HOME PAGE OF SEMMEL-WEIS.ORG Semmel Weis in Landeck, Austria with Die Silberspitze (SilverPeak) in the background Ignaz Semmelweis on Hungarian postage stamp Frodo Ring introduces RED BOX WARNING AGAINST KAPLAN-MEIER Grim Reaper introduces the SAN MIGUEL (2008) TRILOGY IS THERE AN ALTERNATIVE TO INFOMERCIALS? THESE FOUR RATS GAVE THEIR LIVES DEMONSTRATING THAT THERE IS AN ALTERNATIVE. Chinese woman holding giant, bamboo-eating rat Bright future for Johnson&Johnson DARZALEX
FDA Agent Badge gets you into THE JOHNSON & JOHNSON RAP SHEEP Dr ROBERT Z ORLOWSKI, one of the MAGNIFICENT EIGHT represented here as a SUPERMAN in the area of multiple myeloma 83% survival at Months=30 is the inflated survival indicated in a misleading Kaplan-Meier graph Dr Paul Richardson wearing the recommended badge which reflects that Big Pharma's power over him has the strength of $19.6 million Best Hospitals ranking by USNews HOW MANY SUBJECTS PER GROUP? Dr SAGAR LONIAL debates Dr Paul Richardson Meletios Dimopoulos
A VERY SPECIAL INTEREST HERE TO SEE YOU William James Mayo Dr Matt Kalaycio unable to dispute payment Incongruity arrow ODOMZO may exhibit a Kalaycio-Boom in a Mayo Clinic Rochester clinical trial having Dr Francis Buadi as Principal Investigator      


OUR VISIT TO MAYO

PART 3

IS THE KALAYCIO-BOOM UBIQUITOUS?

by Semmel Weis
First published 12Nov2018    Last edited 16Nov2018  12:01pm Pacific Time

Presented earlier were eleven reasons for disbelieving the OpenPayments claim that the 2017 shipment of $1,308,360.06-worth of the Novartis drug TASIGNA to Dr Matt Kalaycio was administered to clinical-trial subjects in what is called here the NOVARTIS-TASIGNA-STUDY (ClinicalTrials.gov ID NCT00471497).  The question asked in that paper a month ago remains unanswered today:

And so the very big question hovers over the $1,308,360.06 that Dr Kalaycio has brought to public attention in his "I have nothing to disclose" article — if he didn't use that 2017 shipment of TASIGNA to conduct NOVARTIS-TASIGNA-STUDY research the way OpenPayments says he did, then what did he use the TASIGNA for?

The present paper does not review the eleven reasons for disbelief cited above, but only adds three details:

  1. that drug misattribution is not characteristic of Dr Kalaycio alone, but rather seems to be widely practiced by doctors acting as investigators in clinical trials;

  2. that drug misattribution is not characteristic of Novartis drug Nilotinib (TASIGNA) alone, but rather is characteristic of Johnson & Johnson's Daratumumab (DARZALEX) as well, the only other drug I have taken a look at so far; and

  3. that two clinical trials which present participant-enrollment data, which the NOVARTIS-TASIGNA-STUDY does not, support the impression of early and total subject disappearance which renders impossible their later becoming the consumers of the drug in question.

In recognition of Dr Kalaycio's bringing to public attention the incongruity of an upsurge of seemingly-gratuitous spending on a defunct clinical trial, it is proposed that such upsurges be called Kalaycio-Booms.

First, then, comes the demonstration that the phenomenon of the Kalaycio-Boom is not characteristic of Dr Kalaycio alone, but rather that it was rife among other American doctors collaborating in that same clinical trial, the NOVARTIS-TASIGNA-STUDY, our attention being restricted to American doctors because they alone have their drug-company-payment amounts and dates published by OpenPayments.

SEVERAL KALAYCIO-BOOMS
IN THE NOVARTIS-TASIGNA-STUDY

The NOVARTIS-TASIGNA-STUDY aimed to show that the new Novartis drug, Nilotinib (TASIGNA) whose patent was secure was better than the old Novartis drug, Imatinib (GLEEVEC) whose patent was about to expire.  The study's chief characteristics are as follows:



ClinicalTrials.Gov information:  clinicaltrials.gov/ct2/show/record/NCT00471497
National Clinical Trial ID:  NCT00471497   (aka: ClinicalTrials.gov ID)
Official Title:  A Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Actual Enrollment:  852 participants   (aka subjects or patients)
Study Locations:  221
Actual Study Start Date:  31Jul2007      marked with  |   below
Actual Primary Completion Date:  02Sep2009     marked with  |   below
Estimated Study Completion Date:  15Oct2018
Collaborators (Investigators):  223       as listed in   Saglio 17Jun2010   and in   Saglio 17Jun2010
Publications:  Saglio 17Jun2010 nejm.org    Kantarjian 01Sep2011 lancet.com
each marked with  !   below


What we are here calling the NOVARTIS-TASIGNA-STUDY is sometimes referred to in the literature as the ENESTnd Clinical Trial which stands for Evaluating Nilotinib Efficacy and Safety in Clinical Trials — newly diagnosed Patients.

INDIVIDUAL-INVESTIGATOR RECEIPTS OF TASIGNA FOR USE IN THE NOVARTIS-TASIGNA-STUDY

Actual
Study
Start
Date
31Jul2007

2007

......|.....






2008

............

Actual
Primary
Completion
Date
02Sep2009

2009

........|...

Saglio
17Jun2010
nejm.org


2010

.....!......

Kantarjian
01Sep2011
lancet.com


2011

........!...






2012

............

Revealed pictorially are the vast time gaps between the heart of the research spanning a bit more than two years across 2007-2009 (in orange month-dots) and TASIGNA shipments years later.  Investigator surnames below are linked to OpenPayments from which the corresponding annual dollar sums were calculated.  Cents were truncated prior to dollar entries into this table.


Investigator
Name
Investigator
Location
Recipient
Name
2013
............
2014
............
2015
............
2016
............
2017
............
KOLIBABA
Kathryn Stegen
Vancouver WA Northwest Cancer
Specialists
711,033 1,089,720 1,184,871 1,216,800 1,593,810
KALAYCIO
Matt
Cleveland OH Cleveland
Clinic
358,766 467,699 643,265 670,075 1,308,360
FLINN
Ian W
Nashville TN Tennessee
Oncology
393,730 662,424 1,228,675 1,128,633 1,154,658
FEHRENBACHER
Louis
Vallejo CA Kaiser Permanente
Northern California
324,896 794,470 605,455 215,456 679,324
POWELL
Bayard Lowery
Winston Salem NC Wake Forest University
Baptist Medical Center
175,358 285,653 236,838 397,874 514,231
SHEA
Thomas C
Chapel Hill NC University of North
Carolina at Chapel Hill
183,962 217,468 394,248 531,062 453,316
ARROWSMITH
Edward R
Chattanooga TN Chattanooga Oncology and
Hematology Associates
49,912 84,866 152,645 266,315 282,382
GLASS
Jonathan
Shreveport LA Louisiana State University
Health Sciences Center
0 5,250 0 0 3,350
GUZLEY
Gregory J
San Antonio TX Cancer Care
Network S Texas
3,427 766 1,814 3,715 2,767
EDENFIELD
William
Greenville SC GHS Greenville
Memorial Hospital
772 2,968 1,708 9,472 2,397
ERVIN
Thomas J
Boca Grande FL Sarah Cannon
Research Institute
100,581 293,697 5,505 3,904 1,798
GOLDBERG
Stuart L
Hackensack NJ Hackensack University
Medical Center Foundation
1,950 6,702 678,210 202,448 0
AKARD
Luke
Indianapolis IN Indiana Blood and
Marrow Institute
285 110,237 122,958 0 0
HARKER
William G
Salt Lake City UT IHO Attn
Jim Buschman
213,876 150,791 8,987 0 0
PAQUETTE
Ronald
Los Angeles CA Resnick Neuropsychiatric
Hospital at UCLA
160,362 28,103 4,690 0 0
HEANEY
Mark L
New York NY Memorial Sloan-Kettering
Cancer Center
55,458 232,285 3,349 0 0
SIEGRIST
Carl W
Cincinnati OH University of Cincinnati
Barrett Cancer Center
100,888 70,980 0 0 0
ALJANADI
Anas
Lansing MI Michigan State University
Breslin Cancer Center
0 9,775 0 0 0
BERRY
William R
Raleigh NC Raleigh Hematology
Oncology Clinic
919 1,900 0 0 0
Grand Total = 23,267,294
2,836,175 4,515,754 5,273,218 4,645,754 5,996,393

If it is reasonable to expect that subjects in clinical trials vanish from the study (mainly by dying or by dropping out) within a year or two of beginning their participation, then the table immediately above should be displaying nothing but zero dollar amounts, simply because none of the subjects originally in the 2007-2009 clinical trial would be available to receive TASIGNA doses in 2013-2017, and so that, to consider the most extreme example, Dr Kathryn Stegen Kolibaba receiving $1,593,810-worth of TASIGNA in 2017 for the express purpose of treating NOVARTIS-TASIGNA-STUDY subjects needs to be regarded as an incongruity demanding explanation because by 2017, that clinical trial is long-defunct and either has too few subjects left to consume that amount of TASIGNA, or more likely has no subjects at all remaining to consume any TASIGNA.

The principle that subject enrollment drops rapidly-and-totally receives no empirical backing in the NOVARTIS-TASIGNA-STUDY because the traditional Overall Survival Graph which comes with subject-enrollments listed along its bottom is not provided.  To make up for this lack, we next examine the two clinical trials, CASTOR and POLLUX, supporting the Johnson & Johnson drug Daratumumab (DARZALEX), (discussed earlier on semmelweis.org at BRIGHT FUTURE FOR J&J DARZALEX?), which two clinical trials do come with Overall-Survival graphs, and which graphs do have rows of subject-enrollment data along the base of each.

SEVERAL MORE KALAYCIO-BOOMS
(this time with enrollment figures)

IN THE CASTOR STUDY
Palumbo (25Aug2016)



ClinicalTrials.Gov information:  clinicaltrials.gov/ct2/show/NCT02136134
National Clinical Trial ID:  NCT02136134   (aka: ClinicalTrials.gov ID)
Protocol No:  54767414MMY3004   (sometimes used in OpenPayments)
Official Title:  Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Subjects With Relapsed or Refractory Multiple Myeloma
Actual Enrollment:  499 participants   (aka subjects or patients)
Study Locations:  107
Actual Study Start Date:  15Aug2014
Actual Primary Completion Date:  11Jan2016
Estimated Study Completion Date:  15Jun2021
Collaborators (Investigators):  Among the collaborators listed at nejm.org/~ , 20 were American, and of these the 17 identified below were found in OpenPayments.
Publications:  Palumbo 25Aug2016   nejm.org/doi/full/10.1056/NEJMoa1606038#t=article


The orange notation was added to the Kaplan-Meier Overall-Survival graph below for use elsewhere, though it is beneficial to take every opportunity to be reminded of the falsity of Kaplan-Meier graphs that is demonstrated by the double-headed arrow on a dashed shaft pointing to the incongruity between

  1. the Daratumumab Curve indicating that at Months=15, 203 of the original 251 Daratumumab Subjects are still alive,

    and yet

  2. the "No. at risk" in the Daratumumab row equalling zero at Months=15, signifying that research staff had never seen even a single Daratumumab Subject alive at Months=15.
This glaring incongruity is concealed from many readers by the study authors neglecting to explain that "No. at risk" really means "Number subjects still enrolled in the clinical trial", "enrolled" subjects being those who have neither died nor dropped out.

The 251 and 0 below were enlarged and colored to facilitate the reader noticing their origin when they emerge in computation and discussion.  The original of this graph can be inspected at the link provided.

CASTOR-Palumbo(25Aug2016)
NEJM CASTOR SUPPLEMENTARY APPENDIX
CASTOR Palumbo Overall Survival graph

Returning now to the subject of Kalaycio-Booms, the calculations in the table below rely on the following information, along with the Number-Daratumumab-Subjects-Still-Enrolled values in the "No. at risk" area at the base of the above graph:

Participants=499     Locations=107     Participants/Locations=499/107= 4.6636 Participants Per Location

MONTHS

FRACTION OF DARATUMUMAB SUBJECTS
REMAINING IN THE EXPERIMENT
AVERAGE NUMBER OF SUBJECTS REMAINING
IN EACH LOCATION     (≈ ROUNDED)
  0 251/251 =  1.0000 4.6636 * 1.0000 = 4.6636    ≈ 5
  3 230/251 =  0.9163 4.6636 * 0.9163 = 4.2733    ≈ 4
  6 176/251 =  0.7012 4.6636 * 0.7012 = 3.2701    ≈ 3
  9   78/251 =  0.3108 4.6636 * 0.3108 = 1.4494    ≈ 1
12   21/251 =  0.0837 4.6636 * 0.0837 = 0.3903    ≈ 0
15     0/251 =  0.0000 4.6636 * 0.0000 = 0.0000    ≈ 0

Fraction estimates above would have been almost identical if calculated from the combined data of both groups, rather than just from the Daratumumab Group.  Generally, though, the Daratumumab Group is of greater interest because it approximates what future patients will experience under Daratumumab therapy.  Also, as the Daratumumab patients are expected to live longer, relying on them might be expected to work against my hypothesis of massive and total subject loss, which anti-hypothesis bias is desirable in helping to disarm suspicion of pro-hypothesis bias.  The estimates in the right-hand column, though, are of average total subjects remaining enrolled from both Daratumumab and Control Groups.

INDIVIDUAL-INVESTIGATOR RECEIPTS OF DARATUMUMAB (DARZALEX) FOR USE IN CASTOR STUDY

Actual Study Start Date:  15Aug2014   marked with  |
Actual Primary Completion Date:  11Jan2016   marked with  |
Publication Date:  Palumbo 25Aug2016   marked with  !

In the individual-investigator table for the NOVARTIS-TASIGNA-STUDY higher above, we saw payments often peaking during the 8th year (2017) following YearOfStudyCompletion=2009.  Below, however, the OpenPayments data available for this Clinical Trial extend not 8 years beyond YearOfStudyCompletion=2016, but only one year beyond, such that we may expect that the full upward motion which constitutes a Kalaycio-Boom has barely begun.  Nevertheless, with the Average Number-Of-Subjects-Remaining-In-Each-Location rounding to zero at Months-Since-Randomization=12, zero subjects enrolled is what our estimate is going to be for 2017, such that, for example, what use within 2017 CASTOR-research-investigator Dr Suzanne LENTZSCH could have found for $54,575 of Daratumumab (DARZALEX) becomes hard to imagine.

Investigator
Name
Investigator
Location
Recipient
Name
2013
............
2014
.......|....
2015
............
2016
|......!....
2017
............
LENTZSCH
Suzanne
New York NY Columbia
University
0
0
30,723
11,987
54,575
NOOKA
Ajay K
Atlanta GA Emory University
Hospital
0 11,050 309,020 72,660 44,115
CHANAN KHAN
Asher A
Jacksonville FL Mayo Clinic
Jacksonville
0
9,200
117,998
26,904
39,481
BAR
Michael H
Stamford CT Stamford
Hospital
0
0
18,747
1,594
28,514
MARK
Tomer M
Aurora CO Weill Cornell
Medical College
0 11,150 6,562 23,560 22,284
MEDVEDOVA
Eva
Portland OR OHSU Hospital
and Clinics
0 0 68,614 21,965 19,082
VESCIO
Robert A
West Hollywood CA Cedars-Sinai
Medical Center
0 0 39,204 16,670 16,488
VOORHEES
Peter Michael
Charlotte NC U North Carolina
Chapel Hill
0 0 15,800 0 6,920
LAUBACH
Jacob P
Boston MA Dana-Farber
Partners Cancer Care
0 0 18,813 20,403 4,201
LIPE
Brea C
Westwood KS University
of Kansas
0
0
19,908
11,331
2,960
WEISS
Brendan M
Philadelphia PA U Pennsylvania
Hospital
0 0 13,500 0 2,500
KLEIN
Leonard M
Niles IL Illinois
Cancer Specialists
0
0
32,781
1,548
2,281
KYASA
Mouhammed
Shawnee Mission KS St Francis
Health Center
0
4,500
21,276
11,619
0
WINER
Eric S
Boston MA Rhode Island
Hospital
0 5,653 4,250 7,990 0
BENSINGER
William Ira
Seattle WA Fred Hutchinson
Cancer Center
0
0
13,929
0
0
SRKALOVIC
Gordan
Lansing MI Michigan State
University
0 4,500 500 0 0
COSGRIFF
Thomas Michael
Metairie LA Crescent City
Research Consortium
0 3,000 0 0 0
Grand Total = 1,252,310
0 49,053 731,625 228,231 243,401


AND STILL MORE KALAYCIO-BOOMS
(this time also with enrollment figures)

IN THE POLLUX STUDY
Dimopoulos (06Oct2016)



ClinicalTrials.Gov information:  clinicaltrials.gov/ct2/show/NCT02076009
National Clinical Trial ID:  NCT02076009   (aka: ClinicalTrials.gov ID)
Protocol No:  54767414-MMY-3003   (sometimes used in OpenPayments)
Official Title:  Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma
Actual Enrollment:  569 participants   (aka subjects or patients)
Study Locations:  145    clinicaltrials.gov/ct2/show/study/NCT02076009?show_locs=Y#locn
Actual Study Start Date:  23May2014
Actual Primary Completion Date:  07Mar2016
Estimated Study Completion Date:  29Sep2020
Collaborators (Investigators):  Among the collaborators listed at nejm.org/~ , 15 were American, all of whom were found in OpenPayments.
Publications:  Dimopoulos 06Oct2016   nejm.org/doi/full/10.1056/NEJMoa1607751#t=article


POLLUX-Dimopoulos(06Oct2016)
NEJM POLLUX SUPPLEMENTARY APPENDIX
POLLUX Dimopoulos Overall Survival graph

Performing the same computations for POLLUX as were performed above for CASTOR:

Participants=569     Locations=145     Participants/Locations=569/145= 3.9241 Participants Per Location

MONTHS

FRACTION OF SUBJECTS REMAINING
IN THE EXPERIMENT
AVERAGE NUMBER OF SUBJECTS REMAINING
IN EACH LOCATION   (≈ ROUNDED)
  0 286/286 =  1.0000 3.9241 * 1.0000 = 3.9241   ≈ 4
  3 277/286 =  0.9685 3.9241 * 0.9685 = 3.8005   ≈ 4
  6 271/286 =  0.9476 3.9241 * 0.9476 = 3.7185   ≈ 4
  9 262/286 =  0.9161 3.9241 * 0.9161 = 3.5949   ≈ 4
12 224/286 =  0.7832 3.9241 * 0.7832 = 3.0734   ≈ 3
15   79/286 =  0.2762 3.9241 * 0.2762 = 1.0838   ≈ 1
18   14/286 =  0.0490 3.9241 * 0.0490 = 0.1923   ≈ 0
21     0/286 =  0.0000 3.9241 * 0.0000 = 0.0000   ≈ 0

INDIVIDUAL-INVESTIGATOR RECEIPTS OF DARATUMUMAB (DARZALEX) FOR USE IN POLLUX STUDY

Actual Study Start Date:  23May2014    marked with  |
Actual Primary Completion Date:  07Mar2016    marked with  |
Publication Date:  Dimopoulos 06Oct2016    marked with  !


Investigator
Name
Investigator
Location
Recipient
Name
2013
............
2014
....|.......
2015
............
2016
..|......!..
2017
............
ORLOWSKI
Robert Z
Houston TX UT MD Anderson
Cancer Center
0 12,500 104,440 39,373 95,777
KAUFMAN
Jonathan L
Atlanta GA Emory University
Hospital Midtown
0 13,000 160,166 49,959 84,579
USMANI
Saad Zafar
Charlotte NC Carolinas
Medical Center
0 28,809 141,612 11,188 51,642
CHARI
Ajai
New York NY Icahn School of
Medicine Mount Sinai
0 24,974 55,582 7,764 51,421
KUMAR
Shaji
Rochester MN Mayo Clinic
Rochester
0 0 91,852 28,740 44,872
MAZUMDER
Amitabha
New York NY New York University
School of Medicine
0 14,350 50,021 100 44,026
ANDERSON
Larry D
Seattle WA U Texas SW
Medical Center
0 0 34,955 18,936 39,941
YASENCHAK
Christopher A
Tualatin OR US Oncology
Research Inc
0 38,479 18,232 28,971 30,733
JAKUBOWIAK
Andrzej J
Chicago IL Univeristy
of Chicago
0 15,802 25,682 39,847 24,957
TARANTOLO
Stefano R
Omaha NE US Oncology
Research Inc
0 19,316 100,647 11,312 24,709
LAUBACH
Jacob P
Boston MA Dana-Farber Partners
Cancer Care
0 11,000 73,608 29,692 2,625
TRICOT
Guido
Iowa City IA U Iowa Hospital
and Clinic
0 30,285 20,158 9,752 1,051
MALLIK
Alka
Austen TX Seton
Healthcare
0 0 32,151 10,024 644
PELES
Shachar
Atlantis FL Florida Cancer
Specialists
0 15,922 88,009 39 0
NARANG
Mohit
Owing Mills MD US Oncology
Research Inc
0 3,120 10,720 0 0
Grand Total = 2,018,066
0 227,557 1,007,835 285,697 496,977

PARTING THOUGHTS

More Questions Raised Than Answered

The only conclusion that can be drawn with confidence is that the claim that drug shipments are dedicated to research is often false.  More detailed conclusions are blocked by the incompleteness and ambiguity of the data.

For example:

  • I have not come across any information as to whether the drug prices reported in OpenPayments and featured above are wholesale or retail or something else, or what their relation is to payments demanded by the doctor or clinic or drug company from the patient or insurer or government.

  • I have been assuming that shipment dollar-values correspond approximately to drug volumes received, but which correspondence would be weakened by price-per-dose changing over time, as perhaps by a sudden price hike upon announcement of FDA approval, or even upon the anticipation of FDA approval, or even upon the impression that clinical-trial results were beginning to look favorable.

  • In order to get a rough idea of what may be happening everywhere, an average number of subjects was assumed at each study location, which if the real number were above or below average, might call for some qualification of some conclusions — which might begin to be true when a release of data permits refined conclusions, but is unlikely to affect the one big conclusion being offered at the moment — that large volumes of drugs are being delivered for use in clinical trials that are defunct.

  • The implicit assumption that subject treatment begins around the "Actual Study Start Date" is not completely accurate because subjects do not all begin their participation on the same date, but rather enroll staggered, meaning spread out over days or weeks or even months, and so the termination of their treatment is correspondingly staggered as well.  Therefore, exact determination of subject availability or unavailability for treatment using Kalaycio-Boom drugs will become possible only when detailed raw data can be accessed.

Unless such very large payments as we have been noting, whether in cash or in kind, are made transparent and are explained and justified, patients will have cause to be concerned that monetary considerations might be taking precedence over the quality of the health care that they receive.

Mayo Clinic Collaborates In Bogus Research

The two yellow cells in the Individual-Investigator tables above indicate Mayo Clinic participation in both CASTOR and POLLUX Clinical Trials, which unfortunately are stigmatized by three powerful indicators of invalidity, namely

  1. the employment in each trial of around 500 participants at over 100 study locations, and with a stunningly-high subject-disappearance rate such that CASTOR was left with zero participants at 15 months of therapy and POLLUX reached zero at 21 months,

  2. reliance on Kaplan-Meier Overall-Survival Graphs to produce an abracadabra transformation of disappeared patients into survivors, as instanced by such absurdities as

    • the CASTOR claim of 203 Daratumumab (DARZALEX) patients surviving at Months=15 when in fact no CASTOR investigator had ever seen even a single patient surviving 15 months of Daratumumab,

      or such as

    • the POLLUX claim of 237 Daratumumab (DARZALEX) patients surviving at Months=21 when in fact no POLLUX investigator had ever seen even a single Duratumumab patient alive at 21 months

    neither of which should be taken to mean that all Duratumumab subjects were accounted for, and none were alive, but is to be taken to mean that all Daratumumab subjects were either dead or missing, and that nobody had evidence that any among the missing were alive, though Kaplan-Meier dared to guess that many were, and dared to offer that guess to patients as scientific evidence of drug efficacy.
  3. sponsorship of the research by the scofflaw Johnson & Johnson which boasts a rap sheet as long as your arm.

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