Autism Street

I recently wrote a letter to the MD/pediatrician participating in the Southwest College Of Naturopathic Medicine’s chelation research. In it, I asked if he would be interested in discussing this research, prior to me bringing it up with the SCNM’s IRB. I also suggested that his involvement might have come only after this so-called ‘research’ was possibly previously rejected by some IRB other than SCNM’s, and wondered if it was possible that he’d been rushed into it without adequate time to review the science. I wanted to give him the benefit of the doubt, and hear what his take on the situation might be. I suggested that perhaps he could point me to a valid scientific or medical resource that could provide evidence that this research is not as bogus as it might appear.

Although his reply was prompt and courteous, I am underwhelmed.

Here’s the response I received from MD, Pediatrician Sanford Newmark:

Dear Dad of Cameron,

“I received your letter and appreciate your concern. However, having seen the email interchange you have had with Dr. Adams, I can’t think of anything new I could add if we discussed the study. One small correction of fact, I was already on board when ASU’s IRB nixed the study. I would not take this as a sign of some inherent flaw in in the study. You have no idea how many excellent studies get disapproved by IRB’s for incomprehensible reasons, especially if the studies are at all outside of the mainstream. ”

“My other comment is that as a clinician treating kids with autism I have met many families who have poured a lot of time and money into chelation therapy. Even if there was very minimal reason to suggest chelation is effective, doing a study like this, even with negative results, could have great value. You may know that a number of respected conventional doctors did controlled studies on Secretin for autism, not because they thought it worked, but because so many people were using it. In fact, the existence of those negative studies helps me more confidently steer people away from secretin treatment. ”

“I hope that is of some help. ”

“Sincerely,
Dr. Sandy Newmark”

So let me break down his response a little and see if I can understand the implications of his reply. Readers, please comment, correct me, etc. Why would ASU’s IRB have rejected this research?

1. He has nothing new to add.
All of the previous questions were answered by a non-medical person, and an MD Pediatrician has nothing to add? With all of the flaws pointed out about this research and he doesn’t want to set the record straight? He doesn’t even want to say he disagrees with my take on this? Perhaps he doesn’t have time - I’d understand that. He doesn’t want to reassure any parents out there that this is safe and meaningful?

Uh oh, here comes a red flag. Pay close attention!

2. According to Dr. Newmark, this study was previously rejected by the IRB of Arizona State University.
I contacted the IRB at ASU but did not receive a reply. As I understand it, IRB’s are not required to disclose information about rejected research. An IRB’s primary function is to ensure the health and welfare of human research participants. There are special FDA considerations for children and vulnerable populations, however the basic role of the IRB is to make sure the research is: legal (complies with informed consent laws and appropriate use of drugs, etc.), ethical (has scientific merit prior to experimentation on human subjects), useful (protocols must meet certain criteria to ensure that the research provides valid results), and last but not least, safe (acceptable risk in terms of potential benefit). So if this research was rejected by ASU’s IRB, as Dr. Newmark states, why is that? I don’t think it is likely illegal, as the informed consent docs could be seen by many as sufficient - could it simply be that ASU’s IRB found this research unethical, scientifically useless, or unsafe?

3. Dr.Newmark wouldn’t take the ASU IRB’s denial as a sign of some inherent flaw in in the study.
Maybe I should try to be open minded about this. Even though their primary function and reason for existence in the first place is pretty clear, I guess it’s possible that they could have rejected it simply because they don’t want this so-called ‘research’ attached to the name of Arizona State University - the hypothesis is less than valid, the methodology questionable, the experiment seems totally unfalsifiable, there’s involvement with a dubious laboratory (see Quackwatch), etc. I wouldn’t want my name on that sign-off sheet either.

4. Dr. Newmark suggests that many excellent studies get disapproved by IRB’s for incomprehensible reasons, especially if the studies are at all outside of the mainstream.
So a group of several educated people get together (from varying backgrounds and without conflicts of interest), study the research proposal, review the appropriate literature, examine the methodolgy, determine whether or not it meets specific legal, ethical, scientfic validity, and safety requirements and disapprovals are common for incomprehensible reasons? I’d venture to guess that the reasons are more often quite able to be understood, even if one might not agree with or like them.

5. His other comment is that as a clinician treating kids with autism has met many families who have poured a lot of time and money into chelation therapy. He suggests that even if there was very minimal reason to suggest chelation is effective, doing a study like this, even with negative results, could have great value.
Having met many families who have poured a lot of time and money into chelation therapy doesn’t mean anything. Wasted time and money does not necessitate a study, unless perhaps they want to prove chelation useless (hey they might not need Doctor’s Data in that case either). Only one small apparent problem with actually proving it wrong in this study - until better methods of measuring and tracking the 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 in the control group. The hypothesis of this experiment seems truly unfalsifiable. Likewise any negative findings about the chelation could be the result of development or behavioral intervention in the control group. Why am I even writing this, they can probably say whatever they want and will be able to explain it in some way - they appear to have left themselves plenty of room.

7. Dr. Newmark pointed out that a number of respected conventional doctors did controlled studies on Secretin for autism, not because they thought it worked, but because so many people were using it.
Hmmm, do ya think so many people were using it because they were told it would work, and desperately wanted it to work? Since when is scientific experimentation on children worthwhile “just because other people are doing it?” See - bandwagon fallacy. I can see use by the masses influencing where reasearch dollars end up. I can see use by the masses warranting a closer look because treatments could be useless or dangerous, in which case a carefully designed study to prove (not assert) that danger or inefficacy, seems like a good idea. I just don’t see how this SCNM chelation study will really prove anything at all, except that ASU’s IRB made a very good decision.

8. Dr. Newmark says the existence of those negative studies helps him more confidently steer people away from secretin treatment.
Not a bad point at all. Too bad this probably won’t be one of those studies. And it’s really too bad that he didn’t learn from this study, prior to jumping on the “mercury causes autism” bandwagon. See - bandwagon fallacy.

I just don’t get it.