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Sunday, 30 September 2018

Egregious - the Richard M. Fleming Story

An RCT paper claiming to show harmful effects of a low-carb diet passed briefly over the internet on the weekend before being shot down in flames.
The title is:

Long‐term health effects of the three major diets under self‐management with advice, yields high adherence and equal weight loss, but very different long‐term cardiovascular health effects as measured by myocardial perfusion imaging and specific markers of inflammatory coronary artery disease.
The paper is published in Clinical Cardiology [edit: not Preventive Cardiology], and is free to access.
https://onlinelibrary.wiley.com/doi/abs/10.1002/clc.23047

[update: the paper above has since been retracted. Its Pubpeer discussion is here
https://pubpeer.com/publications/AA81ABA153565C2A238B191DFE0FB6 ]
[Update: the paper has been quickly republished here, in what may well be a predatory journal https://biomedres.us/pdfs/BJSTR.MS.ID.002006.pdf
Retraction Watch story here: https://retractionwatch.com/2018/11/13/a-convicted-felon-writes-a-paper-on-hotly-debated-diets-what-could-go-wrong/ ]

Three of the authors work at Fleming's medical imaging company in California, one is a deceased psychologist from Iowa, another is a pediatric nutritionist from New York and one is a Kellogg's employee from Illinois.
How this group was able to run a 12-month diet trial in 120 subjects is something of a mystery.

The conclusions:

One‐year body mass changes did not differ by diet (P .999). Effect sizes (R, R2) were statistically significant for all indices. Coronary blood flow, R (CI 95%) = .48 to .69, improved with low‐to‐moderate‐fat and declined with lowered carbohydrate diets. Inflammatory factor Interleukin‐6 (R = .51 to .71) increased with lowered carbohydrate and decreased with low‐to‐moderate‐fat diets.
Conclusions
One‐year lowered‐carbohydrate diet significantly increases cardiovascular risks, while a low‐to‐moderate‐fat diet significantly reduces cardiovascular risk factors. Vegan diets were intermediate.

First I'll consider all the good reasons to reject this study, but after that I'll do something we should always do, even for the worst study - take it at face value.

1) Lead author Dr Richard M. Fleming is a self-confessed and convicted felony fraudster who has admitted falsifying data in another RCT.

Fleming admitted to knowingly executing and attempting to execute a scheme to defraud Medicare and Medicaid healthcare benefit programs in connection with the delivery of and payment for healthcare benefits, items, and services, namely by submitting payment claims for tomographic myocardial perfusion imaging studies that he did not actually perform. Fleming also pled guilty to one count of felony mail fraud in violation of 18 U.S.C. 1341 and 2 for conduct relating to money paid him to conduct a clinical study of a soy chip food product for the purpose of evaluating health benefits. As Fleming admitted during his guilty plea, he received approximately $35,000 for conducting a clinical trial, but he fabricated data for certain subjects.
https://www.federalregister.gov/documents/2018/09/28/2018-21210/richard-m-fleming-denial-of-hearing-final-debarment-order

2) Fleming obtained Robert Atkins' medical records by deception and shared them with Neal Barnard of the vegan activist group PCRM in 2004, another unethical behaviour and one demonstrating that Fleming has a long-standing animus against Atkins and his diet.

https://theskepticalcardiologist.com/2016/12/18/what-does-the-death-of-robert-atkins-tell-us-about-the-atkins-diet/

Now, vegans can do research into this exact question with a high standard of rigour, see Chris Gardner's studies - one can certainly dispute the interpretation of some results, but not the results themselves. And I have reviewed a vegan diet study favourably here (dealing with another Fleming paper in passing) - good results are good results; I don't doubt these diets can have also cardiovascular benefits over the short-to-medium term, but question their long-term effects on mental health, reproductive health, dental health, joint health etc.

3) The trial protocol number on the paper links to a study that was completed in 2002. This explains how a convicted felony fraudster was able to conduct a study. The protocol was posted in 2006, 4 years after the study concluded, which seems unusual on the Clinical Trials website.


https://clinicaltrials.gov/ct2/show/NCT00324545

4) The study has 35 citations - 15 of these are to Fleming's own papers. This self-spamming, which helps boost an author's citation rate, is frowned upon by reputable journals. One of these references has the word "quantum" in the title. Other references are to news articles and book chapters. The low carbohydrate diet references are more than 15 years old. Ref 16 is curious as an anonymous reviewer is given credit for the wording of a paragraph of interpretation, surely a run-of-the-mill interaction with a reviewer.

5) The novel aspect of this paper may lie in the reference to that novel vegan touchstone, Neu5Gc. Pro-tip - if the vegan diet had a magic mechanism, you ought to know it already; some major low-carb mechanisms have been understood for generations. At this rate, if there is a magic mechanism for vegan health benefit, it will be discovered by a low-carb scientist.

We  now  know  that  these  food  choices  and  their  impact  are  at  least partially precipitated by the inflammatory effect of our diets based given our inability to convert Neu5Ac to Neu5Gc and our bodies immune response to the Neu5Gc present in animal protein. 

At this point, let's take the study at face value. the vegan diet avoided animal protein and Neu5Gc, the low carb diet probably included twice as much protein as the other diets (based on reference 6), but the low fat diet included more animal protein and Neu5Gc than the vegan diet.

One‐year lowered‐carbohydrate diet significantly increases cardiovascular risks, while a low‐to‐moderate‐fat diet significantly reduces cardiovascular risk factors. Vegan diets were intermediate.

So Fleming's own study, taken at face value, doesn't support the Neu5Gc hypothesis. In fact, it's unusual for the vegan diet to be inferior to the low-fat diet in any vegan study, and it's unusual for the low carb diet to be inferior to the low-fat diet in any low-carb study.

6) adherence to diets over 12 months was 100%. Of course, this is unheard of and entirely implausible; if honestly reported, it seems to show considerable gullibility or self-deception in the study team.


 That 100% of participants continued on their respective diet plans through a full year of dieting contrasts  sharply  with  much  of  diet  research  experience  with  drop outs  and  with  common experience with difficulties of dieting and remaining on diets. This success can be attributed to attention to well-established psychological principles of habit acquisition and extinction and of behaviour modification through Bandura [17] counseling.

Bandura's ethos seems sensible enough and appropriate for such a project, except perhaps when the people using it for counselling already believe that one approach is preferable to another.

7) the original report of the 2002 study (ref 6), if it is the same study, reports diet groups differently.





8) Implausible randomisation was the red flag that saw the PREDIMED study and many others retracted. Here randomisation of n=120 into 6 groups produced this result:


The  58  female  and  62  male  participants  were  randomly  assigned  to  equal  dietary  groups  by casting  a  die.  There  were  no  statistical  demographic  differences  between  group  assignments. There  were  no  statistically  significant  differences,  or  even  trends,  between  diet  groups  at  the initiation of the study. Since the groups were unequivocally randomized for all fifteen-baseline indices, statistical inference to the initial population, described by Table 1, is appropriate. 


9) Fleming et al state "A  four-month  post-intervention  analysis was obtained to determine post-intervention treatment, which has not previously been reported in the literature."

Post intervention status was in fact reported at 4 years by the Shai et al DIRECT study group.



10) the sponsor is listed as the Camelot Foundation. A search turned up this mention - Dr Fleming is the editor of a predatory journal, and the Camelot Foundation has little other existence online, it seems to be a 501(c)(3) legal tax-avoidance scheme within Fleming's own business.
https://www.omicsonline.org/editor-profile/richard-maximus-fleming/

11) Cardiovascular improvement by Fleming's medical imaging method correlates with improvement in the TG/HDL ratio. Taken at face value, although TG/HDL doesn't improve in Fleming's "low carb" arm, it does in most of the people reading this who have tried a low carb approach, so if Fleming's diagnostics are accurate this is not bad news. Interleukin 6 also improves during fasting but not a ketogenic diet in a 6-day study, but improves in a low carb diet vs a low fat diet in a 6 month study here (as there was at least one previous study in the literature that came to different conclusions from Fleming et al with regard to an outcome they highlighted, this should really have been cited).





Both LFD and LCD led to similar reductions in body weight, while beneficial effects on glycaemic control were observed in the LCD group only. After 6 months, the levels of IL-1Ra and IL-6 were significantly lower in the LCD group than in the LFD group, 978 (664–1385) versus 1216 (974–1822) pg/mL and 2.15 (1.65–4.27) versus 3.39 (2.25–4.79) pg/mL, both P < 0.05.

Taken at face value, Fleming's possibly fraudulent paper predicts cardiovascular benefit from a low carb diet if people get different results from the ones he claims to have produced, which is usually the case in other studies and in real life...


The question is, how did this paper pass peer review with all the red flags above? [edit]



Credit to @MacroFour and Ivor Cummins @FatEmperor for the links regarding Dr Fleming's colourful past.


45 comments:

George Henderson said...

Curiouser and Curiouser - Dr Fleming studied anti-matter for one year, and seems to have acted the part of James Woods acting the part of Max in Sergio Leone's Once Upon a Time in America.
https://www.imdb.com/name/nm6222842/

valerie said...

The abstract also has this gem:
"One‐year body mass changes did not differ by diet (P>.999)."

How can you possibly get P >.999?
Are we supposed to believe that all three groups had precisely the same weight loss after one year?

George Henderson said...

Wow.

I also call this implausible - the best TG/HDL ratio he reports is 2.4.
At this ratio, not great for this kind of study, small dense LDL will predominate, it's less likely that conditions for regression of CAD are present.

Bruce Wilson said...

How did the paper pass peer review? Perhaps Fleming owns the journal.

On a more serious note, you should be careful before accusing somone of fraud.

George Henderson said...

Hi Bruce,

thanks, but the FBI have provided the claim, and I am not accusing this paper of being fraudulent but of being poorly presented and reviewed, so that 1) the methods are not clear, 2) the citations are all over the place rather than addressing the unusual findings, and thus does not explain how another researcher would need to proceed to replicate the results.
The metabolic results are more explicable if the low carb arms were not particularly adherent, but are inexplicable in terms of the literature if adherence was 100% as stated and this was any normal low carb diet advice.
The date of the study, description of location and some other methods should have been supplied. Dr Fleming has contacted me but not contradicted any claim, only stressed the value of his work and the difficulty of running and publishing a private trial in general, as well as the hostile attitude of the soy industry, FDA, AHA etc (he didn't mention the FBI). I can sympathise with this - I'd just like to understand what we're seeing better, I just can't have 100% confidence in 100% adherence and convergence in a randomised trial without knowing a lot more. Dr Fleming also tells me that word and reference count explain some omissions, again I sympathise and know what he means, but I ask you, does it look like these were used wisely?
Reviewers...

Unknown said...

Is the method of measuring cardiovascular risk (perfusion imaging) a validated method of predicting cardiovascular risk? Or is it another well intentioned surrogate? He sounds like an interesting chap bet his talks are well presented.

George Henderson said...

One of his points is that it avoids dangerous imaging radiation. A criticism I've seen of it is, that it's not measuring CVD - no-one in this study was diagnosed with it, for example - but flow-mediated dilation, which is a situational adjustment of blood vessels. FMD is reduced in atherosclerosis, but can be limited without athero being present, and the higher nitrate content of various diets, different electrolytes, etc. could be enough to explain the differences.
I do think it likely that Fleming has good ideas about the causes of inflammation, at least in the context of the usual diet (e.g. I had an inflammatory reaction to beef, but not lamb, before I went keto, but have no such reaction to it now). I am willing to believe that this knowledge indeed benefits his patients. But wishful thinking in the way some things are being reported cannot be ruled out - no-one else has reported metabolic results anything like this from a low-carb diet, especially one with weight loss, and what that diet actually was like is going begging.

Unknown said...

Thanks for the response George. Love your work on here and on twitter. As someone with high cholesterol (LMHR) getting an idea of the total picture of health rather than one lipid metric has helped. I did consider getting a CAC but I don't fit the criteria really (too young), been trying to find other total health metrics to make sure I'm not going down a wrong path, which is why I was asking about that test.

keep at it.
John (UK)

Regret said...

Out of curiosity, are you able to find information on "The Camelot Foundation?" The limited online information that I can locate appears to show the organization went dormant sometime in the early 2000s, but I may be looking in the wrong places.

Dr. Richard M. Fleming said...

I am posting the following TWO statements out of respect for the exchange of information between Mr. George Henderson, Dr. Jason Fung and myself. Both of these gentlemen have responded in what I consider an intelligent manner to my responses to their questions.

While I understand many people seem to believe they know what I think, what I eat, when I use the bathroom, et cetera, I assure you, you don't and I think it is time to address several misconceptions and wrongs done by others.

I am also not posting this to begin a dialogue. I am not trying to convince you of anything. You are not being invited to my home for Thanksgiving meal and there is not a present for you under my Christmas tree. I am making the following TWO statements; period.

FIRST Statement:

I think it’s time to set the record straight. The Federal case was the direct consequence of my raising questions regarding the cause of death of Robert Atkins and exposing misrepresentations made by Big Pharma.

I never said I committed any crimes. In the first instance I said tests were done and billed in a specific way. I don’t do medical billing myself. I’m a physician and I paid someone very well to do the billing. It just so happens that the way in which those tests were billed, are exactly the way the Medicare Manual specifically states they must be billed.

In the second instance I said there weren’t 60-patients in a specific envelope mailed out. I never said there weren’t 60-patients in the study and I never said I made up any data.

I have published more than 80 papers in medical journals, presented more than 70 times at National and International Medical Conferences, have been asked to present at many hospitals for Grand Rounds and other occasions, have published 8-chapters in Medical Textbooks, been Editor-in-Chief of another Cardiology Textbook, have published 4-books for the general public, been trained as a NIH reviewer, have served on multiple Medical panels, been recognized by numerous medical groups, and still review for more than a dozen peer reviewed medical journals.

Not once has my published research been questioned except for studies involving diets. To be clear, these studies have never been questions by the American Heart Association, the vegan community or the vegetarian communities; even though the outcomes of those studies have not always been favorable to them. The only group, which has ever questioned my research, has been the low carb diet pundits and they have attacked the work like elementary school student on a playground during recess who weren’t happy with who was winning dodge ball. There attacks upon people publishing work, which was not favorable to them has resulted in their attacking not only myself but the American Heart Association, the vegan and vegetarian communities and even individuals like Jillian Michaels. They have polarized the medical community and have established a division of the medical journals as demonstrated by the schism between Lancet and the BMJ.

For that reason it is clear that a resolution to this diet debate can only be accomplished by quantitatively measuring changes in heart disease and breast cancer now made possible with FMTVDM; B.E.S.T. Imaging and not merely by looking for changes in weight or blood tests; changes which do not correlate with changes in heart disease or breast cancer.

Dr. Richard M. Fleming said...

Second Statement:

What are DIETS like the KETO DIET really doing to our health?

The real question is what are these diets really doing to people? How do you know the affect of a treatment be it a medication, radiation, surgery or a diet? We treat people based upon what we think we have seen and what we've been told works, but how effective are our treatments and what tests are we using to make those decisions? When I entered Medical School our Dean told us "90% of what we would be taught was wrong" and for those of us who were interested in doing the work to uncover the truth, to please help improve Medicine and Medical care by finding the answers to the questions we didn't even know were questions until we discovered the answers.

In 1991 I published my second paper in Cardiology as a Cardiology Fellow showing the errors made in reading coronary arteriograms and the consequential problems posed to patients as a result. In 1995 I developed the "Inflammation and Heart Disease" and "Angina" Theories. It took several years to overcome decades of obstacles and resistance of the then current models of heart disease, which suggested it was merely cholesterol and narrowing of arteries causing the problem. Nothing could be further from the truth.

Beginning in 1999 following my work showing the errors made in reading coronary arteriograms and the errors made in reading nuclear imaging studies (both SPECT/Planar and PET) I began unmasking the errors in Nuclear Imaging. I not only discovered that the pharmaceutical companies selling their drugs had misrepresented how their drugs worked; a misrepresentation that allowed them to increase their profits by 2-3 folds; but that the nuclear SPECT/Planar and PET cameras being used to diagnose and guide patient treatment were not "quantitatively" calibrated. In other words, they were not accurately counting what they said they were counting. :-(

By 2004, following my introduction of the "Inflammation and Heart Disease" Theory on 20/20, which resulted in almost everyone getting on board the "Inflammation Bandwagon" the shift was not towards further development of "quantitative" methods for finding heart disease and cancer but a more simplistic approach of measuring surrogate blood markers like cholesterol, CRP, homocysteine and a host of other tests which are easy to measure, but did they actually represent a method of measuring changes in heart disease or cancer?

In 2008 I published another paper looking at changes in these surrogate blood tests against a quantifiable measure of heart disease. It turns out, which didn't surprise me, that there is NO relationship between changes in cholesterol, CRP or other blood tests and the actual extent of coronary artery disease or it's change with treatment. The paper was published in "Angiology."

While the diet pundits have continued to conduct and publish studies telling you their diets work by showing you weight loss or changes in cholesterol levels and a variety of other tests, which have nothing to do with actual measurements of heart disease, cancer, or anything else for that matter, I continued focusing on developing the first and only truly AI quantitative test. The test, which not only uncovered the pharmaceutical company misrepresentations, accurately measures not just if you have disease, but where you lie on the actual "Health-Spectrum."

When Judah Folkman attempted to take credit for my work on Breast Cancer Imaging, telling people he had discovered a test, which could accurately find and measure breast cancer, I decided it was time to diligently and quietly pursue this work, which I did.

Dr. Richard M. Fleming said...

After 18-years of work and efforts to patent this quantitative AI method, we have proven that (1) the pharmaceutical companies were less than completely honest in what they told the FDA (something most people now accept), (2) the patented test not only accurately, consistently and reproducible measures where you are on the "Health-Spectrum", rather than a "qualitative" yes you have disease, no you don't have disease approach associated with sensitivity and specificity problems, and (3) because the patented test actually "measures" where you are at, it can not only tell you how much of a problem you have or don't have, but it can actually tell you if the treatment you are receiving is working or not, and if not it provides you and your physician with the measured information to provide patient-specific guided treatment; saving time, money and lives.

So how do you know if your treatment, be it diet, drug, hormonal, surgical, or whatever is working? The answer is simple. You have to be able to "measure" it and that means a quantitative test, which is accurately, consistently and reproducibly able to measure what it is you are trying to treat.

Measuring surrogate blood markers/tests, which aren't associated with changes in heart disease, cancer or other health problems, won't provide you an answer and using "qualitative" tests flawed with sensitivity and specificity issues won't provide you an answer. The only way to answer whether your treatment is working is to be able to MEASURE the extent of a problem you really have; placing you on your "Health-Spectrum." If you don't know where you begin and where you're at, you really can't determine whether what you've done for treatment has made you better, worse or has had no affect.

The name of the patent is FMTVDM and the specific breast cancer component is named B.E.S.T. Imaging. We've published around 20 papers in peer reviewed medical journals in the last year and presented at multiple conferences. FMTVDM;B.E.S.T. Imaging is the first and only truly AI Quantitative Method for measuring heart disease and cancer; including breast cancer.


Dr. Richard M. Fleming said...

Having made BOTH of these statements:

The current level of "discussion" on these diets by many people reminds me of elementary school children fighting on the playground during recess.

Despite the constant arguments about, you cannot honestly call any of this a debate or intelligent discussion, between the low carbohydrate DIETS and the other types of diets proposed by the DIET PUNDITS, there is little if any new or useful information. Study after study show if you change the way a person eats, they can lose weight; BIG DEAL!

These same studies use changes in blood tests to support the benefit they have for reducing heart disease. These studies exclude people whose cholesterol and other blood tests for inflammation go up, thereby making the results look better, while criticizing other studies for not agreeing with them.

The MAJOR PROBLEM with this approach is that I never said that reducing your cholesterol level or your insulin resistance or your CRP level would reduce your heart disease. My "Inflammation and Heart Disease" and "Angina" Theories explain why people develop heart disease and why this heart disease causes chest pain. In 2008 while developing a method to actually MEASURE heart disease my research showed that changes in these blood tests of inflammation didn't match actual changes in heart disease; which means that measuring cholesterol and other blood tests won't tell you if your heart disease is changing.

To know what's happening to your heart, you actually have to measure it. The only quantitative method for accurately, consistently and reproducibly being able to do this is FMTVDM. If the DIET PUNDITS want to know what happens to your heart or breast health (using B.E.S.T. Imaging) when you go on their diets, they will need to measure it with FMTVDM; B.E.S.T. Imaging.

Until then everyone can quit attacking each other. Recess is over and it's time to come back inside for class and learn something.

Respectfully,

Dr. Fleming

Regret said...

With all due respect, I have no interest in your beliefs or "research" findings regarding diets.

I did ask a question about "The Camelot Foundation" which remains unanswered, but the lack of a response and the relative lack of publicly available information on this entity suggest that it may have been created to give the appearance of reputability in the studies that you have published (in, as is suggested in this post, in some less reputable journals). If true, this creates doubt in my mind about the credibility of the research conclusions. If you would like to erase this doubt in readers' minds, you may wish to provide further details on the Foundation. A Google search turns up a Guidestar page noting that the IRS has revoked the tax-exempt status of a foundation with this name.

Also, as you have a law degree, you must know that your argument that "I never said I committed any crimes," seems nonsensical as a matter of law, when you plead guilty. If you believe you are being defamed by people noting that you plead guilty for a crime, you can go ahead and sue, but I'd suggest hiring a lawyer this time rather than representing yourself.

Dr. Richard M. Fleming said...

Dear Regret. I'm not certain who you are nor does it matter. You clearly feel it is easier to hide behind a pseudo name than to be seen in the light of day. You are looking for your 15-minutes. You are like the elementary student who runs up to the teacher saying that one of the other students did something wrong and expecting the teacher to punish the other student. The Camelot Foundation was in fact the non profit we had in Omaha. Since I have a law degree, I would refer you supra to what was already stated. The admission to doing an act which is not illegal is not an admission of a crime. It never has been and it never will be. What is a crime is the conspiracy to hide substantive exculpatory evidence from the jury and expert witnesses to protect the actions of the attorneys. Go back to class.

George Henderson said...

Quite simply, Dr Fleming, we are unhappy that you do not describe the low carb diets you use.
If there is an unhealthy keto or LCHF, we would like to know what amounts of what foods it contains so that we can avoid such a diet. After all, we know that other LCHF or keto diets used in trials have not had the same detrimental cardiometabolic effects; we just want to avoid yours. The references you give for diet data refer to different experiments, the macronutrients are missing, and so on.
A secondary consideration is the lack of discussion. That weight loss did not improve cardiometabolic health on the putative low carb diet in this latest paper is a unique finding - even if we assume low carb is harmful, weight loss should still not produce these effects. The reviewer you cited knew that.
A third consideration is the lack of description of the circumstances of the trial. Where were the subjects seen, over what time period, how often, and so on. This lack of detail makes it hard to visualise proceedings taking place under rigorous supervision. It also prevents us explaining satisfactorily the trial registration dates.

Regret said...

Google: ‘Richard Fleming felon’ and the first hit is the FDA debarment order including,

“Fleming submitted multiple documents in support of his arguments that his guilty plea “does not state a crime” and that he is “actually innocent.” However, section 306(l) of the FD&C Act defines conviction as when a Federal or State court's judgment of conviction or when a Federal or State court's acceptance of a guilty plea. In Fleming's “Petition to Enter a Plea of Guilty,” he stated that he understood the charges against him and that he was voluntarily entering his guilty plea. The court entered a judgment of conviction after accepting Fleming's guilty plea. Federal court is the proper venue for any challenge to Fleming's guilty plea based on a claim of actual innocence, not this remedial proceeding. OSI carefully reviewed Fleming's submission in its entirety, and Fleming does not dispute that the court entered a judgment of conviction or that the court accepted his guilty plea; therefore, Fleming's arguments regarding his actual innocence fail to raise a genuine and substantial issue of fact warranting a hearing”

Dr. Fleming, your repeated protestations of your innocence have already been dismissed by the FDA as bogus, as you plead guilty to multiple felonies.

On the Camelot Foundation issue: Since you have admitted that foundation is not currently active (you appear to have set up shop in California or Nevada after your medical licenses were revoked in the Midwest?), can you give us a date that the Foundation ceased operations? In the FBI press release discussing your conviction, it appears that you moved to Nevada no later than 2009. Was the Foundation operating after that date? The last date I see for the foundation’s 990 IRS return is 2002. However, your LinkedIn profile claims it is still active and a recent paper authored by you lists your affiliation as The Camelot Foundation, with a Yahoo email address.

Medical Director
The Camelot Foundation
February 1999 – Present 20 years
Studio City, CA
A 501(c)(3) designated to investigate heart disease and breast cancer with emphasis on women's health issues.

(So much confuseds my head hurts)

Dr. Richard M. Fleming said...

Hello George, As mentioned earlier, the purpose of posting today’s comments was not to elicit a series of exchanges but to "set the record straight" on a number of issues. That being said, and given your prior civil responses, I will respond to the "considerations" you have stated.

First, in response to your macronutrient component consideration; although others would criticize the lack of micronutrients, et cetera, the specific foods the people consumed during the study were not asked for. Absent the study I was involved in as a Senior Honors student where we studied sodium and hypertension, where we controlled all the food consumed over the course of a week and again several weeks later on the other extreme of sodium consumption by housing the individuals in the research facility making it impossible to leave the facility during that time; we have found, and others have reported, that individuals involved in dietary studies do not keep accurate diaries and tend to tell the principal investigators what they want to hear. This is essentially the same practice patients tend to employ when they come in to see their physicians. The goal of this study was not to have another study loaded with misinformation in diaries provided by study subjects wishing to impress us with how well they followed the diet arm they were a part of. Independent of which study group was being considered, the same flaw exists.

Dr. Richard M. Fleming said...

Secondly, as we have discussed before, the length of the paper was, as are all papers, limited to what the authors and the publishers, believe is appropriate for the journal and space limitations. As the influence of reviewers, editors and journals have demonstrated in recent years; e.g. The Lancet versus The BMJ; much of this “discussion” section is driven by those on the editorial staff, whose focus now appear more agenda driven than science based. It is my perspective that the discussion for the "inflammatory" surrogate markers of disease was more than adequate given the lack of correlation between change in these surrogate markers, weight loss and change in demonstrable end organ disease; viz. in this instance coronary artery disease as assessed using a method of comparing changes in flow reserve; as I have already mentioned above. Hence, if the reviewer you are referring to knows there is a relationship, that reviewer is wrong. I know the reviewer is wrong because these inflammatory surrogate markers, which everyone seems so keen to compare, came from my theories on “Inflammation and Heart Disease” and “Angina” as already mentioned supra (©1-655833842) and I have looked at them and done the comparison work, as noted supra. The “Inflammation and Heart Disease” and “Angina” theories explain the etiology and clinical manifestation of disease but the individual genetic response to multiple environmental impact factors is too variable to produce a correlation between measured changes in weight, surrogate markers and changes in CAD.

Dr. Richard M. Fleming said...

Thirdly, the details of how often the study subjects were seen and what was obtained sample wise was completely covered in Figure 1 of the study and the methods section. Researchers have always believed that where someone is studied and by whom makes all the difference in the world; it doesn’t. When I was a Cardiology Fellow, the second study I published in JACC was on the errors made in reading coronary arteriograms. I was told it was a waste of time because no one would ever publish on the topic again. They were wrong! The next week Beauman from Hopkins published a paper on the errors made in reading coronary angiograms; however, while my study, which got published shortly after Beauman’s, detailed the actual errors and the consequences and what could in fact be done to correct it the errors in reading coronary angiograms, Beauman’s study addressed the misperception that where your cardiac catheterization was done made all the difference in the world. The perspective was that the errors being made, were being made by clinicians not in academic centers and academicians did a better job. Beauman showed this was wrong. Humans incorrectly read qualitative studies because that’s what humans do. So too it is with diet studies. Everyone I listen to tell me they know how to run a diet study and other people, excluding the people who agree with them of course, always do it wrong. I’ve been around long enough that I’ve gotten to hear this from Ornish, Pritikin, Atkins, and now the new generation of Diet Pundits.

Dr. Richard M. Fleming said...

The badly needed answer is a study where we quantitatively measure the actual before and after results of people following different diets. A study comparing the outcomes tête-à-tête. A study were all of the “experts” in telling people how to follow their particular dietary wing of the study, get to be the experts. Clearly, e.g. Ornish couldn’t do as good a job of directing a low carb diet group as you or your low carbohydrate colleagues could and even if he could, he wouldn’t do it with the same fervor as you would and vice-versa.

My focus for the last four decades has been to unmask the errors in testing and the causes of disease states. To that end I’m happy to make my quantitative testing method available through a special licensure providing the test absolutely FREE for those individuals participating in the study. All of you, i.e. the Diet Pundits get to throw whatever you want to as long as you state it in the study methods and it’s clear up front. The caveats being no one receive prescription or OTC medications for any reason. No one gets dropped from the study as failure is an outcome. Should you or anyone you know be interested in participating in this badly needed and long overdue study, please let me know and I will be happy to work to make this happen. The knowledge obtainable for mankind is immense and the number of people who can be helped, even more so.

Dr. Richard M. Fleming said...

Alas "Regret", still hiding behind a pseudo name. I have already answered your question and I have filed a significant number of documents with the FDA (FDA-2013-N-0333, FDA-2018-P-3102, FDA-2018-D-4267-0002) and the Courts including inter alia evidence of the misrepresentations made by the pharmaceutical industry resulting in this case and the intentional hiding of substantive exculpatory evidence of innocence. I don't expect you to appreciate that I was fighting for you, to keep your radiation levels down and keep big pharma from making 2-3 x the profit at your expense. You got your 15-minutes. Recess is over.

Regret said...

Dr. Fleming - Discussions of health issues in a forum such as this are valuable as they permit people to discuss subjects of concern to professionals as well as the public-at-large. In my opinion as a lay person, your lack of candor and attempted misdirection are fooling no one.

As an example of your lack of candor: the fact that you will not be forthcoming about the details of "The Camelot Foundation" suggests that you CANNOT provide any evidence to refute the possibility that this is a fictitious* entity that you use to fluff up your credibility and credentials. In fact, your 2018 Clinical Cardiology paper was withdrawn "due to concerns with data integrity and an undisclosed conflict of interest by the lead author." Retraction notice from the journal available here: https://onlinelibrary.wiley.com/doi/abs/10.1002/clc.23047 Maybe the journal too was unable to confirm the existence of any such foundation?

What explanation can you provide that explains why you are still claiming affiliation and funding from an entity that apparently no longer exists, and hasn't existed since ~2010? I can't think of an innocuous answer, and the fact that you would prefer to question my motives rather than answer the question speaks to your personal integrity as well as the integrity and quality of your research.

As a research scientist and attorney you must understand that hard evidence counts more than opinions or motives. Shouldn't the scientific community, and the public at large, view the possible use of fictitious affiliations and failure to disclose funding sources as signs of possible research misconduct on the part of a researcher? Wouldn't a researcher who is concerned about "setting the record straight" provide clear, concise and responsive answers to questions? Doesn't the public have a right to be sure the health conclusions rendered by research scientists is free from bias or fraud?

I suspect that you will either: a) not reply or b) obfuscate further. In my mind, either of those reactions totally validates the skepticism about your "research" findings expressed on this blog and elsewhere.


*fictitious, in that it no longer exists and has not since its 501(c)3 status was revoked on or around May 2010; for reference see https://apps.irs.gov/app/eos/displayAll.do?dispatchMethod=displayAllInfo&Id=349351&ein=470831590&country=US&deductibility=all&dispatchMethod=searchAll&isDescending=false&city=&ein1=&postDateFrom=&exemptTypeCode=al&submitName=Search&sortColumn=orgName&totalResults=1&names=The+Camelot+Foundation&resultsPerPage=25&indexOfFirstRow=0&postDateTo=&state=All+States

P.S. My use of a commenting "handle" is not to hide my identity, but is an attempt to separate my professional and personal Internet profiles

Dr. Richard M. Fleming said...

Dear Regret,

You remind me of my students; not my good ones. Always trying so hard to be taken seriously bouncing from A to B to whatever, just so you can get attention.

The study was conducted while the Camelot Foundation was actively receiving and disseminating monies and while the Camelot Foundation is not currently actively receiving or disseminating money, I retain rights to the name. I have no plans of releasing the use of the name so that others may come in and take the name.

The Clinical Cardiology retraction was the result of pressure put on the journal by someone, perhaps you?! This typifies the ongoing battles between the journals as I have mentioned previously and particularly as journal publications relate to DIETS. Controlling a journal to guarantee that it only publishes what you want it to publish is not a mark of a scientist nor a grown up. It is the same behavior exhibited by elementary school children at recess in their fights over who is winning a game. It is a lack of maturity and the lack of a disciplined logical mind. If the only way you can win is to make certain the other people are not playing, you lack confidence in yourself and your convictions.

I have read several papers over the years, which I have questioned. The mature intelligent grown up approach is to submit a Letter to the Editor to address these differences not to throw a temper tantrum. But alas “Regret” it is true that in this day and age, the behavior of people have changed and I think most would agree, not for the better.

Dr. Richard M. Fleming said...

The data for the study was all submitted directly to Clinical Cardiology and they stated directly to me that they had no concerns about the outcomes of the manuscript. [“To confirm, we’re not concerned with the outcomes of the manuscript.” Correspondence from Clinical Cardiology 18 October 2018] The logical conclusion is that if they have no concerns over the outcomes, which must be drawn from the data itself and they have seen the data, they must have no true concerns over data integrity. Believe me, I keep emails. ☺

Yes, I believe people have a right to know outcomes. If you can show me a study without potential bias, please do so. That’s why I want all the DIET Pundits to run their own arm of a quantitative study looking at the impact of diets upon heart disease and cancer. Then you can take all the credit and all the blame for the bias you each introduce into the study. As far as the Clinical Cardiology paper data is concerned, I think the correspondence sent to me (supra) satisfies the validity of the data, all of which was sent to the Journal.

The soy data from the Federal case was validated by an ISU statistician who developed the test specifically to analyze the data, more than 5-years after the data was collected and she concluded the data was valid. Another statistician showed that the public defender plagiarized my data and misrepresented his plagiarized data to the witnesses and the jury as fabricated. The Court recordings show that the Judge, along with the attorneys decided to hide this misrepresentation from the jury and the expert witnesses (“the wool can be pulled over their eyes”), along with proof that the billing was done pursuant to the Federal Governments R-5 guidelines, the AMA documents stating the billing had not only been done correctly but in fact probably under billed, other University billing experts statements and Federal case law (Prabhu v US, NV), which specifically states that a physician cannot be found guilty of billing fraud when he bills according to the Governments required billing guidelines.

If what you admit to isn’t a crime, then you are not admitting to a crime. I think I’ve said this enough times, so that anyone interested in the truth will get it and anyone not interested in the truth will continue to stick their head in the sand. You choose!

Dr. Richard M. Fleming said...

I think this sets the record straight. If this is somehow still ambiguous or elusive or unclear or non-concise enough for you, I give up and you can go sit down in the back of the class and wait for recess. It will come.

As far as your pseudo name (“handle”, seriously?), this is just an excuse for your not wanting people to know who you are. Making it very easy for you to attack other people and not have anyone look into your work. If you can’t separate your professional and personal remarks by making it clear which are which, you go ahead and continue to use the “handle” “regret” even though I have no idea whether I am to consider this your professional or personal profile. If professional, you should act accordingly. If this is your personal side, well as I said, just like too many students.

If you seriously want to participate in the study of the measureable outcomes of diets on heart disease and cancer, I extend the same offer to you as I do anyone else, presuming you are someone who is involved with such studies. You now have twice your allotted 15-minutes of attention if not more.

It is one of the best things about teaching, even at the University level; that at the end of the day, you get to send the students home. Again, you won’t be coming over for Thanksgiving and there isn’t a present for you under the tree.

Regret said...

Well, I appreciate the schooling you are providing. To wit, while your 3 responses did not completely confirm my suspicions (which were that you would, a) not reply or b) obfuscate further), I neglected to include an alternative: c) further ad hominem attacks, to which you have resorted before. So yes, I am learning from you.

Your replies did provide a sliver of a response in that you have confirmed that The Camelot Foundation is not a currently active entity. Whatever you mean by "retaining the rights to the name," you did not specify the year in which the foundation ceased operations, which was one of my questions.

Assuming that the IRS website has the right end date (and you can certainly still correct the record by answering my question directly), the foundation was dead as of 2010 and perhaps earlier. Although more than 8 years have passed, you are still claiming an affiliation with The Camelot Foundation in your publications and online. See https://www.oatext.com/pdf/IMM-4-313.pdf for one example of an article you submitted in 2017 and see your current LinkedIn profile. Your replies did not clear up why you still are claiming a current affiliation with a long defunct foundation, which suggests you are using it to dishonestly inflate your reputation.

The reason this is important: in my online perusal of the topic, the discovery of misrepresentations on a researchers resume have lead to discovery of research misconduct. How can we know if that is the situation here if you will not answer simple questions directly?

Q: When did The Camelot Foundation cease operations?
Q: Why have you continued citing an affiliation with the foundation (in publications and in your online CV) after it ceased operations?

Dr. Richard M. Fleming said...

Let me put this more simply for you.

Q1: When did The Camelot Foundation cease operations?

I do not consider the Camelot Foundation to have ceased it's operations. While money may not be coming in or going out, I have retained the use of the name because it represents the meaning behind what I believe in. Doing the right thing for the right reason. Hence, it continues to exist.

Q2: Why have you continued citing an affiliation with the foundation (in publications an din your online CV) after it ceased operations?

Because I consider The Camelot Foundation to still exist. If the only marker of existence is a tax return, you have a sad definition of existence. But perhaps this is what you consider the definition of existence to mean; I do not. Hence, there is no misrepresentation on the CV or elsewhere.

The definition of an ad hominem attack begins with the argument being fallacious. In the absence of anything be false, there can be no ad hominem attack.

Regret said...

Thank you for answering my questions. I now understand that on your CV and research papers you are claiming a research affiliation with an organization that only exists in your head.

Maybe to avoid future confusion, you could update your CV and research affiliation to remove references to you as a "Medical Director" at an organization that only exists in your mind, a Federal tax exempt status that isn't accurate, and is operating in a state that never registered such a foundation. Otherwise, people might get the wrong idea:

Medical Director
The Camelot Foundation
February 1999 – Present 20 years
Studio City, CA
A 501(c)(3) designated to investigate heart disease and breast cancer with emphasis on women's health issues.

Dr. Richard M. Fleming said...

Sadly that was said with all the maturity of the elementary school student on the school playground who insists to the principal that they won the game while hiding behind the pseudo made up name of "Regret."

You make me smile. Recess is over. No more regrets.

Dr. Richard M. Fleming said...

A brief explanation of FMTVDM/BEST Imaging. Measuring instead of guessing.

https://www.youtube.com/watch?time_continue=219&v=X7eGR9rBg-U

Regret said...

Dr. Fleming: I think we’ve covered The Camelot Foundation enough and I appreciate you answering my questions. I’d like to move along to the Fleming Heart and Health Institute, which is also an organization with which you claim a current association.

As the FDA noted (https://www.federalregister.gov/documents/2018/09/28/2018-21210/richard-m-fleming-denial-of-hearing-final-debarment-order): “Fleming [is], the president of, and sole physician at, Fleming Heart and Health Institute, P.C. (FHHI).” This organization was previously registered with the State of Nebraska and you (Dr. Fleming) were the sole officer listed. The state site shows the registration for this entity expired in May of 2004 for non-payment of taxes. In their 2010 article about your sentencing, https://journalstar.com/news/state-and-regional/nebraska/former-omaha-doctor-faces-possible-sanctions-for-fraud/article_04877e84-3dda-11df-a936-001cc4c03286.html, the Lincoln Journal Star notes, “Fleming, formerly of the Fleming Heart and Health Institute in Omaha, lives in Reno, Nev.” (emphasis mine).

A similarly entitled entity, “Fleming Heart and Health Institute L.L.C.” appears on the records for the state of Nevada, with Prof. Richard M. Fleming, M.D., J.D., listed as the registered agent. However this registration shows “revoked,” and may never have been issued. I have been unable to locate any physical address for an institute in Nevada or California with this name, and there is no record of such an organization ever registered with the Secretary of State in the state of California.

So while it appears that FHHI does not appear to have been in operation since at least 2004, you appear to have continued to include the claim that you are affiliated with FHHI for approximately 15 more years including in multiple journals in 2018, and on your current CV on LinkedIn.

Once again, Dr. Fleming, I’d ask for your help in clearing up this misunderstanding.

Q: Is there a current entity called the Fleming Heart and Health Institute (PC or LLC), and if so, in what state is it registered?
Q: If it is no longer operating, in what year did its operations cease?
Q: If it is no longer operating, do you believe it is appropriate, or even ethical, to continue claiming a current affiliation with a now defunct organization?
Q: As you seem to find my inquiries aggravating, don’t you agree that its proper for the public to scrutinize published research for evidence of mistakes, bias or misconduct before accepting the conclusions of the research?

Dr. Richard M. Fleming said...

This has been addressed.

Regret said...

Thus ends our conversation with the self-described “Father of Modern Nuclear Cardiology & Nuclear Medicine.” TTFN

Regret said...

Holy cow, I wasn't intending to return to this, but I just happened to click on Dr. Fleming's Twitter account and saw this tweet from *yesterday* (1/25/19)

"Dr. RM Fleming @NuclearCard / Jan 25 / We're delighted to be included in Women Fitness Magazine where we have the opportunity to help so many women." The "magazine" appears to be a clickbait health blog where people can self-publish articles.

Anyway, Dr. Fleming is glowingly profiled in a puff piece authored by freelancer Jules Lavallee here: https://www.womenfitnessmag.com/what-are-diets-really-doing-to-people/, at the bottom of which appears a "for more information" link to Dr. Fleming's own site: https://rmfmd71.wixsite.com/fhhi-omnific

Following this link, I discover that he is still using his "fictitious" or defunct entities but in this case to market his patented imaging system. He also references the Omnific Imaging, LLC, which I've seen elsewhere, but I can't find this entity registered in California, Nevada or Nebraska, and I found nothing helpful on Google.

"Fleming Heart & Health Institute
FHHI is (sic) the Parent Company for (1) Omnific Imaging, LLC and (2) The Camelot Foundation a 501(c)(3) (sic)..."
"Doing the Right Thing for the Right Reasons (sic)"

Isn't advertising a medical process using false information illegal?

Regret said...

Dr. Fleming-I saw your question on Twitter this morning and suggestion that I am a “KETO stalker.” As I said before, I have no axe to grind in your diet debates and I have no background (or really any interest) in your field(s).

My interest was piqued when I read the Retraction Watch story about your retracted paper and saw your odd defense of your felony conviction in the comments there. I hold no personal animus toward you, but I am questioning the veracity in your many public statements and representations, and am perplexed that you do not seem interested in clearing up the many inconsistencies of your professional background.

In my opinion, the loose way you seem to play with your credentials and background details are consistent with the behavior of a person committing fraud. To be clear, I am not accusing you of fraud, but your responses to questions on these forums have done little to clear up what could otherwise be considered honest mistakes.

My long practice of using a “handle” isn’t intended to hide my identity but to avoid unnecessarily mixing my personal and professional internet profiles. If you’d like me to contact you directly to “unmask” myself to you I can do so, although I don’t know why it matters to you. Just let me know which email address you’d like me to use for this purpose.

I would caution you not to threaten me, either physically, professionally or legally. I am fully prepared to defend myself and as a non-public figure I may have legal options available to me, that a public figure, such as yourself, may not.

Regret said...

Details about appearance in court and appeal: https://www.courtlistener.com/opinion/2476421/fleming-v-united-states/

Dr. Richard M. Fleming said...

Dear KETO stalker, Harassing, stalking and bullying will be seen for what it is. https://www.youtube.com/watch?v=-T7b3ljTehk

Regret said...

Shorter Dr. Fleming: “Please look at me.”

Regarding your current GoFundMe attempt, why exactly do you need $50,000 in order to give away a *free* license to a hospital? Is the money to cover the cost of your self-promotion at “journals” and conferences?

Dr. Richard M. Fleming said...

An excellent question to ask during our television interview. Please remember to ask it.

Regret said...

Sigh. As I previously explained, I don’t know anything about diets, and don’t care to. I’m perfectly happy that you believe the Keto diet is bad for you... for all I know you are right, and I would never argue otherwise.

My questions have been about what I believe are your exaggerated or fabricated credentials, and your unwillingness to simply answer those questions here (and elsewhere) appear to prove my suspicions correct. I truly am sorry that your career appears to have ended with the criminal charges and conviction. I imagine it has been very difficult, financially and personally.

However, it appears that instead of trying to rebuild a medical or teaching career you are trying to hock a new medical process by using exaggerated and/or inaccurate claims about your background and the “research” that may support the efficacy of your process. Further, you are raising funds while continuing the practices that I am questioning. That could be considered fraud, and it appears to violate the terms and conditions of GoFundMe, if my suspicions are accurate.

I doubt you’d credit an anonymous critic with having your best interests at heart, but I recommend you stop any misrepresentation of your credentials or research before you get in legal trouble again. You went to law school: What could happen if you receive money from a donor or medical center and they later sue you for misleading them or turn you over to the state attorney general?

Anyway if you continue down the path you’ve been on, I’m sure you’ll continue to attract critics and observations that your practices appear sketchy. I have almost no hope that you can stop yourself from this behavior at this point.

Dr. Richard M. Fleming said...

You have now reached defamation of character. I am notifying the authorities.

George Henderson said...

Really? I am surprised you still trust the US authorities, given that they railroaded you last time by your own account. In any case, you should consult a lawyer, because it would be a civil case, were it in fact a case.

Regret said...

I really am sorry for you and do not wish you harm.

As you claim to have a law degree, I’m certain you know that defamation in California is a civil matter, so “authorities” will not be interested.

In addition, the alleged defamatory statements must be demonstrably false, and here I am only expressing an opinion or asking you for information. Please point me to a statement of fact where I am wrong, provide evidence of the correct fact, and I will admit to my mistake.

Further, as you are a public figure you would also have to prove “actual malice” on my part, meaning that I must have made the defamatory statement either with knowledge that it was false or with reckless disregard for the truth. Since I am explicitly asking you to provide information so I and other readers can learn the truth, you would have no shot at winning a defamation lawsuit. If I did accidentally make a false statement of fact, you have made no effort to correct me (with facts in rebuttal), so any damages suffered by you as a result of any unintentional error are limited.

Lastly, and as I explained elsewhere, you should be careful about filing a defamation lawsuit because California has an anti-SLAPP measure that would likely apply.

Regret said...

G: Thank you for the insightful comment - I should have thought of that. If you do get a subpoena let me know. I know a fantastic First Amendment attorney that I would love to get involved.