Florida probes: Did stem cell therapy kill cardiologist’s patient? They offer hope to many people burdened with incurable and devastating ailments. But some stem cell therapies have ended up serving heartbreak, instead.
In the latest of many cases that have cropped up across the globe since the first stem cells were isolated in 1998, a cardiologist from Florida stands accused of causing the death of his patient by carrying out an illegal stem cell therapy.
The Florida Department of Health (FDOH) filed a complaint last August (2011), accusing Dr. Zannos Grekos of treating a 69-year-old breast-cancer survivor, found to have blocked carotid arteries, with an “experimental stem cell procedure” that involved injecting autologous bone-marrow aspirate into (her) cerebral circulation.”
According to the state complaint, the woman had consulted with Dr. Zannos on Feb. 17, 2010, complaining of tingling and numbness in her extremities after undergoing six cycles of chemotherapy for breast cancer that had been diagnosed in 2006.
A week later, on Feb. 25, the patient, whose identity isn’t revealed in the complaint, underwent carotid imaging at the cardiologist’s office. This showed a 29 percent blockage of both carotid arteries, the formal complaint unveils.
On March 24, 2010, Dr. Grekos did a cerebral angiogram, an imaging of the brain’s blood vessels and, on that same day, he performed the experimental stem cell treatment at his practice at Bonita Springs, Florida.
Still sedated and not fully awake, the patient was discharged and carried to her home. But sometime that evening, she fell and hit her head. At 2 a.m., paramedics were called and she was taken to NCH North Naples Hospital.
At the hospital, a CT scan showed significant brain swelling and possible hemorrhage. Doctors conducted surgery to relieve the pressure in her brain, but multiple MRIs showed severe brain stem injury and clotting. On April 4, she was taken off life support.
Dangerous, unjustified treatment
In its formal complaint, the FDOH says the treatment “was neither authorized nor recognized by the Federal Drug Administration, (and) Dr. Grekos’s medical records didn’t contain medical justification for the injection of autologous bone-marrow aspirate into (the patient’s) cerebral circulation as a treatment for (her) neuropathy.”
“The treatment had no substantiated medical or scientific value,” the state health department says.
Dr. Grekos has had medical privileges with Florida’s NCH Healthcare System since 1996 and the state’s restriction hasn’t taken this away—or just yet.
In its complaint, the Florida health authorities are asking Florida’s board of medicine to permanently revoke or suspend Dr. Grekos’s license and order the accused to pay fines or “any other relief that the board deems appropriate.”
The FDOH also accuses Dr. Grekos of failing to inform the patient of the risk and benefits and alternatives of the proposed stem cell treatment. He also failed to make it known that the procedure was entirely experimental and unaccepted in the state of Florida, state health authorities say.
Right now, the case is being heard by an administrative court in Tallahassee, Florida. Records from the state Department of Financial Services show that the cardiologist’s insurer paid a settlement of US$250,000 to the family, which hasn’t filed a lawsuit.
The FDOH also imposed an emergency restriction on Dr. Grekos’s license, prohibiting him from “providing any stem-cell treatment, including but not limited to the injection of autologous bone-marrow aspirate.”
The order, made last February (2011), doesn’t bar him from seeing patients if he doesn’t provide the restricted treatment. But in the restriction, the state notes that Dr. Grekos’s care was “far below normal and dangerous, if not criminal.”