LOS ANGELES (AP) - A heart disease treatment
that many doctors consider to be fringe medicine unexpectedly showed
some promise in a federal study clouded by ethical and scientific
controversy, causing debate about the results.
The study took 10 years,
cost taxpayers $30 million, involved several doctors convicted of
felonies and spurred a federal probe into patient safety. Even the lead
researchers say the treatment cannot be recommended without further
research.
The study tested chelation - periodic intravenous infusions that
proponents say may help remove calcium from hardened arteries around the
heart. Chelation has long been used to treat lead poisoning but its
safety and value for heart disease are unproven.
The heart disease version
involves a different drug that does not have government approval for any
use in the United States. However, alternative medicine practitioners
have been ordering it custom-mixed from compounding pharmacies -
businesses like the Massachusetts one involved in the current meningitis
outbreak - and treating people with it.
More than 100,000 Americans
use chelation, often out of distrust of conventional medicine and
sometimes in place of established treatments such as
cholesterol-lowering medicines and stents to open clogged arteries.
Treatments cost $90 to $150 apiece, usually are done weekly for 30 weeks
and then less often, and are not covered by insurance.
On Sunday at an American
Heart Association conference in Los Angeles, researchers said that a
chelation mixture they tested in a study of 1,708 heart attack survivors
led to fewer complications - repeat heart attacks, strokes, deaths,
hospitalization for chest pain or need for an artery-opening procedure.
Four years after treatment,
26.5 percent of the chelation group had one of these problems versus 30
percent of those given dummy infusions.
However, 17 percent of
participants dropped out before the study ended, and only 65 percent had
all 40 infusions they were supposed to get. The missing and incomplete
results make it unclear whether the benefit credited to chelation could
have occurred by chance alone. The results have not been published in a
medical journal or vetted by independent scientists, another reason
doctors are leery.
"The study in my view is
inconclusive," said Dr. Steven Nissen, the Cleveland Clinic's
cardiovascular chief who had no role in the research.
"Chelation has been
practiced by physicians on the extreme fringes of medicine" and many
involved in this study offer "a variety of other quack therapies,"
Nissen said. "I'm really worried about harm coming to the public.
Patients should not seek this therapy on the basis of this trial."
Others including the Heart Association praised the government for doing the study.
"Patients are doing this
with or without our permission" so it's important to test, said Dr. John
G. Harold, president-elect of the American College of Cardiology and a
doctor at Cedars-Sinai Heart Institute in Los Angeles. He said at least
two of his patients had suffered heart failure after getting chelation
in Mexico.
Dr. Gary Gibbons, director
of the National Heart, Lung and Blood Institute, which funded the study
with the National Center for Complementary and Alternative Medicine,
called it "a first step" and urged caution about results that suggest "a
marginal benefit."
This chelation seemed safe
in this study, where steps were taken to minimize complications and
exclude people likely to suffer them, he said. "Further research needs
to be done before this can join the mainstream of cardiovascular care."
Other experts questioned
the results, especially because 60 more people in the group getting
dummy infusions withdrew from the study than in the group getting
chelation. Usually, more people in a treatment group drop out because of
side effects, said Dr. Christie Ballantyne, a Baylor College of
Medicine heart specialist. To find the opposite is "a red flag" that
suggests those who got dummy treatments found that out and decided to
drop out.
"There's something funky
going on here," Ballantyne said. "It raises questions about study
conduct," especially since a difference of one or two people or
complications could have nullified the small overall benefit researchers
reported.
Dr. Clyde Yancy, a Northwestern University cardiologist and a former Heart Association president, agreed.
"It's funny business," he said. "I've never seen a study in which one in five people withdrew consent."
The study's leader, Dr.
Gervasio Lamas of Mount Sinai Medical Center in Miami, said: "The trial
needs to be taken for what it is - a step towards future investigation."
It initially aimed to
enroll 2,400 people in the United States and Canada but recruitment
lagged and the goal was reset to 1,700.
In 2008, a group of
scientists published a long article criticizing the trial, saying
participants had not been warned that others had died from chelation.
More than half of the doctors running the study make money by selling
chelation treatments - a conflict of interest, they complained.
Investigations by the
Office for Human Research Protections and the Food and Drug
Administration found that several doctors doing the study had been
accused of poor practices by state medical boards or involved in
insurance fraud, and at least three were convicted felons. That did not
prevent them from doing federal research, the government decided, and
let the study go on after corrective steps. By that time, 1,500
participants had already been enrolled.
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