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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

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The William Thompson Documents. There’s no whistle to blow.

4 Jan

For those unfamiliar with the story of William Thompson, here’s a brief introduction. William Thompson is a CDC researcher who has worked on vaccine/autism studies. About 2 years ago he approached Brian Hooker (an autism parent and very vocal advocate for the idea that vaccines cause autism) stating that a statistically significant result was not only left out of an old study but that this represented not a scientific decision, but misconduct on the part of the CDC. It is worth noting that “statistically significant” is not the same as “proof of a connection”. Brian Hooker published his own analysis (incorrectly claimed as being the same as the CDC analysis method) in a now retracted paper. The result he presented was that there was an apparent increased risk of autism for one small subset of the study population: African American males, who were vaccinated not on schedule but before age 3.

There are some questions, of course, that this raises. Is this result very strong? Does the lack of inclusion in the paper represent scientific fraud or a legitimate scientific decision?

A few epidemiologists and other scientists have chimed in (for example here, here and here) and stated that the result was very likely spurious and that Hooker’s approach is somewhat flawed and definitely overplayed.

In fact, Brian Hooker’s paper was more of a publicity event than a scientific inquiry. When the paper was published, Brian Hooker and Andrew Wakefield released a video. It is difficult to describe just how bad this video was but here are a two examples. Wakefield tried to put forth the inflammatory claim that the CDC’s vaccine program was a new Tuskegee experiment. Which is to say that the CDC are intentionally allowing African Americans to become autistic due to vaccines as part of some sort of study. Second, according to Andrew Wakefield, the CDC team is so evil that they are worse than Hitler, Pol Pot and Stalin. =Mr Wakefield’s logic being that those dictators were sincere and the CDC team were not. No, really, Hitler was sincere per Wakefield.

In a series of phone calls between Thompson and Hooker (secretly taped by Hooker and released without Thompson’s permission), we find that Thompson was very interested in testifying before congress. It turns out that William Thompson kept much (if not all) of the paperwork involved in this study and, probably at least in part motivated by the hope for a hearing, passed these along to a member of Congress: Bill Posey. It has been claimed that this cache of documents numbers as many as 100,000 pages. Many have hoped that these documents will expose fraud by the CDC. (They don’t)

Congressman Posey released the documents to a journalist recently and, given that they are now in the public domain, Dorit Reiss and I requested that they be made available to us as well. Mr. Posey’s office graciously granted our request and I have spent some time going through them.

For those hoping for an exciting look into CDC malfeasance, sorry to disappoint you. Not only is it not present here, but these documents are very mundane and repetitive. Many people seem to think there will be evidence that the CDC are covering up. No “Vaccines cause autism! How do we cover this up”. Nothing like it. Wakefield and Hooker have already cherry picked–and misrepresented–whatever they could to “best” make their case.

For more introduction, I point you to these articles as a start:

MMR, the CDC and Brian Hooker: A Guide for Parents and the Media

Did a high ranking whistleblower really reveal that the CDC covered up proof that vaccines cause autism in African-American boys?
The “CDC whistleblower saga”: Updates, backlash, and (I hope) a wrap-up
Brian Hooker and Andrew Wakefield accuse the CDC of scientific fraud. Irony meters everywhere explode.

Given that long introduction, what is in the documents? Well, there’s about 1000 pages, not the claimed 100,000. Documents provided by Mr. Thompson and, also, documents that submitted as part of the complaint that Wakefield and Hooker filed with HHS were included in the zip file. Which is convenient as I had submitted a FOIA request for those.

There are multiple drafts of the analysis plan. Analysis Plan is the same thing as the “protocol” that Wakefield and Hooker claim was changed after the first race data were analyzed. And the fact that we have the revisions gives us the chance to check two of the fundamental claims behind the Wakefield/Hooker “fraud” charge against CDC. (1) Did the CDC plan to look at race as an exposure variable? Wakefield and Hooker are claiming (although they use different words) this is what the CDC was doing. This is different from using race as a control variable. (2) Did CDC add the birth certificate analysis after the first race analysis was done, in order to dilute the effect?

No. Very clearly no. I’ve covered (2) already based on information Wakefield and Hooker made available. The final analysis plan was dated Sept.5, the first race analysis wasn’t until late October or early November. And we see the same in these documents.

But now we have new information that answers (1). Here is what appears to be the first draft of the analysis plan. And here is a capture of a very important part:

First Draft Analysis plan segment 1

Note that this draft analysis plan is from April 3, 2001. Well before the final version, the “protocol”, which was September 5. More importantly, this is a long time before a race analysis was started. But even more, notice how there’s an annotation “I would include race as a covariate, not as an exposure variable.” That’s critical–they decided against using race as an exposure variable from the start. Before they did a race analysis. Another point: they were already planning on using birth certificate data right from the start.

William Thompson certainly should have known this, it’s very probable that he did know this. Wakefield and Hooker likely knew this. They showed documents from this collection in their video and elsewhere. But they told us the opposite.

Whether they knew or not, they were wrong. Wildly irresponsibly wrong.

Ever wonder why they didn’t make documents public? We can’t tell if Hooker and Wakefield had all the Thompson documents, but we know they had some. While they cry out for transparency, they were carefully guarding information in order to craft the story they wanted told. The full documents tell a different story.

Let me put this more simply: if Wakefield and Hooker worked for me they would be fired for just their handling of the Thompson story (of course, they would have been fired years ago for many other causes, but promoting this sort of misinformation is simply wrong.)

Also in that same directory appears to be the first draft of the paper (A000071.PDF), with William Thompson as first author. I find it interesting that Thompson is first author there as later it would be Frank DeStefano who would be first author of the published study.

There are also meeting notes. Lots of meeting notes. Here’s the first batch, as near as I can tell. Meetings were held every month or two.

Now is a good time to address the “garbage can” quote. Congressman Posey read a statement from William Thompson into the congressional record. Emily Willingham discussed this in A Congressman, A CDC Whisteblower And An Autism Tempest In A Trashcan. On the other side, here’s an article by Jon Rappoport Bombshell: CDC destroyed vaccine documents, Congressman reveals Bombshell: CDC destroyed vaccine documents, Congressman reveals; CDC whistleblower case is back.

Here’s the thing–there’s zero “bombshell” involved in putting these documents into a confidential bin for shredding/recycling. There’s no reason to keep all these revisions of the analysis plan, all these meeting notes, all this redundant material. I hope people at CDC are not keeping all this paper. Beyond that, the rules are that they have to keep enough information to recreate the study. Aside from the fact that all these meeting notes are not required for that, Brian Hooker proved that requirement was met when he claimed to have done exactly that–recreated the study.

Mr. Thompson also provided a file with ALL Agendas for mmr autism meetings with written interpretation. Which is to say Thompson added his own annotations (purple pen) to the agendas.

Here’s an example of his annotations. And a great example of trying to make data fit a story. Thompson appears to be trying to support the idea that the CDC team changed the protocol to include the birth certificate analysis in response to analyzing the race data:

Race examined before final protocol

The implication that the race analysis and had somehow influenced the final protocol (as Wakefield and Hooker have claimed and this comment appears to support) is just plain wrong. First, as we have already seen, the birth certificate analysis was included from first draft of the analysis plan, in April 2001. That’s four months before this meeting note. Second, the so-called “race effect” isn’t seen in this meeting note. In fact, we see the opposite: “not statistically associated with case/control variable”.

From the phone conversations between Brian Hooker and William Thompson (secretly taped by Hooker), we have found that Thompson was very interested in participating in a congressional hearing. Hooker and his colleagues had been involved in arranging a previous congressional hearing on autism. Frankly it appears to me as though Thompson was involved in a bit of a quid pro quo: Thompson coaching Hooker in ways to spread fear about vaccines in exchange for a chance to be involved in a hearing. Which begs the question: why no hearing based on all that Thompson has laid out?

In case it isn’t already abundantly clear: there’s no hearing because there is no reason for a hearing. There’s no evidence of fraud. Many of the reasons given by Wakefield and Hooker to call this fraud are, well, just flat out wrong. Contradicted by the evidence. For those hoping that Thompson’s personal notes would show some evidence of a cover up, here they are mmr autism study 2001-2002 hand written notes.

Ah, one will say, what about the finding of an association between the MMR and autism for African American boys vaccinated late (between 18 months and 36 months)? Why wasn’t that included in the published paper or public presentations? The reasons given by Thompson/Hooker/Wakefield don’t hold water as I’ve shown. So, what was the scientific reason for not including this result in the paper? Many online writers have discussed how weak this result is; how it is a spurious result. But I’d like to know the reasoning at the time behind the CDC decision to leave this out. As a community member–an autism parent–I’d like to see all the results and understand the reasons why certain results are spurious. Of course it is easy to say now, but leaving this out of the public’s eye was a mistake. It gave Thompson, Hooker and Wakefield the chance to cherry pick, hide information and craft a story that has been very damaging to the autism communities and to public health.

The first thing I did when I heard about this story was email a few epidemiologists I know and point this story out and ask them if they had the data to address the question raised. I no longer feel this way. Why should the autism communities spend precious funds and researcher time every time Andrew Wakefield (Time Magazine’s #1 on their list of great science frauds) comes up with a new story? Especially now that we know the story was built on lies. But consider this: Wakefield and Hooker have not been calling for more research. Instead they are calling for a congressional hearing. If you watched any part of the previous hearings you know they are political theater and have done nothing (NOTHING) to help make a better life for autistics. They have done nothing except provide video and blog fodder for those promoting the failed idea that vaccines cause autism.

Also, consider this: before Thompson Wakefield and Hooker didn’t talk about the issues of racial/ethnic minorities. For the most part, the entire “autism is caused by vaccines” community have ignored minority communities. Why? Because they are a clear example that the vaccine hypothesis is a failure. Prevalence estimates for racial/ethnic minority groups have been typically much lower than for Caucasians (Hispanics are diagnosed at a rate of 1/3 that of Caucasians in California. And this has been consistent for over 10 years.) This presents a huge problem for the likes of Hooker and Wakefield. If vaccines are a major cause of autism, why do minority groups have such low prevalences? If they were honest about their own beliefs, they would be calling for a study into the “protective” effect for minorities. But they don’t. More importantly, if they were real autism advocates they would be calling for better diagnosis, better awareness, better services for these under served communities. Instead they have just ignored these minority communities. That is, until they could use them as part of their campaign against vaccines.

And they still aren’t calling for better services better diagnosis in these underserved groups. Instead they are just trying to recruit as many parents as they into the vaccines-cause-autism camp. Imagine being convinced, wrongly, that you participated in injuring your own child. The charlatans who prey on our community with fake–and sometimes abusive–therapies rely on the vaccine/autism idea for the majority of their business.

The vaccines-cause-autism story is built on lies and it is very damaging. There has been nothing since the Kanner/Bettleheim “refrigerator parent” idea that has caused so much damage to our community. And that is the real story here. A group of people perpetuating a failed idea by carefully crafting a story.

The Zip file provided to me by Representative Posey’s office is at this DropBox link
https://www.dropbox.com/sh/jxtr06s5ddc82s7/AADaZvp7yu_daBhbuZwMfQy4a?dl=0

Again, I am grateful to Representative Posey and his staff for providing these files to me.


By Matt Carey

Press Release: New Research Finds No Evidence That Thimerosal-Containing Vaccines Affect Behavior or Neuroanatomy in Infant Primates

30 Sep

Below is a press release from the Johnson Center for Child Health and Development (formerly Thoughtful House). The press release discusses a recent study which investigated the safety of vaccine schedules (present and past) using monkeys as test subjects.

The study is a follow on study to a previous series of pilot studies involving some of the same authors. The pilot studies were considered by many to be an indication of evidence that vaccines cause autism and other neurological conditions. This larger study shows no evidence of adverse effects from vaccines.

Here is the press release:

New Research Finds No Evidence That Thimerosal-Containing Vaccines Affect Behavior or Neuroanatomy in Infant Primates

(Austin, Texas) – September 28, 2015 – New research finds no evidence that thimerosal- containing vaccines cause negative behaviors or result in neuropathology in infant primates, according to a study that will be published today in the Proceedings of the National Academy of Sciences. In this study, conducted by Dr. Dwight German of the University of Texas Southwestern School of Medicine, and colleagues, infant rhesus macaques received several pediatric vaccines containing thimerosal (a mercury-based preservative) in a schedule similar to that given to infants in the 1990s. Other animals received just the measles-mumps- rubella (MMR) vaccine, which does not contain thimerosal, or an expanded vaccine schedule similar to that recommended for US infants today. Control animals received a saline injection.

Regardless of vaccination status, all animals developed normal social behaviors. Cellular analysis of three brain regions, the cerebellum, amygdala and hippocampus (all known to be altered in autism), was similar in vaccinated and unvaccinated animals.

“This comprehensive analysis of social behavior and neuropathology in 12-18 month old rhesus macaques indicated that vaccinated primates were not negatively affected by thimerosal; the same was true for animals receiving an expanded 2008 vaccine schedule, which is similar to that recommended for US infants today” explained Dr. Laura Hewitson of The Johnson Center for Child Health and Development, one of the principle investigators working on the study. Hewitson was part of a team of researchers from The Johnson Center; the University of Texas Southwestern; the Center on Human Development and Disability Infant Primate Research Laboratory; the Washington National Primate Research Center (WaNPRC) at the University of Washington, Seattle WA; and Texas A&M Health Science Center & Central Texas Veterans Health Care System.

According to Hewitson, the study was designed to compare the safety of different vaccination schedules, including the schedule from the 1990s, when thimerosal was used as a preservative in multi-dose vaccine preparations. The data from this study indicate that administration of TCVs and/or the MMR vaccine to rhesus macaques did not result in neuropathological abnormalities,or aberrant behaviors, like those often observed in autism.


Citation
Administration of thimerosal-containing vaccines to infant rhesus macaques does not result in autism-like behavior or neuropathology. Bharathi S. Gadad, Wenhao Li, Umar Yazdani, Stephen Grady, Trevor Johnson, Jacob Hammond, Howard Gunn, Britni Curtis, Chris English, Vernon Yutuc, Clayton Ferrier, Gene P. Sackett, C. Nathan Marti, Keith Young, Laura Hewitson and Dwight C. German. PNAS

This article can be downloaded for free here.

This study was supported by The Ted Lindsay Foundation, SafeMinds, National Autism Association, and the Johnson and Vernick families. This work was also supported by WaNPRC Core Grant RR00166 and CHDD Core Grant HD02274.

About The Johnson Center
The mission of The Johnson Center for Child Health and Development is to advance the understanding of childhood development through clinical care, research, and education.

Previous Press Releases
For Immediate Release
Contact: media@johnson-center.org
512-732-8400


By Matt Carey

Autism, Denmark and again no link with vaccines.

25 Aug

For a while now, I’ve been hoping that someone would publish data on the current state autism prevalence by birth year in Denmark. Denmark has been used for epidemiological studies for autism since their is a national database for health care. Thus, one can obtain a count of all people in Denmark who have been diagnosed with autism. Which is not the same thing as saying they have a count of all people in the country who are autistic. One can be autistic and not be diagnosed, as we will see.

A recent study using the Danish database is Recurrence of Autism Spectrum Disorders in Full- and Half-Siblings and Trends Over Time: A Population-Based Cohort Study. It’s an interesting study and I feel somewhat guilty for pulling the time-trend data out for my own discussion. In short, the study found that if a family has one child who is autistic, the chance for a subsequent child to be autistic is about 7 times higher than for families without an autistic child. This is fairly consistent with many other sibling studies over the years, but much lower than found in the recent baby siblings study out of the MIND Institute. That might be due to the active surveillance used by the team at MIND. I.e. they were actively monitoring and testing baby siblings.

Much more, they conclude:

Although the results from our comparison of recurrence in full- and half-siblings support the role of genetics in ASDs, the significant recurrence in maternal half-siblings may support the idea of a contributing role of factors associated with pregnancy and the maternal intrauterine environment. Finally, the lack of a time trend in the relative recurrence risk in our data suggests that the likely combination of genetic and environmental factors contributes to the risk for ASD recurrence in siblings or that the risk for recurrence because of such factors has not been affected by the rise in the ASD prevalence.

Very interesting–whatever is behind the higher prevalence among younger siblings, it seems to be the same today as 30 years ago.

What’s the overall prevalence of autism in Denmark according to this study? For childhood autism, they report 0.3%. For all ASD’s, 1.2%.

Autism, we are told by those promoting the autism/vaccine link, is unmistakable. Each autism prevalence report is not an estimate, but an accurate count of every autsitic because there is no way to miss an autistic. Back in the day, Rick Rollens was a constant fixture in the news on autism. He was a strong proponent of the idea that one could not miss autism:

WATSON:
Like many parents, Rick is convinced that Russell was damaged by a series of vaccinations. He strongly rejects the idea that the epidemic of autism can be entirely explained by poor diagnosis in the past because numbers have rose over the last few years.

ROLLENS:
Missing child with autism is like missing a train wreck. For us now to now think that somehow we have better identified a child who can’t talk, who has repetitive behaviour. Who makes no eye contact. Who is self- involved and in many cases self-abusive just defies logic.

Mr. Rollens was wrong on two counts (leaving aside his inflammatory and derogatory language). First, autism is not just the child who can not talk, self-involved and self-abusive. Second, yes, a lot of autistics have been missed. We’ve seen that time and time again. Look at the same population at different times and the later study will have found more autistics. An this goes for autistics with intellectual disability, as shown in the recent UCLA/Utah autism followup: “Today’s diagnostic criteria applied to participants ascertained in the 1980s identified more cases of autism with intellectual disability. ”

But, what about Denmark? A study from 10 years ago looked at autism incidence following the removal of thimerosal in Denmark in 1992. Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data

In that study they found 956 children born in their study period who were diagnosed with autism by 2000:

A total of 956 children with a male to female ratio of 3.5:1 had been diagnosed with autism during the period 1971–2000.

The current Denmark study included individuals diagnosed until the end of 2010. I.e. there were 10 more years of followup. In those 10 years a lot more people were diagnosed. Where there were 956 diagnosed with autism by 2000 (for birth years 1971 to 2000), 2321 were diagnosed by 2010. That’s an increase of 240%. And the new study focused on birth years 1980 to 1999. I.e. the entire 1970’s birth cohort is not included in this count, and they still found over twice as many autistics. Where were they in 2000, when the previous study was performed? Living in Denmark, not identified as autistic.

There are a few factors which are likely behind this increase, but here we have a great example of “increased awareness” affecting autism prevalence.

And, those numbers were for childhood autism. For ASD, the increase is even larger. 10,377 Danes had an autism spectrum disorder diagnosis (for birth years 1980-1999) in the new study (the previous study included none). That’s a whopping 1080% increase. Again, there are a few reasons for this (including the increased awareness above), but here’s what “expanding the definition” does to autism.

Those increases would be an “epidemic” to some if it weren’t for the fact that those autistic Danes were there all along. They just weren’t diagnosed in 2000.

For many years, groups touting the idea that vaccines cause autism have pointed to Denmark as part of their argument. Denmark uses fewer vaccines than the U.S.. Generation Rescue used to have this on their website discussion of vaccines:

Comment: Denmark is a first world country based in Western Europe. Their schedule appears far more reasonable than ours. They have also been reported to have a much lower rate of autism than the U.S. Do they know something we don’t?

What was that Danish vaccine schedule that Generation Rescue recommended?

DTaP at 3, 5 and 12 months
Hib at 3, 5 and 12 months
IPV at 3, 5 and 12 months, plus 5 years
MMR at 15 months and 12 years

No mercury (Denmark phased that out in 1992). No birth dose of Hepatitis B. Fewer vaccines overall than in the U.S.. And the same autism prevalence of about 1%.

If you dive into more details, it gets even worse for the vaccines and/or thimerosal cause autism argument. Let’s look at the prevalence as a function of birth year for childhood autism and ASD from the recent study:

AutismPrevalenceDenmark

Consider this statement from a previous study:

This means that children who followed the full vaccination program during the period 1961–1970 had received a total of 400 g of thimerosal or 200 g of ethyl mercury by the age of 15 months and during the period 1970–1992 they had received a total of 250 g of thimerosal or 125 g of ethyl mercury at 10 months of age. In March 1992 the last batch of thimerosalcontaining vaccine was released and distributed from Statens Serum Institut in Denmark.

The thimerosal exposure was higher prior to 1992 than after. But the prevalence of both childhood autism and ASD is higher after the removal of thimerosal. This is the same result as shown in the 2003 study. The number of vaccines seems to be constant over this time period, so number of vaccines/aluminum/too-many-too-soon or other arguments don’t work either.

How about taking just a single year. The prevalence for ASD in 1996-97 was 1.4%. What is the autism prevalence in the U.S. for that year? To answer accurately, I’d contend we need a count today, not an old one. But people promoting the idea that vaccines cause autism take the CDC reports as absolute measures of autism, comparing each report and telling us all about the epidemic. So, let’s take the CDC number for kids born in 1994: 0.8%. That study was reported in 2009.

So, we have 1.4% in Denmark and 0.8%, nearly half the Danish prevalence, in the U.S.. Denmark had no thimerosal, no Hepatitis B shot (birth or otherwise), fewer vaccines and less aluminum exposure. And much higher reported autism prevalence.

Oddly enough, even though there have been many prevalence studies out of Denmark, Tomljenovic and Shaw didn’t include Denmark in their study “Do aluminum vaccine adjuvants contribute to the rising prevalence of autism?” My guess is that Denmark didn’t fit their conclusion then, and, like Iceland, would make their analysis fall apart now. It is even more odd that Tomljenovic and Shaw didn’t use Denmark as Denmark was used in a faux-study put out by Generation Rescue. In AUTISM AND VACCINES AROUND THE WORLD: Vaccine Schedules, Autism Rates, and Under 5 Mortality Someone at Generation Rescue made the first attempt at the sleight of hand of comparing the autism prevalence in various countries vs their vaccine schedules. At that time, 2009, Generation Rescue claimed that the autism prevalence in Denmark was 1 in 2,200, misrepresenting the 2003 study discussed here. The raw prevalence in this 2008 study was 0.65% or about 1 in 153. That value didn’t fit the thesis that the Generation Rescue author wanted to convey.

One argument found on the internet is that the 2003 Denmark paper fudged the results by clipping the last years off the data presented. An email involving people involved in the study is quoted as saying, “But the incidence and prevalence are still decreasing in 2001“. Oh, my, we are told, the autism prevalence and incidence actually went down after the removal of thimerosal!

But, it didn’t. The prevalence of childhood autism (basically what was studied in the 2003 paper) in Denmark is flat from birth cohorts 1996-2004. Flat. The prevalence of ASD’s do see a decline. That must be it! Evidence that thimerosal was causing autism in Denmark! But it isn’t. The prevalence of ASD in 2003-04 is the same as that in 1990-91, before thimerosal was removed. Why does the ASD prevalence go down? We can’t say for sure, but my strong suspicion is that it’s the same reason why the authors in 2003 were seeing a decrease: too few years of follow up. Autistic kids are typically diagnosed earlier than those with other ASD’s, but the average age was about 5 in Denmark in 2003 (as I recall). ASD kids can have an average age of diagnosis of 8. Recall that the recently released study followed kids up to the end of 2010. It’s no surprise to me that the estimated prevalence for ASD kids born in 2002 is lower than that for kids born in 2000 in this study. And this is consistent with the flat prevalence for kids with childhood autism diagnoses, as they are typically diagnosed earlier and 8-9 years would be enough to find the majority of the autistics in that population.

What about the idea that there’s a “changepoint” in the autism prevalence in Denmark and California pointing to some event in the late 1980s that’s contributing to autism prevalence? For one thing, the present study notes that the recurrence risk doesn’t change with time, so that’s good evidence against such an idea. There is no changepoint in the California data in the 1980’s, as it is exponential and fitting it to two straight lines is just a mistake. What about the prevalence data just released? The data are not finely spaced in birth years, in my opinion, to give a good idea of any “changepoints” in the 1980’s. But there is a changepoint of sorts in the childhood autism data in the 1990’s. The data plateaus at about 1996. But, as already noted, this doesn’t coincide with anything related to vaccines. The ASD prevalence appears to peak at about 1994, but, again, this doesn’t coincide with vaccine events and, I suspect, results largely from lack of follow up for the kids in the later birth years.

How about the MMR vaccine? MMR uptake for young children (MMR1) was basically flat from 1987-1997. Uptake rose somewhat after that. So, during the period that the estimated prevalence was increasing, MMR uptake was basically flat. During the time that the estimated prevalence was either flat (childhood autism) or decreasing (ASD’s), the MMR uptake was increasing. So if we were to play the “correlation equals causation” game, MMR prevents autism. (two notes, preventing rubella infections most likely does prevent some autism and the link above shows a nice example of rubella infections going down after MMR was introduced in 1987. The two points are not linked because most women in Denmark who were infected with rubella before 18 weeks gestation chose abortion, resulting in a low congenital rubella syndrome prevalence).

How about the “fetal cells in vaccines cause autism” argument? It’s one without biological plausibility, but then so was the thimerosal idea. I’d be interested in seeing how the vaccines were produced in Denmark in the 1990’s, but at present, the MMR vaccine there is developed using chicken eggs, not fetal cell lines. And they don’t routinely vaccinate against chickenpox, another vaccine in the U.S. using fetal cell lines. It looks like at least as far back as 1999 they were using egg-based vaccine production for MMR.

So, it appears we have a country with no vaccines grown in fetal cell lines with an autism prevalence as high or higher than that in the U.S.. In other words, the “vaccines from fetal cell lines caused the ‘autism epidemic’ theory” also appears to be debunked by the Denmark data.

In case you are looking for correlations with the vaccine program, here’s the history in Denmark.

So, how about the rise in estimated prevalence in the 1980’s. Is it “real”, as in does it represent an actual increase in the fraction of autistics in the population? It’s a good question and one which could be answered by performing a real study of autism prevalence in adults. The sort of study I and others have called for in the U.S., but that most autism-parent advocacy groups have refused to support. Such a study would not only answer the question of the prevalence, but it would give us valuable data on what has led to success and failure among the autistic adult population.

For those promoting the idea that environmental mercury emissions are a factor in the increase of autism rates, if you have data for Denmark, I’d love to see it. In the U.S., environmental mercury emissions dropped by over 50% in the 1990’s.

Lastly, let’s discuss a comment statement one will read or hear. It goes something like “the autism prevalence was 1 in 10,000 in 1980 and it’s 1 in 1,000 today”. This involves a number of sleights of hand. First, the autism prevalence wasn’t 1 in 10,000 in 1980. It was a few in 10,000 (Wing and Gould reported about 5/10,000). Doesn’t sound like a big deal, but when people start taking ratios (it went up a gazillion percent) a factor of 2 or 3 in the denominator makes a difference. Second, this was the estimated prevalence based on the number of autistics diagnosed at the time. As shown above, the childhood autism prevalence estimate for Denmark in the 1980’s increased by 240% in the past decade. This was not a real increase, but better identification. Third, the comparison is between autism (childhood autism, DSM-III autism or some other restrictive definition) vs. autism spectrum disorders. Also shown above was that the prevalence of ASD’s in the 1980’s increased by a factor of 10, increasing only in the past 10 years.

A factor of 10 in the numerator, a factor of 3 or 4 in the denominator and pretty soon you are talking about a big part of the increases observed.

In the end, none of the above arguments are that new. Or, to put it better, none of the vaccines-cause-autism arguments had much real support. The mercury idea has lost much of the support it had 10 years ago in the parent community, but it persists. The aluminum in vaccines idea has risen to try to take the place of the mercury hypothesis, but it is based on the exact same smoke and mirrors. The idea that the increase in autism is due to the MMR has been scientifically dead for years. And, yet, these ideas persist. And they cause harm, both to the community at large and to the autism community.


Matt Carey

A fishing expedition at Vaccine Court

14 Jul

The U.S. Court of Federal Claims has a section devoted to adjudicating claims of vaccine injury. This is often referred to as the “Vaccine Court”. Individuals or their families can file a claim (petition) the court for alleged vaccine injury.

Information on individuals who are vaccinated are kept by ten Managed Care Organizations (MCO’s) and the Centers for Disease Control as the Vaccine Safety Datalink (VSD) Project. Researchers working as expert witnesses for families in the Vaccine Court have accessed the VSD in the past, and in one case misused their access. Possibly as a result of this, the MCO’s stopped contributing their data to the CDC for a single VSD database. Hence the reason why there are now 11 separate databases, with each MCO retaining control over their data.

One can see how groups who want to argue vaccine injury in court might want access to the VSD. Mark and David Geier have in the past attempted to use the VSD and they were the ones caught misusing the database. They, together with Heather Young, used an older VSD dataset to produce a paper for the Petitioners Steering Committee (the attorneys arguing for the families in the Omnibus Autism Proceeding). A paper for which the PSC was charged $250,000. A paper which was of such poor quality that it was not used by the PSC in the Omnibus.

In a recent decision, the Court heard arguments that the information in the Vaccine Safety Datalink Project should be turned over to their expert, Theresa Deisher, for analysis:

Petitioners seek access to data from the Vaccine Safety Datalink Project (hereafter the VSD Project) to allow their expert, Theresa A. Deisher, Ph.D., to conduct an original study comparing the rate of autism disorder incidence among children who received a particular vaccine, with the rate among children who did not receive that vaccine. As discussed more fully below, petitioners’ expert does not seek to study the MMR vaccine at issue in this matter, but rather the varicella vaccine.

That last sentence is important. The Special Master points out the decision to research whether the varicella vaccine (chickenpox) is associated with autism for good reason. The petitioners are not arguing that the varicella vaccine caused their child’s autism. No, they argue that the child reacted to DNA in the MMR vaccine resulting in autism. So, how a study on the chickenpox vaccine would further their case is somewhat unclear. Why they are not asking for data on chickenpox is even less clear.

The petitioners asked for $260,000 up front to fund the study. To my knowledge, the Court does not fund expert witnesses for efforts not yet performed. Aside from that fact, the Special Master noted that Theresa Deisher’s studies on the subject done to date were already funded.

Dr. Deisher notes that this work was funded by the MJ Murdock Charitable Trust, Pet’rs’ Ex. 26 at 18, which according to information on Deisher’s CV, provided her with a $500,000 grant to study “Population, Bioinformatics and In Vitro Studies into the Relationship between Residual Human DNA Vaccine Contaminants and Autism.” Deisher’s CV at 3. Dr. Deisher’s inability to produce a paper of publishable quality, after receiving a substantial grant, does not lend support to petitioners’ claim that she is capable of competently leading a study.

Yes, half a million dollars so far with no papers published. A manuscript was submitted to Autism Research and rejected. My guess is that the manuscript will soon be submitted to a journal (there are those which will welcome this). Or, one of these journals will seek out Ms. Deisher for her work (I could easily see this being published in a certain Polish journal, for example).

One can apply to gain access to the VSD databases. However, Ms. Deisher has not attempted to access the data in this way, opting instead to gain access through a court order.

As discussed in more detail later in this Order, petitioners acknowledge that Dr. Deisher has not followed the CDC’s usual Data Sharing application process and that she has no intention of doing so.

She did, however, apply for an NIH grant to perform this research. The petitioners claim that the controversial nature of the study resulted in it not being funded. The referee reports, however, were clear that the planned study was weak and Ms. Deisher’s skills were not strong in epidemiology and statistics (among other weak points).

Although petitioners make assertions to the contrary, the evidentiary record before the undersigned contains a withering assessment of Dr. Deisher’s ability to competently lead the proposed study. Petitioners here seek extraordinary relief, and the undersigned is reluctant to substitute her scientific judgment for that of the NIH reviewers—a panel of Dr. Deisher’s peers—who have found her proposed study to be critically deficient. In the undersigned’s view, the NIH reviewers’ comments merit weighted consideration.

“Withering assessment”.

The special master also notes that the request for data from the VSD exceeds the data needed to do the proposed study.

The petitioners do not limit their data request to information that is needed for the study they propose:

Despite the stated limits of her study, petitioners’ request for production from respondent and the MCOs lacks correlative limits for patient age and injury. Instead: petitioners seek authority to issue subpoenae to compel [respondent and the MCOs] to grant the petitioners full and unrestricted access to all data collected by the respondent within the VSD related to the administration of vaccines, and the occurrence of neurodevelopment and other disorders from the inception of the VSD to date.

Which, in my opinion, points to this as a fishing expedition. An attempt to gather any and all data and test multiple questions later–with the probability of a chance “hit” going up with the number of questions tested.

Since the Special Master did not grant access to the VSD, the funding request was also denied.

The petitioners asked that the expert witness fees for Theresa Because petitioners’ discovery request is denied, petitioners’ motion for authorization of interim expert expenses is deemed moot.

The decision also includes much discussion of a large, broad request for information from the FDA on the vaccine approval process. Again, this appears as a “fishing expedition”

Petitioners’ motion does not appear to be a well-considered effort to meet their evidentiary burden under the Vaccine Program; but rather appears to be a brazen attempt to gain access to respondent’s comments on the various vaccine licensing applications in the hope that something therein might be of relevance. As presented, there is nothing in petitioners’ briefing or the record showing that the documents under FDA’s control are necessary to a determination of the issues in this matter

Ms. Deisher’s previous research has focused on “changepoint” analysis of autism prevalence data. She follows the method set forth by two people at the FDA who presented such a changepoint analysis previously. I found that analysis lacking and submitted a comment to the journal on it. I find Ms. Deisher’s analysis lacking as well.

In the end, the petitioners shot themselves in the foot, repeatedly. They made an overly broad request for data (essentially the entire VSD database). They requested the funding for the analysis in advance. Their expert witness’ track record was lacking. The proposed a search of FDA documents without providing a good reason why this was important for their case.

They went fishing and they got skunked.


By Matt Carey

Andrew Wakefield and Vaccine Safety

30 Apr

All about Andy

Even if everything Andrew Wakefield says about the safety of MMR were true it would still not advance the claim that it causes autism.

Having failed, over the past 15 years, to come up with evidence for his theory of a link between the MMR vaccine and autism (or even for his original claim of a link between measles virus and inflammatory bowel disease), Andrew Wakefield has resorted to making wider (and wilder) claims about the safety of MMR. Moving away from his former field of academic gastroenterology, Wakefield has embarked upon studies in paediatrics, vaccinology and public health. These are spheres in which he has neither expertise nor experience – and it shows. He has alleged that surveys associated with the introduction of MMR in Britain 25 years ago were methodologically inadequate, too small in scale, too short in duration or otherwise unsatisfactory. He claims that evidence of adverse reactions was suppressed, conflicts of interests among public health authorities were undisclosed and whistleblowers were silenced. Critics of the programme are alleged to have had their phones tapped, their homes burgled and to have been persecuted by the medical/political/pharmaceutical establishment. Most recently Wakefield has claimed that procedures for dealing with potential anaphylactic reactions within the MMR programme were inadequate.

I do not intend to revisit here the case against Wakefield’s claims about the safety of MMR which is presented in my book MMR and Autism: What Parents Need To Know. (1)On the red-herring of anaphylaxis, including a report of a curiously high incidence in association with separate measles vaccine in a private clinic, see these studies. (2,3,4) Here I would like to pose three questions that arise for anybody who accepts his allegations about the introduction of MMR in Britain after 1988.

1. What about the other countries in which MMR has been introduced?

Surely, if there are significant dangers associated with MMR – which were supposedly ignored in Britain – these would have been noticed in the 60 countries in which the vaccine has been introduced (both before and after 1988)? In fact, the excellent safety record of MMR – 500 million doses and counting – is a major reason for its successful worldwide use. Several countries in Europe and the Americas have been able to declare measles eradicated, apparently without experiencing the sort of adverse effects Wakefield and anti-vaccine campaigners have attributed to MMR in Britain. Indeed, even if public health authorities had succeeded in suppressing reports of adverse reactions to MMR 20 or 25 years ago, these must surely have become apparent by now?

2. Did MMR not dramatically reduce the incidence of mumps meningitis (even if one strain of the vaccine caused a small number of cases)?\

One of the recurring complaints of Wakefield and his supporters is that in the early years of the programme, British vaccine authorities used a brand of MMR including a strain of the mumps virus (Urabe), which was associated with a small number of cases of meningitis, a recognised complication of mumps. In 1992 this was replaced by another strain (Jeryl Lynn) which does not cause this problem. However, if the Jeryl Lynn strain had not been available, it would still have been preferable to carry on with the MMR including Urabe because the benefit of dramatically reducing the incidence of mumps (in the 1980s the commonest cause of viral meningitis) far exceeded the risk of vaccine-related meningitis. A judgement of this sort was made for many years in relation to the use of the oral polio vaccine which caused a handful of cases of polio every year (until it was finally replaced by the currently used injected polio vaccine, which does not carry this risk).

3. Even if MMR is shown to be unsafe in general, how does this support the specific claim that it causes autism?

Wakefield’s strategy appears to be that, if the safety of MMR in general can be put in doubt, the credibility of any particular risk attributed to the vaccine is raised. In reality, this strategy merely draws attention to his failure – over 15 years – to produce any evidence in support of the MMR-autism theory.

Given his failure to substantiate the MMR-autism hypothesis, Wakefield’s persistence in his campaign against MMR has acquired an increasingly irrational character, confirmed by his bizarre video diatribes against leading figures associated with the MMR programme. He is still bitterly aggrieved that British authorities did not accede to his preposterous demand (issued at the notorious 1998 press conference to launch his now retracted Lancet paper) for the replacement of MMR with separate vaccines given 12 months apart. Not a single member of his own team supported this proposal, which was not included in the paper and was in no way supported by it. Such a scheme has never been implemented in any country. Wakefield is further incensed that vaccine authorities insisted on upholding the integrity of the MMR programme in face of his proposal.

If Wakefield had any experience of child health he might have a better understanding of the importance of the organisation of a vaccine programme. Before the introduction of MMR, a measles vaccine had been available in Britain for 20 years, but its administration was unsystematic, uptake remained unsatisfactory and outbreaks continued to occur. In a similar way, rubella vaccine had been given to schoolgirls with considerable success, but occasional cases of congenital rubella were still reported. Mumps vaccine had never been made widely available and cases were seen commonly in surgeries and hospitals. The introduction of the new combined MMR vaccine – within a comprehensive administrative framework, inviting parents into clinics when their children’s jabs were due, properly recording them – brought within a few years a dramatic improvement in children’s health.

If Wakefield had seen, as I have, children suffering from measles, or if he had admitted children to hospital, as I have, with mumps meningitis, or if he had cared for adults with the multiple handicaps of the congenital rubella syndrome, as I have, he might not be so casually disparaging of the MMR programme. But, unfortunately, for Wakefield it is all about Andy and his petty personal grudges against the vaccine authorities who have quite properly put children’s health before his combination of bad science and egotism.

Now, what about that debate?

REFERENCES
1. Michael Fitzpatrick, MMR and Autism: What Parents Need To Know, Routledge 2004; p 128-133.
2. Lakshman R, Finn A (2000). MMR vaccine and allergy, Arch Dis Child 2000;82:93-95 doi:10.1136/adc.82.2.93.
3. Erlewyn-Lajeunesse M, Manek R, Lingam R, Finn A, Emond A (2008). Anaphylaxis following single component measles and rubella immunization, Arch Dis Child 2008; 93:974-975. doi:10.1136/adc.2008.138289;
4. Erlewyn-Lajeunesse M, Hunt LP, Heath PT, FinnA (2011). Anaphylaxis as an adverse event following immunisation in the UK and Ireland, Arch Dis Child 2011; doi:10.1136/archdischild-2011-301163.


By Michael Fitzpatrick

Mike Fitzpatrick calls Andrew Wakefield’s bluff. Wakefield moves goalposts

17 Apr

As recently noted here at Left Brain/Right Brain, Andrew Wakefield asked to debate someone about the MMR vaccine. In specific, he wrote:

The more light that shone on this subject by way of informed, balanced debate, the better. I am offering to debate any serious challenger on MMR vaccine safety and the role of MMR in autism, live, in public, and televised.

Dr Michael Fitzpatrick wrote in Andrew Wakefield: return of the wicked witch, Wakefield’s MMR-autism nonsense had a baleful influence on public health, but he doesn’t bear sole responsibility for recent measles outbreaks. that he would take Mr. Wakefield’s challenge.

As both a GP and a parent of an autistic son who had followed the destructive consequences of Wakefield’s campaign over the past 15 years, I for one would welcome the opportunity to challenge his baleful influence. Are you ready for a debate now, Andrew Wakefield?

As you might surmise from the wording above, Dr. Fitzpatrick has previously attempted to debate Mr. Wakefield and offered to engage in a full debate:

Wakefield has subsequently restricted his public appearances to conferences of sympathetic parents, anti-vaccination activists and promoters of quack autism therapies. When I asked him a question from the floor at one such conference in Bournemouth in February 2007, he simply refused to answer, deferring to another platform speaker. When I offered to debate with him at a follow-up conference in March 2009, the organisers refused.

How has Mr. Wakefield responded?

What I’m suggesting is a formal scientific debate in public in front of an audience that is televised. And specifically Dr David Salisbury I would like to debate you because I believe you are at the heart of this matter. I believe the decisions taken by you and by your committee, the Joint Committee on Vaccination and Immunisation, lie at the heart of this matter.

Yes, having had his bluff called, Andrew Wakefield moves the goalposts. He won’t take on Mike Fitzpatrick. He won’t take on “any serious challenger”. Only Dr. David Salisbury.

In addition to lacking integrity, Mr. Wakefield now shows that he lacks courage.

Mike Fitzpatrick is a physician. He is an autism parent. He has written two books on autism: MMR and Autism: What Parents Need to Know and Defeating Autism: A Damaging Delusion. Hard to find a more “serious challenger”.

Hundreds of children are suffering from measles in the U.K.. This isn’t the time for empty offers of debate. This isn’t the time for publicity stunts. It’s time to own your mistakes and do what you can to fix the problems you helped create. Do you have that courage, Andrew Wakefield?


By Matt Carey