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Feds Investigate Chelation Study

Posted by Chrissie Cole
Monday, September 29, 2008 12:25 PM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, Chelation Therapy, Heart Disease, Alternative Medicine, Disodium EDTA


IMAGE SOURCE: © iStock Photo / Heartbeat / author: Eraxion

The largest alternative medicine study of its kind, ever launched by the U.S. government has been halted while federal officials investigate alleged claims that participants were not fully informed of the inherent risks, reports the Associated Press.

The $30 million dollar study, involves a controversial treatment called chelation therapy (pronounced kee-LAY-shun), a technique typically used to treat individuals suffering from lead or metal poisoning. 1500 heart attack patients were enrolled in the trial.

Officials know of at least two patients that have died, but, the lead doctor of the trial says the deaths were not directly related to chelation therapy treatments and he is unsure how many deaths there are in total.

He further acknowledged some of the doctors involved in the trial have been chastised by state boards and/or have criminal records and were asked to leave the trial. “We believe we have an ethical and safe trial and we are protecting our patients,” Gervasio Lamas of the University of Miami tells the AP.

More than 100 sites that were conducting trials across Canada and United States have voluntarily halted patient enrollment since the beginning of September while the federal officials investigate. Read more information about the TACT Trial.

The intention of the study was to test high doses of mineral and vitamin supplements along with chelation therapy, which has not been proven effective for the treatment of heart disease. Chelation therapy involves IV doses of a drug; in this instance disodium EDTA, which proponents claim will bind to calcium built up in artery walls and therefore flush it from the body.

First approved in 2002, federal officials said several heart patients were examining chelation therapy and the research would help to establish whether treatment was safe and effective.

Health officials canceled a similar study planned to test chelation therapy in autistic children, due to safety concerns. Its use as a potential autism treatment is based on the theory that mercury in vaccines in the form of the preservative, thimerosal, triggers autism.

The heart disease trial should have never been granted approval, it was based on falsely presented safety and effectiveness, said Dr. Kimball Atwood, an anesthesiologist and clinical professor at Tufts University.

Dr. Atwood, along with several others, sent a joint complaint about the trial to the federal research protection agency and published a detailed report outlining the alleged problems with the trial.

The patient consent form lacks important consumer safety information and health warnings. For instance, it doesn’t warn participants, “that patient deaths have been linked to this druge and use,” said Liz Woeckner, report co-author and president of Citizens for Responsible Care and Research, or CIRCARE, a nonprofit group focused on research safety.

The American Heart Association and other groups have spoken out against chelation therapy saying treatment is experimental and of unknown value or risk for heart disease patients. #

1 Comment

Anonymous User
Posted by Mike
Tuesday, September 30, 2008 10:56 AM EST

As a chemist and father of a child with mercury poisoning (autism), I'm so happy the autism/ chelation study was cancelled. This study, like all government studies on autism, was designed to show that chelation doesn't work rather than looking for benefits. For example, it was going to be based on mercury levels in the blood. Every competent toxicologist knows that ethylmercury, the type found in vaccines, quickly clears the blood is rapidly distributed to the brain. The type of chelation agent proposed for the study, DMSA, does not cross the blood brain barrier and would have no effect on this mercury. There are other chelating agents that do work. The best test for evaluating body burden mercury is a Urinary Porphyrin Profile. This test is backed by clinical data collected in studies using primates and dentists. As far as the heart study, the American Heart Association is a big part of the sickness industry. They hate competition, especially from something that actually improves one's health.

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