Researchers stop enrolling participants
Heart disease study scrutinized

By Marilynn Marchione | The Associated Press
September 26, 2008

Federal officials are investigating whether participants in the
government's biggest-ever alternative medicine study were fully
informed of the risks and are being adequately protected, The
Associated Press has learned.

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 investigation 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.

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 and several others sent a complaint about the heart study to the
federal research protection agency, and recently published a lengthy
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, or CIRCARE, a nonprofit group focused on research safety.

More than half of the doctors running the study make money by selling
chelation treatments — a conflict of interest, critics say.

Link: http://www.sun-sentinel.com/features/health/sfl-
flaheart0926sbsep26,0,6618308.story

I'll print the 4 responses in the next post, one of which is mine
which followed this "news"