Heart Study Enrolment Halted Due to Safety Concerns

At Least 2 People Dead

At least 2 people have died in the largest ever study of an alternative medicine and, as a result, the $30 million trial of chelation therapy has stopped enrolment.

Although the lead investigator for the study maintains that the deaths were not directly caused by the treatments, officials are concerned that participants may not fully understand the risks involved and that they may not be appropriately protected while on the study.

The trial seeks to determine whether giving people very high doses of vitamins, in conjunction with intravenous (IV) doses of a drug, in this case disodium EDTA, could benefit older patients who have suffered a heart attack. However, chelation therapy – which is the IV dosing of a drug- has not been proven beneficial in treating heart disease. And EDTA is associated with a risk of kidney failure.

Nevertheless, more than half of the physicians involved in the study make money from selling chelation therapy, which is a direct conflict of interest, some argue. Furthermore, some doctors involved in the study have been disciplined by state boards or have criminal records, and have been asked to drop out.

Currently, there are 1,500 participants enrolled at over 100 study sites in the US and Canada.

An earlier trial of chelation therapy in autistic children was halted completely because of safety concerns.

SEPT-26-08: Government probes chelation-heart disease study [AP: CHELATION STUDY HALTED ]

Legal Help

If you or a loved one has suffered illness in this situation, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Last updated on Sep-30-08