A Critical Absence of Data · Jul 25, 04:00 PM

The toxic metals urine tests marketed by mail-order laboratories such as Doctor’s Data, Inc. are commonly recommended by practitioners of the DAN! Protocol who premise their treatment of autistic children on the scientifically unproven hypothesis that autism is a consequence of chronic, vaccine-induced mercury toxicity. The test can be run as either an “unprovoked” or a “provoked” test; the “provoked” test is conducted after administration of a chelation drug such as DMSA, which draws minerals from the organs and bones and thereby creates artificially elevated levels of these substances in the urine. These artificially elevated levels then provide the rationale for various pharmaceutical and nutritional treatments, which are often costly to parents, stressful to children, and administered for an extended period of time.

During her cross-examination in the July 22, 2008 hearing for the Vaccine Injury Compensation Program claim, Dwyer v. HHS (Case 03-1202V), Dr. Elizabeth Mumper — a Virginia pediatrician and Medical Director of the Autism Research Institute, which developed and promotes the DAN! Protocol — confirmed the observations of many critics of pseudo-scientific autism treatments involving “mercury detoxification” — that is, that there are no reliable reference ranges against which provoked urine test results can be evaluated; that such tests cannot be used to diagnose exposure to mercury or identify its form or source; and that such tests provide no reliable foundation for either scientific conclusions or decisions about the medical care of autistic children.

At the end of her testimony, upon questioning by Special Master Denise Vowell, Dr. Mumper was forced to admit that her scientific opinions and judgments regarding what constitutes an “extraordinarily high body-burden of mercury” in an autistic child are not data-driven, but are based on undocumented “discussions” with unnamed “leaders in the toxicology field” and unspecified “extrapolations from experiences with older populations” — that is, on hearsay, anecdote and speculation.


No Reliable Reference

[Audio excerpt, 614K]

MR. VORIS JOHNSON, DOJ: So in the medical records, there’s only one test that showed mercury outside of the reference range. Is that correct?

DR. ELIZABETH MUMPER: That’s true.

MR. JOHNSON: And that was the provoked test from September 22, 2002, is that right?

DR. MUMPER: That’s correct.

MR. 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”?

DR. MUMPER: That’s true.

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

DR. MUMPER: It is difficult to know what that would be on a provoked test on either sick populations or healthy populations.


No Reliable Diagnosis

[Audio excerpt, 1226K]

MR. JOHNSON: Would you agree that the single post-provocation test from September 2002 is the only evidence on the record specific to mercury?

DR. MUMPER: That would be true.

MR. JOHNSON: If that test result were not reliable – take it away, you can’t rely on it – would you still be able to offer an opinion in this case that thimerosal-containing vaccines contributed to Colin’s autism?

DR. MUMPER: Without that piece of evidence, I would be left with a number of lab tests that would be consistent with but not specifically suggestive of that, so I guess that would be true.

MR. JOHNSON: And the post-provocation test from September 2002 is not specific to a particular species of mercury, is that right?

DR. MUMPER: That is true.

MR. JOHNSON: So it tells us nothing about Colin’s exposure to ethylmercury as opposed to methylmercury, is that right?

DR. MUMPER: That’s correct.

MR. JOHNSON: And none of the other tests that you’re relying are diagnostic of mercury toxicity, is that right?

DR. MUMPER: That’s correct.

MR. JOHNSON: In fact, none of the other tests that you’re relying are diagnostic of exposure to mercury in any amount, is that right?

DR. MUMPER: That would be true.


No Reliable Foundation

[Audio excerpt, 4200K]

MR. THOMAS POWERS: Whatever the reference is, would you describe Colin Dwyer’s post-provocation urine test where it was five times beyond the reference level – would you describe that as normal or abnormal?

DR. MUMPER: Abnormal.

[five minutes later]

MR. JOHNSON: Dr. Mumper, with respect to the September 22, 2002 post-provocation mercury test, you just testified that it is your belief that that result is abnormal.

DR. MUMPER: That’s correct.

MR. JOHNSON: There is no data that would support that statement, is that correct? There is no data to show what normal reference ranges would be for post-provocation testing, is that correct?

DR. MUMPER: Uhm, to my knowledge, that is true.

MR. JOHNSON: Thank you.

SPECIAL MASTER DENISE VOWELL: Let me get this straight, Dr. Mumper, I want to make sure I understand that. If I took a hundred three-year olds off the street out in front of the White House today and we chelated them, you’re telling me that there is no data that would give us a reference range for where they would fall on mercury post-chelation?

DR. MUMPER: I’m not aware that that has been done. It desperately needs to be done. It’s one of the things that we are doing at our research institute is to try to compare porphyrin testing in normal children versus controls. Because that data has not been established. It’s classically hard to get people to volunteer their children at very young ages for research experiments in which they’re being used just to set a control. I’ve tried to do it in my practice, especially if it involves anything either invasive or troublesome like taking home a kit and collecting a first morning urine and bringing it back. It’s difficult to get people to participate in that. But I agree that it definitely needs to be done.

SPECIAL MASTER VOWELL: Okay. And there is no data, then, that would show in anyone the increase between pre-chelation and post-chelation levels of lead or mercury?

DR. MUMPER: There is data that shows that it increases, but the quantification of the amounts that correlate with a specific body-burden have not been determined to my knowledge.

SPECIAL MASTER VOWELL: When we chelate and we measure the amount of mercury excreted afterwards – mercury, lead, whatever heavy metal – you’re saying – I understood that to be a measurement of body-burden.

DR. MUMPER: Right. It is reflective of an increased body-burden. I’m saying that what I don’t have the data to tell you that a four-year old child would go from .01 mcg/g creatinine to 17 mcg/g creatinine if he had a total body-burden of X grams of mercury. I don’t know how to get that information.

SPECIAL MASTER VOWELL: What I’m having trouble understanding is why you can say that 17 is extraordinarily high. What do you base that on? I’m not arguing with you, Doctor, I just want to understand what the basis for your opinion is if you have no reference.

DR. MUMPER: The basis for my opinion is, I would have to say, is looking, is discussions with leaders in the toxicology field and extrapolations from experiences in older populations, but there is a dearth of that information in the pediatric population.

SPECIAL MASTER VOWELL: Okay. Questions from either side based on mine? …All right. Dr. Mumper, you may step down.

Comments


  1. This comment from Mumper makes no sense to me (not surprisingly): “The basis for my opinion is, I would have to say, is looking, is discussions with leaders in the toxicology field and extrapolations from experiences in older populations, but there is a dearth of that information in the pediatric population.”

    There are no data, no reference ranges for urine heavy metals under provoked conditions for humans of any age. And as long as Doctor’s Data is raking in the dough off of provoked tests and offering the results as compared to non-provoked references… why don’t they create a database for “normal” provoked urine levels.

    This is just so pathetic, to me. I hope enough people are appropriately horrified and angry.

    — Ms. Clark    Jul 25, 07:26 PM    #

  2. Think of how many families have paid out how much money for how many years because someone told them their lab tests indicated their kids needed chelation, and of course this and that nutritional supplement and why not throw in some homeopathic tinctures while you’re down the rabbit hole anyway.

    Think of how many years parents have spent thinking “our family’s going to be fine as soon as the chelator does its work and we have our kid back.” Waiting for a perfectly new-and-improved kid who is never going to arrive.

    — isles    Jul 25, 11:06 PM    #

  3. I don’t understand how she can “extrapolate from older populations”? Older populations of autistic children? Or has she done provoked tests on non-autistic children? Or is she referring to DMSA trials of adults?

    I’m curious as to the “extrapolation” methodology. Of course, I pretty much expect there is none.

    — Joseph    Jul 26, 07:19 PM    #

  4. Oh my, shot down by that rascally scoundrel the juvenile Dearth Vader.

    Well, there might not be such a dearth of data if the Autism Research Institute had gotten it’s work in order and had been publishing studies the mainstream peer reviewers could accept, now would there be?

    — Patrick    Jul 28, 12:58 PM    #

  5. There WAS one study that looked at “provoked” heavy metal excretion in autistic children compared to non-autistic controls.

    Soden et al.,24-hour provoked urine excretion test for heavy metals in children with autism and typically developing controls, a pilot study. Clinical Toxicology, June 2007, 45(5):476-481

    In this study, the authors found no statistically significant difference in the provoked urinary excretion of arsenic, cadmium, lead or mercury between the two groups. Granted, it was a very small study, with only 15 autistic and 4 control subjects, but it doesn’t bode well for the association between “provoked” urine mercury and autism.

    So, even if Dr. Mumper could come up with a “normal range” for provoked urine mercury, it wouldn’t mean anything, since there isn’t even a correlation between autism and provoked urine mercury levels.

    Prometheus

    — Prometheus    Jul 30, 11:27 AM    #

  6. Absence of Data PLUS
    Absence of Science PLUS
    Absence of Ethics

    equals

    Absence of Proof

    — TheProbe    Aug 1, 09:04 AM    #