COMMENTARY

A Convicted Felon Wants People to Enroll in a COVID-19 Clinical Trial. What Could Go Wrong?

Retraction Watch Staff

Disclosures

June 01, 2020

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Richard Fleming, a felon convicted of health care fraud who has been debarred by the US Food and Drug Administration, would like to invite you to participate in a clinical trial.

Fleming has registered a study on ClinicalTrials.gov to evaluate what he calls the "Fleming Method for Tissue and Vascular Differentiation and Metabolism" — a method he claims can help physicians assess pneumonia resulting from Covid-19.

According to the notes for the study:

Diagnostic determination of disease and treatment responses has been limited to qualitative imaging, measurement of serum markers of disease, and sampling of tissue. In each of these instances, there is a built in error either due to sensitivity and specificity issues, clinician interpretation of results, or acceptance of the use of an indirect marker (blood test) of what is happening elsewhere in the body – at the tissue level.
The Fleming Method for Tissue and Vascular Differentiation and Metabolism (FMTVDM) using same state single or sequential quantification comparisons [1] provides the first and only patented test (#9566037) – along with the associated submitted patent applications ruled to be covered under #9566037 – that quantitatively measures changes in tissue resulting from inter alia a disease process. This includes inter alia coronary artery disease (CAD), cancer and infectious/inflammatory processes including CoVid-19 pneumonia (CVP) resulting from the metabolic and regional blood flow differences (RBFDs) caused by these diseases.
The purpose of this paper is to make clinicians and researchers aware of this proposed method for investigating the prevalence and severity of CVP – in addition to providing rapid determination of treatment response in each patient, directing treatment decisions; thereby reducing the loss of time, money, resources and patient lives. …

Fleming states he wants to enroll 500 patients who will receive various purported treatments for Covid-19, including, of course, hydroxychloroquine and azithromycin but also remdesivir. He declares that:

As FMTVDM is an absolute quantification method, which cannot be influenced by human error or bias, the final determinant of success or failure of treatment cannot be influenced. However, given the pandemic, medical, nursing, technologist and other healthcare providers will NOT be blinded to data. The availability of the data will allow real time assessment and decision making by the clinicians involved in the care of the patient.

Fleming — whose now-deleted Twitter profile said he was an "PhD, MD, JD AND NOW Actor-Singer!!!" — first came to our attention in 2018 when concerns about a different clinical trial he purported to run led to a retraction of one of his papers. That study was republished in a journal that has been labeled predatory, and then, as Elisabeth Bik has noted, republished yet again.

As one Twitter user wondered, we’re curious how Fleming is organizing and funding the study, given that his organization, the Camelot Foundation, appears to be defunct. And as Nick DeVito, studying at Oxford, put it:

https://twitter.com/Thatsregrettab1/status/1266193327054962690

Fleming has not responded to our questions about the trial.

This article originally appeared on Retraction Watch.

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