In a previous post I introduced two dubious studies, Stem Cell Ophthalmology Treatment Study (SCOTS) and the virtually identical SCOTS2. In these studies, subjects must pay approximately $20,000 for the privilege of participating. I focused on the incoherent design, haphazard conduct, and the self-serving manner the investigators have analyzed and selectively reported their results. Since that entry, I have learned of an ethics investigation and legal battle relevant to SCOTS. Many thanks to Jann Bellamy, JD for procuring the relevant documents and helping me navigate the legal landscape (and do have a look at her recent and related post discussing the actions of several state Attorneys General against dubious stem cell clinics).
This entry will focus on two physicians behind the SCOTS.
Background: MD Stem Cells
MD Stem Cells is listed as the Sponsor of the studies. Clinicaltrials.gov defines “sponsor” as “The organization or person who initiates the study and who has authority and control over the study”. In practice, the sponsor is often the entity that funds the research. Not so for the SCOTS trials, which are funded by patients who each pay approximate $20,000 for the privilege of participating.
What, exactly, is MD Stem Cells? Here is a quote from their website:
We are a consultancy providing information, education, facilitation, and access to advanced stem cell treatments. We act as Sponsor and Dr. Levy is Study Director for clinical trials and treatments involving bone marrow stem cells in Ophthalmology, Neurology, Alzheimer’s, Dementias, Autism Spectrum Disorder, Spinal Cord Injury and Anti-Aging.
MD Stem Cells is sponsoring a stem cell clinical trials in a variety of specialties. I will continue to focus on the SCOTS trials.
There are 2 US Stem Cells physicians relevant to SCOTS: Steven Levy and Jeffrey Weiss
Steven Levy, MD
Dr. Levy is the CEO of MD Stem Cells and Study Director for all the MD Stem Cell studies. He is located in Connecticut. His bio states that: “Following a career in the practice of ophthalmology, Dr. Levy transitioned into life science and healthcare business development.”
A BBC Radio program revealed a possible explanation for Dr. Levy’s career transition. In the program it was asserted that Dr. Levy had lost his license to practice medicine in New York State. I found no New York State record of license surrender for Steven Levy. There is, however, public record of a Stephen Levy, MD (note the spelling Stephen) who voluntarily surrendered his New York medical license in June 2004. This was in response to the State Board of Professional Conduct allegation of “41 specifications of professional misconduct”.
There was also a Stephen Levy MD who surrendered his medical licensed in Connecticut, also in 2004.
So was this BBC Radio allegation of surrender of New York licensure a case of mistaken identity: Steven Levy for Stephen Levy?
The Levy formerly known as Stephen
According to his Linkedin profile, Steven Levy from MD Stem Cells matriculated at Albany Medical College in 1976 and graduated in 1980.
Strangely, Albany Medical College does not list a Steven Levy in their 1980 graduation class, but does list a Stephen N Levy entering Albany Medical College in 1976 (1980 graduating class).
The Stephen Levy who surrendered his license in Connecticut has an educational pedigree bio that matches the Steven Levy at MD Stem Cells.
Docinfo, an aggregation site for licensing information on US physicians, confirms that a Stephen N Levy who graduated Albany Medical College in 1980 surrendered his license in New York and Connecticut in 2004, and holds no active medical license.
So it seems clear that the Stephen Levy who surrendered his license in York and Connecticut is the same person who is now CEO of MD Stem Cell. At some point between 2004 and the present the spelling of Dr. Levy’s first name morphed from Stephen to Steven.
If his position as CEO of MD Stem Cell and Director of multiple clinical trials does not involve patient care, Dr. Levy would not be required to be a licensed physician. So why does this matter? In the BBC Program, a SCOTS subject was informed, for the first time, about Dr. Levy’s run-in with the New York Medical Board. The patient was quite surprised and stated that had he been aware of Dr. Levy’s license surrender, he would not have participated in the SCOTS trial. Perhaps other potential study subjects might be interested in this information, as well.
Jeffrey Weiss, MD
Dr. Weiss is an ophthalmologist with training as a retina sub-specialist. He is the principal investigator in the SCOTS study as well as a couple of other non-ophthalmology stem cell trials carried out by MD Stem Cells. He practices and carries out the SCOTS procedures in Florida.
Dr. Weiss’ involvement in SCOTS earned some unwanted attention from The American Academy of Ophthalmology (AAO). The AAO is the largest professional organization of ophthalmologists. Membership is not required, but the vast majority of US ophthalmologists (>90%) are members. In approximately 2017 the AAO began an ethics investigation into Dr. Weiss’ stem cell practices.
Dr. Weiss attempted to stop AAO’s investigation through the courts. His legal challenges were unsuccessful but, as a result of these lawsuits some of the details of AAO’s investigation have entered the public domain. The court records clearly demonstrate that AAO’s ethical concerns were based on Dr. Weiss’ activity in the SCOTS studies.
AAO engaged with Dr. Weiss to determine whether or not his activities in the SCOTS studies violated the Code of Ethics. Dr. Weiss provided records for the ethics committee to review.
Some of the assertions from the AAO’s review of Dr. Weiss’ records
- Most patient records contain protocol deviation with very poor follow-up documentation.
- The Committee’s analysis indicates that the data does not substantiate the following claims Dr. Weiss has made about his success rates.
- …28 complications were identified in the charts reviewed which refutes Dr. Weiss’s statement to the Ethics Committee that he has treated “treated hundreds of patients without complications, or SAEs”…
- Given the limited follow-up documentation on most subjects, the Committee’s analysis may underestimate the total number of adverse events…This represents a total of 28 of 237 eyes (11.8%) reporting complications among this select group of patients with a minimum of 6 months of followup.
Contrast the 11.8% complication rate (likely an underestimate), to what is currently on MD Stem Cells’ website (accessed 3/24/2022):
Note the final sentence: “Depending on the arm chosen the risk of potential complications has been calculated to be from approximately 0.0008% to 5%.”
Note the upper end of the range is less than half the rate disclosed by an AAO review of records provided by Dr. Weiss. The lower range is a 10,000-fold underestimate!
AAO contracted an expert to review the case, including records provided by Dr. Weiss. Suffice it to say the expert was truly an expert, with impeccable credentials and extensive experience in the design, conduct, and analysis of clinical trials in ophthalmology. Quoting from the expert’s testimony:
- Dr. Weiss’ studies fall below acceptable standards of human subjects research.
- Absence of a control group in SCOTS and SCOTS II is a serious impediment to developing “adequate information on which to base prognostic or therapeutic decisions”…
- …less than 60% of the eyes noted in the 501 submitted charts had follow-up through 6 months, only 168 subjects (34%) had follow-up through 12 months, and only 10 subjects (2%) had completed the entire protocol without deviation or any missing data.With such large percentages of eyes missing outcome data, no meaningful analysis or interpretation of the results on the primary outcome can be made as called for in SCOTS and SCOTS II protocols.Selective reporting on only a small proportion of enrolled patients raises questions about whether only patients with the best outcomes are reported…
- Dr. Weiss has not identified the specific case records supporting results on vision reported in the publications on SCOTS and SCOTS II. The absence of specific records supporting the results brings the accuracy of the reports into question.
Dismissed!
It is notable that deliberations lasted approximately 4 years and withstood challenges in the courts. It seems that Dr. Weiss declined to defend himself, to the fullest extent offered by the AAO. As the judge commented:
Notably, Dr. Weiss refused to avail himself of many of the procedures he was offered. Dr. Weiss did not produce the “data set analysis” that the Ethics Committee requested…And when the Committee held its hearing, he refused to attend.
In the end, the Ethic Committed found Dr. Weiss to be in violation of the Ethics Code. As a result Dr. Weiss was dismissed from membership in the AAO.
Implications for SCOTS
The AAO investigation and ruling were in judgement of Dr. Weiss’ behavior, but they are inseparable from the conduct of the SCOTS studies. The Ethics Committee had many of the same concerns about SCOTS I expressed in my first entry on the subject. They were able to confirm the validity of these concerns using information provided by Dr. Weiss. They found SCOTS methodology to deviate from sound research practice, and its results to be in conflict with public statements on record by Dr. Weiss.
This information should be relevant to potential SCOTS subjects and to providers who would consider referring patients the SCOTS.