Omnibus hearing: Chadwick and Brent
Before we get into day 10 of the hearing ... going back to July of 2006, the Petitioners' Steering Committee (PSC, the lawyers for the parents) finally settled on June of 2007 for the Omnibus hearing. At that time the PSC wrote to Special Master Hastings:
It's interesting to see how many things have changed in the past year. Last year the PSC was adamant that they wouldn't want any specific cases presented. But here we are learning all about Michelle Cedillo and we are going to learn about 8 more individual cases before it's all finished. Autism Diva also wanted to point out that a year ago the petitioners' lawyers said quite strongly that they thought one hour was plenty for cross examination of any witness.
Day ten of the Omnibus hearing started off with testimony by telephone given by Dr. Nicholas Chadwick. He seemed to be on the phone from somewhere in the U.K.
Dr. Chadwick started working with Dr. Andrew Wakefield in 1994. The transcriber transcribed on page 2283 that the lab that Dr. Chadwick worked in was at the Royal Free (as opposed to the Royal 3). That's the Royal Free Hospital for those of you who aren't Wakefieldophiles. By 1996 Wakefield has decided to focus on autistic children and their gut and CSF samples. Dr. Chadwick said he was present in the endoscopy suite when the biopsies were taken from autistic children (2284). His job was to take the material and do PCR on it to look for measles. Ms. Patton asked about how they checked positive results to see if they were false positives.
Dr. Chadwick noted that he asked for his name not to go on a paper that discussed results from the Kawashima lab.
Ms. Chin-Caplan gave a kind of limp cross examination.
But first there was the direct examination of Dr. Brent the toxicologist from the University of Colorado (2302) by Ms. Renzi:
On page 2314 is the beginning of a discussion of an FDA notice of proposed rule making about over the counter antiseptics containing mercury (such as merthiolate). Dr. Aposhian had cited it as evidence that thimerosal was known to be ineffective as a preservative for vaccines and there was no "bona fide" data showing it was safe for such a use. But the proposed rule was really talking about whether or not it was a good idea to sell these mercury based antiseptics over the counter any more (considering that they didn't work so well in the presence of blood and pus, if used in an excessive way could poison the tissue at the site of the wound, and because it could cause allergic reactions). Dr. Brent also discussed that Dr. Aposhian had introduced a reference to a list (called, "21 C.F.R. 310.545" ) of about 700 substances that had been grandfathered in to the acceptable list of drugs when the FDA came into existence. The list included honey (for use in cough syrup), aspirin, caffeine and lidocaine.
Ms. Renzi asked Dr. Brent:
Dr. Aposhian tried to rewrite all the toxicology textbooks by throwing out the adage that "dose makes the poison". Dr. Aposhian said that it was all about how the dose intereacted with the individual patient's biology. However, all that would do, if this reasoning even applied, is push the level of dosage needed for a substance to become a poison up or down for an individual, from page 2336 Dr. Brent says:
Dr. Aposhian, in his testimony, gave several accounts written up in publications as examples of poisonings from mercury compounds and pointed out the adverse reactions from these poisonings. But in every case Aposhian referred to the doses of mercury compound was higher or massively higher than the dose even a baby would get from a vaccine containing thimerosal. In many cases the accounts were not about ethyl mercury and not about thimerosal. There is a discussion of some of these starting on page 2340.
From page 2362:
Fom here one Autism Diva is going to work from some notes, so the wording is kind of telegraphic.
What did the IOM conclude? They rejected the mercury efflux disorder. If you look at the Holmes (discussed starting on 2351) and Bradstreet papers (2356) which are highly questionable it makes the "efflux disorder" completely implausible (2363).
Genetic susceptibility to mercury has never been established. Never been a susceptible sub-population to thimerosal. For example Wilson's disease, the gene was relatively easy to identified (2364). The ASD population has been studied more carefully looking for a genetic susceptibility. There's no evidence presented that Michelle Cedillo has this susceptibility (2364).
Some of the clinical characteristics of Pinks disease or acrodynia, multiple manifestions (2365).
Children were using Calomel as a teething powder. In the acrodyina cases they were almost all about. inorganic mercury.
One individual had acrodynia from thimerosal. Paper demonstrates that urine mercury levels were very high (2366,67).
Autism Diva has to take a break from this for a few hours but wanted to get a partial blog entry posted about day 10. More will come later (maybe tonight).
For those interested, here's a copy of the Goth paper, the one out of UCD about mouse dendritic cells exposed to thimerosal in vitro.
Also, apologies for any bad typos here, as Autism Diva doesn't have the time to hunt for them at the moment, and apologies for not responding to some recent comments on other blog entries. Autism Diva is short on time lately, but will try to respond eventually.
Autism Diva
OD
(Bold emphasis added.)
The PSC proposes to present its case for general causation in June 2007. Given the number of petitioners' testifying experts who hold academic teaching positions, hearings after the conclusion of the academic year would be most practical and create the fewest conflicts for many of the experts. A June 2007 hearing would also provide the parties ample time to complete the designation of their expert witnesses and prepare and submit them to the Special Master, further allowing time for the Special Master to review submissions in advance of the hearings. Hearings in June --- during the traditional summer school recess --- would also give petitioners' families an opportunity to attend. The PSD anticipates the hearing will take approximately 2-3 weeks, as detailed below.
... As the party bearing the burden of proving causation, the PSC reserves the right to present rebuttal witnesses. ...
Petitioners anticipate calling as many as 12 witnesses to testify. ... Petitioners therefore believe that placing time limits on the testimony of each witness is crucial to the efficient and timely progress of the hearing. Petitioners anticipate limiting testimony to no more than two hours on direct, and one hour on cross-examination, for each witness offered by either party.
...
Finally, petitioners strongly object to any proposal that would bring consideration of individual cases or claims into this hearing on general causation. The PSC believes that this hearing should focus solely on issues of general causation, without attempting to apply those general scientific propositions to individual cases or claims.
It's interesting to see how many things have changed in the past year. Last year the PSC was adamant that they wouldn't want any specific cases presented. But here we are learning all about Michelle Cedillo and we are going to learn about 8 more individual cases before it's all finished. Autism Diva also wanted to point out that a year ago the petitioners' lawyers said quite strongly that they thought one hour was plenty for cross examination of any witness.
Day ten of the Omnibus hearing started off with testimony by telephone given by Dr. Nicholas Chadwick. He seemed to be on the phone from somewhere in the U.K.
Dr. Chadwick started working with Dr. Andrew Wakefield in 1994. The transcriber transcribed on page 2283 that the lab that Dr. Chadwick worked in was at the Royal Free (as opposed to the Royal 3). That's the Royal Free Hospital for those of you who aren't Wakefieldophiles. By 1996 Wakefield has decided to focus on autistic children and their gut and CSF samples. Dr. Chadwick said he was present in the endoscopy suite when the biopsies were taken from autistic children (2284). His job was to take the material and do PCR on it to look for measles. Ms. Patton asked about how they checked positive results to see if they were false positives.
A. Well, we sequenced the products of the PCR reaction and could find out whereabouts the virus came from, and in every case it was a lab strain virus based on the sequence and didn't match up with any known wild-type or vaccine strains.He describes that they took blood cells (PBMCs) that might have had measles virus in them, and used them to try to grow out the measles virus in culture, but no measles virus grew in the culture. Then there is this on page 2286.
...
Q Did you personally test CSF samples from autistic children in the lab?
A Yes, I did. Again, they were all negative. I can't recall how many I tested, but they were definitely negative, the ones I did test. (page 2285)
Q. So you personally tested while you were in Dr. Wakefield's lab gut biopsy material, CSF and PBMCs?Dr. Wakefield was comparing his work with detection of measles virus with the work of a Dr. Kawashima in Japan. Dr. Chadwick found that the Kawashima lab was inaccurate because Dr. Chadwick would send duplicate samples, each of which should produce the same result, but in fact they didn't ever produce the same result (2287).
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.
When [Kawashima] told us that he had some positive results he sent us the sequencing data back, but the sequencing data matched up with the positive control samples that we sent out to him, which indicated to me that he had contaminated his samples and they were false positive samples.Dr. Chadwick informed Dr. Wakefield that the Kawashima lab was not producing accurate results (2287).
Q. Every positive result you got was a false positive?
A. Yes. Yes, apart from the case of the positive control samples which we had, which were a measles infection, a brain disease. We were able to detect measles virus in those cases, so I was confident that the methods were working fine (2282).
Dr. Chadwick noted that he asked for his name not to go on a paper that discussed results from the Kawashima lab.
Ms. Chin-Caplan gave a kind of limp cross examination.
Ms. Chin-Caplan seemed to be saying that there was some bad reason for the respondents to ask Dr. Chadwick to testify. She emphasized, "Why?" in a sort of snotty, suspicious way. It was weird. To Autism Diva, who listened to the entirety of Chin-Caplan's cross examinations on day ten, Chin-Caplan was annoying from the beginning of the day right to the end but reached a crescendo of annoyingness at the end of the day. Now that's not exactly a neutral observation, but well into the second hour of Chin-Caplan's cross of Dr. Brent, Autism Diva truly had a strong desire to bang her forehead firmly against a wall. It wasn't because Chin-Caplan was making Dr. Brent look bad, because she wasn't, but because the cross exam went on and on and on about things that sure seemed to make no difference at all to the Cedillo case. And that subtly snotty, accusatory tone was always there.
Q. When you were approached to testify in this matter, what were you asked to do?
A. I was asked to provide a statement regarding the work I did for Dr. Wakefield relating to the autistic patients.
Q. And did you ask, "Why?"
A. Did I ask why? Because it was a case regarding the safety of the vaccine.
But first there was the direct examination of Dr. Brent the toxicologist from the University of Colorado (2302) by Ms. Renzi:
Q. I want to move on to your opinions today. Do you have an opinion whether Michelle Cedillo's autism is causally related to the receipt of thimerosal-containing vaccines in conjunction with an MMR vaccine?
A. Yes, I do have an opinion about that.
Q. What is that?
A. Well, I've looked at the medical records quite extensively. I've reviewed the literature in a great deal of detail, and I think it's clear there's no relationship between thimerosal administration and the development of autism or ASD.
Q. And do you have an opinion whether it is more likely than not that the thimerosal-containing vaccines that Michelle Cedillo received caused an immune suppression that was ongoing at the time she received her MMR vaccine?
A. There's absolutely no evidence that I saw that would suggest that thimerosal in the doses administered in vaccines would cause immunosuppression (2309).
On page 2314 is the beginning of a discussion of an FDA notice of proposed rule making about over the counter antiseptics containing mercury (such as merthiolate). Dr. Aposhian had cited it as evidence that thimerosal was known to be ineffective as a preservative for vaccines and there was no "bona fide" data showing it was safe for such a use. But the proposed rule was really talking about whether or not it was a good idea to sell these mercury based antiseptics over the counter any more (considering that they didn't work so well in the presence of blood and pus, if used in an excessive way could poison the tissue at the site of the wound, and because it could cause allergic reactions). Dr. Brent also discussed that Dr. Aposhian had introduced a reference to a list (called, "21 C.F.R. 310.545" ) of about 700 substances that had been grandfathered in to the acceptable list of drugs when the FDA came into existence. The list included honey (for use in cough syrup), aspirin, caffeine and lidocaine.
Ms. Renzi asked Dr. Brent:
Q. Is this regulation in any way relevant to demonstrate that the doses of thimerosal and thimerosal-containing vaccine are unsafe?From page 2320 to 2324 there's a discussion of the usefulness of in vitro studies. Regarding the Goth and Agrawal (page 2325) studies which discuss thimerosal exposed in vitro dendritic cells from mice and humans (respectively):
A. There's nothing in this regulation that says that.
Q. Or that they cause autism?
A. No. There's nothing that says that (2318).
Q. ... In your opinion, is it reliable science to extrapolate the results of these studies to conclude that immunosuppression will occur in humans following the receipt of thimerosal-containing vaccines?In the following pages up to 2333 there is a discussion of why one can't extrapolate from the Goth study (a UC Davis study frequently linked to Dr. Isaac Pessah of both the veterinary school and the MIND Institute) and the Agrawal study to saying that thimerosal in thimerosal containing vaccines could cause immunosuppression.
A. I think there's no reasonable way anybody could conclude from the Goth and Agrawal studies that the thimerosal from the vaccine would cause immunosuppression.
Dr. Aposhian tried to rewrite all the toxicology textbooks by throwing out the adage that "dose makes the poison". Dr. Aposhian said that it was all about how the dose intereacted with the individual patient's biology. However, all that would do, if this reasoning even applied, is push the level of dosage needed for a substance to become a poison up or down for an individual, from page 2336 Dr. Brent says:
I know there's been discussion about dose here earlier. I was here for some of that discussion. I think there may have been some confusion about the importance of dose so I'd like to just say a couple of words about this.
You know, this concept really goes back to Paracelsus and the famous saying, "Poison is everything. Nothing is without poison." The dosage makes it either a poison or a remedy. He was actually talking about mercury compound at the time.
SPECIAL MASTER HASTINGS: We're on Slide 19 now. Go ahead.
THE WITNESS: And as you see here on Slide 20, the bottom line we take from Paracelsus and is still quoted in every toxicology textbook today as a fundamental principle is that there is no such thing as a poisonous substance. There are only poisonous doses.
There is no substance that at low enough doses will not hurt you, and there is no substance that at high enough doses can be toxic. Water. I've had patients die from water, from drinking too much water. Psychogenic polydipsia it's called. ...
Dr. Aposhian, in his testimony, gave several accounts written up in publications as examples of poisonings from mercury compounds and pointed out the adverse reactions from these poisonings. But in every case Aposhian referred to the doses of mercury compound was higher or massively higher than the dose even a baby would get from a vaccine containing thimerosal. In many cases the accounts were not about ethyl mercury and not about thimerosal. There is a discussion of some of these starting on page 2340.
From page 2362:
Everything we do, every diagnosis we give, has to be given in the form of an ICD code. This is done internationally. If you look, there is no ICD code for a mercury efflux disorder. It doesn't exist. It's not recognized. There is fundamentally no scientific support for the hypothesis that the kinetics of ethyl mercury are any different in patients with ASD than anybody else suggesting an efflux disorder.
I heard testimony when I was here where Dr. Aposhian said well, yes, the problem with the Vacikero study is that they didn't study autistic children, and had they studied autistic children they would have gotten very different results.
Well, in fact there's not one shred of scientific evidence that suggests that autistic children have any different kinetics of ethyl mercury than anybody else.
Fom here one Autism Diva is going to work from some notes, so the wording is kind of telegraphic.
What did the IOM conclude? They rejected the mercury efflux disorder. If you look at the Holmes (discussed starting on 2351) and Bradstreet papers (2356) which are highly questionable it makes the "efflux disorder" completely implausible (2363).
Genetic susceptibility to mercury has never been established. Never been a susceptible sub-population to thimerosal. For example Wilson's disease, the gene was relatively easy to identified (2364). The ASD population has been studied more carefully looking for a genetic susceptibility. There's no evidence presented that Michelle Cedillo has this susceptibility (2364).
Some of the clinical characteristics of Pinks disease or acrodynia, multiple manifestions (2365).
Children were using Calomel as a teething powder. In the acrodyina cases they were almost all about. inorganic mercury.
One individual had acrodynia from thimerosal. Paper demonstrates that urine mercury levels were very high (2366,67).
Autism Diva has to take a break from this for a few hours but wanted to get a partial blog entry posted about day 10. More will come later (maybe tonight).
For those interested, here's a copy of the Goth paper, the one out of UCD about mouse dendritic cells exposed to thimerosal in vitro.
Also, apologies for any bad typos here, as Autism Diva doesn't have the time to hunt for them at the moment, and apologies for not responding to some recent comments on other blog entries. Autism Diva is short on time lately, but will try to respond eventually.
Autism Diva
OD
Labels: autism, cedillo, hearing, hhs, measles, mercury, mmr, omnibus, thimerosal, thimomersa, trial, vaccines
posted by Autism Diva at 1:01 PM
5 Comments:
A memorable moment from the cross-examination of Dr. Brent. (The discussion is based on an earlier reference to some animal studies regarding mercury):
Q: So your genetics can determine whether you're going to be resistant to mercury, or whether you're going to be immunosuppressed, or perhaps even whether you're going to tilt toward autoimmunity, correct?
A: If you're a rodent.
Q: Right. If you're a rodent.
A: Yeah.
I like when Dr. Brent explains that methyl mercury and ethyl mercury have very different effects.
As an example, he mentions products we're familiar with: methyl alcohol and ethyl alcohol. (Page 2345)
At the same dosage, methyl alcohol will either kill you or make you blind, while ethyl alcohol will give you a good time.
Dr. Brent also revealed to the court several instances where Dr. Aphosian mentionned the toxicity numbers for methyl mercury, and incorrectly and deceptively applied them to thimerosal, which is ethyl mercury.
I was thinking of that rodent reference when posting about the MIT scientists finding a way to "reverse" mental retardation in mice.
Dr. Brent's testimony was very enlightening to read, and lucid, and (I thought from the transcript) very patient. I hope he was able to get his Starbuck's afterwards.
I was interested to learn that thimerosal was used to preserve plasma and soldiers received large doses during WWII. Very educational testimony.
Hi
IMHO, the most complete and recent available literature on the issue has not even mentioned or analyzed unfortunately-neither in genetics or transport of toxic elements.
Post a Comment
Links to this post:
Create a Link
<< Home