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      

Dr.  John H.  Noseworthy,
President and CEO, Mayo Clinic,
noseworthy.john@mayo.edu

13Oct2018
Dear Dr.  Noseworthy:

I contrast below two very different responses to the problem of conflict-of-interest — the response of Dr Matt Kalaycio to his conflict-of-interest, and your response to your own.

Perhaps neither response is completely satisfactory.

In any case, happy reading!

Yours truly,
Semmel Weis



OUR VISIT TO MAYO

PART 2

TWO CONTRASTING ATTEMPTS TO MITIGATE
CONFLICT-OF-INTEREST EMBARRASSMENT


by Semmel Weis
First published 13Oct2018  Last edited 15Nov2018  11:59am Pacific Time


DR KALAYCIO IS INDIGNANT

On the left below, Dr Matt Kalaycio is indignant to discover that OpenPayments has published his receipt of $1,308,360.06 from drug companies in 2017, as he doesn't know anything about any such payment, and is unable to find out anything about it either.  Of course he views that payment as disputable, and declares that he intends to dispute it with OpenPayments.

And on the right below can be seen the context in which the $1,308,360.06 makes its appearance on the OpenPayments web site.


FROM THE EDITOR
Full Disclosure
By Matt Kalaycio, MD
20Sep2018     mdedge.com     [red emphasis added]

I have nothing to disclose.

Dr. Matt Kalaycio of the Cleveland Clinic denying receipt of $1,308,360.06 from Novartis
Dr.  Matt Kalaycio
 

That is the first line on my second slide in just about every talk I give.  I have no financial conflicts of interest.  I no longer accept meals from pharmaceutical companies, I no longer conduct pharmaceutical company sponsored research, and I no longer give talks that include honoraria from pharmaceutical companies.  I turn down payments from pharmaceutical companies when I participate in drug-monitoring safety boards and advisory committees.  I do not have a financial conflict of interest.

Or do I?

In preparing to write this essay, I searched the Open Payments website (www.cms.gov/OpenPayments/index.html) for my name.  [...]  I was happy to confirm that I have received no “General Payments,” which are payments for meals, travel, honoraria, consulting, and the like.  However, I was surprised to learn that I did receive “Associated Research” payments.  According to the website, an Associated Research payment is “funding for a research project or study where the physician is named as a principal investigator.”

I still have a few trials open under my name, but none have accrued a patient in more than 7 years.  Nonetheless, I am on record, and publicly so, for accepting an Associated payment for research to the tune of  $1,308,360.06.   [...]

Money corrupts, and that is why research dollars need to be disclosed whenever we discuss research at the podium or in print.

With appropriate indignation, I explored the Open Payments website to learn more of my hitherto unknown payment.  It was attached to a multicenter, randomized clinical trial for which I served as local principal investigator.  The payment was made in January 2017 and our research team cannot verify such a payment was ever received.  According to the website, the payment was not disputed.  I sought to dispute it. Our friends at the Centers for Medicare and Medicaid Services do not make filing a dispute easy.  I first had to register with my home address and create a new password that, of course, needs to be changed every 60 days.  I duly registered and logged into the website as instructed.  I followed instructions and filled in data fields for about an additional 10 pages before being informed that I needed to logout, then log back in, to access the Open Payments application.  When I did that, I was greeted with instructions to register in the Open Payments system.  I then realized that all I had done to that point was register with the CMS.gov portal, not Open Payments.  In for a dime, in for a dollar, I registered with Open Payments.

I almost gave up when they asked me to provide a Physician Taxonomy Code.  It took me a long time to find it.  For those interested, the code for Hematology is 207RH0000X.  With that code entered in the right box, I was only two pages away from being registered and ready to open the dispute.  Failure hit me like a lake effect snow storm.  Despite my diligence, I was not “vetted” and could not file a dispute.  I must have done something wrong and cannot seem to investigate the payment further [...].  [...]

Now, I don’t know if I have anything to disclose or not.  I do know that I have to investigate my payment the best I can, that I have to disclose it if it is real, and that I have to check Open Payments every so often to make sure I am not surprised by an investigative journalist’s report in the future.  Add these to the pantheon of onerous requirements for a successful academic career.

Onerous or not, we have an obligation to disclose our financial ties to industry no matter how entangled we are.  [...]

It is our duty to accurately account for and report them no matter the difficulty in doing so.  Failure to do so can carry tragic consequences.

Dr.  Kalaycio is editor in chief of Hematology News.  He chairs the department of hematologic oncology and blood disorders at Cleveland Clinic Taussig Cancer Institute.  Contact him at  kalaycm@ccf.org.

OpenPayments logo
Dr Matt Kalaycio of the Cleveland Clinic denying receipt of $1,308,360.06 from Novartis
Dr Matt E Kalaycio
Cleveland Clinic, OH
2017
General Payments              N/A
Research Payments            N/A
Associated Research   $1,308,360.06
2016
General Payments              $97.55
Research Payments             N/A
Associated Research   $670,075.76
2015
General Payments             $294.65
Research Payments        $3,569.00
Associated Research   $644,464.10
2014
General Payments           $2,012.11
Research Payments            N/A
Associated Research    $478,032.30
2013 (Aug-Dec)
General Payments         $51,242.79
Research Payments         $2,970.00
Associated Research    $372,274.26
Dr Matt E Kalaycio had some involvement
in drug-company payments
covering Aug2013-Dec2017
and totalling

$3,533,392.58
as downloaded on 23Sep2018 from
OpenPaymentsData.cms.gov

To see where the above numbers come from, click on the OpenPayments link immediately above which will show the 2017 data consisting only of the single number $1,308,360.06.  Changing only the year on that OpenPayments page by means of the drop-down menu available on its upper left shows the same data as above for each of the other years.

The OpenPayments Total is the sum of the payments displayed above it.  "N/A" may be taken to mean "No Evidence of Payments Available".

[Italicized material in this CMS.gov box, as well as the photo, were not in the CMS.gov original.]



DIGGING DEEPER: INDIVIDUAL PAYMENTS

Using the same OpenPaymentsData.cms.gov link as above, it is possible to click on "Payment Information" and select "Associated Research" right under it, and to do the same for each year 2013-2017, which will display all the data shown below, and which reveals that three drug companies have made a total of 12 payments to Dr Kalaycio.

Associated Research Payments Received
At   openpaymentsdata.cms.gov      Date format is  mm/dd/yyyy
2017  Total Associated Research = $1,308,360.06
Dr Matt Kalaycio, Associated Research Payments Received 2017
2016  Total Associated Research = $670,075.76
Dr Matt Kalaycio, Associated Research Payments Received 2016
2015  Total Associated Research = $644,464.10
Dr Matt Kalaycio, Associated Research Payments Received 2015
2014  Total Associated Research = $478,032.30
Dr Matt Kalaycio, Associated Research Payments Received 2014
2013   (Aug-Dec)   Total Associated Research = $372,274.26
Dr Matt Kalaycio, Associated Research Payments Received 2013


A FIRST IMPRESSION: STRONGLY NEGATIVE

Dr Kalaycio Struggles to File a Dispute

Of the twelve payments that drug companies report having made to Dr Kalaycio, he complains of only one, the most recent.  One may hypothesize that he has no intention of disputing the most recent payment for the same reason that he has not disputed the previous 11 — the reason being that they are indisputable.  Dr Kalaycio describes an attempt to file a Dispute with OpenPayments, but only to project the appearance that the task is at every step difficult, and ultimately impossible.

An example of projecting an image of difficulty:

Dr Matt Kalaycio wrote:

I almost gave up when they asked me to provide a Physician Taxonomy Code.  It took me a long time to find it.  For those interested, the code for Hematology is 207RH0000X.

When I tried to find the same thing, I got the answer in under a minute.  My single Google search gave me this top-of-the-page result:

Google finds Physician Taxonomy Code for hematology in 0.35 seconds, whereas Dr Matt Kalaycio complained of how long it took him

Clicking the Google top result called up a cms.gov table, providing the answer just as quickly as "Hematology" could be located in the alphabetized list of specialties in the right-hand column, three lines from that table looking like this (yellow arrows added):

Showing Dr Matt Kalaycio how easy it is to find his Physician Taxonomy Code, Hematology

The impression created is that Dr Kalaycio exaggerates obstacles because he is looking for an excuse to abandon his attempt to dispute the $1,308,360.06 payment.

And, sure enough, despite having made some progress, Dr Kalaycio reports becoming so overwhelmed by the obstacles he keeps encountering that he doubts that he will be able to continue his investigation:

Dr Matt Kalaycio wrote (bold emphasis added):

Failure hit me like a lake effect snow storm.  Despite my diligence, I was not “vetted” and could not file a dispute.  I must have done something wrong and cannot seem to investigate the payment further [...].

And yet Dr Kalaycio could have investigated the payment further by

  1. putting out word at the Cleveland Clinic that he needed someone familiar with the OpenPayments web site to guide him through his submission,

    or by

  2. seeking guidance from the OpenPayments Help Desk, by phone or by email

    Questions about Open Payments?

    Contact the live Help Desk at openpayments@cms.hhs.gov to submit your question.  You can also reach the Help Desk by calling 1-855-326-8366 (TTY Line: 1-844-649-2766), Monday through Friday, from 9:00 a.m. to 5:00 p.m. (ET) excluding Federal holidays.     www.cms.gov

    or by
  3. altogether avoiding the seemingly-impossible task of getting through to OpenPayments to submit his dispute.  That is, all the information that OpenPayments publishes comes from drug companies, which for Dr Kalaycio during 2016 and 2017 had been solely Novartis and during 2013-2015 had been mostly Novartis, and so all that he needed to do was phone Novartis, ask them what was going on, and tell them that he had never received that $1,308,360.06 — and Bob's your uncle!

    Novartis has been submitting mountains of data to OpenPayments for five years.  Novartis knows who to contact at OpenPayments to report an error.

Dr Kalaycio's failure to take advantage of any of these options suggests that he has no intention of challenging that problematic $1,308,360.06 payment.  As of 13Oct2018, more than a month after Dr Kalaycio reports having discovered the OpenPayments allegation of that payment, and describes being indignant at its obvious fictitiousness, OpenPayments continues to report that he has left it undisputed:

     Dr Matt Kalaycio still hasn't disputed that problematic Novartis payment of $1,308,360.06



DIGGING STILL DEEPER:  DISSECTING EACH PAYMENT

Because the individual payments listed above under the heading DIGGING DEEPER: INDIVIDUAL PAYMENTS are only screenshots of what can be seen on the OpenPayments web pages, nothing will happen here if the reader places his mouse cursor on any of the dollar amounts.

On the OpenPayments web pages, however, what happens, as in the case of the $1,308,360.06 payment that Dr Kalaycio denies and denounces, is that its appearance changes to the below, and which signifies that it has been transformed into a link which can be clicked to open a hidden door to a trove of information concerning that payment (and I have made the image below clickable to reach the very OpenPayments page near the bottom of which the original clickable $1,308,360.06 can be found):

This $1,308,360.06 is a clickable link

 
Dr Kalaycio  2017

Research Payment Details for Dr Matt Kalaycio's $1,308,360.06 Research Payment Details for Dr Matt Kalaycio's $1,308,360.06

And performing that click when on OpenPayments calls up a "Research Payment Details" box of information, with its "Payment Amount" equalling $1,308,360.06 and its "Company Making Payment" being Novartis assuring us that we are on the right page.

And now comes a revelation — that "Form of Payment" is "In-kind items and services", where "in-kind" means that not that number of dollars had been paid, but only goods valued at that number of dollars (there were no services).  And — what goods?

Looking down to the heading "Product Details", we see that there is only a "Product#1", and it is the Novartis drug TASIGNA.

And the Novartis drug TASIGNA was delivered to the "Recipient Name" of CLEVELAND CLINIC, from which it may be inferred that the CLEVELAND CLINIC has a drug facility which normally receives all drug shipments, including Dr Kalaycio's TASIGNA, and all of which it stores, and in this case dispenses either to Dr Kalaycio, or to someone else as directed by Dr Kalaycio, because it is Dr Kalaycio and no one else whom Novartis authorizes to take any action concerning the drug.  Of course Dr Kalaycio does not have room in his office to store it, and does not have the refrigeration and humidity control which may be needed to preserve it, and does not have the means to secure it from theft, and does not want to be bothered with the paperwork of accounting for it as it is doled out over the course of the year — and so he is glad to hand all that over to the CLEVELAND CLINIC which already has the facilities and personnel and expertise to store and protect and dispense the huge volume of drugs that every clinic uses, and so is pleased to do the same for Dr Kalaycio's TASIGNA.

And so when Dr Kalaycio denies receiving a $1,308,360.06 payment, as he does in the excerpts below, then it is because he implicitly insists that "payment" can have no other meaning than "payment in dollars", and to his way of thinking he is telling the truth because the 2017 payment was not in dollars:

Dr Matt Kalaycio wrote:

However, I was surprised to learn that I did receive “Associated Research” payments.  [...]  With appropriate indignation, I explored the Open Payments website to learn more of my hitherto unknown payment.  [...]  The payment was made in January 2017 and our research team cannot verify such a payment was ever received.

 

And yet Dr Kalaycio at the same time must be fully aware that a shipment of the Novartis drug TASIGNA (that he alone had been authorized to dispense) was delivered on or about 12Jan2017 into the care of the Cleveland Clinic, and surely must also be aware that in law and in accounting it is useful and conventional to sometimes represent such in-kind payments using their dollar equivalents.

The question needs to be put to Dr Kalaycio whether he has not all along fully understood that where OpenPayments says that Novartis has paid him $1,308,360.06, it really means that Novartis has deposited with the Cleveland Clinic for his exclusive use TASIGNA valued at $1,308,360.06.  And how could Dr Kalaycio not have understood this?  We are right now looking at the explanation of it on the OpenPayments web site which Dr Kalaycio admits to having visited and there seeing the $1,308,360.06 number which he copied into his "I have nothing to disclose" article.

And just what did Dr Kalaycio do in 2017 with his $1.3 million of TASIGNA?  According to OpenPayments, he did in 2017 exactly what he had become habituated to doing through 2013-2016 — he conducted research with it.  For five years in a row, OpenPayments identifies him as "Principal Investigator(s)" of the research described in the title opposite "Name of Research Study", which research I will refer to on the instant web page as the "NOVARTIS-TASIGNA-STUDY", and each year OpenPayments reports Novartis sending him a single shipment of its drug TASIGNA, the value of the TASIGNA escalating from 2013 to 2017 as shown below:

2017     $ 1,308,360.06
2016     $    670,075.76
2015     $    643,265.02
2014     $    467,699.52
2013     $    358,766.11

Total     $ 3,448,166.47


This sharp increase will prove to be of interest further below, where it will be referred to as the Kalaycio-Boom.


A SECOND IMPRESSION: STRONGLY POSITIVE

Despite some incongruities, the fundamentals seem to be in place.  Dr Matt Kalaycio is "Principal Investigator(s)" in a "Research Study" conducted at the CLEVELAND CLINIC.  Optional pluralization indicates that more than one Principal Investigator is possible, but since no others are listed in the space which OpenPayments provides (which is expandable, as is demonstrated in the six-line cell entry opposite "Name of Research Study"), it would appear that Dr Kalaycio is the one and only Principal Investigator, any others perhaps bearing lesser titles and functioning under his supervision.  The research described in the title looks frightfully complicated.  The fact that the title mentions two drug names, but neither of them the Novartis-donated drug TASIGNA, hints that the study might be even more complicated than its daunting title suggests, and so would prove unfathomable to any but an expert in that field, were any access to greater detail granted, which it is not.

However, the absence of a ClinicalTrials.gov ID led me to reflect that the United States does not allow clinical trials to be run without first qualifying for a ClinicalTrials.gov ID, so I packed the entire title that appears opposite "Name of Research Study" into a Google search window, and instantly located a study in ClinicalTrials.gov whose "Official Title" was practically identical to the title of the NOVARTIS-TASIGNA-STUDY, indicating that the ClinicalTrials.gov study and the OpenPayments study were one and the same, and that the ClinicalTrials.gov ID of NCT00471497 applied to both, though for some reason neither Novartis nor Dr Kalaycio provided it to OpenPayments when OpenPayments asked for it:

ClinicalTrials.Gov
clinicaltrials.gov/ct2/show/record/NCT00471497
OpenPayments
openpaymentsdata.cms.gov/physician/168997/payment-information
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)
OPENPAYMENTS 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
National Clinical Trial Identifier
also known as the
NCT Number
and as the
ClinicalTrials.gov ID
is
NCT00471497 NOT SUPPLIED TO OPENPAYMENTS

And so the discovery that the NOVARTIS-TASIGNA-STUDY was registered, and had a ClinicalTrials.gov ID, reinforced the impression of propriety and legitimacy.

A little side investigation brought the clarification that the NOVARTIS-TASIGNA-STUDY aims to compare two drugs, IMATINIB (=GLEEVEC) and NILOTINIB (=TASIGNA).  Furthermore, Novartis owns the patent on TASIGNA, and used to own the patent on GLEEVEC, but the GLEEVEC patent expired in 2015, permitting anybody to manufacture and sell that drug at a much lower price than Novartis had been selling it, and also at a much lower price than Novartis was selling its GLEEVEC replacement, TASIGNA — a situation which provides powerful motivation for Novartis to convince the world that its new drug TASIGNA is better than its old drug GLEEVEC, which might be hypothesized to be the chief goal of comparing the two in the NOVARTIS-TASIGNA-STUDY.

But was that $1.3 million of TASIGNA for 2017 an unjustifiably-large quantity of drug?  Hardly!  A quick look inside ClinicalTrials.gov informed me that NCT00471497 has an "Actual Enrollment" of 852 leukemia patients.  What is one to conclude but that enormous clinical trials happen to be enormously costly?

Sweeping the small incongruities aside for the moment — the big picture projected before us seems to provide a fully-exonerating answer to the question of the $1,308,360.06.  All Dr Kalaycio needed to write in his article was that he had not received a payment of $1,308,360.06, but that the Cleveland Clinic had received $1,308,360.06-worth of the therapeutic drug TASIGNA to be used in research conducted by himself.  Who could find fault with that explanation?

And so why didn't Dr Kalaycio offer that simple and credible and admirable explanation instead of claiming to know nothing about the matter?

I won't keep you waiting long for the answer.


THERE IS NO "NOVARTIS-TASIGNA-STUDY"

At least there does not today exist, nor in 2017 existed, nor existed during the other years of Associated Research Payments 2013-2016 — any ongoing NOVARTIS-TASIGNA-STUDY on which Dr Kalaycio could be working.  There had been one such trial, the NCT00471497 one described in ClinicalTrials.gov, but it was quite different from what reading OpenPayments has led us to visualize, and Dr Kalaycio cannot be considered to have used his shipments of TASIGNA to run any such trial during 2013-2017 for the following eleven reasons.

   #1   Dr Kalaycio would have said that NCT00471497 was what he was doing

This point has already been made above, but is repeated here because it belongs in this list.

If Dr Kalaycio had been running the NOVARTIS-TASIGNA-STUDY in 2017, he would have given the fully-exonerating answer to the question of the $1,308,360.06 — that he had not received a payment of $1,308,360.06, but that the Cleveland Clinic had received $1,308,360.06-worth of the therapeutic drug TASIGNA to be used in research conducted by himself.  But instead, Dr Kalaycio pretended to be bowled over by having that dollar amount attached to him, and pretended also to be unable to even begin to guess what it might mean.

   #2   The ClinicalTrials.gov ID would not have been withheld from OpenPayments

If Dr Kalaycio had been running the NOVARTIS-TASIGNA-STUDY in 2017, he would have supplied its ClinicalTrials.gov ID — NCT00471497 — to OpenPayments.  Neglecting to display this ID number on OpenPayments makes it harder to locate this study on ClinicalTrials.gov, which arouses the suspicion that ClinicalTrials.gov contains information concerning NCT00471497 that the public is not meant to see.

   #3   Novartis sends Dr Kalaycio only one drug

The NOVARTIS-TASIGNA-STUDY compares the two drugs TASIGNA (= nilotinib) and GLEEVEC (= imatinib), but the Novartis annual shipment contains only TASIGNA, and OpenPayments never reports Dr Kalaycio receiving GLEEVEC, not from Novartis and not from anybody.

   #4   Switching drug names sows confusion and discourages reading

Switching drug names without warning sows confusion, and thereby discourages reading, as for example when TASIGNA was used opposite "Product#1", but NILOTINIB opposite "Name of Research Study", with no explanation that they are the same.  A researcher doing research is motivated to be clear; a person faking research prefers a smoke screen.

   #5   One shipment per year rings false

Except for 2013 which was irregular in that only Aug-Dec were covered, the rule seems to be that a single TASIGNA shipment arrives in January and has to last the whole year, which clashes with what might be expected, which would be several shipments per year, as perhaps monthly or bimonthly or quarterly, or irregularly because the researchers wouldn't know exactly how much drug they would need in the upcoming interval, with sometimes more participants dropping out than had been expected, or more enrolling.  And drugs often have a shelf-life which might have expired by June, say, or by October, or whatever.  And the entire year's supply hogs storage space early in the year.  The single January shipment might be expected to have run out at least once during the 2013-2016 interval, because of spoilage or breakage or misplacement or theft or underestimate of demand, or any combination of these factors — and yet a second shipment within a year is never recorded.

A clinical trial does not stock up on a drug once a year for the same reasons that a household does not shop for groceries once a year.

   #6   The number of study participants should have decreased over the years

If there is one regularity that appears with certainty in every clinical trial, it is that participants die or drop out of the study over time, and so that the amount of drug needed to sustain the study decreases proportionately.  But we have already noticed that the dollar value of TASIGNA shipped to Dr Kalaycio almost quadruples between 2013 and 2017, and comes close to doubling between 2016-2017, a sharp increase that will be referred to as the Kalaycio-Boom in further discussion below.

   #7   The NOVARTIS-TASIGNA-STUDY had never been entrusted to Cleveland

The NOVARTIS-TASIGNA-STUDY had been an international study, conducted in 221 Study Locations, of which I have reproduced the first 117 below, hoping to have made my point by the time I completed Italy.

The point that I hope is driven home by means of visual impact is that the contribution of the CLEVELAND CLINIC to the NOVARTIS-TASIGNA-STUDY was infinitesimal.  The only place the CLEVELAND CLINIC is mentioned in the entire ClinicalTrials.gov coverage of the NOVARTIS-TASIGNA-STUDY can be seen in the table below in position 26.

Next, I divide 852 participants by 221 Study Locations to get 3.8552 which will be convenient to round to an average of 4 leukemia-afflicted participants per location.  If CLEVELAND CLINIC participation was average, its contribution to the NOVARTIS-TASIGNA-STUDY consisted of treating 4 leukemia patients.  If above average, it might have treated 5 or 6.  If below average, then maybe 3 or 2.  And so the impression invited by OpenPayments that the entire NOVARTIS-TASIGNA-STUDY was being conducted at the CLEVELAND CLINIC was wrong.  A better bet would be that approximately 1/221 of it was.

The First 117 of the 221 Study Locations Employed in the NOVARTIS-TASIGNA-STUDY
clinicaltrials.gov
USA California 1.  University of California at Los Angeles Dept Hematology Clinic Los Angeles, California USA 90095
2.  Kaiser Permanente - California Southern Dept of Kaiser South 3 San Diego, California USA 92120
3.  Kaiser Permanente - California Southern Dept of Kaiser South 9 San Diego, California USA 92120
4.  Kaiser Permanente - California Southern San Diego Zion Avenue San Diego, California USA 92120
5.  Kaiser Permanente - California Northern Kaiser Med Vallejo, California USA
6.  Kaiser Permanente - California Northern Vallejo Med Center Vallejo, California USA
USA Colorado 7.  Rocky Mountain Cancer Centers RMCC - Colorado Springs Greenwood Village, Colorado USA
USA Florida 8.  Florida Cancer Specialists Dept FloridaCancerSpecialists Fort Myers, Florida USA 33901
9.  Advanced Medical Specialties Research Dept Miami, Florida USA 33176
10.  Cancer Centers of Florida PA Cancer Centers of FL Ocoee, Florida USA
11.  Florida Cancer Institute Flordia Cancer Affilates Orlando, Florida USA 32804
USA Illinois 12.  University of Chicago Section of Hematology/Oncology Chicago, Illinois USA 60637
USA Indiana 13.  Indiana Blood and Marrow Institute Beech Grove, Indiana USA 46107
USA Iowa 14.  University of Iowa Hospitals and Clinics Iowa City, Iowa USA 52242
USA Kansas 15.  Kansas City Cancer Center KCCC Business Office Overland Park, Kansas USA 66210
USA Louisiana 16.  LSU School of Medicine Feist-Weiller Cancer Center New Orleans, Louisiana USA 70115
USA Michigan 17.  Michigan State University / Breslin Cancer Center Lansing, Michigan USA
USA Missouri 18.  Missouri Cancer Associates Dept Boone Hospital Center Columbia, Missouri USA 65201
19.  Hematology Oncology Consultants, Inc Saint Louis, Missouri USA 63136
USA New Jersey 20.  Hackensack University Medical Center Department of Research Hackensack, New Jersey USA 07601
USA New York 21.  Memorial Sloan Kettering Cancer Center Clinical Trials Office New York, New York USA 10021
USA North Carolina 22.  University of North Carolina UNC Lineberger Cancer Center Chapel Hill, North Carolina USA 27514
23.  Cancer Centers of North Carolina Cancer Centers of NC-Raleigh Raleigh, North Carolina USA 27609
24.  Wake Forest University Health Sciences Dept Industry Research Winston-Salem, North Carolina USA 27157
USA Ohio 25.  University of Cincinnati/Barrett Cancer Center Dept Internal Med Cincinnati, Ohio USA 45219
26.  Cleveland Clinic Foundation CCF Cleveland, Ohio USA 44195
USA Oregon 27.  Northwest Cancer Specialists Compass Oncology -BKM Portland, Oregon USA 97210
USA South Carolina 28.  Cancer Centers of the Carolinas CC of C -Eastside Greenville, South Carolina USA 29605
USA Tennessee 29.  Chattanooga Oncology and Hem. Associates Chattanooga, Tennessee USA 37404
30.  Tennessee Oncology Dept Centennial Medical Nashville, Tennessee USA 37203
USA Texas 31.  Texas Cancer Center (Medical City Dallas Hospital) Dallas, Texas USA 75230
32.  Cancer Care Centers of South Texas HOAST CCC San Antonio, Texas USA 78229
33.  Tyler Cancer Center Tyler, Texas USA 75702
USA Utah 34.  Utah Cancer Specialists Salt Lake City, Utah USA 84106
Argentina 35.  Novartis Investigative Site Caba, Buenos Aires, Argentina C1221ADC
36.  Novartis Investigative Site La Plata, Buenos Aires, Argentina B1902AVG
Austria 37.  Novartis Investigative Site Salzburg, Austria 5020
38.  Novartis Investigative Site Wien, Austria A-1090
Belgium 39.  Novartis Investigative Site Bruxelles, Belgium 1000
40.  Novartis Investigative Site Charleroi, Belgium 6000
41.  Novartis Investigative Site Gent, Belgium 9000
42.  Novartis Investigative Site Leuven, Belgium 3000
43.  Novartis Investigative Site Yvoir, Belgium 5530
Brazil 44.  Novartis Investigative Site Fortaleza, CE, Brazil 60440-261
45.  Novartis Investigative Site Brasilia, DF, Brazil 70330-150
46.  Novartis Investigative Site Curitiba, PR, Brazil 80060-900
47.  Novartis Investigative Site Rio de Janeiro, RJ, Brazil 20211-030
48.  Novartis Investigative Site Porto Alegre, RS, Brazil 90560 030
49.  Novartis Investigative Site Campinas, SP, Brazil 13083-970
50.  Novartis Investigative Site Jau, SP, Brazil 17210-080
51.  Novartis Investigative Site Sao Paulo, Brazil 05403 000
52.  Novartis Investigative Site São Paulo, Brazil 01224-000
53.  Novartis Investigative Site São Paulo, Brazil 01401-901
Canada British
             Columbia
54.  Novartis Investigative Site Vancouver, BC, Canada V5Z 4E3
55.  Novartis Investigative Site Vancouver, BC, Canada V5Z 4E6
Canada Ontario 56.  Novartis Investigative Site Toronto, ON, Canada M5G 2M9
Canada Quebec 57.  Novartis Investigative Site Quebec, Canada G1J 1Z4
58.  Novartis Investigative Site Quebec, Canada G1R 2J6
Columbia 59.  Novartis Investigative Site Bogota, Cundinamarca, Colombia 110111
60.  Novartis Investigative Site Bogota, Colombia
Czechia 61.  Novartis Investigative Site Praha 2, Czech Republic, Czechia, 128 20
62.  Novartis Investigative Site Olomouc, CZE, Czechia, 775 20
Denmark 63.  Novartis Investigative Site Copenhagen, Denmark, DK-2100
64.  Novartis Investigative Site Vejle, Denmark, DK-7100
Egypt 65.  Novartis Investigative Site Cairo, Egypt
Finland 66.  Novartis Investigative Site HUS Helsinki, Finland, FIN-00029
67.  Novartis Investigative Site Turku, Finland, FIN-20521
France 68.  Novartis Investigative Site Paris Cedex 10, Cedex 10, France 75475
69.  Novartis Investigative Site Caen, Cedex, France 14033
70.  Novartis Investigative Site Saint Priest en Jarez, Loire, France 42270
71.  Novartis Investigative Site Angers Cedex 1, France 49033
72.  Novartis Investigative Site Bordeaux, France 33076
73.  Novartis Investigative Site Créteil, France 94010
74.  Novartis Investigative Site Grenoble, France 38043
75.  Novartis Investigative Site Lille, France 59037
76.  Novartis Investigative Site Marseille, France 13273
77.  Novartis Investigative Site Nantes, France 44035
78.  Novartis Investigative Site Nice Cedex, France 06202
79.  Novartis Investigative Site Pierre-Benite Cedex, France 69495
80.  Novartis Investigative Site Poitiers, France 86000
81.  Novartis Investigative Site Rennes, France 35019
82.  Novartis Investigative Site Toulouse Cedex 9, France 31059
83.  Novartis Investigative Site Vandoeuvre les Nancy, France 54511
Germany 84.  Novartis Investigative Site Berlin, Germany 13353
85.  Novartis Investigative Site Duesseldorf, Germany 40225
86.  Novartis Investigative Site Eisenach, Germany 99817
87.  Novartis Investigative Site Frankfurt, Germany 60590
88.  Novartis Investigative Site Hamburg, Germany 20246
89.  Novartis Investigative Site Kiel, Germany 24116
90.  Novartis Investigative Site Koeln, Germany 50937
91.  Novartis Investigative Site Leipzig, Germany 04103
92.  Novartis Investigative Site Mannheim, Germany 68169
93.  Novartis Investigative Site Muenchen, Germany 81675
94.  Novartis Investigative Site Ulm, Germany 89081
Hong Kong 95.  Novartis Investigative Site Hong Kong, Hong Kong
Hungary 96.  Novartis Investigative Site Budapest, Hungary, 1097
Italy 97.  Novartis Investigative Site Alessandria, AL, Italy 15100
98.  Novartis Investigative Site Ancona, AN, Italy 60126
99.  Novartis Investigative Site Bari, BA, Italy 70124
100.  Novartis Investigative Site Bergamo, BG, Italy 24127
101.  Novartis Investigative Site Bologna, BO, Italy 40138
102.  Novartis Investigative Site Catania, CT, Italy 95123
103.  Novartis Investigative Site Firenze, FI, Italy 50134
104.  Novartis Investigative Site Genova, GE, Italy 16132
105.  Novartis Investigative Site Milano, MI, Italy 20162
106.  Novartis Investigative Site Pescara, PE, Italy 65124
107.  Novartis Investigative Site Pisa, PI, Italy 56126
108.  Novartis Investigative Site Pavia, PV, Italy 27100
109.  Novartis Investigative Site Reggio Calabria, RC, Italy 89124
110.  Novartis Investigative Site Roma, RM, Italy 00133
111.  Novartis Investigative Site Roma, RM, Italy 00144
112.  Novartis Investigative Site Roma, RM, Italy 00161
113.  Novartis Investigative Site Siena, SI, Italy 53100
114.  Novartis Investigative Site Udine, UD, Italy 33100
115.  Novartis Investigative Site Napoli, Italy 80131
116.  Novartis Investigative Site Napoli, Italy 80132
117.  Novartis Investigative Site Perugia, Italy 06129

... and 104 more Study Locations not shown for a total of 221 ...

   #8   The NOVARTIS-TASIGNA-STUDY had never been entrusted to Dr Kalaycio

OpenPayments having named only Dr Kalaycio as a "Principal Investigator(s)" of the NOVARTIS-TASIGNA-STUDY might have been taken to mean that he was in charge of the entire study, but which he never was, and never came close to being.  More accurate would be to say that he was the Cleveland doctor whom Novartis retained to treat maybe 4 leukemia patients out of the total of 852.  If we guessed that the NOVARTIS-TASIGNA-STUDY had a total of 221 Principal Investigators, one per Study Location, we would not be far off the 223 "Collaborators" who are identified in the PubMed.gov report below, in which Dr Kalaycio can be found fifth row from the bottom:

223 Principal Investigators worked on the NOVARTIS-TASIGNA-STUDY NCT00471497

ClinicalTrials.gov never mentions Dr Kalaycio, just as it never mentions any other Principal Investigator.  The NOVARTIS-TASIGNA-STUDY is entirely a Novartis product, beholden to no one outside Novartis, as is evident also in such of its imperious ClinicalTrials.gov declarations as:

Sponsors and Collaborators:   Novartis Pharmaceuticals
Study Directors:   Novartis Pharmaceuticals
Responsible Party:   Novartis Pharmaceuticals
clinicaltrials.gov    

   #9   The NOVARTIS-TASIGNA-STUDY was long defunct by 2013-2017

And now let us ask in what years these 4 or so Cleveland participants may have been studied.  What the "Study Design" screen-shot below from ClinicalTrials.gov tells us is that

  • the "Actual Study Start Date" (Imformation Icon "The actual date on which the first participant was enrolled") was 31Jul2007, and that

  • the "Actual Primary Completion Date" (Imformation Icon "The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure)" was 02Sep2009.

I pay no attention to the "Estimated Study Completion Date" at the very bottom of the "Study Design" below because it is a number pulled out of thin air and which does not reflect the probability that none of the 4 or so original 2007-2009 Cleveland-Clinic leukemia patients would still be alive and dutifully showing up for their TASIGNA dose 2013-2017, which seems to be the OpenPayments story — and if it is not any of the original 4 or so who are showing up, then who else can it be in 2017 who is dosing away that $1.3 million worth of TASIGNA?

Study Design for NOVARTIS-TASIGNA-STUDY NCT00471497 clinicaltrials.gov

And as for the Kalaycio-Boom that we saw taking place 2013-2017, although we cannot see its beginning, we do see its upward progress in vigorous acceleration long after the "Actual Primary Completion Date" of 02Sep2009 has passed.

   #10   Dr Kalaycio was not included in author lists of the two main publications

The limited role Dr Kalaycio played in the NOVARTIS-TASIGNA-STUDY NCT00471497 is further reflected in his not being admitted into the author lists of the two publications that report the study's primary results, published in 2010 and 2011.  The title in each article differs from the title in ClinicalTrials.gov, but the ID NCT00471497 being the same on the ClinicalTrials.gov web site as in these two articles reassures us that they all address what we are here calling the NOVARTIS-TASIGNA-STUDY.

Included in the snippets from each article below is the statement expressing what had been suspected higher above of being the NOVARTIS-TASIGNA-STUDY'S main goal — to persuade the world that the new Novartis drug TASIGNA (nilotinib) whose Novartis patent held strong was better than the old Novartis drug GLEEVEC (imatinib) whose Novartis patent was due to expire in 2015.

In addition to the author lists supporting the conclusion that Dr Kalaycio had been a minor contributor to the NOVARTIS-TASIGNA-STUDY, and thus an improbable recipient of humongous funds for an expanded NOVARTIS-TASIGNA-STUDY, the 2010-2011 dates on which the NOVARTIS-TASIGNA-STUDY'S primary results are being published also makes it unlikely that large investments would support escalated treatment-administration and data-gathering as much later as 2013-2017.  Most likely would be that once Novartis had used the NOVARTIS-TASIGNA-STUDY primary conclusions to win the regulatory approval it had been seeking, it would have been happy to let that sleeping dog lie.

Saglio (2010)       First article reporting on NCT00471497

New England Journal of Medicine logo
Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia

17Jun2010, 362:2251-2259    nejm.org

[Matt Kalaycio MD is missing from this list of 16 authors]
Giuseppe Saglio MD, Dong-Wook Kim MD PhD, Surapol Issaragrisil MD, Philipp le Coutre MD, Gabriel Etienne MD, Clarisse Lobo MD, Ricardo Pasquini MD, Richard E Clark MD, Andreas Hochhaus MD, Timothy P Hughes MD MB BS, Neil Gallagher MD PhD, Albert Hoenekopp MD, Mei Dong MD, Ariful Haque MS, Richard A Larson MD, and Hagop M Kantarjian MD for the ENESTnd Investigators


[...]

Conclusions

Nilotinib at a dose of either 300 mg or 400 mg twice daily was superior to imatinib in patients with newly diagnosed chronic-phase Philadelphia chromosome–positive CML.  (ClinicalTrials.gov number, NCT00471497.)  [...]

Kantarjian (2011)       Second article reporting on NCT00471497

Lancet logo
Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial

01Sep2011, 12:841-851    thelancet.com

[Matt Kalaycio MD is missing from this list of 14 authors]
Hagop M Kantarjian MD, Andreas Hochhaus MD, Giuseppe Saglio MD, Carmino De Souza MD, Ian W Flinn MD, Leif Stenke MD, Yeow-Tee Goh MD, Gianantonio Rosti MD, Hirohisa Nakamae MD, Neil J Gallagher MD, Albert Hoenekopp MD, Rick E Blakesley PhD, Richard A Larson MD, Timothy P Hughes MD


[...]  This study is registered with ClinicalTrials.gov, number NCT00471497.  [...]

Interpretation

Nilotinib continues to show better efficacy than imatinib for the treatment of patients with newly diagnosed CML in chronic phase.  These results support nilotinib as a first-line treatment option for patients with newly diagnosed disease.  [...]

   #11   Dr Kalaycio confesses to having abandoned all pharma-backed research

But perhaps not much need to continue accumulating evidence — Dr Kalaycio himself puts the kibosh on the OpenPayments portrayal of him as a NOVARTIS-TASIGNA-STUDY NCT00471497 researcher during 2013-2017:

Dr Matt Kalaycio wrote:

I no longer conduct pharmaceutical company sponsored research [...].  I still have a few trials open under my name, but none have accrued a patient in more than 7 years.

By the way, if Dr Kalaycio counts the NOVARTIS-TASIGNA-STUDY to be one of the trials "open under his name", then perhaps he exaggerates his role in that study, as has been discussed above.

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?


A REVISED "RESEARCH PAYMENT DETAILS"

 
Dr Kalaycio  2017

Research Payment Details for Dr Matt Kalaycio's $1,308,360.06 Research Payment Details for Dr Matt Kalaycio's $1,308,360.06

As noted above, the OpenPayments "Research Payment Details" information box places obstacles in the way of a reader understanding what is happening, and thereby encourages the false picture of Dr Kalaycio in 2017 treating all leukemia patients in the Cleveland Clinic for his NOVARTIS-TASIGNA-STUDY.

A few very small changes go a long way toward avoiding this misconception, the most important among the changes being the disclosure of the ClinicalTrials.gov ID of NCT00471497, especially if it could be clicked to transport the reader directly to the wealth of information at ClinicalTrials.gov.

Clarifying the drug nomenclature, as shown in orange opposite, serves to avoid the confusing impression that three drugs are being referred to, when there are really only two, and which clarification immediately exposes the incongruity that Novartis is supplying only one drug for a study that requires two.

Helpful also would be identifying toward the very bottom of the box the two Research Studies reporting the results, and also linking them directly to the articles themselves, as is requested by OpenPayments.

These suggested improvements are so obviously helpful, and so easy to implement, that their absence invites the speculation that it is not clarity but confusion that the creators of this OpenPayments "Research Payment Details" box seek, and especially not the clarity that comes with accessing the ClinicalTrials.gov description of the trial.


THE "NOVARTIS-TASIGNA-STUDY" IS NOT A STUDY

The combo of a vast number of participants (852) scattered over a staggering number of Study Locations (221) is sufficient to justify the conclusion that the NOVARTIS-TASIGNA-STUDY is not scientific research but an infomercial, a condemnation whose justification has already been presented in several articles, among them THE 24-COUNTRY-EXPERIMENT and HOW MANY SUBJECTS PER GROUP?  This unambiguous indicator of scientific invalidity needs to be recognized for what it is, and the practice of offering infomercials in lieu of scientific research needs to be stopped.

Here is Dr Ben Goldacre's comment on the practice of using many study locations with few participants per location, which activity is sometimes called a "seeding trial":

Dr Ben Goldacre portrait

Sometimes, trials aren't really trials: they're viral marketing projects, designed to get as many doctors prescribing the new drug as possible, with tiny numbers of participants from large numbers of clinics.  [...]

The ADVANTAGE trial on Vioxx [...] set out to recruit over 5,000 patients, but their design specified that each doctor should only treat a handful of patients.  This meant that a vast number of participating doctors were required — six hundred by the end of the study.  But that was OK for Merck, because the intention of this study wasn't really to find out how good the drug was: it was to advertise Vioxx to as many doctors as possible, to get them familiar with prescribing it, and to get them talking about it to their friends and colleagues.  [...]

In 2008 [...] the ADVANTAGE trial was described to patients and doctors as a piece of research, in reality, reading the internal documents, it was intended as a marketing trial from the outset.  One internal memo, for example, [...] sets out how the trial was "designed and executed in the spirit of the Merck marketing principles".  Here these were, in order:  to target a select group of critical customers (family doctors); to use the trial to demonstrate the value of the drug to the doctors; to integrate the research and marketing teams; and to track the number of prescriptions for Vioxx written by doctors after the trial finished.  The data was handled entirely by Merck's marketing division, and the lead author on the academic paper reporting the trial later told the New York Times that he had no role in either collecting or analyzing the data.  [...]

But equally concerning is the quality of the data: doctors participating as "investigators" were poorly trained, with little or no experience of trials, and there was no auditing before the trial began.  Each doctor recruited only four patients on average, and they were closely supervised, not by academics, but by sales representatives, who were directly involved in collecting the data, filling out study forms, and even handing out gifts as promotional rewards during data collection.  [...]

Spotting seeding trials, even today, is fraught with worry.  Suspicions are high whenever a new trial is published, on a recently marketed drug, where the number of recruitment sites is suspiciously high, and only a small number of patients were recruited from each one.  This is not uncommon.

Ben Goldacre, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, Signal/McClelland & Stewart, 2013, pp. 213-216.

Reading the above calls to mind the possibility that in the NOVARTIS-TASIGNA-STUDY imbroglio, Dr Kalaycio may be more victim than villain, as by his discovering to his discomfort, perhaps even as early as 2007, that the work he was doing for Novartis was closely supervised by its sales representatives, or even that the sales representatives were directly involved in collecting data, or even that despite his being flattered with the title of "principal investigator" he was playing "no role in either collecting or analyzing the data", and from such an already-compromised beginning, soon finding himself swirling down into the Novartis whirlpool.


NOVARTIS IS AN UNTRUSTWORTHY COMPANY
and
TASIGNA IS AN UNTRUSTWORTHY DRUG


That Novartis is undeserving of trust has revealed itself in many places and at many times, as has been documented in   Novartis misconduct in seven countries.

And to the above can be added the following three items of particular relevance to TASIGNA:

Lancet logo

World Report
www.thelancet.com
Vol 383   21Jun2014   p 2111
Former Novartis employee arrested over valsartan data

Novartis is facing a new scandal after an ex-employee was arrested last week following allegations of scientific misconduct.   Justin McCurry reports from Tokyo.

[...]  Novartis Pharma is still reeling from allegations that it had not disclosed all of the possible side-effects of its leukaemia treatment nilotinib, marketed as Tasigna.  The company’s troubles deepened when a third-party commission it had set up found that employees might have broken Japan’s strict privacy laws by illegally acquiring information about patients involved in clinical trials for Tasigna.

Novartis Pharma KK was initially suspected of failing to report 33 cases of side-effects involving Tasigna, including ten that were deemed severe, to Japan’s health and welfare ministry following a clinical study led by Tokyo University, according to Kyodo news sources.  That revelation prompted an investigation into alleged violation of the pharmaceutical affairs law.  The firm has since acknowledged that at least 10 000 cases involving ten different medicines might have been involved in a safety cover-up dating as far back as 2002.

In April, Novartis Pharma KK responded to the Diovan and Tasigna revelations by replacing its president and two other senior executives.  It is also reviewing all doctor-led studies in which the firm has been involved in since 2011.  Several other employees implicated in professional misconduct have been sacked, while funding for collaborative research with universities and other research bodies has been suspended.  [...]


How atherosclerosis works

Law firm Elias, Gutzler, and Spicer LLC logo
Plailntiffs' Second Amended Complaint
16Mar2017     egslitigation.com


Lauris v Novartis Complaint heading

[...]  Decedent Dainis Lauris, a California resident, was prescribed and took Tasigna for over a year.  Upon taking Tasigna, Dainis Lauris developed several severe, accelerated, and irreversible atherosclerosis-related conditions, which caused, among other things, 100-percent narrowing of his femoral arteries, 40- to 60-percent narrowing of his coronary arteries, and 70-percent narrowing of his cerebral arteries.  At no time while he was prescribed and took Tasigna did Novartis warn Dainis Lauris or his prescribing doctors about the atherosclerosis-related risks Novartis knew were associated with Tasigna.  As a proximate result of Dainis Lauris’s atherosclerosis-related conditions and Novartis’s intentional failure to warn of them, Dainis Lauris died.  [...]


Tasigna Atherosclerosis Lawsuits logo
tasignalawsuit.com
Tasigna May Be One Of The Most Deadly Drugs On The Market Today

According to the National Institute of Health and Novartis may well have known about it years ago

Tuesday, September 25, 2018 — Studies reported to the National Institute of Health back in 2012 indicate that Tasigna (nilotinib) causes heart abnormalities to occur including the deadly and irreversible atherosclerosis in an extremely high percentage of patients taking the anti-cancer drug.  According to the NIH "new electrocardiographic abnormalities were recorded in 20% of all patients and some of them developed severe or even life-threatening coronary artery disease."  In addition, the report states that the independent cancer research organization, Leukemia, produced two papers that found a "prevalence" of peripheral artery occlusive disease (PAOD), and that Novartis contributed to writing the piece.  [...]

Novartis brought Tasigna to market to replace their other highly-successful and financially lucrative anti-cancer drug Gleevec that was soon to go off patent.  Sales growth of Gleevec had grown to close to $2 billion per year and Novartis was not about to let their hard-won business become cannibalized by generic competition.  Tasigna was marketed to specialty pharmacists to replace Gleevec using illegal marketing tactics that cost Novartis a one billion dollar department of justice fine.  The US Department of Justice stated, "Specialty pharmacists were paid under the table bribes to refill Gleevec prescriptions with Tasigna and to overlook the life-threatening adverse side effects of Tasigna" Novartis settled the claim for $390 million for their fraud and deception in withholding what they knew about the atherosclerosis side effects of Tasigna.  [...]



THE REDEMPTION OF DR KALAYCIO

What Dr Kalaycio needs to include in the disclosure statement that he begins handing out to all his patients is an acknowledgement of three facts, each accompanied by a nugget of memorable information, as for example

  1. that his relationship with drug companies is prolonged and profound, as exemplifed by, but not limited to, a total payment to him, covering all OpenPayments categories, of $3.5 million over 2013-2017,

    and

  2. that his chief donor, Novartis, blankets the globe with its wrongdoing, as for example its bribing of Greek politicians resulting in the "worst scandal since the creation of the modern Greek state almost 200 years ago",

    and

  3. what he really did with the $3.4 million worth of TASIGNA that was handed him during 2013-2017.



DR NOSEWORTHY, WILL SHEER CHUTZPAH WIN THE DAY?

You and Dr Kalaycio are faced with the same dilemma — the coming-to-light of drug-industry payments likely to elicit accusations of conflict of interest.

Dr Kalaycio, overcome with remorse, and panicking, responded with coverup, which left him worse off than before.

Your response, on the other hand, shows originality and flair.  Earn a little extra money after office hours? — Everybody's already doing it!  Anyway, the side effects will be entirely positive.  Medicine will improve.  Drug companies will learn about patient care.  Hospitals will get another lens into the highly complex health care marketplace.  What's not to like?  The old fuddy-duddies having nightmares over so-called "conflict-of-interest" were soiling their pants over nothing.  We've entered a new age, haven't we, in which we've left all that sort of paranoid clap-trap behind?  The answer to conflict-of-interest?  Well, since it's a good thing — flaunt it!

Minnesota Public Radio logo

Mayo Clinic CEO's Big Pharma gig:  4 questions

Catharine Richert portrait Catharine Richert Rochester MN  12Apr2017  mprnews.org   [Blue font marks Age-of-Aquarius solution to conflict-of-interest]

Dr Paul Rothman CEO Johns Hopkins Medicine and Dr John Noseworthy President and CEO Mayo Clinic have just met with Donald Trump
Johns Hopkins Medicine CEO Paul Rothman (left) with Mayo Clinic President and CEO John Noseworthy (right), have just met then-President-elect Donald Trump on Dec. 28, 2016, at Mar-a-Lago in Palm Beach, Fla.  Don Emmert | AFP/Getty Images file

Global pharmaceutical giant Merck this week nominated Mayo Clinic CEO Dr. John Noseworthy for election to its board.  While common, experts say these kinds of relationships raise conflict of interest concerns and must be carefully navigated.  [...]

1) How unusual it is for someone of Noseworthy's stature to serve on a pharmaceutical's board?

It's not that unusual.  Noseworthy will join high ranking medical professionals from Johns Hopkins, the Howard Hughes Medical Institute and Memorial Sloan-Kettering Cancer Center on the Merck board.

Research published in the Journal of the American Medical Association showed 41 board members of the 50 biggest drug companies held leadership positions in American medical colleges.

Supporters of these ties say bringing people who run world renowned medical centers like Mayo Clinic together with the pharmaceutical industry can improve medicine.  Drug companies, they say, can learn a lot about patient care from people like Noseworthy.

And it can go both ways.  In a statement, a Mayo spokesperson said that the appointment will give the hospital another lens into the "highly complex health care marketplace and to anticipate major trends in the pharmaceutical industry that may affect patients."

2) What's the concern then about a hospital CEO sitting on drug company board?

Anyone who sits on the board of a drug company has a fiduciary responsibility to that company — you work for shareholders.  For hospitals, where these drugs are administered and sometimes even tested in clinical trials, the relationship raises some important questions.

A hospital executive who sits on a drug company board could feel pressure to get his hospital to buy the drug company's products.

Hypothetically speaking, Noseworthy's presence on the board could potentially "give Merck a leg up" inside Mayo, said Dr. Eric Campbell, a Harvard Medical School professor who researches physician conflicts of interest.

"It could increase the likelihood that the patients who are seen there will get Merck drugs," he said.  "It could also create the impression that the Mayo Clinic is endorsing Merck."

These tricky relationships aren't limited to hospital executives who sit on the boards of drug companies, he added.  His research suggests that 85 percent of doctors have some form of a relationship with pharmaceutical companies.  [...]

His compensation for serving on the Merck board will include $110,000 in compensation and $170,000 in deferred stock per year.  Mayo said this is standard practice for Merck's board members and that it adheres to Mayo policies that allow employees to be paid for board work done on personal time.  [...]


Dr Noseworthy!

Your accepting a seat on the Merck Board of Directors could hurt the Mayo Clinic in several ways.

  • Patients will be scared away from being treated at Mayo upon having it disclosed to them that "President and CEO of the Mayo Clinic, Dr John Noseworthy, annually receives $110,000 in compensation and $170,000 in deferred stock for sitting on the Board of Directors of the same Merck corporation that has been estimated to have caused half a million American deaths with its aspirin-substitute drug Vioxx", and more especially when the Merck executives responsible for those deaths, rather than sitting in prison, may still hold positions of responsibility at Merck.

  • It is the higher-principled physicians who will avoid working at Mayo because they cannot abide an atmosphere which inhibits criticizing Merck products out of fear that such criticism will deprive the Mayo president of his Merck income.

  • The more that news of your Merck collaboration spreads, the greater will be the proportion of medical-school applicants who choose to study medicine for the pharma payments it promises to put into their pockets, and the smaller the proportion who choose medicine so that they can heal and cure.

  • Your demonstration of impunity for conflict-of-interest will encourage Mayo physicians to follow suit, thereby turning their own already-prevalent conflicts-of-interest into an epidemic, all the while weakening their recognition that the conflicts are unethical.

  • The more undisclosed conflicts-of-interest that are created, and the greater the patient empowerment to detect conflicts-of-interest, the more lawsuits Mayo can expect complaining of failure to disclose.

  • I foresee in Mayo's future an upsurge in the number of cases like that of Dr Matt Kalaycio described above in which years of undisclosed involvement with the drug industry are suddenly recognized as culpable, and followed by panic at the absence of exits.


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