title: Why the NIH Trial to Assess Chelation Therapy (TACT) should be abandoned.
abstract: The National Institutes of Health (NIH) Trial to Assess Chelation Therapy (TACT) was begun in 2003 and is expected to be completed in 2009. It is a trial of office-based, intravenous disodium ethylene-diamine-tetra-acetic acid (Na(2)EDTA) as a treatment for coronary artery disease (CAD). A few case series in the 1950s and early 1960s had found Na(2)EDTA to be ineffective for CAD or peripheral vascular disease (PVD). Nevertheless, a few hundred physicians, almost all of whom advocate other dubious treatments, continued to peddle chelation as an office treatment. They claim that chelation dramatically improves symptoms and prolongs life in 80% to 90% of patients. In response, academics performed 4 controlled trials during the 1990s. None favored chelation, but chelationists repudiated those findings. We have investigated the method and the trial. We present our findings in 4 parts: history, origin and nature of the TACT, state of the evidence, and risks. We 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.
authors.affiliation: Newton-Wellesley Hospital, Newton, Massachusetts, UAS. katwood@partners.org
authors.forename: Kimball C
authors.initials: KC
authors.lastname: Atwood
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Woeckner
authors.forename: Robert S
authors.initials: RS
authors.lastname: Baratz
authors.forename: Wallace I
authors.initials: WI
authors.lastname: Sampson
mesh_terms: D002614:Chelating Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015913:Chelation Therapy / Q000009:adverse effects; D017326:Clinical Trials, Phase III as Topic; D000529:Complementary Therapies; D003324:Coronary Artery Disease / Q000628:therapy*; D004492:Edetic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D032984:Ethics, Research; D006801:Humans; D007275:Injections, Intravenous; D009316:National Institutes of Health (U.S.); D012109:Research Support as Topic; D014481:United States
chemical_list: D002614:Chelating Agents; D004492:Edetic Acid