Arthur Krigsman cross-examined at Michelle Cedillo MMR hearing
Brian Deer hosts a transcript from the United States Court of Federal Claims Washington DC, 12 June 2007, featuring Dr Arthur Krigsman
In Cedillo v Secretary for Health & Human Services
June 12 2007
Cross-examination of Dr Arthur Krigsman by Lynn Ricciardella
SPECIAL MASTER GEORGE L 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 associated 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; 6MP; 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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