A heart disease study presented Sunday is being called a $32 million waste of time — and even a danger to public health — by some of the country’s leading health experts.
The study tested whether a controversial alternative therapy, called chelation, could reduce heart attacks and other cardiovascular problems in people who had already survived a heart attack. Chelation therapy, which can remove metals from the blood, is a risky procedure approved to treat rare, life-threatening cases of heavy metal poisoning. Tens of thousands of patients a year undergo the procedure “off-label,” however, paying about $5,000 out-of-pocket, based on the claims of doctors who say it can cure everything from Alzheimer’s to autism.
In a presentation Sunday, doctors said the National Institutes of Health-funded trial found a small overall benefit to chelation, mainly because it prevented heart problems in people with diabetes.
Yet some doctors say the study was so badly run that its marginally positive results are meaningless.
Cardiologist Steven Nissen of the Cleveland Clinic says he’s concerned the study will encourage more patients to get off-label chelation instead of following advice proven to reduce heart disease.
“This study has the potential to be extremely dangerous,” Nissen says, calling it “a poor use of taxpayer dollars.”
At least 30 patients have died from chelation therapy since the 1970s, including an autistic 5-year-old Pennsylvania boy, according to a 2008 report in The Medscape Journal of Medicine.
Even the study’s lead author says the research is not definitive and should not be used to recommend the practice. “The most exciting part of this study is that there may be an unexpected signal of benefit,” Gervasio Lamas, chief of the Columbia University division of cardiology at Mount Sinai Medical Center in Miami Beach, Fla., said in a statement. “We need to understand whether the signal is true, or whether it occurred by chance.”
The trial, known as the Trial to Assess Chelation Therapy, or TACT, has been dogged by accusations of safety and ethical problems.
The study was temporarily halted in 2008 because of concerns over ethics and patient safety. An investigation by the federal Office for Human Research Subject Protections found that patients may not have been properly informed of chelation’s risks.