A $30 million US study of an alternative therapy called chelation has resumed enrolling volunteers with a history of heart attack, despite a federal investigation into whether previous enrollees were told enough about the study's risks, the Associated Press reported Wednesday.
Some 1 500 people have been enrolled in the study, which the wire service said is among the largest ever of an alternative therapy. Chelation is a "treatment used for lead poisoning that has not been proved safe or effective for heart disease," the AP reported.
Chelation, in this case, involves injecting the drug disodium EDTA, which backers claim will thin artery-clogging calcium that is impeding blood flow to the heart.
Some users died
Enrollment in the study was halted 10 months ago amid an investigation by the Federal Office of Human Research Protections on whether study participants had been fully informed about the research and its sponsors. Study critics have complained that some users have died while on chelation, and that more than half of the doctors running the study have a conflict of interest because they sell chelation remedies, the wire service reported.
The study is being co-sponsored by the US National Heart, Lung and Blood Institute and the National Center for Complementary and Alternative Medicine. A heart institute spokeswoman refused comment, citing the ongoing federal investigation, the AP said.
The wire service cited a statement on the website of the American Heart Association that warns "EDTA isn't totally safe," citing potential risks including kidney failure, shock, low blood pressure, convulsions, allergic reactions, heart rhythm problems and breathing trouble.
(HealthDay News, June 2009)