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Did you think that was it? More MMR bull arrives

25 Feb

The recent decision by the Special Masters in the Autism Omnibus case that MMR/thiomersal can’t cause autism according to evidence presented by HHS and lack of evidence presented by Master et al hit the mercury militia hard. They genuinely thought they were going to win.

But, of course, there was a ‘Plan B’ ready just in case. Today we see its co-ordinated unveiling. In part one, that scientific heavyweight Jenny McCarthy, together with her partner Jim Carrey released a press release:

Jenny McCarthy and Jim Carrey’s Los Angeles-based non-profit autism organization, today announced that the United States Government has once again conceded that vaccines cause autism…

Both the inference and the statement of fact are in error here. The United States Government has _never_ conceded that vaccines cause autism. I challenge McCarthy and Carrey to show the statement that contradicts me. Team McCarrey’s announcement today also fails to establish that the US government have conceded vaccines cause autism.

Of course, the historical reference is to Hannah Poling. As has been discussed numerous times, Hannah Poling’s autism has not been shown to have been caused by vaccines. I have asked various people, including David Kirby numerous times to provide back up to their belief the government have said vaccines caused ehr autism. They cannot. They have not. In point of fact, only three of Hannah Poling’s symptoms that were described by both HHS and a scientific case study co-authored by her father as those being caused by vaccines, tally with the DSM (IV) criteria for ASD.

The case of Hannah Poling is a red herring.

As we shall see, so is this ‘new’ case.

Team McCarrey go on:

The announcement comes on the heels of the *recently unsealed* court case of Bailey Banks vs. HHS

If by ‘recent’ one means July 2007 then they may have a point. But I don’t think ‘recent’ can really apply to a case which has had open access to it (Kathleen blogged about it in May 2008) for about a year and a half. So why lie? To add to the drama, whip up mystery and confusion of course.

But now we get to the meat of it – the actual ruling. In Part II of today’s coordinated attack, RFK Jr and David Kirby blogged about this case.

Kennedy jumps straight in:

…last week, the parents of yet another child with autism spectrum disorder (ASD) were awarded a lump sum of more than $810,000 (plus an estimated $30-40,000 per year for autism services and care) in compensation by the Court, which ruled that the measels-mumps-rubella (MMR) vaccine had caused acute brain damage that led to his autism spectrum disorder.

Whereas David is a tad more circumspect:

Is vaccine-induced ADEM (and similar disorders) a neurological gateway for a subset of children to go on and develop an ASD? That question will now become subject to debate…Special Master Abell had no trouble linking MMR to ADEM in Bailey Banks’ case. But linking his ADEM to PDD/ASD was more difficult.

So, lets rewind a little. Bailey was awarded a payment because he was found to have suffered vaccine induced damage. Cool. Thats the system working as it should – a child is damaged by a vaccine, they get compensated. What the MMR vaccine was established to have done in Bailey’s case was cause something called ADEM. What McCarthy, Carrey, Kennedy and David are now all claiming is that this ADEM resulted in an ASD diagnosis.

They rest their case on the conclusion of Special Master Abell:

The Court found that Bailey’s ADEM was both caused-in-fact and proximately caused by his vaccination. It is well-understood that the vaccination at issue can cause ADEM, and the Court found, based upon a full reading and hearing of the pertinent facts in this case, that it did actually cause the ADEM. Furthermore, Bailey’s ADEM was severe enough to cause lasting, residual damage, and retarded his developmental progress, which fits under the generalized heading of Pervasive Developmental Delay, or PDD. The Court found that Bailey would not have suffered this delay but for the administration of the MMR vaccine, and that this chain of causation was not too remote, but was rather a proximate sequence of cause and effect leading inexorably from vaccination to Pervasive Developmental Delay.

On the fact of it, it looks like they are right. But they aren’t.

Bailey has a diagnosis of PDD-NOS (Pervasive developmental disorder not otherwise specified) which is indeed a subtype of ASD.

However, whilst PDD-NOS is a subtype of ASD (alongside autism etc). ASD is in turn a subtype of PDD. As the National Dissemination Center for Children with Disabilities notes, the term PDD actually refers to a category of disorders and is not a diagnostic label. So when Abell refers to Bailey’s vaccine induced ADEM as leading to PDD he is not referring to ASD. He is referring to PDD. Not PDD-NOS, which _is_ a subtype of ASD but PDD, of which ASD itself is a subtype. Or, to quote Wikipedia:

PDD-NOS is often incorrectly referred to as simply “PDD.” The term PDD refers to the class of conditions to which autism belongs.

Abell made something of a worrying statement in his conclusion. I’ll quote from David Kirby:

Abell also chided MacDonald for his assertion that “all the medical literature is negative” in regards to an ADEM-PDD link. “However, soon thereafter, he corrected this statement by clarifying, ‘I can find no literature relating ADEM to autism or [PDD],'” Abell wrote. “It may be that Respondent’s research reveals a dearth of evidence linking ADEM to PDD, but that is not the same as positive proof that the two are unrelated, something Respondent was unable to produce. Therefore, the statement that ‘all the medical literature is negative’ is incorrect.”

Was any evidence that there _is_ a link between ADEM and PDD produced? I’ll have to read through more carefully. Its worrying that the SM is reduced to ‘chiding’ a witness for such a thing as a clarification of terms. Wasn’t he more worried that there was an extreme lack of evidence linking ADEM to PDD at all? Did Petitioners produce _any_ evidence that there was a link? A quick search of PubMed reveals nothing for ‘ADEM autism’ or ‘ADEM PDD’. I don’t want to second guess a Special Master but it does make me worried that maybe he simply didn’t get some of the science.

David also lists some of the symptoms of ADEM:

Symptoms usually appear within a few days to a couple of weeks. They include: headache, delirium, lethargy, seizures, stiff neck, fever, ataxia (incoordination), optic nerve damage, nausea, vomiting, weight loss, irritability and changes in mental status.

None of these say autism to me. I also did fine one ADEM paper in PubMed together with measles:

We report a seven year old male with measles associated acute disseminated encephalomyelitis (ADEM) despite having received measles vaccination in infancy. The diagnosis was based on serum antimeasles antibodies and MRI brain. The patient was managed with high dose corticosteroids along with supportive measures. There was a complete neurologically and physica recovery.

There was a complete mental and physical recovery. This doesn’t seem to indicate causation or autism.

In my opinion based on what I’ve read so far here we have a little boy who either already had or was on the cusp of PDD-NOS. He was also vaccine damaged resulting in ADEM….and thats where the link breaks down. It might be enough for 50% and a feather but the fact that PDD is not PDD-NOS, together with the total lack of any evidence I can see to link ADEM to PDD, let alone PDD-NOS speaks volumes.

One Click Hacks and Homophobes

22 Feb

As blogged by Anthony at Black Triangle the One Click Group – who say they are:

…a British-based international health advocacy pressure group and worldwide raw news hub…

described Brian Deer and his involvement with the MMR case thusly:

By all accounts a gay man and therefore unlikely ever to have to face the multiple vaccine risk agonised over by parents from around the world in relation to their children…

Nice. Sounds to me like they’re a bunch of homophobic stupidniks to me. As Anthony says:

Even if Deer is homosexual, it does not necessarily mean he has no stake in vaccine safety. Homosexuals are not some mysterious alien presence in our society, they have families which include small children. Homosexuals can even adopt children.

Unless you’re a Daily Mail reading OneClickTwit of course.

They are anti-vaxxers of course and really really don’t like Brain Deer much at all. This makes the JABS loonies recently in evidence in the monumental ‘Wakefield‘ post on this blog big, big fans of theirs naturally. Amusingly, these same JABS loonies have been complaining about the horror of Brian Deer _making_ the news and then _reporting_ on the news regarding Wakefield. Not that he has, but thats how they see it. The amusing thing is that one of the straplines of the OneClickGroup is:

We not only break the news, we also make it.

They also proudly boast of receiving ‘7,000 – 33,000 hits per day’…..woah…big time baby!

Just for fun, I ran LB/RB, JABS and OneClickGroup through the Compete analyser which analyses Unique Visitors (a much more reliable indicator of traffic than ‘hits’):

Sadly, you’ll notice only two lines there. OneClickGroup didn’t generate enough statistics to be measurable.

So, this member of the antivaxosphere, carried on from homophobic attacks on Brian to carrying an alleged ‘out of control’ attack from Brian on their owner/Director/whatever – one Jane Bryant. Here’s how its ‘reported’ on the OneClickGroup website:

Brian Deer Is Out Of Control

On Monday 7 April 2008, with the Defence presentation for Dr Andrew Wakefield at the General Medical Council MMR Vaccine Trial UK concluded, Brian Deer went berserk in the Press Room of the General Medical Council. This incredible aggressive behaviour is not that of a responsible and objective journalist with ethics covering a story in the public interest….I entered the GMC Press Room to discover Deer holding court over what he clearly perceived to be his case with the assembled media. Comfortably sprawled in lounging lizard position

Out of control…went berserk…incredible aggressive…holding court…lounging lizard…

and these descriptives are used before Bryant even _begins_ her description of Brian’s behaviour. Thank goodness for impartial media!

When she does get to that transcript (which has clearly been edited) it reveals _more_ editorialising and less fact.

When asked if Deer was the complainant and if this was his case with the GMC, Deer simply exploded. Springing to his feet, placing his body inches from mine and invading my space, Deer proceeded to threaten, to rant and to jab his fingers close to my face.

Brian Deer: “No! I’ve not complained! I’ve got letters from the GMC saying I’m not the complainant! Ask me the question again! Ask me and I’ll tell you!”

Deer continued ranting: “So, you’ve this, um, dribbling idiot here,” gesturing towards investigative writer Martin J Walker who has exposed Deer’s vaccine activities in the aforementioned Complainant, “pumping out this information and you believe it and this is what this whole MMR thing has been about! Andrew Wakefield enjoys giving evidence! You get these CLOWNS who just MAKE THNGS UP as they go along!”

I wondered if any other members of the press ( the ones Brian Deer was holding court over) had reported on this behaviour from Brian. That of threats, invasion of body space and jabbing his fingers close to Bryant’s face. Funnily enough, the answer is ‘no’ – nobody from the other members of the press Brian was apparently ‘holding court’ over when Bryant arrived noticed this. I can find no record of this behaviour in any mainstream media. And there were plenty there. How odd.

Its also worth noting that Brian was right. He is _not_ the complainant and he _does_ have letters from the GMC to establish that fact.

Next in Bryant’s highly selective account was the issue of who was paying Brian. At the end of which despite not mentioning any intimidation she reports:

At this point, people in the foyer piled in to the doorway of the Press Room to witness a fully grown male journalist attempting to intimidate a press colleague and deploying classic bully boy techniques against a very small woman on her own.

What bully boy techniques exactly? Answering her questions? Or is this more of the finger jabbing and space invasion that only Bryant witnessed and reported on? Lets not forget that Bryant also directly accused Brian of threats (‘Deer proceeded to threaten’) – no sign of a threat so far…lets continue.

Jane Bryant: “Why are you being so abusive?”

Brian Deer: “Of who?”

Jane Bryant: “Of the parents, of the children…”

Brian Deer: “What parents have I been abusive to?”

Jane Bryant: “You have just been abusive to me.”

Brian Deer: “Are you a parent?”

Jane Bryant: “Yes, I am a parent, I’m also press. Why are you being so abusive? Get away from me, Brian! Stay away from me.”

With Brian Deer out of control, Editor Polly Tommey of The Autism File showed support.

Polly Tommey: “Stay away from her Brian, keep away. Look, you’re a journalist, give her some space.”

Is Bryant parent to an autistic child? I can’t find anywhere that says she is.

Anyway, notice how Tommey of the antivax magazine ‘The Autism File’ also chimes in. These two poor cowering ladies who are in terror of a man answering their questions. I’ll say it again. I can find nowhere else that reports on the eminently newsworthy story of two women being threatened by an out of control Brian Deer – other than OneClickGroup itself. In a room full of the media no one takes notes, no one turns on their dictaphones and no one turns on their cameras. The _only people_ who capture this threatening, out of control Brian Deer are a couple of anti-vaxxers. What an amazing coincidence.

At this point in the proceeding, Brain Deer calls for security. He has to call them again later that day.

Later on in her piece, Bryant accuses Brain Deer of damaging the equipment of Polly Tommey.

Interestingly, the only person’s equipment that got damaged that day was that of Polly Tommey, Editor of The Autism File. Having left her belongings in the Press Room whilst she went to conduct an interview in the foyer, two of the recordings destined for Autism One Radio were purposefully deleted by someone. I will leave One Click readers to surmise just who the perpetrator might be, who had the access and the motive.

She also says:

The GMC has now categorically on the record refused to deny Brian Deer’s complainant status. They will simply not comment on Deer. So much for Deer’s GMC back up

Which, as we know is simply incorrect. I look forward to Bryant’s correction on her massively popular website.

If you want to see the depths and lengths that St Andy’s fan Club will stoop to, look no further than this. The word of a homophobic woman who seems to mislead people about her status as parent to an autistic person (assuming I’m right about that) and who wants to paint a man as an out of control tyrant when I suspect he was just a bit pissed off.

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Another misinterpreted study. This time they are misusing Israel data

22 Feb

Kent Heckenlively from the Age of Autism blog has recent post up on a study out of Israel on autism. In it, he notes that the “incidence” of autism in Israel actually dropped for a few years

What’s curious, though, is how this population of medical professionals who were supposedly good at identifying and diagnosing autism in 1999, then had a drop of more than 40% by 2002. Did they lose their newly-acquired skills in a sophomore slump? If I’m not mistaken, those were also the years of the vaccine-autism “panic” which began shortly after the publication of Dr. Andrew Wakefield’s article in the Lancet, linking the MMR shot and autism. Was there a drop in vaccination rates in Israel after the Wakefield publication? Did vaccination rates then subsequently go up in later years?

Here’s the figure.

Figure 1 from Israel Autism Paper

Figure 1 from Israel Autism Paper

Let’s do this quickly. The interpretation is nonsense. Start from the fact that Google Ph.D.’s seem to rarely check simple facts using google.

Enter “Israel Vaccine Schedule” into google. The top link is a WHO site.

Take a look at how the MCV (Measles Containing Vaccine) coverage has varied with time.

MCV uptake was increasing steadily up until 2003, when it dropped for two years.

Year MCV Uptake Measles cases
1998 97% 8 (Year of Wakefield paper)
1999 97% 14
2000 97% 36 (year “incidence” starts to drop in Israel
2001 96% 19
2002 98% 2
2003 95% 124
2004 84% 116 (year MCV uptake drops)
2005 96% 2
2006 96% 9
2007 96% 539 (measles spike)

Obviously the drop in autism “incidence” in Israel isn’t related to measles vaccines–the drop in uptake happened after the drop in autism “incidence”. Note that I put “incidence” in quotes. The paper isn’t measuring incidence. I’ll get to that later.

In 2007, something else happened. Measles cases spiked. Yep, 3 years after vaccination rates dropped, there’s a big spike in measles. Are they connected? Possibly. I would want to see information like how many of the 539 measles cases were children 4-5 years old, for example.

Other issues with the paper.

1) they don’t give “incidence” or “prevalence”, really. They are giving the number of people who are getting services for autism. Sorta like the California DDS data. Why is this important? We don’t know how easy it is to qualify for services. We also don’t know how hard they are looking for people with autism. It isn’t the same thing as a measure of all the people with autism.

2) Note that 97.5% of the people with autism are Jewish. About 25% of the population in Israel is non Jewish (if Wikipedia is accurate). So, is being Jewish a “risk factor”, or is there an issue with access to services.

3) According to Mr. Heckenlively, the prevalence of Autism in Israel is 1 in 2,400. I guess low prevalence numbers invalidate studies when they are in Denmark, but not when they are in Israel?

By the way, consider that low “incidence” value for Israel. Now look at their vaccine schedule (I am only listing those for very young children)

DTaPHibIPV: 2,4,6,12 months
HepA: 18, 24 months
HepB: Birth, 1, 6 months
MMR: 1 year, 6 years

Hmmm. Remember how Israel has a low autism “incidence”?

Look at that first big combo vaccine–5 vaccines at once. I guess combo vaccines don’t cause autism, eh?

HepB is given at birth. I guess that isn’t a risk factor either, eh?

Separating out the combo vaccines, I count 28 different vaccines given by 24 months in that vaccine schedule. So much for “too much, too soon”, eh?

Of course, this is stretching the Israel data waaaay too far. Of course we can’t say that the Israel data prove that HepB, combo vaccines and too-many-too-soon are not risk factors. Just like we can’t use these data to support Dr. Wakefield’s hypotheses.

I’m glad to see autism studies come out of new countries. Let’s not use data with big limitations to support our preconceived ideas, shall we?

(note, I made corrections shortly after publishing. These did not change the content substantially. I did change the title to clarify that it is not the Israeli researchers who are misinterpreting the data)

Who carries the authority?

19 Feb

The recent Omnibus decisions are hoped by some to stem the tide of rabid anti-vaccine beliefs espoused by people who shame the name of autism advocacy. On Salon, Rahul K. Parikh says:

In the case of autism, science and reason have too often failed to reach people. And consequently they have turned to the courts. For those of us who believe in the scientific method, the autism trials have not been necessary. But judges, unlike doctors in their cold white coats, still command a great deal of respect, and so perhaps the court’s recent ruling will sink in and finally persuade parents to regain their confidence in vaccines.

Never happen Rahul, never happen. These same anti-vaxxers have already began spin campaigns not only against the legality of the verdicts but against the three Special Masters themselves. To this group, the Special Masters command no respect whatsoever and neither do their verdicts. Take this piece of rampant stupidity from Barbara Loe Fisher:

The U.S. Court of Claims special masters are hampered from considering evidence which has not yet been published in the medical literature regarding potential associations between vaccines and the development of regressive autism

I don’t see how it is possible to make a dumber statement. What she’s saying is she wanted the Special Masters to look at unpublished science. As is well known, unpublished science is not like an unpublished novel. Unpublished science means its science that has not been put through the rigour of peer review, not had its methods examined to ensure they are transparent and reproducable, not had its conclusions reviewd to see iof they are accurate and not had its data examined to see if it is usable. This unreviewed, unpublished ‘science’ is what got us to this stage in the first place. A ten year multi-million pound, dollar and euro effort to close down bad science.

So how does she and people like her get away with saying such things? *Just because they can* . Because people believe extremes and people believe celebrities. People believe bloggers and people believe those who have shared (or think they have) experiences. I’m not saying its right but its true. If anyone genuinely believes this ruling will shut the door on these people they’re wrong. For confirmation of that you need look no further than Rolf Hazlehurt, father of one of the kids who made up the three test cases from the Autism Omnibus.

If we win, we keep going.
If we lose, we keep going.
If we win, the going will be easier.
If we lose, the going will be more difficult.
However, the Court rules, we will keep going.

You have to understand. This is not about scientific truth – or even truth at all – to these people. Its about winning and its about pushing their antivaccine beliefs as fast and far as they can. Even as they claim to not be anti-vaccine they write emails to others clearly showing they are. One of these emails will come to light very soon I believe. Expect to see very familiar names on it.

To these people science has no authority. Doctors have no authority. The Special Masters have no authority. The only people who have authority – real authority – can probably be counted on the fingers of one hand. David Kirby. Jenny McCarthy. Maybe Dan Olmsted. If one of these people were to bow to the obvious and say so publicly then we might have a very different scenario. But they won’t. They have too much invested in esposuing the anti-vaccine line.

Mainstream media have a lot to apologise for also. The red tops, the broadsheets and all those hundreds of little bitty TV channels all over the US that gave the anti-vaxxers airtime in the name of impartiality and allowed them to scare away facts and reason, they need to reverse that policy.

But more than that, scientists and doctors need to get online and blog, get on Twitter and use them. Talk to people in their own language. Screw decorum. Ask people who’ve been using their blogs to support vaccines for _years_ what to do and how to do it. People like Oracand Ben Goldacre are prime examples.

This needs to happen because we’ve already lost one generation of kids to their loony parents. The loony parents who only recognise the authority of celebs, authors and each other in nests of email lists and blogs. If we want to give up another generation to the reach of the internet then keep on keeping on and hope that Rahul K. Parikh is right. But he’s not.

Brian Deer, not a complainant

16 Feb

Just in case you didn’t see it–Brian Deer published more information about Dr. Andrew Wakefield recently. This has caused a lot of furor (we are over 160 comments on that thread already). No surprises there: saying anything which might suggest Dr. Wakefield is anything less than a hero, especially when Brian Deer is doing it, will do that.

Almost all (if not all) of the responses to Brian Deer’s piece has been one big diversionary tactic: attack the messenger. Everyone seems to be studiously avoiding facing the real tough questions. Let’s avoid the ethics questions for the moment. If the details Mr. Deer presented in his article are true, Dr. Wakefield’s autism research has lost any last shred of support. That is a tough pill to swallow for the Wakefield supporters.

David Kirby joined in on the Deer bashing. Seems he read an article by Melanie Philips and rehashed it for his fans on the Huffington Post. He found Ms. Philips’ story to be “very interesting reading”. You see, Ms. Philips postulated:

What the Sunday Times did not report was that the GMC investigation into Wakefield was triggered by a complaint from… Brian Deer, who furnished the allegations against him four years ago.

This was then spun into a story of supposed conflict of interest and a great avoidance of the direct and specific claims of possible misinformation in Dr. Wakefield’s papers.

But, back to Mr. Kirby. He states:

The point is an excellent one. Imagine if a US journalist sued a doctor for libel or misconduct, and then went to the NY Times and asked to be hired as a freelancer to cover the trial that they themselves had instigated in the first place. It wouldn’t happen.

I found that statement very ironic, coming as it did from someone who aided significantly in manufacturing the thimerosal controversy, and who now seems to owe some of his employment to servicing that same controversy.

That said, what about this notion, this postulate as I have called it, that Brian Deer initiated the investigation that he is now reporting on? Well, it turns out that Mr. Deer is not a complainant in the GMC hearings on Dr. Wakefield. Below is a letter to Mr. Deer explaining exactly that.

Strictly Private & Confidential
Mr Brian Deer

25 May 2005

Dear Brian

General Medical Council – Dr Wakefield, Dr Murch, Dr Walker-Smith

I write further to your telephone conversation with Peter Swain last Thursday seeking clarification in relation to your role in the above General Medical Council (“GMC”) proceedings.

I have now had the opportunity to review the GMC’s files. My understanding is that further to your articles appearing in the Sunday Times in February 2004 in relation to your investigation into Dr Andrew Wakefield and the MMR vaccine, you were approached by GMC case officer Tim Cox-Brown, who asked you to supply the GMC with further information regarding this matter.

Your situation as a journalist who has carried out an investigation into the conduct of the practitioners in question is unusual for the GMC. I note from the GMC and FFW’s correspondence files that there does appear to have been some confusion in relation to your role in these proceedings.

In GMC ‘complainant’ cases an individual will have approached the GMC with a complaint against a particular practitioner. If the GMC decides to hold an inquiry, legal representation is offered to the complainant for preparation and presentation of the case before the Professional Conduct Committee.

As stated in Peter Swain’s letter to you dated 16 December 2004, your role in this matter is that of ‘informant’ rather than ‘complainant’. This is due to the fact that the conduct of the practitioners in question has not affected you directly and clearly involves issues of a wider public interest.

As you are aware, your involvement the GMC’s conduct of this case prior to our commencing our investigation and subsequent to our meetings with you on 24 February 2005 and 7 March 2005 has been minimal. We are preparing this case for presentation at the Professional Conduct Committee on the instructions of the GMC. Moreover, we are not able to discuss draft charges with you for reasons
of confidentiality.

We apologise for any confusion in relation to your status in these proceedings and any difficulties this may have caused you. We have made it clear to all parties that your role is that of informant rather than complainant. Please find enclosed a copy of the letter sent to Dr Wakefield’s legal representatives clarifying your status in these proceedings.

We are grateful for information supplied by you and your assistance to date.

Yours sincerely

Matthew Lohn
Partner

So, Brian Deer didn’t initiate the investigation. He wasn’t a complainant. It isn’t like, as in Mr. Kirby’s analogy, Mr. Deer didn’t “sue a doctor for libel or misconduct”.

Let me take a page out of Mr. Kirby’s own playbook:

David, if you read this (and we both know you will), take the message to heart and write a correction to your blog piece on the Huffington Post. Better yet, put up a new one with an explanation and apology.

Omnibus: the decisions are decisive

13 Feb

The first autism omnibus proceeding decisions are in: MMR does not cause autism, either alone or in conjunction with thimerosal.

Having said that, I can imagine that some of my readers are already accusing me of spinning the conclusions. That’s because the spin has already been put forth that the decisions are weak on the idea of general causation. Another theme is that the decisions only pertain to the test case families. But, as we will see, those ideas are the spin.

Here is a section from the From Autism Speaks statement on the Omnibus:

Today the National Vaccine Injury Compensation Program ruled that the combination MMR vaccine — with and without the preservative thimerosal — did not contribute to three particular children’s autism.

Why did they chose to say “…three particular children’s autism” when they know full well that the point of using “test cases” is to discuss general causation?

TACA is less subtle:

The fact that it took this long for these three decisions has to mean that the vaccine injury evidence had some merit. Poor evidence would have produced a negative decision very quickly.

The fact that they took a long time to decide indicates a tough decision? Either they didn’t read the actual decisions or they are deliberately trying to muddy the waters. Seriously. The comments in the decisions are so clear, so decisive, that one just can not make the TACA statement in good conscious.

Take a look at what the special masters actually said. Granted, there are hundreds of pages of decisions and I am picking a few paragraphs out, but I think you will agree–the statements are very (very!) clear. The decisions were not close. It was not a struggle for the special masters to come to these conclusions.

From the conclusion of the Cedillo case by Special Master Hastings:

This case, however, is not a close case. The overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories. The result of this case would be the same even if I totally ignored the epidemiologic evidence, declined to consider the video evidence, and/or excluded the testimony of Dr. Bustin. The result would be the same if I restricted my consideration to the evidence originally filed into the record of this Cedillo case, disregarding the general causation evidence from the Hazlehurst and Snyder cases. The petitioners’ evidence has been unpersuasive on many different points, concerning virtually all aspects of their causation theories, each such deficiency having been discussed in detail above. The petitioners have failed to persuade me that there is validity to any of their general causation arguments, and have also failed to persuade me that there is any substantial likelihood that Michelle’s MMR vaccination contributed in any way to the causation of any of Michelle’s own disorders.

emphasis in the original.

Take a couple of lines out, shall we? Starting with, “…not a close case”. He even emphasized it with italics.

“The overall weight of the evidence is overwhelmingly contrary to the petitioners’ causation theories. ”

and

” The petitioners’ evidence has been unpersuasive on many different points, concerning virtually all aspects of their causation theories, each such deficiency having been discussed in detail above. ”

This is a clear and decisive decision, not doubts about it.

From another section of the decision, this one entitled Summary concerning general causation issue

For all the reasons stated above, I conclude that the petitioners have failed completely to demonstrate that it is “more probable than not” that the MMR vaccination can be a substantial factor in contributing to the causation of autism, in individuals suffering from regressive autism or any other type of autism. To the contrary, the evidence that I have reviewed makes it appear extremely unlikely that the MMR vaccine can contribute to the causation of autism. It is clear that the causation theories themselves are weak, not just the case in specific for Miss Cedillo.

I expect fragments like “extremely unlikely” to be taken out of context.

An entire section of the decision (page 34) is titled, “I have found above that petitioners general causation theory concerning immune damage is without merit.”

As to part (1) of petitioners’ three-step theory (see previous paragraph), I have already explained in detail, at pp. 22-34 of this Decision, why I have found no merit in the petitioners’ theory that thimerosal-containing vaccines in general can damage infant immune systems.

Doesn’t bode well for the next three Omnibus test cases, does it? The second three focus on thimerosal alone.

Back to MMR, there are two more decisions. From the concluding paragraph to the Hazlehurst decision, by SM Campbell-Smith,

Having carefully and fully considered the evidence, the undersigned concludes that the combination of the thimerosal-containing vaccines and the MMR vaccine are not causal factors in the development of autism and therefore, could not have contributed to the development of Yates’ autism.

Again, for emphasis, let’s pull a phrase out: “the undersigned concludes that the combination of the thimerosal-containing vaccines and the MMR vaccine are not causal factors in the development of autism”

From the Snyder case,

To conclude that Colten’s condition was the result of his MMR vaccine, an objective observer would have to emulate Lewis Carroll’s White Queen and be able to believe six impossible (or, at least, highly improbable) things before breakfast. The families of children with ASD and the court have waited in vain for adequate evidence to support the autism-MMR hypothesis.

Pretty strong words, but I can see some people saying that there is the indication that it is just “highly improbably” raised to the sixth power. “Highly improbably^6 is not zero!” we will hear.

From another section, specifically addressing the general causation question:

However, the problems with the case presented by petitioners for general causation are overwhelming. The quality of the petitioners’ experts paled in comparison to the world-class experts proffered by respondent. The theories petitioners’ experts advanced lacked support in both logic and research. As Dr. Ward testified, an hypothesis has a life span. An hypothesis may be biologically plausible at the time it is first advanced. As evidence accumulates, the hypothesis may be strengthened or weakened. The MMR hypothesis may have appeared biologically plausible at its inception, but the accumulating body of scientific evidence has tipped the scales decisively against it. Snyder Tr. at 975. The weight of the scientific evidence is that the measles vaccine virus plays no role in the pathogenesis or triggering of autism. I thus conclude that petitioners have failed to demonstrate that the MMR vaccine can cause autism, even in the highly circumscribed subset of children with regressive ASD and gastrointestinal symptoms.

Again, for emphasis, here is a line pulled from the above “The weight of the scientific evidence is that the measles vaccine virus plays no role in the pathogenesis or triggering of autism”

It will be frustrating to watch the spin continue. I expect to hear “The decisions weren’t really that decisive” for some time to come.

But, the fact of the matter is that these decisions are clear and, well, decisive.

This is not just a statement about the spin-factor, by the way. The vaccine lawyers have just done millions of dollars worth of groundwork for their appeal and later civil cases on the taxpayer’s dollar. The fact that the Court of Federal Claims has issued such incredibly strong decisions makes it much more difficult for those cases, especially the civil cases, to actually go to trial.

Cedillos, Hazlehursts, Snyders

12 Feb

Three brave families who were placed in harms way not by an MMR injection but by a string of bad doctors, worse autism/antivax organisations and really terrible witnesses. A combination of these three factors placed these three families – they who stood for the utterly discredited idea that MMR/thiomersal or MMR alone cause autism – into harm the likes of which said doctors and founders of autism/antivax orgs will never have to face. I recall hearing that the Cedillo’s had taken out a second mortgage on their home to enable them to attend the legal proceedings.

I wonder if the leading autism/antivax groups will have enough about them to pony up to support the Cedillo’s for the rest of their lives? They should, they hung them out like a banner to wave.

This is from the Washington Post:

The decision by three independent special masters is especially telling because the special court’s rules did not require plaintiffs to prove their cases with scientific certainty — all the parents needed to show was that a preponderance of the evidence, or “50 percent and a hair,” supported their claims. The vaccine court effectively said today that the thousands of pending claims represented by the three test cases are on extremely shaky ground.

In his ruling on one case, special master George Hastings said the parents of Michelle Cedillo — who had charged that a measles, mumps and rubella (MMR) vaccine caused their child to develop autism — had “been misled by physicians who are guilty, in my view, of gross medical misjudgment.”

Hastings pinpoints the Geier’s, Krigsman and Wakefield by name in his verdict.

And here’s Special Master Vowell from the Snyder test case:

“After careful consideration of all of the evidence, it was abundantly clear that petitioners’ theories of causation were
speculative and unpersuasive.”

….

To conclude that Colten’s condition was the result of his MMR vaccine, an objective observer would have to emulate Lewis Carroll’s White Queen and be able to believe six impossible (or, at least, highly improbable) things before breakfast.

And here is Special Master Campbell-Smith from the Hazlehurt test case:

Because the linchpin of petitioners’ theory, the finding of persistent measles virus in the biopsied tissue taken from the gastrointestinal lining of autistic children, is glaringly unreliable, the basis for Dr. Corbier’s opinion that the MMR vaccine was causally related to Yates’ autism and his gastrointestinal symptoms is critically flawed and scientifically untenable. Petitioners have failed to prove that their theory of vaccine-related causation is biologically plausible as required by the first prong of Althen. Nor have petitioners demonstrated that the unsupported links of their proposed causal chain cohere to establish a logical sequence of cause and effect as required by the second prong of Althen. Having failed to satisfy their evidentiary burden, petitioners cannot prevail on their vaccine claim.

I should be happy that science has prevailed and I am to a certain degree. The fact that the Vaccine Injury Court demands a very, very low standard of proof should indicate clearly and concisely just how good the rubbish submitted as science was for these kids cases.

I can’t be happy and I can’t take any pleasure in the fact that these kids and their families have been coldly, cynically used by those who demand against all reason that vaccines cause autism. How could any right thinking person? These parents are penniless and will no doubt be coerced into taking part in a shame of an appeal, then civil cases. Civil cases where the standard of science is very much higher. I hope they step back and consider carefully the verdicts of the Special Masters, the horrendous quality of their so-called ‘expert’ witnesses and the utter lack of any science to support them.

Omnibus decisions in–acknowledging the test case families

12 Feb

The Omnibus decisions on MMR are in. Answer: no. Clearly no, they did not find that MMR with or without thimerosal cause autism. The court found that the cases were without merit.

This will obviously be a topic much discussed in the next few days. But, for right now, I’d like to acknowledge the bravery of the families who allowed their stories to be the “test cases” for the omnibus: the Cedillos, the Hazlehursts and the Snyders.

Yes, I agree with the decisions by the Court. Yes, I think the vaccine question has and will continue to sidetrack the greater autism community from more important efforts. But, the Court made a point in the decisions that the families stepped forward with good faith.

They put their lives in the public eye. They can appeal (and I expect it will happen). But they can’t do what the Krakow’s did, and what appears to be an option for the rest of the Omnibus families: change the story and resubmit to the court.

It was a good decision, and good for the autism community as a whole. For me, I’m taking at least a day to process before blogging the decision. In that time, I’d like to acknowledge that the Cedillos, the Hazlehursts and the Snyders put themselves on the line for what they believe in. They did it to try to help other families. I can disagree with them and still acknowledge the bravery of that action.

Kirby blows another irony meter

11 Feb

I need to find a source for militaryp-spec irony meters.

David Kirby has posted a piece on the Brian Deer investigation of Dr. Andrew Wakefield.

Here’s the comment that blew the irony meter:

Imagine if a US journalist sued a doctor for libel or misconduct, and then went to the NY Times and asked to be hired as a freelancer to cover the trial that they themselves had instigated in the first place. It wouldn’t happen.

So, David, you wrote “Evidence of Harm”, massively fanning the flames of the mercury causation theory.

You are now blogging on the Age of Autism blog.

Are you paid for that effort?

I haven’t seen a lot of non-vaccine/autism bylines for you in the past few years. So, if AoA is paying you, it would be a sizable fraction of your “journalist” salary.

If so, couldn’t it be well argued that you created your own “journalist” job?

Ironic, eh?

Ah well…as long as we are discussing Mr. Kirby, here is another of his comments:

In his writing, Deer claimed that Wakefield had made up results about severe MMR reactions in the children just days after receiving the shots, had ignored signs of autism in some kids before they received their MMR vaccine, and changed lab reports on the gut biopsies – among other alleged infractions that have been covered in the two year trial in London of Wakefield et al.

The accusations printed in the Sunday Times are, frankly, outlandish. And they are false.

Hmmm, false? Do you have the facts to back that up? Have you seen the medical records that Mr. Deer has reported on? It seems highly unlikely to this observer.

Let’s look at some of Mr. Deer’s claims:

Supposedly, Dr. Wakefield found measles RNA in the guts of his subjects. From Mr. Deer’s report, the father of child 11 from the Lancet study has stated that he had no fewer than 3 separate tests for measles RNA from the same gut biopsies that Wakefield tested. Three negative results.

Dr. Wakefield claimed that the children were developing normally before the MMR. According to the Deer article, another child from the original 12’s story:

The boy’s medical records reveal a subtly different story, one familiar to mothers and fathers of autistic children. At the age of 9½ months, 10 weeks before his jab, his mother had become worried that he did not hear properly: the classic first symptom presented by sufferers of autism.

Dr. Wakefield claimed that the 12 study subjects were presented sequentially to his hospital, indicating that they were randomly selected. And, yet, none of them were in the Royal Free Hospital’s catchment area–or even the greater London area. That’s one fact that doesn’t take access to the GMC’s records. And it demonstrates a clear non-random nature to the subject choice.

How about the report by Dr. Wakefield that the subjects had regressions shortly after their MMR shot? Again, from Mr. Deer’s article:

This was Child Two, an eight-year-old boy from Peter-borough, Cambridgeshire, diagnosed with regressive autism, which, according to the Lancet paper, started “two weeks” after his jab.

However, this child’s medical records, backed by numerous specialist assessments, said his problems began three to five months later.

A pretty major disconnect between Dr. Wakefield’s story and the medical records.

How about the measles-in-the-gut theory? Dr. Chadwick, working in Dr. Wakefield’s own hospital, testified in the Omnibus proceeding that he told Dr. Wakefield pre-publication that the PCR data directly contradicted the results Dr. Wakefield was publishing. Dr. Wakefield knew when he published that there were good data that showed he was incorrect. How did you sweep that under the rug, Mr. Kirby?

Did Dr. Wakefield fabricate results or is there another reason why he got a lot of very important facts wrong? I don’t know, but I do agree with Dr. Fitzpatrick who asked why Dr. Wakefield’s papers have not been retracted. They should be.

(And I thought Dierdre Imus wrote the worst blog post of the day!)

post-publication note: Dr. Mike Fitzpatrick has written an excellent article on Dr. Wakefield’s studies, including the recent information from Mr. Deer.

Fitzpatrick on the recent Wakefield news

11 Feb

Dr. Michael Fitzpatrick has written the article I wish I could have done–

The MMR scare: from foolishness to fraud?

For anyone looking to understand the timeline and the important questions raised by the Brian Deer investigations, this is a must read.

Dr. Fitzpatrick asks a very important question one must consider–if there is such a big disconnect between what the Wakefield papers report and the actual histories of the children (and the disconnects seem to be very significant), shouldn’t the journals print retractions?

Following Brian Deer’s 2004 revelations about Dr Wakefield’s conflicts of interest arising from undisclosed legal aid funding, 10 of his Lancet co-authors retracted the suggestion of a link between MMR and autism (while upholding the paper’s claim to have identified a distinctive form of bowel inflammation in autistic children). It is now clear that, given the selection bias confirmed by Deer – quite apart from his other allegations – it is not possible to make such a claim on the basis of the Lancet cases. Surely it is now time for the authors to withdraw this paper in its entirety? Perhaps the editor of the Lancet – together with those of the other journals involved – could submit Deer’s allegations to some sort of tribunal, perhaps arranged by the Medical Research Council. For 10 years the world of science has witnessed Dr Wakefield’s foolishness; now it has to ask: has he crossed the line into fraud?

Another good source on the Wakefield studies is in Paul Offit’s book “Autism’s False Prophets“.

You may recall that someone has YouTube’d Autism’s False Prophets. Yes, Story Time with Darwin. If you have problems reading or just want to listen in to the sections on Dr. Wakefield, give “Story Time” a try.

There are a LOT of blogs discussing this. I Speak of Dreams is keeping a running list.

Picking a couple–Respectful Insolence has Why am I not surprised? It looks as though Andrew Wakefield probably falsified his data.

Bad Astronomy has Did the founder of the antivax movement fake autism-vaccine link?

It is worth noting that Dr. Wakefield published a statement of his own as In his desperation, Deer gets it wrong once again.

Dr. Wakefield is in a strange position, since the GMC hearings are still ongoing to determine whether his methods warrant disciplinary action. That said, Dr. Wakefield’s statement responds to a letter that Brian Deer sent prior to publication. It is unclear if this response was sent to Mr. Deer before publication, or if any response was made pre-publication. That said, I wonder why Dr. Wakefield didn’t respond to the specific information from the children’s records which contradicts the story presented in Dr. Wakefield’s papers. What Dr. Wakefield does do is offload responsibility to others–other authors and the parents.

The reporting of the children in the Lancet paper is an accurate account of the clinical histories as reported to Professor Walker-Smith and his clinical colleagues.

One comment that has been made to a blog is worth paraphrasing here. Dr. Wakefield comments in his response:

Finally, I did not “create” a scare but rather, I responded to a scare that parents brought to my attention.

Perhaps Dr. Wakefield didn’t “create” a scare. But, what he did was throw gasoline on a lit match. To stand back and claim no responsibility for burning down the house is quite disingenuous.

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