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Before the MMR science, the press conference

4 Sep

As I’ve already posted not once but twice, yet one more study has been published showing yet one more time that the MMR doesn’t cause autism.

Prior to the lifting of the embargo on the study itself, there was a press conference featuring some of the study authors (Lipkin and Hornig were both in attendance) and several journalists as well as ‘freelance writer’ David Kirby.

Most of the questions concentrated on what this study showed, however someone there wanted to try and use this new study to (somewhat bizarrely) exonerate the O’Leary lab’s role in the poor science done by Wakefield and in the lab’s role in the Cedillo hearing (where it was trounced for poor science).

The whole press conference is here.

As an example, here is David’s first question.

http://webjay.org/flash/dark_player

Now thats more a set of questions than _a_ question, the initial question regarding Hannah Poling is both inaccurate and pointless. Inaccurate as, regardless of what David claims, no statement has been published by anyone that states Hannah Poling’s autism was caused by a vaccine. Pointless as this science has absolutely no bearing on her case. It has never been claimed she had measles virus in her gut.

David’s second point regarding O’Leary is fascinating. Because one of the labs used in this new paper was O’Leary’s and because the lab performed well, David seems to be claiming that that exonerates the O’Leary lab from past errors. I’m not sure how that can be true. As Stephen Bustin clearly showed during the Cedillo hearing, the errors of the O’Leary lab were twofold. The first was one of methodology. They forgot to do an RT step. Now I don’t know what that means but it was clear that it was a fairly serious (and basic) error. What it caused was the O’Leary lab to falsely identify contaminants as measles RNA. The second error was failing to pick this contamination up. So its not just a case of contamination, its a case of poor procedure.

I’m going to hazard a guess here and suggest that since the time of Bustin’s initial investigation (some years ago now) the O’Leary lab have figured out how to do an RT Step.

David’s second question followed:

http://webjay.org/flash/dark_player

So, we’re back to the very small sub-population argument. I really want to know – if the leading supporter of the vaccine hypotheses is now angling towards this ‘sub-sub’ group, what impact does that have on the autism epidemic idea? I mean, how can you have an autism epidemic generated by a very small sub-sub group?

Anyway, the answer to David’s question from the assembled scientists was ‘uh, who knows? That’s not what our study was about’. Or words to that effect.

David’s third (and fourth) questions followed. Please listen carefully to the answers which I’ve left on. You might also want to note the (somewhat amusing) deep sigh from the guy answering David as David keeps trying to make him say that MMR isn’t totally 100% safe.

http://webjay.org/flash/dark_player

And then by the time of David’s attempted fifth question, the answering team were obviously getting a bit fed up.

http://webjay.org/flash/dark_player

So that (to me) is a pretty fascinating insight into the denial that exists even at the very highest levels of the autism/vaccine hypotheses.

Just as a postscript, David asked them (totally randomly it seemed) if the best study would be one of vaccinated vs unvaccinated kids. Here is the reply. A reply grounded in real science.

http://webjay.org/flash/dark_player

New MMR study makes the NAA angry

4 Sep

Oh dear.

As I posted yesterday, MMR still doesn’t cause autism – as reported by yet another group of researchers.

And yet there was something special about this group of researchers. The lead author is Dr Mady Hornig who it seems is trying to turn over a new leaf and recapture her place as a good scientist.

As the link I supplied shows, it was not always thus and for a long time Dr Hornig was a card carrying member of the mercury militia. In fact, she was a regular speaker at conferences organised by SafeMinds and the NAA.

Which makes the press release about this new MMR study by the NAA all the more painful to read.

A Centers for Disease Control and Prevention (CDC) study released today claims there is no link between the MMR vaccine and autism

Thats how the NAA refers the Hornig study all the way through its press release. ‘The CDC study’. Its a little like reading the decree nisi in the lead up to a divorce you just know is going to be long and bitter.

Anyway, lets have a look at the rest of the points the NAA try to make.

…In a 2002 paper where the majority of autistic children were found to have measles in their intestines, the children examined showed a clear temporal link between MMR exposure and regression. The CDC’s attempt to replicate the 2002 study fell far short of proving the safety of the MMR vaccine.

No reference is supplied for this ‘2002 paper’ so I have no idea what to talk about here. Thats not very smart NAA. Also, as discussed yesterday in the press conference, the intent was to replicate Wakefield’s original study. In 1998. Not 2002.

The CDC study was designed to detect persistent measles virus in autistic children with GI problems. The assumption being if there is no measles virus at the long delayed time of biopsy, there is no link between autism and MMR. But NAA says this underlying assumption is wrong. The questions should have been: Do normally developing children meeting all milestones have an MMR shot, develop GI problems and then regress into autism? Do they have evidence of measles and disease in their colons compared to non-vaccinated age and sex matched controls?

Ahhh, I _see_ – so when you don’t like the answer, change the question? Nice one. The NAA are obviously South Park fans, seeing as they just introduced the Chewbacca defense.

In the current CDC study, only a small subgroup of children was the correct phenotype to study……Only 5 of 25 subjects (20%) had received MMR before the onset of GI complaints and had also had onset of GI episodes before the onset of AUT (P=0.03).” The other 20 autistic children in the study had GI problems but the pathology developed before the MMR vaccine.

This really does take the piss in an extreme way. The NAA love the 1998 study by Wakefield which had a group of 12 participants. Now they suddenly don’t like small numbers?

And really, that is besides the point. The authors took some autistic kids with GI issues and then looked to match them to a hypothesis. The fact that the only found a very, very small number who actually fit the description that the NAA would _like_ them to fit is extremely telling. The vast majority of the kids had GI issues _before administration of MMR_ . Now, what does that tell you? Its not difficult to work out.

Inflammatory bowel disease in the absence of MMR RNA does not mean that MMR shot didn’t precipitate the GI disease and didn’t precipitate autism…

Oho…is that the rumble of some goalpost shifting I can hear? I think it is.

Lets be clear. For literally a decade now, the NAA and the groups like it have been claiming that their kids had the MMR, developed gastric issues, then developed autism all as a result of the measles vaccine RNA contained in the measles component of the MMR. This is the hypothesis that the Autism Omnibus plaintiffs are arguing for right now. This study has thrown yet another large, cold bucket of reality over that nonsense. So now, thats _not_ the hypothesis?

Public confidence in the safety of vaccines is at risk until safety studies are performed that are required by law, ethics, and science….blah blah blah

Is it? If that _was_ the case then the only people who have put the public confidence of vaccines at risk are groups like the NAA. There is no way to keep saying the same thing without appearing repetitive: what you believe is wrong. The MMR vaccine does not cause autism. Shut up. Start working _for_ autism.

And is it really the case that public confidence is slipping? I recently wrote about a phone survey that had found that:

….66 percent had heard that “some parents and researchers say vaccines have side effects that may lead to autism, asthma, diabetes, attention deficit disorder and other medical problems.” About 33 percent had not heard of these concerns, and 1 percent was uncertain.

Seventy-one percent of the adults said “the benefits of immunizations outweigh the risks,” while 19 percent “have questions about the risks of immunization,” and 10 percent were uncertain or gave other responses such as “it depends upon the kind of immunization.”

So, its clear that people (in the US at least) are beginning to get some confidence back in vaccines and see the need for them. That is backed up by an article by the American Academy of Family Physicians who report:

Although the alleged link between childhood autism and the vaccine preservative thimerosal still sparks occasional controversy, the good news is that by and large, parents don’t seem to be buying into the hype. According to the latest reports available from the CDC, overall childhood immunization rates in the United States continue to steadily increase.

This is good news. Partly anyway. It is good news for herd immunity and the general level of the health of the US.

However, this is never going to be good news for autism and for autistic people whilst we have the various conspiracy theory addled groups who claim to represent the autism community continually burying their collective heads in the sand whenever yet another study comes out to show them how silly they’re being. I urge two things to happen.

1) Doctors and scientists – please don’t stop talking about this issue once vaccinations reach safe levels. Your job is only part done at that stage. You *must* continue to talk to reach new parents and the parents who can be reached from the autism community. Don’t let these kooks get the control back.

2) So-called autism advocacy groups in the US and UK. You know who you are. You’re doing nothing to help autistic people. Change your ways or shut up.

MMR still doesn't cause autism

3 Sep

In shocking news, yet another study shows that the MMR doesn’t cause autism. The study (which is here for your edification Dear Reader).

attempted to replicate 1998 research by a team led by Dr. Andrew Wakefield, then of Britain’s Royal Free Hospital, in the Lancet medical journal that suggested the vaccine was linked to autism and gastrointestinal problems.

And how did that work out for them?

….they could not find any link and hope their study will encourage parents to vaccinate their children to combat a rash of measles outbreaks.

The ‘official’ study conclusion is:

This study provides strong evidence against association of autism with persistent MV RNA in the GI tract or MMR exposure. Autism with GI disturbances is associated with elevated rates of regression in language or other skills and may represent an endophenotype distinct from other ASD.

Interestingly, the lead author is one Mady Hornig whom you might remember from the infamous Rain Mouse debacle. Seems like she’s turned over a new leaf. Gone are the lurid descriptions of skull chewing and in instead are pleas to vaccinate children from a killer disease. Credit where its due Ms Hornig, well done.

“We found no relationship between the timing of MMR vaccine and the onset of either GI complaints or autism,” Dr. Mady Hornig, also of Columbia, said in a statement.

Another interesting aspect is that the methodology the team used means they utilised three different labs. One of which was the O’Leary lab. This time, they did a good job. Shame they screwed up so bad the first time. Maybe if they hadn’t, things would’ve been over a long time ago. Is it just me or does this paper feel like a few people trying to claw back some scientific credibility?

Anyway, the study also found:

But the study did find evidence that children with autism have persistent bowel troubles that should be addressed.

They still didn’t say whether these bowel troubles (which they found weren’t associated with the MMR) were occurring at a higher rate in autistic kids. Maybe someone will address that one day.

Oh and Rick Rollens was there too, teeth and buttocks clenched no doubt as he congratulated the scientists. He said:

No longer can mainstream medicine ignore parents’ claims of clinically significant GI distress.

Had they ever? I’ve never seen a study that shows that. He also said:

“This study by itself does not exonerate the role of all vaccines”

What a genius. He spotted the phrase ‘Measles Virus Vaccine’ in the study title and worked out the rest all by himself! Nothing gets past our Rick!

So, MMR doesn’t cause autism. No news and of course won’t convince the flat earthers but still – another welcome addition to the ever growing canon of evidence against MMR causation.

Further Reading Elsewhere
Mike at Action For Autism
Kristina at AutismVox
Anthony at Black Triangle
Orac at Respectful Insolence
Steve at One Dad’s Opinion
Phil at Bad Astronomy

Endemic in the UK

25 Aug

Endemic:

Adj. 1. endemic – of or relating to a disease (or anything resembling a disease) constantly present to greater or lesser extent in a particular locality; “diseases endemic to the tropics”; “endemic malaria”; “food shortages and starvation are endemic in certain parts of the world”

Or, another example is measles in the UK.

How very shameful in the year 2008 that we have allowed one person to create an all-encompassing atmosphere of fear – groundless fear at that – that has allowed a disease that 10 years ago was virtually unheard of to return with such vengeance that two children have died in the past two years and many more have been hospitalised.

There are two reasons I find this shameful. Firstly, there is the fact that as an autism parent I am ‘judged’ every time I leave the house. We all are. The people who stare, the people who do double takes, the people whispering behind their hands. What are they saying now? How long will it be before the general public cotton on to the fact that measles _is_ now endemic is largely due to autism parents and the quacks they pay huge amounts of money to? As a community of parents we are divided and when people ask why that is or ‘can’t we just come together?’ on this issue, this is why.

*I cannot condone or stand by quietly whilst the autism community sinks into becoming a convenient media scapegoat. Neither can I stand by and say nothing whilst autism parents sink deeper and deeper into anti-vaccinationism and pretend that hospitalisation and death in the name of chasing a belief for which there is no proof is OK.*

The CDC’s Jane Seward (deputy director of the division of viral diseases) is interviewed today by Scientific American.

…in the 1960s, right before the vaccine was developed, it killed 400 to 500 children every year out of 500,000 reported cases at that time.

That’s a death every 1,111 reported cases. The current US measles epidemic has 163 cases. You’re nearly 15% there already.

Seward also says there were 4,000 cases of encephalitis a year resulting from measles in the 60’s and goes on to describe some of things that can follow on from encephalitis. Quite a lot of anti-vaccine believers say that encephalitis can lead to autism. Taste the irony.

Leaky gut aka intestinal permeability

18 Aug

Leaky Gut syndrome is a hypothesis associated with autism by people who believe that toxins (particularly those caused by vaccines – notably the MMR) weakens the lining of the bowel letting various rubbish thorough (undigested food, toxins, whatever) and triggering an immune response and/or leading to Wakefield’s much-hyped but never backed up Autistic Enterocolitis.

This unverified condition has (of course) been found by any number of Wakefield supporters and yet, curiously, no researchers external to Wakefield’s peers have found any evidence for it and the phrase exists as a diagnosis within that AltMed community.

In fact, its not curious at all as the only groups that _did_ find evidence for ‘Autistic Enterocolitis’ used the now discredited Unigentics lab run by John O’Leary.

Anyway, in Feb of this year a team from the University of Calgary published a Pilot study into the ‘leaky gut’ (posh name: ‘intestinal permeability’) issue.

They enrolled 14 autistic kids (all of whom had parents who reported gastric issues), 7 NT siblings of these kids, and 8 NT non-related controls.

In the ‘leaky gut’ opioid-excess theory, it is proposed that increased intestinal permeability in children allows for increased absorption of dietary peptides, which ultimately leads to disruption of neuroregulatory mechanisms and normal brain development.

The reason for choosing autistic kids who were reported by parents to have gastric issues is that the researchers reasoned that these kids would be more likely to have ‘abnormal gastrointestinal tests’.

In this population, the researchers found:

we neither demonstrate abnormal small intestinal permeability, nor abnormal postprandial responses of the enteroendocrine peptide GLP-2.

…..

It has been suggested that increased permeability may be causally related to the onset of the inflammatory bowel disease and not just a consequence of inflammation. Our data does not support a similar hypothesis in autism.

…..

Our study did not detect differences in the functional gastrointestinal parameters measured in a group of children with autism. Although there may be a subset of children with autism with a specific gastrointestinal abnormality there is no firm evidence yet of a role for gastrointestinal dysfunction in
the etiology of autism.

One of the things the authors reported that struck me was:

The subtle endoscopic and histological findings of lymphonodular hyperplasia in the colon and ileum previously described in ‘‘autistic enterocolitis’’ (Wakefield et al. 1998, 2005) are also seen in normally developing children with similar gastrointestinal symptoms (Furlano et al. 2001).

This is only a pilot study of course so not too much can be read into the results but if the study is expanded upon and replicated then the results would be interesting to see. Its certainly a smallish spanner in the works of the ‘autistic enterocolitis’ believers.

Tags:

Fools rush in – Wakefield's race

15 Aug

In today’s Hampstead and Highgate Express there’s an interesting little piece on Andrew Wakefield’s ongoing legal altercation with the GMC.

A ROYAL Free doctor accused of serious professional misconduct during controversial MMR research admitted that short cuts were made in the quest for fame.

…..

Asked whether Dr Wakefield had pushed him into it, Prof Walker-Smith said: “I think that’s true. If we had not had any urgency to get on with it, we would not be in the muddle we are in now because we would have done it in the usual way by getting a referral. Dr Wakefield was a man in a hurry and in full-time research.

Damn. You know things aren’t going well for you when your co-accused is willing to push you under a bus.

Walker-Smith performed completely unnecessary (in my opinion) lumbar punctures on these kids and lo and behold:

Ms Smith said out of the 12 children, complications materialised in two. “I’m not suggesting that the complications were serious, but you would accept that having a child admitted to hospital overnight with a fever and feeling unwell is worrying for parents,” she said.

Performing lumbar punctures and consequently hospitalising 17% of your case load is not great. Neither is it great to perform blood draws at birthday parties and make children pass out and vomit.

But, we know Dr Wakefield is an impatient man. Remember this testimony given by Dr Nick Chadwick?

Q Okay. Did you personally test the gut biopsy samples for measles RNA?
A Yes.

Q What tests did you perform?
A A PCR test, a polymerase chain reaction.

Q What results did you receive from the gut biopsy materials for measles RNA?
A They were all negative.

Q They were always negative?
A Yes. There were a few cases of false positive results, which I used a method to see whether they were real positive results or false positive, and in every case they turned out to be false positive results. Essentially all the samples tested were negative.

…….

Q So you personally tested while you were in Dr. Wakefield’s lab gut biopsy material, CSF and PBMCs?
A Yes, that’s right.

Q And all the results were either negative, or if they were positive it always turned out that they were false positives?
A Yes, that’s correct.

Q Did you inform Dr. Wakefield of the negative results?
A Yes. Yes.

This was the test to ‘prove’ that measles virus was in autistic kids guts and hence cause their autism. Seems Dr Wakefield was too impatient to listen to his own team.

We expect Doctors to have our primary care interests at heart. We should not expect for them to sacrifice scientific integrity and our children’s wellbeing in order to make themselves famous.

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…

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..

Dear Mercury and MMR Militia

21 Jun

I want to write you all an open letter to offer you my opinion as to where you are going wrong. Before I do, I fully realise that this is a massive generalisation and that some of you won’t hold all the opinions I’m about to go through. I think though, that many of you do.

Three things prompted this open letter. First of all was David Kirby’s trip to the UK. Second was a comment from Kelli Ann Davies where she expressed surprise that some of us might know/guess/whatever the intentions of the science and medical community. Third was Ginger Taylor’s recent sulk about the AAP. I’ll touch on these things as I go through this.

You have a truly massive credibility issue which grows with every passing year. Once upon a time it was an issue with the science/medical community but now it is an issue with the general public. There are a number of reasons why this is so.

1) You cannot keep your story straight. You have (as I said to Kelli Anne) some first class marketing and PR people. As I recall, Lynn Redwood, Mark Blaxill and Sallie Bernard all have marketing qualifications. You also have numerous leading lights who are very, very rich. This means you have ample opportunity to lever your message into the heart of the US media system.

But that means nothing without a coherent story to sell. You don’t have one. I understand that you have recently talked about how the ‘story of vaccines’ has _evolved_ . That is stretching things more than a little. Its mercury, no its MMR, no its both, no its Aluminium, no its all three, no its all ingredients, no its the very vaccines themselves, no its the schedule they’re given. No – its ALL the above. And don’t forget the mitochondria!

The more ingredients you add to the pot, the more you have to explain why they are causative of autism. You didn’t even manage to do this when you were concentrating on just _one_ thing (thiomersal). The above is not an example of an evolving hypothesis. Its an example of an ever widening hypothesis as one after another, your original ideas have been taken down.

Nowhere is this better illustrated than David Kirby’s stumbling backwards and backwards:

In 2005, David said in a FAIR Autism Media interview:

It’s now 2005…..[W]e should see fewer cases entering the system [cdds] this year than we did last year.

When that didn’t happen he then said:

if the total number of 3-5 year olds in the California DDS system has not declined by 2007, that would deal a severe blow to the autism-thimerosal hypothesis…..total cases among 3-5 year olds, not changes in the rate of increase is the right measure.

That didn’t happen either.

You started off by pointing an air pistol at a target 20 feet away and missing. You worked your way through Magnums, Shotguns and Miniguns and kept missing. You currently have a canon wheeled right up to within a foot of the target and you’re _still_ missing.

2) Your science is weak and getting weaker. Sadly for you, the onus was (and still is) on you to provide evidence that vaccines in any of the myriad of hypotheses cause autism. Lets hypothetically agree with you that vaccines are in fact, fashioned by Satan and are in fact, tools of population control. That is not the point. The point is: _do they cause autism?_

There is not one paper that passes muster as valid science that offers corroborating evidence that any vaccine, any ingredient of vaccines or any schedule they are administered in causes autism. This is after over 10 years of trying to find one. What you are increasingly left with is a double conspiracy theory. In one barrel of the conspiracy theory, brave maverick doctors are having their research suppressed. In the other barrel of the conspiracy theory, Big Pharma shills are publishing science to refute the various vaccine hypotheses.

Of course, neither barrel is true. The brave maverick docs are not having their science suppressed. It is simply not good enough to pass peer review.

A good example of this is the science experts being presented at the Omnibus Autism proceedings. No Geier’s. No Jim Adams. No Boyd Haley. No Andrew Wakefield. At least, not so far anyway. And this is in the Vaccine Court, where standards of evidence are way lower than in a civil court, where – by the way – not a few of these same researchers science was not good enough to even be entered as evidence.

And you have this nasty habit of shooting yourselves in the foot. Only today David Kirby posted on the Huffington Post about how rubbish the VSD database was. The very same database the Geier’s recently used to allege a link between vaccines and neurodevelopmental disorders.

And the list goes on. The Hornig study? Refuted by Rick Rollens MIND Institute. The Nataf paper on Porphyrins? Liz Mumper, head of DAN! medical admits that even ‘normal’ children have raised Porphyrin levels. The Bernard et al paper? Refuted. Richard Deth’s work? Exposed and questioned.

3) Your choice of media people to represent you is doing you harm. I am not sure how the idea of latching onto Jenny McCarthy as a spokesperson for the anti-vaccine/autism connection came up. There are a few other celebs I can think of with more gravitas than McCarthy. In truth, you couldn’t have chosen worse. Already, she has made a public fool of herself (and you). As has her partner, Jim Carrey, with his ‘lazy ass’ FUBAR and calls to notice ‘warnings from the universe‘.

I understand that these events feel terribly cathartic to you but I would urge you to take off your rose tinted glasses and see how the real world perceives these kind of things. Its not good. Don’t take my word for it, go to a _mainstream_ news source, discount the people you know as friends/associates who are leaving comments and then see what people think.

You have also latched onto the words of Bernadine Healy. I can see why but she (is/was) a member of a paid lobby group that advances the ‘science’ of Philip Morris to put forward the idea passive smoking isn’t dangerous. How desperate do you have to be to turn to _this_ ‘authority’ for backup?

4) You cannot see that you are being humoured. I know that some of you have been very proud of your success in getting involved with things like the IACC and y’know, thats great – well done to you. And then there’s the ‘coup’ of getting the AAP to attend a DAN! conference and ‘work with’ them. But there’s one thing you seem to have forgotten. AAP members are medical scientists. They will go with the decent science.

I read a blog post from Ginger Taylor today which seemed to be telling the AAP their ‘window of opportunity’ to work with DAN! et al had closed due to the fact they endorsed a letter that a paediatrician had written on how to tackle parents who were nervous about vaccination.

Amusingly, Taylor also chided the AAP for not turning up to the ‘green our vaccines’ rally:

I warned that the window would only be open for a short time unless we saw real action, and would probably close around the time of the Green our Vaccines Rally if they didn’t show up for us in some respect.

Well the AAP didn’t show up for the rally and well… this certainly signals that the window is closed. They want it closed. And it looks like they may be locking it.

Can you not understand that to expect the AAP will turn up for a rally which touts such anti-science as Aluminium and Formaldehyde being at singularly dangerous levels in vaccines and Anti-Freeze being in them at all is the height of arrogant stupidity? Surely you cannot be that naive?

The truth is – and I get this from speaking to AAP, NIH, FDA and NHS members – that you had, and always will have, an opportunity to impress them with decent, peer reviewed science. That’s all you’ve ever needed. And that’s what you’ve never had.

5) The future. The person you’ve decided will be your public face is writing another book. <a href="http://stopthinkautism.blogspot.com/2008/06/today-autism-recovery-tomorrow-crystals.html"She says that:

It’s really an Indigo book…….We’re definitely the Indigos, you know, breaking down these walls so this, you know, New Earth behind us can happen.

And what’s your role in this?

…But people aren’t quite there yet and I kinda had to, not lower my vibration, change my vibration to focusing on the world hearing that message. Hearing that biomedical treatment does help these kids.

And then, slowly, you know I can put it in my speeches. and then in my last book I talked about the indigos and crystals. And I’m just like, I’m really following source, kind of I felt the need to do that, I’m just kind of dribbling it here and there until people, you know, have that spiritual awakening of spirituality.”

That’s where you’re going. You’re close to abandoning any kind of rational basis for your beliefs and just becoming Jenny’s followers in an Indigo Spiritual Awakening to herald in the New Earth..

Laura Hewitson’s Stinker

18 May

Sorry about the title, I couldn’t find a word to rhyme with her last name to infer wrong-doing a la Age of Autism’s ‘Grinker’s Stinker. Anyway….

Meet Laura Hewitson. Laura is the lead and joint author of a trio of papers presented at this years IMFAR as posters.

These papers (also shredded by Orac) purport to show how it is possible to mimic the 1999 US vaccine schedule and give monkeys autism as a reult. Never mind the fact that the results reported don’t sound or present anything like autism (<em>”survival reflexes, tests of color discrimination and reversal, and learning sets”</em> huh??), lets look at Laura Hewitson a bit more closely then I managed to in a quick 10 min post last time.

As I mentioned at the time, Laura Hewitson claims affiliation with DAN! Thats enough in my book to place a rather large red flag against her impartiality.

Now I’ve learnt that her entanglement with the vaccine/autism hypotheses goes very much further than that.

It turns out that Hewitson’s partner is Dan Hollenbeck, an Age of Autism contributor. Hollenbeck owns the website FightingAutism.org and in the top right hand corner of the FightingAutism website are the words:

FightingAutism is now part of Thoughtful House Center for Children.

And we all know who is the big cheese at THoughtful House don’t we? That’s right – one Andrew Wakefield. He’s also the co-author to the three studies poster presented at IMFAR.

Hollenbeck’s asociation with Thoughtful House goes beyond just having a website affiliated with them however. He’s also an employee of Thoughtful House.

Director of Information Technology for Thoughtful House, Dan Hollenbeck received his Bachelor of Science degree in Electrical and Computer Engineering from the University of Wisconsin-Madison in 1992

….

When their son was diagnosed with autism in 2001, the Hollenbecks relocated from Oregon to Pittsburgh in order to accept employment as an Information Technology Manager for a large NIH (National Institutes of Health)-funded medical research organization

….

He is also on the Board of Directors, as well as the Research Committee, for SafeMinds…

So, here we are with three poster presentations from a woman who has an autistic son, affiliated with DAN!, is married to the Thoughtful House IT guy (who also happens to be on the Board of Directors of SafeMinds) and these afore-mentioned poster presentations are also co-authored by Andrew Wakefield.

I wonder just how impartial this science can be?

How about when we throw one more fact into the equation?

437. Laura Hewiston (sic) and Dan Hollenbeck on behalf of Joshua Hollenbeck, Dallas, Texas, Court of Federal Claims Number 03-1166V

That’s right. Hewitson and Hollenbeck are suing HHS for vaccine injury visited upon their son Joshua.

Now, lets turn our attention to IMFAR where Hewitson made her three poster presentations. INSAR have regulations governing the papers and abstracts submitted.

INSAR requires authors to disclose their sources of contributed support (commercial, public, or private foundation grants, and off-label use of drugs, if any). INSAR also requires authors to signify whether there may be a real or perceived conflict of interest. Any potential for financial gain that may be derived from reported work may constitute a potential conflict of interest.”

Now, maybe Hewitson did note the fact that:

a) Her husband is an employee of an organisation that makes money from treating what they allege is vaccine caused autism.

b) She has an autistic child.

c) Said child has been registered for compensation for alleged vaccine damage resulting in autism (I assume they’re part of the Omnibus proceedings then?)

But if she did, then it isn’t recorded in the abstracts posted on the Age of Autism website.

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