SCOTS, Selling Stem Cells, & More Patient Claims of Blindness

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”.

Steven Levy Jeffrey Weiss

Drs. Steven Levy & Jeffrey Weiss, leaders of 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? Continue reading

NEJM paper links 3 blinded patients to publicly-traded stem cell clinic

Do 3 blinded stem cell clinic patients with major or complete vision loss constitute a significant adverse outcome?

I would say so and a new paper details how this happened apparently at a particular publically-traded South Florida stem cell clinic business.

You can see the damaged retinas of one such patient below in an image from a new NEJM paper reporting the severe adverse outcomes. The red areas are hemorrhaging with other substantial damage to the retina as well.

How did this all happen?

stem cells eyes

Kuriyan, et al. 2017 NEJM Figure 2A

Last year the story began to break of multiple patients alleging they had been blinded by different businesses in South Florida. Dr. Thomas Albini presented on some information on this at the FDA meeting last fall, but things weren’t entirely clear. Back then there were also indications of lawsuits by patients related to alleged vision loss due to experimental stem cell offerings against various parties involved.

Now we have more details on some of the cases in this new NEJM article (Kuriyan, et al.) in which the authors attribute these patients’ experiences to a withdrawn “trial”, NCT02024269, which lists Bioheart (now known as US Stem Cell, Inc.) as the sponsor. I put “trial” in quotes because it was withdrawn and also because as best as I can tell this wasn’t a traditional FDA-approved trial of the kind normally based on pre-clinical data and an IND. US Stem Cell, Inc. is a publicly-traded company ($USRM) and its stock has been all over the place this year. I’m not aware of US Stem Cell having FDA approval for what it is doing.

The NEJM article oddly does not mention Bioheart or US Stem Cell, Inc. by name as the place where the patients were given the stem cells, but the authors do clearly link them together and other information further supports this connection. Continue reading

US Stem Cell Clinic sues anonymous critics for libel, seeks IDs from websites

U.S. Stem Cell, Inc.Last month the stem cell community learned that a patient of the business US Stem Cell Inc./US Stem Cell Clinic, previously known as Bioheart, had filed suit in a Broward County Florida Court against the publicly traded company alleging various charges including damage to her eye.

Now US Stem Cell has more recently filed suit in the same court against one or more anonymous online critics for libel/slander. In this new case, US Stem Cell Inc versus John Doe, et al, the company points to specific instances on stock investing message boards where anonymous commenters discussed the company, and alleges that certain comments constitute libel/slander.US Stem Cell Libel Suit

If you are interested in reading the details of this new or the earlier case, you’ll have to search for it on the Broward County Court website using this tool given idiosyncrasies of that website that make it so that one cannot directly link to cases or documents. This is in fact how I found out about the new case when I searched for Bioheart there to see if there was anything new on the patient suit and saw the new suit.

In the newer case, the alleged anti-Bioheart/US Stem Cell comments were made on Yahoo Message Boards and iHub Message Boards. From reviewing the most recent court filings in the case, it would appear that US Stem Cell so far has not been able to identify these commenters so it asked the court to allow subpoenas of Yahoo and iHub to provide the identities of the person or persons who are defendants in the case.

This US Stem Cell situation reminds one of the ongoing case involving PubPeer, where a professor has sued to identify anonymous commenters who he believes caused him injury. Of course there are some major differences, but also a few parallels.

Free speech, public discourse, and transparency are essential to biomedical science including both for academia and in the for-profit stem cell world. I allow anonymous commenters on this blog, but sometimes moderating comments that some individuals make that are extreme such as personal attacks or statements about companies that just go too far is a challenge. There are times I have no choice but to edit or delete them because they violate our comment policy, but I don’t like to do that if it can be avoided so it is a rare event. Also, certain anonymous comments can be some of the best in terms of providing new information or stimulating vigorous discussions. The toughest situation is when comments fall into a gray zone of potentially being useful in terms of providing information or a new perspective, but at the same time including material that is questionable.

These are difficult dilemmas.