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Proof of Fabricated Files in a Vitamin C trial by Paul E Marik et al.

Proof of Fabricated Files in a Vitamin C trial by Paul E Marik et al.

 Below is an email I gather sent to Sentara Norfolk Frequent Sanatorium, the editor of CHEST Journal, and prof Paul E Marik. As repeatedly an allegation against a multi-creator paper is no longer an allegation against any particular person creator. 

To:

The Editor in Chief of “CHEST” Peter J. Mazzone

cc: The Board of Norfolk Sentara Norfolk Frequent Sanatorium

cc: The Compliance officer of Sentara Norfolk Frequent Sanatorium

cc: Prof Paul E Marik

Pricey Editor

Tonight on twitter a paper allegedly describing a 2017 learn about by a “Paul Marik” and physique of workers at Sentara Norfolk Frequent Sanatorium describing a spacious survival rob pleasure in Vitamin C used to be delivered to my attention as a clinical research finding that used to be no longer replicated in extra studies and later reversed. The person said that to their recordsdata no proof of fraud within the behavior of this learn about had been identified. The learn about is chanced on at https://doi.org/10.1016/j.chest.2016.11.036

Sadly within about 5 minutes of reading the learn about it grew to develop into overwhelmingly clear that it’s indeed research fraud and the guidelines is fabricated.

While veritably I’d employ cautious language of “absorbing” or “surprising” patterns within the guidelines and portray “irregularities” and “misfortune”; no such caution is warranted on this case. Right here’s frankly fearless fraud. I gather no longer requested entry to the raw recordsdata or contacted the authors for clarification as the case is fearless no other clarification is most likely.

Allow me to display conceal.

This learn about allegedly describes a sooner than and after learn about, examining the originate of a recent medication regime basically based entirely on vitamin c on mortality in sepsis, claiming a roughly ten fold low cost in loss of life. Every cohort had exactly 47 patients and the patients had been no longer matched. We know this no longer genuine because matching used to be no longer talked about nonetheless because the authors specify that these had been two cohorts of “consecutive” patients, precluding patient matching by definition.

Per this we might maybe perchance quiz that if there used to be no systemic bias the p values for variations in dichotomous baseline characteristics (gender, demographics, comorbidities, diagnoses and many others) would, pointless to claim, centre on 0.5. If systemic variations existed nonetheless the groups might maybe perchance maybe very properly be less equal and p values might maybe perchance maybe merely are seemingly to numbers below 0.5, and this wouldn’t be suspicious in a non-randomised learn about. Systemic biases to p values better than 0.5 aren’t most likely without matching (or some very rare pseudo-block designs no longer relevant right here) except within the atmosphere of fraud.

Sadly every single predominant evaluation (Pneumonia, Urosepsis, Foremost Bacteremia, GI/Biliary, “Different”) is matched perfectly with a p cost from a Fisher unswerving test of 1. 

Indeed of the 23 discrete/continuous variables reported in desk 1 the majority gather a p cost of 1.

The following variables had a p cost of 1, i.e. had been disbursed perfectly evenly for the duration of the two time sessions (or as maximally perfectly evenly as most likely within the case of absorbing numbers).

Acute Kidney Smash: 61 patients

Vasopressors: 44 patients

Foremost Diagnosis – Pneumonia: 37 patients

Coronary heart Failure: 31 patients

Certain blood cultures: 26 patients

Foremost Diagnosis – Urosepsis: 21 patients

COPD: 15 patients

Continual Renal Failure: 15 patients

Foremost Diagnosis – Foremost Bacteremia: 14 patients

Foremost Diagnosis – GI/Biliary: 12 patients

Drug addiction: 10 patients

Foremost Diagnosis – Different: 10 patients

Lack of comorbidities: 3 patients

A more fulsome desk of p values is annexed to the close of this criticism, nonetheless this settle reveals the plotted p values for all 23 dichotomous variables in desk 1. Present that in region of the even distribution between 0 and 1 (or clustering below 1 if the cohorts had been dissimilar) as a exchange most variables gather a p cost of 1, 21/23 variables gather p values over 0.5, and no p cost of below 0.4 is viewed for any of the 23 variables.

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This in reality items a little topic in estimating how unlikely these outcomes are, as basically the most traditional test for fraud on this misfortune incessantly is the Stouff-Fisher, nonetheless this is in a position to maybe perchance maybe merely expose these outcomes infinitely unlikely (as the majority of variables gather a p cost of exactly 1), when genuinely it’s maybe more seemingly that it’s trillions to quadrillions to at least one.

A “snappily and dirty” draw to assess this might be to take into story that the possibility of any one variable having a p cost over 0.4 is 60%, the binomial probability of 23 such measures having no seen values beneath 0.4 is (0.6)^23 or no longer as much as 1 in 100,000, this assumes independence which is maybe a microscopic bit unfair, nonetheless seemingly massively underestimates the improbability of such a finding as the outcomes aren’t evenly disbursed between 0.4 and 1.

There might be merely no motive at the abet of this instead of fraud. The techniques are described clearly and these are explicitly two cohorts of consecutive patients, so the supreme unswerving harmless clarification right here (undisclosed matching by baseline characteristics) failed to happen (and it clearly did no longer anyway as matching patients this exactly wouldn’t be most likely even with hundreds of such patients).

While I designate your desire to act rather, there might be overwhelming and irrefutable proof that recordsdata presented on this paper can not gather come from the draw described, and might maybe perchance handiest gather been untrue, even from the guidelines within the paper alone without from now on proof.

I scuttle you to make a selection this paper, or at the least misfortune an expression of misfortune as soon as most likely.

I gather CC’d the establishment’s integrity officer in case they desire to institute integrity complaints and disciplinary motion.

Yours Sincerely
Dr Kyle Sheldrick
Sydney Australia

Annex 1 p values for every dichotomous variable in desk 1:

Handled pts with Control Patients With Handled pts without Control Patients With out p Payment From Fisher Right test
Male 27 23 20 24 0.5354
No Comorbidity 2 1 45 46 1
Diabetes 16 20 31 27 0.5247
Hypertension 20 25 27 22 0.409
coronary heart failure 15 16 32 31 1
Malignancy 5 7 42 40 0.7586
COPD 8 7 39 40 1
Cirrhosis 6 3 41 44 0.4856
CVA 8 5 39 42 0.5516
CRF 7 8 40 39 1
Morbid Obesity 6 8 41 39 0.773
Immunocompromised 6 4 41 43 0.7398
Drug Addiction 5 5 42 42 1
Foremost Diagnosis
Foremost Diagnosis: Pneumonia 18 19 29 28 1
Foremost Diagnosis: Urosepsis 11 10 36 37 1
Foremost Diagnosis: Foremost Bacteremia 7 7 40 40 1
Foremost Diagnosis: GI/Billiary 6 6 41 41 1
Foremost Diagnosis: Different 5 5 42 42 1
Ventilation 22 26 25 21 0.5362
Vasopressors 22 22 25 25 1
AKI 31 30 16 17 1
Certain blood cultures 13 13 34 34 1

______

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About the author: Vanic
“Simplicity, patience, compassion. These three are your greatest treasures. Simple in actions and thoughts, you return to the source of being. Patient with both friends and enemies, you accord with the way things are. Compassionate toward yourself, you reconcile all beings in the world.” ― Lao Tzu, Tao Te Ching

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