So I read Part A of the Adams paper, where they gave all the kids DMSA plus more DMSA or DMSA plus placebo and measured their mineral excretions. There was no typically developing control group, nor were there any standard reference ranges used for provoked urinary excretion. Would it have been unethical to do this experiment on non-autistic kids? If so, why is it not equally unethical for autistic kids? Without knowing how the results compare between autistic and typically developing kids, does this study really tell us anything about the efficacy of chelation as a treatment for autistic kids?

Anne,
I haven't read any part of the Adams paper, but these are my comments:
1) For a study to be ethical, the benefits to participation need to be greater than the risks - *for the participants.*
2) Giving children (typically-developing or otherwise) a chelating agent is subjecting them to a risk.
3) The risk could be justified if it were balanced against the risk of untreated acute heavy-metal poisoning.
4) The study participants were *not* suffering from acute heavy-metal poisoning, and there was no reason to suspect that they were.*
5) When study participants are disabled children, they are both extremely vulnerable and unable to provide informed consent. The ethical requirements to do no harm are particularly high in this situation.

The study was unethical because it was studying an intervention in vulnerable indivuduals unable to provide informed consent when there was no reason to think that it could provide any benefit at all to these indivuduals, and much reason to think it could harm them.

Extremely unethical.

Their parents may have believed them to be suffering from heavy metal poisoning, but their parents were *wrong*. Other parents may believe that, for instance, their children need to be submerged in water to expel demons, even if that means drowning and killing them; or that they need to be bled or cupped to correct their humours; or that prayer treats diabetic shock and that insulin does not. These parents may genuinely believe these things, but their beliefs are not supported by evidence - in fact, there is much evidence to the contrary - and they are wrong. Mistaken. Any intervention designed to study the effects of cupping in children would be wrong because there is no reason to think it could be of benefit but we do know it harms the child.

If the science is there to suggest that the risks of participation are outweighed by potential benefits, that changes the balance. There is no such science supporting the idea that chelation might be a beneficial
intervention for autistic children. There just isn't. So going ahead and chelating autistic children anyway, with no reason to think it could benefit the children is unethical.


On Sun, Oct 25, 2009 at 12:49 PM, QT - Anne <
qtopic-27-vJvhV4fDnBgw7@quicktopic.com> wrote:

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What makes this particular study so distressing to so many of us is that it went ahead anyway, even though it was so clearly unethical. The implication is that the ethics don't matter because it's only autistic children who are being harmed. This is unacceptable.

"Mississauga mother charged in autistic son's murder" http://www.thestar.com/news/gta/crime/arti...c-son-s-murder?bn=1

"Mom charged in murder of autistic son" http://www.torontosun.com/news/torontoandg...10/25/11522176.html

The autistic son is Tony Khor, he was 15 years old. His body had "obvious signs of trauma." His mother, who has been charged with 1st degree murder, is Seow Cheng Sim.

This is just sad and terrible.

Globe and Mail story about the murder of Tony Khor http://www.theglobeandmail.com/news/nation...son/article1337719/

The deadline for submission of abstracts for presentation at the 2010 International Meeting for Autism Research (IMFAR)is Friday, November 2009. See http://imfar.confex.com/imfar/2010/cfp.cgi.

Edited by author 10-28-2009 12:15 PM
Catching up slightly, I agree that James Adams' chelation trial is unethical, just like the proposed/cancelled NIH chelation trial was unethical.

If you look through Autism Street (the blog) you should find information on how Adams failed to get his trial approved by a university-based IRB. This did not cause him to reconsider. Instead he moved his trial to a naturopathic college, where the standards are even lower than the standards usually applied to autistics. Here's one relevant post http://www.autismstreet.org/weblog/?p=20

Not only is the trial unethical, it is very poorly designed (as Anne notes). Not only were the children unethically experimented on, and subject to important risks with little or no possibility of benefit for themselves, their time and risk and so on were wasted due to the poor design of the study.

There isn't much to learn from this trial except about the standards (or lack thereof) of the researchers, the willingness of some parents to subject their autistic children to unethical experimentation, and the need for ways to protect autistics from being subject to further unethical experimentation. I don't think any of this is news.

Fire alarms go off in my apartment building often enough. There's only ever been one fire previously, caused by careless renovators.

The alarms went off again today and I went out to look around. There seemed to be smoke.

One of the people who lives just upstairs from me arrived, opened his apartment door, and smoke billowed out. You could see some flames in the back.

I ran downstairs and called the fire dept., who arrived very rapidly. The fire is now out. The fire alarms have stopped ringing, at least most of the time.

Apparently the people upstairs left something on, in their kitchen. This is what burst into flames. Fortunately, there doesn't seem to be anything wrong, at least yet, with the electricity in the building. There doesn't seem any damage, yet, outside of the apartment upstairs.

My upstairs neighbours have set off the fire alarms several times before; this is the first time they've actually started a fire. They've sent water pouring down on me once, but I am much better prepared for this--thanks to jypsy and many others who gave me great ideas--than I used to be. Now I have to think about how to be prepared for fires.

I trust that will be enough excitement for today! Glad it ended well, for you at least.

I now have (temporary) custody of a fire extinguisher which more usually lives right outside my door. I actually broke the glass thing it was behind (and noticed much later that in doing so, I had cut my hand) and set out towards the billowing smoke, armed and ready. But fortunately at about this point the fire dept. came to the rescue.

Apparently it was a smallish but very intense fire which produced a huge amount of thick acrid smoke. It no longer smells like something burnt and/or burning in most of my apartment but it still smells very strongly in the stairwell, entrance and halls.

The good thing is that no one was hurt.

Last year, my nest-door neighbor fell asleep while boiling some potatoes. Talk about thick acrid smoke, it was the worst thing I ever smelled! The fire alarm went off, and we both called the Fire Dept. Those taters looked like lumps of coal, and the smell was enough to make anyone throw up.

re fires, Michelle, I hope you have now taken good care of your cut hand. When I cut my shin putting a fire out a few years ago I didn't notice till much later when it was already infected - ended up in hospital for weeks (nightmare, incarceration).

Hi Michelle,

I am glad that the fire in your apartment building didn't cause any damage and is now out.

Not only is the Adams trial unethical to carry out, and its design poor, the characterization of the results in the abstract is unethical.

If you carry out a randomized trial, obviously you intend to determine if there are between-group differences in outcome. If there are no differences in outcome, the trial is a failure, and you should report it's a failure.

Instead, the authors try to spin it as if both groups had been helped equally. They can only do this because neither group was only on placebo all the time. Both groups got one round of DMSA at the start of the trial. So the spin was that one round of DMSA is equally helpful to 7 rounds, when in reality the most reasonable interpretation is that DMSA didn't work at all.

Joseph,

A trial is a failure if it neither proves nor disproves your hypothesis AND it doesn't suggest any new hypotheses.

If it disproves your hypothesis, it's a success. If it proves it - also a success! In both cases you learned something.

A poor trial design will not produce the kind or quality of information that can speak to your hypothesis, either for it or against it, so at the end you are no wiser than before. Therefore poor trial designs are unethical because they waste people's time and money and may place participants at risk, ultimately for no benefit to anyone.
On Thu, Oct 29, 2009 at 12:04 PM, QT - Joseph <
qtopic-27-vJvhV4fDnBgw7@quicktopic.com> wrote:

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http://www.youtube.com/watch?v=KJi_Si_jTHk

"If I had a VOCA"