 |
|
Arthur
Krigsman cross-examined
at Michelle Cedillo MMR hearingFrom
the United States Court of Federal
Claims
Washington DC, 12 June 2007
|
Although
Andrew Wakefield, of the Thoughtful House business in
Austin. Texas, was listed to give evidence at
the first US test case of his claim that
the MMR vaccine caused regressive autism, he
wasn't called by the petitioners. However, Arthur Krigsman [pictured], who,
like Wakefield, had been the subject of official
investigations [which were frustrated by his
non-cooperation] did testify, as the
following transcript shows
CROSS-EXAMINATION
OF DR ARTHUR KRIGSMAN BY LYNN RICCIARDELLA,
IN CEDILLO V SECRETARY FOR HEALTH & HUMAN
SERVICES, JUNE 12 2007
SPECIAL
MASTER HASTINGS: Ms. Ricciardella,please go
ahead.
RICCIARDELLA:
Dr. Krigsman, you're a partner with Andrew
Wakefield at Thoughtful House Center for
Children in Austin, Texas. Is that correct?
KRIGSMAN: I'm
not a partner there, no.
RICCIARDELLA:
What do you do there?
KRIGSMAN: I'm
the director of gastroenterology services at
Thoughtful House.
RICCIARDELLA:
So you're Dr. Wakefield's employee.
KRIGSMAN: No.
He is not an employer.
RICCIARDELLA:
Is that a partnership?
KRIGSMAN: No.
RICCIARDELLA:
What is it?
KRIGSMAN:
It's a working association. I don't own any
share of Thoughtful House, nor am I employed
by them.
RICCIARDELLA:
Would you consider yourself a colleague of
Dr. Wakefield at Thoughtful House?
KRIGSMAN:
Yes.
RICCIARDELLA:
And you're the director of gastroenterology
services at Thoughtful House. Is that
correct?
KRIGSMAN:
That's correct.
RICCIARDELLA:
Now, Doctor, Thoughtful House posted on its
Web site a page entitled "Treatment at
Thoughtful House." Are you familiar with
that page? We'll put it on the screen.
KRIGSMAN: I'm
sorry. I didn't hear the question.
RICCIARDELLA:
Thoughtful House posts on its Web site a page
called "Treatment at Thoughtful
House."
KRIGSMAN:
Okay.
RICCIARDELLA:
Are you familiar with this page of Thoughtful
House's Web site?
KRIGSMAN: Not
offhand, but I would be happy to look at it.
RICCIARDELLA:
Do you know who wrote this page?
KRIGSMAN: I
would not know who authored it, no.
RICCIARDELLA:
You do not?
RONALD HOMER:
Excuse me, Your Honor.
SPECIAL
MASTER HASTINGS: Yes.
HOMER: Is
this filed in evidence?
RICCIARDELLA:
No, it's not.
HOMER: Could
we have a copy of it,please?
RICCIARDELLA:
Sure.
(Pause.)
RICCIARDELLA:
Doctor, if you look on the screen, there is a
section entitled "Medical
Treatment." Do you see that section?
We'll blow it up for you.
KRIGSMAN:
Okay. Thank you.
RICCIARDELLA:
The first sentence begins with the sentence:
"Children with childhood developmental
disorders have disregulated immune
systems." Do you, in your opinion,
believe that all children with developmental
disorders have disregulated immune systems?
KRIGSMAN: All
children? It's unlikely that every single
child with autism would have that.
RICCIARDELLA:
I didn't hear the first part.
KRIGSMAN:
It's unlikely that every child with autism
would have a disregulated immune system, but
that's the case in all of them.
RICCIARDELLA:
Do you think that the majority of children
with developmental disorders have
disregulated immune systems?
KRIGSMAN:
It's my understanding that a number of
studies have demonstrated immune
disregulation in children with autism that
differs statistically from those without
autism.
RICCIARDELLA:
And what studies are those?
KRIGSMAN: I
can't cite them, but there is a good review
on this by Dr. Paul Ashwood that might be
cited in my report. He has a very excellent
review article, in the last two years, of the
immunologic disregulations of autism, a
review of all previous publications.
RICCIARDELLA:
And what about childhood developmental
disorders other than autism? Do you believe
that the majority of those are caused by
disregulated immune systems?
KRIGSMAN: I'm
sorry. I didn't hear the question.
RICCIARDELLA:
Childhood developmental disorders other than
autism; do you believe that those, too, are
caused by disregulated immune systems?
KRIGSMAN: I
have no knowledge of that.
RICCIARDELLA:
Doctor, there is another phrase, under the
section, "Medical Treatment," that
states: "Treatment directed at
correcting immune system abnormalities is
imperative." In your opinion, should all
children with developmental disorders, or,
particularly, autism, receive treatment
directed at their immune system?
KRIGSMAN: I
think that it's appropriate to focus on the
immune system of these children. Direct
knowledge of that comes from my own
experience. The bowel disease that I
described this afternoon is an example of a
disregulated immune system. So, certainly, to
have a theory that you want a direct
treatment at immune disregulation is not
without foundation or support.
RICCIARDELLA:
But do you believe that the majority of
children with autism should receive
treatments for a disregulated immune system?
KRIGSMAN: I
think that a workup needs to be done to
determine if there is an immune
disregulation, or if a clinical observation
warrants it, that's where I would have to
start.
RICCIARDELLA:
And, Doctor, when you say "workup needs
to be done to determine if there is an immune
disregulation," how would a workup
determine an immune disregulation? What do
you mean?
KRIGSMAN:
Those questions are best referred to
immunologists to determine the specific
immunologic aberrations that one might want
to look for, but, again, there are a number
of studies that have demonstrated that this
exists in these children.
RICCIARDELLA:
Now, Doctor, on this same page there is a
section entitled "Gastrointestinal
Diagnosis and Treatment." Do you see
that, what we've just blown up?
KRIGSMAN:
Yes.
RICCIARDELLA:
Did you write this section?
KRIGSMAN: I
either wrote it or was consulted on it.
RICCIARDELLA:
As director of gastrointestinal services
there, you endorse this section of the Web
site.
KRIGSMAN: I
would. This particular part that you're
blowing up now, I endorse.
RICCIARDELLA:
Okay. Now, Doctor, there is a sentence in
this section that says: "Many children
with CDDs have GI symptoms that precede,
coincide with, or appear after the onset of
neurological symptoms or regression. A child
should produce one formed stool per day.
Anything else merits attention." Doctor,
in your opinion, is failure to form one stool
a day a significant GI symptom in an autistic
child?
KRIGSMAN: No.
What this paragraph says is that it merits
attention. What that means is that when you
have, being that we know that these children
so frequently have GI symptoms that are
intense, and they have findings, both
laboratory findings and on biopsy, when you
have something that might deviate from a
simple, one stool per day, you need to direct
attention to that and get a more thorough
history. This paragraph does not suggest that
if you don't have one bowel movement a day,
there is something pathologically wrong with
your bowel. That's a misreading of this
paragraph.
RICCIARDELLA:
And, Doctor, this section ends with the
sentence: "There is also a subgroup of
autistic children that appear to lack GI
symptoms, but without endoscopy evaluation,
the question of an occult or hidden GI
inflammation remains unanswered."
KRIGSMAN:
That's correct.
RICCIARDELLA:
Now, does that mean that for proper diagnosis
and treatment of this subgroup of autistic
children who do not have GI symptoms, that
they should undergo endoscopy evaluation to
evaluate --
KRIGSMAN: No.
It does not mean that.
RICCIARDELLA:
What does it mean?
KRIGSMAN: It
means that it is our suspicion that there is
a bowel disease that is occult, meaning that
it may not produce overt symptoms,
particularly in this group of children who
can't manifest or demonstrate pain. For
example, the presentation of the bowel
inflammation that I spoke about earlier could
be just abdominal pain. In Crohn's disease,
the most frequent presenting symptom is
abdominal pain. Even in the absence of any
other symptom, abdominal pain is known to be
a presenting symptom by itself, in isolation
of Crohn's disease. This particular group of
patients represents a very unique problem in
interpreting conventional symptoms because,
whereas, as pediatricians, we are trained to
observe certain behavior patterns or relying
on what a child says, in these children, we
haven't got the ability to do that because
they don't manifest pain. They don't say it,
they often don't talk, and when they do have
pain, they often manifest it in strange ways
like putting pressure on their belly instead
of just putting their hand on it. For some
reason, this is a behavior that some of them
do. They lean over tables. Why would they do
that? I don't know.
RICCIARDELLA:
So, Doctor, you're saying, in this phrase,
that autistic children who do not have GI
symptoms may nevertheless have inflammation,
but there is no way to know that unless the
inflammation is confirmed by endoscopy.
KRIGSMAN:
Right, but that does not suggest that they,
therefore, should undergo -- what the
sentence that you're highlighting is saying
is that there are a subgroup of patients who
would not manifest overt symptoms, but overt
symptoms are obvious, for example, of
abdominal pain, like I just said, and the
only way to do that is to have a high index
of suspicion so that if you would see a child
who is excessively irritable, for example,
and that's the only symptom that you can tell
that's relatable to the GI tract, even though
he may be irritable for a whole variety of
reasons, one must take that seriously because
that may be the only indication of an
underlying bowel pathology.
RICCIARDELLA:
Now, Doctor, you were an attending physician
at Lenox Hill Hospital from September 2000
through December 2004. Correct?
KRIGSMAN:
That's correct.
RICCIARDELLA:
And is it true that before you resigned your
position, the hospital restricted your
privileges to conduct endoscopies?
KRIGSMAN:
That’s incorrect.
RICCIARDELLA:
What's incorrect about that statement?
KRIGSMAN: I
didn't resign my position, number one.
RICCIARDELLA:
Why did you leave?
KRIGSMAN: I
did not renew my application for appointment
there. Every two years, you need to renew it,
and I chose not to renew it at the end of
2004.
RICCIARDELLA:
During your tenure at Lenox Hill, is it true
that the hospital, at one point, did restrict
your privileges to conduct endoscopies?
KRIGSMAN:
That's not the hospital's position. The
hospital maintains that they did not, in any
way, curtail my privileges.
RICCIARDELLA:
Well, you sued the hospital, didn't you?
KRIGSMAN: I
did.
RICCIARDELLA:
One of the reasons that you sued the hospital
was because you thought that they had
illegally restricted your Privileges to
conduct endoscopies.
KRIGSMAN:
Right. That's correct. My claim was that they
curtailed my privileges, and the hospital's
position was that they did not.
RICCIARDELLA:
Regardless, they were concerned that you were
conducting endoscopies on children,
particularly autistic children, without
medical necessity. Isn't that correct?
KRIGSMAN:
That is correct. They were concerned that the
colonoscopies that were being performed on
these children did not have proper
indications of colonoscopy.
RICCIARDELLA:
And, Doctor, you are licensed to practice
medicine in Texas as well as New York and
Florida.Correct?
KRIGSMAN:
That's correct.
RICCIARDELLA:
And in August 2005, is it true that you were
fined $5,000 by the Texas State Board of
Medical Examiners for misconduct?
KRIGSMAN:
That's not correct.
RICCIARDELLA:
What's incorrect about that?
KRIGSMAN:
There was no misconduct.
RICCIARDELLA:
Did you pay a $5,000 fine?
KRIGSMAN: We
did.
RICCIARDELLA:
What was it for?
KRIGSMAN: The
fine was levied -- the reason for the fine
was because the Thoughtful House Web site,
before I was licensed, stated that Thoughtful
House was open, and patients can call. That's
what the substance of the Web site said. It
gave no suggestion that I was seeing patients
because I wasn't. I wasn't licensed. We
didn't even know when the license would be
coming because it was a very long process to
get licensed in Texas. But because Thoughtful
House, on their Web site, represented that
they were open, the understanding of the
Texas Medical Board was that I was Thoughtful
House and that I was open, and that indicated
that I was available to see patients, and
that, they considered to be misrepresentation
since I was not yet licensed. So they levied
a fine of $5,000, which we chose to pay.
RICCIARDELLA:
Doctor, was your fine in Texas also due to
the fact that you did not report the Lenox
Hill disciplinary action against you?
KRIGSMAN:
That is not correct.
RICCIARDELLA:
Doctor, the minutes from your August 25,
2005, application to obtain a license in
Texas are public, and we have a copy, which
we will put on the screen, and we'll hand to
counsel.
(Pause.)
RICCIARDELLA:
Now, what we've just put on the screen
reflects that a motion was made to allow your
licensure in Texas if you would pay a $5,000
fine due to disciplinary action by Lenox Hill
Hospital: "Falsification of Application
Regarding Nondisciplinary Citation by Florida
and to Misrepresentation Regarding
Entitlement To Practice Medicine." That
was the motion that eventually passed to
allow to obtain your license to practice
medicine in Texas. Is that not correct?
KRIGSMAN: No.
This did not pass, number one. Number two:
This was not the way it ended up. I did not
have to withdraw my application. The
application was never withdrawn. The initial
one was submitted, and it went through. The
other thing you asked before that was
incorrect. The question you asked me was,
isn't it true that this Web site demonstrates
that I did not disclose the Lenox Hill
dispute to Texas Medical Board? That was the
content of your question, and my answer is
that that is completely incorrect. I
disclosed that in its entirety on my
application and made no effort, in any way,
to avoid dealing with this issue in my
application for Texas medical licensure.
RICCIARDELLA:
Doctor, your C.V. states that you're a
clinical assistant professor at New York
University. Is that correct?
KRIGSMAN:
Correct.
RICCIARDELLA:
Are you currently on staff there?
KRIGSMAN:
Correct.
RICCIARDELLA:
When was the last time you taught a class at
NYU?
KRIGSMAN: I
haven't taught there.
RICCIARDELLA:
You've never taught a class at NYU.
KRIGSMAN: I'm
on staff there.
RICCIARDELLA:
Are you salaried?
KRIGSMAN:
From NYU?
RICCIARDELLA:
Yes.
KRIGSMAN: No.
RICCIARDELLA:
Have you ever been salaried at NYU?
KRIGSMAN: No.
RICCIARDELLA:
Now, Doctor, on page 3 of your C.V., you have
an entry entitled "Publications,"
and you have four listings, and, for the
record, I'm referring to Petitioners' Exhibit
60. Under the first listing is entitled
"Suction Rectal Biopsy in the Diagnosis
of Hirschsprung's disease and Comparison of
Two Biopsy Devices."
KRIGSMAN:
Right.
RICCIARDELLA:
And you state that you submitted this paper
to the American Board of Pediatrics on April
20, 1995, about 12 years ago. Is that
correct?
KRIGSMAN:
That's correct.
RICCIARDELLA:
What do you mean by you submitted the paper
to the American Board of Pediatrics?
KRIGSMAN: By
"submitted," it means that, back in
1995, the requirement for completion and
certification of pediatric gastroenterology
training was that you had to submit a
research paper to the American Board of
Pediatrics. It actually is a misnomer to
label it under "Publications"
since, in fact, it did not end up being
published. But what it was was a review and a
paper and a discussion describing exactly
what the title says that was submitted to
them for their review to determine if this
met the criteria to grant me certification in
pediatric gastroenterology.
RICCIARDELLA:
You said it has not been published.
KRIGSMAN: No.
RICCIARDELLA:
The second listing is a paper that you have
published, you co-authored, entitled
"Laryngeal Dysfunction: A Common Cause
of Respiratory Distress Often Misdiagnosed as
Asthma and Responsive to Antireflux
Therapy." That has been published in
2002. Correct?
KRIGSMAN:
That is correct.
RICCIARDELLA:
And the third listing, you term a "slide
presentation" that you presented at
IMFAR, the International Meeting for Autism
Research, in 2004. Now, Doctor, I note,
though, that this slide presentation you also
have listed under "Speaking
Engagements" on page 4 of your C.V.
KRIGSMAN:
That's correct.
RICCIARDELLA:
Was this a speaking engagement or a
publication?
KRIGSMAN: A
speaking engagement. This is not a
publication. You are correct.
RICCIARDELLA:
And the fourth listing, you term a
"poster presentation at IMFAR in
2006," and I believe this is what you
were just testifying to during your direct
examination. Is that correct?
KRIGSMAN:
Correct.
RICCIARDELLA:
And that's a poster that describes the
preliminary results of a study you're doing
with Dr. Stephen Walker and Dr. Karen Hepner.
KRIGSMAN:
That's correct.
RICCIARDELLA:
And this has not been published, has it,
Doctor?
KRIGSMAN:
That's correct.
RICCIARDELLA:
So, among your four listings under
"Publications," it's only the
second listing that is a true publication. Is
that correct?
KRIGSMAN:
That's correct.
RICCIARDELLA:
Doctor, you served as an expert witness for
the claimants in the MMR litigation in the
United Kingdom. Is that correct?
KRIGSMAN:
Yes.
RICCIARDELLA:
And were you offered as an expert in that
litigation as someone who is able to confirm
intestinal inflammation in autistic children?
KRIGSMAN:
Yes.
RICCIARDELLA:
Did you perform any endoscopies on those
children?
KRIGSMAN: On
which children?
RICCIARDELLA:
Any of the children that were the claimants
in the United Kingdom litigation.
KRIGSMAN: I
don't know if any of my patients were
claimants. I don't know that.
RICCIARDELLA:
Now, in addition to your practice at
Thoughtful House, you have a medical practice
in New York. Is that correct?
KRIGSMAN:
Correct.
RICCIARDELLA:
It was unclear during your direct testimony.
Are you still practicing general pediatrics?
KRIGSMAN: No.
I stopped that two years ago.
RICCIARDELLA:
You first met Michelle Cedillo in September
2003, when her parents brought her to New
York to see you. Is that correct?
KRIGSMAN:
Correct.
RICCIARDELLA:
Now, Doctor, you wrote a report in this case,
dated February 4, 2007, which has been filed
as Petitioner's Exhibit 59. I'll go ahead and
hand you a copy of your report for you to
refer to. Do you recall writing this report?
KRIGSMAN: I
do.
RICCIARDELLA:
And on page 2 of your report, you state that,
about Michelle, "Her gross motor, fine
motor, behavioral and emotional development
proceeded in an age-appropriate manner during
the first year, as evident by the
pediatrician's notes and home videos."
Doctor, what enables you to assess whether or
not Michelle was developing in an
age-appropriate manner during her first year
of life?
KRIGSMAN:
This is the history that I obtained, so this
information is from the history that one
usually gets when encountering a patient for
the first time.
RICCIARDELLA:
What type of history did you get? Let me
rephrase that. A history from whom?
KRIGSMAN:
This came from Mrs. Cedillo.
RICCIARDELLA:
Did you review all of the medical records in
this case?
KRIGSMAN: I
don't think I reviewed all of them. I
reviewed my entire medical chart and perhaps
some of the hospital records when she was
hospitalized in Yuma, but, in general, my
charts, Theresa and I have an ongoing
relationship, and she pretty much sends me
everything that --
RICCIARDELLA:
Now, Doctor, is it your understanding, after
reviewing the medical records, that
Michelle's GI symptoms that developed
following her second bout of fever continued
to worsen over the ensuing months?
KRIGSMAN:
That's my understanding. That's correct.
RICCIARDELLA:
Do you have an understanding of how long
those GI symptoms lasted?
KRIGSMAN: It
was really, the vomiting lasted for, like, 10
weeks or 11 weeks or 12 weeks or thereabout.
It sort of tapered off. This is, again, by
the history that I got. I didn't know
Michelle at that point. The history that I
obtained was that the diarrhea lasted for a
good year or two and then became
constipation, primarily constipation,
difficulty stooling. That lasted for about
another year or two - - again, I would have
to look at the exact records -- and then the
diarrhea started again, and it's persisted
since then, so it's been many years now where
the only symptom has been diarrhea.
RICCIARDELLA:
Now, Doctor, you first met Theresa Cedillo at
a DAN, Defeat Autism Now, conference in
October 2002. Is that correct?
KRIGSMAN:
Yes.
RICCIARDELLA:
Do you remember speaking with her about
Michelle at that time?
KRIGSMAN:
Yes, I do.
RICCIARDELLA:
Was that the first time that you had a
discussion with Mrs. Cedillo about Michelle?
KRIGSMAN:
Yeah. I hadn't met her before that.
RICCIARDELLA:
That was the first time you met her.
KRIGSMAN:
Yeah.
RICCIARDELLA:
Now, sometime, Doctor, before January 15th of
2003, you told Mrs. Cedillo that it was your
recommendation that Michelle undergo another
endoscopy. Is that correct?
KRIGSMAN:
That's correct.
RICCIARDELLA:
What was your recommendation based on?
KRIGSMAN: I
stated before that, in the six months
preceding the time that I met Michelle, in
September of '03, her condition considerably
worsened. Specifically, she had lost 20
pounds in the preceding six months. She had
worsening of her diarrhea in terms of the
number of stools per day and also the
consistency of the stool. Her degree of
abdominal pain worsened, so she was much more
irritable and much more self-abusive, and her
arthritis had worsened as well. So the
overall downturn in her clinical condition,
coupled with the fact that the January of '02
colonoscopy was normal, made me want to
search for an inflammatory origin of her
symptoms, and that would require getting a
biopsy.
RICCIARDELLA:
Doctor, do you recall that Michelle was
hospitalized for dehydration on May 17th of
2003?
KRIGSMAN: I
hadn't met her yet, but that's the history
that I got.
RICCIARDELLA:
And, Doctor, at this time, Michelle's
treating gastroenterologist, Dr. -- I'm not
sure of the pronunciation -- Montes, did not
want to perform another endoscopy on
Michelle. Isn't that correct?
KRIGSMAN: I
don't know.
RICCIARDELLA:
Well, referring to Petitioners' Exhibit 28 at
51, which we'll put on the screen, Mrs.
Cedillo sent you an e-mail, and she told you
that Dr. Montes told her that Michelle's
problem of not eating and drinking, in his
opinion, was behavioral in nature and not a
gastro one. Correct? Do you recall receiving
this e-mail?
KRIGSMAN: I
don't recall it, but, obviously, I received
this. I'll be happy to read it now. Can you
magnify it again? Thanks.
(Pause.)
KRIGSMAN:
Okay. I've read it.
RICCIARDELLA:
Okay. But you didn't agree with that, Doctor,
did you, because, on May 19th of 2003, you
responded to Mrs. Cedillo, and we'll put that
up: "If you can't find a GI to explore
her for GI problems, then you could find a
DAN doc near you who could treat her
empirically for suspected enterocolitis with
anti inflammatories or steroids." Do you
recall writing that e-mail?
KRIGSMAN: I
do.
RICCIARDELLA:
And, Doctor, by "DAN doc," you mean
a doctor who is part of the Defeat Autism
Now?
KRIGSMAN:
Well, it's not quite part of it. What I would
mean by that is a physician who embraces the
notion that autistic children with GI
symptoms very frequently have a medical
condition that's responsible for those
conditions.
RICCIARDELLA:
And what did you mean by recommending that
she find someone to treat Michelle
empirically with anti-inflammatories?
KRIGSMAN:
Well, what happens is the story that Theresa
told me was my experience because I had
already seen so many of these children by
this time. It was entirely consistent with
well over 100 children that I had seen an
endoscope and biopsy until then. So, in my
mind, there is very little doubt that, even
then, even never having seen her, just from
the story, the presentation, there was very
little doubt in my mind, coupled with her
labs, that she had an enterocolitis. The best
way to approach that would be to get a
biopsy. There is no question about it. But in
the absence of that, if you just can't do it,
if no one seems to see it that way in Yuma,
or if she physically can't get to one because
of other medical reasons, the biopsy could
not be done to confirm the diagnosis, at that
point, it becomes appropriate to treat
empirically. "Empirically" means
you make the assumption, based upon your
knowledge and experience, that this diagnosis
is the most likely one, and we treat
accordingly. Good physicians tend to avoid
treating empirically because that tends to
obscure some of the findings that you
otherwise could get, and it would leave
questions that potentially could be answered
unanswerable. So you really avoid doing that
whenever possible, but if the situation
doesn't allow for any alternative, then
empiric therapy is accepted.
RICCIARDELLA:
Doctor, further in this same e-mail, you
state that you would be available to be a
sounding board to another physician so long
as that person was responsible and a
prescribing physician. Do you recall writing
that?
KRIGSMAN:
Yes.
RICCIARDELLA:
Now, Doctor, the next day, on May 20th --
KRIGSMAN: I
didn't quite say "as long as they were
responsible." That's a misquote from
what I wrote.
RICCIARDELLA:
"[S]o long as the responsible and
prescribing physician --"
KRIGSMAN: No.
So long as they are the responsible
physician, not that their character is
responsible. In other words, they are
responsible for the care of the patient.
RICCIARDELLA:
Okay. Now, on the next day, on May 20th of
2003, Mrs. Cedillo wrote you back an e-mail,
and I'm referring to Petitioners' Exhibit 28
at 107.
SYLVIA
CHIN-CAPLAN: What number?
RICCIARDELLA:
Twenty-eight at 107.
CHIN-CAPLAN:
Thank you.
RICCIARDELLA:
She stated that she had been talking to Dr.
Cindy Schneider in Phoenix, who, herself, was
a parent of two autistic children. She says,
I quote: "She is not a gastro, so unable
to scope, but very willing to prescribe help
in any way." Doctor, did you ever have a
conversation with Dr. Schneider about
Michelle?
KRIGSMAN: I
don't recall ever speaking with Dr. Schneider
about Michelle.
RICCIARDELLA:
At that time, Doctor, in May of 2003, did you
ever recommend to another physician that he
or she prescribe anti-inflammatories or
steroids to Michelle?
KRIGSMAN: I
don't think so. I don't recall telling any
physician or speaking with any of her
physicians at that point.
RICCIARDELLA:
Doctor, on July 10th of 2003, you wrote a
letter addressed "To Whom It May
Concern," and I'm referring to
Petitioners' Exhibit 28 at 84. In the letter
you state, "Over the past six months,
her --" meaning Michelle "--
inflammatory bowel condition has worsened to
the point of requiring hospitalization for
severe dehydration and malnutrition." Do
you recall writing this letter?
KRIGSMAN:
Yes, I do.
RICCIARDELLA:
And in the letter, you further state,
"I'm only one of three pediatric
gastroenterologists in the United States with
significant experience in diagnosing and
providing appropriate treatment for children
with autism and this particular form of
inflammatory bowel disease that is somehow
associated5 with autism." Now, you made
this statement about Michelle having
inflammatory bowel disease to such an extent
that it required hospitalization before you
had even met her. Correct?
KRIGSMAN:
That's correct.
RICCIARDELLA:
And, Doctor, when you refer to this
particular form of inflammatory bowel
disease, are you referring to autistic
enterocolitis?
KRIGSMAN: I
am.
RICCIARDELLA:
Doctor, you wrote another letter, on August
5th of 2005, addressed "To Whom It May
Concern," and I'm referring to
Petitioners' Exhibit 28 at 73, and you state
in the letter that Michelle needs a
colonoscopy and upper endoscopy, and you
further state that only two individuals in
this country have any experience in the
colonoscopic findings in children with
autism.
KRIGSMAN:
That's correct.
RICCIARDELLA:
Now, Doctor, on July 10th, you were one of
three people who had the requisite
experience, but now, on August 5th, you're
one of two. Who is the third, and what
happened to him?
KRIGSMAN:
That may have been a mistake. Tell me the
years again of these letters.
RICCIARDELLA:
2003.
KRIGSMAN: In
2003. I know that the other person with
experience with these children and scoped a
large number of them is Dr. Tim Buie at Mass.
General in Boston.
RICCIARDELLA:
Whose name was that?
KRIGSMAN:
Timothy Buie, B-U-I-E. He is another
pediatric gastronterologist who has a
specific interest in the bowel disease of
these children.
RICCIARDELLA:
He was at Mass. General?
KRIGSMAN: He
is at Mass. General. The only other physician
in the country -- I don't know why I wrote
three and then two, but either are, at least
at the time of writing this letter, the only
other person who had expressed an interest,
and I had spoken to in looking into these
children, is Dr. Michael Hart, who I spoke to
on the phone. I'm pretty sure I had spoken
with him by then, and he had expressed
interest in looking at these kids and taking
symptoms seriously as a sign of potential
bowel disease and having a lower threshold
perhaps to make a diagnostic biopsy, to have
a high index of suspicion of an underlying
bowel inflammation. He expressed also a
desire to do formal research in this area.
RICCIARDELLA:
And where does Dr. Hart practice?
KRIGSMAN: He
is in Virginia. I don't recall the name of
the hospital.
RICCIARDELLA:
Now, Doctor, you first saw Michelle, I
believe you testified, in New York.
KRIGSMAN: I
should also mention that Dr. Hart has
collaborated with Dr. Wakefield in gathering
data on these patients, and the work has not
yet been published, but I know that the data
has been gathered.
RICCIARDELLA:
Are Dr. Hart and Dr. Wakefield working on a
study?
KRIGSMAN:
Yes, yes.
RICCIARDELLA:
Do you know, have they submitted it for
publication?
KRIGSMAN: I
do not know if it's been submitted. I was not
part of that study.
RICCIARDELLA:
Now, Doctor, you first saw Michelle in New
York in September 2003. I believe that's been
your testimony. Correct?
KRIGSMAN:
That's correct.
RICCIARDELLA:
And on September 25th of 2003, you performed
an upper and lower endoscopy on her. Correct?
KRIGSMAN:
That's correct.
RICCIARDELLA:
And in the results of the endoscopy, you
found lymphonodularity and aphthous
ulcerations. Correct?
KRIGSMAN:
That's correct.
RICCIARDELLA:
And that, you believe, is evidence of
inflammation of her bowel, specifically,
inflammatory bowel disease.
KRIGSMAN:
That is partial evidence. That's correct.
RICCIARDELLA:
And following the September 25, 2003,
endoscopy, you described two
anti-inflammatories. One was prednisone. Is
that correct?
KRIGSMAN:
Correct.
RICCIARDELLA:
What is the other one? I didn't catch that.
KRIGSMAN:
There were three, actually, not two.
RICCIARDELLA:
What are the three anti-inflammatories you
prescribed?
KRIGSMAN:
Prednisone, as you mentioned; Six MP; and
sulfasalazine.
RICCIARDELLA:
Now, Doctor, following the September 25,
2003, endoscopy, did you believe Michelle had
Crohn's disease?
KRIGSMAN: No.
I did not think it was Crohn's disease. If
they asked to label it, I sort of refrained
from giving it a label because I didn't know
what label to give it. It was bowel. It was a
nonspecific enterocolitis of the kind that we
see in autistic children. That's the most
specific I can be, autistic enterocolitis. At
that point, I didn't feel that I had evidence
of the characteristic features that would
enable me to label it as Crohn's disease.
RICCIARDELLA:
Well, Doctor, on November 23rd of 2003, you
wrote another letter, "To Whom It May
Concern," and I'm referring to
Petitioners' Exhibit 28 at 424, and you
state, "As part of Michelle's Crohn's
disease, she appears to have uveitis."
Why did you think, on November 23 of 2003,
that she had Crohn's disease?
KRIGSMAN: I
don't know. I may have been nonspecific in my
terminology.
RICCIARDELLA:
But it's your opinion, Doctor, that she has
Crohn's disease today.
KRIGSMAN:
Yeah, yeah. What convinced me of that, beyond
any question, was the PillCam study. Again,
beforehand, I would be hesitant to label it
as Crohn's disease for the reasons I said. So
whether, in my mind, whether you call it an
indeterminate colitis or Crohn's disease or
autistic enterocolitis, from a treatment
standpoint, it makes no difference because
the treatment approach would be the same.
RICCIARDELLA:
I believe, actually, you wrote about that in
a letter, dated May 4th of 2005. I'm
referring to Petitioners' Exhibit 28 at 679,
and you state, "There are many clinical
similarities between autistic enterocolitis
and Crohn's disease, but they clearly seem to
be two separate entities, at this point;
however, the treatment options are the same
for both."
KRIGSMAN:
That's correct.
RICCIARDELLA:
How are the treatment options the same for
both?
KRIGSMAN:
Well, really, what you want to do is you want
to decrease the level of inflammation by
using anti-inflammatories. That's one large
conceptual approach. The choices of drugs are
many, but to reduce bowel inflammation using
drugs that are described to do that is one
approach, and the second approach is
nutritional, giving enteral feedings. So the
approach to treating Crohn's disease
encompasses both of those, and the approach
to treating autistic enterocolitis involves
both of those as well.
SPECIAL
MASTER HASTINGS: Can I just say for the
record, apparently the quotation you just
read from is on page 680 rather than 679.
RICCIARDELLA:
Oh. Thank you for that.
SPECIAL
MASTER HASTINGS: Is that correct?
RICCIARDELLA:
Yes.
SPECIAL
MASTER HASTINGS: Okay. All right. Go ahead.
RICCIARDELLA:
Now, in May of 2005, were you treating
Michelle as if she had Crohn's Disease?
KRIGSMAN:
Again, from a treatment standpoint, it makes
no difference in my mind what you call it,
because whether it's Crohn's Disease or
intermittent colitis or autistic
enterocolitis, the treatment would be the
same. My approach would be the same.
RICCIARDELLA:
The same medications?
KRIGSMAN: The
same medications, and I didn't mention
before, the third approach you have in
treating both of these diseases would be the
use of drugs that affect the microbial flora
content of the bowel. That's the third large
category, the intervention approach to
treating both Crohn's Disease and also, in
our experience, autistic enterocolitis.
RICCIARDELLA:
Was she receiving the same dosage as she
would, had she had at that time a diagnosis
of Crohn's Disease?
KRIGSMAN: It
would be the same dose, yes.
RICCIARDELLA:
Doctor, during your direct testimony, and I
believe it's in one of your slides, you talk
about the Feldman, Sleisenger, and
Forottran's gastro, intestinal, and liver
disease textbook. Is that correct?
KRIGSMAN:
Correct.
RICCIARDELLA:
You called it authoritative. Is that correct?
KRIGSMAN:
Correct.
RICCIARDELLA:
You also refer to a textbook called Kumar,
Robbins, and Cotran?
KRIGSMAN:
Correct.
RICCIARDELLA:
I hope I'm pronouncing those right. Would you
consider that authoritative?
KRIGSMAN:
Absolutely.
RICCIARDELLA:
Doctor, you say on page seven of your report
that Michelle is an undisputed case of
ASD-GI.
KRIGSMAN:
That's correct.
RICCIARDELLA:
What is ASD-GI?
KRIGSMAN:
ASD-GI is a term that we use --
"we" meaning the people that treat
children with autism and bowel disease
medically -- to designate her as an ASD
patient with GI problems. Not all ASD
patients have GI symptoms. Not all ASD
patients have enterocolitis. But there is a
large subset of children with ASD and, you
know, we can argue from here until tomorrow
how many they are; whether it's 20 percent or
70 percent or whatever. Different papers cite
different numbers. But it's clearly a
substantial portion of children with ASD who
have enterocolitis GI symptoms, biopsy-proven
enterocolitis. ASD-GI is a designation that
we give to those patients to indicate that
they're autistic. But they're the
sub-population of autistic children with
gastrointestinal disease.
RICCIARDELLA:
Is ASD-GI the same thing as autistic
enterocolitis?
KRIGSMAN: No,
I don't think it is.
RICCIARDELLA:
What is the difference?
KRIGSMAN: In
our experience, again, we have autistic
enterocolitis that really describes bowel
disease of the small intestine and of the
colon. But ASD-GI would suggest that the
disease doesn't just involve the small bowel
and the colon. It may involve the stomach as
well, and the esophagus as well; and there
are very predictable abnormalities of both
the esophagus and the stomach that we see
routinely and very frequently.
RICCIARDELLA:
If a child just had a disease of the stomach
and nothing else and had autism, would that
be a case of ASD-GI?
KRIGSMAN:
Correct.
RICCIARDELLA:
And if the child had a disease of the
esophagus and nothing else, would that be a
case of ASD-GI?
KRIGSMAN:
Correct, it's more of a nomenclature. It
tends to put in your mind the notion that
there are gastrointestinal manifestations in
this child with autism, without relation to
the specific organ that that disease is.
RICCIARDELLA:
Now Doctor, in the two text books -- the
Sleisenger/Foroltran's gastrointestinal liver
disease and the Kumar, Robbins, and Cotran
that you agreed were authorization -- does
the term ASD-GI appear anywhere?
KRIGSMAN: No,
it does not.
RICCIARDELLA:
Does the term autistic enterocolitis appear
anywhere?
KRIGSMAN: No,
it does not.
RICCIARDELLA:
Now in the last paragraph of your report on
page eight, you state the following opinion.
"The measles-mumps-rubella vaccine
Michelle received contributed significantly
to her subsequent development of
enterocolitis, and it is the persistence of
the virus in the lymphoid tissue of the bowel
that is causing the ongoing
enterocolitis." So there are two
premises to your opinion, and correct me if
I'm wrong. The first is, you believe she
suffers from enterocolitis, correct?
KRIGSMAN: I
do. That's correct.
RICCIARDELLA:
The second, you believe that the
enterocolitis is caused by the persistence of
measles virus from the MMR vaccine in the
lymphoid tissue of her bowel, correct?
KRIGSMAN: I
do. That's correct.
RICCIARDELLA:
Let's look at the first premises of your
opinion and why you think she has
enterocolitis, and I know that you went
through this in your direct. First of all,
what does "itis" mean?
KRIGSMAN:
Itis means inflammation.
RICCIARDELLA:
And enteritis is inflammation of the small
bowel?
KRIGSMAN:
That's correct.
RICCIARDELLA:
And colitis is inflammation of the colon?
KRIGSMAN:
Correct.
RICCIARDELLA:
So enterocolitis is inflammation of the large
and small intestine?
KRIGSMAN:
That's correct.
RICCIARDELLA:
Now for evidence that she has inflammation of
the large intestine, in fact, on page six you
state, "That Michelle has colitis is
beyond question."
KRIGSMAN:
That's correct.
RICCIARDELLA:
And for evidence that she has colitis, you
cite to the January 2002 endoscopy, the
September 2003 endoscopy, and the June 2006
endoscopy. Is that correct?
KRIGSMAN:
Could you say that again? What page would
that be on?
RICCIARDELLA:
Page six of your report.
KRIGSMAN:
Okay, I'm sorry, what were you quoting?
RICCIARDELLA:
You say, "That Michelle has colitis is
beyond question, as evidenced by colonic
aphthous ulcerations seen on two separate
occasions by two different
gastroenterologists."
KRIGSMAN:
Here we go -- correct, and in the question
before, you mentioned --
RICCIARDELLA:
I just want to make sure I'm understanding
exactly what evidence you're relying upon for
your diagnosis of colitis. Is it the report
of the 2002 endoscopy?
KRIGSMAN: No,
no, it's not.
RICCIARDELLA:
Okay.
KRIGSMAN: I'm
relying on my colonoscopy in September of
2003, and the colonoscopy in 2006.
RICCIARDELLA:
Okay, and you state on page six of your
report that Michelle's diagnosis of enteritis
is also beyond question as evidence by the
presence of small bowel aphthous lesions. For
that, Doctor, you were relying on the
findings from the PillCam, from the June 2006
caps imaging?
KRIGSMAN:
That's correct.
RICCIARDELLA:
Based on these finds of colitis and
enteritis, that's the basis of your opinion
that she has enterocolitis. Is that correct?
KRIGSMAN:
That's not correct.
RICCIARDELLA:
What is the basis of your opinion that she
has enterocolitis?
KRIGSMAN:
That is a portion of my opinion.
RICCIARDELLA:
What else?
KRIGSMAN: My
opinion is based upon the presence of
aphthous ulcerations in the small bowel in
the colon, in a manner and fashion which has
been described to exist in Crohn's Disease
and in the small bowel, in particular, in the
presence of a history of abdominal pain and
vomiting; in the presence of a physical exam
that shows UV-itis and arthritis; in the
presence of elevated sedimentation rates,
CV-active protein, thrombocytosis, and
elevated OmpC test; and with the clinical
response to anti-inflammatory medications
that you would expect for someone who has
enterocolitis. So that constellation of those
observations leads me to conclude beyond any
doubt that this is her diagnosis.
RICCIARDELLA:
Doctor, if the facts were different and
there's no UV-itis and no arthritis, would
your opinion be the same?
KRIGSMAN:
That's a hypothetical question, and I'm not
sure. It depends on the overall scenario.
RICCIARDELLA:
The overall scenario is exactly the same. I'm
just taking out the UV-itis and the
arthritis. Would your opinion that she has
enterocolitis be the same?
KRIGSMAN:
That's a difficult question to answer.
RICCIARDELLA:
So you don't know?
KRIGSMAN: I
don't know, right. The diagnosis of Crohn's
Disease is often based on a combination of
clinical criteria. Unless you're fortunate
enough to have the specific finding like a
stenosis of the small bowel or a fistula or a
granuloma, unless you have that, it's often
difficult to be certain that Crohn's Disease
is the diagnosis. That's why the utility of
the serologic marker, this obsida (phonetic)
I referred to, was such a great advance in
helping us diagnosis Crohn's Disease and also
distinguish it from ulcerative colitis, which
has different markers that are associated
with it. So really, the diagnosis does not
rest on one or two findings. It's really a
constellation of presenting some symptoms in
labs. To chop off one and say we just don't
feel the same way is really hypothetical.
RICCIARDELLA:
Just so I'm clear, can one have enterocolitis
and not have Crohn's or ulcerative colitis?
KRIGSMAN:
Absolutely.
RICCIARDELLA:
Now Doctor, let's look at the second premise
of your opinion, that measles virus from the
MMR vaccine Michelle received is persisting
in the lymphoid tissue of her bowel and
causing enterocolitis. Doctor, do you have an
opinion as to why the measle's virus is
persisting the lymphoid tissue of her bowel?
KRIGSMAN: I
don't have an opinion. I have suspicions
based upon published reports. That's not my
area of expertise. I haven't formed an
opinion, yet. But I suspect that it's due,
and the weight of the literature as reviewed
by Ashood and I mentioned that before,
suggests that there's a skewed inflammatory
response in favor of pro-inflammatory
cytokines versus cytokines that are
counter-inflammatory. That seems to be the
overall pattern in looking at a number of
publications. That seems to be a consistent
finding. The exact levels of cytokines and
which ones may differ from study to study.
But that seems to be overall pattern. So I
suspect, and if you ask me to suspect, it has
to do with a patient's immune activity.
RICCIARDELLA:
Doctor, you're not an immunologist, correct?
KRIGSMAN: I
am not.
RICCIARDELLA:
Doctor, are you saying that you suspect that
she had a disregulated immune system at the
time she received her MMR vaccine?
KRIGSMAN: In
response to your question, that's my
suspicion, what I believe.
RICCIARDELLA:
And do you have an opinion as to why she had
a disregulated immune system at the time of
her MMR vaccine?
KRIGSMAN:
That I don't know.
RICCIARDELLA:
Okay, now in support of your opinion that
Michelle has persistent measles virus in the
lymphoid tissue of her bowel, you cite to the
positive finding in 2002 by the Unigenetics
in Dublin, Ireland of measles RNA in the
tissue sample tested in Michelle, correct?
KRIGSMAN: By
the published report, correct, of their
findings.
RICCIARDELLA:
But from Unigenetics, specific to Michelle.
KRIGSMAN:
Right.
RICCIARDELLA:
Doctor, if these tests from Unigenetics were
shown to not be reliable, would your opinion
still be the same?
KRIGSMAN: If
they were shown, demonstrated not to be
reliable, my opinion today still would be the
same. Because we seem to be mounting our own
evidence with the specimens that I've
obtained. We've shown in at least six
patients with autism, with bowel symptoms,
who underwent a diagnostic endoscopy, looking
for enterocolitis, most of whom had diagnosed
enterocolitis on biopsy -- we've found, using
a different lab and different investigators
in at least six of them that there's vaccine
strain, measles virus genome. So in my mind,
there has been at least preliminary
confirmation of that report. So even if you
were to tell with absolute certainty that the
findings of the lab in Dublin were erroneous,
I still would tend to believe in our own
experience and preliminary evidence anywhere
that there is a virus there. We know it's
there in at least some of the kids.
RICCIARDELLA:
So then I take it from your opinion that if
no test had been done at all, so we don't
have evidence either way, would that have
affect your opinion?
KRIGSMAN: If
there's no evidence either way, that would
definitely affect my opinion.
RICCIARDELLA:
And how would that affect your opinion?
KRIGSMAN: If
there's no evidence, then I might tend to
avoid making an opinion.
RICCIARDELLA:
So if Michelle's tissue had never been sent
to any laboratory, your opinion that she has
persistent measles virus in her bowel would
be different?
KRIGSMAN: I
wouldn't know with certainty, you know, just
to respond to your question, if I knew that
the published reports describing measles
virus were accurate; and in response to your
question, Michelle never had a biopsy or
tested for measles virus. I could reasonably
hypothesize, well, the other clinical
characteristics of this patient are identical
to those patients who were subsequently
confirmed to have measles virus. So I would
certainly be open to that possibility.
RICCIARDELLA:
Doctor, assume the facts are the exactly the
same as this case, but Michelle was shown not
to have inflammation in her bowl -- no
inflammation, but she has GI symptoms. Would
you still be of the opinion that she has
ASD-GI?
KRIGSMAN: If
she has inflammation, so if every test that
we know of to do failed to demonstrate
inflammation -- that's the question?
RICCIARDELLA:
Yes, it's the question.
KRIGSMAN:
Then I would consider giving her a trial of
an anti-inflammatory; and if she responded
the way you'd expect a patient would respond,
with inflammation to an anti-inflammatory,
then I could reasonably conclude that it is
there. I just haven't seen it.
RICCIARDELLA:
What if the facts of this case are the same,
except she never underwent an endoscopy; but
everything else is the same. Would you still
think that she had ASD-GI?
KRIGSMAN:
Again, that's too many "ifs". What
if she had two heads?
RICCIARDELLA:
I mean, the facts of the case are exactly the
same. It's just she had never undergone any
of her five endoscopies. Would you still
think she had ASD-GI?
KRIGSMAN: I'd
have to give that some serious thought.
RICCIARDELLA:
So you don't know?
KRIGSMAN: I
don't know.
RICCIARDELLA:
Doctor, on the last page of your report, you
list the relevant facts to you in this case.
In the first one, you state that the relevant
facts in Michelle's history are (1) the
appearance of classic ASD-GI disease,
together with other signs of systemic
illness, close to following within seven days
the administration of the MMR vaccine. So if
I'm understanding, Doctor, you are saying
that a significant fact for your opinion that
the MMR vaccine caused Michelle's
enterocolitis; that Michelle had symptoms of
systemic illness, within seven days of her
MMR vaccine?
KRIGSMAN: No,
that's a misquote. What I'm saying is that
the appearance of her ASD-GI symptoms, the
symptoms made their appearance, and time has
shown that they were chronic. They never
really remitted.She's had GI symptoms from
the very onset of this period.
RICCIARDELLA:
What symptoms are you referring to?
KRIGSMAN:
Well, initially, she had vomiting and
diarrhea. the vomiting improved. The diarrhea
reverted to constipation. At that point, it
went back to diarrhea, and it has remained
diarrhea for many years. So there's never
been a period of time in Michelle's history
where she's been free of GI symptoms.
RICCIARDELLA:
Is it your understanding that she had GI
symptoms, the vomiting and diarrhea seven
days after the MMR vaccination?
KRIGSMAN:
With seven to fourteen days. That's the
history I got -- so very soon, yes.
RICCIARDELLA:
Would your opinion be different if the onset
of vomiting and diarrhea was one month later?
KRIGSMAN: No,
not in one month.
RICCIARDELLA:
What about two months?
KRIGSMAN: I
would say six months, and let me explain
myself. This question I will answer even
though it's hypothetical, because in our
experience, we've seen many cases of children
with autistic enterocolitis. We've advised
biopsy and confirmed on biopsy to have it,
who when you get a careful history from the
parents, the GI symptoms don't appear until
many months after MMR. Even in those cases
who had a regression immediately after MMR,
some of them don't manifest the symptoms,
like the diarrhea, until months after that.
And all we can rely on is the symptom
presentation. You can't know what's in there
obviously. So that's why I would answer you
that if the appearance of GI symptoms occur
in and last as four to six months afterwards,
I still would consider it related.
RICCIARDELLA:
So anything after six months though, you
would consider unrelated to the MMR vaccine?
KRIGSMAN: Now
we have kits even after six months?
RICCIARDELLA:
I mean, what's your limit. I mean, you just
said six months. Would it be seven months?
KRIGSMAN: No,
again, this has to do with our -- we haven't
quantified, so I can't give you an exact
number. But in my experience, thinking back
over all of the cases we've seen, that's how
I'm going to be answering your question --
that the majority of them, of the children,
who thought they had been diagnosed with
enterocolitis and biopsy. The majority of
them have presented with GI symptoms within
six months of their MMR. This is an opinion,
because it asked me for one and we don't have
it. I can't cite you data. But I also know
from our experience that the onset of GI
symptoms -- many of the children with plastic
regressive autism occurred even over a year,
after the onset of their aggression. So
there's a lot about bowel disease that we
don't understand.
RICCIARDELLA:
From my understanding, if Michelle's diarrhea
and vomiting occurred one year, post-MMR,
would you opinion be different?
KRIGSMAN: The
opinion of what?
RICCIARDELLA:
That the MMR vaccine caused her
enterocolitis.
KRIGSMAN: No,
not if we found the virus there.
RICCIARDELLA:
I thought you just said that it's not
necessary to find measles virus; whether or
not there is a positive finding in measles
virus is not a necessary part of your
opinion. You said that it doesn't matter to
you if the results from the Unigenetics Lab
were found to be unreliable.
KRIGSMAN:
That's not what I said.
RICCIARDELLA:
What did you say?
KRIGSMAN: I'm
not sure what you're referring to.
RICCIARDELLA:
I asked you a question, that if it was shown
that the results from Unigenetics are shown
to be unreliable, would your opinion that she
has persistent measles virus in her lymphoid
tissue of her bowel be different? You said,
no.
KRIGSMAN:
Well, we have our own experience with that.
So what I said was that I would strongly
suspect, based upon our experience, that
that's what caused it. If you asked me if I
would know that for certain, the answer is
no. Because without getting a result on
Michelle, and your question was hypothetical,
where there was no Unigenetics result, but I
still think she had it. I couldn't know that
she had it, unless I had a result.
RICCIARDELLA:
So a positive finding of measles virus is a
necessary component, measles virus R&A in
the lymphoid tissue of the bowel is a
necessary component of your opinion that a
child has persistent measles virus due to the
MMR vaccine?
KRIGSMAN:
That's correct.
RICCIARDELLA:
Okay. Now, Doctor, at the end of your
testimony, you were referring to a poster
presentation that was presented at the IMFAR
conference in 2006. I'm referring to
Petitioner's Exhibit 59 at Tab K. You
describe it as a study that you do with Dr.
Steven Walker and Dr. Karen Hepner. Who was
the other person?
KRIGSMAN: Dr.
Jeff Segal.
RICCIARDELLA:
Jeff Segal -- now you presented on the poster
preliminary data, correct?
KRIGSMAN:
That's correct.
RICCIARDELLA:
This is not a blinded study, is it?
KRIGSMAN: No,
this work was not blinded.
RICCIARDELLA:
Okay, and are you still in the data
collection phase?
KRIGSMAN: We
are.
RICCIARDELLA:
Doctor, who funds this study?
KRIGSMAN:
This study is funded by a variety of sources.
As best as I recall, it was money that came
from the Autism Research Institute. There was
some private funding from individuals, and
there was that private funding from also a
private foundation.
RICCIARDELLA:
Do you have an autism expert in the study?
KRIGSMAN: An
autism expert -- do you mean a neurologist?
RICCIARDELLA:
A neurologist.
KRIGSMAN: No,
we have no neurologists involved in the
study.
RICCIARDELLA:
A psychiatrist?
KRIGSMAN: We
have no psychiatrists involved in the study.
RICCIARDELLA:
Do you have somebody who can verify the
diagnosis of regressive autism?
KRIGSMAN:
They will have been seen. They will have been
evaluated.
RICCIARDELLA:
Do all these children in the study have the
diagnosis of regressive autism?
KRIGSMAN: No
-- I'm not sure. I'm not sure. I don't know
if these kids were all regressive or if these
kids were just autistic.
RICCIARDELLA:
How do you select the kids that participate
in the study?
KRIGSMAN:
Basically, it's just the kids that presented
for an endoscopy, colonoscopy, based upon
their GI symptoms, who we obtain biopsies of
the ilium.
RICCIARDELLA:
Presented to you, or do other people
contribute tissue samples to the study?
KRIGSMAN: No,
these are all patients that were biopsied by
me.
RICCIARDELLA:
By you -- did you charge them for the
endoscopies?
KRIGSMAN:
Yes, sure. But we did not charge them for any
research-related cost. So whatever costs are
involved, to process the specimens for the
research or to test them is not billed to the
patient. They are only billed for that
portion of the endoscopy which is clinically
indicated.
RICCIARDELLA:
What's the sample size?
KRIGSMAN: We
have over 275 specimens that are picked and
have been preserved properly. So that's the
potential pool that was indicated in the
poster.
RICCIARDELLA:
Have you submitted this at all for
publication, yet?
KRIGSMAN: I
mentioned before, it's still a data gathering
process.
RICCIARDELLA:
Now Doctor, were you at IMFAR conference in
2006?
KRIGSMAN: No,
I was not there.
RICCIARDELLA:
Okay, so this poster was not presented by
you, correct?
KRIGSMAN:
Correct, Dr. Steve Walker was there.
RICCIARDELLA:
Now do you know the doctor that right next to
your poster at the IMFAR conference in 2006,
there was a poster contradicting your
findings?
KRIGSMAN: I
had heard that, yes.
RICCIARDELLA:
And that was from Doctors DeSouza, Fombonne,
and Ward?
KRIGSMAN:
Correct; it didn't quite contradict the
findings. That's a misstatement.
RICCIARDELLA:
They have since published the results of
their study in Pediatrics, correct?
KRIGSMAN:
That's correct.
RICCIARDELLA:
I have no further questions; thank you.
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