Dr. Jeffrey Weiss, SCOTS trial, & Patient Claims of Blindness

Two physicians are central to something called the SCOTS trial, Dr. Jeffrey Weiss and Steven Levy. Patients have claimed negative outcomes after participating in the trial. What’s going on here?

SCOTS trial

The recent NEJM paper reporting on the blinding of three patients in Florida may be just the beginning. More information has come out 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. However, 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. There’s a BBC investigation on these allegations reported in a striking radio broadcast and now a new BBC report that raises more concerns on MD Stem Cells.

Dr. Jeffrey Weiss and Steven Levy

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.

MD Stem Cells responds

Via a vision-related Facebook page, MD Stem Cells has just reportedly now responded to the BBC broadcast. Here are excerpts of their side of things:

“We have been asked by your group to respond to the BBC radio program about SCOTS….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…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.”

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.

As an update, the American Academy of Ophthalmology terminated the membership of Dr. Jeffrey Weiss as noted by the BBC.

Overall, stem cell-based approaches to vision loss have real promise. However, in my view interventions should be limited to FDA-approved trials with INDs. Those should have extensive and rigorous pre-clinical data.