A terapia com CT deve ser controlada por órgãos reguladores, trata-se de um tratamento experimental FASE I, cuja segurança e tolerabilidade ainda são alvo de pesquisas pelo FDA em parceria com empresas de biotecnologia e centros de pesquisas.
LEE COUNTY —
Editor's note: An early version of an online story Thursday, March 8, about Dr. Zannos Grekos stated that his Boca Raton attorney had been at the physician’s Bonita Springs practice earlier in the day when he was not.
The Lee County Sheriff’s Office is conducting a criminal investigation into the medical practice of a Bonita Springs cardiologist after one of his patients died last week.
The investigation comes one day after state health authorities suspended Dr. Zannos Grekos’ license, according to a sheriff’s investigator.
The Sheriff’s Office served a search warrant Thursday morning at Grekos’ practice, Regenocyte, 9500 Bonita Beach Road, Suite 310, to start collecting evidence of what’s been going on at the practice, said Lt. Ryan Bell, with the major crimes division.
“We are currently conducting a criminal investigation into Dr. Grekos’ and his medical practice,” Bell said outside of Grekos’ practice. “We have been working with the Department of Health and the Board of Medicine and the Medical Examiner’s Office. It’s still early in the investigation.”
The Sheriff’s Office identified the patient who died as 77-year-old Richard Poling of Newburgh, Ind.
Grekos was expected to come to work Thursday, but did not show up, Bell said. Employees arrived for work Thursday and were cooperating, he said.
“We’re in the process of interviewing all the employees in furtherance of the investigation and everyone has been cooperative with law enforcement,” Bell said.
The state Department of Health issued an emergency suspension of Grekos’ license on Wednesday after he violated an earlier license restriction for performing an unlicensed stem cell treatment in 2010 on a breast cancer patient who later died, according to the restriction order issued in February 2011.
The original restriction prohibited Grekos from doing anything with bone marrow or stem cells in his Bonita Springs office.
In recent years, his practice has evolved from cardiology to performing stem cell treatment in the Dominican Republic, where patients travel to because it the treatment is not approved by the Food and Drug Administration in the United States.
The new suspension order said that last Friday, Grekos performed a stem cell treatment on an elderly man, identified as R.P., with pulmonary hypertension and pulmonary fibrosis.
Pulmonary hypertension is a debilitating illness that involves a type of high blood pressure in the lungs and the right side of the heart. There is no cure. Symptoms are progressive with shortness of breath and fatigue.
Grekos did the treatment by harvesting stem cells from fatty tissue in the patient’s stomach, the order said, and the tissue was couriered to a laboratory to have the stem cells concentrated, the order said.
The order said “he infused or directed” the patient to have the concentrated stem cells infused in his blood stream.
The treatment was performed in Grekos’ Bonita Springs practice, according to the order, and that during it, the patient suffered a cardiac arrest and died.
The state did not disclose the laboratory that was used. In the past, Grekos had patients’ blood sent to a laboratory in Israel for stimulating the stem cells, and then the blood would be sent to the Dominican Republic. Patients would travel there to have the stem cells infused or injected near the damaged tissue.
Bell, with the Sheriff’s Office, said the agency began working with the state health department and the Medical Examiner’s Office less than a week ago.
“The (patient) came here specifically to have treatment (with) Dr. Grekos,” Bell said.
Grekos’ violation of the earlier license restriction is not a crime itself, but Bell said his behavior in connection to that first restriction may be criminal.
“We believe it has risen to level that he has actually committed a crime,” he said.
Grekos released a statement that his heartfelt sympathies go out to the patient’s family.
He said news coverage has contained inaccuracies and that he wanted to set the record straight that he did not perform an illegal or unlicensed stem cell treatment in 2010 or on any patient, according to his statement.
“An official investigation is underway and we are fully cooperating with all authorities,” Grekos said. “We look forward to a thorough and exhaustive investigation of the facts.”
An administrative hearing is scheduled for June where Grekos is expected to contest the original license restriction. The trial-like proceeding has been delayed numerous times.
Local restaurant owner, Neim Malo, who had stem cell therapy 5 1/2 years ago in Thailand, which Grekos arranged, said he stands behind the doctor.
“I didn’t think he did anything in his practice (with stem cells),” said Malo, who owns the Watermark Grille in North Naples.
Malo often spoke at patient education seminars which Grekos held around the community to talk with people with heart disease or pulmonary illness.
“I’m 150 percent behind him,” Malo said, adding the Grekos has arranged treatments for more than 300 people in the Dominican Republic or elsewhere outside the U.S. “There’s been lots of successes and I’ve fundraised for him (and patients).”
Dr. James Talano, a cardiologist in Naples, said stem cell therapy has been found quite effective for some heart and neurological issues and there are numerous clinical trials ongoing.
What Grekos was doing “is not mainstream research type of studies,” Talano said. “He sort of on the margin of mainstream research.”
When asked if Grekos’ actions could be a set back for stem cell therapy gaining FDA approval, Talano said he didn’t think so.
“It is an isolated incident by an isolated practitioner,” Talano said. “The FDA is supportive of these (approved) studies.”
By taking stem cells from fatty tissue in the stomach, some of the fatty tissue may have been reintroduced into the patient’s blood steam and caused a fat embolism that led to the patient’s heart attack, Talano said.
“These patients, for the most part, are so fragile, they look for anything for help,” he said. “He violated the restriction. I could see why he is under a criminal investigation.”
Jimmy Bell, a Texas father who has only received a partial refund from $57,000 he sent to Grekos’ bank account in the Dominican Republic last year, said Thursday that then doctor is getting what he deserved.
He said Grekos stalled last year on treating his 5-year-old son, Jason, who died in December. He said Grekos was stringing him along.
“The way they lied to us and let us on, it’s almost like justice,” he said. “At least he’s not going to be able to do this to another family.”
