Chelation Study Suspended

The Associated Press reports the chelation heart disease study has stopped enrolling people while officials investigate whether participants were fully informed of the risks and are being adequately protected. Partcipating in the study are more than 1500 heart attack survivors including Canadians. Dr. Gervasio Lamas of the University of Miami acknowledged that some doctors who had been involved in the study have been disciplined by state boards or have criminal records and have been asked to drop out. Liz Woeckner, president of Citizens for Responsible Care and Research, or CIRCARE, a non-profit group focused on research safety, is quoted as saying “The consent form is inadequate. It doesn’t tell people, for example, that people have died from this drug,”. Chelation has been highly controversial, and the American Heart Association and other groups have spoken out against it. Chelation involves intravenous doses of a drug disodium EDTA. EDTA ia a synthetic amino acid infused intavenously to remove calcium deposits. It is known to cause kidney failure, bone marrow problems, shock, low blood pressure, convulsions, heart rhythm problems, allergic reactions and breathing troubles. However the trial itself has not been stopped. Legal practitioners will want to consider whether particpants in the study received adequate disclosure of the risks involved. The provision of information in the process of obtaining consent to treatment that is of a trial nature requires a much higher degree of disclosure that that required for medically accepted treatment. The fact of the suspension itself is a material consideration which should be brought to the attention of participants.