For daring to study a discredited therapy, this doctor earned scorn — and a $37 million grant

MIAMI BEACH, Fla. — The new heart patient asked Dr. Gervasio Lamas if he thought chelation therapy was worth a try. “Of course not!” the cardiologist replied emphatically. His Harvard training had taught him that alternative therapies were a waste of time and money, and potentially risky to boot. “I told him it was quackery.”

But Lamas went home that night unsure if he had given his patient the best medical advice. He looked up research on chelation therapy, which removes heavy metals from the body, and found very little data either supporting or contradicting the procedure.

Lamas was troubled by the idea that he had offered this man a medical opinion that wasn’t supported by science. And he decided to conduct a study himself. He had no idea what he was getting into.

Seventeen years later, his research into a therapy many of his colleagues consider bunk has earned him scorn and sideways glances at medical meetings. Some accuse him of wasting taxpayer money. But Lamas persevered — even briefly taking out a second mortgage on his house to help pay for a clinical trial.

Three years ago, he announced results of that $30 million study: Chelation was safe and potentially helpful. The conclusion shocked the mainstream medical world, including Lamas. After all, the procedure had been so discredited that doctors previously could lose their medical licenses for using it.

Now, he’s launching a second trial, with $37 million from the National Institutes of Health, to study chelation’s effect on diabetics with heart disease. That’s not sitting well with some scientists.

Steven L. Salzberg, director of the Center for Computational Biology at Johns Hopkins University, said it’s “just crazy” to do another trial. “There are better ways to use this money to study much more promising treatments of all sorts,” he said.

Salzberg, who writes the Fighting Pseudoscience blog on Forbes.com, said the history of science is littered with studies that began with good intentions or were conducted by nice people, but were still bad ideas. “There are many legitimate MDs who’ve come up with theories that were just wrong, but clung to them, despite all the evidence to the contrary,” Salzberg said. “I wouldn’t put them in jail, but I’m not going to give them $37 million.”

For his part, Lamas said he has learned to ignore the critics and just follows the evidence. If the study had shown chelation to be completely useless, he would have believed the results. So why shouldn’t he believe the data now?

Lamas, chair of medicine and chief of cardiology at Mount Sinai Medical Center Miami Beach, was wounded by the sharp criticism at first. “I used to get sensitive to that stuff,” he said.

But he’s more comfortable now, and says he feels more accepted by his peers. He compares himself to a friend who suddenly starts wearing an odd hat. At first, all you notice about him is the hat — wondering why he’s wearing it. Eventually, the hat just becomes part of the friend, and you say, “That’s a nice hat, where did you get it?” Lamas said.

His colleagues aren’t rushing out to buy their own hats, though. Nobody else is willing to study chelation. Conventional doctors still think it’s junk medicine. Alternative medicine practitioners are happy to have the scientific support, but don’t find it necessary. And drug companies can’t make money on a therapy that had been off patent for decades.

Without Lamas, said his collaborator, Dr. Daniel Mark of Duke University Medical Center, there would be no one looking for answers.

An unlikely champion

Lamas, 64, is an unlikely champion of medicine outside the mainstream. His career has been as conventional — and accomplished — as virtually any of his peers.

Born in Cuba, Lamas arrived in the United States at age 8 speaking no English. But he caught up fast. He went to Harvard for his undergraduate degree and then to New York University for medical school. He trained at Brigham and Women’s Hospital in Boston, and stayed at the Harvard-affiliated hospital for 15 years, building his reputation before leaving for Miami in 1993.

He counts as close friends some of the most respected names in cardiology.

Dr. Judith Hochman, now a cardiologist at NYU Langone Medical Center, was a resident at the Brigham when Lamas, fresh out of medical school, was assigned to be her intern. She appreciated that he didn’t need much supervision — “he was a whiz kid” — and treated her respectfully at a time when women were a clear minority in medicine.

Hochman scoffs at Lamas’s critics. “He’s an outstanding physician and an outstanding scientist, who adheres to the highest ethical standards,” she said. “He’s not one of these types who’s a zealot for x or y or is committed to any particular therapy.”

Colleagues describe Lamas, whom they call Tony, as funny, charming, and unfailingly polite — and two said he dances well. (The compliment made Lamas laugh. He only looks good when salsa dancing, he said, because those colleagues can’t do it at all.)

Lamas’s former mentor Dr. Marc Pfeffer, a cardiologist at the Brigham and Harvard Medical School, thinks chelation is more magic than medicine, but said his friend’s research is important because so many people are using the therapy on their own “without the evidence.”

According to federal survey data, 66,000 people used chelation for all purposes (not just heart disease) in 2002, and 111,000 used it in 2007, the last year for which there is reliable information.

At the Brigham, Lamas was known as “the pacemaker guy” — he spent most of his research time designing pacemaker studies. He couldn’t have done a trial looking at heart failure, “because there was a guy whose career depended on that,” Lamas said. Feeling boxed in, he moved to Miami. He said he also wanted to be closer to his aging father — a doctor, too — and to run his own department: “Sometimes you have to leave home.”

In academic careers, physicians are rewarded for excelling at research; seeing patients is extra. In the life Lamas has carved for himself in Miami, seeing patients comes first.

“For a clinical scientist, you have to have a patient population to understand what the problem is,” he said, sitting in his large, but spare, office, its white walls decorated mainly with his diplomas and awards.

He’s built a strong rapport with his patients. Many academic doctors never think to ask their patients about alternative therapies, and patients don’t feel comfortable revealing them. Lamas’s patients did.

Lamas’ daughter, Daniela, a pulmonologist and critical care doctor at the Brigham, said her father is driven by curiosity and genuine concern for patients, and takes interest in their lives. “It’s not just a job, but part of who he is,” she said.

On a recent day, one older couple drove 45 minutes from Hialeah to Miami to see Lamas, though there’s a Mt. Sinai-affiliated clinic in their town. The doctor tried to convince the man to see a cardiologist closer to home, but he wouldn’t hear of seeing anyone but Lamas.

“I have only one life. I have to take care of that one,” the man insisted.

Speaking his native Spanish, Lamas told the man he needed to dial back on his beloved Cuban food.

“It’s the best. It’s the worst, too,” the man responded in English, nodding.

The last patient of the morning was the first of the day who also had diabetes and therefore was a good candidate for the new chelation therapy trial, called TACT2. A researcher came in after Lamas’s consultation and provided information about the study, speaking in carefully learned Spanish.

The patient’s daughter seemed dubious. She worried aloud about having to drive him to the 40 required appointments, each lasting three hours, while juggling her kids’ schedule. The trial will pay for taxis, the researcher assured her. But she still wasn’t convinced. She wanted to show the study material to her pharmacist husband. And she worried about her father getting bored.

Making a giant clinical trial work is part science, part human relations. Lamas, colleagues said, has been incredibly successful at getting patients and fellow doctors to sign on to the two TACT trials.

Lamas was “masterful” in getting mainstream and alternative doctors to work together on the first trial when both were convinced the other was dead wrong, said Mark, a co-principal investigator on both studies. “Talk about a Herculean task,” he said. “This is about as Herculean as it gets.”

Allan Magaziner, a doctor of osteopathic medicine in Cherry Hill, N.J., who has been involved in TACT since the beginning, said he was impressed that Lamas was willing to think outside the box. “He had the interest and the curiosity, which most doctors unfortunately don’t have,” he said of Lamas. “And he put his career on the line to some extent.”

Mark, director of outcomes research at Duke University Medical Center, compared Lamas to Captain Picard, the captain on the TV show “Star Trek: The Next Generation,” who gets his crew fired up to face whatever is coming next. Like him, Mark said, Lamas “convinces people they want to be on his team.”

Not a zealot

Lamas started the TACT1 trial certain he knew what it would show. He hoped chelation wasn’t dangerous, but he wanted to be able to tell patients with confidence that it was also a waste of their time and money.

Chelation works — if it does — by magnetically latching onto heavy metals sequestered in cells, and flushing them out of the body through the urine. Back in the 1950s when it was first used to treat heart disease, chelation was thought to remove calcium, deposits of which can restrict blood flow through vessels.

Now, Lamas thinks the EDTA (ethylene diamine tetra-acetic acid) chelation drug he uses, a synthetic amino acid that is delivered intravenously, goes after lead and cadmium instead. In one small pilot trial, a patient secreted 3,800 percent more lead the day after an EDTA infusion than the day before, he said.

Cadmium and lead can damage the circulatory system in a number of ways, including by inactivating the body’s antioxidant defenses and damaging the cells that line the blood vessels.

For seven years, Lamas and his colleagues were “blinded” to the results they were collecting, unaware of which of the 1,700 patients had gotten chelation therapy in addition to their conventional treatments for four months, and which had been infused essentially with saltwater.

The trial faced repeated challenges, from an investigation into whether patients were adequately safeguarded against a treatment that conventional doctors considered dangerous to a public call for its abandonment from a group of fellow doctors.

The unveiling of results at a meeting in 2013 shocked everyone. A picture taken afterward shows a roomful of stunned faces. Chelation was safe, the study revealed. And it also seemed to be effective.

Overall, patients getting the active therapy had “modestly” fewer heart attacks and needed fewer bypass surgeries and hospitalizations for chest pain than those getting the saltwater placebo, according to the study, published in the Journal of the American Medical Association. When the researchers drilled down into their data, they realized that the patients who had both diabetes and heart disease saw all the benefits. Among the 633 test subjects with diabetes, there was a 41 percent reduction in cardiovascular events such as heart attacks, over as long as five years.

The trial’s results were received with a hail of criticism. One of the country’s leading cardiologists said it was flawed and a waste of money.

“I see this as $31 million in taxpayer money that did not yield a result that was reliable,” Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, said at the time. “Doing a poor study is worse than doing no study at all.”

Critics said the study was the result of political lobbying on the part of chelation practitioners, and noted that there was no scientific rationale to do the research. The study also relied on clinics that offered chelation — which critics don’t consider proper medical facilities. These clinics also had a financial interest in a positive outcome, and had no experience conducting clinical trials.

Two months later, the Food and Drug Administration called Lamas in to present his results. Agency officials told him that the next step was to do another trial, to see whether chelation genuinely helped diabetics. After spending a decade on the previous trial, Lamas joked that the FDA’s suggestion left him with two options: “My choice was to slice my veins on their conference table or say, ‘Thank you, what a good idea.’ I chose the latter.”

Trial and failure

Despite the time, effort, and money, the initial trial hasn’t had much of an impact. Few mainstream doctors have changed their minds about chelation, and alternative medicine therapists apparently haven’t stopped using it in patients without diabetes — though the trial found essentially no benefit in the broader heart disease population.

At one level, that’s the way it should be. No single scientific study can be considered the truth. Findings must be repeated to be confirmed.

It is the TACT2 trial that should change medical practice when it is finished in five years. If the trial shows no benefit for diabetics, mainstream cardiologists will see it as confirmation of what they’ve believed all along. They’ll be done with chelation forever. (Alternative practitioners, for their part, should stop delivering chelation for all heart disease if the second trial fails, though they likely won’t.)

If, however, it confirms the effectiveness of chelation for patients with both diabetes and heart disease, then mainstream doctors would be remiss in not at least considering a treatment that would be as or more effective than any drug on the market for the vascular complications of diabetes, Lamas said.

“This is a very striking signal that there might be something happening here,” Dr. Josephine Briggs, a kidney specialist and director of the National Center for Complementary and Integrative Health, said of the result of the first trial. But she remains skeptical about chelation: “We really need an answer that is clear-cut.”

Her center funds research into complementary medicine and is one of the government agencies that has supported both trials (along with the National Heart, Lung, and Blood Institute).

Until the results are in, though, Briggs thinks patients should avoid chelation outside of the trial.

“I’m a pretty conventional conservative practitioner. I would never have recommended this,” she said. “This is still a therapy that is not yet proven enough for diabetics and particularly not for non-diabetics.”

Practitioners who use chelation disagree. Tammy Born, an osteopathic family physician who said she treats 30 to 50 patients a day with chelation in her Grand Rapids, Mich., clinic, said the trial encouraged her to start trying chelation earlier, rather than waiting until heart disease is advanced. “I firmly believe in it,” said Born, who has used chelation for decades and charges $90 an infusion, or $1,800 for a course of 20.

“I loved seeing Dr. Lamas’s transformation,” she added. “What I have appreciated about him is he went into this trying to disprove chelation, and when he saw the results and talked to the patients … he said why didn’t we do this all the time?”

For his part, Lamas said the results of the initial trial made him wonder whether there are other alternative therapies out there, dismissed by mainstream medicine, that could be saving lives.

“But that’s for somebody else to figure out,” he said.

His main goal now, he added, is to finish the second study: “I need to see the end of this story.”