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Politics of Mitochondrial-PDD

15 Aug

For most people reading this blog, the story of Hannah Poling is very familiar. She was diagnosed with a condition called “Mitochondrial-PDD” by Richard Kelley of the Kennedy Kreiger Institute (*according to the document David Kirby blogged)

That, of course, is not what makes her well known. A year ago, I doubt many if any readers here would have heard of Mitochondrial-PDD. What makes her well known is that her case before the Federal Court of Claims (the “vaccine court”) was conceded by the U.S. Department of Health and Human Services (HHS).

What did they say? According to David Kirby’s post:

In sum, DVIC has concluded that the facts of this case meet the statutory criteria for demonstrating that the vaccinations [Hannah Poling] received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder. Therefore, respondent recommends that compensation be awarded to petitioners in accordance with 42 U.S.C. § 300aa-11(c)(1)(C)(ii).

The HHS conceded that vaccines caused an injury. In specific, the injury was an “aggravation of an underlying mitochondrial disorder”

It’s worth asking a series of questions at this point, I think

Q) Do all mitochondrial disorders result in autistic features or autism?
A) No.

Q) Do all the children in the 30-child study have vaccine injury?
A) No. It appears that Hannah Poling is unique in that group.

Q) Is mitochondrial medicine a highly specialized field?
A) Absolutely.

Q) Are autism doctors/researchers experienced with mitochondrial disorders?
A) Only a few, and not likely to the depth that the mitochondrial doctors/researchers are

Q) Is anyone going to look at the potential role of vaccines with mitochondrial disorders?
A) Yes.

And that is a key point that deserves some extra attention. Dr. Poling in his letter to the NEJM noted that

Also commendable is the new 5-year research plan of the National Vaccine Advisory Committee, which will entail the study of minority subpopulations, including patients with mitochondrial disorders.

In doing so, he cites the Centers for Disease Control and Prevention’s Immunization Safety Office Scientific Agenda: Draft Recommendations.

Which states:

CISA has formed a working group to identify key research questions and consider study methods related to mitochondrial disorders and immunization, in collaboration with partners.

CISA being the “Clinical Immunization Safety Assessment (CISA) Network”

The document further states as the first lines of the first two bullet points under this proposed study:

Mitochondrial disorders are a heterogeneous group of disorders characterized by impaired energy production.

and

Children with mitochondrial disorders commonly present with a range central nervous system findings.

*Again, note that autism/autistic-features are not the only outcome of mitochondrial disorders.

*I think this proposed study is a good idea. The government has conceded a case, mitochondrial doctors state that the question is open as to whether vaccines could be a stressor that causes a metabolic crisis.

People are pushing for this to be a part of the IACC’s Strategic Plan.

Why?

A group of people, experts in vaccine safety studies, are already going to look at the whole question of the potential role vaccines and mitochondrial disorders. Why carve out the even smaller subset with autism? Or, to put it more directly, why call for a second study, and, at the same time, leave out people who don’t have autism?

The answer is simple: politics. People want the idea of vaccine induced autism in the Strategic Plan. To do so, they are willing to ignore the fact that the study is already being planned and, worse, they are willing to sacrifice a large segment of the potential target population.

It’s just not right. Let the correct groups do the correct study. It’s in the planning stage. If people really care about the question of vaccines potentially causing crises in people with metabolic disorders, support the CISA study.

Why do I have a feeling this isn’t going to happen?

* added on edit.

Kirby, wrong on the radio

14 Aug

First there was the world tour (well, to London). Then there was the national tour (well, around a day’s drive from NYC, or thereabouts). Now, we had David Kirby, live by phone on the radio!

The talk is broken into two hours. Mr. Kirby starts at about 50 minutes into the first hour. And, he doesn’t waste time. He instantly moves into getting it wrong.

First he says that anyone who thinks that the science is on the side of saying there is no link isn’t keeping up with the science. This is because (un-supported assertion coming up) “new stuff comes up virtually daily” coming in from major universities around the world.

Well, yes, new stuff is coming in daily from major universities around the world. There’s all sorts of stuff coming in on a multitude of areas, so, I guess he’s right. But, there isn’t stuff coming in daily to support the vaccine/autism concept. Take the last 5 years. With stuff coming in virtually daily, there should be over 1,000 “stuffs” (nice that he didn’t say “research” or “papers” or “results”, but “stuff”). Did anyone else listen to the Autism Omnibus? Did you notice over 1,000 stuffs being presented, or did you, like me, hear a few studies that may or may not support the idea?

OK, that isn’t a biggie. He moves on quickly into…come on we all can all guess….that’s right! Mitochondria! And, right off the bat, he gets it wrong.

He brings up that just yesterday from the UMDF (good group from what I can see) about the research from the Newcastle and Virginia Polytechnic Institute that Kev and Kristina noted recently.

Mr. Kirby mentions that the study noted that 1 in 200 have a “DNA mutation that may confer mitochondrial dysfunction” and “..this is exactly what Hannah Poling had when she got 9 vaccines in one day.”

OK. Now the facts. The study indicates a number of specific, measurable mtDNA mutations that might lead to mitochondrial disorders. Only one mtDNA mutation has yet been found with Hannah Poling–and this is not one of those studied in the recent paper. A major piece of David Kirby’s arguments so far has been that the mtDNA mutation that Hannah Poling and her mother have is benign. The dysfunction results, according to David Kirby’s interpretation of his source, is in Hannah Poling’s nuclear DNA.

As an aside, Mr. Kirby’s stance has been that the Hannah Poling type of dysfunction is inherited from the father (an apparent misinterpretation of it’s own). I bring this up to point out even more–David Kirby knows that there are major differences between the recent study and the kids in the upcoming 30-kid study that describes children with conditions similar to Hannah Poling (with the exception of any vaccine trigger, but that gets glossed over by Mr. Kirby too).

It is worth reading this comment yesterday from Prometheus.

One thing he notes is that a number of the people identified in this study had mtDNA mutations linked to Leber Hereditary Optic Neuropathy (LHON). You don’t have to go farther than the name to realize that an “optic neuropathy” isn’t “exactly what Hannah Poling had…”

Do I dare listen to hour two?

Mitochondrial Disease in the news again

13 Aug

Before I start I want to thank Prometheus who explained this in as plain language as he could. If I’ve made any errors then they’re mine, not Prom’s.

OK, so, as Kristina has already blogged, Mitochondrial Disease has raised its head into the autism world again. A new study has reported that prior to previous thoughts of a prevalence of 1 in 5000, it may actually be as high as 1 in 200.

Of course, that has also prompted a HuffPo post from David who wants to bring our attention to the fact that there are no studies that say that vaccines don’t cause mitochondrial disorder and hence (with the right sort point mutation) autism. David states that prevalence estimates range between 7 and 20% for mito causing autism. That’s not actually correct. In terms of published science its between 4 and 7%. There are suspicions amongst some researchers that it may go as high as 20% but nothing is published yet.

But back to this new study. David _seems_ to be implying that 1 in 200 people with mito disorders means that between 7 and 20% of 0.5% (1 in 200) of people have mito induced autism (0.001% if we go with David’s unpublished 20%).

But that is not the case. This study is not claiming that 1 in 200 people have a mitochondrial induced _illness_ . It is saying that:

In conclusion, at least one in 200 healthy humans harbors a pathogenic mtDNA mutation that potentially causes disease in the offspring of female carriers.

Key phrase – ‘in the offspring’.

According to the UMDF (United Mitochondrial Disease Foundation) there is only a 1 in 4 chance that even two parents who share the same gene mutation (autism in our case) will produce a child affected with the disorder.

So are the study authors claiming that 1 in 200 could have a mito disease? No, they’ve shown that one in 200 people has _a_ mutation in a mitochondrial gene that (_if_ it were homozygous – could lead to a disease).

So, to establish prevalence for a single gene (which theoretically induces autism in our example) we are looking at:

0.005 * 0.005 * 0.25 = 0.00000625 (1 in 160,000)

(0.005 is 1 in 200. 0.25 is 1 in 4).

Thats quite a lot different than 1 in 200.

Reading the study, you’ll find that what the authors found was that 15 of 3168 (0.47%, 1 in 211) newborns they studied had one of ten types of mutation seen in mitochondrial diseases. Of these 15, the authors were able to find 8 maternal blood samples to determine if these were new (de novo) or inherited mutations. Of the eight, three of the mutations (37.5%) were not seen in the mother’s mitochondrial DNA, suggesting that they were new mutations.

Taken altogether, this suggests that – had maternal blood samples been available for all fifteen children with mitochondrial DNA mutations, that 5.6 of them (0.17%; 1 in 568) would have been new mutations.

Note that none of the newborns – even those with mutations in their mitochondrial DNA – and *none of the five mothers who were found to have mitochondrial mutations were reported to have mitochondrial disease*. What the authors mention as their concern is that couples considering having children be made aware of the risks of mitochondrial disease and that testing for the more common mutations leading to mitochondrial disease be available.

Bottom line: having the mutation does not equal having the disease.

This is an unbelievably complicated area. We’re talking as lay people about an area even the experts talk about as barely mapped out. I am not suggesting David intended to mislead people with the 1 in 200 figure I merely want to highlight the fact that it is not as cut and dried as that.

If you liked this post, thank Prometheus. I could not have written it without his generous help.

Jon Poling and Bernadine Healy

7 Aug

As Kev has noted, Dr. Jon Poling has a Letter in the most recent issue of the New England Journal of Medicine.

As I read Kev’s piece I knew I wanted to make a comment. But as I saw that comment would be really long I saw that it would end up looking more like a mini-blog post. Since I have the keys to the car, as it were, I figured I’d go straight to the blog post.

Dr. Poling makes mention of Dr. Bernadine Healy’s interview at CBS. He states that he agrees with her statement:

“I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show. . . . If you know that susceptible group, you can save those children. If you turn your back on the notion there is a susceptible group . . . what can I say?”

All those dotted lines just begged for someone to look at the parts cut out.  The parts in red below are what Dr. Poling used for his quote. [edit: sorry, the red shows up in the editor, but not the post]

Healy said: “There is a completely expressed concern that they don’t want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people. “First of all,” Healy said, “I think the public’s smarter than that. The public values vaccines. But more importantly, I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show.”

and

“What we’re seeing in the bulk of the population: vaccines are safe,” said Healy. “But there may be this susceptible group. The fact that there is concern, that you don’t want to know that susceptible group is a real disappointment to me. If you know that susceptible group, you can save those children. If you turn your back on the notion that there is a susceptible group… what can I say?“

Dr. Poling says he agrees with her. A HUGE question in this community involves the parts Dr. Poling left out: that “[t]here is a completely expressed concern that they don’t want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people.

Dr. Healy threw the conspiracy theorists a huge bone with that statement. It was a big statement to make and one that is left completely unsupported.

As an aside–this is my biggest complaint about Sharyl Attkisson. Given the nature of the statement and the ramifications of it, she should have asked Dr. Healy for sources or some way to back that statement up. The fact that Ms. Attkisson didn’t and, in fact, helped lead Dr. Healy through her (unsupported) claims gives a lot of credence to the idea that Ms. Attkisson is promoting her own agenda rather than trying to report a story.

But, back to the post at hand: Does Dr. Poling agree with all the statements? Because, he should realize that people will assume he does and blog posts and internet discussions will appear with people generalizing to “Dr. Poling agrees with Bernadine Healy”.

Consider this, Dr. Healy stated that there “…is a completely expressed concern…”. Note the present tense.

Dr. Poling states in his Letter “Also commendable is the new 5-year research plan of the National Vaccine Advisory Committee, which will entail the study of minority subpopulations, including patients with mitochondrial disorders”. He cites this document: “Draft ISO Scientific Agenda for NVAC Vaccine Safety Working Group, April 4, 2008”

Let’s not quibble on the fact that Dr. Poling’s statement implies that the idea of a study is already accepted, when it is a draft. I think we can all agree that the study is very likely going to happen.

Notice the date: April 4, 2008. The Vaccine Safety Working Group recommended looking at people with mitochondrial disorders. (another aside, Dr. Poling makes a big case, joined by Mr. Kirby, that Hannah Poling has a dysfunction, not a disorder. Is the CDC going to look at the wrong subgroup, those with disorders?)

OK, back to the date: April 4, 2008. The date of Dr. Healy’s interview: May 12, 2008.

Dr. Healy’s statement that there (present tense) “…is an expressed concern….”

Not only is the statement completely unsupported….I’m at a loss for the words here. Should I use, “erroneous”, “creates a false impression”, “ignorant of the recent history in the very subject she was discussing”?

So, I, for one, would like to hear Dr. Poling’s opinion on all of Dr. Healy’s statements. I fear that I will not like the result, but at least we’d have all the facts.

(note: I made some edits after posting–just changing a few words to make it read better)

Jon Poling on Paul Offit

7 Aug

Jon Poling writes a letter in the NEJM that says:

Offit’s remarks about Hannah’s case are not evidence-based. He has no access to my daughter’s personal medical records, legal documents, or affidavits. In contrast, physicians from the Department of Health and Human Services (DHHS) who studied this information recommended that the government concede Hannah’s case. The clinical history Offit presents contains significant inaccuracies, and the resulting conclusions are consequently flawed.

This paragraph lies at the very heart of the mystery surrounding Hannah Poling’s diagnosis, concession and the subsequent media-frenzy.

There are two documents regarding Hannah Poling from which all medical information has been forthcoming.

1) Concession Report (This document has been removed due to the possibility of it being illegally obtained). If people really wish to read the document for themselves it can be founf here, at the Huffington post

2) Zimmerman Case Study

These two documents – and only these two documents – have informed *everyone’s* opinion. Aside from these two documents, there is nothing else (aside from Hannah Poling’s medical records). If anyone believes that not to be the case, I challenge them to either link to them or have the Poling’s release them. The Special Masters have made it very very clear that all that needs to happen for *all* records to be released is for the Poling’s solicitor to write and ask.

….in the case that is the subject of the media reports, if the parties who supplied documents and information in the case provide their written consent, we may then be able to appropriately disclose documents in the case.

Until the Polings elect to do this very simple action, they have to assume that people will write about what is available. They will also have to put up with the fact that people like me find it very, very suspicious that they repeatedly claim what they simply cannot back up and then refuse to release information that could clear these issues up straight away.

The Case Report contains _all_ the information necessary to make a judgement on whether:

a) Hannah Poling was diagnosed with autism (she was)
b) Hannah Poling was injured by vaccines (she was)
c) Hannah Poling’s autism was caused by vaccines (it was not)

How do I claim point c) as true? Easily. One takes the symptoms listed in the Case Study as being those caused by vaccines and compares them to the DSM (IV) criteria for autism.

fever to 38.9°C
inconsolable crying
irritability
lethargy
refused to walk
waking up multiple times in the night
having episodes of opisthotonus
no longer normally climb stairs
Low-grade intermittent fever
generalized erythematous macular rash
spinning
gaze avoidance
disrupted sleep/wake cycle
perseveration
expressive language was lost
chronic yellow watery diarrhea
appetite remained poor for 6 months
body weight did not increase
decline on a standard growth chart
atopic dermatitis
slow hair growth
generalized mild hypotonia
toe walking
normal tendon reflexes.

I have emboldened the items which match the DSM (IV). I’ve italicised the items which are repeated.

Hannah Poling’s Case Study was authored by four people. One was, of course, Jon Poling. The other authors are:

John Shoffner. In an interview in Scientific American, Shoffer agreed that the scientific evidence presented in the case did not make enough of a case to warrant compensation. He went on to say:

Shoffner notes that parents and advocates looking to impugn vaccines as triggers for autism—or mitochondrial disease—need direct, not just circumstantial, evidence. “If you were sitting in a waiting room full of people and one person suddenly fell ill or died or something,” he says, “would you arrest the person sitting right next to them?”

….

Jon Poling, says Shoffner, has been “muddying the waters” with some of his comments. “There is no precedent for that type of thinking and no data for that type of thinking,” Shoffner says.

Its worth noting that John Shoffner – unlike Jon Poling – is a mitochondrial specialist.

Andrew Zimmerman: When I attempted to get Zimmerman’s comments about the case, I received the following reply:

Dr. Zimmerman…….is not able to publicly discuss this patient. As a participant in this case, the family provided consent for Dr. Zimmerman to share information with the court, but we do not have parental consent to discuss the patient publicly – as we are bound by HIPAA privacy regulations, as in any healthcare setting in the U.S.

Why? If the Poling’s are so very keen to make an _accurate_ case then surely, giving permission to the doctors involved is the first step? What is it they don’t want Zimmerman to say?

Richard E Frye, as far as I know has not made any public statements on this case.

The report from Dr Offit was not inaccurate. It was accurate to the information we have. If there is more information then I ask the Poling’s once more to _release_ it. They are legally able to and if they really believe in what they claim then they should be doing it right now. Why aren’t they?

Sharyl Attkisson's long history of anti-vaccinationism

1 Aug

As blogged by Mike, Liz, Autism News Beat, Kristina and Orac, CBS reporter Sharyl Attkisson seems to the prime suspect in the matter of how a fax sent to CBS News by Voices for Vaccines turned up on the Age of Autism blog less than 1 day later.

This matters. Reporters are supposed to be independent. They are supposed to give a balanced view. The very act of forwarding this fax to Age of Autism simply confirms that someone at CBS News, mostly likely Ms Attkisson, is deeply affiliated with Age of Autism. This makes her conflicted and she is totally the wrong person to be investigating the autism/vaccine hypothesis.

I went looking to see what else I could find to support my opinion that Ms Attkisson is someone who is not a reporter, but someone presenting her opinion in the name of investigative news. I found plenty.

Take this ‘interview‘ with Rep. Dave Weldon about the Poling case. I put the word interview in single quotes because it really isn’t an interview, its more a series of questions to allow Weldon to trot out a series of inaccuracies supportive of the idea vaccines cause autism. This is the sort of journalist who would ask God ‘tell me God, do you believe in creationism?’ And then give God a five minute run to explain how he does.

She was also the CBS employee (it seems wrong to keep saying she is a reporter) who interviewed Bernadine Healy in which the former Philip Morris shill said we should re-examine the autism/vaccine idea.

Over on the ‘No Mercury’ website, there is a long list of videos of Ms Attkisson (35 in total, dating back to March 2002) of which all seem to be ‘investigations’ into vaccines and other pharma related activities.

This piece which relates some of the most common and mind-numbingly stupid antivax canards around is just about the clearest indication of her loyalties. Anyone who states the following is not impartial and should not be investigating this story:

Non-profits which dispel any vaccine/autism/ADD link have ties to vaccine makers.

How the Hidden Horde were hidden

1 Aug

One of the (many) controversies within the autism community is the question of the hidden horde. The basic argument is:

1) Autism diagnosis have ‘increased’ massively in recent years. Prevalence now stands in the UK at approx1 in 100 and approx 1 in 150 in the US.

2) Something(s) must have caused this large scale increase.

This is where the division point is. Devotee’s of the ‘autism is vaccines/TV/mobile phones/whatever’ ideas say that the increase is not in diagnosis but in autism itself. That there really is a massive increase since the early 90’s in the amount of autistic people. They call this ‘the epidemic’.

People like me think that there may be a small ‘real’ increase but it is very small and what we are seeing is the effect of (to quote an authority on the subject):

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

…..

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.

…..

Still, these rates may not be proof of an epidemic. Why? Because the old rates were either inaccurate….or based on different definitions of autism than the ones we use now.

Interestingly, in the Autism Omnibus hearings, the families are now arguing (after years of ‘epidemic’ talk) that the amount of children allegedly poisoned by vaccines is so small as to be undetectable. Hardly a hallmark of an epidemic.

One of the arguments used by people who believe there has been an epidemic of autism is to say ‘if there has _not_ been an epidemic, then where are all the adult autistics?’ meaning that if the rate of autism has always been 1 in 100 or 1 in 150 then there should be an equal number of adult autistic people to children.

Its a logical thought but it doesn’t take into account one crucial fact; as far as I know, *no* epidemiological study has tried to count the adult autistic population in any country. So we have no real idea how many adult autistic people there are.

We have some clues – such as the 2004 Scottish audit that revealed that 45% of local authorities in Scotland considered adult prevalence grossly underestimated. For example, Perth and Kinross commented:

Figures for adults reflect the national findings that the numbers known to services/diagnosed represent a significant underestimate of those individuals likely to be affected. For example day centre managers locally consider a number of people to be on the spectrum who have had no formal diagnosis.

And this year, the UK Gvmt announced the would be undertaking the first ever audit of autistic adults in England.

But we do have the odd clue thrown to us now and again that shows where the so-called Hidden Horde might be. As the Scottish Audit suggests, they live amongst us, unrecognised or wrongly diagnosed.

Two recent studies from the Netherlands have shed a bit more light on what may be happening with adults.

In ‘Autistic Spectrum Disorders in Adults‘, the abstract states:

The expression of impairments in social interaction, communication, imagination and mental flexibility changes during development into adulthood.

Autism spectrum disorders in adults may mimic, or be overshadowed by, other psychiatric disorders.

Almost a direct agreement with the Perth and Kinross statement from the Scottish Audit.

The second paper ‘Recognition of autism spectrum disorders in adults‘ has an Abstract worth quoting in full;

Autism spectrum disorder was diagnosed in three adults. The first patient, a married man aged 41, was referred to a psychiatrist with ‘impending burn-out’. The second was a 32-year-old male student with schizophrenia and a depressive disorder who was referred to a centre for autism because a friend of his mother’s knew someone with Asperger’s syndrome. The third patient was a 25-year-old woman with a ‘fixation on food’ who was referred by her general practitioner to a psychiatrist for evaluation of longstanding use of antidepressant medication. Autism used to be thought of as a condition of childhood. Only recently has the diagnosis and treatment of autism spectrum disorders become the focus of attention in adult psychiatry. It is made all the more difficult as during development into adulthood, the expression of disorders of reciprocal social interaction, communication, imagination and repetitive stereotypical thinking and actions, change.

This again shows how autism can be ‘masked’ and how diagnostic tests suitable for children may not be suitable for adults. It also touched on another key issue – that only recently have adults begun to be looked at. It also thirdly touched on another issue – comorbidity. All these three people had ‘other’ psychiatric issues. I have no idea if their diagnosticians considered their autism to be comorbid or if their other diagnoses were considered comorbid to their autism. In the end it doesn’t really matter, except in one important regard: By failing to help these people properly when they were children, did their other psychiatric issues grow so pronounced that their autism was ‘eclipsed’ until a suitable diagnostic test was undertaken? If that is the case then we need to be very aware that there is indeed a large population of adults who have not got a full and proper diagnosis and thus are missing out on help they need and deserve.

Thimerosal and Autism on Trial: Closing statement by Mr. Matanoski

31 Jul

This is a portion of the government’s closing argument given by Mr. Matanoski. It is found on the audio from Dwyer called Day02-PM3.

First I want to point out on the specific causation … lawyers are kind of slick they move things around, they kind of play a shell game. When I heard the comments about a specific causation case it made it sound like respondent has a burden here to show what actually caused it. Actually the burden is on the petitioners to show that the vaccine caused autism. And respondent doesn’t have to show that it’s genetic in origin.

And I think that the comments about Dr Leventhal’s testimony on that point are a little off the mark. What Dr. Leventhal was saying, essentially, that most practitioners, most folks who study autism as a profession believe that it’s largely genetic in nature at that’s where the research has been directed and in fact it’s been fruitful in that regard. There’s still much more to do. But everything that has come out has pointed to genetics as very strongly associated with autism and most of the research that has been done has shown that autism would have a prenatal course. That it can essentially be seen, that the preconditions, if you will, for autism are in place beginning before birth, in most instances.

I think there also is a little bit of a misconception about what the force of Dr. Leventhal’s testimony was. He basically was saying that Colin’s case really is sadly no different than many of the cases that he sees, where there is a gradually emerging picture of difference, perhaps delays, but at least difference in the quality of behavior in the child as the child develops. It’s not necessarily apparent right from the start. That’s very rare. Most of the cases it’s apparent later and it may seem that a child has reached certain milestones has subsequently had trouble keeping those milestones. As the condition progresses there often is an improvement. That’s the natural course of the condition. What Dr. Leventhal was saying is, as time has gone on, more and more of the researchers have realized that if you look back in cases, that apparently seemed to have a normal trajectory and then there seemed to be a loss, that you see earlier signs and symptoms that all was not on a normal trajectory from the beginning.
That was the force of his testimony, and that testimony was backed up by other testimony by other testimony that the court has heard before he took the stand.
Dr. Lord who has specifically studied regressive autism made that point quite clear, that as this has progressed the concept of regressive autism has become more encompassing, that autism itself seems to have a progression where it appears that there is a loss but when one goes back, one sees that there is unusual, or differences in development earlier on in almost every case. And what Dr. Leventhal was saying is that as they gotten better, folks who do this for a living, folks who make their lives studying about studying autism they’ve realized that more and more of those cases they can see earlier on. And in very few instances when they’ve studied quite closely do they see that there isn’t some sign that the trajectory or the course is not the same as other children’s.

Dr. Mumper’s testimony which really wasn’t really much of the focus in the closing argument here. She seems to be relying on isolated lab results to come up to a conclusion that vaccines are the cause here. She’s been asked in this case and in other cases what would that pattern be, what do we need to look at? And in fact there doesn’t seem to be a particular pattern. In the King case certain test results were relied upon to draw the conclusion that thimerosal in vaccines were associated with autism in that case, or caused autism in that case. In the Mead case other results were looked at and thought to be, by Dr. Mumper, indicative that vaccines were causing, or evidence that vaccines were causing autism. And now in Colin’s case, we see yet a different pattern of test results being relied upon to reach that conclusion.

In fact those test results, with really no pattern, how can one say that there is any kind of clinical evidence from these test results that one can rely on to make that .. to draw those kinds of conclusions that Dr. Mumper is relying on.

And as you’ll see when you go through the testimony, we believe that she largely moved away from relying on any specific test result when questioned about each specific one she said that essentially that the mercury test result, the positive provocation, was really the only test that she had that showed that the mercury was there, and she was relying on to implicate thimerosal as a cause in this case, but then she admitted that she really didn’t know what the normal range would be for that test.
How can one say that this is an abnormal result when one doesn’t know what normal is?
Her testimony seems to be formed largely by the Defeat Autism Now world view which is that toxins and heavy metals are implicated in autism. And to use the example that Mr. Powers used of Tycho Brahe I think that comes to bear with her testimony as well. It doesn’t matter which test results she’s looking at it always comes back to a heavy metal or a toxin, when it could be that the acidosis that the lactic acid build up could be because the child was crying when the blood was taken. (35 min 30 sec)

…

I’m going to touch now on the general causation because that was a matter of some discussion by Mr. Williams. I see that the glutathione theory which is where we started with this general causation case seems to have dropped out. It wasn’t in the opening statement, it wasn’t in the closing statement. It seems that the theory of causation now is neuroinflammation and largely seems to be neuroinflammation alone. That was a theory that Dr. Kinsbourne recently advaced in this case. It obviously wasn’t present until just a couple of weeks before the trial in May.
This is something after six years in the making, this seems to have come up kind of at the very end.

Mr. Powers and Mr Williams have focused on the causation burden, and say that the information they have given on neuroinflammation meets that burden, that would be the causation burden under Althen and Grant, the specific criteria that they need to meet under that test that the court has articulated, the federal circuit’s has articulated.

Respondent starts a little earlier than that if you will in the calculation and that is about what evidence feeds into Althen and Grant. We start out with the analysis under Daubert about whether there is good scientific evidence to even meet that burden. So obviously the evidence that you have or the evidence that is being offered does not meet the criteria of good scientific or reliable evidence then you have nothing at all to test about whether you’ve met your legal burden under Althen.

Our position has been throughout this that the petitioners’ evidence that they have offered, the testimony that they’ve offered, fails to meet that standard of reliability that is set out under Daubert and that this court applies. Daubert stands for the proposition that there are not multiple kinds of scientific evidence. A kind for scientists to use and a kind for judges to use. There is only one kind of scientific evidence. It is the kind that scientists use. That is the kind that judges are supposed to be looking for as well. …

Kathleen Seidel’s neurodiversity weblog has more from the Dwyer case, including audio excerpts.

Elizabeth Mumper – Autism Omnibus, Dwyer vs HHS

When I heard Mr. Matanoski say, “when one doesn’t know what normal is,” it occurred to me that it could be used as a slogan or strapline for the autism/biomed organization that is led in part by Dr. Mumper.

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Elizabeth Mumper – Autism Omnibus, Dwyer vs HHS

25 Jul

Some highlights, courtesy of a Guest Blogger, er Transcriber 🙂

Beau Johnson DoJ lawyer: Neither the myelin basic protein nor the IGM neuro filament antibody test is diagnostic of any disease is that right?

Mumper: That’s correct.

Johnson: They are very nonspecific findings.

Mumper: That’s correct.

Johnson: And isn’t it true that these antibodies have been reported as elevated in normal individuals with no disease?

Mumper: That is true in some cases. Exactly.

Johnson: And because these markers were measured in the serum rather than the CSF they provide no direct evidence of what is going on in Colin’s central nervous system is that right?

Mumper: I guess I would quibble with how you get direct evidence, in this case in order to get direct evidence of neuroinflammation I guess we’d would really needed to have done a brain biopsy on him in 2002. I can tell you from personal experience that even wanting to look at CSF in children with autism for the presence of inflammatory markers is widely perceived as an invasive procedure. So those of us who might want to be able to document it more directly are constrained from doing so by standards of care criticisms. So we have to rely on other markers, and it’s not a direct marker but I would argue that a clinician would not have the ability to do a direct assessment in a living child.

Johnson: For whatever reason that evidence is just not present in this case, is that correct?

Mumper: That’s true

Johnson: Do you know what protocol Immunosciences used to perform these two lab tests?

Mumper: You know I don’t. I have visited the immunosciences labs on two occasions and talked to the director and viewed their facilities. But I am not a lab scientist. I can tell you that when I visited and had it explained to me it made sense at the time, but I could not reproduce the protocol.

Johnson: Do you know how Immunosciences established it’s references ranges?

Mumper: I do not know the details of that, no.

Johnson: Do you know whether these reference ranges take the age factor into account?…

Mumper: I do not think they are normed for children, but for things like neurofiliment antibodies and myelin basic protein antibodies the values for children would be expected to be less than people as they aged…

Johnson: But you don’t believe that these reference ranges are normed for children?

Mumper: I do not think that they are. That’s correct.

Johnson: Do you know if immunosciences lab ever been accredited by the College of American Pathologists?

Mumper: I do not know if they have. I do know that their work, their lab reports come disclaimers about use for research and careful clinical applicability and those types of things.

Johnson: Do you know if immunosciences is currently performing any clinical testing?

Mumper: I believe they are not.

Johnson: I’m going to show you what we’ve marked as respondent’s trial exhibit 14 and it is a letter that I found on the Immunosciences website.

Mumper: OK.

Johson: Doctor have you seen this letter before?

Mumper: Yes I have.

Johnson: And does this letter reflect that Immunosciences has in fact stopped performing clinical testing as of July 21, 2007?

Mumper: Yes, as i just testified to.

Johson: Do you know why it stopped performing clinical testing?

My understanding from talking to Dr. Vodjani and some health department officials, is that his lab was investigated for their testing as related to mold. Looking for mold evidence of chronic mold exposure as a potential cause of chronic illness. My understanding from Dr. Vodjani that the investigation was perhaps precipitated by a court case in which mold testing had been used and the plaintiff who had claimed damage from mold had won a huge settlement and the health department was concerned about the possibility of on the basis of that mold test and wanted to investigate the lab with regard to that.

Johnson: So its your understanding that the problems with Immunosciences lab were limited to its mold testing?

Mumper: That is my understanding, but I have not investigated all the depth of the investigation, nor read any of the official documents, so I really do not have full knowledge of that.

Johnson: I’m now going to show you respondents trial exhibit 15 which is another letter that I found on Immunosciences website.

Mumper: OK. Thank you.

Johnson: Doctor have you seen this letter before?

Mumper: I believe I have. Yes.

Johnson: Did you receive this letter since it is addressed to “Our valued clients and associates”? Was this sent to you?

Mumper: Yes.

Johnson: This letter is signed by doctor Vodjani?

Mumper: That’s correct.

Johnson: I believe you testified in May that you have an article in press (which has) Dr. Vodjani as the lead author?

Mumper: That is correct.

Johnson: Do you know what CLIA stands for?

Mumper: … I can’t remember…

Johnson: OK and just for the record it’s Clinical Laboratory Improvements Amendments of 1988 and we’ll just refer to it as CLIA for ease of reference.

Mumper: OK

Johnson: Do you know what CMS is?

Mumper: According to the letter it might be Centers for Medicaid and Medicaid Services?

Johnson: That’s correct. CMS regulates all laboratory testing on humans in the United States through CLIA in order to insure quality laboratory testing, is that right?

Mumper: Uhuh.

Johnson: Dr. Vodjani’s letter states in the third paragraph that “CMS had found deficiencies during a 2004 CLIA survey of Immunosciences that led it to conclude that the lab’s test results since 2002 may not be accurate and reliable.” Were you aware of those findings by CMS?

Mumper: Uhm, yes, since I got this letter.

Johnson: I’m not going to show you respondents trial exhibit 16. This is a letter from CMS. Doctor have you seen this letter before?

Mumper: Yes I have.

Johnson: Did you receive this letter?

Mumper: Yes I did.

Johnson: And this letter does in fact say at the beginning of the second paragraph on the first page that: We are writing both to inform you of the current sanction action and to alert you that test results that you received since June 2002 from Immunosciences lab might not be accurate or reliable. Is that what that says?

Mumper: I would like to add that… I did call Mary Jew as suggested in this last line. I can’t remember the details now, but I talked to three different people on the staff. I tried to get information about what particular concerns they had because I was trying to figure out for the labs that I had done on my patients if this were a global concern or if it was related to the mold or if there were tests that I was using that I may still be able to rely upon, and I was very frustrated in not being able to find out from those people who I think their hands were tied as far as talking about an ongoing investigation, what the problems were.

Johnson: We may be able to provide some of that information now. I’m going to show you now what is marked as respondents trial exhibit 17. And this is the CLIA annual laboratory registry from 2005. Have you seen this document before?

Mumper: No I have not.

Johnson: Look on page 5 of this document. Does this indicate that Immunosciences’ CLIA certification was being revoked due to condition level noncompliance?

Mumper: Uhm, cancellation of a approval to receive medicare payment due to noncompliance. Yes.

Johnson: Now I’m going to show you respondents trial exhibit 18. And these are actually excerpts from a much larger report. And this is the, a report from the survey that CMS did of this lab. … does that appear to be correct to you?

Mumper: Based on my thirty second review that does appear to be correct.

Johnson: If you’ll turn to the fifth page of the trial exhibit. This document lists a number of findings in connection with Immunosciences general immunology testing. Is that correct?

Mumper: It appears that that is correct.

Johnson: Were you aware that CMS noted problems at Immunosciences lab in connection with its failure to follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems in the pre-analytic systems?

Mumper: No I did not have access to that information.

Johnson: And were you aware that the CMS found that the laboratory
failed to determine calibration procedures and control procedures based upon established performance applications?

Mumper: No I was not aware of the specifics.

Johnson: And were you aware that the CMS found that Immunosciences laboratory failed to verify the continued accuracy of the test systems throughout the laboratory’s reportable range of test results? …

Mumper: … I was not aware of the specifics.

Johnson: And under sub paragraph I, the CMS found that the Immunosciences laboratory failed to establish the statistical parameters of the unassayed control materials used for it’s various in-house ELISA test systems?

Mumper: I was not aware of that.

Johnson: Ok and these findings all relate to Immunosciences general immune testing is that correct?

Mumper: It would appear that that is the case.

Johnson: And if you will look at the next to the last page of the trial exhibit. Were you aware that CMS found with respect to the anti MPB and neurofilament test in particular that Immunosciences failed to have written policies and procedures, for patient preparation, specimen collection, specimen storage and preservation, conditions for specimen transportation and specimen acceptability and rejection?

Mumper: And what was the date of that that it was not in place? Because it seemed to be on the website when you cited it earlier. And when we sent specimens in 2003 we were able to obtain written instructions about the specimens submitted, they came actually in the test kit.

Johnson: I believe this was from a survey from 2004 …

Mumper: What I was trying to explain to you that as a clinician the test kits came in a box, and there’re the tubes and a series of explanations about how the specimens need to be prepared. … So I can only testify as to what I know… we had procedures to follow when we submitted our blood samples in 2003.

Johnson: And all I’m asking you is that at the time that CMS performed this survey it found that those aspects of Immunosciences laboratory practice to be inadequate. Is that correct?
…

Johnson: Look at the last page of the trial exhibit…at the time it performed this survey with respect to the anti MPB and neurofilament test that Immunosciences failed to provide documentation the laboratory director’s review and approval for those procedures?

Mumper: It does suggest that there was no documentation to show his review and approval… so how much this was a matter of paperwork versus actual analysis, I can’t say.

Johnson: And Dr. Vodjani’s letter of January 16th, 2006 ,he indicates that Immunosciences had planned sue over the survey results.

Mumper: I believe he said he planned to vigorously fight or something to that effect …

(Special Master: And that was trial exhibit 15? …)

Johnson: We have a copy of the settlement agreement from that lawsuit it’s been marked as respondents trial exhibit… Focusing on paragraphs 1, 2 and 3. …

Mumper: OK

Johnson: It appears that one of the conditions of the settlement that Immunosciences would obtain accreditation through the College of American Pathologists or else it would voluntarily withdraw from the CLIA program and cease testing on human specimens, is that correct?

Mumper: That does seem to be the case.

Johnson: Based on the fact that Immunosciences is no longer performing clinical testing, isn’t it reasonable to assume that they did not receive accreditation through the College of American Pathologists…

Mumper: (interrupting) or that they chose not to pursue it I would think would be the two possibilities.

Johnson: Doctor based on this information do you have any concerns about the reliability of the Immunosciences test results?

Mumper: I was not aware that the MBP or neurofilament testing was under contention, and if that were the only thing that I was relying upon to make my judgement I would be concerned that I had over-read the labs. I would give relatively less credence or perhaps even be forced to discount those particular lab tests given  the information in the settlement agreement that I wasn’t privy to knowing the details of.

Johnson: The next test results that you discuss in your report are results from Great Smokies lab that purport to show abnormal glutathione, lipid peroxide and cysteine levels.  Is that correct?

Johnson: … That would have been when Colin was about 3 1/2 years old… So to the extent that these results indicate anything about whether Colin was under oxidative stress at the time … they don’t tell us if he was in oxidative stress at the time of his immunizations. Is that correct?

Mumper: That’s correct.

Johnson: These tests were blood tests is that correct?

Mumper: That’s correct.

Johnson: Do you know if these tests were normed for children?

Mumper: I do not know the answer to that question.

Johnson: And as you note in your report a number of other factors can explain oxidative stress such as poor nutrition. Is that right?

Johnson: Would you agree that a mercury efflux disorder is still a hypothesis at this point

Mumper: Yes.

Johnson: So low cysteine and plasma sulfate levels can’t be diagnostic of that disorder..

and those levels can be explained by a number of other factors is that right?

Mumper: That’s correct.

Johnson:… I’d like to go through all the mercury testing if you don’t mind.

…

Mumper: It would appear that 4-19-02 was the time of the very first visit to Dr. Bock. So there is not evidence that he would have been on a chelating agent at that time.

Johnson: And the result for this test of mercury was that it came back the non-detectable limit … Is that correct?

Mumper: Right.

Johnson: The next test that we found was the December 2002 test and that was a urine toxic metals test… although the report says that there was a chelating agent administered, you don’t believe there was, is that correct?

Mumper: Yes that’s correct.

Johnson: and the result shows no detectable mercury.

Mumper: Yes that’s correct.

Johnson: and the result shows no detectable mercury.

The next test was the December 22, 2002 …The next test was the December 22, 2002 test which is at petitioner’s exhibit page 90 and … this was post provocative test … and this test result showed that mercury was at 17 mcg per gram of creatinine. Is that correct?

Mumper: That’s correct.

…

Johnson: And the report indicates that DMSA was administered in connection with this test … and again the result from this test for mercury was nondetectable. Is that correct?

Mumper: That’s correct.

…

Johnson: There’s only test that showed mercury outside the reference range is that correct?

Mumper: That’s true.

The next test was the December 22, 2002 test which is at petitioner’s exhibit page 90 and … this was post provocative test … and this test result showed that mercury was at 17 mcg per gram of creatinine. Is that correct?

Mumper: That’s correct.

…

Johnson: And the report indicates that DMSA was administered in connection with this test … and again the result from this test for mercury was nondetectable. Is that correct?

Mumper: That’s correct.

…

Johnson: There’s only test that showed mercury outside the reference range is that correct?

Mumper: That’s true.

Johnson: And that was the provoked test from December 22, 2002. … Doesn’t Doctor’s Data say in bold right on the test report that reference ranges are representative of a healthy population under non-challenged or non-provoked conditions?

Mumper: That’s true.

Johnson: So we just don’t know what the normal range would be for a provoked test. Is that right?

Mumper: It is difficult to know…

David Kirby vs Accuracy

20 Jul

As I’ve said before, I like David Kirby personally. We exchange friendly emails. We even recently discussed the idea of having a private blog – readable by all but one that allowed only two posters (David and I) and no commenters. This would, I suggested, give us the opportunity to have a civil debate.

Unfortunately, David was too busy, which was a shame. However, the offers always open should he find a bit more time.

He did have time yesterday to blog a piece for the Huffington Post in which he discussed Amanda Peet and said she was ‘against the medical establishment’ for taking the stance she did. He cited a few things to support his point. I’d like to discuss these things but before I do I’d like you Dear Reader to take note: someone who was at the IACC meeting David talks about (he wasn’t there) will hopefully be posting their account of proceedings on LB/RB.

Anyway. Lets proceed. David’s first piece of rhetoric to support the idea Amanda Peet was against the medical establishment was:

A workgroup report of the IACC (the Interagency Autism Coordinating Committee, which includes HHS, CDC, NIH and others) says that some members want “specific objectives on vaccine research” included in the new, multimillion-dollar national autism research program, as mandated by Congress in the Combatting Autism Act.

I’m sure that some members do want this. Lynn Redwood and Mark Baxhill to be precise. As the upcoming IACC account will show, I don’t think any other IACC workgroup members were interested. (Please see this correction of an ignorant Limey’s take on the US system.)

I would also like to correct David on his characterisation of the Combating Autism Act. The Act contains no mention of vaccines. It specifies environmental research but the words ‘vaccine’, ‘vaccination’ ‘immunize’, ‘immunization’, ‘mmr’ or ‘thimerosal’ appear nowhere in the CAA. I hope David will correct his HuffPo piece accordingly.

Notes from the meeting indicate that workgroup members want federal researchers to consider “shortfalls” in epidemiological studies cited as proof against a vaccine-autism association (by Offit, Peet, et al); as well as a specific plan “for researching vaccines as a potential cause of autism.” The workgroup also says that the final research agenda should “state that the issue is open.”

Once again, David’s notes are coming from two people, Lynn Redwood and Mark Blaxill and indeed – they asked for all these things. The account of the meeting I have heard (from someone who was there) differed somewhat. As a flavour of how much the majority of the working group listened to Redwood and Blaxill, I enclose a teaser quote from chairperson Tom Insel:

“Lyn, your community is not the whole community and there are many people with well thought out concerns about ethics of the concept of prevention and if we want to be inclusive we will not do this.”

Back to David:

July 14, 2008 – Rep. Brad Miller (R-NC), Chairman of the House Subcommittee on Investigations and Oversight, (Committe on Science and Technology) writes to HHS Secretary Michael Leavitt to complain that current federal autism research “shows a strong preference to fund genetic-based studies,” even though there is, “growing evidence that suggests a wide range of conditions or environmental exposures may play a role” in autism.

I blogged that episode here. Suffice it to say that a _politician_ is not representative of the medical establishment. I would urge everyone reading this to read that piece as it suggests amongst other things that Generation Rescue and SafeMinds be responsible for a Board that would serve as a liaison between the IACC and parents of autistic people and autistic people themselves!. After reading that I would urge everyone to contact the following people to express your thoughts (politely!) to the decision makers:

HHS Sec Mike Leavitt (mike.leavittAThhs.gov)
NIMH director/IACC director Tom Insel (tinselATmail.nih.gov)
Everyone here: http://science.house.gov/about/members.htm

Once again, back to David:

Dr. Bernadine Healy, former head of the NIH and the American Red Cross and current Health Editor of US News & World Report tells CBS News that, “Officials have been too quick to dismiss the hypothesis as irrational,” and says they “don’t want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people.”

I still can’t get over the fact that David is using this person to back up his points! He continues to trumpet the opinion of Bernadine Healy who actually did assert that cigarettes do not cause cancer and worked closely with Philip Morris to do so. She also totally reneged on her stance on fetal tissue research when she found herself in the same camp as President Bush. In AoA language she’s a shill.

David then goes on to cite al three Presidential Candidates – as if a politicians opinion in an election year means anything! I definitely fail to see what any of them have to do with being part of the medical establishment.

Onwards:

March 29, 2008 – Dr. Julie Gerberding, Director of the CDC, speaking about the Hannah Poling case on CNN says: “If a child was immunized, got a fever, had other complications from the vaccines, and was pre-disposed with the mitochondrial disorder, it can certainly set off some damage (including) symptoms that have characteristics of autism.”

Er, so? I’m really not sure how this is a ‘point’ for David (or anyone else who thinks its supportive of the idea vaccines cause autism). If she’d said ‘yes, vaccines caused autism in Hannah Poling’s case’ (which no-one ever has by the way, despite statements to the contrary) than _that_ would be a bombshell. As it was Dr. Gerberding was simply speaking what is obvious.

David again:

The CISA Network (Clinical Immunization Safety Assessment), headed by the CDC, receives a report from top researchers at Johns Hopkins University that 30 typically developing children with mitochondrial dysfunction all regressed into autism between 12 and 24 months of life. At least two of them (6%) showed brain damage within one week of receiving simultaneous multiple vaccinations.

Now, I can’t answer this as much as I’d like to. I have spoken to people involved in the preparation and writing of this report (as has David) and I was given two take home points from our email chat:

1) The science is _not yet complete_ . The paper is not published.
2) The authors feel ‘disappointed’ in the slant David has put on their work and are loth to discuss it with anyone else due to that. I was told that David might be rather surprised when everything comes out later in the year.

David once more:

Medical Personnel at HHS concede an autism case filed by the family of Hannah Poling in the federal Vaccine Injury Compensation Program, before the claim can go to trial as a “test case” of the theory that thimerosal causes autism. Though portrayed by some (ie, Dr. Offit) as a legal decision, it is in fact a medical decision. HHS doctors admit that the “cause” of Hannah’s “autistic encephalopathy” was “vaccine-induced fever and immune stimulation that exceeded metabolic reserves,”

First of all, I beg to differ with David. The concession was a legal one. By definition the phrase “autistic encephalopathy” does not exist in mainstream science so if it was used (a fact which has yet to be determined – I invite David once more to link through to the document where this is stated). A simple test of its non-existence is to search for the phrase on PubMed. I got:

Quoted phrase not found.

So we have a multitude of uncertainties here:

1) Nowhere (except in David’s writings) can we find evidence of HHS apparently saying “autistic encephalopathy” caused Hannah Poling’s autism.

2) The phrase itself (“autistic encephalopathy”) does not appear in the entire PubMed database, thus causing me to doubt its use by the medical establishment.

3) Is the concession legal or medical? If a diagnosis does not exist but is used in a legal document then by definition it must be legal – thats my opinion anyway.

David also mentions a HHS Vaccine Safety Working Group meeting but I know next to nothing about that so can’t comment.

I have to say that based on the above, David seems to be attempting nothing more than an intellectual ‘land grab’ i.e. to attempt to paint those who claim vaccines cause autism as part of the medical establishment and those who stand against them as not. Its a good political idea but I don’t think its going to work. There are just too many holes in this particular boat for it to float for long.

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