Dr. Frankenstein testifies

Kathleen has posted another one of her excellent investigative reports on the doings of Dr. Mark Geier, she titled it, "A Case of Good Gatekeeping."

"Gatekeeping," for those who might not be familar with this usage, refers to allowing or denying others access to certain pieces of information. Kathleen Seidel refers to gatekeeping, apparently in reference to the fact that Dr. Mark Geier, in the process of "Frankensteining" together his testimony about a boy who was supposedly made autistic by thimerosal in a saline nose spray decided not to include certain facts about the boy's history, like the fact that his mom smoked half a pack of cigarettes a day during her pregnancy. Notice the use of "Frankenstein" as a verb in a statement from the defendent's lawyer quoted in Kathleen's report.

It's also interesting that the lawyer in this case didn't indicate that mom also had filed a petition for alleged thimerosal containing vaccine damage of her son, and the petition regarding thimerosal doesn't mention the nasal spray petition. That sounds sneaky for some reason, doesn't it?

You really should go and read the whole thing on Kathleen's blog because there are some great parts that Autism Diva removed for brevity's sake. Here are some of the highlights:

A Case of Good Gatekeeping

On June 1, 2007, United States District Judge for the Northern District of California Phyllis J. Hamilton filed a 31-page order in the product liability case, Redfoot v. B.F. Ascher & Company et al. (C-05-2045-PJH). In this case, the plaintiff alleged that Ayr Saline Nasal Mist was the cause of her son’s autism, and that the manufacturers and distributors of Ayr negligently and recklessly failed to disclose known dangers of their product.

The court was not convinced.

...

The Plaintiff’s Allegations

The child at the center of the lawsuit was born on January 1, 2000. In 2002, he was diagnosed with Pervasive Developmental Disorder-Not Otherwise Specified; at the age of three and a half, his diagnosis changed to Autistic Disorder.

In the spring of 2003, the parents learned that certain vaccines and other health-care products contained trace amounts of the mercury-based antimicrobial thimerosal, and that some people believed that thimerosal in medical products could cause neurological damage resulting in autism. Their son had received a routine series of vaccinations in infancy, some of them containing trace amounts of thimerosal; and from the age of two months to three years, his parents treated his recurring nasal congestion with frequent doses of Ayr Saline Nasal Mist, which contained 0.00025% thimerosal.

...

The plaintiff requested an unspecified amount of compensatory and punitive damages. (Although her VICP petition alleged that her son was harmed not by nasal spray but by thimerosal in his vaccines, her suit against Ascher did not reference the vaccine petition or reiterate its allegations; these were mentioned in a motion later filed by the defendants.)

In an expert report dated December 14, 2006, Dr. Mark Geier presented his opinions on “the capability of mercury in thimerosal to cause neurological damage.” He reviewed the history of the use of mercury; the development of thimerosal and its use in medicine; mass environmental mercury poisonings; animal and in vitro studies with mercury and thimerosal, including studies by Thomas Burbacher, David Baskin and Richard Deth; and Bernard et al’s essay asserting a similarity between symptoms of mercury and those of autism. ...

Dr. Geier’s evaluation of the plaintiff’s son listed diagnoses of Autistic Disorder, Toxic Encephalopathy, Porphyria, Mercury Poisoning by Therapeutic Use of Thimerosal, Testicular Hyperfunction, and chromosomal abnormalities. His narrative account of a December 2005 interview with the mother revealed that she smoked approximately a half-pack of cigarettes per day while pregnant, refrained from eating fish, and had eight amalgam fillings in her teeth. ... He was immunized according to the routine schedule, and his recurring nasal congestion was treated with Ayr Saline Nasal Mist. Dr. Geier estimated the child’s total “mercury dose” from Ayr to be 700µg. The mother reported that the child’s development progressed well until the age of one year, at which point his physical and language skills declined. Dr. Arthur Krigsman performed a colonoscopy and diagnosed the child with enterocolitis and “inflammation of the gut.” He became variously a patient of Dr. Jeffrey Bradstreet, a Dr. Bhatia, Dr. Lynn Mielke, and was treated at the Pfeiffer Center. The child was put on a gluten- and casein-free diet, and was subsequently administered prednisone, infusions of secretin, the chelator DMSA and methyl B-12 injections. Beginning in March 2005, he was evaluated and treated at the Lovaas Institute.

...

From these data and his examinations, Dr. Geier concluded that:

“The patient’s neurodevelopmental disorder is the apparent result of a toxic encephalopathy… significantly contributed to by mercury exposure from the Thimerosal-containing nasal spray he was administered… If there was thimerosal in the childhood vaccines, there would have been exacerbation from this additional childhood mercury exposure… [...]”


The Defendants’ Response

The defendants denied the plaintiff’s allegations and requested summary judgment — that is, resolution of the case in their favor. They argued that:

“...[P]laintiffs have no reliable, statistically significant evidence to support their allegation that the Ayr Saline Nasal Mist utilized by plaintiffs is capable of causing autism in the general population, or that the product caused A[...]‘s autism… [T]he scientific evidence offered by plaintiffs is fundamentally flawed, inherently unreliable, and entirely inadmissible. [...]”
(Memorandum in Support of Motion for Summary Judgment)

...

The defendants warned the court that:

“Lacking reliable epidemiological or scientific evidence of any association between TCVs and autism (or mercury-induced neurotoxicity), plaintiffs’ expert witnesses attempt to Frankenstein together a causation argument by extrapolating from in vitro experiments, animal data, and poorly controlled observational studies, while ignoring valid scientific methods. In doing so, plaintiffs’ experts breach the boundaries of legitimate science by employing improper scientific methodology and relying on unproven or improper studies.”
(Defendants’ Motion to Preclude)

The defendants submitted five expert reports in support of their preclusion motion. Pediatric neurologist Paul G. Fisher of Stanford University noted several pertinent matters evident in the child’s family, medical and developmental history, including matters recorded in Dr. Geier’s notes on his interview with the mother, but not mentioned in his final expert report:

“The child was developmentally delayed… sitting at nine months, walking at thirteen months, running at 24 months, and babbling lasting until 12 to 18 months. The child was macrocephalic from birth onward… (and) noted at four to five months to be hypotonic… (The child) has a number of other risk factors more likely to lead to autism, such as a history of speech and language problems, maternal smoke, or idiopathic cerebral dysgenesis. I will testify that there is no medical probability whatsoever that A[...]‘s developmental difficulties are related to thimerosal exposure from Ayr Saline Nasal Mist…”
(Declaration of Paul G. Fisher)

Dr. Fisher also expressed his concern for the child’s welfare, in view of the multitude of therapies to which he had been subjected with no apparent evidence of medical necessity:

“I am a bit perplexed why the child has received so many other therapies if the mother is convinced the child has suffered a toxic exposure from mercury. It would not be useful at any point to provide chelation therapy to try to remove such and it is unclear to me how therapies such as secretin or other medications would affect the boy’s autism. Chelation therapy is known to be dangerous to children and is not medically indicated for developmental issues. [...]”
(Declaration of Paul G. Fisher)

...

Toxicologist Philip S. Guzelian of the University of Colorado Health Sciences Center discussed the matter of chemical toxicity:

...

“...Review of Dr. Lucier’s method to derive exposure (or dose estimates) is futile inasmuch as he provided no equations, inputs or assumptions. Nevertheless, one immediate conclusion is that his calculation must be in error… It appears that Dr. Lucier’s exposure (or dose) estimates overstate the amount of ethylmercury in the Ayr solution by a factor of ten.”
(Statement of Philip Guzelian)

Obstetrician and teratologist Patricia Rodier of the University of Rochester described various prenatal exposures linked to autism (these include maternal rubella infection, thalidomide, valproic acid, ethanol, and misoprostol), and commented on the lack of evidence for the thimerosal causation hypothesis:

“It is unscientific and illogical to accord any merit to an hypothesis for which there are no supporting data and many lines of negative data… The plaintiff’s allegation that thimerosal in nasal spray causes autism is based on the earlier hypothesis of a link between vaccines and autism. Since the vaccine hypothesis has been discredited completely, it would be illogical to find any merit in the allegation.”
(Statement of Patricia Rodier)

...

The Plaintiff’s Rebuttal
...

In her reply to the defendants’ preclusion motion, the plaintiff reiterated and defended the qualifications of Geier, Lucier, Haley, Bradstreet and Krigsman; denied the defendants’ assertion that their opinions were formulated for litigation; collectively characterized the U.S. Food and Drug Administration, American Academy of Pediatrics, Institute of Medicine, World Health Organization, U.S. Centers for Disease Control, U.K. Committee on Safety in Medicines and the European Agency for the Evaluation of Medicinal Products as an “alphabet soup of organizations… who have discounted the link between thimerosal and autism without discussing the motivation for or foundations of their conclusions”; and recounted a number of cases in which Dr. Geier’s testimony was admitted by the courts.


The Court’s Decision

In her decision, Judge Hamilton delineated and weighed the arguments forwarded by both plaintiff and defendants on every point. She reviewed the use of thimerosal in biological products, and recent investigations on a posited relationship between thimerosal and autism; discussed legal standards for expert testimony and scientific evidence; devoted twelve pages to an analysis of Dr. Geier’s qualifications and testimony, assertions, research methods, and the references upon which he relies; and also considered the qualifications of George Lucier, Boyd Haley, James Bradstreet and Arthur Krigsman. Legal standards for granting a motion for summary judgment were explored, followed by a discussion of standards for determining causation in toxic tort cases.

Ultimately, Judge Hamilton excluded the testimony of all of the experts put forward by the plaintiffs; granted summary judgment in favor of the defendants; and dismissed the case on its merits.

...

On Mark Geier’s qualifications to testify

...

“In particular, there is no evidence that Dr. Geier has either the training or the background to diagnose autism or to treat autism in any child. Simply having an “interest” in vaccines and the possible connection between thimerosal-containing vaccines and the development of neurodevelopmental disorders in children is not sufficient to qualify an individual as an expert in either pediatrics or neurology, or regarding the various forms of mercury and their neurotoxicity.

...


Conclusion

“In accordance with the foregoing, the court GRANTS defendants’ motion to exclude expert testimony and motion for summary judgment. The trial date is VACATED. The clerk shall close the file.”
(Order Granting Motion for Summary Judgment)


The Emerging Case Law

The decision in Redfoot v. Ascher adds to a growing series of judicial analyses of the hypothesis that autism is caused by thimerosal poisoning; of the legal arguments advanced by those who seek to extract compensatory and punitive damages for harm alleged to have been caused by thimerosal-containing products; and of the qualifications of the insular coterie of “maverick scientists” and entrepreneurs who profess expertise on the subject of autism causation.

...

“Test Case #2” in the Omnibus Autism Proceeding — alleging that thimerosal alone is capable of triggering autism — is scheduled to be heard before the end of 2007. Experts designated to testify for the plaintiffs include David Baskin, Richard Deth, Mary Megson, Elizabeth Mumper, James Woods, Boyd Haley, and Mark Geier.

...

[Bold emphasis added .]

The judge made it perfectly clear that Dr. Geier was no qualified to be diagnosing children with autism spectrum disorders, and not qualified as an expert in pediatrics or neurology. It's obvious that he's not an expert in pediatric endocrinology, either, but the guy is dosing kids and teens with tremendous amounts of the chemical castrator "Lupron" not to mention "Androcur" which isn't FDA approved for use in the US at all. He's not a toxicologist, but that doesn't stop him from prescribing chelation for children.

This little boy has made the rounds among autism quackery hall of famers. He's seen Jeff "Exorcise 'em" Bradstreet, M.D., who has claimed that bogus lab tests from the O'Leary lab showed measles in kids' spinal fluid when there was none, and of course treated them with expensive IVIG and who knows what all else. Maybe Bradstreet prescribed the (useless except as a placebo) Secretin. This child has seen another Wakefield croney, Dr. Arthur Krigsman who appeared to perjur himself in the Cedillo case and who appeared to diagnose inflammatory bowel disease where there was none in Michelle Cedillo. The boy has been on prednisone, so maybe he got that one from Krigsman, as Krigsman seems to use that one quite a bit, along with Pentasa and 6mp, all of which can have very nasty side effects. He's getting the quack MeB12 shots.

He's seen Lynn Mielke who was JB Handley's son's doctor and who favors using mail order labs and who said in statements to the media that mercury was the second most toxic substance on earth, and later lamented (at the UCD MIND Institute's mini-DAN!) that MD's get such poor training in chemistry in medical school... uh, yeah, Dr. Mielke, apparently, so. At least in your case this is obviously true.

The boy has also been on the GFCF diet and also a soy free diet.

There is commentary on some of the doctors that the boy saw and their non-ranking as experts and commentary on the treatments that the boy has been getting in the court documents, you can read more on Kathleen's blog and she explains how to access the original court documents, too.

Oh, and did you notice that Kathleen shares that case #2 for the Omnibus hearing has been selected? Apparently, Dr. Geier will be put forward as an expert witness in that case... for some reason Autism Diva thinks that means the plaintiffs are really desperate or really don't care if they win, because surely no one is going to take Dr. Geier's word on anything related to thimerosal in court. It has been established over and over again that he doesn't know a single cogent thing about autism or thimerosal, so he just Frankensteins some junk including his own pathetic junk science together and stuffs it into a report, for which he is paid, apparently.



Autism Diva
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