One blogger is quite impressed with the surprising results of the study:

http://www.forbes.com/sites/larryhusten/2012/11/04/nih-trial-gives-surprising-boost-to-chelation-therapy/

But…the other blogger is “not impressed”:

http://www.forbes.com/sites/matthewherper/2012/11/04/civil-war-a-study-says-chelation-might-help-heart-patients-but-doctors-dont-believe-it/

I posted on both of these blogs and your analysis of this study is prominently mentioned, Dr. Atwood.

Science-Based Medicine » The Trial to Assess Chelation Therapy: Equivocal as Predicted…

Chelation was (and is) used as diagnosis and treatment for amalgam removal. Was this possibility never checked?

The problem with heavy metal removal by chelation is that the chelation is not proportional to the accumulated metals. This renders it useless as a diagnosis tool.

Now, thinking about the TACT study, we are faced with the very same problem, from a different point of view. The question to ask here is: How much (heavy) metals did the patients have in their bodies, and how much could be chelated?

If ALL probands had the very same conditions, one could use that study. But in case of chelation the uptake of metals also has to be looked at, including food. And I do doubt, that this ever COULD have been made.

So that is it, the study is useless, and this INDEPENDENT of whatever the results might have been.

We are not told how many of the 79 who discontinued infusions came from each arm, however. Regarding the two deaths that were “possibly or definitely related to study therapy,” could those have been the same two subjects discussed here? It seems unlikely, because in each of those cases “The site investigator has assessed the causal relationship between the study drug and the serious adverse event as not associated stating the cardiopulmonary arrest was due to progression of the disease under study,” and the SAE reports from Duke University barely challenged those assessments. That makes me wonder about the details of the remaining 180 reported deaths, even though they were nearly evenly distributed between the active and placebo groups.

Perhaps this AP story explains:

Other experts questioned the results, especially because 60 more people in the group getting dummy infusions withdrew from the study than in the group getting chelation. Usually, more people in a treatment group drop out because of side effects, said Dr. Christie Ballantyne, a Baylor College of Medicine heart specialist. To find the opposite is “a red flag” that suggests those who got dummy treatments found that out and decided to drop out.

“There’s something funky going on here,” Ballantyne said. “It raises questions about study conduct,” especially since a difference of one or two people or complications could have nullified the small overall benefit researchers reported.

Dr. Clyde Yancy, a Northwestern University cardiologist and a former Heart Association president, agreed.

“It’s funny business,” he said. “I’ve never seen a study in which one in five people withdrew consent.”

Interesting that Marilyn Marchionne got this information but apparently Dr. Lamias didn’t think it worth including in the press release or on his slides. Perhaps one of our readers went to his talk and could tell us if he mentioned this rather important bit of information in his talk itself. Failure of blinding as a cause of this trial’s dubious results is also consistent with doubts about the blinding expressed by Dr. R. W. Donnell six years ago.