Why the NIH Trial to Assess Chelation Therapy (TACT) should be abandoned.

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.

Word use and semantics in alternative medicine: a survey of editors of medical and related journals.

OBJECTIVE: To investigate the views, practices, and policies of medical journal editors on the use of words and phrases present in altmed manuscripts submitted for publication. DESIGN: Postal survey of 56 journals, with journals selected to cover a range of ISI medical/medically related categories and citation scores RESULTS: The overall response rate was 62.5% (35/56); 5.9% (2/34) of responding journals had a policy on word use with respect to altmed; 12.9% (4/31) of editors of journals with no policy had discussed the subject among their staff; 7.4% (2/27) planned to discuss the matter or introduce/improve guidelines; 17.9% (5/28) had discussed the subject with other editors; 10% (3/30) considered the matter to be a problem; and 32% (9/28) had changed altmed wording or had a reviewer suggest changes. CONCLUSIONS: There exists a general lack of policy or discussion on the use of words in altmed papers. Editors do not in general recognize the use of words in altmed as being an issue of special significance. Informed editorial attitudes and policy on the special semantic issues associated with altmed is required to enable journal editors to serve as effective gatekeepers of medical knowledge.

Controversies in cancer and the mind: effects of psychosocial support.

In the last decades of the twentieth century, interest in effects of consciousness on health and illness generated several lines of investigation into effects on cancer. Animal studies showed sensitivity of some cancers to hormonal and stressful influences. However, those findings did not translate into effects on humans, nor did they lead to advances in understanding of human cancer. The proposal that emotional state or stress, mediated through psycho-neuro-immunologic mechanisms would affect cancer generation or growth, resulted in conflicting information. Major surveys found no relationship. The proposal of a cancer personality (Type C) also was not confirmed. Initial observations that depression and stress affected human cancer seem to have best been explained by misinterpretations of cause and effect. By the mid 1990s, a remaining thesis--effect of psychosocial support on longevity and the course of cancer--was yet to be resolved. Initial positive results, especially findings in two popularly quoted studies, were not confirmed; they seem to have been due to inadequate numbers (chance) or to artifacts in study design or implementation. Psychosocial support may result in better adjustment and quality of life, but it does not directly affect the evolution of human cancer.