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Age of Autism on chelation cancellation

18 Sep

I posted yesterday on the cancellation of the NIH study that was going to be examining chelation’s efficacy as an autism treatment.

What I said was that it was a good idea and it is. The simple facts are that autistic children are not toxic. The only labs that consistently find autistic children to be toxic are the labs Dr Jeffrey Brent identified as ‘these ‘doctor’s data’ type of laboratories’. In fact, its probably worth repeating his testimony about these labs:

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

A: Absolutely not….there is no test in medicine that is more valid for for assessing mercury toxicity than an unprovoked urine mercury concentration. [For Jordan King and William Mead]…their unprovoked urine concentration is exactly in the normal range.

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

The standard way of chelating autistic kids is to do a provoked challenge test. As Dr Brent says – you’re supposed to have increased levels with provoked examples.

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

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

To sum up, the labs that consistently find a need to chelate autistic kids use the wrong sort of tests. When expert Toxicologists such as Brent do the proper ‘gold standard’ testing, the results are normal 100% of the time.

Its as simple as pie. You use the wrong test, you’re going to get the wrong results.

And yet, over on the Age of Autism website, they’re getting very angry about this cancellation. The angry opening paragraph to a recent post highlights the lack of logic in their stance:

So who canned the NIMH chelation study as “too dangerous?” Children are given huge doses of chemotherapy and radiation in a desperate effort to save them from cancer – fully knowing the side effects themselves can be deadly. It’s a fair risk most parents are willing to take to help a sick child.

Chemo is a standard treatment for cancer. It is medically indicated. Chelation is not a standard treatment for autism. It is not medically indicated. The reason it is not medically indicated is because there is no evidence metals are linked with autism.

There is a chain of logic that must be followed. If you want a type of treatment to be assessed for its efficacy, then your first step is surely to establish that there is a medical necessity for that treatment. If there isn’t then what you are doing is inflicting a completely unnecessary procedure on a child. In this case, a procedure that has been known to cause lasting brain injury in animals (rats).

The comments on AoA go from the bizarre:

So, why do I sense Pauly PrOffit’s grubby, greedy little fingers on this? This smells like something that he would do

To the paranoid:

THIS HAS BULLSH*T WRITTEN ALL OVER IT!!!

To the conspiracy-esque:

Notice the studies they WON’T do:
Studies on the effects of chelation.
Studies comparing unvaxed and vaxed children for autism.
Studies to find the misdiagnosed adults with autism to prove there’s been no increase.

When is everyone going to wake up to what’s happening?

NB – a study to find adults in Scotland is being planned if I recall correctly.

No-one considers the most likely reason for this cancellation:

a) There is no evidence metals cause autism
b) There is evidence chelation can cause injury
c) There is therefore what any rational person would see as an unacceptable amount of risk to children.

And of course we have the usual ‘my child recovered’ stories. Why do these stories never seem to get written up as case studies I wonder? We’re told there are thousands of them – where? Where in the medical literature are they? Apparently there are lots of rogue paediatricians who believe the antivaxxers so why aren’t they doing case studies on the multitudes of autistic children who are now totally recovered?

Personally I think that is what has bullshit written all over it.

Chelation study 'called off'

17 Sep

CHICAGO – A government agency has dropped plans to test a controversial treatment for autism that critics had called an unethical experiment on children.

The National Institute of Mental Health said in a statement Wednesday that the study of chelation (kee-LAY’-shun) has been discontinued. The statement says the agency decided the money would be better used testing other potential therapies for autism and related disorders.

The study had been on hold because of safety concerns . A study published last year linked a chemical used in the treatment to lasting brain problems in rats.

The treatment removes heavy metals from the body and is based on the fringe theory that mercury in vaccines triggers autism — a theory never proved and rejected by mainstream science.

Yahoo News

Back in June, I blogged about the possibility of the delayed chelation study being released. It had been delayed due to the same ethical concerns that now seem to have scuppered it. I can only view this development with relief. As I said at the time:

Lets be clear. This study is being touted about for one reason and one reason only – to appease the anti-vaccine/autism groups. In the mainstream medical/scientific community (and notably in the toxicology community) it is well known that autistic kids aren’t toxic.

Click on the link above to see some quoted testimony from Dr Jeffery Brent, world renowned Toxicologist. His opinion on the need for chelation of autisitic children is thoroughly discussed. Basically, when you do the provoked, non-standard tests from labs that make a good living from charging for these tests, they come back positive. When experts like Dr Brent do the gold standard tests, 100% of the time they come back normal.

There is no reason to chelate autistic children.

Arthur Allen – vaccine skeptics vs your kids

11 Sep

Whilst, I’m not sure that the people Arthur is writing about are skeptics as I understand the term (having a scientifically valid basis for not accepting an argument or position), I know what he means. And he’s right that it is this group of people vs the health of people everywhere.

The sub-header is even more accurate ‘immune to reason’. One only has to take a look over at the recent rantings on a certain blog we all know about where the latest themes are:

1) Presidential candidate Barack Obama is now a big pharma shill because he told one of them: “I am not for selective vaccination, I believe that it will bring back deadly diseases, like polio.”.

2) The latest study in a long line of studies that show once more there is no link between MMR and autism is both flawed and exonerates one of their heroes.

3) Kathleen Seidel is wrong because….uh….well, no one knows why but she must be. Apparently.

Immune to reason indeed.

As Arthur points out, there is a great deal at stake:

…in the last trimester of her pregnancy, Helena Moran caught a cough that she couldn’t get rid of. She figured she’d picked up the germ—whatever it was—from one of her patients at a Boulder dentist’s office. But the real nightmare began after her daughter, Evelina, was born: The baby began to cough and cough, and then she’d curl up in a little ball and turn blue. At the emergency room, she was diagnosed with whooping cough. She spent the next five weeks in intensive care and suffered permanent lung damage.

Now, this isn’t *all* the fault of the so-called autism community, but as I’ve discussed before, I’m ashamed to say that a lot of it is.

….the movement got a huge boost from the controversy over the mercury-laden preservative thimerosal, which some theorized might be linked to autism. That link has been disproven—by, if nothing else, the fact that autism rates remained steady after pediatricians and public health authorities told manufacturers to stop making thimerosal-containing childhood vaccines in 1999. But the anti-vaccine movement has kept going, finding ever new reasons to distrust immunization.

The are a lot of zealots out there who have fed upon the autism community. A parent who might not believe vaccines case autism listens to horror stories and reads links sent to them from such places of quackery as whale.to who are nothing to do with the autism community but who market their own brand of ridiculousness (the owner of whale.to believes dolphins can manipulate gravity and has the pictures to prove it!) regarding vaccines and the autism parent greedily sucks it down.

Arthur discuss the practice of abusing ‘religious exemption’ by these people:

Right now, in many states, all it takes to get an exemption from vaccine requirements is signing a form. Some, including a group of doctors at Johns Hopkins University, have proposed making it harder—allowing a philosophical exemption only after parents demonstrate a good-faith effort to educate themselves.

But an article I read in yesterdays ‘Edmond Sun’ stated:

….a person “who has reached the age of majority and is mentally competent to do so may justifiably refuse immunizations for himself or herself, but may not impose this refusal on a child, who has no choice in the matter.” Courts have consistently upheld this principle.

That makes sense to me. Who would want to refuse such a simple thing that has no link of any kind to autism?

Arthur closes with the following:

But while questioning authority is healthy, facts are facts. If vaccines really were responsible for autism, it would be too much to ask parents to do the altruistic thing. But more than a dozen studies have failed to discover such a link—and not a single legitimate study has shown that one exists.

He’s spot on. All the celebs and all the money in the world cannot change that simple fact. We need to get past this. Those who believe autism is caused by vaccines need to put up or shut up. They are holding up progress on autism research and causing the health of our societies to suffer.

I urge readers to visit Arthur’s piece and read the comments. The first few demonstrate exactly the sort of mindset Arthur is talking about – the one’s who bring shame on the autism community. They truly are immune to reason.

Autism's False Prophets

5 Sep
Autism's False Prophets. Bad science, risky medicine and the search for a cure - Dr Paul Offit

Autism's False Prophets. Bad science, risky medicine and the search for a cure - Dr Paul Offit

Available now – Amazon UK, Amazon US, Amazon Canada.

NB – Dr Offit is donating all profits from this book to autism research.

So. Here’s the short review: holy shit, this is a good book, you need to buy it and pass it on. Make your local library stock a copy or three.

Here’s the longer review.

The book begins – after a dedication that made me grin from ear to ear – with a quote so acutely apposite that its like Professor Szasz said it to perfectly sum up the book and the last ten years:

When religion was strong and science weak,
men mistook magic for medicine.
Now, when science is strong and religion weak,
men mistake medicine for magic.

I knew Dr Offit got a lot of hate mail. What I didn’t know was the extent and the utter viciousness of it. From the books prologue:

Whilst sitting in my office, I got a phone call from a man who said that he and I shared the same concerns. We both wanted what was best for our children. He wanted what was best for his son, giving his name and age. And he presumed I wanted what was best for my children, giving their names and ages and where they went to school. His implication was clear. He knew where my children went to school. Then he hung up.

I can empathise. I’ve had cowards directly or indirectly threaten my kids too. We know who I’m referring to.

Offit refuses to feel sorry for himself and goes on to describe in painstaking detail the circumstances surrounding the rise and fall of the two main vaccine/autism ideas: MMR and thimerosal. He paints a vivid and (in my experience) completely accurate portrait of Andrew Wakefield as a vainglorious but weak king who simply doesn’t have the courage to admit his own wrongdoing. Offit recounts an anecdote from one time Wakefield supporter, John March. The setting is a meeting between March, lawyer Richard Barr and Andrew Wakefield, called to discuss their litigation strategy.

[March]…presented his data….he told them there was no difference between the children with autism and controls, he suddenly found that the meeting had moved on to a different subject. It was a Damascene conversion for him. He realised that Wakefield could not hear negative results.

Offit (rightly) does not spare Wakefield at all. This is the man who is literally, the architect of the whole idea that vaccines cause autism. Offit quotes Wakefield in an interview with US show ’60 minutes’ in 2001:

I would have enormous regrets if [my theories] were wrong and there were complications or fatalities from measles.

In Feb this year, the Gaurdian reported:

There were 971 cases of measles in England and Wales in 2007 in contrast to 740 the previous year — a rise of over 30% and the highest jump since records began in 1995, said the Health Protection Agency (HPA).

Two teenagers have died of measles in the UK. One in 2006. One in 2008. Are there any signs of Wakefield’s profound regrets?

Offit goes on to study the thiomersal hypothesis from the beginning of the noughties to 2007 and the Cedillo hearings.

It is a strange feeling reading an account of events that you have been so intimately involved in talking about for the last five years. From the bizarre Bernard et al paper and the outright insistence of certain writers and founders of autism/anti-vaccine groups that autism was just another name for mercury poisoning, through Kathleen’s demolition of the Geier’s credibility and science, all the way to Jenny McCarthy’s Oprah showboating.

The main feeling I got was how much a lot of this was now _history_ – as Offit clearly and devastatingly argues, the science has spoken. Vaccines don’t cause autism. And as I blogged about recently, it seems pretty clear that the US public are (rightly) more concerned about the possible resurgence of killer diseases such as measles than they are to keep flogging the dead horse of autism anti-vaccinationism.

But my all time favourite part of the book was the final section. My friends were interviewed at length and the clearest feeling I had from this section was – you threw everything at us. Your money, your influence, your political power. We’re still standing. You threatened us with legal action – we’re still standing. You called us and our children names and threatened their well being. We’re still standing.

Paul Offit has written a real page-turner of a book here. One that should matter to every single autistic person and every single parent of an autistic person. Ultimately, its a book written to support autistic people. Why? because it seeks to close the door on a debate with no scientific merit. Will it do that? Possibly not, we are not dealing with rational people by and large. But what it will do is once and for all dispel the notion that ‘the parents’ who believe vaccines cause autism must be listened to solely because they are parents. Amen to that.

"I don't believe that"

29 Aug

To promote his new book ‘Autism’s False Prophets. Bad science, risky medicine and the search for a cure’ (Amazon UK, Amazon US, Amazon Canada) – and look for a review here very, very soon – Dr Paul Offit went on the US radio show Talk of the nation ‘Science Friday’ earlier today.

It turned into a microcosm of exactly the sort of scenario that those of us who have blogged about this for some time have come to expect. A question, a reasoned response and then a flat statement of denial.

The show began with the show host (who’s name I didn’t catch) asking why people weren’t vaccinating. Offit gave the answers we all know.

Then the show took a turn into what could’ve been a blog argument on any one of a number of blogs – including this one. A caller called Chantelle/Chantal came on the line and essentially asked Dr Offit how it could possibly be safe for a newborn to receive up to 1250micrograms of Aluminium and that there hadn’t been any studies on how Aluminium could affect a child. She said –

that is why I will not follow the CDC’s guidelines….my child will be vaccinated on my own schedule.

(Her emphasis)

Dr Offit answered with a brief overview of Aluminium’s role in a vaccine is and then told Chantal the simple truth – one that I blogged about fairly recently – there’s more Aluminium in between 50 days to a years worth of breast milk than in the entire vaccine schedule:

We live on the planet Earth. If we choose to live on the planet Earth that means we’re going to be exposed to light metals like Aluminium and heavy metals like mercury.

Chantal then seemed (I wasn’t entirely clear) to want to compare kids with kidney issues (who clearly need to be careful with Aluminium) with _all_ kids. As Dr Offit stated – that’s hardly a valid or real-world comparison.

Then the host asked a great question:

Chantal, is there anything Dr Offit could tell you that would change your mind

.

The answer: “Absolutely not”.

And there we have it. That is the rock bottom of every single argument the autism/antivax brigade peddle. Screw the science, screw the facts. I just don’t want to hear it and I will put my fingers in my ears and make ‘la-la’ noises until you go away.

Chantal then goes on to justify this ridiculous stance by saying (a la Jenny McCarthy) that there is no independent science supporting vaccine safety. This is tosh. A study this is submitted for peer review to a science journal is peer reviewed by independent experts from the relevant field all over the world. And then, the ultimate test of impartiality takes place – the science is either replicated or it isn’t. Replicated science _has to be_ by definition be independent of its author. How could it not be? If we want to see the opposite of reproducible science, then that can be arranged.

Chantal goes on to say that Dr Offit ‘makes millions’ from speaking about the safety of vaccines. A bizarre claim that I’m pretty sure is not true. He then goes on to describe the ‘high bar’ that vaccine studies must pass. Studies with tens of thousands of participants.

Next, Chantal tries the ‘too many too soon’ dogma that we’ve become recently familiar with. She claims ‘six at one time is absurd’. Dr Offit gives Chantal some facts to play with on that score too:

…the bacteria that live on their nose [a newborn], or the surface of their throat are literally in the trillions. Those bacteria have between 2,000 and 6,000 immunological components and consequently our body makes grams of antibody to combat these bacteria….The number of immunological challenges contained in vaccines is not figuratively, it is literally a drop in the ocean of what you encounter every day.

(Emphasis his, slight paraphrasing)

Chantal then got a bit snappy.

So tell me…how many studies have been done on vaccine loading, which means five or six vaccines at one time. How many?

Dr Offit’s answer:

Somewhere in the vicinity of the high hundreds to low thousands.

Chantal:

I don’t believe that.

Boom! There it is again – she simply doesn’t believe it. Screw the facts, screw the evidence, my fingers are going right back in my ears…la-la-la-la…I can’t hear you…

Dr Offit explains further that any vaccine in the US has to undergo something called a ‘concomitant use study’. These are to establish that vaccines work OK together.

You have to show that vaccine does not interfere with the immune response or the safety of existing vaccines and similarly that existing vaccines don’t interfere with the immune response or the safety of the new vaccine

Dr Offit said ‘high hundreds to low thousands’ of studies (Chantal didn’t believe that remember). A simple Google search reveals over 1,800 results for that phrase. Searching PubMed for ‘concomitant vaccine’ returns over 700.

Dr Offit closes the interview by saying he doesn’t believe all parents are as close minded as Chantal. He uses a nicer phrase than that as he’s a gentleman but that’s how I see it. Close minded to the point of obstinate stupidity.

For some people, it truly doesn’t matter what the facts are, or what the science is. They just stick their fingers in their ears.

La-la-la.

Kelli Ann Davis doesn't get it

23 Aug

Over on Orac’s blog, a discussion is ongoing about (you guessed it) thiomersal.

One of the usual antivax canards is played beautifully by Kelli Ann Davis when she says:

So Phoenix Woman [another commenter], can you explain to me what the skull and crossbones is doing on the Material Safety Data Sheet (MSDS) if thimerosal is not a poison

This is top notch antivax stupidity. Not only does she entirely miss the point of ‘Phoenix Woman’s’ comment (which was not that thiomersal was not a poison) she also infers that the fact that thiomersal is a poison means that its automatically going to cause damage. She conveniently forgets – or doesn’t care – that the adage ‘the dose makes the poison‘ always applies.

And of course we have the scare tactic of mentioning the skull and crossbones.

Thing is, there are plenty of other Toxic substances used routinely in medicine. Lets have a look at Warafrin – which is at one level rat poison and at another level an anticoagulant. And hey – look at that – the MSDS sheet has a skull and crossbones on it.

Common clinical indications for warfarin use are atrial fibrillation, the presence of artificial heart valves, deep venous thrombosis, pulmonary embolism, antiphospholipid syndrome and, occasionally, after myocardial infarction.

And also

To this day, coumarins are used as rodenticides for controlling rats and mice in residential, industrial, and agricultural areas. Warfarin is both odorless and tasteless, and is effective when mixed with food bait, because the rodents will return to the bait and continue to feed over a period of days until a lethal dose is accumulated.

So, lets spell it out nice and slow for Kelli Ann – the dose makes the poison.

And so, lets have a look at the current dose levels of thiomersal in vaccine shall we?

For an ‘average’ person of 154 pounds, there is 6mg (miligrams) – or 6000 micrograms(µg)) of mercury occurring naturally in the body. So, roughly, a person of 25 pounds has 1mg (1000µg) of mercury (or, to put it another way, 1 pound of body mass gives us 40µg). A healthy newborn weighs on average about 7.5 pounds which gives a mercury body burden of approximately 303µg of mercury.

When we look at the FDA thimerosal content of vaccines currently mandated and add them all up we see that we get 239.2µg of mercury – way under what occurs naturally in the body of a healthy 7.5 pound newborn.

Now, this is not even a fair comparison. I have added up all the vaccines for a child of 6. Including doubling up on doses of a vaccine made by different manufacturers. Quite obviously a child won’t get a Td jab from two different manufacturers at one time. I have also included all the flu jabs – again, no one will get all flu jabs in a single flu season.

The maths is quite clear. There is more mercury existing naturally in our bodies – even those of a 7.5 pound newborn – than the combined total of every single thiomersal containing vaccine on the market.

Conflicts of interest, whats good for the goose…

28 Jul

As recently blogged by Autism News Beat, CBS Evening News (an American news outlet) recently performed an investigation into ‘how independent are vaccine defenders’? Something of an exercise in futility, it concluded that:

Ideally, it [vaccines] makes for a healthier society. But critics worry that industry ties could impact the advice given to the public about all those vaccines.

So, CBS say that the vaccine schedule makes for a healthier society but that the advice given about vaccines could impact the advice given.

Uh…so? Lets go through that again. It makes for a healthier society. Would CBS rather it didn’t? Bizarre.

Specifically, they attack the AAP, the Every Child By Two website and Paul Offit. The AAP has conferences funded by vaccine manufacturers, ECBT takes money from the vaccines industry….in fact, hold on…CBS say in their report (assume breathless excitement reporter voice)

Every Child By Two, a group that promotes early immunization for all children, admits the group takes money from the vaccine industry, too…

Oh do they? They admit it do they? Under the rigour of your intrepid journalism no doubt? Except that information is clearly available for all on their website. I do wonder if anyone from CBS even spoke to ECBT.

And of course there is Paul Offit – the official poster boo-boy for anti-vaccinationists everywhere. The man who dares to make a profit from his inventions! CBS took him to task for holding a patent on a vaccine. Shall we look at another man who made a patent application for a vaccine? That’s right – Andrew Wakefield. Except, unlike Dr Offit, who made no attempt to hide his association with the vaccine he was responsible for, Andrew Wakefield’s solicitors said that ‘Dr Wakefield did not plan a rival vaccine’.

How about other people who make a tidy income from the anti-vaccine industry? The Geier’s maybe who invented their own IRB to make sure that their ‘science’ was unhindered by ethical considerations…..or maybe Dr. Jay Gordon who thinks that the Polio vaccine could be replaced by simply not eating cheese. How much do you charge your clients Dr Jay? How about Laura Hewitson who’s husband works for the Wakefield owned Thoughtful House and who seems to be part of the Autism Omnibus hearings….how independent can her science be? How about the ARI/DAN group who are led by people who clearly have no clue at all as to the medical science they are making a large profit on. How much do each of these people make? How about Rashid Buttar who lists non-existent memberships on his CV and who charges upwards of $800 for a 1 hour consultation fee and who’s ex-patients report being out of pocket by about $20,000 in about a year.

Its up to you Dear Reader – are these things we should be worried about? Are these things CBS should be worried about? Are these conflicts of interest? Does the act of making any sort of money either from treating people or from existing business interests mean you cannot and should not talk about these things? Should we assume that only certain people have an agenda?

In my humble opinion, it should only become an issue when attempts are made to hide these things. Or deny them when they are clearly true. That cannot be said of the AAP, ECBT or Paul Offit. Maybe CBS should be asking to see the balance sheets of DAN doctors or vaccine litigation specialists. What have they got to hide? Maybe CBS should be inspecting the credentials of people who claim to be able to cure autism and reverse old age. Maybe CBS should be looking at the disturbing increase in ties between autism/anti-vaccinationists and scientology.

But I would think in the meantime that CBS will take the easy route of producing crap that informs no one about anything. Lets hope it doesn’t turn around and bite them on the arse eh?

Elsewhere
Orac weighs in too.

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.

Legal Bombshell in Autism Omnibus Proceeding!

17 Jul

This is a Guest Blogged piece, written by a beloved legal expert – Clem Heckenberry.

In what can only be described as a legal bombshell, the Petitioners in the Autism Omnibus hearings seemingly withdrew four of its highest profile experts to support the various claims that say that vaccines cause autism. The experts are James B Adams, Mark Robin Geier, Boyd E Haley and Andrew J Wakefield. The ‘New’ experts are those we recognise from the testimony offered thus far. Indeed, this reporter can find no further mention of Adams, Geier, Haley or Wakefield as expert witnesses for the petitioners.

If this case was in the civil arena, the withdrawal of four experts of such magnitude would in all likelihood result in sanctions, a directed verdict or the total failure of the case as in the time Jeff Bradstreet (another expert for the petitioners) left his clients high and dry. There’s no way to spin this as a positive development for the petitioners.

Drs. Adams, Geier, Haley and Wakefield were apparently unwilling or unable to testify about the substance of their beliefs and ‘science, leaving only the report and testimony of Dr. Asphosian, a scientist who has not devoted significant time to the question of mercury and autism. (At one point in his career it’s alleged that Dr. Asphosian claimed that the argument that ‘the dose makes the poison’ was wrong.)

I spoke with various people about this development and they also agreed that this was knocking out some of the petitioners strongest pillars that autism is related to thimerosal or MMR. All those I talked to considered it difficult to underestimate the near-hilarious reputation of these four experts in the field of autism. Their apparent unwillingness to testify on these matters suggests they cannot sustain their previous assertion that thimerosal or MMR has anything to do with autism.

Although the parties are continuing to submit motions and it appears unlikely that there will be a decision this summer, the withdrawal of these experts are likely to have profound consequences.

UPDATE: There’s a good chance this might be satire, although the facts are true..

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