Omnibus hearing: Fombonne
First an update on who will be the expert witnesses for respondents (the HHS). The following is a list of the witnesses that was posted some time ago elsewhere.
For some reason the transcript from Monday's testimony has not been posted. But the audio recording is available, as it today's (Tuesday's) audio. This set of notes from the audio of the hearing may be fraught with more typographical errors than are usual to Autism Diva blog. Apologies are offered in advance for any particularly egregious typos.
At the beginning of Monday's hearing Special Master Hastings said that both sides agreed that three of the respondents experts, who have submitted reports, won't be required to present those reports orally. These are Fujinami, Gershon, and Zimmerman (highlighted in purple in the above list). There are two witnesses who aren't on the older list above, a Dr. Bustin and a Dr. Chadwick. Autism Diva doesn't know who they are or what their expertise is.
Mr. Matanowski started out by presenting the case of Health and Human Services, the respondents. He pointed out the rather glaring omissions of the case that had been made by the Petitioners Steering Committee (PSC). The following are somewhat rough notes since we don't have the transcript available yet.
Mr. Matanowski mentioned the Daubert standard which is that science presented in courts such as this one must be reliable. At every critical juncture their science has not been reliable. They are presenting a more limited case now.
Mr. Matanowski says that the PSC has pulled a "bait and switch." He said that the Special Masters (the judges in this case) were told by the PSC that there would be a general causation proceeding, that it would encompass all their theories of causation, but late in their proceeding they decided that they would go with a test case approach. This is the approach that the respondents had suggested in the beginning and one that could have been tested years ago.
Mr. Matanoski said: "[The PSC] did tell [the Special Masters] this though, that [the petitioners'] test case would be applicable to a significant number of cases. They said [the Cedillo] case could be applicable to 80% of one firm's cases. Yet throughout the direct examination of their witnesses there was a concerted effort to limit the testimony to one specific case they were resistant to expanding their testimony beyond this case. Again bait and switch ... . It's only through dogged cross examination that we were able to expand the evidence before you so that it could be used in other cases. We intend to give you evidence that you can use in other cases. We intend to give you good scientific evidence."
Good scientific evidence is based on research that has been written up, tested, scrutinized, reviewed, discussed and reproduced. It comes from those who work in the science on a daily basis, from those who work directly with autistic children, not from those who testify for a living.
A serious accusation has been leveled against an important part of the public health arsenal against a preventable disease. An accusation has been leveled the MMR vaccine can cause autism, it's important to answer that. The MMR is designed to prevent a killing disease, 450,000 people die every year from measles. The threat remains real in this country.
Great Britain had an outbreak of measles that happened because Andrew Wakefield undermined confidence in the MMR, people died because of this.
A history of the autism/vaccine connection. In 1996 Andrew Wakefield was approached by lawyers, because he had previously tried to pin Crohn's disease on measles. The lawyers gave him money. Wakefield file a patent for a monovalent miseases vaccine. He would benefit if his vaccine was picked up and used instead of the MMR.
He published a paper on the gut in autism, but didn't tell the editors of Lancet that he had been paid by lawyers, didn't tell them about the patent and didn't reveal that some of the kids in the autism/gut/measles studies were the children of litigants.
In 2004 everything started to crash down on him. Brian Deer's work started to reveal what was behind the whole attack on MMR by Wakefield. Ten of the 11 co-author's of Wakefield's original autism paper retracted their names from the paper, O'Leary who had claimed to have found measles in his lab in Ireland said he didn't believe that measles caused autism. Wakefield was left alone.
Dr. Aposhian conflated the different kinds of mercury with thimerosal.
Dr. Brent will address the question of thimerosal causing immune problems.
Krigsman said it was the (later retracted) 1998 article from Wakefield that convinced him that MMR could cause autism, and that he was given confidence in the paper because Dr. Walker-Smith's name on that paper. But Dr. Walker-Smith has retracted his name from that paper.
Dr. Hepner, their expert, said that MMR causing autism is an unproven hypothesis.
The respondents will show that the theory advanced by the PSC is not biologically possible.
Measles vaccines when left in the brain destroys the brain. It is fatal.
Dr. Byers was testifying outside her area of expertise.
Dr. Brent will testify in the area of toxicology, he has real expertise.
Dr. McCusker is a real immunologist and works in immunology.
Dr. Kinsbourne is not an expert in autism, he's done no original research in autism.
Dr. Cook is one of the preeminent experts in autism genetics.
Dr. Wiznitzer works with children with autism.
There will be a lot of discussion of Unigenetics. The result of the Unigenetics lab is critical, Dr. Bustin and Dr. Ward and to some extent from Dr. Chadwick on what reliance can be placed in the result from that lab.
The Unigenetics lab was a side light created to make money for Dr. Leary and others. One take home is that negatives samples, samples known to contain no measles virus were showing up positive for measles virus.
The first expert witness called is Dr. Eric Fombonne. Dr. Fombonne, whose credentials are impressive to put it mildly, explained the symptoms of autism and the diagnostic criteria used by clinicians. He explained that autism is not something that most parents can see immediately. In diagnostic instruments, they ask parents to estimate what month they first saw certain symptoms or traits, parents don't remember a particular day they first saw something, but they can narrow it to the month, usually. Wakefield's patients' parents however were claiming to know the day that certain traits of autism appeared in their children. This is unheard of by autism clinicians.
At least half of regressive autistic children were not normal before the regression, another study showed that 72% of the children who could be described as regressive autistics actually were not normal before the regression. It's not that the children did not have a real loss of skills, but the majority of
The rate of regression in autism and PDD,nos is about 20%, about 1 in 5 have some loss of skills or a setback before the age of two.
Fombonne explained microscopic findings of brain tissue from autistics that indicate that autism starts long before birth.
He describes macrocephaly as being correlated to autism. About 20% of autistics have macrocephaly at some point. Autistic brains are not only tending to be larger than non-autistic brains, but they are also heavier.
Dr. Fombonne explains that prenatal rubella exposure has been shown to cause autistic symptoms in some children. He explains that prenatal exposure to certain drugs and chemicals has been shown to lead to autism.
He referred to dysmorphology in autism, a study by Miles. They found about 20% of children referred to a clinic had dysmorphic facial features that indicate a different course in not only facial feature development, but also brain development.
He explained that newborn babies born in California and later diagnosed with mental retardation or autism had abnormal amounts of some peptides in their blood at birth, children with cerbral palsy did not have abnormal peptides.
He explained that there are treatments offered to autistics, some of which don't work, some of which may help, but he says there are no cures for autism.
He explains there have been failed models of autism, the refrigerator mother model being one of them.
His professional opinion is that Michelle Cedillo has autistic disorder. Her developmental course looks typical of autism accompanied by mental retardation and epilepsy. Her epilepsy onset at age 10 is not uncommon in autism. She looks like the kind of child he would see in in practice with severe autism and retardation. She saw a speech pathologist in 1997, there's a report from that time.
Was there anything in Michelle's medical records that show that she wasn't developing normally before her MMR.
Yes, there is clear abnormal development in her records. From 4 different lines of evidence.
The first, early onset social communicative abnormalities
Several accounts in professional reports as a baby she was very content, not demanding. These are qualities often retrospectively attached to children who are diagnosed with autism. She was late in terms of social smiling, 4 mos, this is late. Her language was delayed, even if we assume that by December 20th she had 10 words. Dr. Ross reports she used only 10 words, mostly in imitation. Not using words consistently for meaning, and spontaneously.
Comparing 10 words to what would be expected according to population norms, based on an instrument, the Macarthur Communicative Development Inventory. There is a toddler form. It's a scale you can give to parents, asks what kind of gestures they use, a survey of 396 words asks what the child understands, or both understands and uses.
When she was using ten words, she would have been expected to have about 40 words, girls usually have more words than 40. With 10 words she would be falling to the bottom of the distribution. At 15 and a half months she was not normal. She was delayed in her language development.
Strong evidence motor delay
There is clear account in the record, she didn't meet major developmental milestones. She didn't sit up independently until 11 months ... she started to crawl at 9 months. It appears from video that at 17 months and a half she's not walking independently yet.
Early macrocephaly, as shown on slide 35, shows a chart of her head circumference.
As early as 2 months of age she starts to be on the fringe of the chart That it was noted at 2 months that her head is large. At 6 months she's way off the chart, massive abnormal brain growth. There is increasing head circumference, then starts to decelerate at 15 months. This is
described in autism and unambiguously abnormal.
Dr. Ross (Roth?) requested an MRI. Mentioned in his report that a large head has been mentioned in autism. Head circumference is an objective sign that can not be disputed.
They look at video of Michelle, Fombonne introduces his comments by noting that he is not meaning to say anything mean to the parents by pointing out the signs of autism in Michelle before the MMR. The videos show that before, even long before she received the MMR vaccine she was showing signs of autism, including not making eye contact, not responding to her name (even when adults called her name over and over), fixating on Sesame Street video to an unusual degree, flapping her hands and flicking her hands in front of her eyes. She's not using normal baby gestures. Her babbling is unusual, and she never says any words in the videos, even though a normal baby might say words in the same situations shown on the videos. The parents of autistic children frequently use compensatory strategies to engage autistic children. Michelle's parents are shown using these strategies to engage her.
Special Master Hastings made a point of asking Dr. Fombonne if it was unusual for parents to miss signs of autism in their children. Fombonne answered that parents of first children typically miss the signs of autism in their children, parents of subsequent (not first) babies are more likely to notice developmental differences and problems. Diagnosis of first babies tends to come later because parents of first babies don't have a clear idea of what to expect developmentally from their babies. Fombonne said he was not trying to say that Michelle's parents had done something wrong merely because they missed some signs of autism that are plain to see in hindsight.
It would seem that Michelle Cedillo's autism was not caused by the MMR vaccine, not at all.
Autism Diva
notes
Jeffrey Brent, M.D., Ph.D., Physician and Clinical Professor of
Medicine, Division of Pharmacology and Toxicology, University of
Colorado Health Sciences Center.
Edwin H. Cook, Jr., M.D., Director, Laboratory of Developmental
Neuroscience and Visiting Professor of Psychiatry, Institute for
Juvenile Research, Department of Psychiatry, University of Illinois
at Chicago.
Eric Fombonne, M.D., Professor and Head of the Division of Child
Psychiatry, McGill University, Montreal Children's Hospital.
Robert S. Fujinami, Ph.D., Professor of Neurology, Division of Cell
Biology and Immunology and Adjunct Professor, Department of
Pathology, University of Utah.
Michael D. Gershon, M.D., Professor and Chairman, Department of
Pathology and Cell Biology, Columbia University.
Stephen B. Hanauer, M.D., Professor of Medicine and Clinical
Pharmacology and Chief, Section of Gastroenterology, Hepatology and
Nutrition, University of Chicago Medical Center.
Christine T. McCusker, M.D., M.Sc., Assistant Professor, Department
of Pediatrics and Director, Clinical Immunology Laboratory, Montreal
Children's Hospital.
Brian J. Ward, M.D., M.Sc., Chief, Division of Infectious Diseases,
McGill University Health Center.
Andrew W. Zimmerman, M.D., Pediatric Neurologist, Kennedy Krieger
Institute and Associate Professor of Neurology, Psychiatry and
Pediatrics, Johns Hopkins University School of Medicine.
Max Wiznitzer, M.D., Director of the Rainbow Autism Center and
Associate Professor of Pediatric Neurology at Rainbow Babies
Children's Hospital.
For some reason the transcript from Monday's testimony has not been posted. But the audio recording is available, as it today's (Tuesday's) audio. This set of notes from the audio of the hearing may be fraught with more typographical errors than are usual to Autism Diva blog. Apologies are offered in advance for any particularly egregious typos.
At the beginning of Monday's hearing Special Master Hastings said that both sides agreed that three of the respondents experts, who have submitted reports, won't be required to present those reports orally. These are Fujinami, Gershon, and Zimmerman (highlighted in purple in the above list). There are two witnesses who aren't on the older list above, a Dr. Bustin and a Dr. Chadwick. Autism Diva doesn't know who they are or what their expertise is.
Mr. Matanowski started out by presenting the case of Health and Human Services, the respondents. He pointed out the rather glaring omissions of the case that had been made by the Petitioners Steering Committee (PSC). The following are somewhat rough notes since we don't have the transcript available yet.
Mr. Matanowski mentioned the Daubert standard which is that science presented in courts such as this one must be reliable. At every critical juncture their science has not been reliable. They are presenting a more limited case now.
Mr. Matanowski says that the PSC has pulled a "bait and switch." He said that the Special Masters (the judges in this case) were told by the PSC that there would be a general causation proceeding, that it would encompass all their theories of causation, but late in their proceeding they decided that they would go with a test case approach. This is the approach that the respondents had suggested in the beginning and one that could have been tested years ago.
Mr. Matanoski said: "[The PSC] did tell [the Special Masters] this though, that [the petitioners'] test case would be applicable to a significant number of cases. They said [the Cedillo] case could be applicable to 80% of one firm's cases. Yet throughout the direct examination of their witnesses there was a concerted effort to limit the testimony to one specific case they were resistant to expanding their testimony beyond this case. Again bait and switch ... . It's only through dogged cross examination that we were able to expand the evidence before you so that it could be used in other cases. We intend to give you evidence that you can use in other cases. We intend to give you good scientific evidence."
Good scientific evidence is based on research that has been written up, tested, scrutinized, reviewed, discussed and reproduced. It comes from those who work in the science on a daily basis, from those who work directly with autistic children, not from those who testify for a living.
A serious accusation has been leveled against an important part of the public health arsenal against a preventable disease. An accusation has been leveled the MMR vaccine can cause autism, it's important to answer that. The MMR is designed to prevent a killing disease, 450,000 people die every year from measles. The threat remains real in this country.
Great Britain had an outbreak of measles that happened because Andrew Wakefield undermined confidence in the MMR, people died because of this.
A history of the autism/vaccine connection. In 1996 Andrew Wakefield was approached by lawyers, because he had previously tried to pin Crohn's disease on measles. The lawyers gave him money. Wakefield file a patent for a monovalent miseases vaccine. He would benefit if his vaccine was picked up and used instead of the MMR.
He published a paper on the gut in autism, but didn't tell the editors of Lancet that he had been paid by lawyers, didn't tell them about the patent and didn't reveal that some of the kids in the autism/gut/measles studies were the children of litigants.
In 2004 everything started to crash down on him. Brian Deer's work started to reveal what was behind the whole attack on MMR by Wakefield. Ten of the 11 co-author's of Wakefield's original autism paper retracted their names from the paper, O'Leary who had claimed to have found measles in his lab in Ireland said he didn't believe that measles caused autism. Wakefield was left alone.
Dr. Aposhian conflated the different kinds of mercury with thimerosal.
Dr. Brent will address the question of thimerosal causing immune problems.
Krigsman said it was the (later retracted) 1998 article from Wakefield that convinced him that MMR could cause autism, and that he was given confidence in the paper because Dr. Walker-Smith's name on that paper. But Dr. Walker-Smith has retracted his name from that paper.
Dr. Hepner, their expert, said that MMR causing autism is an unproven hypothesis.
The respondents will show that the theory advanced by the PSC is not biologically possible.
Measles vaccines when left in the brain destroys the brain. It is fatal.
Dr. Byers was testifying outside her area of expertise.
Dr. Brent will testify in the area of toxicology, he has real expertise.
Dr. McCusker is a real immunologist and works in immunology.
Dr. Kinsbourne is not an expert in autism, he's done no original research in autism.
Dr. Cook is one of the preeminent experts in autism genetics.
Dr. Wiznitzer works with children with autism.
There will be a lot of discussion of Unigenetics. The result of the Unigenetics lab is critical, Dr. Bustin and Dr. Ward and to some extent from Dr. Chadwick on what reliance can be placed in the result from that lab.
The Unigenetics lab was a side light created to make money for Dr. Leary and others. One take home is that negatives samples, samples known to contain no measles virus were showing up positive for measles virus.
The first expert witness called is Dr. Eric Fombonne. Dr. Fombonne, whose credentials are impressive to put it mildly, explained the symptoms of autism and the diagnostic criteria used by clinicians. He explained that autism is not something that most parents can see immediately. In diagnostic instruments, they ask parents to estimate what month they first saw certain symptoms or traits, parents don't remember a particular day they first saw something, but they can narrow it to the month, usually. Wakefield's patients' parents however were claiming to know the day that certain traits of autism appeared in their children. This is unheard of by autism clinicians.
At least half of regressive autistic children were not normal before the regression, another study showed that 72% of the children who could be described as regressive autistics actually were not normal before the regression. It's not that the children did not have a real loss of skills, but the majority of
The rate of regression in autism and PDD,nos is about 20%, about 1 in 5 have some loss of skills or a setback before the age of two.
Fombonne explained microscopic findings of brain tissue from autistics that indicate that autism starts long before birth.
He describes macrocephaly as being correlated to autism. About 20% of autistics have macrocephaly at some point. Autistic brains are not only tending to be larger than non-autistic brains, but they are also heavier.
Dr. Fombonne explains that prenatal rubella exposure has been shown to cause autistic symptoms in some children. He explains that prenatal exposure to certain drugs and chemicals has been shown to lead to autism.
He referred to dysmorphology in autism, a study by Miles. They found about 20% of children referred to a clinic had dysmorphic facial features that indicate a different course in not only facial feature development, but also brain development.
He explained that newborn babies born in California and later diagnosed with mental retardation or autism had abnormal amounts of some peptides in their blood at birth, children with cerbral palsy did not have abnormal peptides.
He explained that there are treatments offered to autistics, some of which don't work, some of which may help, but he says there are no cures for autism.
He explains there have been failed models of autism, the refrigerator mother model being one of them.
His professional opinion is that Michelle Cedillo has autistic disorder. Her developmental course looks typical of autism accompanied by mental retardation and epilepsy. Her epilepsy onset at age 10 is not uncommon in autism. She looks like the kind of child he would see in in practice with severe autism and retardation. She saw a speech pathologist in 1997, there's a report from that time.
Was there anything in Michelle's medical records that show that she wasn't developing normally before her MMR.
Yes, there is clear abnormal development in her records. From 4 different lines of evidence.
The first, early onset social communicative abnormalities
Several accounts in professional reports as a baby she was very content, not demanding. These are qualities often retrospectively attached to children who are diagnosed with autism. She was late in terms of social smiling, 4 mos, this is late. Her language was delayed, even if we assume that by December 20th she had 10 words. Dr. Ross reports she used only 10 words, mostly in imitation. Not using words consistently for meaning, and spontaneously.
Comparing 10 words to what would be expected according to population norms, based on an instrument, the Macarthur Communicative Development Inventory. There is a toddler form. It's a scale you can give to parents, asks what kind of gestures they use, a survey of 396 words asks what the child understands, or both understands and uses.
When she was using ten words, she would have been expected to have about 40 words, girls usually have more words than 40. With 10 words she would be falling to the bottom of the distribution. At 15 and a half months she was not normal. She was delayed in her language development.
Strong evidence motor delay
There is clear account in the record, she didn't meet major developmental milestones. She didn't sit up independently until 11 months ... she started to crawl at 9 months. It appears from video that at 17 months and a half she's not walking independently yet.
Early macrocephaly, as shown on slide 35, shows a chart of her head circumference.
As early as 2 months of age she starts to be on the fringe of the chart That it was noted at 2 months that her head is large. At 6 months she's way off the chart, massive abnormal brain growth. There is increasing head circumference, then starts to decelerate at 15 months. This is
described in autism and unambiguously abnormal.
Dr. Ross (Roth?) requested an MRI. Mentioned in his report that a large head has been mentioned in autism. Head circumference is an objective sign that can not be disputed.
They look at video of Michelle, Fombonne introduces his comments by noting that he is not meaning to say anything mean to the parents by pointing out the signs of autism in Michelle before the MMR. The videos show that before, even long before she received the MMR vaccine she was showing signs of autism, including not making eye contact, not responding to her name (even when adults called her name over and over), fixating on Sesame Street video to an unusual degree, flapping her hands and flicking her hands in front of her eyes. She's not using normal baby gestures. Her babbling is unusual, and she never says any words in the videos, even though a normal baby might say words in the same situations shown on the videos. The parents of autistic children frequently use compensatory strategies to engage autistic children. Michelle's parents are shown using these strategies to engage her.
Special Master Hastings made a point of asking Dr. Fombonne if it was unusual for parents to miss signs of autism in their children. Fombonne answered that parents of first children typically miss the signs of autism in their children, parents of subsequent (not first) babies are more likely to notice developmental differences and problems. Diagnosis of first babies tends to come later because parents of first babies don't have a clear idea of what to expect developmentally from their babies. Fombonne said he was not trying to say that Michelle's parents had done something wrong merely because they missed some signs of autism that are plain to see in hindsight.
It would seem that Michelle Cedillo's autism was not caused by the MMR vaccine, not at all.
Autism Diva
notes
Labels: autism, cedillo, hearing, hhs, measles, mercury, mmr, omnibus, thimerosal, thimomersa, trial, vaccines
posted by Autism Diva at 1:55 AM
8 Comments:
The Day 6 transcript is on-line, with Mr. Matanoski opening and Dr. Fombonne first testimony.
Reading about Michelle's development, I note many similarities with that of my son. We did not make many videotapes of Charlie---in the only one he is 10 months old, and am I talking a lot. A lot, and he is just sitting.
Reading Dr. Fombonne's testimony is a little scary for me. Our child had a huge increase in head size, but also had the same kind of increase in both height and weight. And I have a big head and so does my husband. There is a gross motor delay but that is getting smaller and smaller.
Is the head size increase out of proportion to the body in asd? Any recent studies about head size that I can look at/send to our neuro?
Thanks for providing this service, Autism Diva. I hope these quacks get shot down before they cause even more harm to paranoid parents.
Thank you for posting your synopses. I haven't had a chance to read the testimony, and am finding it impossible to print out. Thank you for taking all this time and making this effort for the rest of us.
vandychick,
Dr. Fombonne was saying that her head was much larger than normal for a child of her age. It was not just larger than normal, but off the chart larger than normal (much higher than 99 percentile).
Anytime you take your baby/toddler to the pediatrician they measure this kind of stuff and compare it to the normal distribution. If your pediatrician has a pulse, (s)he is paying close attention to this sort of thing.
Factitian,
I realized that I didn't put some important info in my first post. Our child's head circ and height are both over the 100th percentile. They have done all testing they can--MRI even. The theory is that since the increase was proportional, it is not the same as what they see in asd cases.
I just wondered whether the head was out of proportion to the body, as well as to the general population.
We don't have serious delays at this point, but it's worrisome that we could.
Here's some telling evidence of how strong a case Fombonne made, and how little the plaintiffs were left to go on:
The plaintiffs' lawyer seemed to suggest that because Fombonne has had some research funded by Autism Speaks (or the former NAAR, more accurately), and Autism Speaks held a conference on the topic of dealing with GI problems among autistic kids, that Fombonne was somehow contradicting himself when he said he didn't think there was evidence that autistic kids are at increased risk of GI problems. (!)
Seems like a stretch to me ...
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