evidence to indicate that these reactions are desirable. It seems advisable therefore, to continue efforts to produce less toxic and more efficient immunizing agents.

Today, developed countries use acellular pertussis vaccines. Instead of whole killed pertussis bacteria, these vaccines contain only selected antigens, which significantly reduces their reactogenicity. It is commonly believed that acellular vaccines were first developed and introduced in Japan in the late 1970s. However, this is not accurate. The first acellular pertussis vaccine was actually patented in the United States back in 1937. It consisted solely of pertussis toxin treated with formaldehyde. This vaccine was widely used in the U.S. during the 1940s, and trial data showed it had an efficacy of 94%—higher than that of the whole-cell vaccine.

According to the head of the Lederle laboratory, the company actively promoted its acellular vaccine between 1944 and 1948, but ceased its sale in 1948 when it began producing the whole-cell Tri-Immunol DTP vaccine. This shift was driven by new federal regulations that required expensive and labor-intensive efficacy trials for acellular vaccines, while whole-cell vaccines could be used without such additional testing.

Another acellular vaccine was developed in the U.S. in 1949, and clinical trials were conducted in the early 1950s. It showed efficacy comparable to that of the whole-cell vaccine but with significantly lower reactogenicity. This vaccine was produced by Merck and was used in the U.S. in the early 1960s. However, in 1963, Merck discontinued its production and reverted to the whole-cell version—likely for economic reasons, as it was cheaper to manufacture. This very vaccine later served as the basis for the development of the Japanese acellular vaccine in the late 1970s.

Efficacy

It is widely believed that the whole-cell DTP vaccine is more effective than modern acellular vaccines. This belief is based on trials conducted back in the 1930s and 1940s. For the next 50 years, the efficacy of DTP was rarely reassessed. However, when clinical trials of acellular vaccines began in the 1990s, it became clear that the effectiveness of the whole-cell vaccine was not as definitive as previously thought.

For example, in an Italian clinical study published in 1996, the efficacy of DTP was only 36%, compared to 85% for the acellular vaccines. A similar Swedish study reported a DTP efficacy of 48%. In both of these studies, the whole-cell vaccine used was manufactured by Connaught, a company that held a significant share of the U.S. vaccine market.

However, there were also more effective whole-cell vaccines. For instance, a German study found that the DTP vaccine from SmithKline Beecham (Belgium) had an efficacy of 97%.

Safety

Most clinical trials of modern acellular pertussis vaccines used the DTP vaccine as a control group, so these studies cannot provide reliable conclusions about the actual safety of the vaccines. However, there is one fairly large study (3,800 infants) in which the control group received a placebo. The placebo consisted of a mixture of formalin, thimerosal, and aluminum. This study was conducted in Sweden, where DTP had not been used since 1979.

In the vaccine group, four infants died within five months of vaccination. In the control group, not a single child died.

In the first case, a 10-month-old girl developed meningitis caused by Haemophilus influenzae (Hib) nine days after her second dose. She died five days later.
In the second case, a 12-month-old girl died in her sleep one month after her second dose.
In the third case, a 15-month-old boy died ten weeks after his second dose, presumably from pneumococcal infection.
In the fourth case, a 16-month-old boy died of meningococcal disease five months after his second dose.

The article also mentions a fifth death among vaccinated children: six weeks after vaccination, a child was diagnosed with nephroblastoma and died 17 months later.

The fatality rate from invasive bacterial infections in the vaccinated group was 60%, compared to 8% in the control group. The authors concluded that the four deaths among vaccinated infants within five months of vaccination were unexpected and that a possible link between vaccination and an increased risk of fatal bacterial infections could not be ruled out. They attempted to explain what might account for this, but never once mentioned the most obvious hypothesis: that the pertussis toxin included in the vaccine increases the permeability of the blood-brain barrier.

In conclusion, the authors recommended large-scale studies comparing vaccinated and unvaccinated children. Needless to say, such studies have never been conducted.

Paul Offit devoted four chapters to criticizing the film DPT: Vaccine Roulette. But at the beginning of his book, when comparing DPT: Vaccine Roulette to the banned film Titicut Follies, Offit fails to mention that Titicut Follies was officially cleared for public screening in 1991 and, in 2022, was added to the U.S. National Film Registry by the Library of Congress as a work of “cultural, historical, or aesthetic significance.”

The same may well happen one day with DPT: Vaccine Roulette.

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Chapter Four contains 34 footnotes, which include 20 footnotes with studies.

The studies cited tell us that:

Vaccines are unsafe or ineffective (4 footnotes).
How physicians reacted to the film DPT: Vaccine Roulette (6 footnotes).
Studies already discussed in the previous chapter (2 footnotes)
Studies unrelated to vaccination (5 footnotes).
3 studies are presented as evidence of vaccine effectiveness or safety and were discussed in this and previous entries.