Questioning Offit. Part 11. Lawsuits

Chapter 6: Justice

Offit opens Chapter Six by describing lawsuits and compensation awarded to people allegedly harmed by vaccines. He complains that in the early years after its creation, the Vaccine Injury Compensation Program paid out claims not only to those actually injured by vaccines.

Rett syndrome is another childhood epileptic disorder that, like West syndrome and Dravet syndrome, suddenly emerged only in the mid-20th century—after infants began receiving aluminum-containing vaccines on a large scale. The syndrome was first described by Andreas Rett in Austria in 1954, and independently by Bengt Hagberg in Sweden. As with West or Dravet syndrome, children initially develop normally, but then undergo a sudden regression. This often happens shortly after vaccination. Rett syndrome is associated with a mutation in the MECP2 gene, but the condition does not manifest in every child who carries the mutation.

Offit:

The special master turned down Althen’s request for compensation, but, as Offit laments, the Federal Circuit Court of Appeals disagreed and overturned the decision.

The illness that developed in Margaret Alten, which Offit merely describes as “similar to multiple sclerosis,” is in fact acute disseminated encephalomyelitis (ADEM). So what studies does Offit choose to prove that “vaccines didn’t cause her condition”?

The first is a study showing that tetanus vaccines are not associated with Guillain-Barré syndrome. In other words, Offit cites a study that has absolutely no connection to the lawsuit in question, and to keep us from noticing the bait-and-switch, he avoids naming Alten’s actual diagnosis—he just says it was “a disease similar to multiple sclerosis.”

But since Offit brings up this study, let’s take a closer look at it.

In 1976, there was an outbreak of swine flu in the United States. It was quickly followed by the development of a vaccine and the launch of a mass vaccination campaign. Soon, it became clear that the vaccine occasionally caused Guillain-Barré syndrome. After 45 million people had been vaccinated, the program was halted. (Of course, the CDC had known in advance that the swine flu vaccine could cause neurological complications but chose not to inform the public.)

Based on data from the 1976 flu vaccine, CDC authors concluded that if the tetanus vaccine is associated with Guillain-Barré syndrome at all, the illness would have to occur within six weeks after vaccination. The fact that the flu vaccine has nothing in common with the tetanus vaccine—that they are produced using completely different technologies, that the tetanus vaccine contains an aluminum adjuvant while the flu vaccine does not—did not trouble the CDC authors in the least.

They estimated that for every 3 million person-weeks, there should be one background case of Guillain-Barré syndrome unrelated to vaccination. Using simple calculations, they concluded that within six weeks of vaccination, two cases of Guillain-Barré would coincidentally occur following a tetanus shot. Since they found only one such coincidence, they concluded that the tetanus vaccine is not associated with Guillain-Barré syndrome. Though, by the same logic, they just as well could have concluded that the tetanus vaccine protects against Guillain-Barré syndrome.

In fact, that’s exactly what they concluded in the second study Offit cites. CDC authors—including our familiar figure Frank DeStefano—published a paper titled “Decreased risk of demyelinating disease following tetanus vaccination.” However, this study was never actually published in full; only an abstract exists. Offit himself never read the full study, as he notes in a footnote that only the abstract is available.

The third study Offit refers to was already discussed in the previous chapter. It’s a self-controlled case series that supposedly found no link between hepatitis B vaccination and the development of multiple sclerosis. The control group consisted of the same vaccinated individuals, but observed three months after vaccination or later. This study is even more irrelevant to Margaret Alten’s case, since she received the hepatitis A vaccine, not hepatitis B. So, in an attempt to disprove a link between the hepatitis A vaccine and acute disseminated encephalomyelitis, Offit cites a study that allegedly disproves a link between the hepatitis B vaccine and multiple sclerosis.

By the way, there’s another reason why Offit avoided stating Margaret Alten’s exact diagnosis and settled for calling it "a disease similar to multiple sclerosis.” The reason is that there is no longer any real debate over whether vaccines can cause acute disseminated encephalomyelitis. ADEM following vaccination has been documented since the era of smallpox vaccination. Since then, it has been associated with at least a dozen other vaccines, including those for rabies, measles, mumps, rubella, diphtheria, tetanus, polio, pertussis, influenza, and hepatitis B.

Offit:

Here, Offit doesn’t even cite a specific study—he merely refers the reader to his own book. And it’s easy to see why. Numerous studies have found a link between hepatitis B vaccination and rheumatoid arthritis. For example, a 1998 Canadian study found that the hepatitis B vaccine can trigger the development of rheumatoid arthritis in genetically susceptible individuals. Then came a 1999 French study. A large 2001 study conducted among children revealed a sixfold increase in arthritis risk associated with the hepatitis B vaccine. There are also other studies [1] [2] and documented clinical case reports [1] [2] [3] [4].

Of course, there are also studies that found no association. Well—actually not studies in plural, but one case-control study from 2011, funded by the CDC. Actually it did show a 44% increased risk of rheumatoid arthritis following hepatitis B vaccination—but it was not statistically significant.

In a 2001 article, Frank DeStefano—our familiar CDC figure—wrote that the biological plausibility of vaccine-induced rheumatoid arthritis had been demonstrated, but that few studies existed. Since then, apart from the aforementioned 2011 study, the CDC has curiously shown little interest in conducting further research.

Offit:

Among few footnotes, only one actually contains references to two studies. Both allegedly prove that the rubella vaccine does not cause arthritis. But do they really prove that?

The 1992 report by the Institute of Medicine—which, as we've seen in earlier chapters, goes out of its way to ignore vaccine side effects—nonetheless acknowledged a causal relationship between rubella vaccination and acute arthritis. This was unacceptable to the CDC and pharmaceutical companies, who then began funding studies aimed at disproving any such link. Naturally, they didn’t conduct clinical trials comparing vaccinated and unvaccinated individuals—everyone knew how that might turn out. Instead, they opted for case-control and retrospective studies, which are far easier to manipulate toward a desired result. But in this case, they went even further.

It is well known that arthritis symptoms tend to subside during pregnancy and often don’t return until several months after childbirth. And it was precisely during this postpartum period that both of the studies Offit cites were conducted [1] [2]. At the same time, he completely ignores dozens of other studies that found the opposite association.

Let me emphasize this again: after the Institute of Medicine established a causal link between the rubella vaccine and arthritis, the CDC and Merck—the manufacturer of the vaccine—funded studies that supposedly disproved this connection, but they deliberately chose to conduct these studies among women in the postpartum period, despite the well-known fact that arthritis symptoms usually improve during pregnancy and shortly afterward.

Following this, Offit expresses particular outrage as he describes the case of Dorothy Werderitsch:

The studies concerning the link between hepatitis B vaccination and multiple sclerosis were already discussed in Part Eight. Here, Offit once again refers to the very same studies.

He sharply criticizes judges who awarded compensation to individuals allegedly harmed by vaccines. Interestingly, when describing a judge who, while reviewing a study that found a link between the DTP vaccine and infantile spasms, decided to simply exclude all cases of infantile spasms that occurred in vaccinated children—Offit praised him. But the judge who ruled in favor of a nurse who suddenly developed multiple sclerosis shortly after receiving the hepatitis B vaccine—Offit condemns. Because, according to him, studies have proven that multiple sclerosis is in no way related to the hepatitis B vaccine. Moreover, he doesn’t just criticize the judge—he writes that this was “the most illogical, most ill-founded, and most worrisome” court ruling.

Offit speaks about doctors in much the same way—both in this chapter and throughout the book. If a doctor criticizes vaccines, he’s bad and incompetent. But if he defends them—then he’s a great physician. For example, in this chapter, he speaks dismissively of a head of pathology with 40 years of experience who testified in court that a child developed encephalitis following vaccination. Offit declares that “his knowledge of the infant brain is sketchy at best.”

At the same time, he enthusiastically describes and extensively quotes another pathologist and “renowned expert”—Lucy Rorke-Adams, who opposed the aforementioned head of pathology. She claims that newborns supposedly have no myelin, and therefore cannot develop demyelinating diseases. This is, of course, incorrect. Newborns do have little myelin, but they do have it, and cases of demyelinating diseases in infants are well-documented. Including acute disseminated encephalomyelitis—the condition we discussed above, and which Offit described as “similar to multiple sclerosis.” It is a demyelinating disease that can indeed occur in infants, including after vaccination [1] [2] [3].

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In the next part, we’ll talk about the great and terrible. The man, the myth, the legend. Andrew Wakefield, of course.