Archive | July, 2006

Autism Hub Updates

9 Jul

I’ve introduced a few changes to the Hub over the last few days.

Firstly, the whole site has had a substantial redesign. This has (I hope) made things a bit easier on the eye, a bit easier to read the content you’re interested in and generally behave better across a wider range of devices.

There’s still some ongoing backend work which needs to be completed before I start accepting potential new members and there’s a few more front end tweaks to get slotted in to make users lives even easier but these won’t require any substantial aesthetic alterations or any downtime at all.

Secondly, I’ve introduced a range of t-shirts that you can buy via the Hub. Its a very small range at the moment but I’ll be designing and adding more over time.

The reasons I’ve done this is mainly due to the unexpected success and popularity of the Hub. It took me very much by surprise how quickly it took off and the long and short of it is that the Hub needs to start paying for itself fairly quickly.

There are several ways I could’ve gone about getting revenue but I despise adverts on sites (or – even worse – in RSS feeds) and I ‘m very much against the idea of paid-for content in this context so this seemed the best solution – the buyer gets something and I get a cut to go towards the cost of running the site.

I’ve no idea how (un)successful this idea might be as I’ve never done anything like this before but if I do make any money beyond the requirements of the site to sustain itself then I’ll be donating the excess to pro-neurodiversity websites and projects at the end of each year.

Lastly, I’ve just set up a new part of the Hub which is free for anyone to use.

It’s called the ‘autisticus’ and it works in exactly the same way as del.icio.us – it allows you to save interesting stories and blog entries to a central location.

All you need to do is head to the autisticus site, create an account and then add pages/stories/blog entries you want to bookmark. You can tag entries in exactly the same way as del.icio.us and there’s even a draggable bookmark shortcut for your browser. Over time, as more entries get added and tagged, there’ll be a big resource of searchable tags and entries to read and research at your leisure. You cn even add any existing del.icio.us entries you may already have.

So, go join up and start adding entries!

Boyd Haley and Mark Geier: Experts?

7 Jul

In case you didn’t know, as well as vaccines, the mercury militia also think that the thiomersal in RhoGAM given to pregnant mothers causes autism. Alongside the ongoing autism/vaccine omnibus hearings, there has been a RhoGAM hearing as well.

An unidentified couple brought a case against Ortho-Clinical Diagnostics Inc’s RhoGAM product as they claimed that their unidentified child’s (referred to as ‘Minor Child Doe 2’) autism was caused by two shots of RhoGAM – one whilst the mother was 28 weeks pregnant and one administered shortly after the child’s birth. They declared three expert witnesses to speak on their behalf, George Lucier, Boyd Haley and Mark Geier.

The defendants (Ortho-Clinical Diagnostics Inc) put forward a motion to exclude these expert witnesses, which after hearing evidence as to why, the court granted. Yesterday, the court discussed its decisions and let it be known exactly why these three expert witnesses were excluded.

The court conducted a ‘Daubert‘ hearing to decide on the quality of these expert witnesses.

Daubert requires a two-part analysis: first, this Court must determine whether an expert’s testimony reflects “scientific knowledge,” whether the findings are “derived by the scientific method,” and whether the work product is “good science.”. Second, this Court must determine whether the expert’s testimony is “relevant to the task at hand.”

Source.

The way that the court reaches judgement in respect of these two points is as follows:

courts may consider whether the theory or technique employed by the expert is generally accepted in the scientific community; whether it has been subjected to peer review and publication; whether it can be and has been tested; whether the known or potential rate of error is acceptable; and the existence and maintenance of standards and controls. These factors are not exclusive nor dispositive. Since Daubert, the U.S. Supreme Court and lower courts have also identified additional factors that may be considered, such as whether an expert has unjustifiably extrapolated from an accepted premise to an unfounded conclusion, whether an expert has adequately accounted for obvious alternative explanations, or whether an expert is proposing to testify about matters “growing naturally and directly out of research they have conducted independent of the litigation, or whether they have developed their opinions expressly for purposes of testifying.”….Trained experts commonly extrapolate from existing data but nothing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence which is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.” Finally, a bold statement of the experts’ qualifications, conclusions, and assurances of reliability are not enough to satisfy the Daubert standard.

There were two types of Daubert hearing held. In the first instance, the Daubert principles were applied to the issue of general causation (can the thiomersal in RhoGAM cause autism?) and the issue of specific causation (did the double RhoGAM shots cause Minor Child Doe 2’s autism?). If general causation cannot be established then specific causation does not need to be examined.

Boyd Haley’s Strong Beliefs

Lucier and Haley were not put forward as experts able to address the specific causation issue, but all three (Lucier, Haley and Geier) were put forward to address the general causation issue.

On the issue of general causation the court had the following to say:

The court…finds that *Dr. Haley’s report does not state an expert opinion that thimerosal causes autism, rather just that he has a theory about how such a thing could happen*. At best, he expressed “strong belief” that the cause of “neurodevelopmental disorders in infants” is exposure to an organic-mercury compound such as thimerosal. Additionally, Plaintiffs proffered the report of Dr. Lucier, who is an expert in methylmercury and not ethylmercury, which is the substance in RhoGAM. Dr. Lucier does not offer an opinion that methylmercury causes autism, but rather that it may cause “developmental disorders.” Significantly, the Court notes that neither Dr. Haley nor Dr. Lucier asserts that he is an expert on autism nor are they offered as such. In any event, the Court finds that neither of the proffered reports of Dr. Haley nor Dr. Lucier are sufficiently reliable under Daubert on the general causation issue because neither is relevant to the “task at hand.” It would be an unacceptable scientific leap to suggest that they serve as proof, by a preponderance of the evidence, of Plaintiff’s claim that the thimerosal in RhoGAM can cause autism.

Ouch. Let’s make sure we don’t underestimate the gravity of this. Under the Daubert principle, which is very very thorough in terms of scientific methodology, Boyd Haley’s theories about thiomersal causing autism are not anything other than a theory that discusses how such an event might happen. All he can apparently offer is a ‘strong belief’ that he is right.

This left the court with the thorny problem of Mark Geier.

Mark Geier Takes A Licking

Much of Geier’s testimony was dependant on a review of the scientific literature. Under the Daubert principle, the literature itself must also undergo examination under the Daubert principles.

At the close of Plaintiffs’ presentation at the Daubert hearing, Plaintiffs argued that their evidence would support such a conclusion. In response to Plaintiffs’ position, Defendant challenged Plaintiffs’ proffer by way of a cross examination of Plaintiffs’ expert Dr. Geier and by offering its own experts to *demonstrate that Plaintiffs’ experts used unsound methodology or otherwise failed to follow sound protocol*. Having closely considered the evidence and arguments both by Plaintiffs and Defendant, the Court has made a number of findings with respect to the testimony by Plaintiffs’ primary expert Dr. Geier. These findings form the basis of the Court’s ultimate conclusion that *Plaintiffs have not met their burden under the Daubert analysis*.

Oh dear. So Geier and the evidence he presented did not meet the Daubert principles. Lets discuss this further.

The Court has taken into account…..the fact that Dr. Geier has testified as an expert witness in about one hundred cases before the National Vaccine Injury Compensation Program of the United States Court of Federal Claims. It is noteworthy that in more than ten of these cases, particularly in some of the more recent cases, Dr. Geier’s opinion testimony has either been excluded or accorded little or no weight based upon a determination that he was testifying beyond his expertise.In this case, subject to the Court’s Daubert analysis, Dr. Geier’s testimony is being offered by Plaintiffs for presentation at trial to support Dr. Geier’s ultimate conclusion that the thimerosal in RhoGAM caused Minor Child Doe’s autism.

Let’s remind ourselves that in those cases, Geier’s testimony has been described as, ‘speculation that is directly contrary to the conclusions reached
in well-respected and numerous epidemiologic and medical studies ranging over two decades’, ‘did not reach “the level of evidentiary reliability that Daubert requires because it is not based upon scientific validity, valid methodology, peer review or testing, and more than minimal support within the scientific community’, ‘intellectually dishonest’, ‘nothing more than an egregious example of blatant, result-oriented testimony’ and that he himself was a ‘”professional witness in areas for which he has no training, expertise, and experience’.

What else did the court have to say?

…the Court notes that, in fact, a literature review can be an appropriate part of a method of determining general causation. However, a literature review must still be performed appropriately. As revealed by his testimony at the Daubert hearing, Dr. Geier, however, relied upon a number of disparate and unconnected studies, including the findings of Dr. Haley and Dr. Lucier, to reach a piecemeal conclusion with respect to general causation.

The court went on to admit that, in common with a couple of journalists I can think of, when one hears Geier speak and hears his testimony it sounds persuasive on the face of it. However, it soon became clear that when one looked past the thin veneer of ‘disparate and unconnected’ studies, the threadbare nature of the ‘association’ became very very clear.

However, upon being subjected to extensive cross examination, much of Dr. Geier’s analysis, based upon his collective review of a motley assortment of diverse literature, proved, in the Court’s view, to be overstated. For example, in examining Dr. Geier’s methodology, the Court notes that Dr. Geier could not point to a single study, including anything that he had published, that conclusively determined that the amount of thimerosal in RhoGAM when given not to the fetus but to the mother, as in this case, could cause autism. *It is also significant in the review of his methodology that Dr. Geier could not point to a single study that conclusively determined that any amount of mercury could cause the specific neurological disorder of autism.*

The court closed its look at the literature review with the following:

This Court must find more than the “hypothesis and speculation,” engaged in by Dr. Geier in this instance….

Double ouch. Most of Geier’s testimony revolved around this literature review. Not only was court already looking at him with extreme skepticism, it also – quite rightly – dismissed his presentation of the review _including the review materials themselves_ as resulting in nothing more than ‘hypothesis and speculation’. The court further noted that not even this (his own!) literature review can support Geier’s general causation testimony.

Thus, while Dr. Geier’s presentation of the literature as part of his methodology might at first glance appear convincing, the disconnected literature he presents does not add up to the opinion and conclusion that Dr. Geier is offering. Accordingly, the Court finds that *Dr. Geier’s literature review, in this instance, does not meet the Daubert standard of being both derived by the scientific method* and relevant to the “task at hand.

Again, this is important stuff. This was the first real courtroom test of the scientific literature that the mercury militia have built to support the thiomersal/autism hypothesis. Have a look at the references – the Holmes baby study was presented, as was the Hornig mouse study amongst others. It was collectively adjudged not to meet Daubert standards in that it was not possible to say it was derived using scientific method.

To put it less politely, its a bunch of crap.

The court also discussed the other part of Geier’s testimony relating to general causation – his examination of VAERS. In this it concluded that:

the Court finds that Dr. Geier’s published VAERS studies have been severely criticized by The Institute of Medicine as having “serious methodological flaws,” analytic
methods that were “non-transparent,” and generally “non-contributory with respect to causality. More specifically, one of the particular criticisms leveled at Dr. Geier’s study was that, as a passive reporting system, it would be inappropriate to calculate incidence rates based upon the data in V AERS because it “does not have complete reporting of all adverse events and because many report events lack a confirmed diagnosis or confirmed attribution to vaccine.”

Geier has also written two papers regarding RhoGAM and had the cheek to submit them as part of his literature review. However, as they had not been accepted for publication, nor peer reviewed and as the court expressed doubts over both the methodology utilised in these papers and the odd ‘coincidence’ that these papers were embarked on shortly after the instigation of the case being heard, they threw them out too.

And so, that’s the issues of general causation stone dead. At this point, the court would be fully justified in not proceeding further. However, they did move on to address Geier’s testimony is respect of specific causation.

Mark Geier Takes A Kicking

The court accepted that a differential diagnosis was a sound method of establishing a basis for allowing _expert opinion_ with regard to specific causation and this indeed, was the method Mark Geier used to attempt to illustrate specific causation in Minor Child Doe 2’s case. However, we need to make sure we understand this. The court is _not_ saying that a differential diagnosis is automatically good enough to illustrate specific causation. It is saying that *if* the person offering the differential diagnosis is a recognised expert, that that differential diagnosis stands a better chance of being accepted as ‘good enough’ to establish specific causation.

…even if the Court were to assume that general causation had been shown in this instance, the Court finds that Dr. Geier’s application of the differential diagnosis technique suffers from its own irregularities.

Bad enough, but then the real humiliation follows:

First, the Court notes that Dr. Geier is not a pediatrician or a pediatric neurologist. In fact, *testimony was presented to the Court that Dr. Geier was not even successful in sitting for his Medical Board examination in the specific field of pediatric genetics*.

Triple Ouch. That one had to hurt. They’re essentially questioning if Mark Geier is even qualified to undertake a differential diagnosis _at all_. Let alone qualified to offer an expert opinion on one. _Let alone_ qualified to offer an expert one on a question of specific causation.

The court also took Geier to task for his failure to include the most widely accepted scientific theory regarding autism causation – genetics. It beggars belief that he would attempt to offer a *differential* diagnosis without even mentioning this possibility.

Although Dr. Geier apparently has considered a number of specific genetic disorders in performing his differential diagnosis, the Court finds that his failure to take
into account the existence of such a strong likelihood of a currently unknown genetic cause of autism *serves to negate Dr. Geier’s use of the differential diagnosis technique as being proper in this instance*

and that therefore…

….the Court finds that Dr. Geier was not specifically qualified to perform a differential diagnosis of a pediatric neurological disorder, and, that he did not properly perform the differential diagnosis

Oops. I hope John and Jane Doe feel suitably recompensed for their ‘experts’ testimony.

The court goes on to make a few interesting comments and comparisons regarding the Omnibus vaccine proceedings, noting that those proceedings have until the end of this year to submit papers to establish causation and that the defendants in this case were also defendants in those proceedings. They then wrap up with:

Accordingly, notwithstanding the valiant effort by Plaintiffs in this case, Defendant’s Motion for Summary Judgment must be allowed and this case must be dismissed with prejudice.

And that’s that.

Significant Conclusions

Awhile ago, I posted regarding a series of comments from Lenny Schafer in which he discussed his hopes that the thiomersal court cases would be easier to prove in a court of law than they would in the scientific realm. I think after this ruling its clear to see why they will not.

This is a significant turn of events for numerous reasons. Firstly, it was the first time that autism had been attempted to be directly linked to thiomersal. That gambit failed. Secondly, it was the first time the body of evidence the mercury militia has accumulated thus far was tested in court. It failed to be recognised as scientifically valid. Thirdly, it was the first time that Geier or Haley had stood as expert witnesses in a court case relating directly to the thiomersal/autism hypothesis. They were both found severely wanting in that respect.

Let’s remember that the vaccine Omnibus hearings have until the end of _this_ year – less than six months away now – to augment the evidence found wanting in these hearings.

For the mercury militia, times is just about up.

Full court listing and decision document.

Further discussions here: Autism Diva, Orac, Prometheus and Kathleen provides a HTML version of the decision on neurodiversity.com

Canada Speaks: No, It’s Not Vaccines

6 Jul

Pediatrics have published a new paper, *Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links With Immunizations* authored by Fombonne et al.

Pre-empting an NAA style ad hominem attack, the authors declare their conflicts early.

In the United Kingdom, Dr Fombonne has provided advice on the epidemiology and clinical aspects of autism to scientists advising parents, to vaccine manufacturers, and to several government committees between 1998 and 2001. Since June 2004, Dr Fombonne has been an expert witness for vaccine manufacturers in US thimerosal litigation. None of his research has ever been funded by the industry.

As they don’t agree with the paper this has caused the usual suspects, notably Safe Minds and FAIR Autism Media to highlight these aspects of the paper in an attempt to claim these invalidate the papers findings. Mark Blaxill of Safe Minds says that:

According to an analysis by SafeMinds, however, the study […] should be treated with skepticism, for a number of reasons.

Whilst David Ayoub states that:

“This is just another heavily biased study by an author with a long track record of financial ties to the drug industry, and whose previous views on the epidemiology of autism have been discredited,” wrote Ayoub

So, as far as the mercury militia are concerned, the following points are an issue.

1) Fombonne’s alleged financial ties to the drug industry. One assumes he is referring to Fombonne’s pre-stated offering of advice on the epidemiology and clinical aspects of autism and the fact that he’s an expert witness for vaccine manufacturers.

Let’s cut the shit here shall we? Richard Deth is a petitioners’ expert witness in major vaccine litigation. So are the Geier’s. So are various others. They have an equal ‘special interest’. Should we dismiss their papers out of hand? Either we allow *all* or allow *none*.

2) Fombonne’s previous views on the epidemiology of autism have been discredited.

Really? They have? By who? In what journal was this ‘discrediting’ published? Lets be clear here. Ayoub uses the word ‘discredited’. He didn’t say, ‘challenged’. He didn’t say ‘contraversial’ he said ‘discredited’.

David Ayoub by contrast, thinks that Rashid Buttar – a man who’s own patients think he’s a money grabbing quack – is an industry expert:

The 2 top chelation people in the world are Gary Gordon, MD, and Rashid Buttar, MD, he adds.

It’s my opinion that anyone who thinks Rashid Buttar is ‘top’ of anything autism related needs get his head back to reality pretty quickly.

3) Mark Blaxill at least takes a stab at something substantive. He questions the study methodology on two points. Firstly, he tries to insinuate that what might be true for Canada might not be for the US. Secondly he states that some of the study subjects may have received thiomersal from other vaccine sources than those noted in the study.

Fombonne et al write that:

The findings ruled out an association between pervasive developmental disorder and either high levels of ethylmercury exposure comparable with those experienced in the United States in the 1990s or 1- or 2-dose measles-mumps-rubella vaccinations.

So the word ‘comparable’ is used. Fombonne et al never attempt to state that it is a fact that what’s true for Canada is true for the US. However, its also true that there wouldn’t seem to be any good reason for _not_ thinking that. Why would the US and Canada be different? Surely thiomersal is thiomersal?

After that weak stab at something relevant, Blaxill retreats to Ayoub’s tactics of smear and spin.

Dr. Fombonne wrongfully claims that large-population studies in the United States, England and Denmark also disprove a link between mercury and autism, and he states that “there is no autism epidemic.”

The one mention of the word ‘Denmark’ in the entire paper is this one:

Our results are entirely consistent with cohort, case-control, and other ecological studies performed in Denmark and Sweden.

Fombonne et al never claim that these studies disprove anything. They merely note that consistency between those studies and their own. I can’t locate the use of the word ‘England’, ‘UK’, ‘united kingdom’ or ‘Britian’ anywhere in this paper so I fail to see why Blaxill mentions them.

Blaxill is guilty of intellectual dishonesty many times in his ‘rebuttal’. None more so than when he states that:

He conveniently ignores the vast body of scientific evidence that has shown that environmental factors such as mercury may have caused the increased number of autism diagnoses in the US and other countries.

Fombonne et al do not at any point discuss generalised ‘environmental factors such as mercury’. They discuss the key question regarding thiomersal and MMR. It raises questions about Blaxill’s integrity that he would try and switch the focus onto something he and his group explicitly have targeted to something much more general and which Fombonne et al does not address. This is a pattern becoming more and more apparent from key members of the mercury militia. As science continues to fail to support any causative link between thiomersal, MMR and autism, these groups are becoming much more generalised in their terminology. Expect to see more of this as 2006 draws to a close.

Blaxill also claims there is an increased number of autism diagnoses yet he fails to point to evidence for this. Fombonne’s own research on this point indicates a high but stable prevalence.

Blaxill continues:

Dr. Fombonne’s actions have not historically been in the best interest of families with autism—he has declared himself an expert witness on behalf of various pharmaceutical companies in thimerosal-related litigation.

By contrast, the Geier’s actions have not been in the interests of autistic peoples. And in fact this whole point about ‘best interests’ is childish in the extreme. The _only_ interest that science should adhere to is that of honest science. To suggest otherwise leaves a question mark over the objectives of Blaxill’s actions.

Several independent federal agencies and respected scientists and researchers have received federal funds to investigate the autism epidemic and the biological
plausibility of a link between mercury and ASDs.

Why is this even mentioned? Why not wait for them to be completed? Like this one already is.

Multiple studies have indicated that there is a connection between childhood vaccines containing thimerosal and the incidence of autism.

Blaxill (maybe purposefully) doesn’t mention _who_ might’ve conducted those studies, or where they were published. I’m guessing that he means the Geier’s but that recent revalations regarding their integrity and the quality of their work, made him think twice about saying their names for the record. Can’t say I blame him.

Skeptico, Orac and Autism Diva also comment on this study.

Judge Rotenberg Center – Good on Pain, Bad On Web Work

1 Jul

I recently blogged about the Judge Rotenberg Center and a few employee’s and ex-employee’s came to offer their opinions that it was OK to inflict pain on people until they did what you want.

Like most quacks, they failed to show any evidence that their way was any better then a non-pain inducing methodology so one was left with the conclusion that they used pain as a tool because it appealed to their natures as people.

Anyway, I’ve been taking a long hard look at the JRC website and received a bit of information which led to what I believe is a breach of US law governing personal data and data protection issues.

I’m going to have to talk broadly here as I don’t think it would be ethical for me to show you exactly what steps I took to stumble across this data. However, not only are the full names of all current staff members on public display, there are documents I’ve found which contain a full listing of all current students, represented by initials, together with details about which schools/units they’ve attended prior to JRC. There are also documents which mention at least 4 students full names, together with photographs of these students.

Let’s also be clear that the method I utilised to get to the data under discussion did not in any way reflect any hacking, cracking, injecting or otherwise any unethical practices. It came from a chance mouse click and some really dreadful .NET coding on behalf of the JRC’s web developer(s).

In the US it is the Dept of Health and Human Services which have governance over the regulations that dictate what is legally acceptable and what’s not under HIPAA.

From the HIPAA site:

Generally, what does the HIPAA Privacy Rule require the average provider or health plan to do?

For the average health care provider or health plan, the Privacy Rule requires activities, such as:..[]…Securing patient records containing individually identifiable health information so that they are not readily available to those who do not need them.

It seems pretty clear to me (but remember I’m not a US citizen or overly familiar with the intricacies of US law) that the posting of student personal data on an insecure web server where it can be accessed by a chance mouse click is a clear contravention of the above legal guideline.

I posted what Id found to an American friend I trusted and this person was able to replicate what I’d done and was also presented with the same confidential data. As an American citizen my friend is free to make a complaint following the process outlined here and in fact I understand this process is underway. The official complaint contains full details of how the data was discovered and exactly which data it was that was found.

Upon checking the source code of a few pages (the source code is the code that a web page is written in) I was shocked to find the following statement:

<!--#include virtual = "connectDB.asp"-->

I have altered the path and file name referred to but essentially this file is used to declare a connection to an online database. I now knew the exact path to the .asp file that contained the database server name, username and password which means that it would not have been to difficult, if I was so inclined, to connect to the JRC online database. I was _not_ so inclined and so I have no real idea what’s in the database but I would imagine it would be pretty important stuff. It’s also further illustration of the woeful state of the security on the JRC website.

Student safety is paramount and so if any JRC staff are reading this, please email me and establish exactly who you are (no anonymity allowed) and I will tell you exactly how this confidential data was accessed. I’ll even make a few suggestions as to the nature of the coding error and how you might fix it.

I don’t suppose this breech will result in JRC getting shut down but I think it will ensure the close attention of data protection specialists and probably ensure a hefty fine. Here’s hoping. I’ll keep this blog up to date with how the complaint goes.

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