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:
Fleming has not responded to our questions about the trial.
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You might also like to catch Dr. Wax’s interview this week of “Dr. who?” AKA Fleming.
You can find it here: https://www.facebook.com/94889574836/posts/10158603200204837/?d=n
~one Twitter user
According to the trial registration, “study chair” Fleming is conducting a clinical trial testing FDA regulated drugs for diagnosis and treatment in patients with Covid-19. Since there are no approved treatments for Covid-19, and IND application to FDA is required.
Per the FDA debarment notice, Fleming is prohibited “for 10 years from providing services in any capacity to a person that has an approved or pending drug product application.”
https://www.govinfo.gov/app/details/FR-2018-09-28/2018-21210
Perhaps Retraction Watch could clarify with FDA that the debarment includes provision of services in FDA regulated research.
Thank you, I’ve wondered about that too. I doubt he’s actually conducting any trials, since he appears unaffiliated with an institution that can provide health services, so maybe just registering an imaginary trial doesn’t cross the line. If he has crossed the line (for example, by including false information on his trial application, as it appears he has), he might face more trouble than a more lengthy debarment. It’s possible that this behavior violates the plea agreement reached when he plead guilty.
Source: https://www.healthgrades.com/media/english/pdf/sanctions/HGPYA59E0F8B7C744ECBB05212010.pdf
According to this State of Nebraska “Petition for Disciplinary Action,” Fleming is “permanently excluded from Medicare, Medicaid, Tricare, and all other federal healthcare programs.”
I verified that he is on the exclusion list accessible here: https://oig.hhs.gov/exclusions/index.asp and that site says:
“ OIG has the authority to exclude individuals and entities from Federally funded health care programs for a variety of reasons, including a conviction for Medicare or Medicaid fraud. Those that are excluded can receive no payment from Federal healthcare programs for any items or services they furnish, order, or prescribe. This includes those that provide health benefits funded directly or indirectly by the United States (other than the Federal Employees Health Benefits Plan).
OIG maintains a list of all currently excluded individuals and entities called the List of Excluded Individuals/Entities (LEIE). Anyone who hires an individual or entity on the LEIE may be subject to civil monetary penalties (CMP). To avoid CMP liability, health care entities should routinely check the list to ensure that new hires and current employees are not on it.”
Based on this, it sounds unlikely that Fleming/Dr. who? would be in a position to legally run a clinical trial.
He’s now uploading “results” to SSRN:
https://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=3524558
By the way, Fleming has a new Twitter account: @medicinesDarkk1 (although I’m blocked). Profile: “Physicist-Nuclear Cardiologist-Biologist-Chemist-Psychologist and a few other things,” the latter phrase undoubtedly is an oblique reference to “convicted felon.”
https://youtu.be/xl_lBg4VnsQ
“We have reviewed and validated our SARS-CoV-2 data.
We have noted special circumstances for the use of a number of the treatments included in our NCT04349410 study effecting the outcomes .
We have also noted some drug-drug interactions that are mitigating benefits and in some instances worsening the disease.
If you are a researcher or clinician working with SARS-CoV-2 and you would like the raw data, please send a message to this youtube channel with contact information. I will not post the message and try to answer any questions you might have or perhaps hear from you with any insights you have gleaned from your work.
Thank you!”
Dr. Fleming has posted a preprint of the results of his trial, available here: https://doi.org/10.21203/rs.3.rs-96840/v1 https://www.researchsquare.com/article/rs-96840/v1
Highlights: 23 sites, 7 countries, 1,800 patients, 10 treatment arms. No other authors other than Fleming and son. None of the sites were identified, although the ill-formatted tables (apparently due to unfamiliarity with Acrobat) include Table 3 showing the country of the sites. No funding was required for this study (?).
Interestingly, the Clinicaltrials.gov site shows that on October 8, Fleming changed the “treatment arms and interventions” details on all of the tested protocols. This is 3 weeks AFTER the trial was concluded. An example of the changes:
Experimental: Treatment 1
ORIGINAL
Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days, and Azithromycin 500 mg IV on day 1, followed by 250 mg IV on days 2-5 (to prevent bacterial superinfection ).
REVISED
Hydroxychloroquine 200 mg po q 8 hrs (600 mg qD) for a total of 10-days , OR Hydroxychloroquine 155 mg IV every 8-hours (600 mg qD) for 10-days if patient is intubated and Azithromycin 500 mg IV on day 1, followed by 250 mg IV on days 2-5 (to prevent bacterial superinfection ).
https://clinicaltrials.gov/ct2/history/NCT04349410?A=6&B=7&C=merged#StudyPageTop
Dr. Fleming has a new Twitter handle https://mobile.twitter.com/Lys_og_sannhet where today he tried to tie Ivan O. and Retraction Watch to Leona Helmsley, Enron, and others in a conspiracy against… well, it isn’t clear. No doubt it’s bad.
Oh my gosh, look at his followers! https://mobile.twitter.com/Lys_og_sannhet/followers
QAnon, Antivax and more.
That is one bright spot: he doesn’t get much attention so he probably can’t cause too much harm.
A handle like “Lys_og_sannhet” (“Light and Truth”) is liable to appeal to conspiracists, alas.
Dr. Fleming has been responding to some of my needling in the comments on the preprint: https://www.researchsquare.com/article/rs-96840/v1.
He is still unwilling to provide any evidence that the study was actually conducted. I confirmed online that the trial was not registered in 4 of the countries in which it was purportedly conducted: India, S Africa, Philippines and Cuba. From what I have read, these countries require registration even if a study is already on NCT site (but if anyone is an expert on this knows differently, please share).
His responses have now devolved into a repetitive challenge to debate me in a podcast after I reveal my identity. I see no value in aiding his efforts to seek YouTube stardom, especially since he won’t answer the most basic questions truthfully.
The author continues to refuse to make even redacted data available to the public for analysis. There doesn’t seem to be a clear rationale for this reluctance, but one may be right to have concerns that the data would not survive close scrutiny by the research community more broadly.
https://twitter.com/doctor_i_am_the/status/1335632875266306048?s=21
The author appears to have been unable to get the paper published by a legit journal. Resorted to “predatory” journal instead: https://biomedres.us/pdfs/BJSTR.MS.ID.005443.pdf
Full of unbelievable material and badly faked statistics, it is unlikely to ever be retracted.