Omnibus Autism Proceeding closing statements: thimerosal

7 Jun

While the vaccine hearing is not entirely concluded, apparently the portion where the public can listen in by phone, or download the audio, is over. There will be a little more testimony in July from some experts for the government who couldn’t make it in May, and the petitioners will probably have some of their experts back to try to rebut what those experts have to say.

For this blog entry I have transcribed the of the end of Mr. Powers’ closing argument for the parents’ lawyers (the Petitioners Steering Committee, aka PSC) and all of Mr. Matanoski’s closing argument made on May 30th, Day 15 (the relevant audio clip is found here.) My take on Mr. Powers closing remarks summing up the case the PSC had made for the mercury parents’ side was that he spent perhaps most of it whining about how mean the Dept. of Justice lawyers were (!) and explaining how rules of discovery are applied in civil court (which is apart from how discovery is handled in vaccine court.) I don’t remember him making any big points on how his experts were right, but maybe I missed them.

Where my transcription begins, Mr. Powers had just been explaining that they expected more science to come in that would be supporting their side and that they’d be sending it to the Special Masters and to the DoJ lawyers hot off the press, apparently. Considering the kind of stuff that the PSC has presented at the last minute previously(several times) I wouldn’t think that what they see as being in the pipeline would have any weight to it. What’s bizarre, in my opinion, is that the PSC has been saying that the science that supports their position was being finished up and would be “in” any minute now, for about the past 4 or 5 years.

Mr. Powers: … The petitioners will do everything that we can to bring that information to the Special Masters, to share it with the respondent, but ultimately with the idea that litigation strategy in this program is really not what should be driving the consideration of the science but ultimately,again the unique position of the respondent here reflecting the responsible of the mission to keep up to date consider the science, protect public health, consider the science and and apply it in a way that’s gunna provide the best information to the three of you in deciding the general issues and the specific issues in all of these cases. Thank you.

Special Master Campbell-Smith (?): Mr. Matanoski.

Mr. Matanoski: Thank you ma’am. In putting together my closing remarks, though the time that we have is brief, I would feel it would be tremendously an error on my part not to acknowledge the families that were involved here, Mead and King family. probably the most poignant moments in this trial was hearing the … testimony of Mylinda King and George Mead discussing William and Jordan. We thank them for their participation. Certainly our hearts go out to them and to all the families that have autistic children. We may be litigating one side of this issue but we certainly have tremendous respect and admiration for all of them.

You have a threshold matter before you that’s a scientific matter, however, that you must address.
And obviously a scientific question necessarily turns on scientific evidence and there are certain legal standards that must be applied in this courtroom and every courtroom to how you handle scientific evidence, indeed what can even be considered reliable scientific evidence. The supreme court has spoken: it’s evidence that must be tested, subject to publication and peer review. It’s evidence that has general acceptance in the scientific community.

On the PSC side of the ledger of the evidence you have not heard that yet, you’ve heard speculation– pure and simple.

What you’ve heard in terms of comments from Mr. Powers this morning suggests that that evidence as far as the petitioners are concerned, the PSC is concerned, is still not available. He talks about the dynamics of science, and ongoing studies, which in some ways may imply a lack of evidence, scientific evidence that is available to the PSC, at this point, to prevail.

Now the PSC’s case started with a curious approach they put on evidence, or put on testimony, that was designed to undermine evidence against their claim. That was the testimony of Dr. Greenland, but Dr. Greenland’s testimony and his whole postulate depended on a supposition. The supposition was that the petitioners would prove to you a case that their mechanism applied to clearly regressive cases only.

Now you’ve heard from Dr. Deth and his hypothesis, who said that it did not apply only to clearly regressive cases.

You heard this morning from Kinsbourne who said that he hasn’t even looked to see if his hypothesis would have any application to non-regressive cases. So he can’t even address whether his hypothesis is only limited to clearly regressive cases.

All of the abundant epidemiological evidence that has addressed the precise matter that is whether thimerosal containing vaccines can cause autism or are associated with autism is back on the table. It never was off. Dr. Greenland’s supposition is in error.

If you follow the mechanisms proposed by the PSC here to their logical conclusions they fail to show that thimerosal containing vaccines are the cause, They propose that inorganic mercury is the causative agent. Inorganic mercury is not specific to childhood vaccines, it’s in what we eat, it’s in the air we breathe. It may be, if we have poor dental health, it may be in the fillings in our mouth.
They fail to specify how much inorganic mercury is necessary to cause autism
their experts consistently refused to say, in fact when they did say they essentially said, any amount.
They’ve pushed the threshold down so that any exposure to inorganic mercury could be a potential cause for autism.
They’ve described causal mechanisms that are so general that they apply to virtually every disease and to every case of autism.

Oxidative stress is seen in conjunction with almost every disease. You even see it after trotting or jogging you even get it after you bang your thumb … hammering in a nail.

Neuroinflammation is seen in a variety of neurological diseases including Alzheimer’s and Parkinson’s disease for example.

And in the Vargas study every single autistic patient in that study had neuroinflammation: regressive, non-regressive, young and old alike. These are nonspecific causal mechanisms that are proposed to you. In the end you could just as easily conclude that a tuna sandwich or a dental filling could cause autism, as a childhood vaccine. And to flip it around you could just as easily consider that an 80 year old man who received a flu vaccine would get Alzheimers from it.

Mr. Powers commented about uh what I describe I guess is, or his description, of a smear campaign or heavy handed treatment of the petitioners experts. You take the witnesses as they come. Now perhaps there was an explanation and you’ve heard it for the events that transpired with his departure from the University of Toronto. But again you take the experts as they come. When Dr Deth and said that he is willing to come before you say that his hypothesis you should rely on it to make a finding of this import, even though he’s not willing to say to the scientific community that it’s acceptable without further testing, I think that bears consideration.

Dr. Kinsbourne when he sat in the witness chair, he put his credibility on the line. He’s coming before you saying, “Rely on me. Believe me, Trust me as an impartial scientist.” Because that’s how he’s coming to testify to you. You deserve to know whether he gets that kind of trust.
You know, he’s known to you, you’ve seen him here many times. If you go back and look at the cases that are currently active in front of the Special Masters’ office you’ll find that he’s retained or offered an expert opinion saying vaccines cause harm in over 30 cases. In the past year he’s authored one article in a medical journal. I think that tells you whether he’s coming to you as a witness who spends his time in the courtroom or as a, an impartial scientific expert witness who is adding some value to what your deliberations are from the point of view of reliable science.

And good science and reliable science comes from testing, publication, critical review, validation, verification of results. It’s performed by those who work in the fields, apply scientific method to their research.

The supreme court tells us that it can’t be untested hypotheses, as Dr. Deth has essentially described his causal mechanism.

And good science won’t be first revealed in the courtroom as Dr. Kinsbourne’s hypothesis is. But it’s going to see the light of day through critical discussions of the research among the scientists themselves.

It’s not reliable science, indeed it’s not any kind of science, to sit at your computer to take your last litigation driven report, run “find and replace”; find “measles vaccine” and replace it with “thimerosal containing vaccine.” A litigation driven contrivance such as that has no place in the courtroom. The supreme court has mandated that.

Now when the trial began, Mr. Powers described thimerosal containing vaccines as a relic of history.
Perhaps that was a reference to allowing some leeway, in what your evidentiary standards are, would be to (provide) some grading on the curve as to the science you would accept. In fact they’ve done to make this anything but a relic of history. The day that they said that they held a press conference to discuss the case. Their experts are here are telling you that trace amounts of mercury that are in vaccines, that the flu vaccine could be enough to cause autism.

Whether we like it or not, this issue before you is of great importance the issue before you, great attention has been drawn to it.
Just last week TIME magazine had vaccines and the safety of vaccines as a cover issue.
Many eyes are going to be turned to this court to see how you handle the scientific evidence before you and it’s not just the parents in front of you who have brought claims,
it’s for parents who haven’t brought claims who have autistic children and who are wondering if by getting them vaccinated they are somehow responsible for that condition,
it’s for scientists who work in relevant fields,
it’s from those who treat autism,
and it’s going to be viewed by parents who are wondering whether they should get their children vaccinated or not.

I’m going to be blunt at this very late hour and having brief remarks. Are you going to decide that question on the say-so of Dr. Deth and Dr. Kinsbourne, or you going to decide that question on the evidence given to you by witnesses like Dr. Catherine Lord, Dr. Eric Fombonne and professor Sir Michael Rutter.

Are you going to look at and consider the fact that every reputable … independent medical organization that has considered this issue the Institute of Medicine, the American Academy of Pediatrics, the European Medicine Association, the World Health Organization, have all concluded that thimerosal containing vaccines do not cause autism.

Are you also going to consider that every court that has had to consider this claim before it, before you have considered it, in fact, has found that the claim is so lacking in merit that it should not even be presented to a jury.

Reliable scientific evidence at this point is all on one side of the ledger. Vaccines don’t cause autism. Thank you.

The audio clip:
http://static.boomp3.com/player.swf?song=bcjjum1boomp3.com

Mitochondria and autism:time to recalibrate

6 Jun

We all have heard a lot about mitochondria and autism in the past few months.    This message has been dominated for the most part by David Kirby.  Someone got some of the confidential court documents to him, and he leaked one to the public, and discussed another in a news story. 

So, it seems like we are stuck with the idea that “there are a lot more Hannah Polings out there” and “20% of autistics might have mitochondrial disorders” and “1 in 50” (or some such number) “are at risk.” Since the Polings aren’t releasing their information, the government isn’t releasing it’s information, the reasearchers can’t talk and haven’t submitted their paper yet,  we are sort of stuck.  There just isn’t any other specific information out there on people with mitochondria issues and autism.

Is this really the case?

As it turns out, no, this is not the case.  There are a number of descriptions of people with mitochondrial disorders and autism.   And, guess what, they present a different story than we have been fed so far.

We all know about the case study on Hannah Poling.    But, in terms of how many kids (and, presumably, adults) have mitochondrial disorders come from Dr. Oliveira’s group in Portugal.  People tend to use the estimate for autism+mitochondrial disorders from his work (about 4%), but they don’t look closely enough to see that he actually describes a few details on 11 individuals.  In addition,  Dr. DiMauro’s group discussed five individuals in their paper. Gargus of UCI discussed three brothers as well.  Most recently,  Tsao and Mendell discussed two individuals in this paper.

Total it up, and we have information on 22 individuals to consider when we ask the question, “what does autism look like in mitochondrial energy challenged individuals”?

Another way to put it, does mitochondria+autism=Hannah Poling?  Did they all undergo regression ?  Of those that regress, did they all appear normal before regression?   I want to know, because this is what we are being told: autism with mitochondrial disorders/dysfunction result in kids who look normal and then regress.

We get this from David Kirby, who makes statements like:

“That would mean some 190,000 Americans with mito issues who, after normal births and development, suddenly stopped talking and regressed into autism following some kind of childhood fever.”

He seems to be getting this from statements in Hannah Poling’s Rule 4c reports and discussions with the researcher who made them.  Statements (from the Rule 4c report) that describe Hannah Poling as having:

“an etiologically unexplained metabolic disorder that appear[ed] to be a common cause of developmental regression.” He continued to note that children with biochemical profiles similar to [Hannah Poling] develop normally until sometime between the first and second year of life when their metabolic pattern becomes apparent, at which time they developmentally regress.”

David Kirby also uses comments from the researcher stating that he is working on a study of 30 kids similar to Hannah Poling who all underwent regression.  In that as yet submitted study, only Hannah Poling is considered a definite case of vaccine injury.  There is another child whose regression did occur within 7 days of a vaccination.  Somehow, this “possible” case of vaccine injury morphs into a “definite” in the later sections of David Kirby’s blog piece.   I also find it odd that David Kirby claims that people are already preparing to challenge the idea that only 2 of the 30 are possibles.  This, even before the paper is submitted!

Given all the qeustions that are raised, I’d like to know more about what kids with mitochondrial disorders and autism look like.  Don’t you?

The Kids

Let’s first take a look at the DiMauro group paper.  DiMauro’s group discusses 5 kids.  Of those patient 5 had a fever at 14months and showed regression. “At 14 months of age, she had a viral illness with high fever, encephalopathy, regression of previous acquired skills, and significant acidosis. She gradually recovered and continued developing slowly.” Sound like Hannah Poling?  Consider however that she showed developmental delay by 6 months (along with a number of other problems). She did not appear “normal” as Hannah Poling is described before her regression.  Another big difference: Patient 5 had clear mitochondrial disorder.  She has 70% mtDNA depletion in a biopsy sample.  While she is described as “gradually recovered”, she never spoke and is significantly challenged in many areas.

And that is the closest example we get to Hannah Poling in these studies

Patient 3 in the DiMauro study is described as having “…neurologic deterioration during intercurrent illnesses and recovered gradually over several weeks.”  However, he doesn’t fit the “Hannah Poling” mold as he had clear impariments since early infancy.  

The other three patients in the DiMauro study did not have any mention of regression.   There is an Aspie, a PDD kid and a kid with excellent visual/spacial skills but delayed speech and language.

OK, so the DiMauro study doesn’t have “Hannah Polings”.  What about Oliveira?  He describes 11 kids with possible, probable or definite mitochondrial resperatory chain (MRC) disorder.   Of these 11, only 1 is noted as having an “autistic regression”.  (No, it is not noted if this was coincident with vaccination).

One interesting fact in the Oliveira paper: they were studying older kids.  All the kids (with mitochondrial disorder or not) were in the 11-14 year old ages.  Why do I find this interesting?  Because I read a lot of people postulate on the web that Hannah Poling no longer shows “biomarkers” for mitochondrial dysfunction and, thus, thet disappear with age.   People are trying to say, essentially, “A lot of older kids were probably ‘Hannah Polings’ but their tests won’t show mito dysfunction because they are too old” as in, “they were vaccine injured even though we have no proof.”   Since these same people tend to rely on Oliveira’s data to estimate the prevalence of mitochondrial disorders in autism, it seems a bit of a stretch.

In our search for more “Hannah Polings”, we seem to be striking out.  But, there are still two more papers to consider.

Tsao and Mandell describe two patients.  Both were globally delayed from “the early months of life”.  Neither child developed expressive or receptive language, and one never sat up or walked.  Again, these were not “apparantly normal” kids who went through regressions.

Gargus and Imtiaz describe three children, all siblings, who have “a weak mitochondrial defect and a recognized 15q inverted duplication” (we’ll discuss some genetics in another post). The older had poor eye contact and echolalia from early infancy. He developed stimming behavior at age 3 and, sadly, died after a one-day illness at age 5.

OK, sidetrack here.  The authors describe this as  “At age 5, after a 1-day illness, he died suddenly with respiratory arrest and shock, characteristic lethal presentation of a carnitine-deficient fatty acid oxidation”.  In other words, illness can be fatal to the energy challenged.  This is precisely why doctors recommend vaccinating people with mitochondrial disorders, or at least, their close family members.

Back to the paper, the younger twin bothers (monozygotic, monochorionic) hit their developmental milestones in their first year. However, they showed language delay and limited eye contact. One had a near-SIDS event at 4 months, and was the more “severely affected” of the two.

So, the kids in the Gargus study aren’t “Hannah Polings” either as they didn’t regress and showed signs of being “not normal” from early in life.  Now, I suspect people will latch on to the “near SIDS event” at 4 months and suggest that is connected to 4 month vaccines.  No mention of vaccination is made in the paper.

Discussion

There is a huge variation in the presentations of the individuals in the above studies, leaving one to ask, “what can we take away from all of this?”.   One answer is that the huge variation is precisely one of the take-away points: if you think that autism is a spectrum disorder, you shouldn’t be surprised that the mitochondrial energy challenged present as broad or broader of a spectrum.

Second, everyone keeps looking to mitochondria+autism=”must be regressive”.  It just isn’t so.  The “30 child paper” will apparantly concentrate on regressive kids, but the other papers already published do not.

The majority of the individuals described in the DiMauro, Oliveira, Gargus, and Tsao papers show no regression. Of those who do regress, they were not “developing normally” before the regression.

The Bottom Line

The bottom line: Hannah Poling does not appear to be a good representative of the kids with mitochondria issues and autism.   The individuals discussed in papers other than the Hannah Poling case study are very different from her.  Even the other kids in the paper that will concentrate on regressive autism are mostly not like her in one major aspect: they didn’t suffer vaccine injury.

Does that mean that we can’t and shouldn’t learn from Hannah Poling?  Absolutely not.  But, we need to have experts look at and understand all the kids with mitochondrial disorders and autism.  We need this to be a scientific investigation to arrive at real answers, not a series of public relations events to shape the public view.

Green our vaccines – the outreach effort

5 Jun

Whilst Team McCarrey were busy wowing the ‘hundreds‘ of people at the Green our vaccines rally yesterday, one face was notably absent from proceedings.

David Kirby was in good old Blighty, enjoying our lovely summer drizzle and grey skies.

Mr. Kirby will speak about recent legal, political and scientific developments in the United States in the ongoing vaccine-autism controversy. The briefing is open to Peers in the House of Lords, Members of Parliament, their Staff, members of the Media, and Invited Guests. It is sponsored by His Lordship Robin Hodgson, Baron Hodgson of Astley Abbotts, Shropshire.

Now, I’ll come clean. David and I had tried to arrange a meet up so we could rage amicably at each other over a huge quantity of alcohol. Unfortunately, as it so often does, life intervened and I had to cancel.

This meant I also couldn’t attend his talks.

However, I could do something. I could ask my MP to formally protest David’s presence in Parliament to brief Lords, Peers and MP’s. Truth be told I was pretty annoyed by this – why is it so easy for a journalist to swan in and command the attention of the government and opposition and yet untold hundreds of autistic people and their families never really get a look in.

My MP was agreeable and did a bit of reading up on the issues David would be talking about in his briefing so he could debate if needed as well as protesting on my behalf.

Turns out that this wasn’t strictly necessary. When my MP reported back to me this morning he told me that David was briefing an audience of one (1) MP (mine, who only attended as I asked him to) and four Lords (one of whom was David’s sponsor I would guess and his cronies). No press attended, aside from a few people/press my MP described as “….obscure journalists who have become consumed by this issue.” so I’m thinking probably oneclickgroup, JABS and various other marginal nobodies.

So, not the most auspicious of presentations. As it turns out though, something of a blessing in disguise – my MP seems quite keen on me getting the chance to present myself which would be interesting.

Unstrange Minds – UK release

5 Jun

I wrote about Unstrange Minds in 2006 when it was first published in the US only.

Cover of Unstrange Minds

It gives me huge pleasure to note that Icon Books have now released the UK version (also available on Amazon UK.

I loved Unstrange Minds unreservedly. Professor Grinker sent me a galley copy to read before it was published and I read it in a couple of weeks worth of train journeys to and from my workplace. So absorbed was I that I very nearly missed my stop more than once.

Its a book about two things. Firstly it is a Fathers paen to his autistic daughter. The love and respect he has for his daughter permeates every single page. It is clear that he finds his daughter fascinating and wonderful. Through the pages, we do too.

Secondly, it is a book about the ‘autism epidemic’ or rather the lack thereof.

The shift in how we view autism….is part of a broader set of shifts taking place in society.

Grinker goes on to take the reader through the often fascinating history of autism as a diagnostic label (Kanner is pronounced ‘connor’ – who knew??) to illustrate his theory of the apparent rise in autism prevalence being intrinsically linked to these cultural changes such as the growth in child psychology as an area of practice, the decline of psychoanalysis, the rise of advocacy organisations, greater public awareness to educational needs and change in pubic policies:

Doctors now have a more heightened awareness of autism and are diagnosing it with more frequency, and public schools….which first started using the category of autism during the 1991 – 1992 school year are reporting it more often….Epidemiologists are also counting it better.

One of the most fascinating parts of the book for me was Grinker’s exploration of autism in non-Westernised cultures such as South Africa and Korea. In some ways it was like reading about how autism was viewed here 20 years ago.

When [Milal School] was being built in the mid-1990s, some of the wealthy residents of this quiet neighborhood south of the Kangnam River in Seoul picketed the site, cut the school’s phone lines, physically assaulted school administrators, and filed a lawsuit to halt construction, because they believed that the presence in the neighborhood of children with disabilities would lower property values. The school opened in 1997, but only with a compromise. It was required to alter its architecture so that the children were completely hidden from public view. Some of the protestors were brutally honest. They said they didn’t want their children to see or meet a child with autism.

That seems (and is) outrageous to us but 20 years ago I can easily imagine this happening in the West. One only has to look at the recent experiences of Alex Barton to see how quickly the West can regress to barbarism.

I can’t recommend this book highly enough. Go buy it now.

Green Our Vaccines – the reality

4 Jun

Green our vaccines at 09:15

Contrary to the press reports and the frenzied claims of Jenny McCarthy of rally participants numbering between 8 to 10,000 it seems according to police who accompanied the rally that there were between 500 – 1,000 participants. I cannot source that quote, for which I am sorry. I hope to be able to source it very soon but where I got it from is not available just yet.

The above photo was taken at 09:15. The below photo was taken at the end of the rally.

Green our vaccines crowd

It certainly doesn’t seem to be a very imposing crowd.

People who watched the start of the rally via webcams (my ISP decided to go down today of all days) say that a very loose straggly crowd walking very slowly took about 20 mins to pass a fixed point.

Someone else attending the rally said (again, in confidence):

There were about 500 people at the rally today, about half of whom were children. The press conference lasted for about an hour and a half. The speakers were, in order: Dr. Jay Gordon, Boyd Haley, Dr. Jerry Kartzinel, RFK Jr., Jim Carrey and Jenny McCarthy. RFK Jr. spoke at length about the science disproving a link between vaccines and autism. He said that all that science is paid for by the pharmaceutical industry and that top vaccine advocates such as Renee Jenkins and Paul Offit are in the pockets of these companies.

Other notables in the crowd included JB Handley, Scott and Laura Bono, the Hazlehursts and Jim Moody.

Update: seems the media are cottoning on to the low turnout. As noted by Catherina in the comments, News Channel 10 say:

Hundreds rally against child vaccinations

Seems like the saw through the pretence this wasn’t an anti-vaccine rally too. Well done them.

Apparently, the stupidest quote of the day comes from Jim Carrey:

If fire engines were running over people on the way to a fire, we wouldn’t say there shouldn’t be fire engines. We would ask the fire engines to slow down. That’s our message to the CDC – that we need to slow down the vaccination schedule.

There you have it, fire engines should slow down on their way to a fire. Jim Carrey’s other invaluable contribution was apparently taunting ‘big pharma’ for not finding a cure for autism whilst at the same time:

finding cures for “that great scourge restless legs syndrome, also known as lazy ass disease.”

Thats the same ‘lazy ass syndrome‘ that is associated with pregnancy, varicose vein or venous reflux, folate deficiency, sleep apnea, uremia, diabetes, thyroid disease, peripheral neuropathy, Parkinson’s disease and certain auto-immune disorders such as Sjögren’s syndrome, celiac disease, and rheumatoid arthritis.

Oh and ADHD of course. The same ADHD that is included on the front page blurb of Groups Jenny McCarthy is on the board of.

Update II: If anyone would like to pass on Carrey’s kind words to the RLS community, you can do that at their website.

Later on Carrey apparently asked the rhetorical question ‘how stupid do you think we are‘. Heh.

Here is Jim Carrey’s quotes in the full context of his speech, courtesy of Autism News Beat – once again, venturing into the heart of woo-land.

Green Our Vaccines Coverage Elsewhere

Me
Kristina
PalMD
Kristina (again)
Ginny Hughes
Mike Stanton
Orac
Liz Ditz
Orac (again)
and again!
and again!!!
Kristina (once more)
Stifled Mind
Sharon
Seeing Beauty
S.L.
S.L. (again)
Mike Stanton (again)
Steve
Clotted Cognition

In honor of the “Green our Vaccines” rally: facts from the Omnibus Autism hearing

4 Jun

The lawyers for the parents in the Omnibus Autism hearing (thimerosal portion) have been claiming that one cause of “clearly regressive” autism is thimerosal at vaccine doses, even the dose of thimerosal in one vaccine. One of their supports for this odd claim is that whatever DAN! docs do to help their patients deal with “mercury toxicity” makes the kids less autistic or healthier or something. It’s all pretty vague. Dr. Mumper spoke confidently of what chelation had done for autistic kids and the boys under discussion in this portion of the trial were chelated multiple times in spite of never having shown any elevated mercury levels in their urine tests (even their chelated urine mercury levels were what would be expected for a typical person being chelated).

So what about this claim? If you do any old treatment and you think it makes the patient better in some perhaps very vague, undefined way, is this evidence of anything? Eric Fombonne, expert in autism epidemiology and clinician who works with autistic children and adults says, “Mais non.” Well, actually he said the following

Ms. Ricciardella (?): Are there standards that are used by the medical and scientific community before a treatment is recommended?

Dr. Fombonne: Yes, there are different kinds of standards to evaluate the efficacy of interventions the rule is to rely on the evidence that is the most robust that stems from a randomized clinical trial which are usually double blind placebo controlled for this method there is no study which has been relying on this method for the practices and treatment that have been discussed this morning [by Dr. Mumper]

Ms. Ricciardella: Do you have experience with randomized clinical trials?

Dr. Fombonne: Yes actually, I do. I started my research career and did my thesis my first two publications, I think, have to with randomized clinical trials.
And I am currently, we have tested the efficacy in a randomized clinical trial of a treatment which is not which is not biomedical which is a language based intervention to improve communication skills in young children with autism.
And we did a randomized clinical trial. It’s a 12 weeks treatment and we allocated at random parents and their children to a group where they were immediately treated with this intervention and there was a waiting list for the control group and 36 families in each group so it’s quite powerful in terms of it’s statistical power.
I just wanted to share with you my, my, our findings that it’s an intervention that everybody likes, eh and when we did the trial we had all the impression that it was actually achieving some positive results. The parents were happy and were convinced that the methods were showing some efficacy, and we did too.
But as we did the study well we didn’t analyze the data before the data were finally collected and when we broke the blind and looked at the results and there is no difference between the two groups–which is breaking my heart, in some ways–but this also shows that our experience as clinicians and as parents can be misleading.
And I think the field of autism has been replete over the last 30, 40 years of treatments and interventions that practitioners engage in when the parents apply to their children. And the story has been that when you take these practices and put them to rigorous empirical test, that of a randomized clinical trial, usually the story is much more disappointing. And a case in point is the secretin trial.

I don’t know if it was Ms. Ricciardella asking the questions, but that’s my guess. After this portion he explained about how many parents and clinicians from all over the world had been so excited about secretin when it became popular, and how for about 5 years clinicians used it and had some great stories to support it’s use. But when the double blind, placebo controlled studies were completed it turned out to be no more effective than placebo. And if someone tells you that there were “responders” you can tell them that there were “responders” to the sterile-saline injections, too, so why not just go with those, since they are cheaper than secretin? Besides which there’s no reason to expect that secretin (much like sterile saline) ever would do anything for the symptoms of autism. Further, the Mead boy got one or two injections of it but the family didn’t continue with them, apparently they weren’t so great for that child. Perhaps they decided to go with worm eggs, maternal fecal implantation enemas or even Eskimo oil (possibly purchased from Dr. Green’s office) instead.

http://static.boomp3.com/player.swf?song=bjsb2fd<a style=”font-size: 9px; color: #ccc; letter-spacing: -1px; text-decoration: none” target=”_blank” href=”http://boomp3.com/listen/bjsb2fd/fombonne-randomized-control-trial”>boomp3.com</a&gt;

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Green Our Vaccines Eve – Dr Jeffrey Brent

3 Jun

On the eve of the ‘green our vaccines‘ rally, I thought it might be interesting to share a ten minute or so segment from the Autism Omnibus.

Giving evidence is Dr Jeffrey Brent:

Jeffrey Brent, M.D., Ph.D. is a sub-specialty board certified medical toxicologist. He is an active member of the medical school teaching faculty and is an attending physician on the clinical pharmacology/toxicology consultation service at the University Hospital. Currently he holds the rank of Clinical Professor of Medicine at the University of Colorado Denver. Dr. Brent has a long list of publications, virtually all related to clinical toxicology. He is senior editor of Critical Care Toxicology: The Diagnosis and Management of the Critically Poisoned Patient and serves as Editor-in-Chief of Toxicological Reviews, a major international state-of-the-art review journal devoted to human toxicology.

Dr. Brent is the former President of the American Academy of clinical Toxicology, the largest organization in the world devoted to this discipline. Currently he serves as a member of the Board of Directors of the American College of Medical Toxicology.

We pick up testimony around five and half hours into day 15. I’ve transcribed directly from the audio, so please forgive minor errors. Emphasis is Brent’s, inserts are marked [].

Q: Dr Mumper discussed today some key aspects of chelation therapy….as a medical toxicologist do you see any reason for the chelation to remove mercury from either Jordan King or William Mead in these cases?

Absolutely not….there is no test in medicine that is more valid for for assessing mercury toxicity than an unprovoked urine mercury concentration.

[For Jordan King and William Mead]…their unprovoked urine concentration is exactly in the normal range.

On the other hand, they have been chelated. And the justification for that chelation with regard to mercury comes from what you see in the right hand column where in both cases, 4 out of 5 provoked examples have been…uh…increase urine mercury. Well, you’re supposed to have increased urine mercury with provoked examples! Therefore there is absolutely no indication based here or anywhere else I saw in the medical records that suggest that there is any mercury effect in these children and therefore that was absolutely no reason to chelate them for any mercury related reason.

Q: Dr Mumper also testified today to seeing an increase in lead levels in children and that chelation may help with the adverse effects from lead. Is there any scientific or medical basis for that statement?

It is true that chelation therapy is the appropriate therapy for lead toxicity. However, the records do not reflect any lead toxicity in the case of either of the two children at issue here, Mead or King. Neither of them have had an elevated blood lead level and a blood lead level is the ‘gold standard’ test for lead toxicity. Because, contrary to testimony that was given earlier today [Dr Mumpers – KL], blood lead remains elevated and it will be elevated for years in children that have lead toxicity. It equilibrates with tissues and if there’s high tissue burden there will be high blood burden.

Q: So you disagree with Dr Mumper that the blood levels would only test for acute toxicity?

Thats absolutely wrong. So there was no indication therefore for treating these two children with a chelator for any lead effects.

Q: Is there any other accepted tests for lead toxicity, other than blood?

Blood is the ‘gold standard’ and there are no other accepted tests in medicine now that we can routinely get blood/lead levels.

Q: Was there anything about the levels you observed in the medical records [of either King or Mead – KL] post chelation that would cause you to think that these were extraordinarily high levels of excretion upon chelation?

No. You always expect to see levels in the urine bump post-chelation. It would happen to any one of us. There are no validated reference ranges post chelation, thats why they’re not used in medical practice – there is no valid way of using them and in fact if you look at these two children they had mild increases in urine/lead excretion as I recall but they were nothing different than what you would normally expect to see if you gave a chelator to them.

Q: And you’ve given chelators to a lot of children?

I’ve chelated a number of children.

A: There’s nothing here that would be out of the ordinary – from your experience – absent, even in the absence of a standard reference range.

Well, in truth we don’t (?) urine/leads because the ‘gold test’ is blood/lead so I haven’t looked at many urine/leads in children that I have chelated. So I can’t speak to that in my experience. But I have seen a number of patients now come to me because of these ‘doctor’s data‘ type of laboratories which are based on urines – chelated urines – and they always have high leads in their chelated urines and I tell them ‘well, lets just do the gold standard test, lets get a blood/lead level and so far, 100% of the time they’ve been normal.

Q: Are the post chelation mercury levels in either of these two boys in excess of what you would see…or in excess – I take it there’s no standard reference range…?

No standard reference range. You do tend to see small increases, they’ve had minor increases in their mercury excretion over the reference ranges over the non-provoked. It was certainly not very dramatic and certainly well within the range of what you would expect to see. For example if you look at the studies that I cited where they were studying chelators and they were looking at the effect of the chelator on urine/mercury excretion.

Now thats a valid time to do a post chelation mercury – if you want to study the effect of the chelator. And if you look at the normal controls in those studies, when they give them a chelator you do see some increase in the urine/mercury excretion and its a moderate increase and its really not very different than what we saw in these children [King and Mead – KL]

Q: Have you chelated children for lead or mercury toxicity?

Actually, both.

Q: And under what circumstance did you chelate for mercury toxicity?

I’ve had a number, but probably the most common and the most dramatic relates to the fact that I live in Colorado and in the Rocky Mountain area there people who are still panning for Gold…..[they extract the gold from ore using liquid mercury]…and to get rid of the mercury [afterwards] they will heat it. In their house. In their kitchen. When you volatilise mercury like that [it gets into the air]….and I’ve had a number of families have become profoundly mercury poisoned.

Q: So when Dr. Mumper said that she saw ‘mobilisation’ of heavy metals by chelation and then assumed that the chelation was beneficial – do you agree with that statement?

No, I think what you see is – you give a chelator, you look in the urine and there’s more than in the non-chelated reference range is for the metals in the urine and its what you would normally expect. It tells you nothing about mobilising stores of heavy metals.

Q: Dr Mumper also talked about supplements. And those supplement were referred to increase Glutathione to treat mercury toxicity. Do you agree that that therapy is warranted in cases?

Glutathione? No. Supplemental glutathione to treat mercury toxicity has no validity at all.

A quiet concession

3 Jun

While much has been made of a certain “concession” lately, it is worthwhile noting that the past month has seen a significant shift in the mindset of people pushing the autism “epidemic”.  In vaccine court it was the petitioners (plaintiffs) who opened with the admission that if there is any group of people with autism as a result of vaccine injury, the number would be so small as to be invisible to epidemiological studies.  (This didn’t stop them from closing with the latest Geier paper claiming that they can see the effect of thimerosal on the autism rates.)

But, this hasn’t been such a sudden shift.  As far back as last November, David Kirby noted:

“Finally, to all those who are going to post comments about the autism rates in California not coming down, following the removal of thimerosal from most vaccines: You are right. The most likely explanation is that thimerosal was not responsible for the autism epidemic.”

Baby steps….baby steps…

That’s my way of saying to those who would bravely rise up in their seats and proclaim, “stop the hate speech!” that the above is progress.  Sure, we still have to continue to endure the “epidemic” language for now.  Why he can’t just admit it in full, I am not sure.  Oddly, Mr Kirby doesn’t put forth a valid suggestion of what caused this “epidemic” of non-thimerosal-induced autism.  He does try a last-ditch effort to prop up the possibility of a thimerosal-induced-autism-epidemic with claims of immigration and pushing the goalposts back to 2011.  

But, I felt I had to acknowledge the fact that even Mr. Kirby is stating that the most likely answer is that it is not thimerosal before I go on.  Because, if one looks at the data just a little farther, one can find a likely answer for why there is a larger number of young people identified with autism than older people.  It isn’t news to us, and it isn’t news to Mr. Kirby and the rest: one likely reason is substitution.  I don’t know which they would try to avoid more, admitting that substitution is a big effect or an MMR jab, but let’s look a the data.  Just a peak. 

Consider  Autism as a function of age in the CDDS (California Department of Developmental Services) data.  Keep in mind, this is service data–i.e. this is a count of who is receiving services from the CDDS, not a count of who has autism in California.  This is not epidemiological grade data.   But, since it has been used so much, let’s move forward, keeping the caveats in mind. (click on the graph if you want to see it larger and more clear)

 

So, Autism count vs. age (data in black), what do we see?  Of course, we see a big peak in the younger ages.  This is the “Tidle Wave” or “Tsunami” or “Insert Other Hate Speech Term Here” that people like to use to make this scary.  But, as you have noticed, I have included the data for “Mild Mental Retardation” as well, in red.   What do we see there?  A dramatic dip in individuals identified with mild mental retardation in the younger ages.  Does anyone believe that something happened in California to reduce the number of people with intellectual disabilities?  If so, they aren’t very vocal about it.

If I were reading this for the first time, I would be suspicious of someone using only one mental retardation category.  Believe me, all mental retardation categories show much lower numbers in the younger age brackets.

This is a clear indication of “administrative substitution”.  [edit–see comments below] Joseph has done a lot of work on the CDDS data in the past and notes (below) that it is very difficult to draw conclusions about substitution from the publicly available data.  However, this is similar to what people have reported in the literature especially using special education data: people with autism have very likely been mislabeled, their autism label was “substituted” for a different label.  They weren’t “missed” as the favorite straw-man arguement would have it, but mis-labeled.

One person in the AutismOne media discussion (as reported by AutismNewsBeat) kept saying, “you ain’t seen nothin’ yet”, implying that the future is going to be very different from the past.  I have to agree, in the future, more adults with autism will be correctly identified.  They won’t be in hospitals with schizophrenia diagnoses, for example.  This will be a good thing.

Frankly, I’d like to see that change come sooner.  I’d like to see adults properly identified and appropriately served now.  We have to move away from baby steps and take bigger steps away from the “epidemic” and acknowledge that unidentified/misidentifed adults with autism are almost certainly out there.

Instead, we have people asking to “Green Our Vaccines“.  The “Green Our Vaccines” idea is a very cute way to mask the typical “epidemic” speech.  But it is the same old story: autism is vaccine injury and new.  Note that almost all of the groups sponsoring the “Green our Vaccines” rally are autism-related.   Sorry to divert to that topic somewhat, but I can’t help thinking that all that effort is being put into that rally by people who actively supress the existance of adults with autism.  I can’t help thinking that the present and the future would be better if they were acting to help everyone with autism, now.

(noted, this has been edited to more correctly reflect Joseph’s opinions on substitution.  Also, I missed another Green Our Vaccines link.)

How many autistic amish?

3 Jun

Yesterday, Joseph wrote a great post that looked at the prevalence of low functioning autism amongst the Amish and found it correlated strongly with non Amish sources.

Today, I want to look at the Amish through the lens of the ‘new’ prevalence that The Autism Omnibus Petitioners expert witness (for the families) Professor Sander Greenland testified to.

Now, as we all know, when Dan Olmsted first started writing about the Amish he claimed that both Amish children are never vaccinated and that the Amish either don’t have autism, or it is very rare.

It has been established since than that Omsted’s ‘reporting’ (which constituted asking a water cooler salesman) somehow missed the fact that the Amish actually do vaccinate in pretty high numbers.

Since that time, as the autism/vaccine hypothesis has become weaker and weaker we have seen a ‘silent switch’ amongst its proponents. Gone is the talk about ‘epidemic’ and hundred of thousands of children ‘poisoned’ to be replaced with talk such as:

My message is this: “We need more research to determine if a small subset of kids is genetically susceptible to lifelong neurological injury from something, or things, in our current vaccine program.

This has been echoed by Dan Olmsted. When Autism News Beat stepped into woo-land and visited Autism One, Dan Olmsted was quoted on camera as saying (this is a hurried transcription, apologies for slight errors):

…you try to listen for anything that’s useful in terms of information. Sometimes they tell you things that they don’t mean to in terms of how..uh..you know we learned things about the Amish from a blogger who tried to destroy my reporting about that because he basically talked to somebody who confirmed that there were very few cases of classic, regressive autism. So…it’s, you know…that’s the way it is…

So, we can see that the ‘silent shift’ is underway. Nobody acknowledges it but the media people amongst the autism/vaccine believers have switched their stance. Now we’re only looking for a small subset of regressive cases.

This was born out by the families expert witness Professor Greenland. He was asked to tackle the epidemiology for autism and stated that the number of kids made autistic by vaccines (assuming it had happened at all) was so small it could not be detected by epidemiology. He contended that it was in fact a subset of a subset he called ‘clearly regressive autism’.

Using his data, we could see that ‘clearly regressive autism’ accounts for 0.015% of a given population. According to Elizabethtown College the Amish population of the US is about 220,000.

So, in real terms we are looking for (0.015% of 220,000) 33 ‘clearly regressive autistic’ people.

According to Mark Blaxill, Olmsted has already found:

….less than 20 cases

Which is good news. It means he must already be over halfway in finding all the ‘clearly regressive autistic’ people he needs to in order to establish the Amish have the same rate of ‘clearly regressive autism’ as the rest of us.

The Amish Anomaly is an anomaly in one respect only – it is anomalous to keep silently shifting the numbers you want to find. Now that David Kirby, Dan Olmsted and the Autism Omnibus families are all on record as only looking for a ‘small subset’ isn’t it time that the Amish Anomaly was seen for what it is – anomalous.

Is the Prevalence of Low Functioning Autism Among the Amish Actually Lower Than Expected?

2 Jun

Note: For purposes of this post, the term ‘low functioning autism’ will refer to autism that co-occurs with mental retardation, or an IQ evaluated at less than 70. The validity of this accepted nomenclature is not the topic of this post.

–

Summary

The prevalence of low functioning autism among 2-9 year-old Amish children in Lancaster County, Pennsylvania, has a lower bound of 14.2 in 10,000. This is in line with the prevalence of reported autism with mental retardation in the California DDS system (at most 13.1 in 10,000) for the same age cohort. Additionally, it is not too far away from the prevalence of low functioning autism as ascertained by more methodologically rigorous epidemiological studies.

While no assertion can be made about the prevalence of high functioning autism among the Amish, the existence of an “Amish anomaly” is unsupported and appears increasingly unlikely.

Background

Dan Olmsted had written a well-known series of articles where he claimed (1) that Amish children are never vaccinated [source] or that only a small percentage are [source], and (2) that the Amish either don’t have autism or that autism is exceedingly rare among the Amish.

These claims were subsequently scrutinized by Prometheus, Autism News Beat and Lisa Jo Rudy. They investigated the matter and found that both claims are most likely mistaken. Autistic children do exist among the Amish, and the Amish do indeed vaccinate. The Amish of Illinois appear to vaccinate at a rate of 90%. Lisa Jo Rudy’s source provided a figure of 70% for the Amish in Lancaster County.

Apologetic responses by Dan Olmsted and Mark Blaxill (PartI and Part II) followed. The gist of the responses is that Dan Olmsted was not actually negligent in his reporting. Olmsted claims he did attempt to contact The Clinic For Special Children without much success. Additionally, Olmsted and Blaxill claim that while the Amish do vaccinate, they do so at a lower rate than that of surrounding communities, and therefore, they argue, the finding of an “Amish anomaly” is still relevant to the hypothesis that vaccination is an autism risk factor. (The responses also appear to indicate that those who scrutinize Olmsted’s reporting are “wackos” and say “some stupid things” — I’m guessing this was done to discourage further criticism).

Notwithstanding these responses, it is clear that the credibility of Olmsted’s reporting suffered a substantial blow. Take, for example, one of his most popular findings: That the few autistic children he came across happened to be ones who were vaccinated. This finding is rendered completely inconsequential by the mere fact that most Amish children are vaccinated at least once.

What I really want to address in this post, nevertheless, is the persistent claim that autism is exceedingly rare among the Amish, with a focus on low functioning autism.

Why low functioning?

Dan Olmsted was not likely looking for high functioning children, and even if he was, it is improbable he had the means to properly ascertain the prevalence of high functioning autism. The expertise required for such an endeavor is non-trivial. A methodology that consists of “asking around” is not likely to produce an accurate result.

Furthermore, Dr. Strauss of The Clinic For Special Children had told Autism News Beat that they do not screen for ASDs, nor do they see high functioning autistic children at their clinic.

Strauss says he doesn’t see “idiopathic autism” at the clinic – children with average or above average IQs who display autistic behavior. “My personal experience is we don’t see a lot of Amish children with idiopathic autism. It doesn’t mean they don’t exist, only that we aren’t seeing them at the clinic.”

Strauss says a child in the general population is more likely to have autism detected early and to receive a diagnosis than an Amish child. “An Amish child may not be referred to an MD or psychologist because the child is managed in the community, where they have special teachers,” he says. “We know autism when we see it, but we don’t go actively into the Amish community and screen for ASD.”

[source]

With all due respect to Dr. Strauss, I think a clarification is in order before we proceed. I believe he mixed up terminology in his statement to ANB. Idiopathic autism simply means that no cause has been determined for a particular child’s autism. There may or may not be mental retardation in idiopathic autism. The same is true of non-idiopathic autism.

It seems plausible that The Clinic For Special Children generally only sees autistic children who are low functioning. The important thing is that this is the case of the children in a study we will discuss shortly.

Another important clarification is that when I talk about low functioning autism I am not referring to Autistic Disorder vs. “full syndrome autism” vs. PDD-NOS vs. Asperger’s Syndrome. This appears to be a common point of confusion. There may or may not be mental retardation in Autistic Disorder. It is not a requirement in the diagnosis.

Minimum Prevalence Calculation

I am not going to count autistic children Dan Olmsted claims to have found. This is because it is unclear how many exactly he found where, given his reporting methodology, nor is it clear what the characteristics of the children are. Furthermore, I personally don’t consider his reporting reliable.

Thankfully, there is a peer-reviewed study we can use: Strauss et al. (2006). This is a study of Old Order Amish children from Lancaster County. In Table 1 of the paper we see they look at 9 patients, ages 2 to 9, 100% of whom have mental retardation, and 67% of whom have pervasive developmental delay or autism. In other words, this study identifies 6 low functioning autistic children. Let’s consider this the minimum number of autistic children, ages 2 to 9, among the Amish of Lancaster County. At this point we just don’t know if The Clinic For Special Children has come across other low functioning autistic children.

Also of note is that the children “had no distinguishing physical features, and growth trajectories were normal, although all patients had relatively large heads and diminished or absent deep-tendon reflexes.” This tells me that there was nothing noticeably odd about these autistic children that would lead someone to believe they are different to non-Amish autistic children. The fact that a genetic etiology was determined in these cases by top geneticists is of no consequence to a prevalence calculation in my view.

The Amish population of Lancaster County is about 25,200 (Raber’s 2004 Almanac via this web page). Their life expectancy is similar to that of the US general population. However, they have high population growth, with their population doubling every 20 years. This is similar to population doubling in India, which I will use as a reference to calculate the number of 2 to 9 year olds among the Pennsylvania Amish. According to the CIA World Factbook, 31.5% of the Indian population is 0 to 14 years of age. Extrapolating from this, I will estimate that 16.8% of the Lancaster County Amish are 2 to 9. In other words, there are 4,234 such children.

Since we know there are at least 6 low functioning autistic children in this community, the absolute minimum prevalence of low functioning autism for the cohort is 14.17 in 10,000.

California Comparison

No methodologically sound exhaustive autism screening has been carried out in the Amish population. We only know about cases that have been reported. This is why I thought a comparison with California reporting would be fair. It may not be precise, since the ascertainment methodologies are not the same, but I don’t believe it can be called an unfair comparison. Further, I do not believe the well known limitations of California DDS data make the comparison unfair either.

As of December 2007, there are a total of 17,029 children 2 to 9 in California classified as autistic and who have sought DDS services [source]. Most of them do not have mental retardation. We don’t know exactly how many have mental retardation, but we can determine a ceiling on that. For this, I counted how many autistics total have mental retardation, plus – to be fair – how many have “unknown” mental retardation status. This came to 32.67% of all autistics in the system. Since this proportion is known to have dropped considerably as more young children have been diagnosed in recent times, it follows that 32.67% is an upper bound percentage when it comes to children. In other words, there should be at most 5,564 known low functioning autistic 2-9 year olds in the California system.

Since the 2-9 population of California is 4,248,774 (2006), the prevalence of reported low functioning autism for the cohort is at most 13.1 in 10,000.
Comparison to Epidemiology

I often discuss how the prevalence of already recognized autism, and the prevalence of screened autism (or true prevalence) are two very different things. In particular, when autism is thoroughly screened in populations with intellectual disabilities, a lot of autism which wasn’t previously thought to be there is suddenly found (e.g. Shah et al. 1982; La Malfa et al. 2004; Matson et al. 2007).

Epidemiological studies are not necessarily perfect in this regard, but their methodology goes considerably beyond any work currently available as far as the Amish population is concerned. Let’s take Yeargin-Allsopp et al. (2003), for example.

Cases were identified through screening and abstracting records at multiple medical and educational sources, with case status determined by expert review.

The prevalence of low functioning autism from this Atlanta study was 23.12 in 10,000.

There are two UK studies by Chakrabarti & Fombonne (2001; 2005) ascertaining the 4-6 prevalence of PDD. The derived prevalences of PDD with mental retardation from these studies are 16.15 and 17.5 in 10,000, respectively.

Finally, we have a Chinese study, Zhang & Ji (2001), with a finding of 11 in 10,000 autistic children, all of whom were “intellectually disabled.”

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