In a previous post, I introduced two dubious studies, Stem Cell Ophthalmology Treatment Study and SCOTS2. The subjects have to pay $20,000 for the privilege of participating in these studies. I focused on the incoherent design, haphazard conduct, and self-serving manner the investigators have analyzed and reported their results. I have learned of an ethics investigation and legal battle related to SCOTS. Thanks to Jann Bellamy, who procured the relevant documents and helped me navigate the legal landscape, I have a better idea of the actions of several state Attorneys General against dubious stem cell clinics.
Two physicians are behind the SCOTS.
The studies are sponsored by MD Stem Cells. The sponsor is the person who has authority and control over the study. The sponsor is the entity that funds the research. The SCOTS trials are funded by patients who each pay $20,000 for the privilege of participating.
What is 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.
Stem cell clinical trials are being sponsored by MD Stem Cells. I will keep focused on the SCOTS trials.
Steven Levy and Jeffrey Weiss are Stem Cells physicians.
Dr. Levy is the Study Director for all the MD Stem Cell studies. He is in Connecticut. After a career in the practice of ophthalmology, Dr. Levy transitioned into life science and healthcare business development.
There is a possible explanation for Dr. Levy's career transition. According to the program, Dr. Levy lost his license to practice medicine in New York State. Steven Levy did not have a New York State license surrender record. There is a public record of Stephen Levy, MD who surrendered his New York medical license in 2004. The State Board of Professional Conduct had an allegation of professional conduct.
Stephen Levy surrendered his medical license in Connecticut in 2004.
Was this allegation of surrender of New York licensure a case of mistaken identity, Steven Levy for Stephen Levy?
Steven Levy graduated from Albany Medical College in 1980.
Albany Medical College does not list Steven Levy in their 1980 graduating class, but does list Stephen N Levy in their 1976 graduating class.
The Steven Levy at MD Stem Cells is related to the Stephen Levy who surrendered his license in Connecticut.
Stephen N Levy, who graduated from Albany Medical College in 1980, surrendered his license in New York and Connecticut in 2004.
Stephen Levy surrendered his license in York and Connecticut and is now the CEO of Stem Cell MD. At some point between 2004 and the present, the spelling of Dr. Levy's first name changed.
If his position as CEO of MD Stem Cell and Director of multiple clinical trials does not involve patient care, he would not need to be a licensed physician. Why does this matter? For the first time, a SCOTS subject was told about Dr. Levy's run-in with the New York Medical Board. The patient said that he would not have participated in the SCOTS trial if he had been aware of Dr. Levy's license surrender. Other potential study subjects might be interested in this information.
Dr. Weiss is 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. He practices SCOTS procedures in Florida.
Dr. Weiss' involvement in SCOTS earned him some unwanted attention from the AAO. The AAO is a professional organization. The majority of US ophthalmologists are members. The AAO began an ethics investigation into stem cell practices.
Dr. Weiss tried to stop the investigation. Some of the details of the AAO investigation have entered the public domain because of his legal challenges. The court records show that the ethical concerns of AAO were based on Dr. Weiss.
The Code of Ethics was the subject of a discussion between AAO and Dr. Weiss. The ethics committee will review the records provided by Dr. Weiss.
- 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.
The 11.8% complication rate is likely an underestimate.
Depending on the arm chosen the risk of potential complications has been calculated to be from 0.0008% to 5%.
An AAO review of records provided by Dr. Weiss shows that the upper end of the range is less than half the rate disclosed. A 10,000-fold underestimate is what the lower range is.
An expert was hired by AAO to review the case. The expert had a lot of 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.
The deliberations lasted over four years and withstood challenges in the courts. It seems that Dr. Weiss didn't want to defend himself. 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.
The Ethic committed that Dr. Weiss was in violation of the Ethics Code. Dr. Weiss lost his membership in the AAO.
The conduct of the SCOTS studies are more important than the behavior of Dr. Weiss. In my first entry on the subject, I mentioned that the Ethics Committee had many concerns about SCOTS. They were able to confirm the validity of the concerns using information from Dr. Weiss. SCOTS methodology deviated from sound research practice and its results were in conflict with public statements made by Dr. Weiss.
The information should be relevant to potential SCOTS subjects and to providers who would consider referring patients.
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