Deposition of Kennneth Bock, M.D.
February 27, 2004.
In 2002, Steven B. Edelson, M.D., of Atlanta, Georgia was sued by a couple (Mr. and Mrs M) who charged that Edelson had defrauded them and negligently diagnosed and treated their autistic child (GM). According to the suit documents:
- Edelson had promised a high probability of success while warning that failure to undergo his treatment soon might lead their son to develop Parkinson's disease.
- Although Edelson quoted a $7,000 price for testing, the fees requested after the family arrived at the Center totaled $11,000.
- To obtain the tests, approximately 20 tubes of blood were withdrawn from the boy in one sitting, causing him to lose consciousness.
- One the first day, before the test results were in, Edelson diagnosed the boy with " neurotoxicity," "allergic diathesis," and "hyperactivity."
- The treatment involved "detoxification," ozone, chelation and I.V. vitamins administered by unsupervised workers who apparently have no formal nursing training or professional license of any kind.
- The daily treatments were painful, involving multiple intravenous administrations with many changes of needle sites due to technician errors.
- The boy was also required to endure multiple daily sessions of sauna "sweat" therapy, followed by intense exercise.
- The nutritional supplement regimen included approximately 70 pills and capsules per day, which caused him to vomit after ingesting them.
- The boy also had adverse physical and behavioral reactions to the ozone and sauna detoxification therapy.
- Instead of improving, the boy's condition became much worse. He lost approximately thirty pounds and reversed progress he had made through behavioral and educational therapy.
- To pay the total cost, which exceeded $40,000, the parents had to mortgage their home.
There is no scientific evidence that autism has a toxic or allergic basis or that any of the disputed teatments has any value for autistic children. Kenneth Bock, M.D., who practices "integrative medicine" in New York State and specializes in treating autistic children, was deposed as an expert on behalf of Dr. Edelson. At the time of the deposition, Bock was also president-elect of the American College of Advancement in Medicine, a group whose primary activity has been to promote nonstandard usage of chelation therapy. D uring the deposition, Bock revealed that he was a co-investigator in a study of enzyme potentiated desensitization that the FDA had halted for reasons he said he could not recall. (The study, which involved use of an unlicensed biological product, was terminated by the FDA in 2001 because the investigators had (a) failed to obtain informed consent from the subjects, (b) coerced the subjects to sign waivers absolving the investigators of all legal liability as a condition of participating in the study, (c) charged research subjects for the investigational drug product without permission, and (d) failed to file an Investigational New Drug application, which is the fundamental prerequisite for testing investigational new drugs on human subjects.)
To establish malpractice, it is necessary to establish that the practitioner failed to meet the generally acceped standard of care. During the deposition, Bock indicated that he has had no special training in autism but considers himself an expert. Yet he refused to specify a standard of care or state whether various things Edelson did were within such a standard. In 2004, the case was settled with payment of an undisclosed sum to the plaintiffs.
IN THE SUPERIOR COURT OF FULTON COUNTY STATE OF GEORGIA
SM and TM, individually and as next friend of their son, GM, a minor, Plaintiffs,
- against -
STEPHEN B. EDELSON, M.D., and
THE EDELSON CENTER FOR ENVIRONMENTAL
AND PREVENTATIVE MEDICINE, INC.,
CIVIL ACTION FILE NO. 2002DV63276
Deposition of KENNETH BOCK, M.D., held on February 27th, 2004, commencing at 1:05 p.m., at 185 Fair Street, Kingston, New York, before Kimberly Burke, a Shorthand Reporter and Notary Public in and for the State of New York.
On Behalf of the Plaintiffs:
DOUGLAS R. KERTSCHER, Esquire
Hill, Kertscher & Pixley, LLP
3350 Riverwood Parkway
Atlanta, Georgia 30339-3351
ELIZABETH T. KERTSCHER, Esquire
Law Offices of Elizabeth T. Kertscher, LLC
The Watkins Building
114 East Ponce de Leon Avenue
Decatur, Georgia 30030
On Behalf of the Defendants:
JO A. JAGOR. Esquire
Carlock, Copelane, Semler & Stair
285 Peachtree Center Avenue, N.E.
2600 Marquis Two Tower
Atlanta, Georgia 30303
MR. KERTSCHER: This is the deposition of Dr. Kenneth Bock taken for discovery purposes under the Georgia Civil Practice Act We will reserve all objections except as to form. Doctor, you have the option, as you probably know, to either sign this transcript after reading it or you can waive your signature. That is your option completely.
MS. JAGOR: He is going to read and sign.
KENNETH BOCK, M.D., having been first duly sworn by the Notary Public, was examined and testified as follows:
EXAMINATION BY MR. KERTSCHER:
Q. Doctor, how many depositions have you given in your life?
A. Several; probably in the neighborhood of maybe six.
Q. How many of them were you an expert witness?
A. I was an expert witness six times.
Q. Were you testifying on behalf of the plaintiff or the defendant in all six of those instances?
A. Four times for the defendant and two times for plaintiff.
Q. Were the defendants that you testified on behalf of all alternative medicine doctors? MS. JAGOR: Objection to the form, "alternative. "
A. Can I answer after that?
Q. Yes. There is no judge to rule on the objections here today, so you can just go ahead and answer.
A. I believe three were alternative medicine.
Q. Who was the fourth that you believe was not?
A. The fourth was a case involving Lyme disease.
Q. Did it involve alternative medicine or alternative treatment?
A. It regarded treatment, but it wasn't alternative medicine.
Q. The two plaintiffs that you testified for, did either of those cases involve alternative medicine?
MS. JAGOR: Same objection.
A. Yes. Just so you know for the record, I would prefer the use of the word integrative medicine rather than alternative. I'm going to answer your questions as if you said integrative medicine.
Q. I appreciate that. So from your prior experience, you kind of know the drill. I'm going to ask you questions and if you don't understand what I'm asking you, please don't answer that question and ask me to rephrase it in some way; is that a fair agreement here today?
Q. When were you contacted by Ms. Jagor's office?
MS. JAGOR: In this case, Doug?
MR. KERTSCHER: Yes, let's start out with this case.
A. Months ago. I don't remember exactly when.
Q. Would you say it was the summer of2003; is that a fair characterization?
A. I would probably say about summer, early fall, somewhere around there.
Q. How many times have you talked with Ms. Jagor or her office about this case?
A. Several. I would say certainly less than ten maybe.
Q. More than five?
A. Probably in that neighborhood, five or six. You have to give or take, I don't know exactly.
Q. We have talked a little bit off the record earlier today about billing rates and things. How much have you charged Ms. Jagor or her law firm so far?
A. I have billed them $5,000 and change.
Q. Is that a retainer, or how did you come up with that number?
A. That was for work I had done.
Q. So you told me that your hourly rate for medical review was $350 an hour; is that right?
Q. So you have done, by my quick math, roughly between fifteen and twenty hours of medical record review to charge a total of $5,000?
A. Something like that.
Q. Is there any outstanding money that you believe you're owed from Ms. Jagor and her law firm that you have not billed for yet, such as your meeting today or your discussions last night?
Q. How much do you believe is owed that you haven't billed for yet?
A. I haven't figured it out yet, but it's for the hours we spent last night, this morning, and some hours of review.
Q. How many of those hours, approximately? Let me break it down the way you did. Some hours of review, I think was the last category that you listed; how many hours of "some hours of review" have you spent?
A. It could be four hours.
Q. Then for the meeting last night, how many hours was that?
A. Two hours.
Q. And then finally for the meeting this morning with Ms. Jagor, how many hours was that?
A. That was a little more than two hours.
Q. So I calculate that an additional -- a little over eight hours that you believe you're owed by Ms. Jagor and her law firm that you have not billed for yet?
A. It could be between eight and ten. This is not exact; I haven't done it yet, so I haven't figured it out.
Q. Eight to ten hours; is that at $350 an hour?
A. Yes, it is.
Q. So in addition to the $5,000 you have already billed them and made off this file, there is another possibly $3,500, not counting the deposition that you're billing for today?
Q. And then you billed my office $2,000 to sit for four hours today; that's what we talked about earlier?
A. I wouldn't say I billed you to "sit."
Q. Fair enough.
A. We could be sitting on a beach. This is a little different. I would like to qualify it a little different than that, please.
Q. Sure. You billed us $2,000 to sit for four hours of deposition here today; is that right?
Q. As I understand it, you're going to suspend the deposition at 5 :00 today and we may be done, but are you prepared to go past 5:00 today if we need to?
A. If we need to. If you're talking about a few minutes. I mean, if you're talking about hours, that would not work, but if you're talking about a few things to wrap up, I am a reasonable person.
Q. I respect that. Jo knows that we are entitled to seven hours if we needed it and I'm not necessarily sure we need it, but under the Uniform Superior Court Rules, we are entitled to seven hours of deposition before we have to get leave of the Court. As I understand it, you would not be able to sit for seven hours of deposition today; is that correct?
MS. JAGOR: We can discuss it, Doug, as it comes up.
THE Wl1NESS: If the time comes up, we can discuss it I was told that it was going to be four hours; if you need more time, I have no problem in discussing that with all of us.
Q. Fair enough. Let me ask you if you know Dr. Edelson personally?
A. I wouldn't say personally; I know him professionally.
Q. Have you met him?
A. I have met him, yes.
Q. How many times?
A. I believe once, although I may have seen him at another conference.
Q. Have you spoken with him other than those one or two times?
Q. On the telephone?
A. Yes. .
Q. What were those telephone conversations about; if you know?
A. I actually was putting together a workshop on heavy metal detoxification and I had called him to ask him to give a lecture.
Q. When was that?
A. The workshop was in November, so it was several months before that. I don't remember exactly when.
Q. Did he give that lecture?
A. No, he was unable to do it.
Q. Have you spoken with him at any other time?
A. I spoke to him at a conference. I don't recall if there was another phone call about a question that may have come up after a lecture he gave or something. I may have called him a couple years ago. I believe so, but I can't remember exactly.
Q. What was the lecture he gave?
A. He gave a lecture on his approach to autism spectrum disorders. Q, A couple of years ago; could this have been in the year 2000?
A. It could have been. I'm sorry, I don't remember exactly when it was. I go to a lot of conferences. It's hard for me to exactly remember.
Q. I have looked at a fair bit of your written materials including your CV which Ms. Jagor provided to us and the written documents there, and it looks as though all of your speaking and writing on autism spectrum disorders began in the year 2000. Does that jibe with your recollection of things?
A. It probably began more in 1999.
Q. I didn't see in your CV and I may well have missed it, but I didn't see in your CV any speaking engagements or written items that you had prior to the year 2000; is that correct?
A. I would have to check. My recollection is that it goes back to 1999.
Q. But certainly no earlier than '99. You weren't focusing on the autism spectrum disorders and treatment thereof prior to 1999; is that correct?
A. Certainly not lecturing about it as intensely, no.
Q. My question is more directed towards what you were focusing on in your practice. Were you focusing on the treatment of autism spectrum disorders prior to 1999 in your practice?
A. It was a part of my practice since 1999; it has become a major part of my practice.
Q. When you saw Dr. Edelson speak and you called him after this workshop, was that at the point in time when you were beginning to make autism a larger part of your practice?
A. I don't recall that being the case actually.
Q. What was it that you saw him speak about that caused you to call him?
A. There was something about his approach that I queried him about and I can't remember exactly what it was. It was just something that he spoke about that a question came up and I called him about it. I remember that.
Q. Was it something new that you wanted to add to your practice, or was it something that didn't quite make sense to you and you wanted to see if you could put two and two together by talking to him about it?
A. No, it was just more of interest, I think.
Q. And you don't remember the topic at all other than autism spectrum disorders?
A. No; I think it was more involved with heavy metals actually.
Q. Heavy metals as they relate to autism spectrum disorders?
A. I mean heavy metal detoxification.
Q. We skipped over something a minute ago and I wanted to clear it up. Were you retained by Ms. Jagor and her law firm in any other case other than the current . . . case?
Q. Did you consult with her office as part of the Bush case?
A. She called me about the Bush case, because I was a treating physician.
Q. On the Bush case, were you retained in any way; were you paid for any of your consultation?
A. Not that I recall.
Q. What documents have you reviewed in preparation for your deposition here today?
A . A number of documents, the complaint, the affidavit.
Q. Was that the affidavit by Dr. Baratz perhaps?
A. No, there was a confidentiality document.
MS. JAGOR: It was a qualified protective order, I guess it's called.
A. And all of GM’s treatment records.
Q. Treatment records with the Edelson Center?
A. Yes, with the Edelson Center and some third-party records that were there. Would you mind if I just looked at some of the documents; I like to be precise.
Q. Sure, with our time constraints in mind.
A. Depositions of Dr. Edelson and of the M’s, the Emory University School of Medicine Department of Psychiatry documents relating to his autism spectrum disorder, Dr. Adrian Sandler's deposition, and the technical report that the pediatrician wrote on the diagnostic and management of autism spectrum disorder in children, the deposition of Boyd Haley. Did I say the Edelson website? I got some data off the Edelson website and the Edelson Center's patient information. I'm not sure I said those. There is patient information that he has for his patients that I reviewed.
Q. Is this from his handbook?
A. Yes, I think that's what it was probably from, and some kind of regulation of ozone I reviewed. I believe that's all of it
Q. If you think of anything else as we go through here today, just pop in and add it, but I appreciate that. Do you recall reading the diary written by Mrs. M. while Graham was being treated at the Edelson Center, a diary of concerns; it's in handwritten form?
Q. You do recall reading that?
Q. Okay, very good. What do you charge, by the way, for travel time? I'm sure you have talked to Ms. Jagor about coming to Atlanta to testify; is that right?
Q. What do you charge for travel time for you to go to the airport, maybe have to go to the City, I don't know.
A. Yes, you know we are up here, so you have to travel for things like that. That didn't come up with this case; I was coming down here. So my fee for travel, I would probably have to figure it out, in was going down.
Q. At $350 an hour to get in the car, drive to New York, go to LaGuardia, fly to Atlanta., take a taxi to a hotel; all that is $350 an hour; is that right?
A. It may be. I didn't put that together because you were here, so I can't say exactly, but there would be a charge for travel time definitely.
Q. Then you said it was $5,000 for a day in court?
Q. Let me talk a little bit about your background in your CV. It looked as though you were in a general practice and a family practitioner with the Rhinebeck Health Center from 1979 to 1994; do I have that right?
Q. Correct me, please.
A. Do you mind if I have my CV in front of me?
MS. JAGOR: You don't have to remember; you can look at your CV. He has an updated CV also, if you want the update.
MR. KER TSCHER: Yes, we would like to have that.
A. Actually, I think you may have misread it, because I have been at Rhinebeck since 1983 to the present.
Q. Right I understood you graduated from medical school in 1979; is that right?
Q. What did you do from ‘79 to ‘83?
A. I did a residency in family practice.
Q. During your residency in family practice, did you treat any autistic children?
A. Most likely, yes.
Q. Any that you can recall here today beyond just speculation?
A. That was many, many years ago. I saw patients in all different situations. It would be speculation pretty much saying I recall a face and a name; I don't.
Q. I understand certainly it was a family practice residency not focused specifically on autistic children or even children for that matter, but just a family practice residency?
A. Yes, pediatrics is part of family practice for sure.
Q. Sure, but other than that one component of family practice residency, there was no specialization in autism?
A. That's correct.
Q. And in medical school, you didn't take any special courses in autism; did you?
Q. Then in your practice with the Rhinebeck Health Center which you started immediately after your residency from '83 to '94 is what I took from your CV - and you correct me if I'm wrong -- I understand you have a version that I don't have.
A. Just so you know, all of those things at the beginning are the same. It's updated; just meaning I updated the ending.
Q. So from '83 to '94 you had a family practice in the Rhinebeck Health Center, am I correct in that?
Q. Correct me please, I'm sorry.
A. Firstly, the Rhinebeck Health Center was started in '83 and it was started as an integrative medicine practice. It was never started as just a family practice.
Q. From '83 to '94, did you treat any autistic children?
Q. How many?
A. I would say probably a few.
Q. "A few" being one to two?
A. Maybe several more than that; there was probably not a huge number in those days.
Q. Would you say certainly less than ten, or would it be speculation and you really can't say? .
A. Yes, it would be, because I had a very varied practice then and I saw many kids, and certainly kids in the autism spectrum are part of it, so I would be speculating as to numbers.
Q. So you're not able to further qualify your earlier answer of a few?
A. Right. I think a few leaves it that it's not a huge amount, but it's not a few. I would rather not give a definitive number.
Q. That's fine. That it was many years ago. With any of those few autistic patients that you treated during that eleven-year period, did you use any of the treatment modalities that you currently use today?
A. Some of them.
Q. Which ones; do you recall?
A. Looking for a nutritional approach, biochemical, metabolic imbalances, allergies and sensitivities.
Q. Anything else?
A. Those are probably the main things.
Q. Then in '94 it looks like you co-founded with your brother the Center for Progressive Medicine; is that correct?
Q. And you continue to work both there and at the Rhinebeck Health Center to the present day; is that correct?
A. That's correct
Q. Now I understand you were practicing an integrative medicine approach at the Rhinebeck Health Center. That's what you have testified to here today; is that correct?
Q. So how is the work done at the Rhinebeck Health Center different than the work done at the Center for Progressive Medicine?
A. It's no different.
Q. Fair enough. One is in Rhinebeck and one is in Albany; is that correct?
Q. Do you split your time driving back and forth between the two, or are you primarily in Rhinebeck?
A. Primarily in Rhinebeck.
Q. Fair enough. Then I think your testimony was earlier today that it was in '99 when you began focusing a large portion of your practice towards autistic children; is that right?
Q. You have written a book on asthma and you have written a book on immunity issues called "The Road to Immunity," and you have recently written a book called "The Germ Survival Guide." I looked at some of the materials on those including some of the just chapter headings. I really didn't have time to read all of them, although I am sure they were very well written.
A. Thank you.
Q. None of the chapter headings in those three books specifically identified autism; is that your memory of the chapter headings in those three books as well?
A. That is correct.
Q. And you have identified earlier that you had a varied practice leading up into '99, and from looking at least at your website, you continue to have a varied practice; is that a fair characterization of your practice today?
A. Varied with a huge, huge emphasis on autism spectrum disorders and ADD and ADHD.
Q. Let's focus for right now on autism spectrum disorders. In '99, approximately what percentage of your practice was spent treating children with autism spectrum disorders?
A. It's hard for me to give you percentages. I like to be fairly accurate and I'm just not sure I can give you a precise percentage.
Q. Are you able to in 2000 put a percentage? And I understand that this is an approximation.
A. I can safely say that it has been significantly increasing as to the percentage of my practice.
Q. Beginning in '99?
A. Yes, beginning in '98-99.
Q. What I want to try to get a sense on is as it's steadily increasing, are we talking about -- and again just focusing on children with autism spectrum disorders -- are we talking about an increase of about ten percent to where it would be forty or fifty percent, or exactly what sort of percentage are we talking about?
A. Greater than that, much greater than that.
Q. I don't know anything about your practice, Doctor, I can't guess.
A. I would say basically the largest increase in my particular practice -- I'm not speaking about the practice as a whole -in my particular practice there -- has been in autism spectrum disorders and, you know, I have cared for people for many, many years, so obviously I can follow them; that's part of the integrative medicine approach, it's part of the family medicine approach. But within the scope of my practice, the children with autism spectrum disorders has increased so that it's now hundreds and hundreds; many, many hundreds.
Q. You're talking about hundreds of kids. Dr. Edelson, for example, has testified that over the period of time before he saw GM, which would be a seven-year period - that he may have seen - I think his estimation was 400 autistic children over a seven-year period between '94 to 200 I. When you say "hundreds and hundreds," are you saying that you have also treated as many of 400?
A. Yes, I think more than that.
Q. Have you had any fellowships or professorships where you were specializing in autism?
A. By "fellowship," do you mean like a board certified fellowship, so to speak?
Q. Have you had any professorships where you have taught at a school or anything about autism?
A. I have lectured much about autism, but not a “professorship.”
Q. I have seen one study that you did and I was unable, from looking at what I read, to put a date on the study, but it was involving nine children and treating them with transfer factor and analyzing their improvement under the APGAR scale. When was that study done?
A. That was a pilot study done a number of years ago. It was an unpublished study; it was done probably -- it may have been around 2000. It may have been.
Q. It involved nine children; am I correct in that?
Q. And you have called that a study, albeit an unpublished one?
A. It was a pilot study. Sometimes. Pilot studies are done on a smaller number of kids. There are pilot studies which are published with ten children or ten adults. A pilot study can be a small number sometimes.
Q. Was that the first study, whether pilot or not, that you were involved in involving autistic children?
A. I believe so.
Q. Have there been any other studies since the nine-child pilot study in 2000? Have there been any other studies involving autistic children that you have been involved in?
A. I am presently about to embark on several studies.
Q. But before today. I understand that everybody has big plans in the future.
A. It's not big plans. They're all in place. I am going to do a number of studies.
Q. But the answer then to my question would be, No, there have been no other studies between 2000 and today?
Q. Thank you. Let me expand upon that a little bit. What is your view about whether a study should be peer-reviewed?
MS. JAGOR: Objection to the form. Is your question: Should a study be peer-reviewed?
MR. KERTSCHER: I am asking him.
Q. I guess what I'm trying to get to is: Are you familiar with what is called an IRB?
Q. At what point should a study have an IRB?
MS. JAGOR: Objection to the form.
Q. If you know.
A. It depends on the study.
Q. Can you be a little more specific in your answer, Doctor?
A. Sometimes preliminary studies that you're just trying to look at something at your own practice or you may just be accumulating data, it could be very helpful. Different types of studies provide different information and have different values, so does every study have to be peer-reviewed? No.
Q. Should a study have accepted protocol?
A. I don't know what you mean by "accepted protocol."
Q. Should a study be guided by some sort of the medically accepted protocol in order for it to be validly informative?
A. The question is vague, because I don't know what you mean by "medically accepted protocol. "
Q. Did you use any kind of mainstream accepted protocol or commonly used protocol when you did your nine-person pilot study in 2000?
MS. JAGOR: Objection to the form.
A. You do a pilot study sometimes as a preliminary study, so you're not talking about looking to have a pharmaceutical BFD approved, if that's what you're referring to as medically accepted protocol. So there are certain things that we do in a practice that sometimes you might put a few patients together and look at outcome studies. That's more and more being done these days and those are very valid, and I'm not sure what you're asking really.
Q. I think you answered it Let me ask a related question. I'm going to try to focus in on the only autism study that you have testified about, the nine-child pilot study. Did you have a control group for that study?
Q. In looking at some of your materials, you talk about a subset of autistic patients with regressive behavior after MMR vaccinations; have I got that right?
Q. Regressive behavior in the autism spectrum?
A. We would call that regressive autism or regressive encephalopathy.
Q. You have done a fair amount of literature, at least that I have found on that topic, that subset, and I guess what I was curious about was how much of that subset was part of your practice? In other words, if your practice has greatly increased in treating autistic children since beginning in '99, how much of those children are children that belong to that subset that showed regressive behavior in the autism spectrum after MMR vaccinations?
A. A significant population, a significant percentage of those children.
Q. -- of the patients that you treat?
Q. By "significant," you mean seventy-five percent, eighty-five percent or ninety-five percent?
A. No, not that high. Certainly greater than fifty percent, I would say, probably who regress, what we refer to the regressive population, as opposed to early onset autism which may occur more at birth, so I would say, it's much greater than fifty percent. I don't want to put a figure like eighty-five percent on it, because I'm not great with percentages but a significant, significant percentage.
Q. Okay. Is your approach to those patients different than your approach to the --what I believe you just said was the early onset autistic patients which make up the other smaller percentage of your autistic patients?
A. It's a similar approach.
Q. How is it different?
A. It's a similar approach. The difference is that the children with early onset are a much more difficult population to help.
Q. Are you able from your review of the records, the significant review that you have done, are you able to determine to a reasonable degree of medical probability which category GM falls in?
A. If I can look at the records for a second.
Q. Let me ask a follow-up question before you do that. Was there anything in Dr. Edelson's records that suggested to you which category GM falls in, the early onset or the regressive?
A. If you give me one second, I will be happy to answer that question.
(Break in the proceeding)
Q. Doctor, before you answer my question, you just reviewed a bound version of medical records with a blue cover. I was watching my watch and it looked like we had a four-and-a-half to a five-minute delay. Does that sound right?
A. It seemed like less. It seemed like three minutes, but that's okay, something like that
Q. Go ahead.
A. Would you ask your question again?
Q. I was just trying to determine -- and I'm using your criteria as best I can and you correct me where I'm wrong, but you have identified two subsets of autism that you treat -- one being early onset and the other being regressive, and I asked you if you knew which one GM was?
A. I'm not sure.
Q. Is there anything in Dr. Edelson's records that you saw where Dr. Edelson says Graham is regressive type, Graham is early onset type, or Graham is undeterminable? Did you see where Dr. Edelson considered those subsets that you used?
A. Not that I can recall from the records.
Q. You, on your CV, list the Great Lake Academy of Medicine; do I have that right?
A. Maybe the Great Lake Academy of Clinical Medicine.
Q. Thank you. You are a member of that; is that correct?
Q. Did you participate in an EPD study run by Dr. Shrader?
Q. Can you tell the jury how that study ended?
A. Sure. That was a study of a low dose -- EPD stands for Enzyme Potentiated Desensitization -- it was a technique using low dose allergens with potentiation with an enzyme that was developed in England. A study was started in the United States, and I was a part of that study for a number of years, and then apparently there was some type of issues that came up and the study was halted in this country.
Q. Was it halted by the Food and Drug Administration?
A. I believe so. I know that it was halted at that time.
Q. Do you know why the Food and Drug Administration shut down the EPD study when you were involved in Great Lake Academy of Clinical Medicine?
A. I think it had something to do with some IND issues. I think they wanted -- this was being done under the auspices of IRB, the Institutional Review Board, and I believe the FDA wanted to take it to the next level, either an independent IND, investigation of new drugs, or something like that. I'm not sure of all the particulars, but I knew there was some issues that had to be dealt with, and so the study was terminated.
Q. You're aware that the study was shut down by the FDA because the FDA believed in any way that the study was being run with improper paperwork; is that fair?
A. I don't know if that's fair. I just know that there was an incredible amount of paperwork in that study. There really was a whole office set up for the paperwork.
Q. Do you know whether or not the FDA contended that that study was done improperly in any way?
A. I'm not sure.
Q. Did you ever receive correspondence from a man named L. Terry Chappell about that study?
A. In reference to that study, I may have. I know Dr. Chappell, so over the years I have corresponded with Dr. Chappell on various issues. Did I receive correspondence about that study? I may have received correspondence from Dr. Chappell about the IRB relating to that study. I can't be sure, but if there was a correspondence about the study, it was probably about the IRB.
Q. Or of the lack of an IND?
A. Well, the director of that study was Dr. Shrader, not Dr. Chappell.
Q. Right. I'm asking you if you got some correspondence from Dr. Chappell on that study or the termination of that study?
A. It was years ago. I can't recall exactly.
Q. Was that in about the year 2000 that it was shut down?
A. I don't know. It may have been; it was a few years ago.
Q. Let me ask you the same thing I asked Dr. Edelson. Do you think that it's important for a practitioner such as yourself to follow FDA regulations?
A. Well, my understanding is that the FDA doesn't regulate doctors.
Q. That's not my question. I'm not asking you to make a legal conclusion on who the FDA does or does not regulate. What I'm asking you is: Do you think, in your opinion, that a practitioner of your type, that it's important that your office and your centers to comply with FDA regulations to the extent that they apply to you?
A. I need you to be more specific about that kind of a question. What kind of regulations are you talking about?
Q. What FDA regulations do you think that your centers do not need to comply with?
A. I can't answer that question, because
MS. JAGOR: I am going object to the form of the question.
Q. By your answer, I'm taking it that there are some FDA regulations that -- you can't identify them here today, but there are some FDA regulations that you don't think your offices should comply with?
A. I didn't say that.
Q. So then the other answer is true, that your offices should comply with all FDA .
KENNETH BOCK, M.D. regulations as they apply to you?
MS. JAGOR: Objection to the form.
A. I can't answer that question, because I don't understand what you're asking.
Q. It's a simple question, I think, and I'm not sure what your confusion is over and maybe you can help me understand that. Should your office follow FDA regulations or not?
MS. JAGOR: Objection to the form.
Q. Yes or no?
MS. JAGOR: He already asked you to qualify what regulations.
Q. All FDA regulations such as they apply to you.
A. I'm asking you to elucidate to me what you mean by "all FDA regulations." I'm not sure we are considering the same things. I need you to clarify that question for me.
Q. What parts of all FDA regulations do you not understand?
KENNETH BOCK, M.D.
A. I would like you to clarify what you mean by "FDA regulations." What are you asking me about? I will be happy to answer if I understand what you're asking.
Q. Let me try to get more narrow. Do you know what FDA regulations are? Have you ever heard those two words before or seen them like that together before?
Q. If someone says FDA regulations, do you have an understanding of what that means?
Q. What is your understanding of the term FDA regulations?
A. FDA regulations may be FDA approval for a certain drug.
Q. That would be one example of FDA regulations.
A. If that's one example, then there are many instances where doctors across the country use medications that are FDA approved for one occasion and they use them for another occasion, so by your question would that be that we are all -- the doctors across the country that are doing this are not following FDA regulations?
Q. I understand there is FDA approved use and then there is called off-label use which is what you're referring to.
Q. I'm not referring to off-label uses. I'm just asking about FDA regulations. Let me try to help you. Are there FDA regulations that apply to equipment in your office? We agree that the FDA does not regulate medicine; you and I are on agreement on that.
Q. I think we can also agree that there are certain devices and drugs that the FDA does regulate; do you agree with me on that?
MS. JAGOR: Objection to the form.
A. I will agree. I'm not up on everything that the FDA regulations have ever advised for every drug or device.
Q. Is it important that your offices follow FDA regulations as they apply to drugs and devices that may be used in your office?
A. Again, we are beating a dead horse when you talk about FDA-regulated drugs. I'm going to tell you that myself, as well as all physicians across the country, use FDA-regulated drugs for off-label uses, which would not fall under "FDA regulations," because they're off-label uses. So yes, the FDA has regulations, but there are many extenuating circumstances that have to be considered. When you are asking me to answer that question in a broad way, I can't answer the question that way.
Q. If there is a device that the FDA bans in this country and says is illegal, should that device be in your office?
MS. JAGOR: Objection to the form. Could you be more specific so he can answer the question?
MR. KERTSCHER: I am going to let him answer my questions, Jo. He is under oath today.
MS. JAGOR: He has been asked and he answered that question.
MR. KERTSCHER: No, he hasn't.
MS. JAGOR: He has asked you to be more specific.
Q. Go ahead, Doctor.
A. I would like you to be more specific. I am having a difficult time with the question that you're asking me.
Q. I'm asking about an FDA device that the FDA says is illegal in this country; should that device be in your office, in your opinion? And if your answer is "I don't know," I will accept that, but I think I am entitled to an answer to that question. Do you think that FDA illegal devices, according the FDA, should be in use in your office?
A. You mean something that is unequivocally -- and I put that in there, because there may be just, as I said, with FDA approved drugs and off-label uses, because of the vague nature of the question, there may be some devices that there may be questions about or that there may be some equivocal. You're saying something that is definitively, no question, "illegal"?
Q. Let's go with that. I want you to be comfortable. If something is definitively illegal, should that be in your office?
A. What would define it as such? What would define it as definitively illegal?
Q. Definitively illegal is a term you used and we are talking about FDA regulations.
MS. JAGOR: Objection to the form. There is no question on the table that can be answered right now.
A. Could you be more specific? I will be happy to answer your questions if you're just more specific.
Q. I don't think that you are, but let me try it again one more time. We have got seven hours and we may have to use them all. But my question to you is: If there is a definitively -- I'm trying to use your terms to make you more comfortable. A definitively illegal device as stated by FDA regulation, should that be in use in either of your offices?
A. I guess if you use the term definitively without question, I would say -- the reason why I'm having trouble answering the question is because of the questions that come up when you're not sure of certain types of uses of medications or devices. Where would that definitively be listed? I used the word definitively, but where would that definitively be listed? Would it be in the law; you tell me?
Q. I'm just using your term, Doctor.
A. But I'm saying that, as I rethink it, where would that be listed?
Q. So you're telling the jury that you're not comfortable with the use of the term "definitively illegal"?
A. No, I'm not telling the jury that.
Q. I'm just trying to understand.
A. If something was clearly one hundred percent illegal, then it wouldn't be in my office.
Q. Thank you, Doctor. Where did the EPD agents that were used in the Great Lakes study that you participated in come from, sir?
A. The EPD originated in England and the agents came from a company in the states where they were manufactured, or they came from England and were distributed in the states. I'm not sure. I don't know if there was a company set up in the states to manufacture it or if it came from England.
Q. Were they distributed from an apartment in New York City?
A. I don't know. I mean, they. . .
Q. Were those EPD agents, that were made in England that you used in the Great Lakes study, legal in this country?
A. To my knowledge, they were.
Q. Where did you get that knowledge? Who told you that they were legal?
A. Dr. Shrader, who was the chief investigator of the study, had many correspondences with the FDA, to my knowledge, under all of the auspices of an IRB. And throughout that study there was never, to me, any question of illegality ever.
Q. But certainly if there was, it would have, concerned you?
A. Yes, not only myself, but Dr. Shrader. I was very aware that there was dialogue, and Dr. Shrader was very involved in making sure everything was done properly, to my knowledge, and during that study there were many doctors across the country involved in that study, and there was never a question of illegality. Once there was any of these issues that came up at the end when it was terminated, we stopped administering the EPD until the issues were taken care of.
Q. Because you wouldn't have wanted a substance that wasn't legal in your office? If someone had told you that the EPD agent you were using was illegal, you would have stopped using it immediately, right? Definitively illegal.
A. Yes, if there were no questions about it, and I'm sorry to have to qualify it so much, but you understand that when it comes to some of these questions there are questions about it. If you're asking a question about EPD, I would say, unequivocally I never had one question during the time I was in that study that EPD was in any way illegal.
Q. Fair enough. There is a lab in your office?
Q. Is that CLIA certified?
A. Yes, at a fairly high level I should say.
Q. When did that happen?
A. That happened numerous times. You get certification, I believe, every few years.
Q. When was it first certified?
A. I would have to ask that. . . I would be happy to ask my lab director. I don't have that information off the top of my head.
Q. Do you have an approximate date?
A. I don't want to venture to guess, but I can certainly get that for you if you would like it
Q. In your practice in treating autistic patients, I assume that it's your opinion that you observed the standard of care in treating autistic children; is that correct?
A. That's another vague question. What do you mean "observed the standard of care"?
Q. What part of "observed the standard of care" don't you understand?
A. I would like you to define that to me. When you're asking me a question, I want to be clear about the question that I'm going to answer.
Q. Why don't you just answer it in your understanding of the term "observed the standard of care"?
A. Yes, I most definitely observed the standard of care.
Q. Let's look at some of your practices and make sure I understand them. With regard to your CV, you believe, don't you, Doctor, that it's important to be truthful and accurate in your CV?
Q. Do you believe that it's important to be honest and truthful to the parents of the autistic patients you're treating?
Q. You are a member of Defeat Autism Now?
Q. And they issued a policy statement in May of 200 I that had your name on it, on the second page, as one of the authors?
A. Yes. MR. KERTSCHER: Let's go ahead and mark that as Exhibit 40. (plaintiffs' Exhibit 40: MERCURY DETOXIFICATION CONSENSUS GROUP POSITION PAPER, marked for identification)
Q. I'm handing you Exhibit 40. On page two of Exhibit 40, do you see where it says "The Consensus Position Paper"?
Q. It says: "The consensus position paper represents the current views of the undersigned physicians and research scientists." Do you see that sentence?
Q. Then you see your name," Kenneth Bock, Rhinebeck. New York"?
Q. And they had your permission to put your name on page two of this DAN study?
A. Yes; I wouldn't call this a study, by the way.
Q. I'm sorry, you're right. It's a consensus group position paper; thank you for clarifying. This is from May of 2001; do you recall that?
Q. Did you actually travel out to San Diego or Arizona to participate in the creation of this consensus group position paper?
Q. Let me ask you to turn to page sixteen.
A. Just so you know, you asked the place and there is a mention of Dallas, Texas on page two, so I may have gone there, just for the record.
Q. That's fine. I wasn't trying to mislead you about where the conference occurred. That's a completely irrelevant fact I think we all would agree. On page sixteen, do you see where it says "Disclaimers for Medical Practitioners"?
Q. Do you see item number three where it says: "At the present, it is impossible to determine which patients will benefit from these therapies with great accuracy. Some patients who seem to be perfect candidates will have no improvement and others who seem to have little to recommend the therapy will show marked improvement"?
Q. Is that the sort of thing that you tell the parents of your autistic children when they come to you?
A. I would say, yes, with a qualification. I would say, speaking for myself, that I tell parents that there are no guarantees; you can't be certain of the response. I tell parents that a treatment that will help a majority of kids in the autism spectrum may cause an adverse reaction in another child. Part of the work we are doing for DAN is to try to home in and be able to, as best we can, define those subgroups.
Q. With reference to that statement that you just made, in your extensive review of the records, your fifteen to twenty-hour review of the records provided to you, did you see any evidence that Dr. Edelson made statements like the one that you just made to the M’s?
A. I wasn't able to hear what he said, so that needs to be said, of course, but I believe I saw in the record something about making sure he said there was no guarantee of success, if I'm not mistaken.
Q. In what part of the record did you see that?
A. I think in some of the informed consents it may have been mentioned. I will be happy to look them over if you would like me to.
Q. Other than the informed consents, did you see that in any other place?
A. I can't recall.
Q. When talking to the parent of an autistic child who is seeking alternative or integrative treatment, would it be inappropriate to tell that parent that every child in the treatment gets better?
A. Would it be inappropriate to tell a parent that -- I am just going to rephrase it so I understand -- would it be inappropriate to tell a parent of an autistic child that every child gets better?
MS. JAGOR: Objection to the form.
A. I wouldn't say that.
Q. Let me ask you to turn to page seventeen and number three of Exhibit 40, the DAN protocol. It says: "Despite miraculous case reports heard on the grapevine and on the Internet, these therapies will not work for every autistic person. Even those who do improve may have slow or incremental improvement." Do you agree with that statement from the consensus group position paper?
Q. Is that something that you tell the parents of autistic children? Do you tell them things along those lines?
Q. Let me talk a little bit about your treatment regimen for autistic children. Describe it for me and how you come about it? Just keep Exhibit 40; we are going to refer back to that several more times.
Q. If you can describe for me how you create your treatment regimen for an autistic child?
A. First I do an in-depth evaluation.
Q. Let's stop. How do you do an in-depth evaluation; what do you do to perform an in-depth evaluation?
A. My first visit is an hour and a half long; I do an extensive detailed history.
Q. Why is that important?
A. Because I treat each of these children as an individual. They have similar diagnostic categorizations, but there are different etiological factors that contribute to their condition.
Q. So a good practitioner in your view should do a detailed history of an autistic child?
Q. Go ahead, I'm sorry. You do a one-and-a- half-hour evaluation and take a detailed history?
A. Right. I go through the records that are brought to me from the previous consultations, immunization records, their previous labs.
Q. Do you request those from the parents?
Q. So the medical records you review, you request the parents to bring you, and you would then review previous medical records including the previous immunization records and previous lab test results?
A. I'm not limited to those, but I like to have the previous records that are pertinent to what is going on.
Q. Certainly that's important in making an informed decision. Go ahead, what do you do next?
A. I listen very closely, and that's very important, to what the parent and/or parents are saying.
Q. And I get that sometimes your in-depth evaluations go longer than one-and-a-half hours? I bet it could go two or three or four?
A. Yes, it sometimes goes longer than an hour and a half, yes.
Q. So in listening closely to the parents, you ask them questions about the child's behavior problems they're having with the child, how the behavior progressed, I assume, those sorts of things?
A. Yes, but also I'm looking for clues to what may be contributing to the child's problems, and that's the biggest thing that I do and where I have the most impact or I can have the most impact on the child's health.
Q. What else do you do as part of your in-depth evaluation?
A. I do a physical examination. I thought I said that; if I didn't say that, I want to make sure I do say that.
Q. Describe the physical examination?
A. It's generally a complete physical examination looking at the child's various organ systems. I look at the skin -- do you want me to go through the whole thing?
Q. If you don't mind, just briefly. I know we are limited by time.
A. You look at behavior, you look at skin, lymphatic, head, ears, eyes, nose and throat, neck, thyroid, lungs, heart, abdomen, an anal inspection of the buttocks and anus for any rashes. You look at genitalia, extremities, muscular, skeletal, and of course neurologic.
Q. And that probably takes several minutes. You're very good at it and you have done it very quickly, but it probably takes several minutes to do that, I would say?
Q. Did you see anywhere in the lengthy medical record review that you did for this case where Dr. Edelson did that on GM?
A. I saw a physical in there.
Q. Do you know where you saw that?
A. I can find it. It was in the records; I remember seeing it in the records.
Q. Done by Dr. Edelson?
A. I don't know if it was done by Dr. Edelson. I saw a physical examination; it's not unusual for a physician's office to have a physical examination done by a PA or a nurse practitioner.
Q. You saw a physical exam done by someone at the Edelson Center?
Q. We will come back to that. You do an in-depth evaluation and you do a physical exam; tell me what you do next?
A. Then I do a laboratory evaluation.
Q. What labs do you take?
A. It's not "one size fits all" as far as the in-depth evaluation; I'm trying to figure out which direction we need to go in. I am looking for potential contributing underlying etiology causes, so I want to know what may be contributing, and the history and physical will point me in certain directions. And then there are other things that we know from our experience and from literature what may be abnormal in children, and we want to check that. So I look at things ranging from CBC, chemical profiles, urinalysis, thyroid function tests. I look at food allergies and sensitivities, biochemical and metabolic imbalances, nutrition deficiencies, immune deficiencies, autoimmunity. There are tests for these kinds of things. Sometimes there is evidence of a chronic infection, certain viral infections. We look at stool samples, urine samples. I talked about nutrition, and there are different tests to look at nutritional imbalances.
Q. Is that all, Doctor?
A. That's not all. You have to consider the specific history of the family history.
Q. Right, I understand that it's different for each one. What I'm trying to get right now is the universe, as best you can tell me.
A. You could look at coagulation abnormalities, you may have to look at x-rays, abdominal x-rays if the kid is feeling constipated. I mean, I don't want to leave anything out and say it's not important I am trying to tell you that the evaluations can be fairly in-depth.
Q. Right. You have listed eleven categories of things you can look at, understanding that under each category there may be several ways to check for the biochemical and metabolic disorders. I understand that. Is there anything else that you have not mentioned; any other general categories?
A. Heavy metal testing. I talked about minerals and mineral imbalances, but I want to be more specific about heavy metal testing.
Q. I didn't hear you mention hair samples.
A. I didn't mention hair samples.
Q. You do not check hair samples?
Q. Why not?
A. Hair samples are not licensed in my state, New York State.
Q. I saw in some of your materials where you said hair analysis can be overused, I think, and I can't remember the other terms you referred to about that.
A. Where is that? Could you point that out to me?
Q. This was actually written by your brother, Steven Bock. That's your brother, is that correct?
Q. This is something he did called "Diagnosis and Treatment of Heavy Metal Toxicity." Have you ever reviewed that article that your brother wrote?
Q. On page four, your brother wrote: "Hair analysis is often overutilized for diagnostic and therapeutic regimes." Do you agree with that statement that your brother made?
A. Yes, but I think it has to be qualified. I think he may have been -- I can't speak for my brother. We have the same last name, but I want to be very clear I'm not speaking for my brother.
Q. I understand. I wouldn't speak for mine either.
A. Thank you, then you know. There are some practitioners who may use hair analysis -- and they may not be medical doctors, they may be other types of health care practitioners -- to completely guide therapy and over-interpret the results of hair analysis. I think that's what he was referring to.
Q. Why is hair analysis not legal in your state?
A. You have to understand that New York State is a difficult state when it comes to labs. There are number of labs that are licensed across the country and they're not licensed in New York State.
Q. I understand that you are not employed by any regulation agencies for the State of New York, medical department or medical licensing bureau, so I suspect that your answer may well be "I don't know," but let me just ask you: Do you know why hair analysis is not legal in your state?
A. I guess I can say I don't know.
MR. KERTSCHER: Let's take a five-minute break.
(Break in the proceeding)
Q. Doctor, we were talking about hair samples when we went off the record. Do you have any opinion as to the accuracy or lack thereof of hair samples separate and apart from the fact that they're not legal in the State of New York?
A. I don't use them.
Q. S. the answer is, No, you don't have any opinion?
A. I don't have any. I don't use them, so I don't have an opinion.
Q. You would agree with me though, wouldn't you, Doctor, that urine tests are generally more accurate than hair samples?
A. Let me rephrase that about not having an opinion. I don't use hair analysis. I know some people do, and hair analysis when interpreted in the context of a whole picture may give some information about heavy metals.
Q. Would you agree with me that urinalysis is more accurate in terms of a determination of heavy metals than hair analysis?
Q. You were talking about the universe of tests that you may run on children depending on what you find in your initial evaluation. Is there any test that you run on every autistic kid no matter what?
A. Is there a test that I run?
Q. Yes, sir.
Q. Which is that?
A. CBC, a chemical profile, urinalysis.
Q. Anything else?
A. I don't like to say every case, because I treat children as individuals. So I would like to rephrase it as the majority or most. There are situations where you're unable to do them because of cost factors and other reasons, so I would like to not say every child, but I will certainly give you the thing I run on most children. Every child certainly who is going to be considered for any kind of heavy metal detox is going to have to have a CBC and a liver profile and kidney function, which is part of the smack.
Q. Why do you run those?
A. Because you're going to monitor kids when you have them on detox.
Q. So you do the liver profile and the kidney function tests?
A. And the CBC.
Q. Anything else?
A. I run mineral tests, red blood cell minerals.
A. Because I'm looking for mineral deficiencies, which are frequent in these kids, as well as evidence of heavy metal toxicity. Food allergies and sensitivities I frequently run. I hope you respect that I don't like to say every, because it's not "one size fits all" the way I treat children.
Q. I understood that before and all I'm trying to get is the ninety percent or more category.
A. Okay, that's reasonable. And again, it's in the context of if these children have not had testing shortly before they have seen me; if they have had a thyroid function test by another physician, I won't rerun it. I frequently run stool analysis, and in the regressive autism subset I would run tests of autoimmunity and certain nutrient levels, Vitamin A, for instance. With many of the children, I will do an amino acids, fatty acids profile and urinogenous acids in most children.
Q. Anything else?
A. Let me make sure I didn't miss anything. I said that I did testing of autoimmunity in many kids. Tests for metabolic imbalances.
Q. And we are still in the ninety percent or more category.
A. Well, I said, in many kids. I don't know about ninety percent, because again, these tests can get expensive, and so I have a discussion with the parents about the evaluations. Clearly there is some metabolic testing that I really prefer to get. Some of the tests I'm listing I get on most of the kids I see.
Q. You said something that I wanted to ask you about. You said the tests can get expensive.
Q. What do you bill your patients for the tests that are run?
A. In New York State the tests are billed by the labs.
Q. So you don't bill any extra cost to your patients for the labs that you prescribe? They're billed directly from the labs?
A. There may be a handling fee, a small handling fee for something like that.
Q. What is that small handling fee?
A. It depends on the test. It could be $10, it could be $20, it could be $40.
Q. SO there is a minimal handling fee?
Q. You don't take the lab cost, let's say it's $100, and you don't add an extra $100 onto that?
A. In New York State that's not the way it's done.
Q. Is that the only reason that you do it? Is there any law against doing that in New York State?
A. I believe so.
Q. Do you have any opinion about whether or not it is proper or not to do that in the absence of such a law?
A. I don't have an opinion about that. I don't know how it is in every state.
Q. Do you run, with any of your autistic patients, the Washington University Autoantibody Study?
A. I don't.
Q. Do you run, with any of your autistic patients, a Jejunal Fermentation Study?
A. I don't. I know that some do, but I don't.
Q. Do you run, with any of your autistic patients, an amino acid analysis study?
Q. Do you run, with any of your autistic patients, a serotonin and dopamine antibody study?
A. Not generally.
Q. Let me ask you if you know anything about the Washington University Autoantibody Study?
A. Yes, I am aware of it.
Q. Why don't you use it?
A. You know, you can name me a thousand tests and say, Why don't you use every one? You get information certain ways. It could be a valuable test. I'm not even sure it's licensed in New York. New York is a very strict state for licensing, as I said. There are many tests performed across the country that you can't do in New York.
Q. It doesn't sound like you have even investigated it?
A. I haven't investigated that particular test.
Q. Why isn't it something that you have looked into?
A. Because I get other tests for autoimmunity. We look at various things. I get other tests of autoimmunity.
Q. Why don't you do the Jejunal Fermentation Study?
A. I get information from other ways.
Q. Do you know whether or not that study is legal under FDA regulations?
A. I don't use the test, so I don't know. I would speculate it is because I have read about the test.
Q. Why don't you use the serotonin and dopamine antibody study?
A. Again, it's a matter of how many tests you get, and I get the information -- those are for autoimmunity, and I look at other things for autoimmunity. Autoimmunity is a very important thing to look at and I look at it in other ways.
Q. What are the other ways that you look at autoimmunity?
A. You can do a myelin basic protein test and the glial fibrillary acid protein test.
Q. Why do you choose those tests as opposed to the ones we just talked about?
A. Not everybody practices exactly the same way. Why does one doctor choose to do it one way and another doctor chooses to do it another way?
Q. Doctor, I'm asking about in this specific instance why you choose those tests over the Washington University Autoantibody Test and the Jejunal Fermentation Study?
MS. JAGOR: It's been asked and answered.
A. They are tests that I use to give me the information that I need to help me with the directions that I need to go in helping these children.
Q. For whatever reason you have chosen those tests, because you prefer those tests over the Washington University Autoantibody Test and the Jejunal Fermentation Test?
A. These tests work for me and I don't find the need to get every single test. I could get one thousand more tests.
Q. Do you agree with me that sometimes there can be too many tests taken then; right?
A. Well, there are many different ways to look at things and different physicians have different ways of looking at things.
Q. I'm asking you. You're the witness here today.
Q. Can there be too many tests given?
A. Can there be too many tests? If somebody saw a patient and got every single test that existed under the sun for conditions that are not related to what they're looking at or they came to you for, that's too many tests. But are there different types of tests that people can get for the same situations and different approaches, sure.
Q. Do you use the IGE and IGG Food Study Test?
Q. Do you use the fibrinogen level study?
Q. You already said you don't use any hair analysis study?
Q. Do you use any skin tests?
A. We do skin tests in our office.
Q. On autistic children?
A. Generally I do blood tests more than skin tests on the children.
Q. Why is that?
A. It's just that you can get a lot of information with one stick. That's just my preference.
Q. Do you believe that you can get more information from a blood test than a skin test?
A. You can certainly get more information from one blood test than you can from one skin test. You have to get multiple skin tests to get the same information.
Q. We were going through your protocol and you told me that you do an in-depth evaluation that can be several hours. You do a pretty in-depth physical examination and you do a lab evaluation. Typically, how many labs do you order in a typical patient? I counted eight or so labs that you run on the majority or the vast majority; the mineral test, the CBC, the thyroid testing and all of the tests that you identified earlier. Typically, how many tests do you run for an autistic patient?
A. Some of them are bunched together, so it may be confusing. You may get three tests as kind of a sub unit just so you know, unless you want me to break down every single thing. The oxidative stress profile may be two tests rather than one; do you know what I'm saying?
Q. Yes. We are still in the vast majority of patients that you see and we are trying to identify what you do most of the time.
A. You know, I would say anywhere probably between ten and fifteen maybe. Let's say if you do zinc and copper; I am separating the zinc and copper in that situation.
Q. Moving then down into your protocol, what do you do nex1 after you have administered the lab tests? Let's presume that you don't have the lab results back yet; what do you do nex1 with your typical autistic patient?
A. First of all, I just want to correct you, you said "several hours." The examination in my office takes several hours; my evaluation is probably an hour and a half. But I just want to be correct.
Q. Fair enough.
A. The evaluation in my office is more than just myself. I am sorry, your question is: What do I do next after I have done the labs?
A. Then I have them come back when the lab results are back, and I spend a considerable amount of time reviewing the lab results and then creating a treatment program.
Q. You review that with them in person?
A. Generally in person, yes.
Q. Is that a better practice than doing it, say, via mail?
A. It's my practice. Sometimes it's done via phone if somebody can't get in for some reason. I like to do it in person if we can.
Q. Why do you like to do it in person as opposed to just mailing the lab results to the parents?
A. Firstly, because there is the potential for misinterpretation, as we talked about before with hair analysis. And again, I don't use it, but that is a real one that shines for people misusing it. There are too many ways that parents can misinterpret lab tests, and I like to be able to explain the results. Labs are important in the context of a clinical situation. I'm a clinician and I treat the patients. The labs are helpful, but you don't want to let a parent get scared by a misinterpretation of a lab test.
Q. That sounds reasonable. You don't make a diagnosis until after you have see the lab results?
A. That's not true. I'm a physician; I'm a clinician. My professors at the University or Rochester would cringe if you said that and I cringe when you say that. We are not just laboratory-lookers. When I see a patient, I have an assessment and impression of a patient. The day I see them I have looked at all of the patient's labs, I have a patient's consultations, past records and past labs, so I would say clearly I have an impression on the first visit I see a patient. I always have an impression.
Q. And from some of the things I have seen, you write pretty detailed impressions as I recall?
Q. In fact, on the impressions that I have seen, you often can have a half-page-long discussion of your impression in some of your records?
A. Have you seen my records?
Q. There are some things that are available on the Internet. But I get to ask the questions here today.
Q. You write pretty lengthy impressions; don't you, Doctor?
Q. And you feel that that's a better practice than writing a one-word impression?
A. I'm not going to judge. There are many doctors that only write one-word diagnoses.
Q. Let me ask you: Why do you write a lengthy impression?
A. I write a lengthy one when indicated, and there are times when I might create a mutiple diagnosis. I do usually do a pretty thorough impression, but I don't want to judge anybody. I'm not sure what you have looked at.
Q. I'm not asking you to judge anybody. I'm asking you about your procedure and why you do it one way as opposed to doing it another way. Why do you do a lengthy impression?
A. When I see a patient for the first time, I spend a lot of time and I put a lot of thought into writing my note so that when I go back to that note, it helps me see what I was thinking, what directions I'm thinking in. My notes are helpful to me the next time I see them and so on.
Q. So there is a real benefit then in your mind to a detailed medical note with a detailed history and a detailed thought process?
A. For me, that's the way I do it.
Q. Sure. Do you have any sort of handbook that you provide to your parents of autistic children?
Q. Why not?
A. I just don't.
Q. Is there any particular reason that you don't do that?
A. No, we just don't.
Q. There is an autistic testimonial on your website from Rose Roughton. Are you aware of that?
A. It may be. I know Rose and I know her son. If you say it's there, it's probably there.
MR. KERTSCHER: Let's go ahead and mark this as Exhibit 41..
(Plaintiffs' Exhibit 41 : PATIENT TESTIMONIALS, marked for identification)
Q. There is a series of testimonials from various patients. Several of them -- well all of them except for one do not deal with autism. There is one from Ms. Roughton, if said that correctly, that deals with autism on Exhibit 41; do you see that, Doctor?
Q. It appears as though that was certainly one of your most successful patients or more successful outcomes; is that correct?
A. I don't know if it's one of my more successful. It was certainly one of my successful ones.
Q. You have put it up for public display on your website and in fact put the lady's name, so I'm assuming that that's certainly an outcome that you're proud of; is that a fair statement?
A. Yes. Just so you know, these were written probably years ago, some of these.
Q. Fair enough. Looking at some of the treatments that Ms. Roughton talks about; do you see where she talks about EPD?
Q. And Secretin and some other studies? I don't have a copy in front of me.
A. Modified diet supplements.
Q. Those techniques were helpful with Ms. Roughton's son?
MS. JAGOR: Just so you know, this is cut off.
MS. KERTSCHER: That's the way it prints off the website. I don't know why.
Q. From your record review, you're aware that Dr. Edelson did not use EPD or Secretin with GM; is that correct?
Q. This goes a little bit back to some of the DAN materials that we talked about earlier. Even though apparently this is an outcome that you're proud of, this patient is still nonverbal or at least is described as being non-verbal; is that right?
A. Yes. Just so we know, this is a child that I have been taking care of from years ago.
Q. Could you define "years ago"?
A. Probably before 1999. This was a child that was being treated with EPD, so this was in probably the mid-to-late '90s.
Q. Was that a child that was part of the Great Lakes EPD study?
A. Any child that was given EPD was part of that study.
Q. What I guess I'm trying to get at is although there was a successful outcome, the patient is still nonverbal or at least was described as being still nonverbal. Ms. Roughton wouldn't say that her son was cured of autism; would she?
A. No, but just so you know, this was years ago. I wouldn't call this one of my more successful outcomes by any stretch of the imagination.
Q. I can only go by what is on your website, Doctor?
A. This was done years ago.
Q. You don't tell the parents of your children autistic patients that you're going to cure that child of autism; do you?
A. I don't use the word cure.
Q. Would it be responsible for a doctor to tell the parents that their child was going to be cured of autism?
A. Is going to be like definitively cured?
Q. Just as I said it.
A. Can you rephrase the question, again?
MR. KERTSCHER: Would you read it back to him. please. (Question read)
Q. Also in your practice, do you administer multiple shots to your autistic patients at one time?
A. What do you mean by "multiple shots"?
Q. To the extent where there are multiple shots in one sitting?
A. I would like you to be a little more specific, what you mean by "multiple shots"? I'm not sure what you mean.
Q. More then ten.
A. What kind of shot?
Q. Well, for example, allergy shots?
A. I wouldn't call them allergy shots. Shots are different than allergy tests. If we are clear that it was allergy testing, then if I was doing skin testing, I very well may do more than ten.
Q. But you don't do skin testing, I think you testified earlier?
A. No, no, I said we do skin testing in my office.
Q. So you do in some instances give multiple shots to your autistic patients as part of skin testing?
A. Yes, in certain circumstances.
Q. What circumstances are those?
A. I would say it would be the circumstances where a child was troubled by lots of allergies and the blood testing wasn't as helpful as it needed to be and we needed to do skin testing. I think I mentioned to you that it was my preference to do blood testing first with these children.
Q. Would you agree that multiple shots as part of skin testing is a painful procedure for an autistic child?
A. It may be.
Q. Have you ever had an autistic child pass out during skin testing in your office?
A. As I mentioned, I don't do skin testing that often with autistic children.
Q. So the answer to the question would be no?
A. The answer would be no.
Q. Is it an appropriate practice to administer multiple shots as part of skin testing right out of the gate without first attempting blood testing?
A. There are different ways to do allergy tests, and skin testing is one way to do allergy testing that certainly is appropriate in certain situations.
Q. You qualified it with "in certain situations," and the certain situations you gave me earlier was when the blood testing was not as helpful as it needed to be; do you remember that testimony?
A. Yes, that's my preference, and I think I said before that there are various ways to test for allergies and doctors can use various techniques to test allergies.
Q. Do you use a syringe to inject materials for skin testing or do you use skin pricks?
A. No, I use a syringe. What you're referring to, I believe, is intradermal testing as opposed to skin pricks, and when you're testing food allergies, skin pricks are highly inaccurate so you need to do intradermal.
Q. But again, as I understood what you testified about, it's your choice of practice to do the blood test first before you engage in the skin testing?
Q. Can autistic children be heard screaming at your office if I were to visit there on a daily basis or a regular basis?
Q. Screaming in pain?
A. No, they scream.
Q. I understand that autistic children have outbursts?
A. If they don't get their way, they scream, so yes, if you have enough autistic children in the building at the same time you're going to hear screaming.
Q. Fair enough. How far do you go to encourage your parents to undergo treatment with you when they have financial difficulties?
A. I discuss the lab tests with them and the cost and we arrive at an evaluation and treatment plan that takes into consideration where they are.
Q. Is it appropriate in your mind to compare an autistic child that can't get certain treatment to a leukemia patient that is dying because they can't afford a bone marrow transplant?
A. I can't comment on that, because the doctor is bringing up examples of something to make a point. I mean, it's hard for me to comment on that in that sense.
Q. If you had a look at the specific way in which it was said, would that help you comment on it?
A. If you want to show me something specific, I might be able to give you a little bit more.
Q. Let me ask you this: What is the importance, in your way of thinking, of tubulin antibodies in the diagnosis or treatment of autistic children?
A. It's another autoantibody.
Q. I understand we have already covered the fact that you don't use it in your practice; right? You don't use testing for that in your practice?
A. No, not regularly.
Q. How instructive, in your mind, is it whether or not tubulin antibodies exist in an autistic child?
A. How important is it; is that the question?
A. We discussed this before, but I would be happy to reiterate it. It's just another example of an autoantibody to a neuro antigen and there are multiple neuro antigens that you can look at. As I mentioned, there are a couple that I look at and that's one that you can look at. The presence or absence of that is another pointer.
Q. In your practice you certainly are truthful with your patients about whether or not there is a presence or absence of a neuro antigen antibody in their child; right?
Q. And it would be inappropriate to be untruthful about whether or not there was a presence or absence of a neuro antigen antibody in their child?
A. Unless I made a mistake and read a lab wrong or something and I mistakenly told the patient that something was that there wasn't. That would be an error. Definitely it's appropriate to give patients the proper lab results.
Q. How much do you think it's appropriate to encourage patients to undergo your treatment or to undergo your integrative approach to autism?
A. My job as a physician and as an integrative medical physician is to do the best I can to help my patients, and since we are talking about children in the autism spectrum, I will limit it to that, if that's okay. I'm going to do the best I can to evaluate things and to come up with an evaluation that I think is appropriate, that's also an evaluation that is doable in the context of the family, and then a treatment plan that I think is appropriate and doable in the setting of the family. And so, you know, I will lay it out. It's a partnership with my patients and their families especially when it comes to decisions. I will make recommendations and the families will do the best they can to follow them, and I understand and I respect that and we move forward.
Q. I think that that's a reasonable approach, Doctor. I understand that you prescribe various supplements for your patients as part of their treatment regimen; is that correct?
Q. Do you carefully assess how the various supplements may interact with each other in the system? Is that something that's important to you when you're prescribing them?
Q. Is it appropriate or inappropriate to have a level of supplements prescribed where an autistic child is taking seventy pills a day?
A. I should say that unfortunately many of the children require multiple supplements because they have many, many imbalances.
Q. I am not talking about multiple. I'm talking about seventy?
A. Seventy supplements or seventy pills?
Q. Seventy different pills.
A. It's a high number, but I would say that certainly in the beginning of treatment when the kids are really, really imbalanced, that they require higher numbers of supplements. So I'm not going to say a certain number is inappropriate.
Q. How long should a child take seventy supplements a day before it becomes inappropriate?
MS. JAGOR: Objection to the form.
A. It's really based on the clinical situation, the clinical progress, the clinical picture of how the child is doing, etc., etc. On subsequent evaluations along the line, you may make adjustments.
Q. SO there could well be some situations where a child may need to take seventy pills a day for six weeks?
A. Yes, maybe.
Q. Have you ever seen any in your career?
A. I don't know about that exact number, but there are situations when these kids take many, many supplements.
Q. So you have seen in situations in your career where patients were taking almost seventy pills a day for six weeks?
A. I don't want to put a number on it, but I would just say that there are situations where I have seen some kids take and benefit from many supplements for a certain period of time. I don't want to put a number on it.
Q. How many of those situations can you recall as you sit here today?
A. Some of the kids really have a lot of imbalances and they need to be dealt with. Most of the kids need more than one or two supplements to start with for sure.
Q. That's not my question. My question is: How many instances have you seen that it was appropriate for autistic children, in.your medical judgment, where it was appropriate to take seventy pills a day for six weeks?
MS. JAGOR: If you know.
A. If you want me to answer the question with seventy, I'm going to say I don't know because I can't speak to seventy pills.
Q. Do your autistic patients come and receive ongoing regular treatment where it would be four days a week at either of your centers?
A. Not frequently.
Q. What I understand from looking at your materials is that you do not use high heat sauna therapy on your autistic children; am I correct on that?
Q. Are you aware of any scientific or peer-reviewed studies that the theory that support a high heat sauna therapy can cure autism?
A. Again, I would not like to fall in the trap of "curing autism," but there are different opinions and positions that far infrared sauna can be helpful in the detoxification of children within the autism spectrum.
Q. Can you cite those studies to me?
Q. Is there anything in your review of the record that suggests to you that infrared sauna was used by Dr. Edelson on GM?
A. I don't know. I know there was a sauna; I don't know exactly the type of sauna.
Q. From my review of your materials, I take it that you do not use treadmill therapy as a means to cure autism or to improve autism?
A. If you want to make it easier -- maybe you don't want to, but it would make it easier for us to confer if you used the words improve or help rather than cure, because I'm going to have to qualify it every time because I don't like to use the word "cure."
Q. The question, Doctor, is about treadmill therapy; do you use it on your autistic patients?
Q. Are you aware of any scientific and peer-reviewed studies that support that treadmill therapy can somehow cure or improve autism?
Q. I take it from reviewing your materials that you don't use ozone therapy, am I correct, on your autistic patients?
Q. Are you aware of any scientific or peer-reviewed studies that support that ozone therapy can cure or improve autism?
Q. Let me back up. Why don't you use high-heat sauna therapy on your autistic patients?
A. Are you differentiating high heat from lower infrared?
Q. I think we are going to talk about them both, but let's start with high heat.
A. High heat is not a therapy that I have been using, like I said before, with everything else.
Q. Why not, Doctor?
A. Why not?
Q. You're an expert witness in the case; I'm entitled to know why not?
A. It's not something that I look to as a part of my treatment program.
Q. Why not?
A. Because if I'm going to use saunas, I'm going to use a lower far infrared sauna.
Q. Why don't you use lower far infrared saunas?
A. We are looking into that at the present time.
Q. Why haven't you been in the past?
A. Just because there are so many things that one does with these children, you know.
Q. I assume you're trying to do the best that you can for your autistic patients; right?
Q. You're not holding anything back for these autistic kids that come to you for help; right? You're giving them the best treatment you know to give them; aren't you?
A. Yes, and what I want to say to that is, I'm always looking for more answers. I'm always looking for treatments that will help these kids.
Q. I'm curious about this infrared sauna stuff that you're looking into right now. Where are you looking into that?
A. I have been talking with people about far infrared saunas and we are looking at compiling some of the literature on far infrared saunas in terms of detoxification. When I look at implementing things into my practice, I do it probably a little bit slowly, because I have got many, many things going on and that's how things go.
Q. Talking with people, let's break that down, who have you talked with about high infrared heat?
A. It's not high, it's far infrared.
Q. So it's not high heat. I think of a sauna as what I have at my gym where it's hot and I sweat. You're telling me that infrared is not like that?
A. The heat in your sauna at your gym may be 180 or 200 degrees; far infrared is at 120 to 130 degrees.
Q. So it's a lower heat?
Q. Whom have you talked to about that?
A. Jake Johnston gave a lecture at a medical detoxification conference on far infrared saunas.
Q. Why aren't you looking into higher heat suanas?
A. Because I would prefer to use a lower heat far infrared.
Q. Why do you prefer lower heat?
A. It's more comfortable, it's a different technology. It's the direction that I want to go into.
Q. Why do you want to go in that direction?
A. It's more comfortable.
Q. It's uncomfortable for a young autistic child to be in a high heat sauna; isn't it?
A. It may be in terms of sweating.
Q. Let's assume also with treadmill therapy, that the treadmill therapy is. going to also cause sweating; correct?
Q. So is it important in your view as a doctor that if you had patients undergoing high heat sauna therapy and treadmill therapy -- is it your view that it's important to watch the weight of the child and to carefully measure that?
A. I would say it's important to monitor various parameters.
Q. Can weight be one of the child's parameters?
A. Yes, weight would be one of them.
Q. For an eight-year-old child to lose ten percent of his body weight in a six-week period of time, would that be a good thing or a bad thing, or don't you know?
A. It's not a good thing.
Q. And you as a medical doctor would be concerned about that if one of your patients lost ten percent of his body weight over a six-week period of time?
A. I would certainly be aware and monitoring it.
Q. Let's talk about chelation. I noticed on your CV that you had a notation about advanced proficiency in chelation therapy. It looked like either a course or some type of degree that you got; can you help me understand that better?
A. Sure. There is an organization that I am the president-elect of called ACAM, American College for the Advancement of Medicine, and we teach doctors a workshop on chelation therapy. There is a procedure by which you can achieve a basic proficiency and then advanced proficiency in chelation.
Q. It's kind of like a test?
A. Yes, it's testing. It's a two-step procedure. One is via written exam and the other is with chart review and oral exam.
Q. And this is something that you went through to help educate yourself about the use of chelation therapy?
Q. I am assuming since you're the president-elect of ACAM that you think that it's. a good thing for a practitioner to use chelation therapy; is that right?
Q. Are you aware from your review of the file whether or not Dr. Edelson ever took either of these tests or the workshop that ACAM offers on chelation?
Q. What are the potential side effects of. chelation, and I understand there is DMPS,. DMSA, and if you need to break it down by each chemical you can. It's not a chemical; it's a compound, but what in general are the side effects that you're aware of?
A. Mineral imbalance is one, leukopenia, which is a low white count, abnormalities in liver function, abnormalities in kidney function, allergic reactions. Those are some of them.
Q. I'm working on a case right now, if it's done improperly, chelation leaches too much calcium out of your body and without enough calcium, your heart can't beat; right?
A. Well, calcium is certainly an important mineral to have in balance, yes.
Q. Let's just be honest about it. If it's done improperly, one of the possible problems with chelation is death?
A. If done improperly, yes. It's certainly a rare occurrence, but one needs to know how to do chelation therapy properly.
Q. And if done improperly someone could die?
Q. We are going to talk to about the DAN protocol in Exhibit 40, but since you mentioned ACAM, let me talk about that. ACAM'S protocol on chelation in 1997 on DMPS; are you familiar with that? Do you know what that said?
A. ACAM's protocol?
Q. Yes, sir. That's the organization that you're president-elect of; right?
A. Yes, it is. I'm not exactly familiar off the top of my head of what it says.
Q. Do you know whether or not ACAM in 1997 took the position that DMPS cannot be used at all without lND approval from the FDA?
A. In 1997 that may have been the case. I'm not sure.
Q. Do you know whether or not now DMPS can be used without IND approval from the FDA?
A. My understanding is that it can.
Q. Do you know what the legal status of DMPS was in 2001 on whether or not it could be used without an lND approval from the FDA?
A. I'm not one hundred percent sure, but again, I would say I think that it was not FDA approved, but it was a legal substance.
Q. SO it's your belief then that in 2001 it could have been used without IND approval from the FDA?
Q. Certainly though, according to the DAN protocol, DMPS is the more toxic of the chelation compounds; isn't that true?
A. I'm not one hundred percent sure of that, really.
Q. Let's turn to the DAN protocol in Exhibit 40. You will recall that this was the consensus group position paper that your name was on page two of; right?
Q. Looking at page ten under detoxification; do you see that?
Q. Let me ask you first, do you use DMPS in your practice, Doctor?
A. In children in the autism spectrum, no.
Q. Why not?
A. Because DMSA is an FDA-approved drug.
Q. I understand that and I agree with you. Why don't you use DMPS?
A. Because we are using DMSA for off-label use as well, because it's not only strictly for lead toxicity and there is a huge, huge safety record for DMSA in thousands and thousands of kids with lead poisoning, and we are very, very comfortable with it.
Q. Are you suggesting that DMPS does not have that same safety record?
A. I think it doesn't have the same numbers of kids it's been used on, certainly not in this country. And I will qualify my answer from just a few minutes ago, that DMPS is relatively safe, to my knowledge, but that because of its status as being legal but not FDA approved, in the children in the DAN protocol, we prefer to go with DMSA.
Q. Looking at the DAN protocol on the DAN consensus group position paper, of which you were a part, on page ten on the first paragraph under detoxification. The next-to-the-Iast sentence under detoxification says that: "There is far less experience using DMPS, especially in children, and the adult experience with it has shown that it is significantly more toxic than DMSA." Do you see that?
Q. Do you agree with that statement from your consensus group position paper?
A. This was referring to injectable DMPS as opposed to oral DMPS, I believe. This was written a few years ago and at the time I think that was the consensus opinion of this group. I think there was some contributors to this consensus group that didn't agree with that.
Q. Were you one of them?
A. I don't think I had a strong opinion about that. There were many, many people that rendered opinions about various things.
Q. Well, that's not what it says. What it says is: "This consensus position paper represents the current views of the undersigned physicians."
A. Yes, but it also says: "No one is more aware than the undersigned that this document represents merely a beginning step in our long-term efforts to solve an exceedingly difficult problem. We have much to learn." So the information is evolving.
Q. I agree with you one hundred percent about that. This was compiled and published in May of 2001; right?
A. Three years ago.
Q. When did GM begin treatment with Dr. Edelson; do you know that?
A. I would have to look to know exactly; I believe it was in December of 200 I.
Q. Let me try to get an answer to this question, Doctor: On page ten of the consensus group position paper, do you agree that at least as of that time, at least as of May of 2001, that the adult experience has shown DMPS to be significantly more toxic than DMSA?
A. I would agree that that was the consensus opinion that we arrived at, yes.
Q. Do you agree or disagree with the next sentence, that DMPS is currently not approved for any use by the US FDA?
A. In 2001, I think it was correct that it was not approved.
Q. SO, Doctor, from your review of the records, do you know whether or not Dr. Edelson used DMPS twice a week on GM?
A. Yes, that's my understanding from the review of the records that he did use DMPS.
Q. Do you believe that that was medically appropriate; is that your testimony here today?
A. I am saying that he used it. Again, it was legal. It was not FDA approved, but it was legal in this country. It has a lot of experience in Europe.
Q. That's not my question.
A. Was it appropriate? It was appropriate for his purposes in terms of detoxification.
Q. You're the expert here today, not him. He has had a long time to testify and he will have more, I suspect. I'm asking you today: Was it appropriate in March and April of 2001 -- which are the dates when it was done, and you can look at that -- in March and April of 2001 for this child at that time, was it medically appropriate to use DMPS on that child twice a week?
A. I'm going to tell you that I know physicians who used DMPS on children and I'm not going to say it's not appropriate. I don't use it, but I wouldn't say it's not appropriate.
Q. Why not, Doctor? We have established that it's more toxic than DMSA, we have established that it wasn't approved by the FDA at the time, so why is it appropriate to use it on a child twice a week? And we are going to talk about the doses and how often, but why is that appropriate?
A. Because I think physicians involved in detoxification have the ability and the right to choose medications and natural substances that will promote detoxification that they think in the best interest for their patients.
Q. I'm not asking if he has the ability and the right. I'm asking you if in your medical judgment - because you're a medical expert identified here today -- if it was appropriate?
MS. JAGOR: He answered that. Asked and answered.
MR. KERTSCHER: He has not answered that question. He has answered another question: Did he have the right to do it? The jury is going to ultimately determine that.
MS. JAGOR: He said that it was appropriate for his purposes.
Q. What about his purposes made it appropriate?
A. He was working on detoxifying this child and the regimen he chose included DMPS.
Q. We are going to talk about using all three of the cocktail together, but focusing on DMPS, what was it about GM -- given what you agree with here in the DAN paper, I still don't think I understand why that was medically appropriate?
A. DMPS chelates heavy metals from sites that DMSA may not hit as well or reach as well.
Q. What sites did GM need hit from DMPS from your lengthy review of the record?
A. Heavy metals don't just go to one tissue; heavy metals get deposited in tissue thoughout the body. That's one of the problems with heavy metals. DMPS reaches certain heavy metals and there are a number of physicians who feel it reaches certain places that DMSA doesn't, so that is why it's used.
Q. What places did GM need reached?
A. Wherever his heavy metals are. I couldn't look inside his body and see exactly where every heavy metal was.
Q. Did Dr. Edelson look inside his body?
A. My understanding was that he was trying to detoxify the heavy metals from this child and in his judgment he used what you call the "cocktail."
Q. So, your testimony is that it's not what you would have done, but it was appropriate for his purposes. I still can't reconcile the two, Doctor. Your testimony has been that the substance was not FDA approved at the time, that it's more toxic than an alternative of DMSA, and you have told me that it reaches other places that OMS A can't reach, but you haven’t told me that there were any of those places that needed to be reached in this particular patient and you haven't explained to me why DMPS was an appropriate choice at that time?
A. I can say this, Dr. Edelson has a lot of experience in the detoxification of children and his experience was that he used these three together. There are some people I know that use DMSA, there are some people that use DMPS, there are some people that use both. There are several chelating agents and it's a matter of what heavy metals are present in the child and it's a matter of what your experience is with DMPS. This says that it is significantly more toxic and there are some people who disagree with that.
Q. What about you, Doctor, you're the expert? I don't think you testified that you disagreed with it.
A. I know colleagues of mine who use DMPS that don't feel it's more toxic.
Q. I'm going to move on. When DMPS or this cocktail of chelating agents is used as you saw used in GM in 2001, what types of supplementations are needed to insure that the child retains appropriate mineral and nutrient levels?
A. Certain mineral supplements.
Q. Which ones?
A. Things like zinc, magnesium, calcium, chromium, selenium and those kinds of things.
Q. Let's talk about that. On page twelve of the DAN protocol it talks about zinc. It says that zinc should be given before, during and after chelation; do you see that, Doctor?
Q. Did you see any evidence in the records provided to you, that you spent a lot of time reviewing, that Dr. Edelson gave zinc supplements prior to, during and after detoxification?
A. Well, I believe the child was on minerals, significant doses of mineral supplementation.
Q. That's not my question. Before, during and after each individual chelating day -- and this is talking specifically about DMSA -- do you know specifically if the child was given zinc?
A. I don't know.
Q. Do you know if selenium was prescribed by Dr. Edelson?
A. I believe he was on multiple minerals which included zinc and selenium, but I would have to look specifically again at every one. My understanding is that he was.
Q. Looking at appendix A of the DAN protocol, Exhibit 40, Doctor, can you identify for us which record it is that tells you that GM was getting zinc and selenium?
A. I would be happy, if you want me to, to go to the records.
Q. Let's move on, because unfortunately we are time constrained, but I'm going to make a note and we will come back to this, because I have been over these records probably as much as Jo has and probably as much as you have, and I sure didn't see it, but I would like you to help me with it, but we are a little time constrained.
A. I would be happy to.
Q. Appendix A, Detoxification regimen of Exhibit 40; do you see that?
Q. How much did GM weigh at the beginning of his detox regimen?
A. I am going to check the records, if you don't mind.
Q. Is that an important fact in determining chelating agents, Doctor, a child's weight?
Q. Can you explain why you don't know that, as you're here to give an expert opinion here today?
A. I know his weight, but I want to be precise.
Q. What do you think it is?
A. I believe it was in the high seventies, but I would like to double-check.
Q. Fair enough. If you come across anything about zinc in there too while you're going through that, give me a holler.
A. His weight on 12/26/00 was 74-1/2. I would just like to say for the record that I like to go to the records to be more precise rather than speculate, so I hope that's not looked at as a problem.
Q. That's fine, Doctor.
A. Thank you.
Q. It doesn't really matter what I think. It only matters what the jury thinks at the end of the day. How many milligrams then of DMSA under DAN protocols are the appropriate maximum milligrams appropriate for GM?
A. According to Appendix A; is that what you're referring to?
Q. Yes, that's the first thing I'm asking you.
A. By this appendix, it would be approximately 400 milligrams.
Q. Do you have some difference of opinion with the consensus group position paper on that topic?
A. I generally do it by ten milligrams per kilogram.
Q. SO for a 74-pound child, how many milligrams per day would you administer?
A. In the range of350 milligrams.
Q. So you're even more conservative than the DAN detox regimen?
Q. Would it be inappropriate then to give 800 milligrams of DMSA in one day to a 74- pound child?
A. You understand that the 350 milligrams that I say are three times a day, so the total would be 1050. It's ten milligrams per kilogram TID, three times a day. This is every eight hours.
Q. It says every eight hours?
A. Yes, I think you may have misinterpreted that.
Q. Let me ask you this: What is lipoic acid?
A. It's a substance that is sometimes combined with the DMSA; it's a sulphur-containing compound.
Q. Why is it combined with DMSA?
A. There is a thought that it may help -- when this protocol was written, there was a thought that it may help to remove mercury from the brain.
Q. Did you agree with that thought in the consensus group paper?
Q. Do you see any evidence in the records that Dr. Edelson used lipoic acid with DMSA when he applied it to GM?
A. No, but the caveat is that you should even use DMSA first for a certain period of time before you use lipoic acids. You don't use lipoic right at the beginning.
Q. Along those lines, as I understand the DAN protocol on page sixteen, it's more appropriate to fix the child -- where a child is found to have intestinal problems, you fix that before you administer chelation?
A. Generally that's the case, yes.
Q. On DAN protocol page 16, item number one, you would agree with that statement? I keep calling it the DAN protocol, but it's actually the consensus group position paper.
A. I agree with that, yes.
Q. Did you see any evidence in the records that you have reviewed that Dr. Edelson attempted to cure the patient's underlying gastrointestinal and nutritional problems before beginning heavy metal detoxification?
A. I'm not certain of the timing of it, but in my reading of the chart, it looks like he may have began some of the gastrointestinal therapies fairly early on. It looks like it was seven months later that he underwent the detoxification, and it looks like he had him on certain things before that, so if I am reading the record correctly, it looks like certain things were started.
Q. I don't think he treated the child for over a seven-month period, so I'm not sure that I would agree with your interpretation of the chart. I am aware of two visits in December of 2000, and then basically he was an in patient beginning on March 7th of 2001 and the chelation detoxification was begun almost immediately.
A. If I may add, there is a note here on January 23rd, 2001 that says: "The patient has abnormalities of B6 deficiency, mild maldigestion, dysbasias and sarcosine elevation." Then he goes on to say that he will require B6, magnesium and taurine.
Q. Do you have some belief, Doctor, that those three things were begun prior to March 7th of 2001?
A. I just know what it says here, so I'm not certain about that.
Q. That's not something that you made clear in your mind before you came to your deposition today; the chronology of events?
A. I have the chronology here, but whether a doctor suggests something and the patient doesn't start it until they come back in a couple of months, I don't know.
Q. Isn't it a doctor's responsibility to go over and see which part of the treatment began when?
A. Yes. However, you can't always control what the patient does.
Q. Is there something in the record that suggests to you that the M’s were in any way noncompliant that anything that Dr. Edelson recommended?
Q. DAN does not recommend EDTA; do you agree with that statement?
Q. Do you recommend EDTA as a chelating agent for autistic children?
A. No, not generally.
Q. And I think, as I understand it, you only use DMSA as your chelating agent; is that right?
A. If I had a child that was really heavy, heavy, heavy lead toxic, there may be a time where I would consider EDTA. So again, I don't like to shut the door, because I treat children as individuals.
Q. Is there some evidence in the record that GM was heavy, heavy, heavy lead toxic?
Q. DAN and you seem to agree that EDTA is not recommended for detoxification of autistic children. Why not?
A. In these children we are more concerned -although we are concerned with multiple heavy metals, we are very much concerned with mercury, and EDTA is not as good a chelator of mercury.
Q. Did you see anything in GM's chart that suggested to you that EDTA was appropriate medicalIy?
A. Well, he had numerous heavy metals that were elevated on some of the heavy metal testing, and I believe if you want me to look, I can tell you exactly which ones they were.
Q. But wouldn't DMSA have been sufficient for those?
A. Well, in my practice that's the way I do it, but again, I don't want to fall into at all suggesting that "one size fits all." And even with the DAN protocol, this is suggested protocol come by a consensus of a number of physicians, but I don't think anybody would say that this is the only way to do it. I think it's unfair to say that a physician who has a certain experience with other ways is wrong.
Q. Let's be more specific about the other ways. We have been using the term cocktail of DMSA, DMPS and EDTA. Did your review of the record suggest that all three of those chelating agents were used on GM?
Q. Did it suggest that they were used in various combinations at various times, at least about twice a week?
A. I think it varied from one day per week to twice a week.
Q. And that went on for approximately six to eight weeks; is that correct?
A. Somewhere around that period of time.
Q. Are you aware of any scientific evidence that suggests that using a cocktail of chelating agents in that way can improve autism?
A. I have heard it spoken of, and I believe I may have seen it in writing from Dr. Edelson. Certainly I have heard him lecture about it.
Q. Other than what Dr. Edelson wrote, you said you have heard a lecture. Who gave that lecture?
A. Dr. Edelson.
Q. Is there anyone other than Dr. Edelson that in the scientific community has offered any support for using a cocktail of chelating agents to improve autism in the way seen here with GM?
A. I believe there are other DAN physicians who do use more than just DMSA. I don't; I don't know them all. I would say that I don't believe he is alone in using more than one chelator or using this cocktail of three.
Q. That wasn't my question. My question is: Is there any scientific support that it works?
A. I believe he has reported results with it.
Q. Other than from him?
A. I am not aware. I have not seen any other published data.
Q. Do you know if his study that he published had a control group?
A. I don't know.
Q. Have you read his book?
A. I have looked it over, yes.
Q. Have you read it cover to cover?
Q. How often should the CBC be rechecked when administering regular chelating agents such as the cocktail that you see in GM?
A. We do it a little bit different. If you would like, I can tell you the way that I do it. We check CBC every four treatments, which is every two weeks. So it would be every two months. We use a little bit of a different protocol than he uses.
Q. You're using the best treatment you know for your patients; aren't you, Doctor?
A. The ones that I have determined that I think are best are the ones that I want to use for my patients.
Q. But I take it that you wouldn't testify that it was inappropriate to check the CBC less frequently than Dr. Edelson?
A. It's a different protocol, so I would say that it's something that you want to monitor. You want to monitor the CBC, as I mentioned before, as well as lung function and kidney function. This was a shorter period of time; it wasn't two months, I guess.
Q. Is it important to check frequently the CBC in a patient that has shown some liver function problems while you're giving them chelating agents?
A. If they have liver function problems, you want to follow their liver function for sure.
Q. Let me talk about something you just referenced. You said something about a shorter period of time. How long do you tell the parents of your patients that it is going to take before they should expect improvement, or that the reasonable treatment will last, or are you even able to tell the parents of your patients that?
A. In terms of detoxification?
A. I tell them it's usually one to two years of treatment.
Q. When you're talking about detoxification, predominantly chelation is the method you use?
A. Chelation is a broad term, but it's not only pharmacological. Sometimes you use natural chelation with herbal or nutritional chelators.
Q. Sure. So, you wouldn't tell your patients that after six weeks of admittedly intense chelation and regular chelation in detox therapy that they were completed with their therapy; would you? It would be inappropriate to tell a parent of an autistic child that they had completed their therapy after about six weeks of intense detoxification such as was done by Dr. Edelson here; wouldn't it?
A. I don't do this, so I wouldn't do it because in six weeks of my treatment, it would be much less intense than this. So I would certainly not tell them that we were finished at that time.
Q. Okay. Have you seen the certificate of completion that was given to the M’s by Dr. Edelson and the Edelson Center?
A. I don't recall seeing that.
Q. Doctor, I'm going to show you what was identified in volume two of Dr. Edelson's deposition. You did review volume two of Dr. Edelson's deposition; didn't you?
Q. Let me show you what was identified and attached to that deposition as Exhibit 28 (indicating).
A. I don't recall seeing that.
Q. Is this the first time that you have seen that?
A. I believe so.
Q. SO that was not provided to you before today?
A. I f it's in the documentation, it may have been and I don't remember it.
Q. Did you look at the exhibits to the depositions?
A. Yes, I looked at all of them.
Q. So if it had been attached, you would have seen Exhibit 28?
A. By the way, this is where you probably would find the answer to the question about the minerals right in front of there (indicating). All I can say is I don't recall seeing that. I looked at this months ago and I may have seen it, but I don't recall.
Q. Do you give certificates of completion to your parents at any point?
Q. Do you think that it's possible that that sort of documents might be misleading to the parents of an autistic child?
MS. JAGOR: Objection to the form.
A. It may be an opportunity -- I don't want to use the word opportunity, I'm sorry about that word -- it may be a chance for misinterpretation. My sense of why this would be given would be to reinforce that the child just went through a detoxification program. It's somewhat intense, and this is to congratulate them and may be some reinforcement for the parents, but I don't know.
Q. Was there anything in your records, including the diary records written by the mother, that you reviewed that suggested that GM's autistic symptoms were improved with this treatment?
A. Were improved with this treatment, no.
Q. Having reviewed all of the records and the depositions and such, do you have any opinion as to why GM didn't improve, or do you know?
A. I don't know.
Q. What do you know about the placebo effect in alternative medicine in autistic children?
A. I'm not certain what you mean by that question. There is a placebo effect in all treatment; I wouldn't just put it as being only in alternative medicine.
Q. I can accept that. You agree then that there certainly can be a placebo effect with treatment such as that given by Dr. Edelson?
A. Any kind of treatment given by any kind of physician could have a placebo effect or a component of a placebo effect.
Q. On the DAN protocol, Exhibit 40, if you look at page fifteen, it talks about when treatment should be stopped.
Q. At the very bottom in the last paragraph at the bottom on page fifteen.
Q. I guess my question to you is: Do you agree with the statement: "Obviously, if the child shows no significant progress during therapy or experiences regression, this would be another indication to stop treatment". Do you agree with that statement?
A. Yes, I think you need to read the next sentence though to keep it in context.
Q. Do you believe that it's appropriate for a physician to sell marked-up tests, medicines and supplements out of his office?
A. Can you separate them, please?
Q. Do you believe that it's appropriate for a physician to markup the tests that he prescribes; to mark them up and increase the cost?
MS. JAGOR: Objection to markup.
Q. To markup by one hundred percent as Dr. Edelson has testified.
A. I don't have an opinion, but that's not something that is done in my state.
Q. SO you have no idea whether it's right or wrong?
A. It's not something that -- no, I just answered the question.
Q. Prescribed medicines that the doctor prescribes, do you have an opinion of whether or not it is appropriate for the doctor to mark those up as much as one hundred percent?
MS. JAGOR: Objection to "marked up."
A. I'm not going to say it's not appropriate.
Q. You are familiar with the American Medical Association; aren't you?
Q. Are you aware that they have issued a statement that that's inappropriate, because it may tempt some doctors to prescribe the medications that they are selling and reap greater profits?
A. I know there are several things that the AMA says, but that's not dictum for all physicians. It's a certain group of physicians that join that; it's my understanding now that it's probably less and less than it's ever been.
Q. You're not a member of AMA?
Q. Do you agree or disagree with them that it may present something of a conflict of interest for doctors to markup the same things that they are prescribing?
A. I think it does not necessarily present a conflict of interest.
Q. Do you do it in your office?
A. With medications?
Q. Your practice is -- I called it earlier alternative medicine and you understood what I meant, but you said you preferred the term integrative medicine, I think.
Q. Doctor, do you sell supplements from your office?
Q. I looked at some of the prices on your website and the ones I saw were $16 or $17 for certain supplements. How much profit do you make off of your supplements?
A. The markup varies on the supplement and there are different factors involved. There is a markup, but it varies.
Q. It varies from what to what? What is the highest markup and the lowest markup?
MS. JAGOR: Objection.
A. I'm not sure. I would have to look at it.
Q. Do you mark anything that you sell up by a hundred percent?
A. I would like to look at that actually before I answer it. I know the markup varies for various supplements.
Q. So your answer is you don't know how much you mark up your supplements?
A. I know that there is a certain suggested retail price for the supplements, and I know that some supplements are discounted, and I know they vary, so there is a range.
Q. I know there is a range and I was asking you if you can identify it for me in an approximate way?
A. A markup could go anywhere from ten or twenty percent to maybe, if the suggested retail was -- one hundred percent, meaning if it was $4, I would sell it for $8 or something like that.
Q. You're speculating?
A. I'm speculating, because I don't have all of the data in front of me. I just know that there is a markup.
Q. Going to the DAN protocol on page sixteen, in the middle of the page do you see where it says: "The theories and medical models on which these therapies are based are not universally accepted in the medical community and are being vigorously studied by a number of researchers." Did you agree with that?
A. I agreed with that certainly in 2001, yes.
MR. KERTSCHER: Let's take a short break.
(Break in the proceeding)
Q. Doctor, do you consider yourself an expert on autism?
Q. Are you an expert in the causes of autism?
A. As much as anyone, since there is no known one cause of autism. I consider myself an expert in the multi-factor etiology of multiple causes that may contribute to autism spectrum disorders. I would answer that question that way, because I think it has to be recognized in that light.
Q. Are you an expert in the treatment of autism?
Q. Your treatment and diagnosis methods, are they accredited by a body or any group?
A. It's my understanding that there is no accrediting body for the treatment of autism spectrum disorders.
Q. Is your method of diagnosis and treatment of autism accepted by mainstream medicine?
A. It's an integrative medicine approach and mainstream medicine is more and more opening up to integrative medicine approaches; that's the best I can answer that, because certainly there are numbers of mainstream physicians that accept this approach and there probably are numbers who don't.
Q. SO you're not able to answer whether or not it's accepted by mainstream medicine?
A. Tell me what you mean by mainstream medicine.
Q. I need a yes or no. Just how you describe mainstream medicine in your use of the English language; I need a yes or no or I don't know, and then you can explain.
A. I don't know, based upon the question.
Q. Is your type of diagnosis and treatment of autism subject to any peer-review or been subject to any peer-review?
A. Peer review meaning that if I treated a patient, is somebody peer-reviewing it?
Q. Yes, sir.
A. That's not done in medicine; people don't peer-review your treatment of patients.
Q. I'm asking about your method of diagnosis and treatment; have they been subject to peer review?
A. Certainly a number of them have been written by peer-review journals.
Q. Are you able to explain the mechanism by which your prescribed treatment can improve autism in a child?
A. I'm sorry, I didn't get that.
Q. Are you able to explain the mechanism by which your prescribed treatment can improve autism in a child?
Q. Are you able to set out any statistical correlations between your treatment and the improvement of autism?
A. I'm not clear on your question.
Q. What part of it aren't you clear on?
A. What do you mean by "statistical correlations"?
Q. However you interpret that in the English language, sir.
A. I'm not clear. I can't answer a question I'm not clear about.
Q. Do you think that your treatment of autism has reached a scientific stage of verifiable certainty?
Q. Are you able to say what is the standard -- of care for treatment of autism in an eight-year-old?
A. I can speak of the standard of care in terms of the integrative medicine approach for certain.
Q. But not the mainstream approach; is that right?
A. I can speak of what I assume you mean by the word mainstream approach and I can speak about -- in my field, I can certainly speak about the standard of care and what I think is.
Q. Doctor, let me try to make sure I understand the depth of your opinions in this case. You certainly have spent a lot of time reviewing a lot of documents. Are you going to testify at the trial of this case that the consent Dr. Edelson obtained from the M’s, the consents and the disclosures made by Dr. Edelson were adequate?
Q. What do you know about the disclosures made by Dr. Edelson?
A. I wasn't there for the conversations he had with the M’s; I believe that is obvious. However, I read the consents, and there are numerous consents, and they really explained things I feel quite well, and they were signed consents so that the parent seemed to understand what she was reading.
Q. So your opinion that Dr. Edelson's disclosures and consents were adequate is based solely on the signed consents that certainly are exhibits to the M’s depositions; is that right?
A. Mainly. Nothing else comes to my mind at the moment, but that is certainly the main place where that comes from.
Q. Are you going to testify that the tests used by Dr. Edelson were appropriately used and reported to the M’s?
A. Yes, with the caveat that apparently there was an error made in terms of Tubilin.
Q. But it's your belief that everything else about the tests were appropriate?
A. Yes, in the context of his workup of this child in the autism spectrum disorder, yes.
Q. Are you going to testify that the treatments employed by Dr. Edelson are proven in this case; the treatments that Dr. Edelson performed on GM?
A. Again, what do you mean by "proven"?
Q. However you define it in the English language, sir.
MS. JAGOR: Objection to form.
A. I would say certainly in terms of clinical experience and outcome studies, yes, I would say they are.
Q. Whose clinical experience?
A. The clinical experience of multiple DAN practitioners and Dr. Edelson's clinical expenence.
Q. Is it your belief that Dr. Edelson is a member of DAN?
A. I'm not aware of his membership status.
Q. Have you ever spoken to Dr. Rimland about Dr. Edelson?
A. No, not that I remember.
Q. Is there anything in the multiple records you have that suggests to you that Dr. Edelson is a DAN doctor?
Q. Let me say this: Is it your belief that the treatment regimen in the records you reviewed is appropriate under DAN protocol?
A. He has his own protocol. He is not following the DAN protocol.
Q. Let me ask you again then, are you going to testify that Dr. Edelson's treatment, exactly as he used them for GM, are proven and safe?
A. You're asking me that question with a broad blanket and I would say it again, it has been proven to a certain extent. You saw what the DAN documents said about the evolving state of knowledge; he has a lot of clinical experience, outcome studies, etc.
Q. What about Dr. Edelson's testing procedures in this case is proven?
A. They're proven by the results he's had, the publications he's made.
Q. Proven by anyone else but him?
A. Various aspects of his treatment are proven by numbers of other people who use it.
Q. Which aspects are those?
A. Food allergy diagnosis, autoimmunity -- there are many, many cases of autoimmunity in autism, all the different treatments. He has his own protocols, just as many other doctors have their own slant.
Q. So it would be because he has his own protocols and many doctors have their own slants; there is no other proof out there, other than his own studies that he has put out there, that his precise methods are safe and effective?
A. WelI, if he is the main one using his specific protocol as you're asking me the question, then I can only go by what he has and what has been reported by him.
Q. Are you going to testify that Dr. Edelson engaged in appropriate monitoring and documentation with regard to GM, or are you going to testify that you don't have any opinions towards that?
A. My testimony will be related to specific questions about that.
Q. Did Dr. Edelson engage in appropriate monitoring of GM?
A. The child was monitored.
Q. How so?
A. Every day the child got treatment there was a monitoring of his blood pressure, pulses and temperatures. There was little reports written and things like that.
Q. Do you know whether or not the child was left alone with a chelation IV in?
A. I don't know that.
Q. You didn't see that in the M’s deposition?
A. It might have been in there. There was a lot of papers I read and I would have to go back and look. You have to realize that there are stacks of papers here.
Q. Assuming that I'm not lying to you and they testified that way, is that appropriate monitoring? Could you testify that that was appropriate monitoring?
MS. JAGOR: Objection to the question. It assumes.
A. How long was the child left and what do you mean by "left alone"; was there somebody in the room or was there somebody in the next room?
Q. Left alone without any medical care; left alone by medical practitioners for a long period of time; the testimony has been and will be ten to twenty minutes.
MS. JAGOR: Objection to that question and the hypothetical that it poses.
A. I mean if it's somebody walking out of the room a second to talk to somebody -- I would like to know the specifics. I would be happy to answer these questions when I'm given the exact specifics and able to comment or give my opinion, or not have an opinion based on the specifics rather than a hypothetical.
Q. Doctor, you read that deposition?
A. I did, yes.
Q. So I'm going to ask you under the conditions described in the deposition for GM's treatment while he was being chelated, was that appropriate monitoring?
A. I would like to go back to the deposition, because I don't have the exact facts off the top of my head. As you recall, there is a lot of paperwork. I would be happy to look at it and get the specifics but I don't have it off the top of my head.
Q. Well, we are going to probably have to resume the deposition over the telephone. That will be something we will talk about when we go off the record.
Q. Are you going to testify, or are you going to not have an opinion, as to whether or not Dr. Edelson appropriately adhered to his fiduciary duty by marking up the sale of tests and prescribed medicines to the M’s?
A. I don't have an opinion.
Q. Are you going to testify that it was appropriate, or are you going to testify that you don't have any opinion, with regard to the letters and communication written by Dr. Edelson to the M’s?
A. Am I going to testify to what?
Q. The letters written to the M’s prior to their treatment -- you did read those; didn't you, Doctor?
A. Yes, what are you asking me?
Q. Is it going to be your testimony that those letters were perfectly appropriate in the context of the doctor/patient relationship; is that going to be your testimony, or are you going to testify that you don't have an opinion?
A. What I'm going to testify to is I would be happy to have them put in front of me what the specifics are and have me dissect them and give you opinions that are based upon exactly what was said.
Q. We are going have to resume this deposition. Do you have any other opinions, whether I have asked it or not today? I have tried to be comprehensive in everything. I think you would agree with that?
Q. But whether I have asked it or not today, . are there other opinions in your mind about this case? Maybe you have talked about them with Ms. Jagor or maybe you just have them in your mind that we have not talked about today?
MS. JAGOR: That's a broad question and I am going to object to that.
MR. KERTSCHER: It's an intentionally broad question and I am allowed to do it.
A. Just in the interest of being complete, I am not thinking of anything at this moment, but I don't want that to be looked at as there being nothing else. It's a very broad question.
Q. Let's enter into an agreement then. I'm sure you agree that an ambush is not a good thing; do you agree with that?
Q. So, let's have an agreement then that if there is something that comes to your mind, an opinion that you have not testified about here today, that you will let me know that through Ms. Jagor.
A. If something comes to my mind that I think would be appropriate, I would be happy to do that, but I just want it to be clear. Let's say when we are at trial or what have you, if somebody asks me a question and I answer it and somebody says you didn't say that before -- I can't think of everything; that's what I'm trying to say.
Q. That's why I'm saying if something occurs to you before trial or you discuss something with Ms. Jagor that is a new opinion; let's say you walk out of here today, it's perfectly human to walk out of here today and you might go to bed tonight and you might think of things from a whole different angle and you might think of something new. I would like your agreement, because we both agree that an ambush is a bad thing, that you will let Ms. Jagor know that so she can let me know, so we can follow up.
MS. JAGOR: Let me just say this for the record. He has opinions about Dr. Sandler that were not explained today.
THE WITNESS: Yes, that's something that I had opinions about that didn't come to my mind. That's what I'm trying to say when you give a broad question like that -- it's late in the day.
Q. I understand; that's why we just made our agreement. I respect that and I am sure that you will too.
Q. While we have a few more minutes. First of all, have you ever met Adrian Sandler?
Q. In the autistic community, have you ever heard of him?
A. Not before this case.
Q. Did you look at his curriculum vitae before or after you read his deposition?
A. I looked at it before. I looked at the report that he chaired.
Q. The question was if you looked at his CV.
A. I'm not sure if I did. I would have to look and see if I have his CV. I read his report. I'm not sure if it was in that report; I'm not certain that I have his CV.
Q. Is that an important factor to you in whether or not he is qualified to be talking about autism, what his resume looks like?
A. I would like to see it. However, I read the report that he did and I know that he chaired that committee.
Q. What in that report on the committee that he chaired is important to you in the context of this case?
A. Well, it's a different approach and I think it's important to recognize that. In this case we are talking about an integrative medicine approach, and in that report it's a conventional medicine approach, and so many of the things that I looked at in this case that were done in this case may be a different viewpoint.
Q. You have talked all day about how different doctors have different viewpoints and Dr. Edelson has a lot of different viewpoints than you have, and you said that you're not going to pass judgment on Dr. Edelson; right?
A. Well, in terms of some of the things you asked me about specifically, yes.
Q. Such as the cocktail chelation and all that. You just told me for the last four hours that different doctors have different viewpoints and you're going to be respectful of Dr. Edelson's viewpoint. Is there any reason why you shouldn't be respectful of Dr. Sandler's different viewpoint?
A. Well, I am certainly respectful. I certainly am respectful of his viewpoints. I may not agree with him wholeheartedly in certain ways, and I would be happy to explain that.
Q. In what ways do you agree with him?
A. Let me pull out his testimony.
Q. While you're looking through that, let me ask you a couple of quick questions.
Q. You mentioned the ACAM workshop for chelation that you attended and now oversee as president-elect of ACAM; are there materials that are given out to the attendants of that workshop?
A. Which one; heavy metal detox?
Q. With chelation.
A. With chelation therapy?
Q. Yes, sir.
Q. And you have those in your office?
A. We have them in ACAM.
Q. Where are the ACAM headquarters?
Q. Where in California?
A. Laguna Hills.
Q. Are there any other materials that you give the parents of autistic children? You said before something about a handbook; are there other materials that you give out?
A. I may refer them to various places.
Q. Such as?
A. I may recommend a gluten-free diet and I may refer them to certain places, to gluten-free places, books, the Internet. I am pretty broad-based.
Q. What is a typical place that you refer a parent of autistic children?
A. I may refer them to some mothers of autistic children that have got a lot of experience, that may do some counseling for the patients so they help them with the processes of diet and so on. I try to get them support.
Q. I understand that and that's a noble purpose. I was just trying to figure out where you were sending them.
A. I might actually, at a consultation with a person, give them the names of people that they may be able to talk to and give them a list of certain books that they can get.
Q. I'm sorry, I interrupted you earlier. You can continue looking at the places where you agree with Dr. Sandler.
A. I mean, there are statements that he makes such as there is no single pathognomonic developmental deficit or behavior that is characteristic of all children with autism; he references heterogeneous neurogenetic disorder, the boy-to-girl ratio 4 to 1.
Q. You're referring to the committee paper; right?
A. Yes. For his testimony, we would have to have a lot of time for me to go through everything, but I will just open to a page. In very general terms, I think that the standard of care includes a very careful history, a thorough examination, looking for possible etiology and other associated problems that may be present.
Q. I take from what Ms. Jagor has said that you and Ms. Jagor have had some discussions about things that you disagree with Dr. Sandler on; right?
Q. You're going to point them out today and you have talked about those with Ms. Jagor; haven't you?
Q. You haven't told me once today that you disagreed with Dr. Edelson.
A. I said he did things that I don't do.
Q. Right, that's a little bit different, but you said that everybody is entitled to their own opinion and their own approach. I guess what I want the jury to know is: Why are you eager to disagree with or criticize Dr. Sandler, but you absolutely refuse to criticize Dr. Edelson?
MS. JAGOR: Objection to form.
A. First of all, I'm not criticizing Dr. Sandler.
Q. You're not? You're saying you do some things different from him?
A. It's important to recognize the different approaches that we have.
Q. And he would concede that, I'm sure.
A. Yes, and so you may say that it's criticism, but I would like to make you aware that there are different approaches. Many of my colleagues use a different approach, it doesn't mean that he's wrong. I'm not saying he is wrong. I'm saying that there are many ways to do certain things, and I will be happy to expound on that. Just like the treatment of many different conditions, there are different ways to do it.
Q. And Dr. Sandler has one way, and Dr. Edelson has one way, and you have a third way?
Q. And so as I understand what you're saying right now, you're no more interested in criticizing Dr. Edelson's different approach from you, than you are of criticizing Dr. Sandler's different approach from you?
A. It's not criticism. To make it much clearer, I think in the interest of this case there is a difference in the integrative medicine approach versus the conservative approach that Dr. Sandler exposes in his deposition.
Q. We all agree on that.
A. I just want to be very clear. You asked me that and I am just making it clear.
Q. We all agree that the doctor has a different approach. Is there some criticism of Dr. Sandler that you're here to level though on his approach?
A. It's just certain comments and interpretations that he made of some of things that Dr. Edelson did that I would disagree with.
Q. What were some of those?
A. Speaking about mercury, I think he spoke mostly about high levels of mercury and really didn't address the problems that are being more and more exposed about low levels of mercury.
Q. Are you looking at notes that you have in front of you?
A. I have a couple of bullet notes that I took.
Q. Those are in your handwriting?
Q. So you don't like Dr. Sandler's comments or you disagree with Dr. Sandler's comments about mercury?
A. The word "disagree" I don't like; we have a different view of that. I felt like he didn't really -- he talked more about normal levels of mercury or high levels of mercury, but many of us believe that there are problems with low levels of mercury, chronic low level exposure. Some very recent research has come out or is about to come out.
Q. Is there something in the records in this case that suggested to you that GM was the victim of a chronic low level exposure of mercury?
Q. What was that?
A. He had elevated red blood cell mercury levels; it's in the blood. That's clearly an indication of that.
Q. What else is on your bullets? If could see it, it might just speed this up.
A. I will be happy to give it to you if you can read my writing. There are a couple of things.
Q. I can't read it. What are the other three items?
A. It talks about the kind of nutrient studies, and there is certainly a lot of information on the autism research institute site. There are many studies about B6 and magnesium in children in the autism spectrum. So there is information, and I think he pretty much downplayed it. I think he was talking about a lot of double-blind placebo control studies and the use of nutrients. We don't see a lot of that. The drug companies don't fund things like that, so one has to be aware of that when you evaluate some of the literature.
Q. You don't disagree with him that the double-blind control studies, that there are none, you just are sympathetic to the fact that there are none because there is not a lot of funding from drug companies?
A. There are some studies -- I can't quote them off the top of my head -- but Dr. Rimland is very aware of them and they're on the autism research website also. There are many; some of them are controlled. The same thing as diet; there are no controlled studies with diet. There was a study published in 2002 under nutritional and neuro science that talked about the diet and it was a single; it wasn't a double-blind placebo control, it was a peered study. There are a lot of different ways to do studies and you don't want to lose sight of the value of studies other than just the traditional drug company double-blind placebo control. That's one of the things I wanted to say. The other thing is --
Q. You're on the third item now?
A. I guess it's the third or fourth. He talked about the use of amphotericin and he talked about liver and kidney toxicity, and I believe he was thinking about what he learned in medical school that amphotericin can be nephrotoxic, kidney toxic when used IV, and in this case it was used P.O., orally. If it is given orally, it is quite safe:. I just wanted to clarify that, because it looks like he is using a very strong medicine and it wasn't IV, it was P.O. I think Dr. Sandler thought he was using it that way.
Q. Anything else?
A. I think the biggest thing would be the fact that when he diagnoses patients in the autism spectrum, he is more proposing the behavioral treatments and educational treatments like ADA, and I very much agree with him that they're important in terms that every one of the children that I treat go through those treatments. It's very, very important. But he does not believe in the integrative medicine approach. He talks about possible etiologies, but in much more limited way than we would. In integrative medicine, we do that on a much larger scale and we look for the contributing underlying etiologies, and I think that's not what he does.
Q. He described himself as an evidence-based doctor and that he looks for etiologies where there is evidence in the literature that they are autistic etiologies. Are you suggesting that some of this armament that you have described is supported in the literature?
A. Some of it is supported in the literature; some of it is supported clinically, some of it is being more supported as we go on; the information is evolving. The information from the DAN group from that consensus in 200 I to now is light years; the research in terms of the biochemistry, the metabolic imbalances, the heavy metal toxicity, so it's well-founded in science. We are very much interested in evidence based, but there are also clinical things that you can't ignore that are very important as well. I wanted to say that it's a different approach and I'm not criticizing him. I don't doubt that he is very good at what he does, but this approach is broader and more inclusive and so I would disagree with a number of things.
Q. When you say "this approach," you're specifically referring to your approach?
A. The integrative medicine approach. I think certainly my approach is not the same as Dr. Edelson's but there are certain similarities in terms of the treatment.
Q. Because I suspect that Dr. Sandler, were he to give your approach the same thorough analysis that he gave Dr. Edelson's, might find a lot more areas of agreement than he found with Dr. Edelson, but that's just my suspicion. Were there any other points of disagreement that you had with Dr. Sandler other than the ones you just made?
A. None that come off the top of my head. However, I would reserve the right if somebody asks me something about his testimony.
Q. I respect that and you will remember our agreement that if you think of something else, you will tell Jo?
MR. KERTSCHER: I have got to go.
MS. JAGOR: I have one question.
EXAMINATION BY MS. JAGOR:
Q. Dr. Bock, how long did you set aside to have this deposition today?
A. As long as we needed. I was told it was going to be four hours, but as long as you needed to get it done.
MS. JAGOR: Thank you. That's all.
This page was revised on July 21, 2004.