The liquid swirling down the dangling, plastic tube and into Richard Curren’s vein might prevent future heart attacks and other cardiovascular problems in the 73-year-old diabetes patient.
This liquid infusion, Curren’s second, with 38 more to come over the next 10 months, might also be saline — a placebo that helps researchers sort the efficacy of treatments in clinical trials.
And five years from now, when all the data from more than 1,100 patients across 100 sites in the United States and Canada, including Mount Sinai Medical Center, is crunched and analyzed, medical professionals might find that chelation therapy just plain failed.
But Dr. Gervasio Lamas, chairman of medicine and chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center, is very optimistic about this clinical study, a follow-up to the 2002-2012 Trial to Access Chelation Therapy (TACT), which he oversaw.
That outcome astounded him.
“These are spectacular results. If I really thought there’s nothing here, I wouldn’t be spending this amount of time [15-plus years] on it,” he said of the treatment that has been shown to “grab” and remove toxic metal pollutants — like lead or cadmium — from the blood.
Lamas is one of several local clinicians who have entrenched themselves in years-long studies researching treatments to help diabetic patients.
At UHealth — University of Miami Health System, Dr. Gianluca Iacobellis, professor of medicine and the director of UM’s Hospital Diabetes Service, said his studies indicate an active role of epicardial fat in predicting diabetes and coronary artery disease. He has pioneered and validated a simple ultrasound technique to measure this fat surrounding patients’ hearts.
Iacobellis is leading several clinical trials on novel diabetes drugs targeting this fat. The drugs have been shown to dramatically shrink the fat volume (by up to 40 percent), which leads to a significant improvement in diabetes-related heart diseases, he said.
“I think this will definitely open new avenues in diabetes treatment,” he said.
Type 2 diabetes has been a part of Curren’s life for 12 years. The Mount Sinai clinical trial patient said he is 50 pounds overweight. And while the retired travel agent and graphic arts photographer — who also worked as a magician, taught scuba diving and trained dogs professionally — used to be very active, he’s become more sedentary over the last few years. Still, his wife of 53 years, Sheila Curren, a licensed clinical social worker, urges him away from the fried chicken and hamburgers and toward fresh greens. Not that he doesn’t sneak a potato chip from time to time.
Even though Curren might be receiving a placebo instead of the actual intravenous treatment mixed with oral vitamins, he said sitting through the three-plus-hour procedure once a week (for a total of 40 weeks) is worth it.
“I have two goals: I hope I’m furthering the research and I’m hoping it will improve my health,” he said, bottle of water, a copy of “Miami Babylon” and step-tracking watch at his side. “I also hope I’m not getting the placebo.”
Still, said Xiaoou Pan, a clinical research coordinator for cardiology research at Mount Sinai, some people’s health improves just from the placebo. She credits the psychological effects stemming from the patient’s feelings of receiving medical care.
In the original TACT study, according to Lamas, the chelation treatment reduced the recurrent cardiac events in patients by 41 percent, the number of heart attacks by 50 percent and deaths by 43 percent over five years. For TACT2, in which Curren is taking part, doctors are hoping to test more than 1,100 patients in the United States and Canada.
The National Center for Complementary and Integrative Health (NCCIH) of the National Institutes of Health (NIH) has awarded $37 million to Mount Sinai and the Duke Clinical Research Institute to initiate this second trial. The results the first time around were such a surprise to clinicians that medical professionals shook their heads, wondering if the results were a fluke, Lamas said.
Chelation therapy has been used since the 1940s for treating people suffering from industrial lead poisoning. Then, Lamas said, “one bright physician” contemplated whether the treatment might extract calcium out of the coronary arteries. High calcium levels in the blood have been linked to heart issues.
But the treatment slipped into the alternative medicine arena and reputable scientists later dismissed it as quackery.
More than a decade ago, one of Lamas’ diabetes patients asked about chelation therapy, having heard about it. Lamas delved into research and opted to spearhead the original TACT study.
“I had been taught my entire professional life that this treatment was nonsense. But, by God, it turns out that chelated patients who received active infusions had fewer cardiovascular events,” he said of TACT.
“Following the treatments, patients by the next day were excreting (urinating) 4,000 percent more lead, 700 [percent] more cadmium, 250 percent more aluminum and 150 [percent] more nickel. It was shocking,” Lamas said.
The doctors’ responsibility at this point, Lamas said, is to reproduce the original study and nail down the results, to show that TACT wasn’t a statistical anomaly.
And these doctors need patients’ help to do this. Hence, the effort to recruit patients for the studies.
Recruiting diabetes patients
TACT2 is recruiting participants to be part of a study at more than 100 clinical sites throughout the U.S. and Canada. Candidates must be 50 or older, have diabetes and have experienced a prior heart attack. Interested patients can contact the study team at www.tact2.org or by calling 305-674-2260. Additionally, you may contact Dr. Lamas directly at firstname.lastname@example.org.