Search results for 'encephalitis'

Yes, California children are dying of measles. Today. It’s called SSPE. Andrew Wakefield, Del Bigtree, Polly Tommey, stop lying about it.

2 Nov

One of the very frustrating aspects of the vaccines-cause-autism myth is that my community–autism parents–are largely responsible for spreading the misinformation and the fear. One need only look at Jenny McCarthy, Generation Rescue, the National Autism Association, TACA (Talk about Curing Autism), Polly Tommey, and almost any online discussion about vaccines to see the misinformation being spread by autism parents.

Listen to someone spreading the fear about the MMR vaccine and you will almost always hear, “measles doesn’t kill”. I’ve heard it a number of times from Andrew Wakefield. Remember him? He’s the guy whose unethical research 20 years ago fueled the fear we have today. His current effort is a fake documentary called “Vaxxed”. His team includes Del Bigtree (a former actor and low level producer for daytime TV) and Polly Tommey (an autism parent and Wakefield ally). As part of their PR tour for their film, they’ve given a number of personal appearances and posted video to Facebook. Watch them a few times and you will see Wakefield’s team–especially Del Bigtree–that measles is not a fatal disease. That no one has died of measles in California, they say. Del Bigtree focuses on California a great deal. He’s from California. California had a sizable outbreak recently and, partially as a result of that, changed their laws on vaccines for students.

Del Bigtree is wrong, as he usually is. Measles does kill. The death rate in France over the past decade has been about 1 in 2000, And that’s the number for people killed during the infection. The recent outbreaks in California have not resulted in immediate deaths, but we haven’t had outbreaks as large as those in France. However, measles is killing people in California right now. It’s killing them with the long-term infection called SSPE. People in California have died in recent years, and one is currently dying of SSPE. SSPE is incurable. It’s a slow, agonizing death.

Want more facts about SSPE?

What is Subacute Sclerosing Panencephalitis?
Subacute sclerosing panencephalitis (SSPE) is a progressive neurological disorder of children and young adults that affects the central nervous system (CNS). It is a slow, but persistent, viral infection caused by defective measles virus.

and read more from that same site:

What is the prognosis?
Most individuals with SSPE will die within 1 to 3 years of diagnosis. In a small percentage of people, the disease will progress rapidly, leading to death over a short course within three months of diagnosis. Another small group will have a chronic, slowly progressive form, some with relapses and remissions. A very small number (approximately 5 percent) may experience spontaneous long term improvement and regain lost function. Prevention, in the form of measles vaccination, is the only real “cure” for SSPE.

You can read more but here’s what we are talking about: in addition to the people who die from measles infections, measles infects the brain in some people and they die. They die over years, slowly losing function. Spending years knowing death is coming.

And a recent study shows that SSPE has been happening in California. People have died in recent years. Someone is dying right now of SSPE.

There are a number of news stories about this. Below is the abstract from the conference.

Subacute Sclerosing Panencephalitis: the Devastating Measles Complication is More Common than We Think

Background: Subacute sclerosing panencephalitis (SSPE) is a fatal complication of measles. Thought to be rare, SSPE incidence decreased with routine measles vaccination, but infants with measles remain at highest risk of this complication. We reviewed SSPE cases in California from 1998-2016 to understand current risk factors for SPPE.

Methods: SSPE cases had a clinically compatible illness and either 1) measles IgG antibody detection in the cerebrospinal fluid; 2) characteristic pattern on electroencephalography; 3) typical histologic findings in brain biopsy; or 4) medical record documentation of SSPE-related complications. Cases were identified though a state death certificate search, reports from the Centers for Disease Control and Prevention, or through investigations for undiagnosed neurologic disease. Measles IgG detection was performed using indirect enzyme immunoassay at the California Department of Public Health (CDPH) or by immunofluorescence assay at clinical laboratories.

Results: Seventeen SSPE cases were identified. Males outnumbered females 2.4:1. Twelve (71%) cases had a clinical history of a febrile rash illness compatible with measles; all 12 had illness prior to 15 months of age and measles vaccination. Eight (67%) children were living in the United States when they had measles. SSPE was diagnosed at a median age of 12 years (range 3-35 years), with a latency period of 9.5 years (range 2.5-34 years). Many cases had long-standing cognitive or motor problems prior to diagnosis. Among measles cases reported to CDPH during 1988-1991, incidence of SSPE was 1:1367 for children < 5 years, and 1:609 for children < 12 months at time of measles disease.

Conclusion: SSPE cases in California occurred at much higher rate than previously published among unvaccinated children who were infected with measles in infancy. Protection of infants younger than 12-15 months of age, when measles vaccine is routinely administered, requires avoidance of travel to endemic areas, or early vaccination prior to travel. Clinicians should be aware of the possibility of SSPE in patients with compatible symptoms, even in older patients with no specific history of measles infection. SSPE demonstrates the high human cost of “natural” measles immunity.

Let’s pull that last sentence out for emphasis:

SSPE demonstrates the high human cost of “natural” measles immunity.

The study above is based on something called data. Del Bigtree bases his arguments on a Brady Bunch episode.

No, I’m not making that up, Del Bigtree claims that since there was a Brady Bunch episode about measles, it must not have been a big deal in the 1960’s. That’s about as logical as saying, “well, there was this TV show about being in the Marines called ‘Gomer Pyle’. So, obviously, the Vietnam War was no big deal.”

I have zero belief that Del Bigtree (or Jenny McCarthy, Generation Rescue, the Age of Autism blog, Andrew Wakefield, or any of the rest) will change their claims that “measles is no big deal”. Why? Because Del (and the rest) are cowards. It takes guts, serious courage, to stand up and say, “I was wrong”. It takes guts to break from your community and say, “people, this position is dangerous”.

It takes the sort of courage that Del Bigtree and the rest just do not have.

—
by Matt Carey

Was autism ever a first advocacy priority for those promoting the idea that vaccines cause autism?

2 Mar

Years back the evidence was rolling in debunking the hypotheses that the MMR and/or thimerosal in vaccines causes autism. At that time I naively wrote some colleagues in online writer’s community about how perhaps the groups that had been advocating about autism being a vaccine-induced epidemic would now become actual autism advocacy groups. They were at a fork in the road: become autism organizations or focus solely on vaccines. But acting like they were doing both was no longer going to work. One writer responded in a way that has stuck with me as he has been shown to be dead on right. Dr. David Gorski (who writes at Science Based Medicine among other places) was the colleague and I he said essentially: it has always been about the vaccines for them and it always will.

Years later it’s obvious: Dr. Gorski was correct. I was wrong. And we are seeing good examples of that now in this measles outbreak as groups like Safeminds and, of course, the Age of Autism blog chime in with articles downplaying the dangers of measles. A prime example recently came on AoA from Mark Blaxill. Mr. Blaxill is largely responsible for the thimerosal scare of the past decade. He wrote a paper (published in the non peer reviewed Medical Hypotheses) Thimerosal and autism? A plausible hypothesis that should not be dismissed. It was junk when it was published, it’s junk now.

His recent article on AoA is “Measles Hysteria — The Truth About a Non-Epidemic in Eight Simple Slides”. It’s junk and one could spend an article debunking each point. But Let’s take a more focused look. He has a slide “Why Measles is No Longer a Threat in the U.S.” (click to enlarge)

M Blaxill misinfo 1

So, it was supposedly 1500 infections ago that someone in the U.S. died of measles. Only 1 in 1500 or so and so it’s not a big deal. Mr. Blaxill even called (or got someone from his organization to call) the CDC for a statement. Who knows what was asked, what was said. Maybe the CDC spokesperson made a mistake. You see, Dr. Vincent Iannelli at Pediatrics.About.Com actually tabulated measles deaths in the U.S. in recent years. Even with a low infection rate, people die of measles and have died in the U.S.. After presenting the data for each year he summarizes:

So that’s 10 measles deaths since 2000 and at least 7 measles deaths since 2005.

Why do people say that there have been no measles deaths in the United States in the past 10 years? Whether they are misinformed or intentionally trying to misinform people, they are wrong.

One can confirm this on the CDC Wonder website. Here’s a screenshot.

This isn’t about proving Mark Blaxill wrong on some point. Because in the end it doesn’t matter if it’s one death or ten deaths, it’s too many. But I suspect 1 death or 10 deaths wouldn’t change Mr. Blaxill’s assertion that measles is a minor deasease.

\Those 10 measles deaths Dr. Iannelli mentions are deaths that occur during the infection, usually from complications like pneumonia or encephalitis. But the thing about measles is that it can kill years later. There’s a condition called SSPE, Subacute Sclerosing Panencephalitis. You see, for some people, the measles virus enters the brain and stays there. And slowly kills.

From Dr. Iannelli:

About 6 to 8 years after having measles, children with SSPE develop progressive neurological symptoms, including memory loss, behavior changes, uncontrollable movements, and even seizures. As symptoms progress, they may become blind, develop stiff muscles, become unable to walk, and eventually deteriorate to a persistent vegetative state.

Children with SSPE usually die within 1 to 3 years of first developing symptoms

and

That’s 32 SSPE deaths since 2000 and at least 19 SSPE deaths since 2005. Why so many? Many of them can likely be attributed to the large number of cases associated with measles outbreaks from 1989 to 1991.

There is no cure for measles infection. There is no cure for SSPE. One can read more about SSPE at the link given above or at a recent article at Science Based Medicine: SSPE: A Deadly and Not-That-Rare Complication of Measles.

Mr. Blaxill includes a quote from someone in the 1963 who stated that measles is of “moderate severity” or “low fatality”. Perhaps to someone who lived through the early 20th century when measles was even more deadly, this might seem so. Perhaps. But not now. And how can someone ever use the phrase “self limiting” about a disease that can lead to SSPE? SSPE is only “self limiting” in the death of the patient.

Another of Mr. Blaxill’s slides shows the decline in measles infections and deaths following the introduction of the vaccine. Mr. Blaxill annotated this with his own observations (click to enlarge):

M Blaxill misinfo 2

Here’s the thing that pops out of that graph: the death rate has remained constant at about 1 in 1,000 since at least 1950. Take a look at any datapoint in the deaths and go up a factor of 1,000 and there’s the infection rate. And that doesn’t account for SSPE deaths years later.

Over the years I’ve found that Mr. Blaxill often takes an unreasonable and unfounded stance on issues. But since when is a death rate of 1 in 1,000 low enough to state “Why Measles is No Longer a Threat in the U.S.”?

For comparison, Mr. Blaxill informs us that there have been 80 deaths attributed to measles containing vaccines reported to VAERS (the Vaccine Adverse Event Reporting System) in the past 10 years. He ignores, as most people do who use VAERS in this manner, to include the disclaimer one must acknowledge in order to access VAERS data, which concludes that VAERS data do not imply causality. But let’s for the moment assume that every report to VAERS is causal. 80 deaths. There are about 4 million babies born in the U.S. each year. About 90% get the MMR vaccine. Twice. Over 10 years. That’s nearly 80 million doses of MMR vaccine administered. So, even if we take each report to VAERS as causal, that would be 1 death in 1 million doses. 1 death in 500,000 infants. This is a huge over estimate given the assumptions, but let’s do the difficult: compare these numbers. To Mr. Blaxill 1 in 500,000 is too many, but 1 in 1,500 is “low fatality”.

Even using the Mr. Blaxill’s flawed assumptions, his logic doesn’t make any sense.

Let’s take a look at Mr. Blaxill’s concluding slide so I can bring this back to how it shows that he has abandoned not just logic but also the autism community. I’ve highlighted one sentence that is particularly important. (click to enlarge):

M Blaxill misinfo 3

Measles has ceased to be a dangerous illness? Seriously? First, the idea that we can accept 1 out of 1000 people dying due to measles is just astonishingly bad advocacy. For that point alone we in the autism community need to distance ourselves from Mr. Blaxill and people like him. These irresponsible actions are not the actions of the autism community.

That said, let’s consider this key phrase: “in healthy children”. If you will, try to recall back in the day when Mr. Blaxill presented himself as an autism advocate. Actually, we don’t even have to go back that far, only recently he was telling a congressional hearing:

In New Jersey, 1 in 29 boys born in 2000 were diagnosed autistic.

What’s going on? Why are so many American children sick?

The message he had for many years was that autistic children are sick. Not healthy. His former organization (Safeminds) would be quick to point out a number of conditions that are more common in autistics than in the general population. Since even by his own definition autistics are not “healthy”, why should we let measles return in force to the U.S.? Of course it is Mr. Blaxill’s failed hypothesis that vaccines are making children “sick”. But let’s consider this very real point: the developmentally disabled are more likely to become sickened by infectious diseases and they are more likely to die (Why vaccination uptake matters to the autism community).

And that’s ignoring the fact that a large fraction of autistics are also epileptic. And a huge trigger for seizures is infectious disease and the prolonged fever that comes with it. Perhaps Mr. Blaxill is unaware of the term status epilepticus, the situation where someone gets into a state of constant seizures. And, yes, this can be brought on by infection.

Or perhaps Mr. Blaxill has forgotten the emphasis his community placed on mitochondrial disease and autism just a few short years ago.

From a U.C. San Diego Metabolic Deseaese Center website, the paragraph: What is Mitochondrial Disease?

If a child is stricken with a catastrophic disease affecting three or more organ systems, or if a child has been afflicted with a relapsing disease that affects two or more organ systems and leads to slow but measurable deterioration, he or she may have a mitochondrial disease. At times, mitochondrial diseases can cause isolated symptoms. These may include unexplained seizures, low blood counts, dystonia (abnormal muscle tone or spasms), blindness, deafness, dementia, ataxia (stumbling or tremors), cerebral palsy, heart failure, or progressive muscle weakness. More often, however, several organ systems are affected in sequence, one faltering or failing after another. Good periods are frequently punctuated by abrupt deteriorations that are caused by simple infections. For children with mitochondrial disease these infections can be life threatening, and leave them with deficits that cannot be recovered.

Emphasis added. Some fraction of our population does have mitochondrial disease. Allowing diseases like measles back would put this community (as well as those with mitochondrial disease without autism) at huge risk.

I’d like to say that Mr. Blaxill, like many in the “autism is a vaccine-induced epidemic” camp, has lost his way. A very valid question is whether Mr. Blaxill and his colleagues were ever on the path of autism advocacy. Was it always, as Dr. Gorski opined, about the vaccines?

While I’ve entitled this article “Was autism ever a first advocacy priority for those promoting the idea that vaccines cause autism?”, in the end motivations are secondary. Mr. Blaxill’s actions are and have been irresponsible. They are an example of the actions of a group of faux autism advocates that have a history of irresponsible actions. Not just to public health but to the autism communities.

—
By Matt Carey

Yep, measles is still a killing disease

21 Mar

Vaccines are a side show to the autism discussion, I know. And, yes, I know I spend a lot of time on this side show. One reason is that the autism parent community has a segment which does a lot to harm public health by creating fear of vaccines. With the resurgence of measles in the U.S., we are seeing the discussion rise again. For example, Dr. Robert “Bob” Sears has chimed in on facebook (see a discussion at Respectful Insolence here) as has Dr. Jay Gordon on twitter (see a discussion at The Poxes).

Inevitably these discussions include statements about how people suffer injuries or even death from measles. This is then countered by claims that with good nutrition, sanitation and vitamin A, no one will suffer lasting consequences. The CDC makes this very clear:

Even in previously healthy children, measles can be a serious illness requiring hospitalization. As many as 1 out of every 20 children with measles gets pneumonia, and about 1 child in every 1,000 who get measles will develop encephalitis. (This is an inflammation of the brain that can lead to convulsions, and can leave the child deaf or mentally retarded.) For every 1,000 children who get measles, 1 or 2 will die from it. Measles also can make a pregnant woman have a miscarriage, give birth prematurely, or have a low-birth-weight baby.

But people think this is an acceptable risk, or downplay this risk. One way they do this is to estimate risk of harm by the fraction of the total population, not the fraction of the population infected. That made some sense in the old days when a sizable fraction of the population was infected each year and everyone would be infected at some point in their lives.

Consider this old graph. In a bit we will get to the edit that was done and how deceptive that is (click figure to enlarge):

measlesmortalityusa1971-75_1

The rate of measles infection dropped by about 30x between 1964 (before the introduction of the vaccine) and 1971. With that came a drop in deaths from measles. A factor that is very interesting, and very much misused, is the fact that the death rate from measles was steadily dropping before the introduction of the vaccine. Hence the “vaccines didn’t save us” myth. Had we just waited, the death rate would have dropped to the same level anyway. There’s a line extrapolating from the data that “shows” that.

First off–hooray for medical advances. They have improved the survival rate from measles. Damned glad they did. But, what about that line? Well, you can draw a line through pretty much anything if you try hard enough. It doesn’t mean anything if you don’t understand the mechanism causing the trend. Why should we expect the trend before 1965 to continue for the next 45 years?

While engaging in online discussions about measles outbreaks, I ran across this website from the U.K.. The table is “Measles notifications and deaths in England and Wales, 1940-2013”. The public health officials in the UK are supposed to be “notified” of every person infected with measles, so “notifications” are “cases”. Let’s consider the notifications. (click figure to enlarge)

Measles Notifications UK

This isn’t normalized to the total population, it’s just the raw number of cases in any given year. I’ve taken the liberty to point out some events which happen to coincide with changepoints in the graph. First is the introduction of the measles vaccine, after which the number of cases per year dropped dramatically. Second is the introduction of the MMR vaccine which, again, was followed by drops in the number of cases. Lastly we see the publication of Andrew Wakefield’s now-retracted Lancet study. Shortly after which, the number of cases started to rise again. Yes, correlation is not causation, but time after time, with vaccine after vaccine we see the same thing: introduce a vaccine and the incidence of that disease decreases.

OK, we’ve looked at notifications. What about deaths? Let’s take the number of deaths and normalize by the number of notifications. In other words, let’s look at what fraction of those infected died.

Measles Deaths UK

Pre 1960 there was a steady drop in the fraction who died. Again, yay medicine. And, yes, yay nutrition and sanitation. After 1960, though, the fraction who died leveled off. 2-3 people per 1000 infected died. (it averages to about 2.6/1000 from 1960 onward).

None of this is news. In Measles Elimination in the United States, a team from the CDC writes:

By the late 1950s, even before the introduction of measles vaccine, measles-related deaths and case fatality rates in the United States had decreased markedly, presumably as a result of improvement in health care and nutrition. From 1956 to 1960, an average of 450 measles-related deaths were reported each year (∼1 death/ 1000 reported cases), compared with an average of 5300 measles-related deaths during 1912–1916 (26 deaths/ 1000 reported cases)

Catch that–that’s people from the CDC saying “yay healthcare! Yay nutrition!” and “yay vaccines!”.

Did nutrition, sanitation and improved medical care reduce the fraction of people who died from measles infection? Absolutely. Was it enough? No. Can we draw lines from old data and claim that the number who would die today would be 4 in 100 million today? Well, sure, you can draw the line. It’s dishonest, but given the source that’s not surprising. As I wrote above, you can draw a line through anything. Doesn’t make it true. If you don’t know the reason why a trend is happening, or the limitations on that trend, it’s meaningless. In this case there was a “hard floor”. There are deaths from measles that sanitation, nutrition and modern medicine can’t prevent. People still die from measles. Measles deaths in France (modern sanitation, nutrition and medicine) were seen at a rate of 3/1000 in recent years. Pregnant women, fetuses, small children and the infirm are more likely to suffer. Which is why when people like “Dr. Bob” Sears and “Dr. Jay” Gordon downplay the risks of measles–in effect telling their readers to keep relying on the rest of us to provide herd immunity–people like me speak up. Yes it’s a diversion from autism, but it’s a diversion fed by some of my fellow autism parents. And it’s an important diversion.

—
By Matt Carey

A cause célèbre for those claiming vaccines cause autism

1 Mar

If you participate in online discussions about autism and vaccines (and I’d advise you to spend your time more productively), you will often hear about how the U.S. Court of Federal Claims (the “Vaccine Court”) has compensated numerous cases of autism, the government just doesn’t admit it. These are often referred to as “secret” compensations, even though the decisions are in the public record. And, quite frankly, the families were not compensated for autism claims.

One family whose story has become a cause célèbre thanks to David Kirby is now the topic of a new Court decision. In this new decision, the court responds to the parents request to have past court documents redacted. They would like to stop being approached by members of the media.

Before we get to the new decision, consider Mr. Kirby’s story:

The parents, who did not want to be interviewed, specifically asserted that [child] “suffered a Vaccine Table Injury, namely, an encephalopathy” as a result of his MMR vaccination on December 19, 2003.” (“Table injuries” are known, compensable adverse reactions to immunizations.)

Alternatively, they claim that “as a cumulative result of his receipt of each and every vaccination between March 25, 2003 and February 22, 2005, [child] has suffered . . . neuroimmunologically mediated dysfunctions in the form of asthma and ASD.”

(child’s name redacted by me)

The parents didn’t want to be interviewed. They also presented two claims, one encephalopathy and one autism. Mr. Kirby focused on the autism claim, even though it wasn’t compensated. Mr. Kirby states:

Whether HHS agreed with [child]’s parents that his vaccine-induced brain disease led to ASD is unknown. The concession document is under seal.

Actually, it was known. The proffer of an award was titled “Proffer on Award of Compensation; Measles-Mumps-Rubella (MMR); Table Injury; Encephalitis.”

The child was being compensated for a table injury: encephalitis. Within that document, it is clearly stated:

On June 9, 2011, respondent filed a supplemental report pursuant to Vaccine Rule 4(c) stating it was respondent’s view that Ryan suffered a Table injury under the Vaccine Act – namely, an encephalitis within five to fifteen days following receipt of the December 19, 2003 MMR vaccine, see 42 C.F.R. § 100.3(a)(III)(B), and that this case is appropriate for compensation under the terms of the Vaccine Program

Emphasis mine.

Even with this information showing the family were not compensating autism clearly in the public domain Mr. Kirby tells us it’s “unknown”. Then, true to Mr. Kirby’s style, he leads his readers to the evidence supporting the possibility that it was ASD while never coming right out and saying it.

Perhaps the feds were loath to concede yet another vaccine case involving autism. Four cases in the Autism Omnibus Proceedings were recently compensated. Three of those cases are marked with asterisks, indicating the government did not conclude that autism can be caused by vaccines. But the fourth autism case that was paid out in 2013 ([child]’s case? We don’t know) has no such caveat.

Mr. Kirby was referring to the HRSA statistics page that lists vaccine court petitions filed and compensated. At the time Mr. Kirby wrote his piece, the statistics report did include autism cases. They no longer do, so you have to check archived pages to see what he’s referring to.

At the time of Mr. Kirby’s article, there appear to have been two cases where someone in the Omnibus Autism Proceeding did receive compensation (I don’t have reason to believe Mr. Kirby was in error, but the archived page doesn’t show four cases). Both of those cases had asterisks.

*May include case(s) that were originally filed and processed as an OAP cases but in which the final adjudication does not include a finding of vaccine-related autism

Mr. Kirby concluded with:

Meanwhile, as HHS says it “has never concluded in any case that autism was caused by vaccination,” it is still underwriting autism treatments such as ABA for children in its vaccine-injury program.

Which basically reads as “the government is making a distinction without a difference”. I.e. the reader comes away with the impression that the government really are compensating autism.

We knew then that these parents didn’t want to talk to the media. They didn’t want to speak with Mr. Kirby, to become his latest cause célèbre. And now we know that they still do not want this attention and we read once again that the case was not compensated for autism. From a recent decision:

“Petitioners have made these requests because they have had the misfortune of being frequently contacted by members of the media who mistakenly believe they were compensated for their alternative autism allegation when Petitioners were actually compensated for a Table Injury encephalopathy.”

Given the family’s clear intent to get out of the public’s eye, I am hesitant to put this article out. But perhaps, just perhaps, some of those using this family as part of their constant fight to keep the autism/vaccine idea alive might reconsider.

—
By Matt Carey

Dr. Bob’s Facebook delusions

21 Jan

Dr. Bob Sears is best known for his 2007 work, The Vaccine Book, ostensibly written “to give parents a balanced look at pros and cons of vaccination so that they can make an educated decision.” In reality, the book has only added to the unnecessary fear, uncertainty and doubt about vaccines that have driven thousands of parents to leave their children vulnerable to preventable diseases. And while America’s medical establishment has caught on to Sears, he still enjoys a following. His book has sold about 50,000 copies, and Sear’s Facebook page lists over 6,000 followers.

Last week Sears told his FB followers that we can only truly know that vaccines are safer than the diseases they protect us from if the CDC studies health outcomes of vaccinated and unvaccinated children. Sears no doubt includes autism in those “health outcomes”, since he has advised parents to avoid vaccinating their autistic children until they are “recovered” from the disorder.  Anti-vaccine activists have been agitating for such a study for years, most recently at the shameful Congressional anti-vaccine hearing last November 29. Jenny McCarthy’s Generation Rescue even attempted such a survey by telephone in 2007. It found that autism was more common among unvaccinated children than vaccinated.

Epidemiologists tell us such a study, done well, would be unethical, since it would mean leaving many thousands of children vulnerable to disease, just to prove what medical science already knows – that vaccines don’t cause autism. Sears says there are enough totally unvaccinated children around to conduct such a study, and on Facebook he cited a paper that supposedly shows that 5-10 percent of American children have never been vaccinated.

 The IOM and the CDC continue to hide behind the claim that to do a comparative study of unvaccinated versus vaccinated children would be unethical. But as long as they neglect to do this research, many parents will continue to decline vaccines over the concern about lack of safety research.

The IOM states that one challenge of an unvaccinated study is that there is an inadequate number of study subjects, as less than 1% of children are completely unvaccinated. I don’t agree with this statistic. It’s more like 5%, and could even be 10%. One brand new international study revealed that 10% of households surveyed had children who were completely unvaccinated. 10%!!! And it was the more educated and wealthier families that were more likely to be unvaccinated. The IOM’s claim that there aren’t enough unvaccinated children to study simply isn’t true. With over 4 million babies being born in the U.S. every year, they would have their pick of about 400,000 unvaccinated children to study each year.

Sears links to a meta-analysis of vaccine surveys published last summer in the journal Tropical Medicine and International Health. Xavier Bosch-Capblanch from the University of Basel, Switzerland, and his team reviewed 241 nationally representative household vaccination surveys in 96 low and medium income countries. The percentage of unvaccinated children (ages 12-59 months) was 9.9% across all surveys, but ranged from zero percent (Albania,Peru, and Uzbekistan) to 28.5% (Ethiopia). Sears’s claim that ten percent of American children are completely unvaccinated puts the country on par with Namibia (9.2% in 2007), Haiti (10.3% in 2006), and Yemen (10.9% in 2006). It also means that scores of developing countries, including Vietnam (1%) Tajikistan (.9%), and Sierra Leone (1.9%), should think twice before issuing visas for American children.

If Sears was truly serious about helping parents make an educated decision, he could have cited Allison Kennedy, a CDC epidemiologist, who  surveyed parents to examine intentions, behaviors and concerns about vaccines. In Confidence about vaccines in the United States: Understanding Patient Perceptions (2011), her team found  about two percent of US children aged six or younger were totally unvaccinated. Those numbers are in line with Smith et.al. (2004), which reported a minuscule .3% unvaccinated of children 19-35 months old. The CDC’s 2010 National Immunization Survey found that 1 percent of toddlers were completely unvaccinated.

Despite Sears’s best efforts, the percent of fully vaccinated children has increased over the past decade. That’s discouraging news for Sears and others who have doubled down on a vaxed v. unvaxed study. But overall rates should not mask the real harm of anti-vaccine propaganda  – encouraging community clusters of vaccine rejectionism that have led to unnecessary suffering. One such cluster incubated a measles outbreak in San Diego in 2008. The index patient was a boy who had just returned from a trip to Switzerland. By the time the virus was contained, four others came down with a disease that can lead to pneumonia, encephalitis, and even death. His family’s pediatrician? Dr. Bob Sears.

What kind of doctor, you might ask, would encourage parents to withhold an important vaccine? The kind who aligns himself with the worst elements of the antivaccine movement. The kind who misrepresents published science so as to fuel the anti-vaccine movement’s push for an unethical study. The kind to fabricate his own, untested vaccine schedule, then package it in The Vaccine Book.

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By Autism News Beat

35 Nobel Laureates are all in the pocket of Big Pharma?

27 Jun

Yes. A group of 35 Nobel Laureates has been accused of working with the “vaccine industry”. Those familiar with the online discussions of autism and vaccines will likely be unsurprised that this claim comes from the Age of Autism blog. Given the odd nature of this claim, most will likely be unsruprised that this will take some lenghthy introduction.

The article at the Age of Autism is Write the President of Cameroon to Defend Dr. Luc Montagnier, which opens so many questions. Why do they want to defend Luc Montagnier? Why would one write the president of Cameroon to do so?

Luc Montagnier received the Nobel Prize in medicine in 2008. His research has since moved into some rather questionable territory. For example, he claims that DNA from bacteria can, in highly diluted samples, induce low frequency electromagnetic radiation. This brings us to his connection to the autism communities. He claims that he can detect the electromagnetic radiation from the blood of autistic children, but not from non-autistic children. He claims that this radiation is a sign of pathogentic bacteria, and, further, claims that based on this one might treat autism with long term antibiotic therapy.

Here is part of his summary from when he presented these ideas at AutismOne this year:

There is in the blood of most autistic children — but not in healthy children — DNA sequences that emit, in certain conditions, electromagnetic waves. The analysis by molecular biology techniques allows us to identify these electromagnetic waves as coming from already known bacterial species. This correlation, which is based on more than one hundred children of European origin, naturally does not prove a causal relationship. However, a therapy first started by a group of independent clinicians and now performed in conjunction with laboratory observations reinforces the idea that systemic bacterial infections play a role in the genesis of symptoms of autism.



These are, to put it politely, extraordinary claims. They are without the extraordinary evidence which would support them.

Those with experience following the autism/vaccine discussion will not be surprised that even with these odd claims, the alternative-medical community has embraced Luc Montagnier eagerly. He has a Nobel Prize, after all. And these groups have shown a strong desire to establish some credibility. Most of their proponents are non-medical specialists (think Kerri Rivera whose presentation at AutismOne promoted using a bleach as an oral and enema-based “therapy”) and their medical specialists include people whose reputations are less than stellar (for example, Andrew Wakefield and Mark Geier).

Luc Montagnier ties his theory into the permeable-gut theory of autism.

Our working hypothesis is that immune dysfunction associated with inflammation of the intestinal mucosa leads to the introduction of bacterial components, including neurotoxins,
into the bloodstream, creating oxidative stress as well as microvascularities, especially affecting meningeal vessels and finally specific neuronal damage.




And questions whether risks are worth the benefit for vaccines in the modern world:

My position on vaccines has not changed over the last 30 years: the principle has proved to be excellent in the past. Smallpox has been eradicated in the world thanks to the use of vaccination, with attenuated vaccinia virus. But some had to pay a horrific price: encephalitis in a certain number of children. Over the years, vaccinations against bacteria and viruses have multiplied, appearing as the most cost-effective way to prevent epidemics. However, side effects are becoming more important and a single death cannot be tolerated any longer. Many parents have observed a temporal association – which does not mean causation – between a vaccination by puncture and the appearance of autism symptoms. This should not be neglected by the medical community and public health decision makers. It is therefore of prime importance to study the risk factors, both environmental and genetic, which could be involved in order to prevent them. Presumably, vaccination, especially vaccination against multiple antigens, could be a trigger of a pre-existing pathological situation in some children. The vaccine denialists are not the courageous individuals who raise the problems of vaccination accidents, but are those people who deny the existence of these tragic accidents. The latter believe in the dogma “vaccines are good”, period. They are forgetting the Hippocratic oath: primum, non nocere. First, do no harm.

He has credentials. He claims to have a potential cause and potential treatment for autism. He supports the gut-brain theory and is openly skeptical about the way vaccines are used. Is there any surprise that the vaccines-cause-autism/alternative-medicine groups support him?

A news article on the Nature website discusses some recent controversy involving Luc Montagnier. In Nobel fight over African HIV centre Declan Butler writes

A fledgling AIDS research centre in Cameroon, already struggling to find a scientific leader, is now facing insurrection from an unlikely quarter: a group of 35 Nobel prizewinners.

The laureates are calling for the centre’s interim scientific director, fellow prizewinner Luc Montagnier, to be removed from the part-time post. Observers say that unless the leadership crisis is resolved quickly and decisively, it could harm the prospects of the Chantal Biya Inter­national Reference Centre (CIRCB) in Yaoundé.

Yes, 35 Nobel Laureates have signed a letter asking an AIDS center in Cameroon to reconsider hiring Luc Montagier in a part time post.

The laureates argue that his embrace of theories that are far from the scientific mainstream, as well as what they claim are anti-vaccination views, risk hurting the CIRCB’s research, health-care programme and reputation. Montagnier has suggested, for example, that water can retain a ‘memory’ of pathogens that are no longer present1; that the DNA sequences of pathogens emit electromagnetic waves that could be used to diagnose disease2, 3; and that stimulating the immune system with antioxidants and nutritional supplements may help people to fight off AIDS4.

1) Montagnier, L., Aïssa, J., Ferris, S., Montagnier, J.-L. & Lavalléee, C. Interdisciplin. Sci. 1, 81–90 (2009).

2) Montagnier, L. et al. Preprint at http://arxiv.org/abs/1012.5166 (2010).

3) Montagnier, L. et al. Interdisciplin. Sci. 1, 245–253 (2009).

4) Butler, D. Nature 468, 743 (2010).

One could argue that it is this last point which is the most important, and the likely strongest motivation for the group of Laureates to write their letter. From reference 4:

Since then, Montagnier has supported non-mainstream theories in AIDS research that have put him at odds with other scientists. Most recently, he has argued that strengthening the immune system with antioxidants and nutritional supplements needs to be considered along with antiretroviral drugs in fighting AIDS, in particular in Africa.

“Montagnier’s embrace of pseudoscientific and fringe agendas over the past few years has been seized on by AIDS denialists and other fringe groups, who make the case that Montagnier now supports their crazy views,” says John Moore, an AIDS virologist at Cornell University in New York. Montagnier says that AIDS denialist groups misrepresent his thinking.

My suspicion is that the group of 35 Nobel Laureates are very concerned that an AIDS treatment center in Africa might take a path towards non-scientifically based treatments.

The Nature news article does mention Luc Montagnier’s connection to the autism communities:

The last straw for Montagnier’s critics seems to have been his appearance in May alongside vaccine sceptics at a conference in Chicago, Illinois, organized by US patient-advocacy groups AutismOne and Generation Rescue. Montagnier’s talk, on his hypothesis that bacterial infections may be one of many causes of autism spectrum disorder, states: “There is in the blood of most autistic children — but not in healthy children — DNA sequences that emit, in certain conditions, electromagnetic waves.”

The same groups who greeted a single Nobel Laureate with such vigor have now 35 other Nobel Laureates who consider this move by Luc Montagnier to be “the last straw” in his actions. That is a rather stunning rebuke.

And, as already alluded to above, a rebuke which has not gone unanswered. The Age of Autism blog is calling for support for Luc Montagnier. Their article, Write the President of Cameroon to Defend Dr. Luc Montagnier, begins:

A recent article in Nature shows that the vaccine industry has been closing ranks against Dr. Luc Montagnier ever since his brilliant lecture at AutismOne last month. In particular, 35 Nobel Laureates, led by one who sells commercial products to the vaccine industry, sent a letter to the President of Cameroon protesting Dr. Montagnier’s leadership position on a national research organization dedicated to HIV research.

Immediately we read that it is the “vaccine industry” closing ranks against Luc Montagnier, and the Nobel Laureates are led by one with a link (however tenuous) to the vaccine industry.

What is more stunning in this article is the fact that they never address the simple question of whether it would be good for the AIDS community in Cameroon to have Luc Montagnier on board at the Center. The letter is entirely focused on arguments that vaccines cause autism.

In conclusion, the evidence to date shows that Dr. Luc Montagnier’s serious consideration to the vaccine-autism connection is as correct as his original discovery of the Human Immunodeficiency Virus. Please do not cave to the coercive and corrupt powers of the vaccine industry, which includes an old rival who previously tried to take credit for Dr. Montagnier’s Nobel Prize-Winning discovery of HIV. We believe that through his work on autism, Dr. Montagnier has further demonstrated a level of scientific rigor and innovation of unparalleled accomplishment that could hold significant promise for patients suffering from AIDS, as it does for patients with autism.

What the autism/vaccine discussion has to do with Cameroon’s decision whether to keep Luc Montagnier on board for an AIDS center is not a part of the letter. This letter has frankly nothing to do with Cameroon’s decision whether to keep Luc Montagnier on board at an AIDS center. It is just a rundown of the rather weak arguments behind the vaccine-autism proposed link, with a liberal dose of “coercive and corrupt” powers language. This may come as a bit of a harsh surprise to the author of the letter, but, this letter will only serve to help convince the President of Cameroon to let Luc Montagnier go.

It is likely that the president of Cameroon will not do much fact checking, but should he chose to, here’s one section that takes no interpretation:

The latest CDC Autism and Developmental Disabilities Monitoring Network report from one US state found a 20% decrease in autism spectrum disorder prevalence in children born in 2000, the first year after a joint statement was made in the United States by the American Academy of Pediatrics and the US Public Health Service calling for thimerosal to be removed as soon as possible. This is the first statistically significant decrease in autism reported in this surveillance system’s decade long-history.

The prevalence estimate went from 1 in 110 to 1 in 88. That’s an increase.

Here is Luc Montagnier’s own response to the letter submitted by the 35 Nobel Laureates: Luc Pr Luc Montagnier HIV – AUTISM – VACCINES: FACTS and HOPES

The combined measles, mumps, and rubella vaccines and the total number of vaccines are not associated with development of autism spectrum disorder: The first case-control study in Asia.

24 Apr

A paper from researchers in Japan studies the questions of whether vaccines cause autism. In this study, The combined measles, mumps, and rubella vaccines and the total number of vaccines are not associated with development of autism spectrum disorder: The first case-control study in Asia, the authors use a case-control method. The study is moderate in size, 189 autistics and 224 controls.

OBJECTIVE: The aim of this study was to investigate the relationship between autism spectrum disorder (ASD) and general vaccinations, including measles-mumps-rubella (MMR) vaccine, in Japanese subjects, a population with high genetic homogeneity.

PATIENTS AND METHODS: A case-control study was performed. Cases (n=189) were diagnosed with ASD, while controls (n=224) were volunteers from general schools, matched by sex and birth year to cases. Vaccination history and prenatal, perinatal, and neonatal factors from the Maternal and Child Health handbook, which was part of each subject’s file, were examined. To determine the relationship between potential risk factors and ASD, crude odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated, and the differences in mean values of the quantitative variables between cases and controls were analyzed using an unpaired t-test. Moreover, MMR vaccination and the effect of the number of vaccine injections were investigated using a conditional multiple regression model.

RESULTS: For MMR vaccination, the OR was 1.04 (95% CI, 0.65-1.68), and no significant differences were found for the other vaccines. For all of the prenatal, perinatal and neonatal factors, there were no significant differences between cases and controls. Furthermore, regarding the presence of ASD, MMR vaccination and the number of vaccine injections had ORs of 1.10 (95% CI, 0.64-1.90) and 1.10 (95% CI, 0.95-1.26), respectively, in the conditional multiple regression model; no significant differences were found.

CONCLUSIONS: In this study, there were not any convincing evidences that MMR vaccination and increasing the number of vaccine injections were associated with an increased risk of ASD in a genetically homogeneous population. Therefore, these findings indicate that there is no basis for avoiding vaccination out of concern for ASD.

The authors confirm multiple previous studies that the MMR vaccine does not increase the reisk of autism. They also present results that the number of vaccine injections also does not increase the risk of autism.

The authors also find that the number of injections is does not increase the risk of autism.

The MMR vaccine was used in Japan from 1984 to 1993, and the study includes children born from April 1984 to April 1992. Controls were selected according to these criteria:

One to two controls were selected for each case, matched by sex and year of birth and recruited as volunteers from general schools in the Kanto area, the same area where YPDC patients reside. Consent for participation in the present study was obtained from the parents (or legal guardians) of the students. Students who had previously been recognized as having developmental problems and were already receiving care were excluded, as were those whose records in the MCH handbook were missing or illegible and those with a history of vaccination in another country.

The team had a pool of 354 autistics to work from in this geographic region and time period. They were unable to obtain controls for all of these 354, so 189 autistics were randomly selected as cases.

Among the patients who initially consulted the clinic between April 1997 and March 2011, 1875 cases of ASD were identified. Of these, 89 cases were excluded because the MCH handbook was missing or the vaccination record in the handbook could not be read, and 3 were excluded because they had received MMR vaccination overseas. Of the remaining 1783 cases, 1429 were born before March 1984 or after May 1992, leaving 354 cases (males: n = 286, 80.8%) born between April 1984 and April 1992, the possible time period for MMR vaccination. The ASD group consisted of 280 subjects with Autistic disorder (79.1%), 27 subjects with Asperger disorder (7.6%), and 47 subjects with Pervasive developmental disorder not otherwise specified (13.3%).

MMR was not universally given in Japan during this time, and here are the vaccination rates for the cases and controls:

The vaccination rates in cases and controls were as follows: MMR, 24.9% of cases and 24.1% of controls; Measles, 66.7% and 62.9%; Mumps, 58.2% and 49.1%; Rubella, 57.1% and 53.6%; DPT, 97.9% and 97.8%; Polio, 97.4% and 98.7%; B-encephalitis, 88.4% and 92.0%, and BCG 96.3% and 97.3% (Table 1). The mean times of each vaccine injection in cases and controls were as follows: DPT, 3.8 times of cases and 3.7 times of controls; Polio, 1.9 times and 2.0 times; B-encephalitis, 1.7 times and 1.8 times (Table 2).

The authors note that this is the fourth case-control study on autism and the MMR, but that those studies relied upon more genetically heterogeneous populations:

The three previous case–control studies focused on the relationship between ASD and MMR. Specifically, the investigation of DeStefano et al. was based on the Metropolitan Atlanta Developmental Disabilities Surveillance Program [31]; Smeeth et al. used data from the UK General Practice Research Database [32]; and DeWilde et al. examined the association using the UK Doctors’ Independent Network Database [33].

As a side result, the authors tested whether maternal hypertension was associated with autism. They found an odds ratio of 2.4, but that this result was not statistically significant. This is in contrast to a recent study from the U.C. Davis MIND Institute.

Here is table 1 from the study, giving the odds ratios for MMR and other vaccines (click to enlarge):

Criticisms will include: the moderate size of the group, the selection criteria, the fact that the controls were volunteers and might therefore have some selection bias, the fact that not enough controls were recruited to include all the autistics, and the fact that most children who did not get the MMR received the measles, mumps and/or rubella vaccines as individual vaccines, the fact that vaccine uptake is high in Japan, the lack of a “vaccinated vs. unvaccinated” structure to the study and more.

Taken alone, yes, this would not be convincing evidence that the MMR vaccine doesn’t increase the risk of autism. This doesn’t mean this isn’t a good study. Further, it is well worth noting that this study does *not*stand alone. Multiple studies have shown that the MMR does not increase the risk of autism.

Also worth noting is that by looking at the total number of injections, this study in essence considers the question of whether “too many too soon” is a cause of autism. Based on these results, within the limitations of the study, the answer is no.

No Evidence of Murine Leukemia Virus-Related Viruses in Live Attenuated Human Vaccines

6 Jan

There has been much discussion of XMRV, Xenotropic murine leukemia virus-related virus, here at Left Brain/Right Brain and elsewhere in the past few months. The reason for the discussion here is the (now shown to be false) idea that XMRV is implicated in autism causation. Two papers have addressed this question and found no evidence of a link. XMRV came to prominence as a possible candidate in causing chronic fatigue syndrome (CFS). Multiple papers have found no evidence of a link between XMRV and CFS (fan example is discussed here) and the original paper on the topic was withdrawn by editors of the journal Science after it became clear that those results were suspect.

The idea that autism and XMRV was promoted by David Kirby, whose efforts also strongly promoted the debunked autism-epidemic-caused-by-mercury idea. Mr. Kirby’s article at the Huffington Post was Is Autism Associated with A Viral Infection?. In this he quoted CFS/XMRV researcher Judy Mikovits:

And then Dr. Mikovits dropped a bombshell that is sure to spark controversy.

“On that note, if I might speculate a little bit,” she said, “This might even explain why vaccines would lead to autism in some children, because these viruses live and divide and grow in lymphocytes — the immune response cells, the B and the T cells. So when you give a vaccine, you send your B and T cells in your immune system into overdrive. That’s its job. Well, if you are harboring one virus, and you replicate it a whole bunch, you’ve now broken the balance between the immune response and the virus. So you have had the underlying virus, and then amplified it with that vaccine, and then set off the disease, such that your immune system could no longer control other infections, and created an immune deficiency.”

Mr. Kirby went on to write:

So there you have it – a possible explanation of regressive autism in a significant number of cases associated with immune system deregulation triggered by vaccination.

Of course, much more work is needed to nail down the exact significance of such an association. For example, is the virus implicated in the cause of autism, or do children harbor the virus as a result of autism?

Yes, Ms. Mikovits and David Kirby were proposing a possible link between autism, XMRV and (of course) vaccines.

That was October 2009. Fast forward to today, two years later and we see

A) Neither Ms. Mikovits nor anyone else has published the data supposedly linking XMRV and autism

B) Two studies have looked for evidence (and failed to find any) of a link between XMRV and autism,

Lack of infection with XMRV or other MLV-related viruses in blood, post-mortem brains and paternal gametes of autistic individuals.

PCR and serology find no association between xenotropic murine leukemia virus-related virus (XMRV) and autism.

C) Evidence has arisen that much of the data linking XMRV to CFS is faulty.

Studies on XMRV are still ongoing. If experience from the vaccine-autism-epidemic idea tell us anything, the idea that XMRV causes CFS and/or autism will die slowly and even more data are needed.

To that end, a recent study explored whether XMRV is a contaminant in live virus vaccines. (note that in other vaccines, the XMRV is likely as dead as the other constituents of the vaccine). You can tell the result from the title: No Evidence of Murine Leukemia Virus-Related Viruses in Live Attenuated Human Vaccines.

Background

The association of xenotropic murine leukemia virus (MLV)-related virus (XMRV) in prostate cancer and chronic fatigue syndrome reported in previous studies remains controversial as these results have been questioned by recent data. Nonetheless, concerns have been raised regarding contamination of human vaccines as a possible source of introduction of XMRV and MLV into human populations. To address this possibility, we tested eight live attenuated human vaccines using generic PCR for XMRV and MLV sequences. Viral metagenomics using deep sequencing was also done to identify the possibility of other adventitious agents.

Results

All eight live attenuated vaccines, including Japanese encephalitis virus (JEV) (SA-14-14-2), varicella (Varivax), measles, mumps, and rubella (MMR-II), measles (Attenuvax), rubella (Meruvax-II), rotavirus (Rotateq and Rotarix), and yellow fever virus were negative for XMRV and highly related MLV sequences. However, residual hamster DNA, but not RNA, containing novel endogenous gammaretrovirus sequences was detected in the JEV vaccine using PCR. Metagenomics analysis did not detect any adventitious viral sequences of public health concern. Intracisternal A particle sequences closest to those present in Syrian hamsters and not mice were also detected in the JEV SA-14-14-2 vaccine. Combined, these results are consistent with the production of the JEV vaccine in Syrian hamster cells.

Conclusions

We found no evidence of XMRV and MLV in eight live attenuated human vaccines further supporting the safety of these vaccines. Our findings suggest that vaccines are an unlikely source of XMRV and MLV exposure in humans and are consistent with the mounting evidence on the absence of these viruses in humans.

Yes, there is no evidence of XMRV in vaccines. This is rather anticlimactic given the evidence already in place that XMRV is not linked to autism, and the fact that the XMRV/CFS link is already tenuous at best.

The blogger erv has done the most thorough job following the XMRV study out there, including discussing the paper above. Others have taken up where David Kirby left off and promoted the idea that XMRV and autism are linked, and that vaccines are a possible part of that link. I would hope that those people would see the value in letting their readers know about this paper (and others, and the retractions).

Law Firm Faces Legal Action Over Handling Of MMR Vaccine Case

21 Sep

This story is in the U.K. version of the Huffington Post. The article, Law Firm Faces Legal Action Over Handling Of MMR Vaccine Case, brings the question of MMR litigation back up, but in a different way. First, the families are claiming that encephalitis, not autism, was the claimed injury. Second, they are suing the law firm that handled the case, not the vaccine manufacturers.

Three families who claim their children suffered a potentially fatal illness from the mumps, measles and rubella (MMR) vaccine are suing a law firm they say grouped them with a now discredited case over a link between the jab and autism.

A case was brought against the manufacturers of the MMR jab – Smithkline Beecham, Smith Kline & French Laboratories and Sanofi Pasteur MDF – in 2007, over claims that the jab caused autism in children. However three families who say the vaccine caused encephalitis in their children, not autism, believe they were unable to claim compensation because of the way the case was dealt with.

Note that the Huffington Post has the dates wrong in the section quoted above. The case was brought in the late 1990’s and abandoned in 2003 when lack of evidence resulted in a loss of public funds to support the investigation further.

The BMJ also covers the story, noting that in 2002 the then chairman of the UK’s Committee on Safety of Medicines, Alasdair Breckenridge, said: “There is sound evidence that mumps vaccine containing the Urabe stran of virus is associated with a risk of meningitis and [has} no proven additional benefits. The risk to children of a potentially serious neurological complication makes its use unacceptable.”

Since the focus here at Left Brain/Right Brain is primarily autism, and the Wakefield case has been discussed (and discussed, and discussed), I expect that most readers know the basic story. But, indulge me for a moment while I give a short history.

Back in the mid-1990’s, some families believed that MMR caused their child’s autism. They sought both legal and medical expertise to pursue their case. The legal end was led by Richard Barr of the firm Alexander Harris. For medical expertise, they (parents and leagal team) approached Andrew Wakefield, a research gastroenterologist who had just recently implicated the measles vaccine in Crohn’s disease.

After Mr. Wakefield and his team published their first paper in The Lancet in 1998 (a paper since retracted), he became even better known for his views on MMR. Sometime after this, attorney Richard Barr was contacted by a public health insider with concerns about the MMR. Mr. Barr and Mr. Wakefield met with this “whistleblower” in secret.

The thing is, the concern was about encephalitis from the mumps component. Not autism from the measles component, as was Mr. Wakefield’s hypothesis.

The meeting between Mr. Wakefield and this gentleman became known only recently, 1998, while Mr. Wakefield faced charges before the General Medical Council. Mr. Wakefield released details of his story and threatened to disclose the name of the “whistleblower”. Mr. Wakefield later followed through on this threat.

This raises very important questions. Most notably, why didn’t the legal and scientific team working on MMR litigation follow up on the mumps/encephalitis question? The idea was known to Mr. Wakefield and Mr. Barr. The MMR litigation went forward with the theory that the measles component was causing autism, and failed.

And now some parents consider these events to be a strong enough case to sue a law firm handling their case: Alexander Harris.

The families claim the MMR vaccine brought neurological injury and are suing the law firm that brought the original litigation against the vaccine’s manufacturer.

As part of the group autism case, the families claim they were deprived of the compensation likely to come from bringing individual actions.

Mr. Wakefield’s discussion of his meeting with the “whistleblower”, together with commentary from Brian Deer, is in the video below:

While Mr. Deer focuses on how Mr. Wakefield is treating the “whistleblower”, another big question is left open by this discussion: did Mr. Wakefield act on the information he was given? Did the attorneys? The secret meeting in the train station makes a rather dramatic story, but it doesn’t really reflect well on Mr. Wakefield.

Questions in advance of study analyzing vaccine court cases for autism

20 Apr

A study is in review looking at the records of the vaccine court and, purportedly, showing that a large number of the cases compensated involve autistics. Robert Kennedy Jr. was prepared to give a press conference on the paper, but this got called off. There has been chatter about a study like this for a few years now and I’ve been curious about what the results would be. I was then curious why the chatter basically died down.

The big question I would have for the author of this study and for Mr. Kennedy should he get his press conference is: how many of these children were compensated for a residual seizure disorder following DPT vaccination?

Why ask that question? The “table” is a list of reactions which the Court will assume are vaccine-caused if they happen within the prescribed time after vaccination. The table is created with the best knowledge available at the time. What happens when the best knowledge available changes? After much deliberation, the table changes. That’s what happened to residual seizure disorders as an injury for DPT vaccines. It was part of the original table, but as new research came out showing that residual seizure disorders were not a risk from DPT vaccines, it was removed from the table.

This isn’t a small issue. The idea that residual seizure disorders could be caused following DPT vaccination are basically what created the Vaccine Act, the special Court and the rest of the program as we know it today.

As of today, there have been 2,699 cases compensated within the program. Of those, by far the largest share is due to the DPT vaccine, with 1,267 compensated claims. That’s 47%. Pretty high percentage especially when you consider the DPT (the whole cell vaccine) was discontinued 15 years ago.

Let’s say that there are a lot of cases in the court where autistics have been compensated for injury. How many of these people were compensate for what was an incorrect assumption of fault? Epilepsy is common in autistics. It is certainly reasonable to think that a number of autistics were compensated for residual seizure disorders.

It will be interesting to see how they address this question in the paper, if they address it at all. It will be interesting to see how Mr. Kennedy addresses this problem, if he addresses it at all.

If you want more details on the history, here is some of it, with some links.

Take a look at the original vaccine injury table (from the mid-late 1980’s) for the DPT vaccine:

DTP; P; DTP/Polio Combination; or Any Other Vaccine Containing Whole Cell Pertussis Bacteria, Extracted or Partial Cell Bacteria, or Specific Pertussis Antigen(s).
Illness, disability, injury, or condition covered: Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration:
A. Anaphylaxis or anaphylactic shock 24 hours
B. Encephalopathy (or encephalitis) 3 days
C. Shock-collapse or hypotonic-hyporesponsive collapse 3 days
D. Residual seizure disorder in accordance with subsection (b)(2) 3 days
E. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed

Take a look at the table now for pertussis containing vaccines:

I. Tetanus toxoid-containing vaccines (e.g., DTaP, Tdap, DTP-Hib, DT, Td, TT)
A. Anaphylaxis or anaphylactic shock 1 0-4 hours
B. Brachial neuritis 6 2-28 days
C. Any acute complication or sequela (including death) of above events 4 Not applicable

It’s a lot shorter. Note specifically that “Residual seizure disorder” is now gone. Here is how residual seizure disorderwas defined:

(B) in the case of any other vaccine, the first seizure or convulsion occurred within 3 days after administration of the vaccine and 2 or more seizures or convulsions occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit.

The change came in 1995. The reasons were not arbitrary, as noted here in the announcement in the Federal Register. They were working from recently published and studies:

During the process of analyzing the comments received in response to the NPRM, the Agency became aware of the imminent publication of a 10-year follow-up study to the National Childhood Encephalopathy Study (NCES) (Madge N., Diamond J., Miller D., Ross E., McManus C., Wadsworth J., Yule W. The National Childhood Encephalopathy Study: A 10-year follow-up. A report of the medical, social, behavioural and educational outcomes after serious, acute, neurologic illness in early childhood. Developmental Medicine and Child Neurology 1993; Supplement No. 68;35(7):1–118; Miller D.L., Madge N., Diamond J., Wadsworth J., Ross E. Pertussis immunization and serious acute neurological illness in children. British Medical Journal 1993; 307:1171– 1176, hereinafter ‘‘Miller study.’’).

Because the Miller study looked specifically at the relationship between vaccine administration and subsequent neurological damage, the Department determined that it should not proceed with publication of the final rule until there had been a sufficient opportunity to consider the conclusions of the new Miller study. Accordingly, the Department asked the IOM to convene a Committee for purposes of evaluating the Miller study in light of the conclusions of its initial report. On March 2, 1994, the Institute of Medicine issued a report entitled ‘‘DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis.’’

The pubmed link to the NCES study (Madge et al) is here. The Miller study is available in full here. The IOM report is here.

To pull one short quote out as to why the table changed:

The consensus of the Commission was that the original table in the statute requires modification to make it consistent with current medical and scientific knowledge regarding adverse events associated with certain vaccines.

Basically, they found that the research which had been used for the first Vaccine Injury Table was wrong to assume cause for residual seizure disorders following DPT vaccines. Again, I await the chance to see if the upcoming paper addresses this important issue. If a large number of the autistics were compensated for an injury which modern science says isn’t really an injury, the readers of the study need to know this.

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