Have more patients been blinded by stem cell clinics?
The recent NEJM paper reporting on the blinding of three patients in Florida may be just the beginning of information beginning to flow on negative outcomes for patients who are customers of stem cell clinics selling non-FDA approved offerings. The NEJM authors linked the loss of vision to interventions received by patients from the publicly-traded company US Stem Cell, Inc., but different patients also in Florida have been alleging that they were blinded by a different entity, the “SCOTS trial”.
I’ve blogged about SCOTS several times before including the patient allegations of being blinded and various other concerns. Now there’s a new BBC investigation on these allegations reported in a striking radio broadcast.
Two physicians are central to the SCOTS trial, Drs. Steven Levy and Jeffrey Weiss. A number of patients have alleged negative experiences including patient George Gibson, who is one focus of the BBC report. But by contrast another patient named Doug Oliver has said that he had very good results from SCOTS. How do we in the broader stem cell community try to understand the SCOTS situation? It’s difficult right now, but can we learn anything from the BBC investigation?
In the process of the BBC radio program, we hear George and the BBC journalist Phil Kemp try to talk to those running SCOTS, but have no luck. At one point the radio program says that apparently the cops are even called on George and Phil for what seems to be simply waiting and hoping to talk to Dr. Weiss.
George and other SCOTS patients paid around $20,000 for access to the non-FDA approved, experimental therapy consisting of injections of bone marrow stem cells into the eyes. It’s not clear how the cells were prepared and why some patients may have had severe adverse events. Besides Doug Oliver were other patients concretely helped? Is there documented evidence of benefits?
The SCOTS situation is rapidly evolving in terms of what the stem cell community is learning so hopefully more clarity will emerge soon.
Via a vision-related Facebook page, SCOTS has just reportedly now responded to the BBC broadcast. Here is their side of things:
“We have been asked by your group to respond to the BBC radio program about SCOTS. We wish to thank the hundreds of members of Vision Quest Advocacy Network for their continued interest in stem cell research for eye disease and their personal contributions to this site.
At this time we have the following comments on the BBC program:
BBC radio is not a peered reviewed medical publication and their stories are not subject to any independent verification. Stories are selectively edited not to present accurate information, but to keep their audience emotionally engaged. Their purpose in producing the story was not to move stem cell research forward or to help patients overcome otherwise irreparable vision loss, but to increase their listenership.
BBC never obtained permission from the patients to allow us to reveal our own eye exam findings or other ophthalmologists’ exams to rebut their accusations. In fact, they never asked us for any eye exam findings at all – because their goal was never to obtain the truth. The goal was clearly stated by the patients in their story: to deny other patients access to the option of treatment with bone marrow stem cells in a monitored, Institutional Review Board (IRB) approved study.
Because of our need to remain compliant with HIPAA privacy laws, we were unable to reveal exam specifics regarding these patients. The real facts are that, following their treatment in SCOTS, improvements in vision occurred for at least some eyes. Certain of the patients could readily navigate Dr. Weiss’s office, interact with his staff and walk through the parking lot and office building independently after SCOTS when they could not do so before treatment – even while claiming visual loss. If any worsening of vision did occur in an individual eye, medical information exists to substantiate the cause was underlying medical issues or natural progression of their already severe eye disease, and was not a result of the SCOTS procedure.
While we are not allowed to be patient specific, there are numerous medical conditions that could cause worsening vision in an individual eye including cardiovascular disease, arrhythmias, insulin dependent diabetes, severe renal disease, behavioral issues, poor lifestyle habits, withholding of preoperative medical information and chronic non-compliance with treatment of medical problems or other eye diseases. Any of these issues could affect vision irrespective of treatment in SCOTS or SCOTS2 and not because of it.
We caution the Vision Quest Advocacy Network that there is much more to this story than has been presented by BBC. There has been an attempt to extort money from Dr. Weiss in exchange for not defaming SCOTS and charges have been filed with the authorities in Florida. BBC has potentially violated civil privacy statutes in Connecticut as well as at the federal level and legal action against them is being explored.
Dr. Levy has performed an excellent job in his non-medical role in SCOTS and SCOTS2 including all business and project management functions as Study Director.
All clinical and treatment decisions are made solely by Dr. Weiss, a board certified, fully licensed ophthalmologist and fellowship trained retinal surgeon with decades of retinal surgical experience. In SCOTS and SCOTS2, Dr. Weiss has treated hundreds of patients and over 47 different retinal and optic nerve conditions, making him truly the most experienced ophthalmic stem cell surgeon in the world today. The SCOTS trials remain the largest and most carefully performed eye stem cell treatment studies in the world and the only one treating both optic nerve and multiple retinal diseases with bone marrow stem cells (BMSC) – not fat or adipose derived stem cells.
Please be aware that we were specifically asked by Vision Quest Advocacy Network to respond to the BBC broadcast. We consider this Facebook site to be for patient to patient discussions alone. We do not follow this forum and, because of privacy and study ethics concerns, will not respond to public questions. Patients who are interested in the study and wish further information should contact us through www.mdstemcells.com or email Dr. Levy directly at email@example.com
Jeffrey Weiss MD and Steven Levy MD – The Stem Cell Ophthalmology Treatment Studies.”
The bottom line now?
Hopefully the FDA and Florida state officials are investigating the situation. On the BBC broadcast Leigh Turner says that he contacted the FDA with his concerns on this “trial” years ago, but it’s unclear what if anything the agency has done about SCOTS.
Overall, stem cell-based approaches to vision loss have real promise, but in my view should only be done in FDA-approved trials with INDs (or equivalent in other countries) based on extensive rigorous pre-clinical data.