There Is No “Alternative Medicine”

“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.

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.

Rashid Buttar, an osteopathic doctor in North Carolina, may be the most famous chelation evangelist, thanks to his ties to the anti-vaccination activist Jenny McCarthy as well as his high-profile 2009 treatment of the cheerleader Desiree Jennings. Jennings said a flu shot had left her able to walk only sideways or backward—a symptom that was reportedly ameliorated by listening to Coldplay, and by chelation. News outlets loved the story. Today, Buttar has a thriving clinic that offers 59 forms of IV therapy, advertised with strident anti-establishment rhetoric: “It’s about time, and long overdue, that you are finally made aware of the facts.”

“Alternative medicine” is itself a strange notion, in that there are really only three kinds of medicine: medicine that is proven to work, medicine that is proven not to work, and medicine that has not been conclusively studied. The problem with treatments in the latter two domains—aside from expense and risk of adverse effects—is that they may divert sick people from legitimate therapies. As Nissen put it, patients in need of serious medical care “get some kind of wacky therapy. I see this all the time in my practice.” He considers this a public-health issue, with chelation research diverting money from pressing causes. “Americans spend $40 billion a year on quack therapies,” he said, adding that this doesn’t mean the government should fund studies of them all.

Of course, even though it sometimes seems otherwise, the medical community is capable of reversing its positions in the face of new research. Taking estrogen after menopause once seemed to help prevent heart attacks, but research later showed the opposite. Doctors used to recommend low-fat diets; now we regret demonizing healthy fats. Lamas says unexpected results should be welcomed, because they give doctors a new handle on disease. One of his takeaways from this study is that environmental pollutants are a modifiable risk factor for cardiovascular disease. “Stated that way, it seems reasonable.”

The toppling of old teachings is rarely swift, though. As the Stanford cardiologists David Maron and Mark Hlatky wrote in American Heart Journal, referring to Lamas’s study, doctors’ biases can blind them to unexpected results. Similarly, in one of the American Heart Association’s journals, the cardiologist Sanjay Kaul of Cedars-Sinai Medical Center noted a double standard on the part of many doctors, contrasting their resistance to research on “so-called dubious quack cures” with their eager anticipation of studies on “de rigueur cures such as gene transfer or stem cell therapy.”

Mainstream institutions seem to be slowly warming to the discussion. The Mayo Clinic invited Lamas to deliver a grand rounds lecture to its cardiology department last month. In April, he returned to Brigham and Women’s, where he’d trained, to do the same. The lecture hall was overflowing, with the paragons of cardiology gathered in the front row. “These are people that I’ve known for many years,” Lamas said, “but they’re not going to let you get away with bullshit.”

Lamas has asked the NIH to fund another study, this one focusing on people with diabetes, to test his findings. That would begin in 2016. In the meantime, his hospital will become the first in the United States to offer EDTA treatment for cardiovascular disease. “I think this will bring some recognition to the hospital as well as some flack,” Lamas said. “I’ll take the flack.” He believes he can no longer tell patients that a statin medication, an ACE inhibitor, and annual cardiac stress tests are all he has to offer. “That doesn’t really go along with my medical ethics. I feel like I’m lying.”