Feds probe $30 million alternative medicine trial
According to a report from the Associated Press, over 1,500 heart attack survivors have already signed up for the chelation trial but the National Institutes of Health
NutraIngredients-USA.com contacted the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health (NIH) to comment on the reports, but no comment was received prior to publication.
The Trial to Assess Chelation Therapy (TACT) is costing $30 million and involves over 120 medical centers, clinics, and physicians' offices in the US and Canada.
Chelation therapy uses the man-made amino acid EDTA. The compound is claimed to bind to calcium in the arteries and remove it from the body. A build up of calcium in the arteries leads to a hardening of the arteries and an increased risk of cardiovascular complications.
Since chelation treatment also strips the body of vitamins and minerals the participants are also receiving high-dose vitamin supplements.
“Many people are considering using chelation therapy because of the belief that it may treat heart disease. However this has not been scientifically proven,” explains NCCAM on its website. “Past studies did not show benefit, but may have been too small to be conclusive. That is why the National Institutes of Health is conducting this large study to find out whether chelation therapy is safe and effective in treating heart disease.”
However, reports of two deaths amongst the participants and the acknowledgement that some of the researchers involved have been asked to quit following disciplinary or criminal records revelations, has refocused attention on the trial.
The trial’s leading researcher, Dr Gervasio Lamas of the University of Miami, told the AP that the deaths were not connected to the treatment, and he defended the trial.
"We think we have a safe and ethical trial and we're protecting our patients," said Dr Lamas, according to the AP.
The decision to suspend recruitment was reportedly taken by Dr Lamas following the announcement of the NIH probe.
The main problems have come about by suggestions that the study was based on misrepresentations concerning the safety and effectiveness of chelation therapy. Moreover, others have criticized the consent form, which was described as inadequate by Liz Woeckner, president of Citizens for Responsible Care and Research, or CIRCARE, a non-profit group.
The American College for Advancement in Medicine (ACAM) a not-for-profit association advocating the use of complementary and alternative medicine announced its support for the NIH’s decision to suspend patient registration “until allegations of impropriety can be proven false”.
“ACAM believes that the TACT trial represents a important milestone in assessing the role of chelation therapy in modern healthcare and respects the decision of the NIH,” said ACAM.
"We believe that the Office of Human Research Protection (OHRP) will find that the allegations are of a political nature,” said Jeanne Drisko, MD, ACAM’s president.
“To serve the best interests of participants enrolled in the TACT trial and all patients and their physicians who seek answers about chelation therapy, we call for a swift end to the moratorium and resumption of the trial."
