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A VERY SPECIAL INTEREST HERE TO SEE YOU William James Mayo Dr Matt Kalaycio unable to dispute one of the payments in his KALAYCIO BOOM 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 4

DR NOSEWORTHY: PLEASE PERMIT DR BUADI
TO DESCRIBE HIS EXPERIMENT


by Semmel Weis
First published 08Dec2018   Last edited 21Dec2018  12:19am EST

ODOMZO advertisement holding out the hope of longer and happier life

In evaluating the quality of Mayo Clinic Rochester care, we have focussed primarily on Dr Francis Buadi because he was the only one of the five Mayo physicians we met who actually administered treatment, and because he stood out among the five also for receiving by far the largest OpenPayments from drug companies, and more particularly because all six of the drug companies that reported making those payments follow traditions of a scofflaw modus operandi, most notably the biggest-paying of the six, Novartis.

Until quite recently, however, the defense that Dr Buadi's drug-company receipts support research of which Dr Buadi is principal investigator seemed to justify only the feeble admonishment that his association with drug companies can be imagined to have weakened his impartiality, but falls short of proving wrongdoing.

However, Dr Matt Kalaycio's bringing to public attention in the Hematology News of 20Sep2018 the phenomenon tentatively labelled The Kalaycio Boom suggests the fresh approach of questioning the propriety, event the legality, of OpenPayments when they consist of shipments of drugs putatively for use in a clinical trial, but in a volume which exceeds what the dwindling number of patients in the trial need, even to the point of shipping millions of dollars worth of a drug putatively for use in a clinical trial which has lost all its patients, so that there is nobody left within that clinical trial to be treated by the shipped drug, as has been demonstrated and discussed in

Two Contrasting Attempts to Mitigate Conflict-of-Interest Embarrassment
and
Is the Kalaycio-Boom Ubiquitous?

The question raised in the above discussion remains unanswered to this day: If these millions of dollars of drug shipments are not being used for research as claimed, then what are they being used for?

In the case of Dr Buadi, OpenPayments reports Novartis making four "Associated Research" shipments of its drug ODOMZO, care of the Mayo Clinic Rochester, and valued as below:

23Mar2017      $ 305,153.33
11Jan2016 $   2,939,653.51
28Jan2015 $ 1,108,630.77
29May2014 $ 33,000.00
2013 $ 0.00

TOTAL $ 4,386,437.61

What can be seen in OpenPayments Research Payment Details for 2016 below is true as well for the other three years of the four Novartis payments — that Novartis Pharmaceuticals Corporation was shipping the drug ODOMZO for use by Principal Investigator Francis Buadi in his clinical trial titled

PHASE 2 TRIAL OF LDE225 AND LENALIDOMIDE MAINTENANCE POST
AUTOLOGOUS STEM CELL TRANSPLANT FOR MULTIPLE MYELOMA

NCT02086552-payment-details-01

NCT02086552-payment-details-02
NCT02086552-payment-details-03
NCT02086552-payment-details-04

Three of the defects that have been noted in previous inspections of OpenPayments "Research Payment Details" pages reappear above, namely that

  1. confusion is sown by a single drug being identified only as ODOMZO opposite "Product #1", and only as LDE225 opposite "Name of Research Study" (and in still other places inside ClinicalTrials.gov as Sonidegib) making it seem as if these are different drugs when in fact they are one and the same,

    and that

  2. "Links to Research Study" is followed by nothing more informative than "N/A", the absence of a written report making it impossible to detect violations of scientific method which could invalidate the research,

    and that

  3. "ClinicalTrials.gov ID:" is followed by nothing more helpful than "N/A", making it harder for the reader to find the information on the clinical trial in ClinicalTrial.gov.

Nevertheless, an easy path to ClinicalTrials.gov coverage of this Francis Buadi clinical trial was to pack the entire OpenPayments Name-of-Research-Study shown above into a Google search window (without quotation marks, and of course using CTRL+C to copy and CTRL+V to paste), and to click on the first Google hit of a ClinicalTrials.gov page, where it is likely to be discovered that, except for permitting lower-case charaters, the ClinicalTrials.gov Official-Title turns out to be identical to the OpenPayments Name-of-Research-Study already quoted above, and to see presented new information from which inferences can be drawn, as for example the following information and inferences which have immediate relevance:

Official Title:  Phase 2 Trial of LDE225 and Lenalidomide Maintenance Post Autologous Stem Cell Transplant for Multiple Myeloma

ClinicalTrial.gov ID:  NCT02086552

Actual Enrollment:  28
Actual Study Start Date:  17Jan2014  marked with orange  |  below
Actual Primary Completion Date:  15Jan2018  marked with blue  |  below
Months outside the NCT02086552 ODOMZO-treatment protocol marked with blue  .  below
Months inside the NCT02086552 ODOMZO-treatment protocol marked with orange  .  below
Dates of the four ODOMZO shipments marked with black  .  replace orange below

ODOMZO (= Sonidegib = LDE225) treatment protocol:  "Patients receive sonidegib [...] on days 1-28 [...].  Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.  clinicaltrials.gov/ct2/show/record/NCT02086552

The dotted time line below facilitates identification of possible discrepancies between the large volume of drug shipped for use in NCT02086552 and the small amount of the drug that would be needed to treat the few if any patients still enrolled in NCT02086552.

Investigator
Name
Investigator
Location
Recipient
Name
2013
............
2014
|...........
2015
............
2016
............
2017
............
2018
|...........
BUADI
Francis
Rochester MN Mayo Clinic
Rochester
0
$ 33,000
$ 1,108,630
$ 2,939,653
$ 305,153
Unavailable

As is evident from the treatment protocol above, the longest a participant can receive ODOMZO is 28 days per course times 18 courses equals 504 days, which falls just short of one year five months.

Several alternative scenarios, then, might have taken place:

  1. If all 28 participants started treatment on or about the "Actual Study Start Date" of 17Jan2014 then completing the longest permissible treatment duration of one-year-five-months would take them to Jun2015, so that their treatment protocol would not permit them to consume any ODOMZO from that largest-of-all $2,939,653 11Jan2016 ODOMZO shipment that we are questioning.

  2. However, if the researchers had no access to ODOMZO until the arrival of the first shipment of 29May2014, and it was on or about that date that they all began their treatment, then the longest they could have continued treatment would be until Oct2015, and so again they would have been entirely unavailable to consume any of that $2,939,653 11Jan2016 ODOMZO shipment.

  3. However, if upon the arrival of the first shipment of ODOMZO on 29May2014, the 28 participants had not all been recruited and ready to start treatment immediately or soon, but rather continued to trickle in over an interval of two more months, which is until Jul2014, then the latest any of them could have completed treatment would be Dec2015, and so again none of them would be consuming NCT02086552-protocol ODOMZO from that $2,939,653 11Jan2016 ODOMZO shipment.

  4. However, if for any reason some participants trickled in over a longer interval, say all the way to Dec2014, and even some continued to drift in through 2015, then there are several additional reasons why none might remain available to consume any of the NCT02086552-protocol ODOMZO shipment in 2016 — or at least very few: (a) the full-length ODOMZO treatment lasting one year five months would sometimes or often be terminated because of participants exhibiting "disease progression or unacceptable toxicity"; (b) some or many participants would die; (c) some or many participants would drop out of the study (would be "censored" is how the researchers would have described it).  The cumulative effect of these three eventualities, (a) to (c), might contribute to producing in Dr Buadi's clinical trial what is seen in clinical trials generally and which can be expressed in the rule-of-thumb that after one year of chemotherapy, it is not rare to find zero subjects remaining in a clinical study, and after two years, it is likely that zero subjects remain.  And thus it seems not unreasonable to question whether the shipment of $2,939,653-worth of ODOMZO in 2016 was really all being consumed by NCT02086552-protocol study participants, as OpenPayments suggests, or whether some — maybe even all — of the 2016 ODOMZO was being put to an as-yet-unexplained Kalaycio-Boom use.

The expectation that all or most participants may have disappeared by 2016 is encouraged by the very small number of participants who had enrolled in the first place — a mere 28.

Dr Noseworthy!  The Mayo Clinic encourages its patients to ask questions, and to keep asking until they feel satisfied that they have gotten answers.  Before you is an instance of a patient asking a question bearing on the conduct of a Mayo doctor.  The question is the use to which Dr Buadi put the 2016 and 2017 ODOMZO shipments represented as needed for his NCT02086552 clinical trial.  A member of Dr Francis Buadi's research staff may be able to fill in the numbers at the rate of one participant per minute if working from hard-copy data, and within a fraction of that time if the data have been digitized.  Of course no participant identification is required beyond the numbering 1 to 28.  Future patients might be interested in this data even if not being treated with ODOMZO, because the data may reflect on the integrity of all concerned parties — Novartis, the Mayo Clinic, and Dr Buadi.

Please ask Dr Buadi, or Novartis, or whoever has this information to disclose it.  It may show that suspicion had been unfounded, which you can be sure I will loudly proclaim, to the relief of Novartis and Dr Buadi and the Mayo Clinic.  And if it shows that suspicion is justified, it will point to improvements in integrity that need to be made, to the benefit of all concerned.

First— What is the cost of a daily dose of ODOMZO?  And did this cost remain constant over the interval 2014 to 2017?

Second — When is Dr Buadi expected to publish the results of his NCT02086552 Clinical Trial?

And finally, to permit patients to not just speculate, but to accurately determine, whether Dr Buadi is putting his ODOMZO shipments to their putative and legitimate research use, or to some hidden Kalaycio-Boom use — What are the dates that fit into the table below?

Participant ID Date first
ODOMZO dose
(yyyy/mm/dd)
Date last
ODOMZO dose
(yyyy/mm/dd)
Participant-01
Participant-02
Participant-03
Participant-04
Participant-05
Participant-06
Participant-07
Participant-08
Participant-09
Participant-10
Participant-11
Participant-12
Participant-13
Participant-14
Participant-15
Participant-16
Participant-17
Participant-18
Participant-19
Participant-20
Participant-21
Participant-22
Participant-23
Participant-24
Participant-25
Participant-26
Participant-27
Participant-28

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