The June 16 edition of Pulse of Health Freedom discussed the suspension of the NIH-sponsored clinical trial for chelation therapy known as the TACT study. The study’s investigators and coordinators have now been notified to resume all TACT activities, including the chelation infusions, patient follow-up, and vitamin distribution.
Critics of the study alleged that inadequate safeguards were being taken to ensure the protection of the human research subjects. But the subtext—at least in some quarters—was anger that federal money was being used to test “alternative medicine.” To address the criticisms, the Compliance Oversight Coordinator at HHS’s Office of Public Health and Science requested that the three institutions involved (Duke, the University of Miami, and Mt. Sinai Medical Center) investigate the allegations. The institutions did so, and submitted their findings in November to the Compliance Coordinator. The Compliance Coordinator evaluated their responses, and on May 27 sent a letter to the institutions requesting they develop a plan by June 30 to address the criticisms.
Chelation therapy has been practiced by a significant minority of physicians in the US since 1952, and has been administered to many thousands of patients with a high degree of safety. Chelation therapy involves the use of a man-made amino acid that chelates heavy metals from the body—primarily lead and, to a much lower extent, mercury. Mainstream medical studies have linked lead exposure to elevated blood pressure and mercury exposure to a higher incidence of cardiovascular events like heart attacks.
Go to www.acam.org to read more about chelation therapy and the TACT trial.
Even as the TACT Trial resumes, a threat by the FDA to ban the chelator used by most physicians remains outstanding. The FDA has said that such a ban is a possibility but has not provided any further information.
Pulse of Health Freedom June 30, 2009