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”.

Dr. Jeffrey Weiss, Steven Levy, SCOTS trial
Dr. Jeffrey Weiss and Steven Levy, leaders of 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?

Eye injection
Eye surgery image from Wikipedia.

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.

6 thoughts on “Dr. Jeffrey Weiss, SCOTS trial, & Patient Claims of Blindness”

  1. Hello,
    I wish to comment that my husband had a remarkable experience with Dr.Weiss and the SCOTS stem cell trial. His vision went from 20/400 in both eyes to 20/80 and 20/100. I dont know why other patients had a bad outcome but blaming it on the study cannot be 100% correct as it did give my husband back his vision….
    We are so thankful to of found Dr. Weiss…

    1. Robin,
      I’m skeptical of this “trial” at least in part because it seems to have no controls.
      Also, in my opinion the past eye injection work by this group hasn’t been published in rigorous, peer-reviewed journals.
      They’ve also seemed to have brushed off the claims by a number of patients of serious side effects.
      In my opinion they (and others) should not be charging patients to be subjects in an experiment using unproven and non-FDA approved stem cells.
      At first, it seemed like they were open to do an interview with me for The Niche, but I never got answers to my questions I sent them back in May, which were mostly direct, common sense inquiries:
      My best to you and your husband,

  2. Good Day All
    I believe that I am another who went through the SCOTS stem cell procedure and ended up with a bad outcome. In 2014 with great hope I had it done and 6 months after I developed a detached retina which I strongly feel was caused by SCOTS intervention. After several costly operations at the U of Miami Hospital I have given up on repairing it. I wish that I had never heard of Dr. Weiss…
    Please contact me if you have had a similar bad experience. arisstek@rogers.com


  3. Thank you for posting! As someone with a neurological eye condition I was considering SCOTS study but stumbled onto your blog and followed the BBC link. I appreciate it very much.

  4. So isnt this time to Catch the bad witch and stop ruining medicines,vitamins and treatements?sorry for been anonime,but this therapy is promissing and shouldnt be taken as something that can be abused for profit or sabotaged

  5. Someone in the know needs to deal with this exoneration statement and either concur or rebut it. It has been carefully craftet, one may assume, under legal guidance. Is it factual? Is it relevant?

    Then there are the difficult technical questions, like how could non-homologous BMSC ever be helpful in the retina or optic nerve?

    Considering the composition of the US government and its aversion to regulation of all types, I would not hold my breath waiting for definitive, accurate, or effective and relevant FDA regulations on stem cell procedures of any kind.

    It seems that we consumers are subject to the propaganda of stem cell clinics which can make a very convincing case, and that we are left in the dark without enough substantiated evidence to decide for ourselves what to do when contemplating this sort of treatment. We need more help which is integritous and in-depth with concrete recommendations. We have failed to get it. Do the big donor corporation control these outcomes like they control the American congress?

Comments are closed.