Dr. Adams: Is there a paper in the horizon?

Back in June, 2006, Dateline NBC did a story titled The unorthodox practice of chelation which was primarily about a small double-blind trial on chelation therapy that Jim Adams and colleagues had designed. The following is an excerpt of the interview where Dr. Adams is asked about publishing potential negative results of the trial.

John Larson: What happens in the end, after all this hard work? If you find that there really is no relation between mercury and autistic behavior. Will you be disappointed?

Jim Adams: Disappointed, yes. But whatever way it turns out, we’ll report it. If it doesn’t help, we’ll report it. And if it does, we’re gonna report that, too.

When were the results expected? End of 2006.

Jim Adams predicts he'll have the final results of his study by the end of the year, and we'll have them first, here on Dateline.

Whatever flaws the trial might have had, it is worrisome that this much time has elapsed since the results were supposed to be made available either to the media or in the form of a paper. I don't know the reasons for the delay. Maybe there are valid justifications, maybe there aren't. D'oC over at Autism Street already discussed the delay back in June.

There are surely ethical questions as to whether such a trial should be done in the first place. But it seems to me that more serious ethical questions are raised by a failure to publish results.

Why do I say this? First, there's a general issue of scientific ethics. Imagine what would happen if researchers had the habit of sitting on results they don't like. The literature would be filled with self-selected results and random noise beyond what would be expected by mere chance.

Second, suppose the study had found there are therapeutic effects to chelation therapy. It would appear to me that the sooner the results are published, the sooner bigger and better replications of the study could be carried out to identify responders, and the sooner children could be treated.

Third, suppose the study determined there are adverse effects to the treatment. Considering the popularity of chelation therapy, it would certainly be wrong to withold this kind of information.

Is it plausible that chelation with DMSA was found to have adverse effects? Yes, in fact, a trial of DMSA with rats had found that, in the absense of lead intoxication, it could contribute to cognitive deficits (source).

Additionally, even though a paper has not been published, preliminary results from the trial are known because of presentations Jim Adams has done, e.g. Preliminary Results of 3rd DMSA Study (2007).

Dr. Adams compares a group receiving 7 rounds of DMSA vs. another getting 1 round of DMSA. In a global impression scale, 8% of the children getting 7 rounds are found to be doing slightly worse or worse vs. 0% of the children who got 1 round of DMSA. Of those who got 7 rounds, 87% are found to be doing slightly to much better vs. 84% of those who got 1 round. In the "No Change" category we find 17% of children who got 1 round vs. 4% of those who got 7. (You'll note that those percentages don't add up, but that's how they are reported in the presentation.)

This brings up a question as to whether about 8% of the children suffered adverse effects after only 7 rounds.

Dr. Adams also finds that DMSA increases excretion of potassium and chromium, and that it raised glucose and triglycerides.