When you think of Florida, what else crosses your mind first? Orange juice? Heat and humidity? Beaches? Disney? I don’t know if this says more about me or the state, but these days I think of stem cells.
Florida and California are the two biggest hotbeds of the for-profit stem cell clinic world, each with a dizzying array of clinics, claims, alleged or confirmed patient injuries, and a feeling of chaos at times. You can see zoomed-in maps of Southern California and Florida clinics from the Cell Stem Cell paper that Leigh Turner and I published in 2016, where we found nearly 600 clinics in the U.S. and many in South Florida.
A new Florida Sun Sentinel newspaper piece takes a much deeper look into stem cell clinics in that state compared to many other media pieces we’ve seen. What we learn applies not just to many Florida stem cell clinics, but also the key stem cell clinic issues more broadly across the U.S.
In the new investigative piece entitled, “Florida a destination for desperate patients buying unproven treatments”, reporter Diane Lade, talks to a number of parties involved including patients and clinics. The piece comes to four main conclusions, which largely ring true to me as someone following this area:
“– Some of these clinics’ medical procedures are questionable, experts say, such as injecting patients with experimental stem cell solutions in both eyes at the same time, risking blindness.
— Florida clinics use online seminars, high-tech websites and listings in the federal database ClinicalTrials.gov to market their treatments to patients. They tout Florida sunshine and tourist attractions such as fine hotels, beaches and unique shopping districts.
— Some stem cell clinics use hard-sell tactics (editor’s note: embedded link is mine) and lead patients to rake together thousands of dollars, as insurance doesn’t cover stem cell treatments.
— State and federal regulators rarely have stepped in to stop these advertising and medical practices.”
But the piece brings in some other notable and new information via quotes and more.
Some of the Florida clinics like many here in California and in other states argue that they are simply helping patients and that profits aren’t a major motivating factor, but I’m skeptical.
From The Sentinel:
“Clinic operators, however, say they are giving consumers the medical miracle of stem cells right now instead of forcing them to wait years while the government’s regulatory wheels slowly spin.
“I don’t do this for money but to give hope to these people and try to help them, to give them treatments that are scientifically good,” said Dr. Burton Feinerman, owner of the for-profit Stem Cell Genetic Med Clinic based in Wellington.”
That word “miracle” worries me whenever I read it whether it is coming from a clinic or from an academic stem cell researcher as we recently saw in a Smithsonian piece on stem cells for stroke. Related to the above quote, I also have to ask what “scientifically good” means? Is there impartial peer review? Proper controls? Pre-clinical data?
Also, do patients know what they are getting for their money and the potential risks?
The Sentinel also describes some patient experiences including Tammy Rivero’s stem cell transplant at another clinic called The Lung Institute. The article indicates that Rivero took out a loan on her house to pay the clinic:
“At the clinic’s suggestion, Rivero said she used the only thing of real value she owned: She took out a home equity loan on her 112-year-old small, wooden house, where her mother was born, at the end of a dirt road in rural Hildebran, N.C.”
Rivero reportedly had high hopes for the stem cells:
“I was going to get healthy and have a life, start working again,” said Rivero, who feels like she’s suffocating if she spends more than 10 minutes without supplemental oxygen.”
Once patients get one transplant, stem cell clinics sometimes indicate more is needed at additional expense, and that was reported by the patient here as well:
“Rivero said she was surprised to learn after the procedures that she would need to spend even more for best results.
The institute urged her to pay an additional $70 a month post-treatment to “reboost” her stem cells, Rivero said. Her discharge documents also “strongly” recommended she buy four supplements, ranging from $16.95 to $45 each, as well as a $120 PowerLung AireStream breathing training device.
She couldn’t afford the extra fees, and today her condition is worse. Rivero said doctors have given her less than a year to live.
“I risked everything I had in the world,” she said, in tears.”
This kind of patient story is increasingly common. The Sentinel reports on a second patient Howard Bennett who also allegedly has issues with the clinic. These patients are reportedly part of a lawsuit:
“Bennett and Rivero are part of a lawsuit filed against the Lung Institute, alleging the clinic’s marketing and business practices are deceptive and unfair.
The lawsuit’s attorney, Ben Vinson of Tampa, is seeking class-action status. Vinson said he has about 30 former Lung Institute patients who could be plaintiffs if the suit proceeds.”
I wasn’t aware of anything like 30 patients potentially being involved in that situation. That’s a big number.
The Sentinel article also touches on the so-called SCOTS trial, where some patients have alleged losing vision also down in Florida:
“Ahmad Farouki, of Lauderhill, had been slowly going blind for 15 years due to congenital retinitis pigmentosa when he turned to Dr. Jeffrey Weiss, a Margate retinal specialist. Weiss is the principal investigator for the Stem Cell Ophthalmology Treatment Study, which he runs in collaboration with MD Stem Cells in Connecticut.
Weiss injected both of his eyes with stem cells drawn from Farouki’s bone marrow in October 2015. Not only did his vision not improve, Farouki said, but he was devastated to discover he could see nothing out of his left eye, which had been his better one.”
This kind of patient report is deeply concerning and The Sentinel also focuses on a second SCOTS patient, George Gibson, who reported a negative outcome as well. In these cases, another level of concern is that it isn’t clear how the patient consent process went:
“Whether Farouki and Gibson were completely informed of the risk is questionable.
On an 11-page “informed consent and permission” document, neither man initialed an “acceptance of risks” paragraph, confirming they understood the treatment was experimental and not guaranteed.
“That shouldn’t have happened,” Weiss said.”
The patients complained to the State of Florida, but met a dead-end so far and Weiss apparently says some claims are false:
“Farouki and Gibson filed a complaint against Weiss with the Florida Department of Health. Documents show the state’s Board of Medicine in March said its review found no “probable cause” and closed the case.
Weiss said Farouki and Gibson are spreading inaccurate information about their treatment results.”
More generally, state medical boards have not been particularly active on the stem cell front. In this case with Florida, it’s hard to know why exactly that state closed the case.
Weiss has some ideas about why there have been criticisms:
“He joins other stem cell clinic operators who say their main motive is to help those whom traditional medicine has failed. He said any criticisms are due to “tremendous envy and jealousy” from the medical establishment because of what he’s been able to accomplish.”
A few other patients reportedly have felt they had positive outcomes for their vision from SCOTS and The Sentinel mentions one such case.
In the big picture with stem cell clinics in the U.S., without hard data with proper controls that is peer reviewed, it is difficult to know how to interpret the various patient-reported outcomes in the bigger picture. In some of the Florida clinic situations, notably eye damage such as retinal detachment or scarring has been documented by independent physicians. I’m not sure the extent to which independent physicians have reviewed potential positive outcomes.
I believe patients should not be charged to be subjects of unproven experiments and that clinics should not engage in this kind of practice without solid pre-clinical data to back it up or without getting approval from the FDA first. Also, if the main goal is to help patients in need, then why not only charge the patients “at cost” with no profit margin?
The Sentinel also touches on the Florida stem cell clinic, US Stem Cell (US Stem Cell, Inc. is the apparent company for US Stem Cell Clinic and is publicly traded company $USRM), which reportedly has been linked with some cases of blindness as a negative outcome:
“In August, the FDA sent a warning letter to U.S. Stem Cell, insisting the Sunrise clinic was in breach of federal regulations and could face injunctions or property seizures.
A clinic spokeswoman on Thursday said the clinic “has continued to engage in open dialogue with the FDA.”
In response to the new FDA guidelines, clinic representatives in a November statement said U.S. Stem Cell thinks “patients have a right to utilize the cells in their own [bodies] to help promote natural healing” and that their therapies are safe.
Despite the FDA’s warnings about its practices, the company continues to operate and this month opened a new West Palm Beach operation under the name Regenerative Wellness Clinic.”
Overall, I believe that Florida, California, and Texas along with other states with growing stem cell clinic presences need to actively provide state-level oversight including by state medical boards and additional FDA attention, on top of their recent positive steps, will be needed. This Sentinel piece provides a lot of different info and views in a balanced way, which together helps everyone understand this complex area somewhat better via the example in one hot-bed state.
I like the title of the piece. It is factually correct.
Dear Admin:
Would you base your judgement of the quality of FDA-authorized clinical trials on investigative reporting newspaper articles? No, you would not. Instead you would require objective scientific study design, unbiased data gathering, scientific and statistical data analysis, and scientific interpretation of the results, along with a good dose of comprehensive cautionary discussion thrown in to consider effects of unknown omissions and various forms of bias.
If we really want to know what is going on in private stem cell clinics, on average and in scope, we should require the same level of diligence in their assessment. If it is such an important worry, the FDA should expend some of its resources to either conduct such investigations itself or fund the research by other scientists. In this way, we can make better policy decisions for how best to advance stem cell medicine, based on objective data evaluations and not on highly biased, sensationalized, selective news reports.
James at Asymmetrex
James – If you are expecting not to see bias, perhaps you should be reading a different blog! 😉
@Bill,
How many stem cell blogs are out there? In 2010 this website was just about it. Now there are a few more thankfully with some diverse perspectives at times, but still not many and especially few that post regularly.
Bill, good point! Agreed.
@James,
As I think we’ve discussed before, there isn’t a lot of hard information out there. The stem cell clinics are generally not open to providing their data, their SOPs, their mishaps, etc. to the public for peer review and analysis so how does one diligently assess them beyond using what information is out there from the FDA such as in letters and 483s, in the media, what the clinics do sometimes say privately or publicly or post themselves on their websites, what patients have to say, and such?
Yes, the FDA should devote more resources to the clinic arena and perhaps that will happen or is already happening under Dr. Gottlieb’s leadership. Understandably, not all of that will end up in the public domain.
I don’t see how the Sentinel piece is sensational. It seemed generally balanced to me and included numerous quotes both from clinics and patients.
Paul
Dear Admin:
Your kidding with me, right? The title of the piece is, “Florida a destination for desperate patients buying unproven stem cell treatments.” That title pretty much sets the agenda and the narrative contrived for it.
Well, let’s see the facts. Many patients who consider clinics are desperate, the stem cell ‘treatments’ there are unproven, & Florida is one of the top few states for the # of clinics…so what’s the problem?
Well, let’s see Admin. If you based your characterization of the private stem cell clinic industry on the experience and behavior of the estimated 250,000 or more patients who seek and get stem cell treatments in private clinics in the U.S. each year, instead of a selected few sensationalized events in negative narrative news reports, you would discover that many, many, patients are not “desperate.” They, in consultation with their physicians, are making informed decisions to evaluate new medical treatment options for chronic health disorders – many which are not life-threatening (by your own investigative studies), but may significantly impact their quality of life – that are relatively safe, though their degree of predictable effectiveness is largely unreported, though it may be known to some treating doctors.
This is too large and significant a medical activity to either ignore or prohibit without a proper governmental investigation. It can and should be investigated like any other complex activity in our society that requires sound science to support good policy for limiting harm and maximizing benefit. But policy driven by prejudice, innuendo, and lay press articles does not serve the public good at all. Let the press articles raise concerns, but not also be the basis for policy decisions. Scientific investigations and evaluations first. It is an easy out to accuse the clinics of not being forthcoming with data when no government agency has asked then for it with the purpose of learning about their experience, knowledge, and expertise; and without the prejudice of shutting them down.
James @ Asymmetrex
FDA is a paper tiger. Chances of even getting noticed by them are very small, at least up to now. I’ll wager that new clinics will continue to open at a faster rate than the FDA can or will close them down.
OK, now I’m depressed…
Well, I hear ya. But it’s better to know about the situation as maybe a way to help to make it better.