Autism Complementary and alternative medicine Medicine Quackery

The Geiers humiliated?

I had tried to give the Dr. Mark Geier and his son David a rest for a while, as I suspected my readers may have been getting a little tired of my bashing them, no matter how deserved that bashing may have been. After all, they do shoddy science in the service of “proving” that mercury in vaccines causes autism. They concoct dubious IRBs riddled with conflicts of interest to “approve” their research. When the evidence that this is not the case becomes more and more compelling, they add a twist of a claim that many autistic children suffer from “precocious” puberty,” which requires treatment with a powerful hormone blocking drug called Lupron (my take on this here). Unfortunately, the Geiers use very loose criteria to diagnose “precocious puberty,” so much so that almost any child could qualify, particularly given the leading questions that parents are asked regarding their children’s development of secondary sexual characteristics. Most recently, Kathleen Seidel has documented how the Geiers have now stopped referring to “precocious puberty” and started calling it “hyperandrogenicity in autism,” as if the two terms are interchangeable. (They’re not.)

But last week, a truly delicious judicial ruling came down. If you think the Kitzmiller v. Dover decision was a lovely slapdown for “intelligent design” creationism, you’ll love U.S. District Court Judge James Beatty’s ruling against the Geiers’ clients that came down on July 6 in the case of John and Jane Doe v. Ortho-Clinical Diagnostics, Inc.

Basically, this case involves parents suing Ortho-Clinical Diagnostics because they believed that the thimerosal in RhoGAM given to the mother while she was carrying the child. RhoGAM is the trade name for Rho(D) immune globulin. This particular antibody is used to prevent hemolytic disease of the newborn that can happen when an Rh-negative mother has been sensitized to the Rh antigen by bearing an Rh-positive child (which can only happen if she has a child by an Rh-positive father, resulting in an Rh-positive fetus). The facts of the case are summarized as follows:

Plaintiffs allege that Minor Child Doe 2 (“Minor Child Doe”) has suffered severe neurodevelopmental disorders and permanent injuries from exposure to toxic levels of mercury. Plaintiffs claim that this mercury exposure resulted from one single shot of RhoGAM that Jane Doe received while 28-weeks pregnant and another shot of RhoGAM that Jane Doe received shortly after Minor Child Doe’s birth. Plaintiffs argue that this limited amount of thimerosal, which contains a mercury derivative, in both of those shots given to his mother caused Minor Child Doe to develop autism approximately sixteen months after his birth.

Relevant to my discussion:

In order to prove their claims Plaintiffs designated three experts on the question of whether thimerosal could cause autism: Dr. Mark Geier (“Geier”), Boyd Haley, Ph.D. (“Haley”), and George Lucier, Ph.D. (“Lucier”).

Yes, this is one of the first real judicial cases conducted over whether thimerosal can cause autism. In this case, the claim is that it can affect the fetus in utero, although I’m puzzled how a shot of RhoGAM after the birth of Minor Child Doe could have anything to do with affects on the child. The implication seems to be that mercury in the mother’s breast milk contributed to her child’s autism, but, given the tiny amount of thimerosal in a single vial of RhoGAM, that seems a stretch even if you accept that mercury might be related etiolotically to autism. In any case, the judge had to rule on the admissibility of the scientific evidence and address the qualifications of the expert witnesses, particularly Dr. Mark Geier. Basically, Judge Beatty used a commonly used legal standard known as the Daubert standard, which takes its name from the case Daubert v. Merrel Dow Chemicals. Basically, according to Daubert, Federal Judges were to become the “gatekeepers” for expert testimony, requiring them to rule on the admissibility of expert scientific testimony. Basically, there are two prongs to this standard: relevancy (the testimony of the expert must be relevant to the facts of the case and the determination of a judgment) and reliability (the expert must have developed his conclusions from the scientific method). As Judge Beatty summarizes:

The nature and necessity of a Daubert hearing is derived from the case of Daubert v. Merrell Dow Pharms., 509 U.S. 579, 113 S. Ct. 2786 (1993). Under Daubert, this Court must rule on the admissibility of expert scientific testimony. 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.” This gate keeping function is important because, “due to the difficulty of evaluatig their testimony, expert witnesses have the potential to be both powerful and quite misleading.”

In Daubert and related cases, the U.S. Supreme Court has elucidated a number of factors for District Courts to consider when determining whether to admit expert testimony under Federal Rule of Evidence 702.4 For example, the U.S. Supreme Court stated in Daubert that 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.”

So how did the Geiers do under the Daubert standard? Not well at all. Indeed, Judge Beaty gave Dr. Mark Geier a serious slapdown. He starts out, however, by simply summarizing some basics, namely that Dr. Geier based his claims mainly on a review of the literature rather than his own work, pointing out that the research cited by such an “expert” must also meet the Daubert test and concluding that Dr. Geier’s testimony did not meet the Daubert standard. Some commentary in the ruling that justifies this conclusion:

He [Geier]is a medical doctor who specializes in obstetrical genetics with a Ph.D. as well in genetics. He is board certified in medical genetics and forensic medicine. However, it is significant to the Court that he is not board certified in pediatrics or in pediatric neurology, nor is he certified as an epidemiologist or biostatistician. Dr. Geier did serve as a researcher at the National Institutes of Health for 10 years and worked as a professor at John Hopkins University. While he has published more than 50 peer-reviewed medical papers, none of these prior publications were on the specific issue at hand, that is, whether RhoGAM with thimerosal causes autism. The Court has taken into account, as well, 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.

Ouch. That one’s going to leave a mark. But Judge Beatty was just getting warmed up. First he dispenses with Dr. Boyd Haley’s contribution, finding 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.

And all this is summarized in a single footnote! But Dr. Haley is lucky; he got off easily compared to Dr. Geier. What Judge Beatty says about Dr. Geier and his testimony is even more damning. Commenting on previous findings in previous cases that in which Dr. Geier’s testimony was dismissed on the basis of “largely irrelevant” qualifications; his being a “professional witness in areas for which he has no training, expertise, and experience”; his “speculation that is directly contrary to the conclusions reached in well-respected and numerous epidemiologic and medical studies ranging over two decades”; his “neither being board certified nor [having] formal training in pediatrics and pediatric neurology”; his work not being “based on based upon scientific validity, valid methodology, peer review or testing, and more than
minimal support within the scientific community”; and, my favorite of all, a finding that Dr. Geier’s testimony was “intellectually dishonest” and that his affidavit was “nothing more than an egregious example of blatant, result-oriented testimony.”

“Results-oriented testimony”? Talk about a serious spanking! Yep, that just about sums up it up. He might as well have said “results-oriented research,” which is pretty much the totality of the Geiers’ work with respect to vaccines and autism. It gets better, though:

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 that the small amount of thimerosal received in this case by the mother of Minor Child Doe during the course of her pregnancy and shortly after the child’s birth, could cause autism. Dr. Geier’s methodology consisted of attempting to connect various individual studies that had developed the existence of certain findings such as thefollowing: (1) mercury exposure could destroy neurons; (2) high levels of methylmercury exposure may cause developmental defects in children (Faroe Islanders study and Iraq study); (3) mercury can be transmitted through a mother’s milk to her suckling child (Iraq study); (4) thimerosal can cross the blood-brain and placental barriers (this study considered doses of 1,000 micrograms of thimerosal, whereas the product RhoGAM has only about 10 micrograms of thimerosal); (5) direct and multiple (6x) injections of 50 miligrams of thimerosal can kill or deform embryonic chickens; (6) topical use of thimerosal as an antimicrobial by pregnant women may have caused birth defects; (7) a mouse model exposed to thimerosal in a way mimicking a childhood immunization schedule developed physical, psychological, and (Holmes study).Thus, on its face, all these study results, when pieced together, would seem to support Plaintiffs’ general causation theory, as offered by Dr. Geier, that RhoGAM could cause autism.

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. Even with respect to the Holmes study, which was an important part of Dr. Geier’s methodology and ultimate conclusion, Holmes states the following in the last sentence of the paper: “Our study provides further insight into one possible mechanism by which early mercury exposures could increase the risk of autism.” (emphasis added). Such a conditional statement cannot meet the preponderance of the evidence standard that Plaintiffs need to meet to show that the thimerosal in RhoGAM could cause autism. This Court must find more than the “hypothesis and speculation,” engaged in by Dr. Geier in this instance, in order to allow Dr. Geier to rely upon the methodology he used in forming a conclusion based upon his review of the literature presented to the Court. In any event, Dr. Geier’s conclusion in this matter is not supported even by the literature he presented to the Court. Moreover, Dr. Geier’s conclusion that the peer-reviewed literature he has relied upon supports his theory that autism can be caused by thimerosal is flatly contradicted by all of the epidemiological studies available at this time.

I couldn’t have said it better myself. Indeed, I’ve made many of the very same points about the very same studies in previous posts (1, 2, 3). Indeed, Judge Beatty said essentially the same thing that I and others have said about the shoddy methodology and downright horrible statistical analyses used when the Geiers mined the VAERS database. And I particularly like the description of all the studies the Geiers rely upon as “a motley assortment.” Man, are they ever motley! They’re a bunch of poorly related studies, some shoddily performed, some represented as supporting a link between autism and mercury when in reality they do not. And that’s the best evidence the mercury militia can come up with to counter large, well-designed studies that don’tfind a link.

The court was also not fooled by some of the Geiers’ latest work, which has not yet been published, that Dr. Geier tried to sneak in to show that maternal exposure to RhoGAM causes autism:

Nevertheless, looking at these studies in conjunction with Dr. Geier’s literature review, the Court remains unpersuaded that Dr. Geier’s testimony meets the Daubert test, particularly because Plaintiffs have failed in each instance to show: (1) that the theory employed by Dr. Geier is generally accepted in the scientific community; (2) that Dr. Geier’s most recent and most applicable work concerning RhoGAM has been subjected to peer review and publication; and (3) that Dr. Geier properly controlled his studies and maintained standards: particularly, that he failed to take into account that RhoGAM is not the only Rho D immunoglobulin on the market and RhoGAM’s competitor did not contain thimerosal, and Dr. Geier admittedly has not separately analyzed which of his patients received Defendant’s product RhoGAM and which received some other Rho D immunoglobulin to determine respective autism rates. Moreover, the Court is particularly concerned as to a potential bias in Dr. Geier’s methodology and ultimate conclusion given the recency of Dr. Geier’s research into the cause of autism, which he admittedly began in only the last two and a half years, a time period that also represents the pendency of this lawsuit.

“The court is particularly concerned as to a potential bias”? That’s about as close as the judge can get to calling Dr. Geier a biased hack that you’ll see in legal language.

You may have noticed that I haven’t said all that much in this post and have mostly selected choice tidbits from the ruling to bolster my point. It’s the same sort of thing that I did with the Kitzmiller decision, because it’s the same sort of decision, when a judge, with startling clarity and vehemence, completely stomps on pseudoscience. Such decisions are rare and to be savored when they appear. Also, when the judge is mirroring my viewpoint in slapping down pseudoscience so well, I see little need to add a lot of my own commentary, except for a bit of background and (when I can’t help it) a bit of sarcasm. Indeed, I was tempted to quote the judge further as he ripped Geier to shreds for his poor differential diagnosis skills and the fact that Geier never even considered or mentioned alternate hypotheses for the causes of autism. Geier never even mentioned the most obvious hypothesis other than his bête noire (mercury), namely genetic causes, which also happens to be the one that most investigators consider to be the primary cause, with others likely to be much less important. That Geier never even mentioned genetics as a cause, even if only to dismiss it and explain why he considered it less likely than mercury, reveals the depths of his bias, a bias that Judge Beatty clearly saw through. Throwing just a pinch of salt in the huge gaping wounds he had inflicted on Dr. Geier’s credibility, Judge Beatty also pointed out that Dr. Geier could not pass his Boards in Pediatric Genetics, which means he is not certified even to be making differential diagnoses in that field.

Mark Geier should just be exceedingly grateful that this decision weighs in at only around 25 pages, rather than the 100+ pages Judge Jones produced in the Kitzmiller decision demolishing “intelligent design” and its adherents who testified in the case. Perhaps the reason the ruling is so short is because the plaintiffs’ evidence was so bad that the case was dismissed with a summary judgment with prejudice.

But the issue of the Geiers aside, what’s really interesting about this case is what it might mean for the Autism Omnibus hearings. As Kevin Leitch points out, Drs. Geier and Haley are two of the main expert witnesses and have been found severely wanting, as has the best evidence the mercury militia can come up with thus far. After a judicial humiliation like this, Mark Geier and Boyd Haley as “expert witnesses” are probably now liabilities to the plaintiffs in the Omnibus case. Mark Geier can continue to be the Don Quixote of the mercury militia, tilting at windmills made of mercury, but his credibility as an expert witness may have just taken a fatal blow. At least, we can hope that’s the case.

Note: Prometheus and Kevin Leitch have also commented on this ruling.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

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