Chelation therapy: a $31 million study

A study that unexpectedly, divisively suggested that using chelation to rid the body of metals could prolong some lives

There Is No “Alternative Medicine”

Sébastien Thibault

A controversial treatment designed to remove environmental metals from the body might be effective in treating heart disease. Will one renegade doctor persuade the rest of the medical establishment to consider it?

“For me, this is the big one.” Gervasio Lamas, the chief of Columbia University’s cardiology division at Mount Sinai Medical Center in Miami Beach, took out his phone and tapped the battery. “Cadmium. This thing ends up in the dump in West Palm Beach, and then I end up drinking it.”

Having recently finished a $31 million study of chelation therapy—a study that unexpectedly, divisively suggested that using chelation to rid the body of metals could prolong some lives—Lamas has joined a growing battalion of physicians concerned about the health effects of heavy metals.

Chelation has for some time occupied a crucial niche in mainstream medicine. The therapy, which commonly involves an intravenous infusion of ethylene diamine tetraacetic acid (EDTA), was approved by the FDA in 1953 to treat lead poisoning. Today, if you find yourself uncharacteristically bellicose after eating some antique paint, any credible doctor will recommend chelation. EDTA will form an ionic bond with the lead in your blood, flushing it through your kidneys and into your urine. You will begin to cast metal forth with haste and ardor, and you will be well. But Lamas was not interested in using chelation to prevent lead-induced psychosis. He was interested, as so many cardiologists are, in heart disease.

Every year, more than 100,000 Americans undergo chelation, most at the hands of alternative-medicine practitioners. Sick, desperate, and uninformed or misinformed, they believe that “cleansing” their blood via chelation will address conditions as varied as arthritis, hormonal disorders, and cardiovascular disease. In the process of their treatment, they are cleansed not only of bodily metals, but also of a few thousand dollars.

One day in 1999, a disheveled man (Lamas describes him as resembling Lieutenant Columbo, but with heart disease) came to Mount Sinai asking whether chelation therapy was worthwhile. “Of course not,” Lamas told him. “That’s quackery. It might be dangerous, it’s certainly costly, and it’s not going to do you any good.”

But that night, Lamas found himself dwelling on his dogmatic response. “It’s not like I had a class on chelation therapy,” he told me, his eyes closing as he smiled. On the windowless walls of his office hang his Harvard degree, a certification of training from Boston’s prestigious Brigham and Women’s Hospital, and one of his many New England Journal of Medicine articles—his past work includes seminal research that changed how cardiologists use pacemakers. Earlier in his career, he said, researching an alternative-medicine practice never would have crossed his mind. In Miami, though, the culture is more “open-minded.” So he called up the National Institutes of Health and set about procuring the funds to get to the bottom of his Columbo dilemma.

“They offer every bizarre treatment possible … They’re warning people not to get immunized.”

Fourteen years and 55,222 infusions later, the results of Lamas’s massive chelation study were revealed to him. (As the principal researcher in a double-blind study, he did not know which treatments had contained EDTA, and which a placebo.) A definitively positive finding stood to change the way heart disease is treated: if EDTA proved beneficial and safe, it could be used to treat the half million or more Americans who survive heart attacks each year. “I’ve never been in a trial where I had such great desire for one result,” Lamas said. “There were organizations that are really focused on preventing chelation-therapy research.” He continued, “That turned my stubbornness up. So I wanted it to be positive.”

And it was positive, officially. People who received chelation after a heart attack had a 26 percent chance of another heart attack (or stroke, or hospitalization for angina, or a procedure like bypass surgery) within the next five years. People who got placebo infusions had a slightly higher risk—30 percent (a difference that’s statistically significant, but barely). Among patients with diabetes, the result was more impressive: chelation reduced deaths in diabetic heart-attack survivors by 43 percent over five years. But this subset of patients was small. And an unusually high number of people had dropped out of the study.

Critics used these points to cast doubt on Lamas’s findings. Even before the study was completed, self-appointed medical watchdogs published blistering critiques, highlighting the fact that more than half of the clinics in the study practiced alternative medicine, and some offered notoriously unscientific treatments. When Lamas’s results were published in The Journal of the American Medical Association last year, they were accompanied by a scathing editorial from Steven Nissen, the chairman for cardiovascular medicine at the Cleveland Clinic, who called the study a dangerous failure.

Nissen had perused the Web sites of the clinics involved in the trial, and was appalled.

“They offer every bizarre treatment possible,” he told me, from stem-cell therapy for growing breasts, to treating diabetes with cinnamon.

“They’re warning people not to get immunized. These are the same people that are going to be doing a high-quality scientific trial? You gotta be kidding.” Nissen is adamant that Lamas’s study will be seen as an endorsement of chelation and will lead to a public-health “catastrophe.”

Lamas and his co-authors anticipated pushback, and the study’s conclusion is guarded. He read aloud to me from the copy on his bookcase:

“These results provide evidence to guide further research but are not sufficient to support the routine use of chelation therapy.”

“That’s a huge word, routine,” I said.

“I fought for that word. I spoke with the editor in chief of JAMA and said, ‘Listen, you gotta give the clinician a way out.’ So they let routine stay in. I, personally, have no routine patients.”

If you dig into the medical journals, you’ll find that in 1956, a group of Detroit doctors conducted an early, tiny study of chelation’s effect on people with heart disease. Of 20 patients, 19 experienced “unusual symptomatic relief” following chelation, and six showed improvements on their electrocardiograms. The researchers hypothesized that since atherosclerotic plaque contains calcium, it made sense that binding calcium with EDTA and flushing it from the body would be therapeutic. “A way is open,” they wrote, “that must be substantiated by time and the independent results of many competent investigators.”

Those competent investigators never materialized. Pharmaceutical companies did not invest in research, because they couldn’t make any money on cardiovascular chelation—the relevant patents have expired. And so chelation fell into the hands of the practitioners whose Web sites Nissen toured.

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