Elizabeth Mumper – Autism Omnibus, Dwyer vs HHS

25 Jul

Some highlights, courtesy of a Guest Blogger, er Transcriber :)

Beau Johnson DoJ lawyer: Neither the myelin basic protein nor the IGM neuro filament antibody test is diagnostic of any disease is that right?

Mumper: That’s correct.

Johnson: They are very nonspecific findings.

Mumper: That’s correct.

Johnson: And isn’t it true that these antibodies have been reported as elevated in normal individuals with no disease?

Mumper: That is true in some cases. Exactly.

Johnson: And because these markers were measured in the serum rather than the CSF they provide no direct evidence of what is going on in Colin’s central nervous system is that right?

Mumper: I guess I would quibble with how you get direct evidence, in this case in order to get direct evidence of neuroinflammation I guess we’d would really needed to have done a brain biopsy on him in 2002. I can tell you from personal experience that even wanting to look at CSF in children with autism for the presence of inflammatory markers is widely perceived as an invasive procedure. So those of us who might want to be able to document it more directly are constrained from doing so by standards of care criticisms. So we have to rely on other markers, and it’s not a direct marker but I would argue that a clinician would not have the ability to do a direct assessment in a living child.

Johnson: For whatever reason that evidence is just not present in this case, is that correct?

Mumper: That’s true

Johnson: Do you know what protocol Immunosciences used to perform these two lab tests?

Mumper: You know I don’t. I have visited the immunosciences labs on two occasions and talked to the director and viewed their facilities. But I am not a lab scientist. I can tell you that when I visited and had it explained to me it made sense at the time, but I could not reproduce the protocol.

Johnson: Do you know how Immunosciences established it’s references ranges?

Mumper: I do not know the details of that, no.

Johnson: Do you know whether these reference ranges take the age factor into account?…

Mumper: I do not think they are normed for children, but for things like neurofiliment antibodies and myelin basic protein antibodies the values for children would be expected to be less than people as they aged…

Johnson: But you don’t believe that these reference ranges are normed for children?

Mumper: I do not think that they are. That’s correct.

Johnson: Do you know if immunosciences lab ever been accredited by the College of American Pathologists?

Mumper: I do not know if they have. I do know that their work, their lab reports come disclaimers about use for research and careful clinical applicability and those types of things.

Johnson: Do you know if immunosciences is currently performing any clinical testing?

Mumper: I believe they are not.

Johnson: I’m going to show you what we’ve marked as respondent’s trial exhibit 14 and it is a letter that I found on the Immunosciences website.

Mumper: OK.

Johson: Doctor have you seen this letter before?

Mumper: Yes I have.

Johnson: And does this letter reflect that Immunosciences has in fact stopped performing clinical testing as of July 21, 2007?

Mumper: Yes, as i just testified to.

Johson: Do you know why it stopped performing clinical testing?

My understanding from talking to Dr. Vodjani and some health department officials, is that his lab was investigated for their testing as related to mold. Looking for mold evidence of chronic mold exposure as a potential cause of chronic illness. My understanding from Dr. Vodjani that the investigation was perhaps precipitated by a court case in which mold testing had been used and the plaintiff who had claimed damage from mold had won a huge settlement and the health department was concerned about the possibility of on the basis of that mold test and wanted to investigate the lab with regard to that.

Johnson: So its your understanding that the problems with Immunosciences lab were limited to its mold testing?

Mumper: That is my understanding, but I have not investigated all the depth of the investigation, nor read any of the official documents, so I really do not have full knowledge of that.

Johnson: I’m now going to show you respondents trial exhibit 15 which is another letter that I found on Immunosciences website.

Mumper: OK. Thank you.

Johnson: Doctor have you seen this letter before?

Mumper: I believe I have. Yes.

Johnson: Did you receive this letter since it is addressed to “Our valued clients and associates”? Was this sent to you?

Mumper: Yes.

Johnson: This letter is signed by doctor Vodjani?

Mumper: That’s correct.

Johnson: I believe you testified in May that you have an article in press (which has) Dr. Vodjani as the lead author?

Mumper: That is correct.

Johnson: Do you know what CLIA stands for?

Mumper: … I can’t remember…

Johnson: OK and just for the record it’s Clinical Laboratory Improvements Amendments of 1988 and we’ll just refer to it as CLIA for ease of reference.

Mumper: OK

Johnson: Do you know what CMS is?

Mumper: According to the letter it might be Centers for Medicaid and Medicaid Services?

Johnson: That’s correct. CMS regulates all laboratory testing on humans in the United States through CLIA in order to insure quality laboratory testing, is that right?

Mumper: Uhuh.

Johnson: Dr. Vodjani’s letter states in the third paragraph that “CMS had found deficiencies during a 2004 CLIA survey of Immunosciences that led it to conclude that the lab’s test results since 2002 may not be accurate and reliable.” Were you aware of those findings by CMS?

Mumper: Uhm, yes, since I got this letter.

Johnson: I’m not going to show you respondents trial exhibit 16. This is a letter from CMS. Doctor have you seen this letter before?

Mumper: Yes I have.

Johnson: Did you receive this letter?

Mumper: Yes I did.

Johnson: And this letter does in fact say at the beginning of the second paragraph on the first page that: We are writing both to inform you of the current sanction action and to alert you that test results that you received since June 2002 from Immunosciences lab might not be accurate or reliable. Is that what that says?

Mumper: I would like to add that… I did call Mary Jew as suggested in this last line. I can’t remember the details now, but I talked to three different people on the staff. I tried to get information about what particular concerns they had because I was trying to figure out for the labs that I had done on my patients if this were a global concern or if it was related to the mold or if there were tests that I was using that I may still be able to rely upon, and I was very frustrated in not being able to find out from those people who I think their hands were tied as far as talking about an ongoing investigation, what the problems were.

Johnson: We may be able to provide some of that information now. I’m going to show you now what is marked as respondents trial exhibit 17. And this is the CLIA annual laboratory registry from 2005. Have you seen this document before?

Mumper: No I have not.

Johnson: Look on page 5 of this document. Does this indicate that Immunosciences’ CLIA certification was being revoked due to condition level noncompliance?

Mumper: Uhm, cancellation of a approval to receive medicare payment due to noncompliance. Yes.

Johnson: Now I’m going to show you respondents trial exhibit 18. And these are actually excerpts from a much larger report. And this is the, a report from the survey that CMS did of this lab. … does that appear to be correct to you?

Mumper: Based on my thirty second review that does appear to be correct.

Johnson: If you’ll turn to the fifth page of the trial exhibit. This document lists a number of findings in connection with Immunosciences general immunology testing. Is that correct?

Mumper: It appears that that is correct.

Johnson: Were you aware that CMS noted problems at Immunosciences lab in connection with its failure to follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems in the pre-analytic systems?

Mumper: No I did not have access to that information.

Johnson: And were you aware that the CMS found that the laboratory
failed to determine calibration procedures and control procedures based upon established performance applications?

Mumper: No I was not aware of the specifics.

Johnson: And were you aware that the CMS found that Immunosciences laboratory failed to verify the continued accuracy of the test systems throughout the laboratory’s reportable range of test results? …

Mumper: … I was not aware of the specifics.

Johnson: And under sub paragraph I, the CMS found that the Immunosciences laboratory failed to establish the statistical parameters of the unassayed control materials used for it’s various in-house ELISA test systems?

Mumper: I was not aware of that.

Johnson: Ok and these findings all relate to Immunosciences general immune testing is that correct?

Mumper: It would appear that that is the case.

Johnson: And if you will look at the next to the last page of the trial exhibit. Were you aware that CMS found with respect to the anti MPB and neurofilament test in particular that Immunosciences failed to have written policies and procedures, for patient preparation, specimen collection, specimen storage and preservation, conditions for specimen transportation and specimen acceptability and rejection?

Mumper: And what was the date of that that it was not in place? Because it seemed to be on the website when you cited it earlier. And when we sent specimens in 2003 we were able to obtain written instructions about the specimens submitted, they came actually in the test kit.

Johnson: I believe this was from a survey from 2004 …

Mumper: What I was trying to explain to you that as a clinician the test kits came in a box, and there’re the tubes and a series of explanations about how the specimens need to be prepared. … So I can only testify as to what I know… we had procedures to follow when we submitted our blood samples in 2003.

Johnson: And all I’m asking you is that at the time that CMS performed this survey it found that those aspects of Immunosciences laboratory practice to be inadequate. Is that correct?

Johnson: Look at the last page of the trial exhibit…at the time it performed this survey with respect to the anti MPB and neurofilament test that Immunosciences failed to provide documentation the laboratory director’s review and approval for those procedures?

Mumper: It does suggest that there was no documentation to show his review and approval… so how much this was a matter of paperwork versus actual analysis, I can’t say.

Johnson: And Dr. Vodjani’s letter of January 16th, 2006 ,he indicates that Immunosciences had planned sue over the survey results.

Mumper: I believe he said he planned to vigorously fight or something to that effect …

(Special Master: And that was trial exhibit 15? …)

Johnson: We have a copy of the settlement agreement from that lawsuit it’s been marked as respondents trial exhibit… Focusing on paragraphs 1, 2 and 3. …

Mumper: OK

Johnson: It appears that one of the conditions of the settlement that Immunosciences would obtain accreditation through the College of American Pathologists or else it would voluntarily withdraw from the CLIA program and cease testing on human specimens, is that correct?

Mumper: That does seem to be the case.

Johnson: Based on the fact that Immunosciences is no longer performing clinical testing, isn’t it reasonable to assume that they did not receive accreditation through the College of American Pathologists…

Mumper: (interrupting) or that they chose not to pursue it I would think would be the two possibilities.

Johnson: Doctor based on this information do you have any concerns about the reliability of the Immunosciences test results?

Mumper: I was not aware that the MBP or neurofilament testing was under contention, and if that were the only thing that I was relying upon to make my judgement I would be concerned that I had over-read the labs. I would give relatively less credence or perhaps even be forced to discount those particular lab tests given  the information in the settlement agreement that I wasn’t privy to knowing the details of.

Johnson: The next test results that you discuss in your report are results from Great Smokies lab that purport to show abnormal glutathione, lipid peroxide and cysteine levels.  Is that correct?

Johnson: … That would have been when Colin was about 3 1/2 years old… So to the extent that these results indicate anything about whether Colin was under oxidative stress at the time … they don’t tell us if he was in oxidative stress at the time of his immunizations. Is that correct?

Mumper: That’s correct.

Johnson: These tests were blood tests is that correct?

Mumper: That’s correct.

Johnson: Do you know if these tests were normed for children?

Mumper: I do not know the answer to that question.

Johnson: And as you note in your report a number of other factors can explain oxidative stress such as poor nutrition. Is that right?

Johnson: Would you agree that a mercury efflux disorder is still a hypothesis at this point

Mumper: Yes.

Johnson: So low cysteine and plasma sulfate levels can’t be diagnostic of that disorder..

and those levels can be explained by a number of other factors is that right?

Mumper: That’s correct.

Johnson:… I’d like to go through all the mercury testing if you don’t mind.

Mumper: It would appear that 4-19-02 was the time of the very first visit to Dr. Bock. So there is not evidence that he would have been on a chelating agent at that time.

Johnson: And the result for this test of mercury was that it came back the non-detectable limit … Is that correct?

Mumper: Right.

Johnson: The next test that we found was the December 2002 test and that was a urine toxic metals test… although the report says that there was a chelating agent administered, you don’t believe there was, is that correct?

Mumper: Yes that’s correct.

Johnson: and the result shows no detectable mercury.

Mumper: Yes that’s correct.

Johnson: and the result shows no detectable mercury.

The next test was the December 22, 2002 …The next test was the December 22, 2002 test which is at petitioner’s exhibit page 90 and … this was post provocative test … and this test result showed that mercury was at 17 mcg per gram of creatinine. Is that correct?

Mumper: That’s correct.

Johnson: And the report indicates that DMSA was administered in connection with this test … and again the result from this test for mercury was nondetectable. Is that correct?

Mumper: That’s correct.

Johnson: There’s only test that showed mercury outside the reference range is that correct?

Mumper: That’s true.

The next test was the December 22, 2002 test which is at petitioner’s exhibit page 90 and … this was post provocative test … and this test result showed that mercury was at 17 mcg per gram of creatinine. Is that correct?

Mumper: That’s correct.

Johnson: And the report indicates that DMSA was administered in connection with this test … and again the result from this test for mercury was nondetectable. Is that correct?

Mumper: That’s correct.

Johnson: There’s only test that showed mercury outside the reference range is that correct?

Mumper: That’s true.

Johnson: And that was the provoked test from December 22, 2002. … Doesn’t Doctor’s Data say in bold right on the test report that reference ranges are representative of a healthy population under non-challenged or non-provoked conditions?

Mumper: That’s true.

Johnson: So we just don’t know what the normal range would be for a provoked test. Is that right?

Mumper: It is difficult to know…

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12 Responses to “Elizabeth Mumper – Autism Omnibus, Dwyer vs HHS”

  1. isles July 25, 2008 at 12:04 #

    I am actually starting to feel bad for Mumper. It may be that she actually didn’t realize how much she was trusting the wrong people. (Not that a good scientist should base a lot on trust anyway…)

    It must be horrible to have the slow, sinking realization that you’ve staked your career on a mirage.

  2. DT July 25, 2008 at 13:16 #

    At least Mumper confirms that doing lumbar punctures in kids with autism is udesireable and is “widely perceived as an invasive procedure”.

    Remind me again – didn’t Andrew Wakefield subject his group of autistic children to this unnecessary procedure?

    (PS The question is rhetorical – we all know the answer is yes)

  3. Albert July 25, 2008 at 14:01 #

    Pretty devastating. They clearly have no case. Later in the testimony, the special master says something like “so if there are no reference ranges, no values for what a normal post-provocation value should be, then how can you say that Colin Dwyer’s post-provocation value of 17 is extremely high?” The special master clearly “gets it.”

  4. Evonne July 25, 2008 at 17:04 #

    DT — yes, exactly.

  5. Prometheus July 25, 2008 at 20:53 #

    Poor Dr. Mumper. That terrible sinking feeling as you begin to realize that your belief system is coming around to bite you in the rhetorical behind. The slow realization that you’ve made a fool of yourself – in public.

    Right now, I’ll bet she’s feeling just like a Christian Scientist with appendicitis – she has to either renounce her “faith” or pay the consequences.

    Sadly, I can’t find it in my heart (or brain) to feel too sorry for her. She has the education and training to tell real science from pseudoscience – which is more than can be said for the parents she led down the primrose path.

    I guess I just keep thinking of those poor children getting stuck with needles for pointless tests.

    No, I don’t feel to sorry for Dr. Mumper at all.

    Prometheus

  6. The transcriber July 26, 2008 at 00:27 #

    My transcript has some glaring errors at the end, here is a slightly cleaner version of that part at here starting 30:37 of Day02-AM2 audio file.

    “Mumper: It would appear that 4-19-02 was the time of the very first visit to Dr. Bock. So there is not evidence that he would have been on a chelating agent at that time.

    Johnson: And the result for this test for mercury was that it came back in the non-detectable limit … Is that correct?

    Mumper: Right.

    Johnson: The next test that we found was the September 20th, 2002 test and this was a urine toxic metals test. Is that correct?

    Mumper: That’s correct.

    Johnson: And I believe you testified that although the report indicates that there was a chelating agent administered, you don’t believe there was, is that correct?

    Mumper: Yes that’s correct.

    Johnson: And the result shows that the mercury was in the non detectable limit.

    Mumper: Yes that’s correct.

    Johnson: The next test was the September 22, 2002 which is at petitioner’s exhibit 4 page 90 and … this was post provocative test … and this test result showed that mercury was at 17 mcg per gram of creatinine. Is that correct?

    Mumper: That’s correct.

    Johnson: And the report indicates that DMSA was administered in connection with this test … and again the result from this test for mercury was nondetectable. Is that correct?

    Mumper: That’s correct.


    (37:04)
    Johnson: So in the medical record there’s only one test that showed mercury outside the reference range is that correct?

    Mumper: That’s true.

    Johnson: And that was the provoked test from September 22, 2002. Is that correct?

    Mumper: That’s correct.

    Johnson: Doesn’t Doctor’s Data say in bold right on the test report that reference ranges are representative of a healthy population under non-challenged or non-provoked conditions?

    Mumper: That’s true.

    Johnson: So we just don’t know what the normal range would be for a provoked test. Is that right?

    Mumper: It is difficult to know…”

  7. The transcriber July 26, 2008 at 04:08 #

    Posted it to the wrong blog entry. Here it is again.

    From Day02-PM2 audio file Tom Powers, PSC lawyer and Bennett Leventhal, autism expert

    http://www.psych.uic.edu/faculty/leventhal.htm

    Powers: Now as a psychiatrist is it, and you, how long have you been practicing as a psychiatrist?

    Leventhal: finished my residency and fellowship in 1978, so thirty years…

    Powers: In the years preceding 1978, isn’t it true that psychiatrists attributed autism in large part to what is called the refrigerator mother, or the lack of affection a lack of bonding. Was that the general cause of autism that was attributed in describing the etiology.

    Leventhal: No that’s not actually accurate.

    Powers: Refrigerator mom was a descriptive term generated by Dr. Bettleheim, post Vienna, post World War II, to describe what he believed was the cause of autistic spectrum disorders. Isn’t that correct?

    Leventhal: It was one of his concepts, but Dr. Bettleheim wasn’t a psychiatrist, he was actually not even a psychologist, he was an educator.

    Powers: And in the years since then that theory of causation has been disproven. Correct?

    Leventhal: It was never proven, so other theories have taken form it was never a proved theory.

    Powers: The theory you believe that autism is entirely genetic. Do you believe that autism is entirely genetic?

    Leventhal: No sir.

    Powers: Do you see room for environmental contributions to the appearance of autistic symptoms in some children.

    Leventhal: Yes

    Powers: Can you identify what you believe to be known environmental contributors to the appearance of autistic symptoms in children?

    Leventhal: Well we know very well that the environmental interventions make a difference, and the modification of the environment, so things like ABA affect the clinical presentation of the disorder, education, speech and language, change the clinical presentation of the disorder. Those are all environmental interventions.

    Powers: And I’m not speaking of environmental interventions you would agree with me that be that environmental exposures can actually be the biological cause of autism. So for example prenatal exposure to thalidomide, do you believe that prenatal exposure to thalidomide can cause autism?

    Leventhal: I think what you are trying to do is make a sweeping generalization and as I think Mark Twain once said no generalization is worth a damn including this one. And I think generalizations just aren’t terribly useful here. you have to talk about specifics.

    Powers: And that’s why I asked you …

    Leventhal: (interrupting) So if there’s,

    Powers: (simultaneously with Leventhal) Let, let

    Leventhal: if I

    Powers: (over the top of Leventhal) I asked you

    Leventhal: ..if I can finish my question, uh answer I’d be happy to

    Powers: Well, I asked you a specific question

    Leventhal: I’d be happy to…

    Powers: (cutting Leventhal off) Do you believe that prenatal thalidomide exposure can contribute to the appearance of autism in some children.

    Leventhal: This is not a matter of belief.

    Powers: Do you believe that there is, or let me put it this way, as a scientist do you recognize that there is an association between prenatal thalidomide exposure and the appearance of autism?

    Leventhal: What do you mean by association?

    Powers: A causal relationship.

    Leventhal: That has not been demonstrated, so the answer to that is, until it’s been demonstrated I can’t really tell you.

    Powers: Do you believe that, or do you think that evidence shows an association between terbutaline exposure prenatally and the appearance of autistic symptoms?

    Leventhal: I am not aware of any causal mechanism that would support that.

    Powers: Are you aware of any scientific data or scientific literature that would support an association between maternal rubella and the appearance of autistic symptoms in the child?

    Leventhal: You just used the word association, so there are data on an association between maternal rubella and autism.

    Powers: Would it be your scientific opinion that those associations are suggested of a causal link between maternal rubella and the appearance of autistic features in some children.

    Leventhal: It’s not been demonstrated. Until it’s been demonstrated, I don’t know if there is a causal link. There’s a big difference between association, correlation and causality.

    Powers: And that’s why I am asking you specifically if you believe that there’s a causal association between these various prenatal exposures and the appearance of autistic symptoms in the children who were the product of those exposed pregnancies. Do you believe that there is scientific evidence supporting that there is a causal relationship?

    Leventhal: As I said to you, I don’t believe. There’s what I know and what I don’t know. I am not aware of, I have no knowledge of, a casual link between rubella and autism. There’s an association but there’s not a causal link to my awareness.

  8. isles July 26, 2008 at 04:29 #

    I think Leventhal is a little too hesitant to draw connections between thalidomide and maternal rubella (each) and autism, but dang, he’s got great witness skills! Not letting Powers push him around one bit.

  9. Tsu Dho Nimh July 29, 2008 at 17:39 #

    Holy Erlenmeyer flasks! Risking a child’s well-being on testing done in a non-accredited lab?

    My med-tech senses are tingling!

    Aristo Vojdani, Ph.D., M.T.
    Aristo Vojdani received his PhD in Immunology and Microbiology from Bar Ilan University, Israel, and completed his post-graduate work at Tel Aviv University Medical Center and the University of California Hospital

    http://www.yourmedicaldetective.com/public/148.cfm

    He has some “patents” on treating autistic children, and diagnosing things by slapping patents in immuno assay (apparently not thre reagents, the process.)

Trackbacks/Pingbacks

  1. False Controversy: Autism and Vaccines - July 25, 2008

    [...] Left Brain/Right Brain offers a transcript of Autism Omnibus testimony of Dr. Elizabeth Mumper, the President and CEO of the Rimland Center for Integrative Medicine, which clearly states its use of the Defeat Autism Now! protocol. In responding to questioning about lab test results for “neurofiliment antibodies and myelin basic protein antibodies,” Dr. Mumper did not seem completely aware that results from the lab that did the tests, Immunisciences, might not have been “accurate and reliable,” and that the lab did not (it seems) receive accreditation through the College of American Pathologists. — In other words, there is more than a little reason to question the reliability, and the accuracy, of the test results that supposedly make a case for vaccine-induced neurological damage in the children whose cases are being presented before the Autism Omnibus. [...]

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    [...] can her science be? How about the ARI/DAN group who are led by people who clearly have no clue at all as to the medical science they are making a large profit on. How much do each of these people make? [...]

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