A convicted felon wants people to enroll in a COVID-19 clinical trial. What could go wrong?

Richard Fleming

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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21 thoughts on “A convicted felon wants people to enroll in a COVID-19 clinical trial. What could go wrong?”

  1. 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.

    1. 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.

  2. 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.

  3. 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.”

  4. 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!”

  5. 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

  6. 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.

  7. I received an email this morning from dr Fleming stating that the Pfizer vaccine is a biological weapon and will kill those who’ve taken it.
    This prompted me to look up the name and I have foundxsome very worrying facts here.

  8. https://en.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements
    And yet still they continue the poison the world even with the death jab covid, and no nobody is questioning those institutions and let them get away with deaths they caused.
    You people need to wake up, instead pointing the finger to one person who not even killed a single person only of alleged fraud of for some reason he pledged guilty to(plea bargain).
    Time big pharma is starting to pledge guilty to the deaths they caused over the years instead getting away with murder, and continue to do so, they plea bargained their way out of it by just paying back less then 1/1000 of the provit they made on killing humans with their dug.
    For fck sake wake up, you are beeeing played.
    You jabbed people are going to find out in the next 10 years.
    How many of you have heart pounding in their chest after a simple walk, how many have pains in their chest, of gotten heart problems.
    And still you believe bigpharma convicted multiple times for fraud and deaths(see list, of convictions), over one person who made one misstake and plead bargained for the one case he is linked to.
    You people are insane, no brains to think with and only want to hear and see untill they die, you people have lost you marbles.
    To be frank i can’t wait until the 10 years are over, i will be thinking about you and how you got gaslighted into taking something that killed them in the long run.
    Manny of you wont be there to witness the man hunt to prosecute the guilty ones including the colborators out there.
    Why do you think ceo borla is not speaking to the press unless there is a list of pre defined questions, and you spineless cowards who constantly live in fear get what they fear the most a sudden death!

  9. Dr. Richard M. Fleming’s PhD diploma has been verified as fake by the university he claims jointly awarded it. Observers can see for themselves that there are several things wrong with it, including obvious copy and paste of signatures on the left and two identical font e-signatures on the right. Upon closer inspection, the President of the Board of Regents is incorrectly named, the “State Universities of Iowa” is an incorrect reference to the former name of the University of Iowa, and the dates of matriculation and graduation with this “PhD” are 1968-1974, corresponding to Fleming’s ages 12-18 and predate his bachelor degree. Laughable.

    Furthermore, Dr. Fleming often uses the word “attorney” or “lawyer” to describe himself, yet the American Bar Association Professional Ethics 1-100 cite that the term is only to be used by those admitted to a State Bar and able to practice law. I cannot find any state bar associations for Dr. Fleming but would be happy to be corrected, as I only checked CA, NV and TX (his post conviction states of residency) and not all 50 states (I believed it futile at that point).

    Dr. Fleming also represents himself in several instances (very recently) of have certain credentials, but I verified his current statuses:

    – American Board of Internal Medicine (status: not certified)
    – American Society of Nuclear Cardiology (expired 2002; cannot be current “Fellow” either, as he claimed in a 2022 video “oath”)
    – Certification Board for Nuclear Cardiology (not listed)

    Lastly, his Cardiology Fellowship at the University of Texas Health Science Center resulted in him NOT being ABIM Board eligible for the subspecialty of Cardiovascular (per court documents because Dr. Fleming likes to sue everyone and every institution who takes action against him – but he never seems to prevail).

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