Quote NO LOL, "They were legally blind before the operation. "
100% FALSE dis-information ("Misinformation" per the Miguel bloggy tales). TOTALLY, TOTALLY FALSE.
Thee New England Journal Of Medicine, one of the oldest and most prestigious medical journals in world history and in this nation, said EXACTLY THE OPPOSITE, in the article its editors vetted and reviewed, an article written by EXPERT EYE SURGEONS who reviewed what was referred to as the "hack job" and similar termed "procedure" done at U.S. Stem Cell Clinic, w/ Comella overseeing it all.
The court filed documents and again, EXPERT TESTIMONY of the eye surgeon who tried to salvage the women's eye sight also stated, "THEY HAD FULLY FUNCTIONAL LIVES, COULD SEE TO LIVE A REASONABLE LIFE ETC AND ARE NOW TOTALLY, LEGALLY BLINDED, LITERALLY HAVING THEIR EYE BALLS ESSENTIALLY BLOWN OUT, by a NON M.D., introduced to them as "YOUR DOCTOR" and while they were FALSELY POINTED TO THE Clinicaltrials.gov website for what was a SHAM clinical trial, actually no "clinical trial" at all, just a CASH FOR HACK BUTCHER JOB" (paraphrased, but near word for word, including commentary in an Op-Ed penned by thee Dean of Harvard Med school).
Your statement COULD NOT BE MORE GROSSLY WRONG OR FACTUALLY INCORRECT to state they were "ALREADY BLIND". WRONG !
POST ONE LINK TO ANY SOURCE, ANY ARTICLE, ANY COURT DOCUMENT, ANY MEDICAL JOURNAL that states, "THE LADIES WERE ALREADY BLIND", LOL !! Cause it DOES NOT EXIST and WILL NOT BE FOUND. Not a chance in H.
RECENT NEW ARTICLE DATED ONLY ABOUT FIVE SHORT MONTHS AGO-
Published in the FLORIDA DAILY BUSINESS REVIEW, April 11, 2017.
HOLY FREAKING COW? This is a local South Florida paper, and the female business writer/author for a South Florida paper printed since 1926, she says there is a "INVESTIGATION PENDING" regarding USRM and their blinding of at least three women at their little "clinic" biz thingy, as written about in the world's top medical journal, THEE NEW ENGLAND JOURNAL OF MEDICINE. HER FREAKING WORDS, NOT MINE, LOL !
DIG THIS RECENT INFO- wild stuff if you ask me (Someone should try and contact the author to see if she'll reveal her sources or what she knows?). AMAZING INFO IF YOU ASK ME:
Celia Ampel, Daily Business Review April 11, 2017 The procedure was supposed to treat their macular degeneration—but instead, it made them blind. The two women who lost their sight have settled their cases against a South Florida eye doctor as their experience draws national attention.
Coral Gables law firm Grossman Roth Yaffa Cohen filed lawsuits on behalf of the two patients, both over age 70, who traveled to Sunrise and paid $5,000 each for what they believed was stem-cell therapy that would help with age-related vision loss. According to thecomplaints, U.S. Stem Cell Inc. injected each woman in both eyes with what it claimed were stem cells harvested by removing fat tissue from patients and processing the tissue to isolate the cells.
Instead, both women quickly ended up blind, with one of them unable even to perceive light. Their experience was highlighted March 16 in the New England Journal of Medicine after doctors at the University of Miami's Bascom Palmer Eye Institute observed the results of the injections.
"The patients paid for a procedure that had never been studied in a clinical trial, lacked sufficient safety data, and was performed in both eyes on the same day," the physicians wrote in the journal article. Experimental injections in both eyes, they continued, "are both atypical and unsafe."
The final claims in the litigation were confidentially settled days before the article was published, drawing attention from the New York Times, the Associated Press and BuzzFeed. U.S. Stem Cell and the nurse who performed the 2015 procedures settled earlier in both cases, which were filed in separate circuits, one in Miami-Dade and one in Broward.
The last remaining defendant was Dr. Shareen Greenbaum, an ophthalmologist with Hollywood Eye Institute who performed pre-procedure exams on the patients, according to the lawsuits. Greenbaum settled with plaintiff Elizabeth Noble in 2016, but the case filed by the other patient, Patsy Bade, did not reach a settlement until last month.
Bade alleged Greenbaum became involved with U.S. Stem Cell through a friend she met at her gym. Starting in 2013, the doctor was held out as the principal investigator for what was listed as a clinical trial on the U.S. National Institutes of Health website ClinicalTrials.gov. (According to a warning now posted on the site, the studies listed on the site are not necessarily endorsed by the NIH.)
According to the lawsuit, Greenbaum realized the company was nothing more than a for-profit business after hearing U.S. Stem Cell employees lie to patients and seeing there would be no gathering of information or follow-up with the patients about the procedure. But she agreed to stay on to do the pre-procedure exams.
"Dr. Greenbaum did nothing to communicate her concerns about the clinical trial, nor did she do anything to dissuade Ms. Bade from going forward with this procedure," the complaint alleged.
Greenbaum's attorney, Marc Ganz of Nosich & Ganz in Coral Gables, declined to comment. Grossman Roth partner Andy Yaffa, who represented the patients, also declined to comment on the settlements except to say they were to the mutual satisfaction of the parties.
U.S. Stem Cell Inc. said in a statement that it does not currently treat eye patients and that its clinics "have successfully conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions reported."
No criminal charges have been filed over the injections. An investigation is pending.
[color=purple]Grossman Roth just took on another stem-cell therapy case in Atlanta, and more of these cases may pop up around the country if oversight isn't ramped up, the authors of the New England Journal of Medicine article warned.
"Although numerous stem-cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem-cell clinics are treating patients with little oversight and with no proof of efficacy," the doctors wrote."
END OF ARTICLE from a local Florida biz journal and author.
AN INVESTIGATION IS PENDING???
HOLY FREAKING COW ??? The author uses the words "CRIMINAL CHARGES" and then "INVESTIGATION IS PENDING"? WTH? Sh*t, checked my dictionary and "PENDING" means "on going" or "waiting a decision" or "in process awaiting an outcome" etc?
WOWZA !!
SEE THAT WORDING...THEY "ENDED UP BLIND"...that means they WERE NOT BLIND, LOL !! WRONG !
Or just go to thee NEW ENGLAND JOURNAL AND READ THE ENTIRE THING THAT STARTED THIS BALL ROLLING and IMO, earned Comella and USSC a big ole "FDA WARNING LETTER", one that has a good chance of sinking their leaky boat if you ask me.....straight to the bottom...and maybe even worse consequences....
COURT "testimonials" BLIND LADIES !!
The biggest "news" ole BHRT/USRM ever got, LOL! (well, now I think the formal “FDA WARNING LETTER” may be eclipsing even the THREE BLIND LADIES NEWS). Google "U.S. Stem Cell Florida" and 8/10 of the top, page 1 Google search returns used to be BLINDED LADY'S REAL NEWS, now it’s mostly the FDA SITE ITSELF WITH THE WARNING LETTER and WARNING LETTER PR and then NPR and TIME Mag and some other major news outlets on the “FDA WARNING” to Comella and the clinic biz. It's tough to get on Google page-1 results, but they did it by golly !
JUST STUNNING allegations and facts revealed by that local, Florida based investigative journalism team.
ALL about the USRM little "stem cell clinic" they peddled as "THEIR CLINIC" but in SEC filings then state they only own 33% of it, and which FL secretary of state docs show was organized by good ole Kristin Comella.
How far did the NEW ENGLAND JOURNAL OF MEDICINE "news" spread - well, sure looks WORLD WIDE TO ME? We of course now know with 100% CERTAINTY the FDA knows all about this and is “on it” like STINK ON A MONKEY (just read the 483’s and inspection dates in the warning letter, it’s all there), all happening when they were supposedly reviewing that ole RMAT "data" or whatever per bloggy tales, LOL !
I mean how the hell could the FDA not know about this medical damn fiasco, which even involved falsely pointing patients to the "clinicaltrials.gov" database, according to the published expert testimonial allegations, let alone non M.D.'s being introduced as "YOUR DOCTOR", LOL !! Yeah, and the ole FDA is gonna hand over the keys to the jet and let these dudes do more human experimentation? Personally, I doubt it IMO.
BUT, it freaking gets even better than THAT SCATHING FLORIDA written article linked above:
Read what the Dean of freaking HARVARD MEDICAL SCHOOL personally penned in an editorial about what the ole "clinic" is doing to folks, and the subsequent "news" heard round the world when probably the most prestigious and oldest medical journal in existence, THEE NEW ENGLAND JOURNAL OF MEDICINE wrote about this cluster F they did during their NON FDA APPROVED ole "treatments":
"Gross violation of professional and possibly legal standards"
Those words were penned by (and he's writing about USRM):
"In an editorial accompanying the journal report, stem cell expert Dr. George Daley, dean of Harvard Medical School, called the clinic's treatment careless.
"This report joins a small but growing medical literature highlighting the risks of such wanton misapplication of cellular therapy," he wrote. Providing such treatments for profit outside a proper research setting "is a gross violation of professional and possibly legal standards," he said."
THAT is the DEAN of the HARVARD MEDICAL SCHOOL, in his own words, talking about U.S. Stem Cell Clinic, LLC and how they blinded THREE WOMAN (three at least that are known at this point)
When the damn DEAN of perhaps the most prestigious medical school on PLANET EARTH takes time to write an editorial, to accompany a paper that reached publication in the NEW ENGLAND JOURNAL OF MEDICINE, well, you got some problems at your "biz" IMO.
Don't "think" the freaking FDA listens to the DEAN of the Harvard Med School? That is one tight fraternity of folks there, and they influence Washington D.C. in a big ole way, in every aspect. The pinnacle of the IVY LEAGUE and their graduates hold seats often, on every key committee and chairmanship and position of power in every circle of influence that matters.
The damn DEAN of the Harvard Med School singled out USRM and U.S. Stem Cell Clinic and published about it, in his own writing, on his own dime and time. WOWZA.
NEJM "new" Article how USRM BLINDED WOMEN:
ALL published in one of the world's most prestigious and oldest and most credible medical journals, DATED MARCH 16th, 2017, which makes it RECENT NEWS to me. It's almost impossible to get published in the NEJM; it can easily take 6 months from a paper being submitted, to then extreme vetting and peer review, to even "hoping" to being assigned a publication date in such a world class medical journal. FEW doctors/researchers ever get their papers or writing accepted for publication in the NEJM. It's the stratosphere of medical publication.
THE FACT, FACT, FACT that the New England Journal editors and peer review committee accepted it for publication, makes it an extremely important piece of medical literature, just on the merits and credibility of the NEJM alone. THUS, the reason the article/medical paper is receiving WORLD WIDE PRESS COVERAGE.
The author's themselves, world recognized medical experts and the NEJM itself use words like "horribly botched" and "bad beyond measure" what was done to these three, grossly misled woman, who have now had their lives ruined for all intents and purposes according to the expert and world class MD's interviewed and cited in the NEW ENGLAND JOURNAL OF MEDICINE (In addition to such experts as Harvard, Stanford MD's and PhD scientists among many experts contacted and asked for commentary in several of the subsequent articles cited/linked below).
TRULY WORLD-WIDE "NEWS" COVERAGE...YEPPER:
Because of the extreme prestige and incredible reputation and credibility of the NEJM, that RECENTLY PUBLISHED MEDICAL ARTICLE/paper, it just got spread literally WORLD WIDE via being picked up by every major and credible NEWS SOURCE ON PLANET EARTH, just to name a few: DRUDGE REPORT, NY Times, Wall Street Journal, CNN, NPR, NBC, ABC, Washington Post, AP news wire services, Reuters, several of the UK major papers, as far south as New Zealand, and then India, Singapore news (hello Southeast Asia/Asia Pacific last time I navigated those airways), Africa (oh gee, ANOTHER continent), Japan (uh oh, major, major world power, big time newspapers and TV news, that covers East Asia, getting real close to China) plastered all over Canadian press, looks like probably EVERY major "Florida" news source ran with it and still going, the N. America papers look like they covered every major outlet from Alaska to the Eastern seaboard and everything in between including powerhouses like Chicago, many stories only being hours old as of this AM (Magazines now picking it up too; just made Men's Magazine, which happens to land in just about EVERY DOCTOR'S OFFICE I've ever had the pleasure of parking my butt in their waiting room lobby, in the past 5 years or so), and it literally propagated rapidly across the "news wires" to reach and cover the entire planet….literally:
Looks WORLD WIDE TO ME....and still going (wonder how their little clinic biz thingy is gonna survive this mess? Anyone looking up their name to research um, is gonna find these stories/links for YEARS to come IMO, as they're in the who's who of major publications/press now). Oh wait, MAYBE THAT’S WHY THEY CHANGED CLINIC NAMES TO “STEM CELL CENTERS OF EXCELLENCE” and created the ole “GACP” thingy….eh….ya think maybe…..I know what I think….LOL !
SEE THAT DATE ON THE NEJM "recent" published MEDICAL ARTICLE. It's dated MARCH 16th, 2017, which to me, MAKES IT RELATIVELY "RECENT" NEWS. NOT "old" as is falsely being claimed. It can take a long, long wait to get published and get a publication date in the NEJM. Who knows how long ago that excellent paper was submitted for review and publication?
LOOK AT THAT, freaking CIRM, the California major stem cell group/govt agency ran the story. DAMN, that can't be good for ole USRM, especially if they're now trying to pitch the FDA for some supposed "approval" for gawd knows what?
“About TODAY Singapore’s second most-read newspaper, TODAY offers quality content in a convenient, compact format. The free newspaper offers readers an unrivalled package of the top local and international news reports, as well as insightful, thought-provoking commentary and analysis. “
Singapore, so that's SouthEast Asia/Asia Pacific region. BAMMO, spreading like WILDFIRE (NO, not the 70's song by Michael Martin Murphy)
THAT is a butt load of free "coverage" for a pretty much no name, micro lil medical "clinic" in ole Florida and their PENNY STOCK "PARENT" COMPANY and ole “Chief Science Officer” and ole "33% owner of said clinic" per SEC filings...seems to me. Like the FDA didn’t “see” this (unlike the BLIND LADIES), along with every prospective customer or medical researcher and anyone else of importance in the "Stem cell world", LOL???
Gawd, it's got more coverage than freaking Beyonce and Justin Bieb combined if you ask me, LOL !! And it ain't the "good" kind of coverage if you ask me for my lousy SUB TWO CENTS worth....gawd what a freakin mess.
I'd guess EASILY MILLIONS of people read THAT "NEWS"....what did someone post....that the ole "RADD FESTIVAL" (LOL, gawd that cracks me up....just gives me visions of Jeff Spicoli for some reason..RAD DUDE !) ...1000 people versus MILLIONS who read about the TALE OF THREE BLIND LADIES in pretty much every major news publication around this planet...WOWZA...wonder how many read the “bloggy tales” versus all those major FACT BASED NEWS OUTLETS ABOVE???? A few hundred “maybe” versus literally MILLIONS…..eh ?????
AGAIN...PRODUCE ONE, ONE CREDIBLE LINK or M.D. STATEMENT OR INVESTIGATIVE JOURNALISM OR MED JOURNAL ARTICLE OR SIMILAR that states, "THE THREE ELDER LADIES WERE ALREADY LEGALLY BLIND"....cause it is a 100% FALSE STATEMENT and FACTUALLY DOES NOT EXIST.....NOPER...NOT A CHANCE IN H.......
QUOTE OF FULL ARTICLE, FACT BASED, NOT MISINFORMATION:
" Three women blinded after stem cell injections at Broward clinic
BY DANIEL CHANG
MARCH 16, 2017 7:13 PM
When three elderly women with a common age-related eye disease were blinded after receiving stem cell injections at a Broward County clinic in summer 2015, the red flags were apparent to Thomas Albini, a clinical ophthalmologist with the University of Miami Health System’s Bascom Palmer Eye Institute.
Raising Albini’s suspicion were the women’s accounts of what had happened: Each had both eyes injected on the same day with stem cells extracted from their body fat. They received little to no follow-up care or evaluation before or after the treatments. And they paid $5,000 each for the procedure.
“When that all was revealed, I was just in disbelief that this was happening in Broward,” said Albini, who helped care for two of the three women and co-wrote an article in this week’s New England Journal of Medicine detailing his experience.
“I knew that things like this could happen in other countries that don’t have a sophisticated medical regulatory environment,” Albini said Thursday. “But I really was naive to the fact that this could happen in the United States. Then I realized I was just as naive about it as the patients were.”
The CEO of the publicly traded company for which the Sunrise clinic is named and where the women received the stem cell injections said he believes the article was intended to hurt the company’s finances.
Albini’s article, which was co-written with nine other physicians, exposes what he calls a “loophole” in the U.S. government’s oversight of unproven treatments involving stem cells. It also raises questions about whether federal regulators are doing enough to protect patients from risky medical procedures — especially ones that project the false impression that they are government approved.
He said he co-wrote the article to alert physicians and patients to the dangers of unwarranted claims about the healing power of stem cells, which Albini said hold great promise but remain largely untested for clinical use.
“For us to get to the point where we can establish good stem cell therapy,” he said, “we have to do good research that is ethical and also scientific. Whatever these patients had, it was neither ethical or scientific.”
In a written statement issued Thursday, Mike Tomás, CEO of U.S. Stem Cell, a biotech company that Tomás said has a minority interest in the clinic, called the NEJM article “old news” and suggested it had been published to challenge the company’s most recent financial report that revenue had risen by 38 percent, from $2.2 million in 2015 to $3.03 million in 2016. Tomás’s statement was issued in response to a Miami Herald request for comment made to the clinic, U.S. Stem Cell Clinic.
Tomás, who is a judge for the Miami Herald’s annual Business Plan Challenge, also pushed back on suggestions that the clinic’s stem cell treatments are unsafe.
FOR US TO GET TO THE POINT WHERE WE CAN ESTABLISH GOOD STEM CELL THERAPY, WE HAVE TO DO GOOD RESEARCH THAT IS ETHICAL AND ALSO SCIENTIFIC.
Dr. Thomas Albini of Bascom Palmer Eye Institute
“For nearly 20 years our clinics have conducted more than 7,000 stem cell procedures with less than 0.01 percent adverse reactions reported,” he said in the written statement. Tomás declined to comment on the patients, citing federal privacy rules. But he added that the clinic no longer offers eye treatments.
The three women, ages 72, 78 and 88, all had macular degeneration, a common eye disease among the elderly that can lead to vision loss. They received the stem cell injections at a clinic in Sunrise that incorporated in 2014 as Regenestem Health and that same year changed its name to U.S. Stem Cell Clinic.
Within 36 hours of their treatment at the Broward clinic, two of the three women went to the emergency room at Bascom Palmer for blinding conditions, including increased blood pressure in their eyes, excessive bleeding, retinal detachment and dislocation of their lens. Although the women had moderate vision loss prior to the stem cell treatments, a year later their vision ranged from total blindness to 20/200, which is considered legally blind.
“The thing that was most alarming when I saw these patients come to Bascom Palmer was the fact that they had this procedure done on both eyes in the same day,” Albini said. “If you’re going to do something experimental, God gave us two eyes. Do it in one eye at a time. Even commonplace surgeries like cataracts are not performed on both eyes on the same day.”
Albini spoke to two of the women and believes they might have been misled into thinking that they were participating in a legitimate clinical trial sanctioned by the National Institutes of Health, part of the U.S. Department of Health and Human Services, because at least two of the women said they learned about the stem cell procedure through the website ClinicalTrials.gov — an NIH database that lists publicly and privately supported clinical studies conducted around the world.
“They think that when they see that, that it’s a rubber stamp of approval from the United States government and somebody has investigated this and said this is a legitimate therapy,” he said. “What became quickly apparent to me was that it wasn’t clear they had participated in any sort of clinical trial. It didn’t sound like a trial in terms of any of the follow up or the evaluation.”
Congress established ClinicalTrials.gov for many reasons, including to provide information about publicly and privately sponsored clinical studies, said Renate Myles, an NIH spokeswoman, in a written statement.
The information on the website is provided by study sponsors or principal investigators, but posting on ClinicalTrials.gov does not necessarily reflect endorsement by the NIH, Myles said.
“ClinicalTrials.gov does not independently verify the scientific validity or relevance of the trial itself beyond a limited quality control review,” she said in the statement. Myles urged patients to talk to their doctors before participating in a study and she noted that the NIH has now posted a more prominent disclaimer on the website.
For-profit clinics offering unproven stem cell treatments and making unsubstantiated claims to about their ability to cure a range of medical disorders have proliferated in the United States after first gaining popularity overseas, said Timothy Caufield, a professor of health law and science policy at the University of Alberta in Canada.
Many have evaded regulation by the Food and Drug Administration in part because they use stem cells extracted from a patient’s own body and because they don’t manipulate those cells too much before re-injecting them — a process considered a medical procedure and not a drug.
“Some of these clinics are making promises about therapies for ALS, for cancer, for autism, for everything,” Caufield said, “and of course more for cosmetic procedures, like anti-wrinkle, anti-aging.”
But, Caufield said, there are very few stem cell therapies approved for clinical use, and that regulation is not preventing the science from advancing. He urged patients to consult the International Society for Stem Cell Research’s patient handbook before considering stem cell therapies.
“There’s this perception that there are all these stem cell therapies out there that are close to clinical application that ... are being held back by regulators and if they just step back, there would be all these treatments,” he said. “It’s just not the case. The science isn’t there yet.”
Congress established ClinicalTrials.gov for many reasons, including to provide information about publicly and privately sponsored clinical studies, said Renate Myles, an NIH spokeswoman, in a written statement.
The information on the website is provided by study sponsors or principal investigators, but posting on ClinicalTrials.gov does not necessarily reflect endorsement by the NIH, Myles said.
“ClinicalTrials.gov does not independently verify the scientific validity or relevance of the trial itself beyond a limited quality control review,” she said in the statement. Myles urged patients to talk to their doctors before participating in a study and she noted that the NIH has now posted a more prominent disclaimer on the website.
For-profit clinics offering unproven stem cell treatments and making unsubstantiated claims to about their ability to cure a range of medical disorders have proliferated in the United States after first gaining popularity overseas, said Timothy Caufield, a professor of health law and science policy at the University of Alberta in Canada.
Many have evaded regulation by the Food and Drug Administration in part because they use stem cells extracted from a patient’s own body and because they don’t manipulate those cells too much before re-injecting them — a process considered a medical procedure and not a drug.
“Some of these clinics are making promises about therapies for ALS, for cancer, for autism, for everything,” Caufield said, “and of course more for cosmetic procedures, like anti-wrinkle, anti-aging.”
But, Caufield said, there are very few stem cell therapies approved for clinical use, and that regulation is not preventing the science from advancing. He urged patients to consult the International Society for Stem Cell Research’s patient handbook before considering stem cell therapies.
“There’s this perception that there are all these stem cell therapies out there that are close to clinical application that ... are being held back by regulators and if they just step back, there would be all these treatments,” he said. “It’s just not the case. The science isn’t there yet.”
END QUOTE OF FACTUAL ARTICLE IN THE MIAMI HERALD....NO DIS-INFORMATION....
It's stated 100% FACTUALLY, that the women WERE NOT BLIND prior to the butchering of their eyeballs at USSC. They all three COULD SEE and had fully functional lives. TOTALLY FALSE to "try" and claim or state otherwise.
The FDA just sent a serious WARNING LETTER to the clinic that blinded these women- and that is probably what got the FDA "ball rolling" if you ask me. Now it's gonna be a FDA WRECKING BALL if you ask me...a freaking bulldozer.....
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