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Zannos Grekos，居于佛罗里达州一诊所，此君曾风云成体干细胞治疗界，出于美国的严厉管制，将干细胞分离处理任务移交以色列一实验室，并在多米尼加完成干细胞治疗。近2年前，他在佛罗里达诊所遇到对一名主诉肢体疼痛和麻木的乳腺癌患者，在进行小脑血管造影后直接注射其自体骨髓干细胞，术后尚未清醒情况下让患者出院回家，当晚摔了一跤，凌晨即又住院。2周后患者因脑干损伤出血过世。更要命的是，患者家属认定同意书签名的伪造的。佛州卫生部门指出他违犯6项规定，禁止其再从事任何干细胞治疗活动，并建议吊销行医执照。此行为是否违反法律还正在调查中，现在只是一个阶段性的处理结果。
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Health Care Zone
; I( W1 T4 j8 {6 j- E5 O; IStem Cell Death? Dr. Zannos Grekos’ Controversial Stem Cell Therapy, Y4 q' |6 E! t% N3 x
HCZ on January 29, 2012
4 s5 f( F: H, @ U0 }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.
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! ~& |5 |% w( ?8 u: YIn 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.
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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.”: l* R) P; { c3 B* h& z; d) ~" c' c
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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.
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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.
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( t/ T" F5 X% s9 z: P7 l; dOn 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.
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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.; ]4 h+ z5 N- ] t# i
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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.
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8 g, d# _( M( X0 _Dangerous, unjustified treatment
: S. T) u8 u4 UIn 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.”
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“The treatment had no substantiated medical or scientific value,” the state health department says.
$ z9 B- K7 s! A* \0 kDr. 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.
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5 s2 A! x. W# L. hIn 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.”# O4 P( [0 O. Y y
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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.- W! U9 x1 W. } D. |3 j
5 C+ ?( ]9 k$ g0 l! xRight 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.. d0 |+ g& o1 @* y# P' \& T
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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.”4 j6 t& l' g. x
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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.”
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/ l8 x& }9 m( y& y2 D- G“The use of unorthodox stem cell transfusions for diseases that have shown no benefit can be extremely dangerous,” the emergency order reads.; Q* y( \( T+ _! U, J
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Forged consent?
; r% h; C) q+ O0 kIn the latest twist in the case, Florida health authorities are questioning whether the patient had signed off on the irregular procedure in the first place.9 v7 ?' e, U# F7 O: X, s2 w" h, F
: I4 y1 C# x2 z6 K# DThe queries arose after the patient’s spouse said in recent depositions that her signature didn’t look authentic on medical documents—including on a consent form.
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5 t( W; C7 L4 |- h7 VBoth Dr. Grekos’s lawyer and state attorneys are set to present handwriting experts and the state said it might add to its complaint the accusation that Grekos violated office surgery rules.1 k9 z$ r }' |' n$ m4 {; g
: M/ \9 |) d( POn Jan. 4, Administrative Law Judge Susan Belyeu Kirkland agreed to postpone the final hearing to March 20-23 from Jan. 18-20, after the defense lawyer made a motion for this, saying the new allegations will require his team to hire additional experts to help mount a defense.
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. F0 V5 ^9 R! `9 M, a0 JAcceptable practice or felony?# u& ~8 q2 z1 i8 l% F x
So far, Dr. Grekos has maintained that the procedure he conducted on the ill-fated patient was nothing more than bone-marrow aspiration, permitted and done all the time in the United States.
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$ X/ l% s, [/ W% [) b/ i$ TBecause it’s considered experimental, stem cell therapy hasn’t been approved by the U.S. Food and Drug Administration. But hundreds of people, desperate to cure their incurable conditions, travel outside the U.S. to places like China, Mexico, South Korea, Turkey, Ukraine and the Dominican Republic, where therapies are either part of legitimate clinical trials in that country or illicit or “fake” and dangerous procedures.2 y# W2 k/ I+ s9 X
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For years, Dr. Grekos has been promoting stem cell therapy for heart and lung disease, as well as other conditions.+ A$ i# C9 Q3 W& c" B
) |/ P7 D6 z, L4 j/ L$ S# N6 KOne of his main treatments aims to restore damaged heart muscles in patients with congestive heart failure or stimulate collateral blood vessels in patients with other forms of heart disease.
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His treatment involves a patient’s own adult stem cells and doesn’t involve embryonic stem cells. Instead, Dr. Grekos draws blood from his patients at his Bonita Springs practice, and then sends this to a laboratory in Israel where the stem cells are derived and cultivated with growth factors to induce growth.
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The millions of new stem cells that spring up are then sent to a hospital in the Dominican Republic, where a medical team affiliated with Dr. Grekos injects the stem cells into the patient’s damaged heart muscle, coronary artery or lung tissue.
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Because the treatments aren’t FDA-approved and can’t be paid for with insurance, they can cost patients about US$50,000 out of pocket.
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For many years, Dr. Grekos has been holding seminars in Southwest Florida to talk to residents about his experimental treatments.9 i H' J4 d7 L5 H5 [+ Y$ y
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In many of his talks, he cites patients who he says have benefited from his stem cell therapy—including 20-year-old Andre Lampkin, of Bedford, Texas, who survived a life-threatening bout with bacterial meningitis.
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4 C& I3 Z/ A& L: x% M9 W- v; ?8 d; ULampkin’s extremities were damaged beyond repair and doctors had to amputate his hands and legs below his knees. Dr. Grekos claims his stem cell therapy helped the young man recover, the Naples News.com, a local Naples, Florida news site, reports.8 F/ I0 \. P! Z% R: k
" {+ Y- ?1 D4 K5 m$ e1 XThe Florida health department’s emergency restriction doesn’t prohibit Dr. Grekos from holding his seminars or seeing patients in his cardiology practice.
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“Talking at a seminar regarding a procedure he cannot perform does not constitute another violation,” Department of Health spokeswoman Jessica Hammonds said. But if he were to demonstrate a “how to” on a patient or do a stem cell procedure at the seminar, that would be a violation of the order, she said.
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Violations. `: U* ^ u9 F7 E% c$ G. R
In its complaint, the FDOH said Dr. Grekos violated Florida medical statutes when he:$ ]# I7 B- a( \: h
• Failed to show appropriate medical records that justified the treatment for injecting autologous bone marrow aspirate into his patient’s cerebral circulation for the treatment of neuropathy
% j% z" }. L! B2 i7 t• Performed a procedure that had no medical or scientific value for the treatment of the patient’s neuropathy& }- }, I _4 q! r
• Performed a procedure that had no proper medical foundation for success- `; K s9 C% E* ~
• Performed a procedure that was “entirely experimental and not an accepted or proven treatment” in Florida
9 O! h5 g6 _1 k. G• Performed a “dangerous and unwarranted” procedure and one that was “medically unnecessary
4 f- S4 Y& ^ d' j/ o• Performed a procedure that put the patient at an inordinate risk of death and/or injury.. j7 l1 J- C& E, H( c$ A! t1 E
- s* b0 h+ _: h( i) v% V1 HSome of those whose depositions so far were of Dr. Mark Moskowitz, an oncologist; Dr. Michael Lusk, a neurosurgeon; Dr. Richard Roland, a pulmonologist; and Dr. Nancy Iott, an emergency room physician on staff with the NCH Healthcare System. Depositions were also taken from the patient’s husband, daughter and son.
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. u$ F2 ~# \5 r; z) r' wInformed consent questioned in Florida patient's death after stem-cell treatment
% m9 Y' a& e5 p/ F: F+ QJanuary 6, 20129 G% {6 {& Q$ e8 p3 D; R7 I
Bonita Springs, FL - Florida cardiologist, Dr Zannos Grekos (Regenocyte Therapeutic, Bonita Springs, FL), stands accused of contributing to a patient's death by administering an unjustified stem-cell therapy. In the latest twist in the case, Florida Department of Health (FDOH) lawyers are questioning whether the patient ever signed off on the novel therapy in the first place.2 @" i3 a( {& m3 V6 |7 n
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In a formal complaint filed in August, the FDOH states that Grekos treated a 69-year-old patient who had breast cancer and 0% to 29% bilateral stenosis of the carotid arteries with an "experimental stem-cell procedure" that included injecting autologous bone-marrow aspirate into the patient's cerebral circulation. The patient was discharged without fully waking from sedation, the complaint alleges, and then later fell and hit her head at home. She died in the hospital soon after, and CT scan and MRIs confirmed the presence of a severe brain stem injury and infarct of the cerebellum. The complaint states that the patient's death resulted from the infarcts of her left cerebella and left medulla.' X, J3 z" J0 i, I# `9 C4 t+ ^2 @
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The FDOH alleges "the treatment provided by Dr Grekos to [the patient] was neither authorized nor recognized by the Federal Drug Administration, [and] Dr Grekos's medical records did not contain medical justification for the injection of autologous bone-marrow aspirate into [the patient's] cerebral circulation as a treatment for [her] neuropathy. Dr Grekos's treatment of [the patient's] neuropathy by the injection of autologous bone-marrow aspirate into the cerebellar circulation had no substantiated medical and/or scientific value."( G# v8 d1 ?9 x) `; P
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The FDOH is asking the state's board of medicine to either permanently revoke or suspend Grekos's license and administer fines or "any other relief that the board deems appropriate."# ~1 x7 Z' H q# ]/ D
! H, f* v: q( ^9 Y1 ~% X% _% ?In February 2011, the FDOH issued Grekos an emergency restriction order. The order restricts Grekos from "providing any stem-cell treatment, including but not limited to the injection of autologous bone-marrow aspirate." The order does not bar Grekos from seeing patients if he does not provide the restricted treatment.# ?) I1 U2 e, _- ^8 m- M
7 Q) Y+ K( \- D$ H- D5 DThe case is working its way through an administrative court in Tallahassee, FL. On January 4, Administrative Law Judge Susan Belyeu Kirkland agreed to schedule the final hearing on the case for March 20-23. Grekos's attorney Richard Brooderson had asked the judge to move the hearing back from the original dates of January 18-20 because of issues that arose during discovery that require Grekos's lawyers to hire additional experts to help mount a defense.( \8 b1 t9 N {1 | r3 g
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As reported by Naples Daily News, one of the important issues that arose in the depositions is that the husband of the deceased patient believes the signature on certain key documents, including the patient informed-consent form, is not the patient's signature. So Brooderson and the FDOH will both likely be hiring handwriting experts to testify [1].
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0 P. O4 T) Y+ ]' }- q. _- P$ EThe lawyers for the FDOH and Grekos have not yet responded to heartwire's request for comments.$ w, e9 p6 c& Y9 B- v* x
Source
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) g' Y# G5 s4 x; K! E' B Freeman F. Question raised if Bonita stem cell doctor's patient who died signed consent form. Naples Daily News, January 2, 2012. Available here.
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2 O6 s/ [+ i# T___________________________________________________________________________________________________________________________7 ~2 G; k% K9 h; c7 Z- L
Cardiovascular Business/ w2 P9 K/ d1 b/ ] n
Florida card questioned on patient death after stem cell treatment
5 F2 ~8 f7 \3 n( F& A$ ]Written by Kaitlyn Dmyterko ) L0 W0 X' v* G3 I0 Y
January 9, 2012
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Florida cardiologist Zannos G. Grekos, MD, is under legal scrutiny due to his patient's death after receiving a stem cell treatment. Investigators are looking into whether the stem cell treatment played a role in the patient’s death and the Florida Department of Health also is questioning whether the patient signed off on the investigative treatment." j; D3 R4 X: ?1 n H7 Z
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In 2006, Grekos treated a 69-year old breast cancer patient who underwent six rounds of chemotherapy and radiation followed by Arimidex, a treatment for post-menopausal women with hormone receptor-positive early stage breast cancer. Post-treatment, the patient complained of damage to her peripheral nervous system.
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: c* @7 N8 Y, Q! [' P+ e4 xOn Feb. 17, 2010, the patient inquired about possible stem cell treatment to treat the chemotherapy-induced neuropathy. An imaging exam, obtained Feb. 25, 2010, showed a 0 to 29 percent bilateral stenosis in the patient’s carotid arteries and a cerebral angiogram was performed on March 24, 2010. A complaint filed in August 2011 by the Florida Department of Health alleges that Grekos performed an experimental stem cell procedure on the patient by injecting autologous bone-marrow aspirate during the cerebral angiogram procedure.6 u. c3 ]. M" _7 S3 s0 _
" k; \7 u2 y+ IInvestigators allege that the stem cell treatment provided was not authorized by the FDA, and was unjustified. Additionally, lawyers say that the patient’s medical records did not contain information about the stem cell operation.
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“Dr. Grekos' treatment of [the patient’s] neuropathy by the injection of autologous bone marrow aspirate into the cerebellar circulation had no substantiated medical and/or scientific value,” according to the report. The patient later died from severe brain stem infarcts of the cerebellum.
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1 y+ m4 e2 Z# o$ ^. }The complaint alleges that Grekos failed to practice medicine accordingly and violated Section 458.331(1)(t) of Florida Statutes by:
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Failing to show appropriate medical records that justified the treatment for injecting autologous bone marrow aspirate into the patient’s cerebral circulation for the treatment of neuropathy;5 ]" C0 G+ r' H/ j
Performing a procedure that had no medical or scientific value for the treatment of the patient’s neuropathy;
' d- Q0 {! P5 x1 G9 P. t2 o( }. [ Performing a procedure that had no proper medical foundation for success;
u6 g. L' g+ t, P6 O3 W8 l# f7 M Performing a procedure that was “entirely experimental and not an accepted or proven treatment” in Florida;
$ C1 @4 y) z; T/ {/ a; ] Performing a “dangerous and unwarranted” procedure and one that was “medically unnecessary;” and5 O, G0 @! L9 \
Performing a procedure that put the patient at an inordinate risk of death and/or injury.: V% a; _2 z$ p
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The filings also allege that Grekos failed to inform the patient of the risk and benefits and alternatives of the proposed stem cell treatment. Additionally, Grekos allegedly failed to make it known that the procedure was entirely experimental and unaccepted in the state of Florida.+ ]0 R; K" Q& \) v5 X9 v
$ C) @& _2 p9 X6 g" Y4 ICurrently, Grekos’ license is restricted by emergency order of the department. Under the restricted license, Grekos is prohibited from providing stem cell treatment that includes injection of autologous bone marrow aspirate.
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, R/ g- S; d0 FNaples News reported that the deceased patient’s husband believed that signatures on certain consent forms may have been forged, and said that a handwriting expert may be called in. A hearing scheduled for Jan. 18 has been delayed due to new developments, according to the news organization.2 A6 v& B# v: M
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Grekos is employed at Bonita Springs, Fla.-Regenocyte Therapeutic, a corporation specializing in stem cell therapies and regenocyte technologies.) ~2 z; H# t0 b/ [' N
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发表于 2012-1-31 12:01
