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Major Chelation-Heart Disease Study Enrollment Halted Pending Investigation

Sep 26, 2008 | Parker Waichman LLP The Associated Press is reporting that the U.S. government’s largest ever alternative medicine study has stopped enrollment while “officials investigate whether participants were fully informed of the risks and are being adequately protected.”  Over 1,500 heart attack survivors are involved in the $30 million research, which is testing chelation therapy, a controversial treatment typically used in lead poisoning.  Those directing the research—conducted at 100 sites around the U.S. and Canada—voluntarily stopped patient enrollment when the investigation began. People already enrolled are still being treated, said a spokeswoman for the National Heart, Lung and Blood Institute, study co-sponsor with the National Center for Complementary and Alternative Medicine.

While more than two people have died, the Miami doctor leading the study—Dr. Gervasio Lamas of the University of Miami—said the “deaths were not a direct result of the treatments,” according to the AP report.  Lamas also admitted that he is unclear precisely how many deaths have occurred and acknowledged that some doctors involved “have been disciplined by state boards or have criminal records and have been asked to drop out,” the AP says.

The huge endeavor was designed to test very high doses of vitamin and mineral supplements and chelation (pronounced kee-LAY-shun), and involves intravenous doses of a drug, disodium EDTA, that some believe attaches to the calcium that builds in arterial walls, helping to flush it from the body.  Chelation was recently considered in autism research; however, the government stopped that study citing safety concerns.  Meanwhile, according to Dr. Kimball Atwood, an anesthesiologist in suburban Boston and an assistant clinical professor at Tufts University, this study was based on misrepresentations about safety and effectiveness and "should never have been approved."  Atwood and others sent a complaint to the federal research protection agency, and recently published a lengthy report outlining problems.  "The consent form is inadequate. It doesn't tell people, for example, that people have died from this drug," or that the drug carries a black-box warning, said a report co-author, Liz Woeckner, president of Citiz
ens for Responsible Care and Research—CIRCARE—a nonprofit research safety group.  The federal Office for Human Research Protections determined there was merit to the complaint and opened an investigation.

According to the AP, over half of the doctors involved receive income selling chelation, a possible conflict of interest.  Study documents misrepresent what previous studies have found and "omit abundant evidence of injuries and deaths," Atwood wrote.  Woeckner and Atwood site physician licensing and criminal record problems.

The American Heart Association and other groups have spoken out against chelation.  "EDTA isn't totally safe as a drug. There's a real danger of kidney failure," bone marrow problems, shock, low blood pressure, convulsions, heart rhythm problems, allergic reactions and breathing troubles, the heart association site says.  "A number of deaths in the United States have been linked with chelation therapy and some are on dialysis because of kidney failure caused, at least in part, by chelation therapy," the site says, according to the AP report.


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