NEW: Dave acknowledges the KETO-CTA failures 🚨
Here's the summary of the first major communication since the KETO-CTA show:
1⃣ Primary Outcome
Dave agrees that the absence of the pre-registered primary outcome was a problem. However, Dave claims that he didn't realise it wasn't there, as he thought it was in Table 3. Darius points out that this matter makes them look like amateurs as researchers, as someone should have spotted this, particularly given how invested in the study they were.
2⃣ Who's Responsible?
There is a suggestion that there were team errors, but Dave does not wish to divulge on any personal mistakes attributable to others. Understandably, he wishes to remain a team player, along with taking the role of leader.
He notes that he had many other projects ongoing, suggesting that this may have compromised his ability to remain as detail-oriented as possible. He wants to acknowledge his responsibility in the failures surrounding this study, agreeing that the ownership is on him for mistakes made. The LMHR Facebook group were clearly disappointed by these events, and Dave feels particularly bad for letting these people down.
3⃣One Paper vs Multiple Papers
The full dataset will not be released. Dave notes that he will release some more data in a table as part of a response to LTTEs. He would like to release the full dataset as per his stated commitment to data transparency, but he states this is not feasible due to data privacy concerns.
Darius asks why it wasn't made clear that there would be future papers, as this would have avoided confusion related to how incomplete this paper is. Dave notes that this is not uncommon in the body of research, whereby author authors often publish their data in steps, rather than covering everything in a single paper. The authors have blood banked, which will facilitate further analyses.
4⃣ LDL vs Plaque Progression
Darius correctly points out that the authors and many authors doubled down on "no association with LDL", rather than focusing on the plaque progression. Dave states that this is an interesting "mystery" that we should all be trying to understand. Darius feels that this "blows a hole" in the lipid hypothesis, re: extent of LDL-C and risk of atherosclerosis.
5⃣ Baseline vs 1-Year Progression
Dave discusses the issue of baseline PAV (%) and that of a 1-year change, suggesting that it's strange that there was a disproportionate increase in the 1-year observed period vs the previous extent of plaque accumulated in preceding years. He then notes that he would have anticipated a "very strong skyrocketing of events" anecdotally in the LMHR FB group if there's a doubling of PAV.
6⃣ Methodology of Cleerly
Dave notes that he is in talks with the CMO of Cleerly to try to figure out the quantitative assessment of plaque via Cleerly and what it means. He hypothesises that there could be a "noise floor", where there is noise involved in explaining some of the plaque progression outcomes given how low the baseline plaque is among LMHRs. He also adds that extra-luminal plaque would be difficult to quantify given the low baseline plaque.
7⃣ Next Steps: 2-Year Follow-Up
Dave notes that they will be aiming to follow-up again at 2-years, extending duration of tracking plaque progression.
8⃣ Glucose Control, Diet & Plaque
Darius raises the issue of glucose control and heterogeneity in diet. He states that he knows one of the "regressors" who was very tight with their glucose control. Dave acknowledges this point, noting that "keto" can vary widely.
9⃣ Thank You from Dave
Dave thanks his critics. He notes that JACC Advances has been a great partner. He hopes that the LTTE responses can showcase that they are in fact addressing the details. He would like to be able to move toward less formal discussions once this process is sorted. He will continue to be quiet on social media in the interim.
🔟 Get Scanned
Darius suggests that people need to get scanned (CAC, followed by CCTA depending on CAC). Dave says he has never been more bullish on imaging.
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It sounds like there's more to come. For now, we await scholarly dialogue via JACC Advances, as it seems the paper will not be corrected or retracted, but responses will be issued in response to LTTEs.
@theproof@nicknorwitz@drmatthewnagra@MichaelAlbertMD@ChristofferBN@drpablocorral@NutritionMadeS3@DrNadolsky@DrNadolsky@drmatthewnagra@BudoffMd@Drlipid@dr__idz@DrIronJunkie@ethanjweiss@_earthling74@realDaveFeldman@ZKForTre@ProfKausikRay@_GregSchmidt@GladstoneB81859@kevtharris@alexleaf@upRootNutrition@Marijn3D@Special_Cactus@Pl4ntbased
Calm down buddy. It’s almost 5am here and I’ve just landed back from Turkey.
I will message you in the day about what the specific debate proposition should be, what your views are on the study and we can find a mutually agreeable time 👍🏼
•I am board certified in internal medicine
•I am board certified in obesity medicine (which includes nutrition)
•I have published 15+ papers, case reports, consensus statements, and LTEs and reviewed countless more
•I have lectured on nutrition at Grand Rounds at several universities throughout the USA, including in the Yale system, VCU system and University Hospitals to name a few
And unlike you, I have never taken a cent from industry
The audience can decide for themselves … and they have
Are you okay in the head Tro? This is our paper 😂🤦🏽♂️ Feel free to actually read it this time. Instead of talking for the sake of it…
Tro yet again demonstrating a terrible ability to interpret research. 💀
https://t.co/0gL28mldTp
Excuse me @BudoffMd . Do you have any ounce of integrity left? No one paraphrased you, this is your direct quote from the interview (video below).
“We don’t even have the proofs yet from Elsevier. This is very premature, the proofs haven’t been approved yet. I haven’t approved ANY version of the paper yet (KETO CTA study). So, this pre-draft or this draft is incomplete because I haven’t gone through it and approved anything yet.”
You clearly state you haven’t approved ANY version of the KETO CTA study and that this current paper is a pre draft DESPITE you happily discussing study results on Brett Sher’s podcast a few days earlier 🤦🏽♂️
Just own up and admit that you lied, admit the study is a shambles and that you should have reviewed it more thoroughly to include the primary outcome before accepting it for publication.
🚨🚨 I’m sorry but this is ridiculous. @BudoffMd Is the senior & a corresponding author on this paper, yet he’s claiming here in his interview with @NutritionMadeS3 that he hasn’t seen or approved ANY version of the KETO CTA study… 🤦🏽♂️
One small problem. He’s literally written about the paper on X when it first came out!!❗️❗️Everyone in academia knows that the senior & corresponding authors receive ALL communication regarding the manuscript and by definition HAVE to sign off on it at multiple time points before anything is published. Not to mention the full on PR campaign that followed via multiple news outlets and large podcasts where @nicknorwitz misrepresented the findings (of course) and spoke with prominent figures about it.
I don’t understand whether he thinks other academics, professionals and doctors are this stupid? 🤦🏽♂️
Budoff also claims that @AdrianSotoMota should NOT have released the NCPV = 18.8mm3 figure nor does he have the data to do so.
Just own up, admit fault that this is just one big shit show and maybe, just maybe you won’t look like a bunch of dishonest, lying, trying-to-save face charlatan researchers looking to confirm your low-carb bias?
FROM FADS TO FACTS ✅ Todays episode is out with @dr__idz - busting all things seed oils, carnivore, plant mylks and glucose trends #mythbusting#foodforthought
https://t.co/jePtVUwZiK
@Shellaemeliana1 Semangat ya fatt, fokus sama yg ada didepan kamu. pliiisss gak usah terlalu overtinking dan satu lagiii semoga bisa lebih ngerasain tambahnya nikmatnya beribadah
@wdwdyi Dulu anti bgt ldr, tapi nyatanya malah jadi nikah sama yg ldr. Tergantung orangnyaa siii.. jauh tapi gak neko neko bikin jadi percaya dariapada sama yg deket tapiihh banyak polahh 🙃🙃