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Fees for the Omnibus Autism Proceeding hit $7M

20 Feb

In the United States, the court hearings on whether vaccines cause autism were held under the Omnibus Autism Proceedings (OAP). These proceedings represented over 5,000 families who filed for consideration that they had a child who (a) suffered a vaccine injury and (b) this injury resulted in autism.

The OAP heard six “test cases”. Each test case represented both the question of whether the specific test-case child considered suffered a vaccine injury and also the general question of whether the idea that vaccines cause autism was proven.

The first three test cases considered the question of whether the MMR vaccine could cause a vaccine injury resulting in autism. The second three test case considered the question of whether thimerosal containing vaccines could cause vaccine injury resulting in autism.

The decisions from the MMR cases have been handed down, and they were unanimously and definitively against the MMR causes autism theory. These have been appealed and that appeal was denied. I believe an appeal to the U.S. Supreme Court has been either filed or planned.

The decisions in the thimerosal cases have not been handed down yet.

The OAP was a very long process, starting in 2002 and still ongoing, involving multiple law firms and many lawyers and experts. It has been an expensive process. We are slowly learning just how expensive.

Last year an interim award of over $2M in legal fees was granted for lawyers working on the Cedillo test case. That was the first case heard in the MMR segment of the AOP.

The Court has now granted an interim award of $2,300,000 for the King test case, the first heard in the Thimerosal segment of the AOP.

During an unrecorded telephonic status conference on July 1, 2009, the law firm of Williams, Love, O’Leary, and Powers (WLOP) agreed to reduce its interim attorneys’ fees and costs request from $3,101,764.84 to $2,300,000.00, including $2,070,000 in fees and $230,000 in costs. Respondent’s counsel then indicated that respondent will not object to that amount. WLOP’s reductions included: the withdrawal of time and expenses relating to direct legislative lobbying, that is, any activity relating to efforts to affect the outcome of the political process; the withdrawal of time and expenses relating to “case specific” work in cases other than this claim, and unrelated to “general causation” work on the OAP; the withdrawal of time and expenses WLOP conceded were related exclusively to civil cases outside of the Vaccine Program; and the withdrawal of time and cost claims relating to public relations and media work during the pendency of the OAP. In addition, WLOP generally reduced the fees it requested for time spent on the OAP. Finally, WLOP agreed to significantly reduce the expenses for which it sought reimbursement, particularly those costs incurred while on travel.

Let me highlight a couple of statements:

the withdrawal of time and expenses WLOP conceded were related exclusively to civil cases outside of the Vaccine Program.

and

WLOP’s reductions included: the withdrawal of time and expenses relating to direct legislative lobbying, that is, any activity relating to efforts to affect the outcome of the political process

Bold is mine.

Apparently, the law firm applied for and was denied funding for work done for civil cases that were outside of the vaccine program and for lobbying efforts. What were they thinking trying to get tack that onto their fee request? Let’s face it, the Omnibus has already subsidized any upcoming civil cases by giving the lawyers time to research their arguments and pay experts. And, really, asking the program to pay for lobbying?

This is only an “interim” fee request. Fees are still mounting, and not all the past fees have been assessed:

Of note, this Decision resolves all fees and costs requested by the WLOP firm in the King interim fees application, at Tabs A & B of that application. This Decision does not resolve the amounts requested at Tabs C through U of that application.

I don’t know how much is involved with “Tabs C through U”, but it sounds like the remaining fees could be considerably more than the $2.3M granted.

It is interesting to note that the father/son team of David and Dr. Mark Geier have expert fee requests submitted (and as yet unpaid) for this case, even though they were not called as witnesses and, to my knowledge, did not submit expert reports:

This does not resolve the vast majority of fees and expenses relating to Drs. Geier and Young. The majority of expenses relating to Dr. Geier, David Geier, and Dr. Young are included in the PSC Committee Costs, at Tab C of the initial Fee Application

The Geier’s are well known “experts” in the vaccine court. Young, I suspect, is the same person as co-authored a paper with the Geiers purporting to show a link between neurodevelopmental disorders and thimerosal in vaccines. That paper was reported to have been recieved funding “…from the Autism Petitioners’ Steering Committee of the no-fault National Vaccine Injury Compensation Program (NVICP).”

I am all for petitioners in the Vaccine Court having access to good experts. I don’t consider the Geier team to meet that standard. Should the Petitioners’ Steering Committee have decided to fund this reasearch, I see that as their expense, not one that should be passed on to the vaccine program. Dr. Mark Geier has been referred to in court documents as:

There are multiple cases where Dr. Geier’s opinion and testimony have been given little or no weight because they exceeded the scope of his expertise.

and

Dr. Geier is “a professional witness in areas for which he has no training, expertise, and experience”

I frankly suspect that funding The team of Young, Geier and Geier in this instance is another attempt to get the Vaccine Program to pay for work the lawyers expect to use in the civil cases that will follow the likely rejection of the Vaccine Court hearings. Remember, they weren’t called as expert witnesses in the Omnibus.

One other expert witness of note, Dr. Vas Aposhian, is also mentioned in the fee ruling:

This decision resolves the $34,048.25 that WLOP requested for expenses related to Dr. Aposhian ($31,750.00 in fees; and $2,298.25 in expenses incurred in May 2008). This decision does not resolve the $207,382.53 in fees and expenses included in the PSC Committee Costs for costs relating to Dr. Aposhian, nor does it resolve the $7,910 requested by Williams Kherkher for costs associated with Dr. Aposhian. See Tab C at 3887 and Tab E at 4396-98.

We don’t have the decisions from the King hearing yet, but here are some comments from the Cedillo decision:

Thus, concerning this issue [genetic hypersensitivity to mercury], I conclude that the testimony of Drs. Brent and Cook was persuasive, and that the testimony of Dr. Aposhian was not.

I find that Dr. Brent’s testimony on this point [the lack of an established mercury efflux disorder] was persuasive, and that the testimony of Dr. Aposhian was not.

I wonder if Dr. Brent, whose expertise was persuasive, will be paid anything like the roughly quarter million dollars that Dr. Aposhian has billed.

So we have $2M in fees granted for the Cedillo hearings, and now $2.3M for the King hearings. This is part of a total of over $7,000,000 requested in interim fees:

In their application, the petitioners sought a total of $7,202,653 for interim fees and costs. This total reflected the fact that this case was, as explained above, one of the “test cases” in the OAP. Because this was a “test case,” in which the petitioners sought to present all of the “general causation” evidence concerning the theory that thimerosal-containing vaccines can cause autism, several different law firms participated in the development and presentation of the evidence, while five expert witnesses prepared expert reports and testified at length for petitioners during the evidentiary hearing. The high total sought reflects the participation of all those law firms and expert witnesses.

I don’t think anyone is surprised that this is a very expensive proceeding.

Millions of dollars were spent trying to prove the now discredited (and never well supported) hypothesis of Dr. Wakefield. The thimerosal hypothesis also never had much substance, and has cost millions more.

One thing good out of all this is that the proceeding also paid to compile expert reports from some real experts debunking the MMR and Thimerosal myths.

Wakefield, O’Leary and Bustin

4 Feb

Below is an old post from 2007 when the Omnibus hearings were in full swing. It goes through the testimony of Professor Stephen Bustin and why it was so deadly to the MMR hypothesis. I thought now might be an ideal time to republish it.

On Day 8 of the Autism Omnibus proceedings, the MMR section of the hypothesis under examination (that thiomersal and MMR together cause autism) was examined. Just to briefly generalise about the MMR hypothesis –

It was hypothesised that measles virus (MV) from the MMR was travelling from the injection site, to the gut and then to the brain where it either a) causes autism or b) in conjunction with thiomersal causes autism. Wakefield claims to have found MV in the gut of several kids. Krigsman claimed to have replicated this work. They both used the lab of one Professor John O’Leary (Unigenetics IIRC) in Ireland.

So, on Day 8 of these proceedings Stephen Bustin came to the stand. Bustin is possibly _the_ world expert on the techniques used in the O’Leary lab that he claimed led to identifying MV in autistic kids gut and brain. The technique is called PCR. Not only does Bustin use PCR every day, he has 14 papers in the peer reviewed literature on PCR, over 8 book chapters and is personally the author of the _A to Z of Quantitative PCR._ which is considered ‘the bible’ of PCR. One of his papers has been cited over 1,000 times. Another has been cited over 500 times. He both organises and speaks at international PCR conferences (1934 – 37).

Basically, when it comes to PCR – this is the guy.

The first part of Bustin’s testimony concentrated on an explanation of PCR techniques and how these techniques were employed in a key study relied upon the week previous to make the MMR/Cedillo case: Uhlmann 2002. This paper describes the _exact process that Unigentics lab used to carry out their PCR work_ .

This is a mind bogglingly techie area so I’m going to try and stick to laypersons terms. Basically, the Uhlmann study is badly flawed. The key issues related to controls. Uhlmann (and a subsequent, as yet unpublished Walker poster presentation) didn’t use any.

a positive control is an essential control that tells you whether your assay is working, so what you would do is you would take the target that you’re interested in detecting and put it into a test tube and use your assay to detect it. If you don’t detect it, you know there’s a problem with your assay because it’s a positive control. If you do detect it, you know your assay is working. If you do this consistently each time, you know how efficient your assay is from day to day.

The positive control is simply something that tells you that your assay is okay.

Q And a negative control?
A A negative control is something very crucial. There you leave out your target, so if you don’t detect it then that means that there’s no amplification, which is what you want. If you do detect a positive in a negative control then you know there’s a problem with your assay because it should not be there, and you always get suspicious of any assay that gives you a positive result in a negative control.

So, back to Uhlmann:

Q And did Uhlmann provide the information necessary to establish whether these controls were working as expected?
A No. One of the surprising aspects of this paper is they give you very little information about how the assay was performed, about what the results actually were, and it really does not let you evaluate at all how reliable and consistent the results are.

Q Is there any discussion in Uhlmann about contamination?
A No.

Q Is this important?
A It is essential because obviously if you are trying to detect a very low copy number target and there is contamination around, and if you do not know whether there’s contamination around, then you can’t rely on your assay.

……

Q Now, did Uhlmann discuss how the RNA was handled?
A No. As I think I said one of the things about this paper is that it’s fairly unique in my experience, and it’s given no information at all about what actually was done. It actually tells you in outline what they did, where they got their samples from and that they prepared RNA, but it gives you no information whatsoever about, for example, the quality of the RNA the quantity of the RNA and how the different RNAs were extracted from different samples which they refer to.

Without being sure of how RNA is handled, it is impossible to rule out contaminants. i.e. that the samples are contaminated. And there’s more:

Q Did you also identify a mismatch between the measles virus sequences listed in the paper and the probes?
A Yes. This is, again, well, it suggests that there’s a problem with the probe design.

Q Now, regarding consistency and reproducibility did Uhlmann provide any data regarding amplification sensitivity or efficiency?
A No. I need to come back to what I’ve been saying several times now. There’s this lack of information that doesn’t allow you to evaluate this paper properly in terms of its validity.

And specifically regarding the Walker poster presentation:

….Now, as I tried to point out today I think virtually every expert in this case has referred to controls are essential. You always want controls of your samples. There’s no controls on this. So even though this is a poster presentation at the very least there should be a negative control on there to show that the PCR in the negative control hasn’t worked.

We don’t have that information. So this immediately invalidates these results because we can’t now say whether these are genuine or not because there’s no negative control there. So that’s a real problem….

Q Unless these issues are resolved would you have confidence at least in what’s been presented from the Walker lab?
A I can’t have any confidence because there’s actually no results I can evaluate without referring to a negative or a positive control, and these don’t give them to me.

So basically, Mr PCR – the guy who literally wrote the book on PCR – thinks these two things – the Uhlmann paper and the Walker poster presentation – are essentially useless.

Lets also not forget that these two items describe the exact methodology that Unigentics – O’Leary’s lab – used to state that Wakefields/Krigsmans and a multitude of private cases had MV in their samples.

Oh yeah – and as for the old crapola about the two clinical studies done thus far not repudiating Wakefield et al because the look at blood, not gut, Bustin states emphatically:

this is not an assay that is at its limits so this should be easily detectible, and it also means that if you’ve got that much measles virus in a gut sample it probably is in other cells as well and you should be able to detect it, for example, in blood.

In blood.

Turning to Unigenetics itself, as part of the failed UK litigation against MMR, Bustin was asked to look at the lab and samples that the Unigentics team had worked on. For this work he put in an astonishing 1,500 hours of work.

Now, Professor O’Leary’s own controls tell us that this should have been shifted upwards because this is much poorer quality RNA. The evidence from his own data is completely clear. There’s no such shift. This must mean that whatever this is is a contaminant that has been introduced after the sample has been formalin-fixed.

So by definition this cannot be part of the original biopsy because if it had been it will have shifted upwards.

Ouch. But the next one is a body blow to the entire MMR hypothesis.

…if you have a reference gene in that sample that is a cellular reference gene you should detect it if the RNA is of good quality.

If you don’t detect it there’s something wrong with the RNA. As Professor O’Leary’s SOP states, if we can’t detect the GAPDH we shouldn’t use the sample for analysis, which makes perfect sense.

Now, it happens that Professor O’Leary did use those samples for his analysis, and that’s why I was able to then hopefully identify what the contaminant is.

To summarise: O’Leary’s RNA was poor quality. There is no reference gene. There is something wrong with the RNA. O’Learys lab SOP (Standard Operating Procedure) states that in the events of this happening, they shouldn’t use the sample for analysis. But they did use it. They used contaminated RNA for their analysis. And Bustin has identified exactly what the contaminant was.

But first, what is _definitely not_ ?

If you detect a target that is apparently measles virus in the absence of an RT [like this one] step by definition it can’t be measles virus because it has to be DNA [measles virus does not exist as a DNA molecule]. It’s a very simple concept. At least it is to me. It’s not to everyone else.

Whatever it is that O’Learys lab is picking up in their lab tests, it cannot possibly be Measles virus. No RT step was taken:

What I immediately observed was that they had forgotten to do the RT step

No RT step means it’s DNA. Measles virus does not exist as a DNA molecule. That’s simple medical fact. Bustin later summed up:

So all of this evidence suggests very, very strongly that what they are detecting is DNA and not RNA. Because measles virus doesn’t exist as a DNA molecule in nature, they cannot be detecting measles virus RNA. They are detecting a contaminant. All of the additional evidence, from the nonreproducibility by Professor Cotter of the same samples that Unigenetics analyzed to the analysis of the data where there are discordant positives, where the negatives came up positive, suggests very, very strongly to me that there is a lot of contamination in the laboratory, which is not unusual, but they have not handled it very well in how they have troubleshot their problems.

So I have very little doubt that what they are detecting is a DNA contaminant and not measles virus, and I do not believe there is any measles virus in any of the cases they have looked at.

And just as an added kick in the teeth:

Q Now, we know that cerebral spinal fluid samples were sent from Dr. Bradstreet to Unigenetics for testing. Do the same concerns you’ve outlined here apply to that testing?
A Yes. Exactly the same concerns would apply to that.

This testimony exposes the MMR hypothesis as totally dead in the water. What a waste of time, money and health.

Elsewhere

Arthur Allen in the Huffington Post
Autism Diva

Special fevers, mitochondria and autism

30 Dec

Thats right, its back.

Ginny Hughes, writing for the Simons Foundation writes about new methods of detecting mitochondrial damages that may lead to autism. Of course, since last year that inextricably calls to mind Hannah Poling.

Just as a quick refresh, Hannah’s case was compensated by US Gvmt who accepted that vaccines caused a fever which triggered an underlying mitochondrial dysfunction which in turn led to ‘autism like symptoms’. This is oppose to ‘vaccines caused her autism’ which you’ll find a lot of people claiming.

The crux of the matter is fever. Mitochodrial dysfunction appears to be largely triggered by fever. Without the fever there’s no dysfunction. Without the dysfunction theres no autism.

Jay Gargus, professor of physiology and biophysics at the University of California, Irvine who’s studied mitochodria for 20 years makes a very telling point in this piece:

“It terrifies me that people will be making arguments [from this work] that further enhance the panic about vaccines,” Gargus adds. “Obviously, getting a vaccination will sometimes give you a fever, but the kid’s going to get a fever sooner or later anyway. It’s not like it’s a special fever.”

All kids get ill. They’re going to get fevers. In fact a lot of the things that vaccines try and prevent cause fevers. Flu for example. What vaccines don’t do is give a child a ‘special’ autism causing fever. Thats because there _is_ no special autism causing fever and no special autism causing vaccines either.

Pass the Maalox: An AoA Thanksgiving Nightmare

30 Nov

It is no secret that I don’t appreciate the humor or the pseudoscience at the Age of Autism blog. Frankly, the pseudoscience is worse than the humor as it is so damaging to the autism communities. But, both are an embarrassment.

So, you can imagine my reaction to their recent post “Pass the Maalox: An AoA Thanksgiving Nightmare“. If you haven’t seen it, someone spent her Thanksgiving holiday with photoshop making a picture of the favorite people to hate look like they are eating a baby.

You know the reaction they wanted: outrage. You know the one they actually get: a heavy sigh. As in, “Oh, well, here we go again with AoA’s embarrassing approach to autism blogging”

Why blog it? Because it is a good introduction to what I’ve wanted to write since the recent articles at the Chicago Tribune. (if you haven’t read them, do. email them to all those well meaning people who keep sending you links to miracle cure websites. They are here and here ).

What is the message I wanted to write? Simple. To all the Age of Autism readership: people like the Tribune writers, Tom Insel, Paul Offit and others are not your enemy. These people are not standing in your way.

Your lack of good science is what is standing in your way.

Unfortunately, that isn’t likely going to change. You flat out stated that Autism is just a misdiagnosis for mercury poisoning. You were wrong, but you can’t admit it. You bet everything on the idea that mercury and/or the MMR vaccine caused an epidemic of autism. You were wrong, but you can’t admit it.

The “nightmare” you are living is of your own doing. You created a false model of autism. It isn’t the fault of the many (MANY) observers who tell you you are wrong.

Your lawyers and “scientists” put together the best story they could in the vaccine court–the Autism Omnibus Proceeding. They claimed that MMR or thimerosal caused autism, and set out to prove it. They failed.

You really should read the expert reports submitted for the Autism Omnibus Proceeding. The people who wrote these reports aren’t your enemy. The facts they report are the enemy of the house of cards you built.

Reports from the Cedillo trial

Report of Jeffrey Brent, toxicologist.

Report of Edwin Cook, psychiatrist and geneticist.

Report of Eric Fombonne, psychiatrist and epidemiologist.

Report of Robert Fujinami, immunologist.

Report of Michael Gershon, neurogastroenterologist.

Report of Diane Griffin, immunologist and virologist.

Report of Stephen Hanauer, gastroenterologist.

Report of Christine McCusker, pediatric immunologist.

Report of Brian Ward, neurovirologist

Report of Max Wiznitzer, pediatric neurologist.

Report of Andrew Zimmerman, pediatric neurologist.

Declaration of Nicolas Chadwick, Ph.D.

Critique of Dr. Hepner’s letter, by Stephen Bustin, world expert on PCR.

Affadavit by Stephen Bustin, world expert on PCR.

Affadavit of Bertus Rima, molecular biologist, measles virus expert.

Reports from the Dwyer trial
Report of Bennett Leventhal, child psychiatrist

Reports form the Hazelhurst Trial
Report of Thomas MacDonald, immunologist.

Report of Christine McCusker, pediatric immunologist.

Report of Robert Rust, Pediatric Neurologist.

King Hearings

Report of Jeffrey Brent, toxicologist.

Report of Manuel Cassanova, psychiatrist.

Report of Steven Goodman, epidemiologist.

Report of Jeffrey Johnson, toxicologist, expert on oxidative stress.

Report of Dean Jones, professor of medicine.

Report of Thomas Kemper, neurologist.

Report of Catherine Lord, psychologist, world expert on autism.

Report of Richard Mailman, professor of psychiatry, pharmacology and neurology.

Report of L. Jackson Roberts, professor of pharmacology and medicine.

Report of Patricia Rodier, expert in autism and mercury toxicology.

Report of Sir Michael Rutter, professor of developmental psychopatholgoy, world expert on autism.

Letter from Carlos Pardo-Villimazar to Thomas Kemper


Another expert report by Eric Fombonne


Expert report of Robert Rust


Another report of Robert Rust

Supplemental report of Jeffrey Brent


Expert report of Michael McCabe

Expert report of Bertus Rima

Supplemental report of Brian Ward

Supplemental report of Max Wiznitzer

Letter from Michael Oldstone to Brian Ward

Another supplemental report by Max Wiznitzer

News Reports demonstrating misuse and misunderstanding of autism science

Autism treatment: Science hijacked to support alternative therapies
By Trine Tsouderos and Patricia Callahan, Chicago Tribune

Researchers warn against misusing report

Autism treatments: Risky alternative therapies have little basis in science
By Trine Tsouderos and Patricia Callahan ,Tribune reporters

Experimental treatments

Autism treatment: Success stories more persuasive to some than hard data
By Trine Tsouderos and Patricia Callahan ,Tribune reporters


Questionable treatments for children with autism


Autism doctor: Troubling record trails doctor treating autism
Second of two parts By Patricia Callahan and Trine Tsouderos ,Tribune reporters

Miracle drug’ called junk science
By Trine Tsouderos ,Tribune reporter

An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All
Amy Wallace, Wired Magazine

You folks at the Age of Autism would like to pretend that there are a few people standing in the way of the “obvious” conclusions that mercury and the MMR vaccine caused an autism “epidemic” and that alternative medicine offers a cure.

You are wrong on every count. It isn’t a few people. It is almost everyone who looks at the “data” you have to offer. It isn’t just epidemiology, either. The mechanisms you present are just not supported by any real science. Your problem isn’t that there are people in your way. The problem is that your “data” is junk. Sorry, there is no nicer way to put it. There is no hard evidence for an epidemic. If there is a real increase in real autism incidence, you guys are actually standing in the way of finding the real causes. As to the “cure” offered by alternative medicine, that’s my thanksgiving nightmare: the idea that some “alternative” doctor from the Age of Autism stable is treating my child with poorly conceived “therapies” based on the same junk science you folks promote.

That sends shivers up this autism parent’s spine.

Number of cases before the vaccine court drop off dramatically

28 Oct

We often hear about how there are about 5000 cases before the vaccine court claiming autism as a vaccine injury. What we don’t hear is that almost all of those cases were filed years ago.

Take a look at the data on the number of cases filed per year. Or, take a look at this graph I made of the data (click to enlarge):

Cases submitted to the vaccine court by year

Cases submitted to the vaccine court by year

Red shows autism cases filed. Black shows non-autism cases.

Not much needed in the way of discussion. Autism cases peaked in 2003, six years ago. Autism cases are now at about the same level or less than non-autism cases. It has been low and flat since about 2006.

I know I’ve done a lot of vaccine-oriented posts lately. This is a good indication that I need to spend time on other subjects.

Fever Plus Mitochondrial Disease Could Be Risk Factors for Autistic Regression

24 Sep

Autism, regression, mitochondrial disease and vaccines. With a combination like that, this paper is likely going to be very important.

Fever Plus Mitochondrial Disease Could Be Risk Factors for Autistic Regression

Here is the abstract:

Autistic spectrum disorders encompass etiologically heterogeneous persons, with many genetic causes. A subgroup of these individuals has mitochondrial disease. Because a variety of metabolic disorders, including mitochondrial disease show regression with fever, a retrospective chart review was performed and identified 28 patients who met diagnostic criteria for autistic spectrum disorders and mitochondrial disease. Autistic regression occurred in 60.7% (17 of 28), a statistically significant increase over the general autistic spectrum disorder population (P < .0001). Of the 17 individuals with autistic regression, 70.6% (12 of 17) regressed with fever and 29.4% (5 of 17) regressed without identifiable linkage to fever or vaccinations. None showed regression with vaccination unless a febrile response was present. Although the study is small, a subgroup of patients with mitochondrial disease may be at risk of autistic regression with fever. Although recommended vaccinations schedules are appropriate in mitochondrial disease, fever management appears important for decreasing regression risk.

The authors note neurologic regression in general (not just autistic regression) is observed with patients who have metabolic diseases:

Patients with mitochondrial diseases, like many patients with metabolic diseases, are at increased risk of neurologic regression in conjunction with stressors such as fever, infection, and dehydration.

They studied 28 patients who met DSM-IV criteria for autism and diagnostic criteria for mitochondrial disease.

They define regression and whether it is related to fever thusly:

Autistic regression was defined as loss of developmental skills that included speech, receptive skills, eye contact, and social interests in individuals ❤ years of age. A relationship between fever and autistic regression is defined as regression beginning within 2 weeks of a febrile episode without the suggestion of infectious meningitis or encephalitis.

One comment–the definition of regression is somewhat vague to me. What is also critically important in this discussion is whether there were any signs of autism before the regression. Or, as some may put it, is this regression into autism or autistics undergoing regression? Is there a mix of pathways?

They state that 17 of the 28 patients studied underwent an autistic regression. This is higher than the roughly 25% value for autistic regression they assumed for the general autism population, and statistically significant.

In other words, they are saying that autistic regression may occur more often with kids with mitochondrial diseases.

They note that some of the fevers could be linked to vaccination:

The 17 individuals with autistic regression could be divided into 2 groups, those who regressed with fever (70.6%, 12 of 17) and those who regressed without identifiable linkage to fever or vaccinations (29.4%, 5 of 17).

And,

No individual showed regression with vaccination unless a febrile response was present.

They discuss the concerns with vaccination in the conclusion, noting that vaccination is still recommended for children with mitochondrial diseases. My experience in discussing this issue with mitochondrial disease experts is that they find vaccination to be extremely important. If, for some reason, they decide to not vaccinate a child with mitochondrial disease, they insure that all family members are vaccinated to protect the child.

Children with identified mitochondrial diseases are routinely managed carefully by their physicians with aggressive fever control and hydration. In this context, vaccination of children with mitochondrial diseases is recommended. In our experience, the vast majority of patients with mitochondrial diseases receives a full vaccination schedule according to American Academy of Pediatric guidelines without consequences, particularly when physicians are sensitive to fever control and hydration. In our patients with mitochondrial disease and autistic spectrum disorders, the vaccines did not appear related to the neurologic regression.

I will note again that I feel autistic regression as defined is too vague. Were the patients on the spectrum before the regression? Were they typically developing before the regression?

At least two children were noted to have multiple regressions (a sibling pair). That indicates that at least in some cases, regressions occurred in people already autistic. There just isn’t other information on this.

Another area I would like to see discussed further is on siblings:

Affected siblings were identified in 35.7% (10 of 28).

Affected how? Mitochondrial disease. But, are they also autistic? It would seem not since they included one sibling pair.

This is a big question to me. While the spotlight has been shown on the possibility of mitochondrial disorders being linked to autistic regression, the more general question is more important: could fevers induced by vaccination result in any regression (autistic or otherwise) in people with mitochondrial disorders.

Another question in my mind in this study. Are there patients who underwent regression from non-autistic to autistic) after age 3? According to the Johns Hopkins group, this doesn’t happen. According to them, there is an age window where the regressions could result in autism. This is a very important question in how these patients might fit in to the broader spectrum of autism.

Autism Omnibus: Snyder appeal denied

12 Aug

The appeals for the MMR phase of the Omnibus are now concluded: all three were denied.

The Autism Omnibus Proceeding is the way the “Vaccine Court” has taken on the task of deciding the merit of the theory that autism is a vaccine injury. The petitioners had two basic theories: (a) the MMR vaccine can cause autism and (b) the vaccine preservative thimerosal can cause autism.

Three hearings were heard for each theory. In each hearing a single individual took the role of a “test case”. So, each hearing not only represented the case of a single child, but also presented “general causation” evidence as to whether MMR or thimerosal could cause autism.

The six test cases (three MMR and three thimerosal) have been heard. The MMR cases were ruled upon, and all three were denied. All three were appealed. And, now, all three appeals have been denied.

Here is the conclusion of the appeal for the last of the MMR test cases, that of Colten Snyder:

As the special master’s decision makes clear, Colten, and by extension, his family, have dealt with significant adversity for many years, and, like the special master, the court is very sympathetic to their circumstances. However, the court cannot be ruled by emotion and base its determination solely upon the adversity endured by petitioners’ family. Moreover, it is not the task of this court to determine whether vaccines cause autism or other neurodevelopmental disorders. Rather, the court must decide whether the special master, considering the record as a whole, rendered a decision that was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. She did not. Her decision was entirely rational and fully supported by the record. Thus, the court DENIES petitioners’ motion for review. Pursuant to Vaccine Rule 30(a), the clerk is directed to enter judgment in accordance with this decision.

Very solid decision. The appeal was denied.

Looking back through the document one finds that the Judge noted that the case for MMR causing an injury was clearly not supported, and that the Special Master did not make an error in her decision:

The court finds no error in the special master’s findings. The special master’s conclusion that petitioners did not present a biologically plausible medical theory is clearly supported by the record. She found that the various aspects of petitioners’ theory were not scientifically sound and that the lynchpin of their theory was wholly unreliable. See id. at *87-93 (petitioners’ theory),
116-35 (Unigenetics’ reliability). Next, the special master’s conclusion that petitioners had not established a logical sequence of cause and effect is also supported by the record.

In a statement reminiscent of the Cedillo hearing (first MMR test case) the Judge noted that the medical records show that the “onset of symptoms” did not occur when the petitioners thought:

She [the special master] found that based on the medical records, the onset of Colten’s symptoms did not occur at the time suggested by petitioners.

It is worth reading or skimming the decision. It is a good summary of the case and the evidence presented. I don’t want to quote much more of the document here, with this exception.

Petitioners’ charge–that the special master feared a public backlash against vaccines if she ruled in their favor–is preposterous. There is not a shred of evidence to support petitioners’ claim;70 it rests solely on petitioners’ speculation. Merely because the special master found that petitioners did not carry their burden of proof does not diminish her integrity or render her decision unsupported. Claims of error by a losing party against a decision maker are hardly unusual, but should be grounded in reality.

One thing that bothered me greatly was the implication in the appeals that the Special Masters were acting improperly out of some hidden motive such as trying to protect the vaccine program or fear of public backlash. Sometimes it is difficult for a lay person like myself to understand whether such arguments are expected and “just part of the game” or whether they are attempts to impugn the integrity of the Special Master. I have read enough comments on other blogs to see that many readers are willing to accept that members of the judiciary could act to deny children due process.

I’m glad the Judge in this appeal took the time to respond to these false allegations.

Autism Omnibus: Cedillo appeal denied

11 Aug

In the Autism Omnibus Proceeding there were three “test case” hearings to decide if autism can be considered a “vaccine injury” due to MMR. In all three cases, the special masters (judges) decided that there wasn’t enough evidence. In fact, it “wasn’t even close”.

All three have been appealed. The first appeal was denied a few weeks ago.

The second appeal decision is in, for the test case that was the hearing for Michelle Cedillo. This case had the most “general causation” information and so was the most complicated.

As with the Hazelhurst appeal document, this document is a very good summary of the hearing.

Here is the summary of the appeal arguments:

The Cedillos assert seven arguments in their motion for review to show that the Special Master’s decision is arbitrary, capricious, an abuse of discretion, and contrary to law: (1) A panel of three Special Masters should not have heard the general causation evidence; (2) The Special Masters should not have allowed the last-minute expert reports and testimony of Dr. Stephen Bustin; (3) The Special Master improperly discounted the medical diagnoses and opinions of Michelle Cedillo’s treating physicians; (4) The Special Master improperly ignored concessions made by Respondent’s expert witnesses; (5) The Special Master ignored important aspects of Michelle Cedillo’s evidence; (6) The Special Master abused his discretion by refusing to consider important post-hearing evidence; and (7) the Special Master’s decision was contrary to law. Petitioners’ arguments four and five include multiple sub-parts, specifically raising the testimony of six expert witnesses and seven substantive areas of Petitioners’ evidence that the Special Master allegedly mis-evaluated.

Probably the key to the entire MMR-causes-autism idea, and the first subject that the appeals judge covered was the question of whether measles virus can be considered to persist in intestinal tissue. The petitioners case in this respect depends heavily on studies by Dr. Wakefields group and samples taken from Michelle Cedillo which both rely on the Unigenetics laboratory of Dr. O’Leary.

Without the test results of the Unigenetics Laboratory, Petitioners have lost a cornerstone to their causation theory. The fact that Petitioners did not prove the existence of any persistent vaccine-strain measles in Michelle Cedillo’s body leaves Petitioners well short of meeting their prima facie case that the MMR vaccine played any role in causing Michelle’s autism. Under these circumstances, Petitioners failed to meet their burden of proof by a preponderance of the evidence, and thus the burden never shifted to Respondent to rebut Petitioners’ proof. See Althen, 418 F.3d at 1278. The Special Master’s decision regarding the Uhlmann Study and the Unigenetics testing is reasonable in all respects, and could not in any sense be regarded as arbitrary, capricious, or an abuse of discretion.

Since the MMR test cases were heard, another very important study has been published, further showing that there is a lack of persistent measles virus in children with autism and bowel problems.

Without going into the details on the other points in the decision, we can jump to the conclusion and see that it is succinct and clear:

The issue before our Court is not to determine the causes of autism. The Court can only hope that medical professionals succeed in identifying the causes and developing a cure for this tragic disease. Rather, the Court’s task is to weigh the Special Master’s February 12, 2009 decision under the applicable review standards of the Vaccine Act, and determine whether it should affirm or modify the decision to any extent. After performing this review, the Court is satisfied that the Special Master’s decision is rational and reasonable in all respects, and is in accordance with law. For the reasons addressed above, the Special Master’s decision is AFFIRMED.

Or, to put it more succinctly:

Petitioners still have the burden of proving their claims by a preponderance of the evidence, and the Special Master reasonably concluded that they failed to do so.

There is still one more MMR appeal in the works. Given the results of the first two, my guess is that the attorneys are preparing for the next step in the journey towards a civil case.

Without more evidence to support their case, I would have serious doubts about the MMR hypothesis winning in a civil trial. Since the omnibus hearing, there is more good evidence against the MMR hypothesis and the plaintiffs will face more stringent evidence rules.

It’s time for David Kirby to disavow the autism epidemic

3 Aug

The idea that mercury caused an epidemic of autism is both wrong and very damaging to the autism communities. Many contributed to this damaging notion., but David Kirby without a doubt carries a good quantity of the blame for his book “Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy” and efforts since.

Mr. Kirby often tries to hide behind the notion that he is just “trying to spark a national debate”. Sorry, but that is nonsense. He actively promotes the idea that vaccines cause autism. It is unclear to this reader whether Mr. Kirby is currently being paid for his efforts. In the past he cherry picked information and packaged it in seemingly self-consistent packages to convince people that an epidemic did occur.

He has now moved to a tag-team approach for presentations to the US congress. He presents information to support the idea that vaccines could cause autism. He then let’s Mr. Mark Blaxill take over to promote the epidemic with the old, tired arguments.

It’s like Mr. Kirby still wants to be able to say, “I never really said there was an epidemic. I was just sparking a discussion.” It’s Mark Blaxill that is actually calling it an epidemic.

Nonsense.

This has been bothering me for some time. It came up again strong when Mr. Kirby commented on a blog piece. David Kirby doesn’t generally participate in the online discussions-even to the point of not answering comments on his own blog pieces. He broke that tradition recently in a blog piece on the Mother Jones website: Breaking: Vaccines still don’t cause autism

My response to Mr. Kirby incorporated much of what I was considering for a future blog post. So, rather than paraphrase what I wrote, here it is in full:

Mr. Kirby,

I see your usual arguments above. I see, also, the usual gaps in your discussion. Over the years, you have gone from promoting the “vaccines caused an epidemic of autism” to dancing around the subject of the false “epidemic”, neither stating that there was an epidemic, nor admitting your mistake. Could you comment somewhere, on the record: was there an “epidemic” of autism caused by mercury? You seem to leave that to your colleague, Mr. Blaxill, giving yourself some form of plausible deniability. It is irresponsible.

You rely heavily now on the NVAC recommendations. Why do you leave out so many comments by NVAC?

The NVAC is assured by the many epidemiological studies of the effects of mercury exposure done in a variety of populations, which have demonstrated that thimerosal in vaccines is not associated with autism spectrum disorders in the general population.

Are you prepared to agree with NVAC that the data are in and that there has been no epidemic of mercury caused autism? It would be the honest thing to do.

You rely heavily on the idea that mitochondrial disorders are related to autism. You pushed heavily on your blog the idea that mitochondrial disorders are caused by mercury, without substantiation. In fact, this idea is strongly rejected by the very experts you rely upon.

Further, you leave it implied that children with mitochondrial disorders and autism indicate a link to autism as a vaccine injury. This is clearly not the case.

Why do you leave out the fact that most children with mitochondrial disorders and autism do not show regression. Without regression, it is clear that vaccine injury is not causing autism in these individuals?

Why do you leave out the fact that in the one study of children with mitochondrial disorders and autism, it is clear that vaccines are not causal in the vast majority of cases, and could be questionable in the one case cited so far?

You cite that there could be a sizable population of autistics who have a mitochondrial dysfunction. Yet you leave out the public statements by one of the very doctors who supported the Hannah Poling case in vaccine court that any such injuries are rare. This from the few doctors who support the idea of mitochondrial disorder as a vaccine injury. Other specialists have stated that it is far to early to draw a conclusion that mitochondrial disorders caused by vaccination is even “rare”.

Why have you not removed your blog piece that was so erroneous that you were forced to rewrite it within a day, with an admission that you seriously erred? Isn’t that a form of dishonesty?

Are you prepared to join Rick Rollens, one of the strongest proponents of the vaccines-cause-autism notion, in stating that the idea that MMR causes autism has been tested and MMR is no longer suspect?

I will ask again, if you are going to cite NVAC, are you willing to join them and state that mercury did not cause an “epidemic” of autism?

Would you at least be willing to include quotes from NVAC that are, shall we say inconvenient, to the notion of a vaccine induced “epidemic” of autism? Quotes such as:

Vaccination almost certainly does not account for the recent rise in ASD diagnoses; however, public concern regarding vaccines and autism coupled with the prevalence and severity of ASD warrant additional study in well defined subpopulations.

This quote makes it clear that
a) NVAC does not support the idea of an autism “epidemic” caused by vaccines
b) NVAC is not calling for studies of vaccines and autism due to evidence presented so far, but, instead, by public concern.

Mr. Kirby, your half truths and misleading arguments cause great harm to the autism communities, as well as to public health. You personally are responsible for much of the public’s misconception that mercury caused an “epidemic” of autism. Don’t you agree that you personally should publicly refute your previous stance?

Being wishy-washy on the epidemic question and letting your colleague Mark Blaxill push the idea in your tag-team briefings is just dishonest. Either you still believe in the mercury-caused-epidemic (and you are wrong) or you should be clear that it was a mistake.

It was a mistake. Earn some respect. Admit it.

Autism Omnibus: Hazelhurst appeal denied

29 Jul

The Autism Omnibus Proceedings is, for better or worse, one of the big stories in the world of autism news. Hearings have been held, using the best science and arguments that could be brought to bear. The two theories were (1) does MMR cause autism and (2) does thimerosal cause autism.

Each theory was tested using three “test cases”. Essentially, three trials for each theory, each discussing an individual child plus arguments on “general causation”.

So far, the decisions are only in on the MMR question. The answers were clear and decisive: “this is not a close case”.

The Omnibus decisions are not the end of the vaccine/autism lawsuits. Not by a longshot. The first step was an appeal, and the first appeal has been decided.

Here is the conclusion of the Judge who heard the appeal for the Hazelhurst case:

In hearing this appeal, the court is not without sympathy for Yates, the Hazlehursts, and the other children and families dealing with autism and autism spectrum disorders. And this court, like the special master, acknowledges both the burdens many of these families have faced and the tremendous love and support they have shown their children. The facts, however, do not support petitioners’ appeal and we have no choice but to deny their motion. Accordingly, for the reasons set forth above, the special master’s decision of February 12, 2009, is AFFIRMED.

I.e. the appeal failed. The decision stands. The Court holds that MMR does not cause autism.

The judge’s decision in the appeal gives a good summary of the original case. If you want to read about the Hazelhurst case, it would be the first place I would send you.

From the appeals judge’s ruling, here are the two “cardinal” flaws in the petitioner’s case:

1) First, the special master explained that petitioners’ experts based their opinions on the characteristics of the “wild-type” measles virus rather than on the characteristics of vaccine-strain measles, despite the fact that the measles vaccine is distinguishable from the wild-type measles virus in several key respects.

2) Second, the special master observed that petitioners’ experts further based their opinions on studies (detecting the presence of the measles virus in the gut tissue of autistic children) that the special master found to be unreliable.

The special master considered the presence of the measles virus in the gut to be the “linchpin” of the petitioner’s case. In other words, they needed to show reliable data or studies demonstrating that the virus was still in the tissues of the children long after the vaccination.
The two studies they had to rely on were (a) that by Dr. Wakefield’s team and (b) an unpublished study by Dr. Stephen Walker, presented as a poster at the 2006 IMFAR conference. Well, the Wakefield study was pretty well discredited, and the Walker study was never published.

In the appeal, the Hazelhurst’s lawyer argued that the testimony of Dr. Stephen Bustin should not have been considered. Amongst the arguments were that some of the information was submitted at the last minute.

No arguments were made that Dr. Bustin was wrong in his analysis of the O’Leary laboratory. That was one of those strange moments in law–no one challenged Dr. Bustin on being right. The judge hearing the appeal noted that the rules for the Vaccine Court are different from a typical court of law. Specifially, the rules are designed specifically to allow more information in to inform the Special Master. The judge further noted that under the typical rules of evidence, the Walker study would never be admitted anyway.

If you haven’t read about Dr. Bustin’s testimony, you should consider it now. Dr. Bustin basically discredited the entire “persistent measles in the gut” idea by showing that the O’Leary laboratory that made tests had serious methodological flaws and, basically, couldn’t make the tests at all.

The Hazelhurst’s lawyer then argued that the Special Master failed to include all the relevant evidence., In specific, that the Walker study wasn’t given due weight.

Again, one of those strange moments in law. The laywers moved directly from trying to get the Special Master to exclude evidence that was clearly relevant, to claiming that the Special Master had to include all relevant evidence. I guess that’s why I am not a lawyer. I couldn’t pull that off with a straight face.

As it turns out, even the witness for the Hazelhurts’ side stated that the Walker study wasn’t reliable:

Respondent additionally notes that Dr. Hepner herself acknowledged that the preliminary data from the study was “not useful at this time” (Cedillo Tr. at 682), declined to draw any conclusions about the biological significance of the Walker group’s findings (Cedillo Tr. at 682), and identified what respondent describes as several significant drawbacks to the study, including that the experiments had not been “blinded”28 and had lacked negative controls.

So, it is rather moot as to whether the Walker study was considered, since it doesn’t really provide substantial evidence to support the MMR theory.

The third main argument used in the appeal was that the Special Master failed to decide on a “critical issue”. Namely, whether regressive autism exists as a separate phenotype.

The Special Master wrote in his decision, and the appeals judge agreed: since the decision held that MMR doesn’t cause autism, there was no point in deciding on the question of regressive autism as a separate phenotype.

Given that the expert testimony was against this idea, it is probably better for the petetioners that this question was left unanswered.

The main result is, of course, the original decision was upheld. Looking forward, it doesn’t look good for the MMR theory to win in civil litigation from my perspective. The Bustin testimony is very damning to the little evidence there is, and that will be allowed in a civil case. The Walker study, however, will almost certainly not be allowed as it is unpublished and has severe limitation

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