The federal Trial to Assess Chelation (TACT) study is once again enrolling heart attack survivors. The study’s leader, Dr. Gervasio Lamas of the Mt. Sinai Medical Center in Miami, voluntarily suspended enrollment last fall after allegations were published in Medscape critical of the consent form given to patients and of the safety of the trial.The federal Office of Human Research Protections’ investigation about whether participants were told enough about possible health risks remains ongoing, but TACT enrollment has resumed. The National Heart, Lung and Blood Institute is sponsoring the study with the National Center for Complementary and Alternative Medicine. The $30 million study is one of the largest alternative medicine experiments ever launched. It has enrolled 1500 volunteers since 2002, and hopes to enroll a total of 1700 participants.
The study tests high doses of vitamin and mineral supplements as well as chelation, a treatment generally used for lead poisoning that involves intravenous doses of a drug, in this case disodium EDTA. Proponents claim it can flush out calcium that has built up in artery walls. Stiff or clogged arteries can lead to heart problems. While chelation therapy remains controversial to many researchers in mainstream medicine (the American Heart Association, for example, has spoken out against it on their website), it is currently effectively used by physicians worldwide, is used in major European spas, and has thousands of articles in the worldwide medical literature to support its use.
The study was criticized in part because several of the sites involved physicians whose practice generates revenue from chelation therapy, claiming it posed a “conflict of interest.” Adopting that particular standard across the board would, of course, preclude most conventional physicians from participating in any clinical studies whatsoever.
More information about the TACT trial is available at the American College for the Advancement of Medicine’s website.