Ann: Remestemcel-L for COVID-19 MIS-C published in Pediatrics, page-196

@DocMcstuffins

Thanks for the invitation to refute your post (#: 51100019). I accept.

Apologies for taking 48 hrs to respond, but I discovered that you managed to find time to post variations on your opinion 19 times in this specific MSB thread in that 48 hour period. So, that means something, as @LeftYahoo might say. I’ve tried to respond to all of them.

First, let me congratulate you on finding time to educate forum participants – its no easy task to post from 3:55pm to 10:49pm one day, then get up before 6:25am next morning & repeat-post your opinion solidly until 3pm and then come back after dinner for another round. All on one MSB thread! How you find time to read, reflect & post on other MSB threads, much less get any medical work done on your patients, I cant imagine.

Second, I don’t know you, am not attacking you as you suggest, and have no personal feelings of any kind in relation to you. However, I do ‘feel’ minded to defend the right of fair publication in an MSB stockholders discussion forum of published case reports from respectable journals regarding MSB candidates. Hence, this rebuttal.

Third, I won’t go over the concessions and admissions you’ve made to @bedger & @imback that you didn’t acknowledge the patients’ unresolved continuing conditions. Sadly, these admissions weren’t voluntary.

Fourth, this is merely a case report. All the data is not published in the report & you should know that. You show no respect for and give no credit to the editors of Pediatrics, an eminent journal for qualified pediatricians in America i.e. members of the US Academy of Pediatrics. The Pediatrics journal editors (not the case report authors) advised:

“ This is a prepublication version of an article that has undergonepeer review and been accepted for publication but is not the final version of record… The journal is providing anearly version of this article to expedite access to this information. “

Fifth, remaining core points in your posts are, sadly, wrong – the posts are saturated with false and misleading statements/ half-truths, reasonably likely to deceive the average reader IMO. I sincerely hope you did not intend that result. You must admit your forum post name & advice that you are a medical doctor can only make this likely.

I’ve listed below some of the false/ misleading statements claimed repeatedly as facts by you, with the relevant HC post #. Then I give authentic quotations i.e. the authors’ genuine corresponding statements in the Pediatrics article. Your misstatements are apparent on any comparison & IMO require no further explanation:

1. “profound hypertension is absolutelysomething they glossed over as well” #51087454

o Cf. Correct quotation: “ Both children developed rebound hypertension after resolution of their hypotension, potentially reflecting the interaction between restored cardiac output and continued systemic endothelial dysfunction. “

o Cf. “ Patient #2 required prolonged pharmacological treatment for her hypertension.”

o Cf. “ Main Clinical findings - hypertension; nicardipine > lisinopril (Patient #2)”

2. “ it's funny they say there's no adverseeffects and go on to mention one kid is still on antihypertensives” #51087454

o Cf. Correct quotation: “Neither child experienced adverse effects associated with remestemcel-L administration.”

o Cf. “both children tolerated remestemcel-L well with no adverse effects, consistent with remestemcel-L’s previously-reported favorable safety profile in children”.

3. “ I bring up BNP because they mention itas a selling point” #: 51087653

o Cf. “ many important clinical and laboratory parameters remained markedly abnormal, especially direct and indirect measures of cardiac dysfunction/injury (e.g., decreased LV function/need for inotropes; elevated levels of BNP and troponin-I), systemic/cardiac/endothelial inflammation (e.g., elevated levels of C-reactive protein, procalcitonin, ferritin, and total white blood cell count), and endothelial dysfunction (e.g., hypotension/need for vasopressors; elevated levels of D-dimer and fibrinogen). Thus, they were considered for remestemcel-L treatment under the expanded access program and met inclusion/exclusion criteria.”

o Cf. “ Both children showed rapid normalization of their LV ejection fraction and B-type natriuretic protein as well as…”.

4. “ Its all speculative and the fact theysay "we feel they would've been worse without it" [sic] and areemployed by MSB is wildly inappropriate.” #: 51096515

“ The fact they were on MSBs payrolljust really doesn't help the optics of their feeling.” #: 51100772

o Cf. “ Case Report Authors:

§ Allison Ross Eckard, Medical University of South Carolina (MUSC), Department of Pediatrics

§ Kenneth M. Borow

§ Elizabeth H. Mack, MUSC, Department of Pediatrics

§ Elizabeth Burke

§ Andrew M. Atz, MUSC, Department of Pediatrics

KMB is a consultant to Mesoblast, Inc. EB is an employee of Mesoblast, Inc. All others declare no conflicts ofinterest.”

5. “ Yeah if that's all they did that'sfine. They didn't. They drew conclusions not based on the data available (wefeel it was because of remestemcell).” #: 51122459

“ You can't say from the data thatit was likely remestemcell that did this. But they're comfortable saying that.” #: 51122459

“ State the facts. Don't say we"feel" the treatment helped. “ #: 51101821

“ No, what I'm saying is thepeople who authored the study are doing a disservice by stating they feel thekids got better due to Remestemcell.” #: 51097472

“ I specifically said the fact theysay that they feel that the kids got better because of the therapy is the issue. ” #: 51100772

o Cf. Correct quotation “ Collectively, the data suggest that remestemcel-L has a favorable efficacy and safety profile, “.

o Cf. “ Although both children were showing some level of clinical improvement when they received the experimental product, the data suggest that remestemcel-L contributed to further improvements in myocardial and endothelial function and promoted additional reductions in systemic and cardiac inflammation “

o Cf. “ This treatment appears promising as a novel immunomodulatory cellular therapy for children with clinically-significant cardiovascular manifestations of MIS-C. “

o Cf. “ Collectively, the data suggest that remestemcel-L has a favorable efficacy and safety profile, including among children with steroid-resistant acute graftversus-host disease.2 “

o Cf. “ Thus, based on MSC’s anti-inflammatory, immunomodulatory, and beneficial effects on endothelial function, as well as remestemcel-L’s safety data in children, this therapy holds promise as an effective and novel treatment for MIS-C “

o Cf. “ Based on these properties and our successful treatment in two children, remestemcel-L may be a promising and effective treatment for MIS-C, especially in children with significant cardiovascular involvement “

o Cf. “ Remestemcel-L exhibits beneficial effects relative to the cardiac and vascular pathophysiology associated with MIS-C and an excellent safety profile in children. This therapy holds promise as a novel treatment for MIS-C. “

o Cf. “ Although speculative, our two patients may have fared far worse without remestemcel-L treatment.”

6. “ I'm guessing the population isquite small and variable as it's quite rare but no mention of the standarddisease progression.” #: 51097594

“ It's still a very rare and newcondition” #: 51133771

o Cf. MorrisSB, Schwartz NG, Patel P, et al. Case Series of Multisystem InflammatorySyndrome in Adults Associated with SARS-CoV-2 Infection — United Kingdom andUnited States, March–August 2020. MMWR Morb Mortal Wkly Rep 2020;69:1450–1456 which I posted for you, but you didn’t read.

So, the authors - a majority of whom weren't on MSB's payroll - were peer-reviewed & did not individually or collectively at any time say “the kids got better due to Remestemcel” or “we feel it was because of remestemcel” or‘we feeltheywould have been worse without it‘, (nor did they use any remotely similar terms such as ‘we believe’, ‘we just know’, ‘we sensed’, ‘we experienced’ etc ).

It seems you just made it all up.