September 28, 2008
Government Investigates Alternative Medicine Test
By MARILYNN MARCHIONE
By Marilynn Marchione
The largest alternative medicine study the government has ever launched has stopped enrolling people while officials investigate whether participants were fully informed of the risks and are being adequately protected.
More than 1,500 heart attack survivors are involved in the research, which tests a controversial treatment called chelation. It is mainly used to treat lead poisoning.
More than two people have died, although the Miami doctor leading the study said the deaths were not a direct result of the treatments. He said he doesn't know exactly how many deaths have occurred.
He also 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.
"We think we have a safe and ethical trial and we're protecting our patients," said the leader, Dr. Gervasio Lamas of the University of Miami.
Federal officials confirmed their inquiry of the $30 million study on Thursday. Those directing the research, conducted at 100 sites around the United States and Canada, voluntarily stopped enrolling patients earlier this month after the investigation was launched.
The research was designed to test very high doses of vitamin and mineral supplements and chelation, which has not been proved effective for heart disease. Chelation (pronounced kee-LAY-shun) involves intravenous doses of a drug, in this case disodium EDTA, that proponents claim will bind to calcium built up in artery walls and help flush it from the body.
Conventional treatments for heart disease include medicines, surgery and artery-clearing angioplasty.
When the study was approved in 2002, federal officials said many heart patients were exploring chelation therapy, and the research would give answers about whether the treatment was safe and effective.
A similar philosophy was behind an effort to test chelation on autistic children. However, the government recently scrapped that plan, citing safety concerns as one reason.
The heart disease study was based on misrepresentations about safety and effectiveness and "should never have been approved," said Dr. Kimball Atwood, an anesthesiologist in suburban Boston and an assistant clinical professor at Tufts University.
He sent a complaint about the heart study to the federal research protection agency, and recently published a report detailing alleged problems.
"The consent form is inadequate. It doesn't tell people, for example, that people have died from this drug," said a report co- author, Liz Woeckner. She is president of Citizens for Responsible Care and Research. More than half of the doctors running the study make money by selling chelation treatments - a conflict of interest, critics say.
The heart disease research was designed to test the effectiveness of very high doses of vitamin and mineral supplements and chelation in comparison with conventional treatments for heart disease that include medicines, surgery and angioplasty.
Originally published by BY MARILYNN MARCHIONE.
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