Enrollment resumed in controversial NIH chelation trial

Enrollment has resumed in the Trial to Assess Chelation Therapy (TACT), a large and controversial $30-million NIH study, according to an AP story by Marilynn Marchione. Last year in August the trial was suspended when the Office for Human Research Protections received complaints about consent forms and safety issues. The suspension was originally reported in detail by Michael O’Riordan in Heartwire.

Prior to the suspension, an article in Medscape J Med by Atwood and colleagues helped ignite the controversy. In the article, the authors

“present evidence that chelationists and their organization, the American College for Advancement in Medicine, used political connections to pressure the NIH to fund the TACT. The TACT protocols justified the trial by misrepresenting case series and by ignoring evidence of risks. The trial employs nearly 100 unfit co-investigators. It conflates disodium EDTA and another, somewhat safer drug. It lacks precautions necessary to minimize risks. The consent form reflects those shortcomings and fails to disclose apparent proprietary interests. The trial’s outcome will be unreliable and almost certainly equivocal, thus defeating its stated purpose.We conclude that the TACT is unethical, dangerous, pointless, and wasteful. It should be abandoned.”