Left Brain Right Brain

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

Kathleen has written part one of a multi-part look at some of the recent actions of those purveyors of Lupron, the Geier’s.

Seems that a new study of theirs; ‘A Clinical and Laboratory Evaluation of Methionine Cycle-Transsulfuration and Androgen Pathway Markers in Children with Autistic Disorders’ was accepted for publication in Hormone Research and published online prior to being published traditionally.

The interesting bit is the claim of institutional affiliation to Department of Biochemistry, George Washington University, Washington, D.C., USA.

Intruiged, Kathleen contacted Dr. Allen Goldstein, Chairman of the GWU Department of Biochemistry and Molecular Biology to ascertain exactly what the Geier’s affiliation to GWU was. His reply was a bombshell and a further mark against the Geier’s honesty and reliability:

He described the affiliation with the Department of Biochemistry in the Hormone Research article as “fallacious,” and stated that it conveyed a “significant misrepresentation” of Mr. Geier’s position in the field of biochemistry.

I urge you to go and read the rest of Kathleen’s investigation into the Geier’s. Its a compulsive read.

As I understand it, this is _far_ from the end of the matter. There will be further parts to this ongoing issue. Keep an eye on the Neurodiversity weblog.