Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned

Kimball C. Atwood IV, MD; Elizabeth Woeckner, AB, MA; Robert S. Baratz, MD, DDS, PhD; Wallace I. Sampson, MD

Disclosures

Medscape J Med. 2008;10(5):115 

In This Article

Conclusion

The many case series of chelation for cardiovascular disease provide no basis for nullifying the uniformly negative results of the several RCTs. The risks for chelation are more than trivial. The evidence against chelation is more than sufficient to disqualify it from further human trials. Experts in cardiovascular disease and in clinical trials, particularly those who are acquainted with the history and literature of chelation, agree with that assessment.

These points have been misrepresented by the PI, the TACT protocols, the NCCAM Web site, the 2003 TACT consent form, and by trade organizations that stand to gain from the NIH casting their members and practices in a favorable light. The trial appears to exist not because of a real scientific or medical need, but because a powerful congressman successfully manipulated the NIH through its most politically vulnerable appendage, the NCCAM.

There is little basis for predicting that the TACT will yield a reliable or definitive result, and even less for predicting a favorable effect on clinical practice. Numerous co-investigators are unfit to care for subjects in a human trial or to submit trustworthy information to the NIH.

The TACT is pointless, dangerous, unethical, and a waste of public funds. It should be stopped immediately and permanently, and its origin and nature subjected to an independent, comprehensive inquiry. If the NHLBI has assumed primary responsibility for the grant, we are optimistic that this now may happen.[184]

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