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Update on the NIH “Trial to Assess Chelation Therapy”

A few days ago, while gathering information for last week’s post about intravenous hydrogen peroxide, I noticed this:

ACAM Supports NIH Decision to Suspend TACT Trial

September 3, 2008, Laguna Hills, Calif. — The American College for Advancement in Medicine, ACAM today announced its support for the National Institute for Health’s (NIH) decision to suspend patient accrual of the Trial to Assess Chelation Therapy (TACT) Trial until allegations of impropriety can be proven false.  ACAM believes that the TACT trial represents a important milestone in assessing the role of chelation therapy in modern healthcare and respects the decision of the NIH.

ACAM continue to work with Dr Tony Lamas to answer the unfounded allegations of impropriety.

“We believe that the Office of Human Research Protection (OHRP) will find that the allegations are of a political nature. To serve the best interests of participants enrolled in the TACT trial and all patients and their physicians who seek answers about chelation therapy, we call for a swift end to the moratorium and resumption of the trial,” said Jeanne Drisko, MD, President of ACAM.

I alerted a few others, including Stephen Barrett of Quackwatch, who queried the news room of the National Heart, Lung and Blood Institute (NHLBI: the joint sponsor, along with the NCCAM, of the trial) and got this reply:

The investigators and institutions performing the Trial to Assess Chelation Therapy (TACT), in conjunction with their Institutional Review Boards, have temporarily and voluntarily suspended enrollment of new participants in the study. NIH has not issued any announcement or press release about this action. To contact the Office for Human Research Protections’ (OHRP) press office, call Pat El-Hinnawy, (202) 253-0458.

The “allegations of impropriety” mentioned in the ACAM press release had been made by my co-authors and me in a comprehensive article previously introduced on SBM here. The article is available in its entirety here. In June, we made a formal complaint to the federal Office of Human Research Protections (OHRP), citing that article and additional information posted on SBM here. That our complaint was the instigating factor for the recent “decision to suspend patient accrual” is suggested by an email that I received last week:

I would like to know who is paying you guys off. Finally we have a chance to assess Chelation therapy and put the issue to rest and to find out whether or not it really works and you bozos screw it all up. I know that the trial was stopped and it is your fault. What are you afraid of? Why are you not decrying all of the injuries caused by medications and unnecessary surgeries? Why are we the citizens of the US deprived of a trial of EDTA so that we can judge for ourselves?

Anyone who is a thinking man, can only be disappointed in you. [sic]

Binyamin Rothstein, D.O.

Rothstein, unlike many of his fellow ACAM members, does not appear to be a TACT investigator. Like them, however, he touts chelation, intravenous hydrogen peroxide, and other baseless and dangerous treatments. He has harmed patients, his protestations nothwithstanding. His medical license was revoked in 2005, but that hasn’t hindered him from using smoke and mirrors in his relentless pursuit of profit from nonsense. He’s even managed to promote himself to the public without revealing key items from his resumé—one of the many reasons that even the most diligent regulation can’t always protect the public from scoundrels.

But back to the point of this post. The TACT should now be stopped altogether. It is far worse, in numerous ways, than the recently abandoned NIMH “chelation for autism” trial. Contrary to the ACAM press release, our objections to the TACT are scrupulously documented and not “of a political nature.” They are of a scientific and ethical nature. They cannot be proven false, because the evidence for them is overwhelming.

Posted in: Clinical Trials, Medical Ethics

Leave a Comment (16) ↓

16 thoughts on “Update on the NIH “Trial to Assess Chelation Therapy”

  1. Karl Withakay says:

    Let’s here it for the good guys!

    I ran across this article at 3AM this morning while working on an email outage issue for my firm:

    http://news.yahoo.com/s/ap/20080926/ap_on_he_me/med_heart_study_probe_6

    I skimmed through it so fast (I was rather distracted at the time), I didn’t even notice you were quoted in the article. I’ll have to re-read the whole thing.

  2. overshoot says:

    It is far worse, in numerous ways, than the recently abandoned NIMH “chelation for autism” trial.

    Although the subjects may be denied properly informed consent, at least they are adults. The subjects aren’t being sedated and forcibly restrained to make them comply.

  3. Harriet Hall says:

    I’ve read many criticisms of the comprehensive article by Atwood et al. but I have yet to see any criticism that actually addresses the points made in the article. I wonder whether the critics even actually read the article. Or if they did read it, were they capable of understanding it?

  4. Joe says:

    Congratulations, I hope your position prevails.

  5. daijiyobu says:

    Dr. Atwood,

    NDs — self-proclaimed science-experts

    (e.g., http://www.lemmo.com/articles_oncology.pdf )

    – may differ with your assessment of TACT [I don't]…

    This morning, I was touring through a Canadian naturopath’s web site — Lemmo, W. (ND Bastyr) {where he hosts the article by Rubin, D. (ND SCNM) which is the above link} — and incidentally came across this claim specifically as regards chelation therapy (see http://www.lemmo.com/chelation.html ):

    “chelation therapy is an office treatment which on average for 20 to 40 infusions runs an estimated cost between $2000-$4000 dollars. Thus, both the benefit-risk profile and the cost- effectiveness of chelation are likely superior [!!!] over bypass and angioplasty.”

    Really!!!

    Really scary.

    His bio. states he is a member of the International Society of Chelation Technicians.

    -R.C.

  6. mandydax says:

    Chalk one up for reason. When I read that SBM post about the IV H2O2, well, I think the best emoticon for my reaction is D: . I’m really glad that this blog has made a difference, and I hope to hear more of your successes against quackery and the unethical in the future. Congratulations and keep up the good work.

  7. scotsilv says:

    Harriet writes:

    “I’ve read many criticisms of the comprehensive article by Atwood et al. but I have yet to see any criticism that actually addresses the points made in the article. I wonder whether the critics even actually read the article.”

    It doesn’t matter if they read it or not; their response would be the same. Ad hominem attacks or logical fallacies of one form or another, which (as at http://www.nizkor.org/features/fallacies/ad-hominem.html) simply do not invalidate an argument. Such logical fallacies are largely the M.O. of scoundrels.

    By the way, regarding “ACAM continue to work with [PI] Dr Tony Lamas to answer the unfounded allegations of impropriety”:

    … Dr. Gervasio Lamas, director of Cardiovascular Research and Academic Affairs at Mount Sinai Medical Center in Miami, is apparently the PI. Per the link, “Dr. Lamas is also spearheading a clinical trial at Mount Sinai to test chelation therapy, an alternative medical treatment for coronary artery disease.”

    Regarding Mt. Sinai Medical Center, I’d written on my experience there at this link:

    Organizational Learning Disability? Miami Beach Hospital gets an “F” on Informatics
    (at http://hcrenewal.blogspot.com/2008/04/pearls-before-swine-hospital-gets-f-on.html)

    In retrospect, I can perhaps better understand why they found a Medical Informaticist of my background “not the right fit” for Director of Medical Informatics.

    While I did not meet their CV Research Director, I did meet their Chair of Internal Medicine and touted my ethics and my ability to build advanced information systems in cardiology and other specialty domains (as I did at Christiana Care) that could be used to great advantage in assuring excellent science.

    Theoretically speaking, of course, I can imagine they could have had concerns with the issues my ability and desire could (potentially) create for an organization whose Director of CV Research & Academic Affairs was running controversial ‘chelation trials’, and for the IRB that reviewed same.

    My blogging might have also been a deciding factor.

    I was not the “right fit” indeed for Director of Medical Informatics there, and now humbly agree with that assessment.

    In the spirit of Medical Informatics, which deals in elimination of ambiguity in terminology among other issues, I also invite the ACAM to clarify (with references) what they mean by “We believe that the Office of Human Research Protection (OHRP) will find that the allegations are of a political nature.”

    To my untrained eye, the only “politics” I see in the “allegations” are a well-documented, sound critique of what appears to be cavalier pseudoscience, biomedical incompetence and quackery.

  8. You and your colleagues are to be congratulated on your thorough study showing the numerous flaws with the NIH TACT study. It’s too bad it took the NIH several years to suspend the trial, but at least you got their attention. I hope they will halt it completely. I blogged on this topic also, at http://genefinding.blogspot.com/2008/09/nih-halts-chelation-study-after.html.

  9. Derek says:

    Wonderful article. I applaud your thoroughness.

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