Autism Street

Summary Conclusions

My previous post details an extensive e-mail
conversation with a researcher on this study

-one of the lead researchers conducting a study chelating autistic children with DMSA at the Southwest College of Naturopathic Medicine in Arizona.

“DMSA Treatment of Children with Autism and Heavy Metal Toxicity”

It quickly became fairly clear that unless a parent did the amount of reading that I did, or had the conversations with peers and physicians that I did, or had the e-mail conversation with Jim that I did, there would be no way that a parent could make an “informed” decision about their child’s participation in this research.

If you have the time, and want to understand the reasons for my conclusions, and the ’scientific’ answers provided by Jim in his e-mails, you should really read through the e-mails in the previous post. Do the research, follow the links, and keep asking questions. Don’t take my conclusions as applicable for all, understand for yourself, and draw your own conclusions.

Here, the essence of the nine developed questions about this ‘research’ is presented along with associated conclusions.

1. Assuming it is possible that mercury toxicity causes or contributes to autism, is it ethical to administer chelation as part of the process to determine whether or not a child has toxic levels of mercury that require additional chelation (or qualify them for phase two)?

Current conclusion: To be ethical in terms of scientific merit prior to human experimentation this would require scientific proof that a) mercury causes or contributes to autism, and b) autistics have higher levels of mercury. That scientific proof is just not out there, nor was it provided by Jim in our e-mail discussion. This research appears unethical due to lack of scientific merit.

As part of FDA guidelines for clinical trials involving the “off-label” use of FDA-controlled medications, was this study reviewed by an IRB?

Addendum: This Study Was Rejected By ASU’s IRB

Current conclusion: Review by an IRB apparently took place making this research legal. Was the IRB shopped? Was the IRB Misled? Did the IRB act responsibly? Was this research previously rejected by other IRB’s? Further investigation into the IRB used and their subsequent approval, is probably warranted.

2. Is there a recognized, and accepted standard for measuring/determining actual mercury toxicity by the process of chelation being employed in phase one?

Current Conclusion: To be recognized this would require standard assays, published norms, and correlative studies that support those norms. The correlative research would need to be published in peer-reviewed medical journals and available to an IRB on PubMed. The methodology being employed (and claimed as supported by the ‘research’ provided by Jim) does not appear to meet this criteria, and in the eyes of the ‘real’ peer-reviewed scientific community it would probably not prove anything.

Addendum: Follow-up On Laboratory/Methodology and Additional Follow-up

3. What are the mercury excretion levels required (and associated standard) for qualification for phase two?

Current Conclusion: To answer this appropriately and scientifically would require standard assays, published norms, and correlative studies that support those norms. The correlative research would need to be published in peer-reviewed medical journals and available to an IRB on PubMed. The methodology (including norms) being employed (and claimed as supported by the ‘research’ provided by Jim) does not appear to meet this criteria. In the eyes of the ‘real’ peer-reviewed scientific community it would probably not prove anything.

4. Why isn’t the Glutathione controlled or double-blinded in phase two?

Current conclusion: The glutathione is always given with DMSA in phase two as part of the experimental design. It is not controlled so as to understand the effects of DMSA chelation or glutathione cream alone. The design of this experiment is not necessarily scientifically rigorous as possible.

5. Is the application of cream containing Glutathione being controlled? Are the parents applying it? If the quantities of cream are controlled, is the length of time it remains on the skin being controlled? If parents are to ensure that the cream is applied and remains for specific length of time on a specific area, are they all following an identical procedure?

Current conclusion: Parents are supposed to be following identical procedures as defined by the instructions given by the researchers. Parental consistency will be an arguable source of error.

6. Are the urine samples being collected throughout the study being collected by an independent third-party, or by the parents?

Current conclusion: Urine samples are being collected by the parents for respect of family privacy and convenience. Although respect for privacy and convenience is desirable, the possibility for contamination exists, especially since testing for trace metals at only one lab (a ‘questionable’ lab in the eyes of the scientific community - source Quackwatch).

7. Are all samples (blood and urine) being sent to at least two independent laboratories for validation of lab results? Are the labs industry-standard as used by other major medical providers in the Phoenix and Tucson areas?

Current conlclusion: They are only going to Doctor’s Data. There is way too much funny business going on with respect to Doctor’s Data labs and autism research for my scientific and parental taste. See Quackwatch or research it on your own, there’s plenty of information out there.

8. Phase two criteria stipulate no changes in medications, diet, supplements, or behavioral intervention. Why isn’t behavioral intervention being curtailed altogether so as to remove it as a possibility in skewing the results? It is clearly the case that most autistic children receive differing quantities, qualities, and modes of behavioral intervention. Combined with the fact that autistic children all experience developmental progress to different degrees, at often unknown times, at different rates, and quite possibly as a result of behavioral intervention, how will this experiment isolate the effect of the chelation therapy alone? How will this experiment prove (not assert) that a difference in the chelated group vs. a control group is due to the chelation, and not behavioral intervention or developmental progress, or a lack thereof in the control group?

Current conclusion: To Jim’s credit, he states that to discontinue beneficial therapies would be unethical. This experiment would likely be entirely inconclusive in the eyes of the scientific community. Until better methods of measuring and tracking that varied therapies and the results of those varied therapies, any positive results could be attributed to the chelation, while any negative results could be attributed difference in therapies or lack of developmental progress. The hypothesis of this experiment is truly unfalsifiable due to lack of measurement and tracking of results of behavioral intervention. The very design of this experiment lacks rigors and focus of the ‘real’ scientific method. As far as results, in the eyes of the peer-reviewed scientific community it probably won’t prove anything. I wouldn’t expect to see the results of this research published in a peer-reviewed mainstream medical journal indexed on PubMed anytime soon.

9. Will the study provide for emergency treatment (financially and otherwise) for an adverse reaction (however unlikely) if needed?

Current conclusion: At one point, Jim sort of said something along the lines of maybe, but then stated that the limits of care are clearly stated in the documentation available to parents on the SCNM website. If something really bad happens, hopefully and probably it won’t, but if it does, and your child has an adverse reaction (such as anaphylaxis) and your child needs emergency treatment in the form of an ambulance, ER visit, or specialist - You are on your own! Does your insurance cover incidents that arise from experimentation with investigational drugs?

Okay, so those are my conclusions. It’s obvious to anyone who reads the e-mails that I was irritated by the fact that this research was promoted (although not necessarily endorsed) by the Arizona DES/DDD. But why beyond that, does this research itself concern me? For a personal reason, go back and read my post More Research, More Questions: A Chelation Study in Arizona, but be aware that my reasons for qeustioning this research are bigger than just the personal one.

Based on the scientific research I reviewed, and the e-mail conversation I had directly with the lead researcher - Jim, a PhD, I think this research lacks the ethics and scientific merit that should have been required by an Institutional Review Board (IRB), prior to experimentation on humans. It looks like “bad science”. Contrary to the conclusions of current research, this particular research appears to be based on assertions that mercury causes autism, and that autistic children have higher levels of mercury.

- This research could be perpetuating false hope for treatment of autistic children in hundreds of involved parents here in Arizona, as well as elsewhere.

- This research is funded by dollars that potentially could have funded more ’scientific’ research - really, scientifically, and provably benefitting autistic children.

- Time spent participating in this study, or new therapy starts witheld as a requirement of the protocol, might be otherwise used for useful and scientifically valid therapies.

- This research could theoretically lead to expensive and essentially ‘worthless’ chelation treatments or expensive glutathione skin creams being sold to area parents – all under the infomercial-like guise of less than peer-reviewed science available on PubMed.

-Notes: A certain Jeff Bradstreet, M.D. and Jane El-Dahr, M.D. are listed as consultants on this research. Jim, the PhD ’scientist’ is a tenured professor in Chemicals and Materials Engineering at Arizona State University. This study is often incorrectly referred to in the community and on the internet as the “ASU Chelation Study” and sometimes “The University of Arizona Chelation Study”, although it has absolutely nothing to do with ASU or The University of Arizona.