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DR PAUL RICHARDSON:
DOES PSEUDO-DISCLOSURE LEAD TO MISINFORMED CONSENT?

by Semmel Weis
First published 11Jan2018     Last edited 11Sep2018  11:46pm



TWO SCIENTISTS DISCUSS ASCO?

The ASCO POST NEWSREELS video shows what viewers might well regard as two scientists, Drs Sagar Lonial and Paul Richardson, discussing the top presentations of the 2016 ASCO [American Society of Clinical Oncology] Annual Meeting:

Multiple Myeloma:
Expert Perspectives on Treatment Advances


2016 ASCO Annual Meeting

Sagar Lonial, MD, of Emory University School of Medicine, and Paul G. Richardson, MD, of the Dana-Farber Cancer Institute, discuss the top presentations on multiple myeloma delivered at this year’s meeting.     PLAY ASCO VIDEO

Dr Sagar Lonial and Dr Paul Richardson at ASCO 2016



"DISCLOSURES" IS DESIGNED TO NOT DISCLOSE

"DISCLOSURES" at the beginning of the video is unlikely to shake anybody's confidence in the integrity of its participants, mainly because it is presented for approximately one second such that nobody will be able to take it in.  If any drug-company name is noticed during that one second, it may be Onxy, because it appears on the upper-left where a reader would naturally begin to read, but Onxy isn't going to convey much, as it does not exist — it is possibly a misspelling of Onyx, just as Sqiubb is possibly a misspelling of Squibb.

In any case, being able to examine the ASCO diclosures for more than one second may not seem likely to trigger any eureka insights or ring any warning bells:

ASCO DISCLOSURES, FIRST VERSION

Conflict-of-Interest disclosures of Drs Lonial and Richardson at ASCO 2016



PHARMAS RE-ORDERED TO CORRESPOND

However, if the DISCLOSURES display is edited slightly, not only by correcting its spelling, but more importantly by ordering the Pharmas in each line so that they correspond, a revelation does emerge, which is that the affiliations of Lonial and Richardson are pretty much the same, which would become even more apparent if it were simultaneously disclosed that Millennium is the same as Millennium Takeda, and that Janssen is wholly owned by Johnson & Johnson, and that Onyx has a clinical-trial collaboration and supply agreement with Janssen:

ASCO DISCLOSURES, SECOND VERSION

Dr Lonial, Consultant to:
Bristol-Myers Squibb, Celgene, Novartis, Millennium           , Janssen               ,  Onyx

Dr Richardson,  Member of Advisory Committee for:
Bristol-Myers Squibb, Celgene, Novartis, Millennium Takeda, Johnson & Johnson

And so what might at first have appeared to be two independent scientists weighing evidence in a discussion now begins to look more like two scientists enjoying nearly-identical affiliations, and therefore more likely to find themselves agreeing than discussing.



PHYSICIAN INVOLVEMENT
IN DRUG-COMPANY PAYMENTS


Calculating each scientist's OpenPayments Total reveals that they "consult" and "advise" not for nothing:

Dr SAGAR LONIAL of the Emory University School of Medicine
Dr SAGAR LONIAL
Winship Cancer Institute of Emory University, Atlanta GA
Dr PAUL G RICHARDSON of the Dana-Farber Cancer Institute
Dr PAUL RICHARDSON
Dana-Farber Cancer Institute, Boston MA
2016
General Payments        $35,309
Research Payments        $2,757
Associated Research   $873,616
2016
General Payments           $86,361
Research Payments         $16,383
Associated Research   $4,718,058
2015
General Payments        $37,140
Research Payments        $6,216
Associated Research   $923,287
2015
General Payments           $59,331
Research Payments         $16,478
Associated Research   $4,434,189
2014
General Payments        $34,003
Research Payments        $9,139
Associated Research   $595,628
2014
General Payments          $98,483
Research Payments          $7,057
Associated Research   $6,612,461
2013 (Aug-Dec)
General Payments        $25,003
Research Payments        $4,577
Associated Research   $222,993
2013 (Aug-Dec)
General Payments           $13,235
Research Payments           $7,538
Associated Research   $3,578,222
Dr Sagar Lonial has involved himself
in drug-company payments
during Aug2013-Dec2016 totalling

$2,769,668
as downloaded Feb2018 from
openpaymentsdata.cms.gov
Dr Paul Richardson has involved himself
in drug-company payments
during Aug2013-Dec2016 totalling

$19,647,796
as downloaded Feb2018 from
openpaymentsdata.cms.gov
CAUTION!

"The transparency display of transactions from applicable manufacturers and group purchasing organizations to physicians and teaching hospitals does not necessarily mean any of the reported financial relationships are improper."  openpaymentsdata.cms.gov

"Sharing information about financial relationships alone is not enough to decide whether they’re beneficial or improper.  Just because there are financial ties doesn’t mean that anyone is doing anything wrong."  cms.gov/OpenPayments

"If you are a physician who served as a principal investigator on a research study, you may see the payments associated with that research study listed under your name.  This does not necessarily mean the payments are attributed to you."  FAQ #12224  cms.gov/OpenPayments

Incorporating the OpenPayments information above produces a further-upgraded DISCLOSURES statement suggesting that what at first might have been taken to be two independent scientists searching for truth, begins to look more like two drug-company representatives promoting the same drugs:

ASCO DISCLOSURES, THIRD VERSION

Dr Lonial, working as "Consultant" Aug2013-Dec2016,
involved himself in payments totalling  $2.8 million  made by

Bristol-Myers Squibb, Celgene, Novartis, Millennium           , Janssen               , Onyx

Dr Richardson, working as "Member of Advisory Committee" Aug2013-Dec2016,
involved himself in payments totalling  $19.6 million  made by

Bristol-Myers Squibb, Celgene, Novartis, Millennium Takeda, Johnson & Johnson




HOSPITAL INVOLVEMENT
IN DRUG-COMPANY PAYMENTS


And drug companies make payments not only to doctors, but to the hospitals they work in as well, and whose OpenPayments data adds to the picture that is beginning to emerge:

LOGO of the Emory University Hospital LOGO of the Dana-Farber/Brigham Women's Cancer Center

EMORY UNIVERSITY HOSPITAL
1364 Clifton Road
Atlanta GA 30302
DANA-FARBER CANCER INSTITUTE
450 Brookline Ave
Boston MA 02215
2016
General Payments       $3,921,980
Research Payments   $20,215,692
2016
General Payments       $3,727,295
Research Payments   $49,153,159
2015
General Payments       $4,077,086
Research Payments   $19,919,025
2015
General Payments       $3,549,399
Research Payments    $34,714,274
2014
General Payments       $2,772,598
Research Payments   $25,029,453
2014
General Payments       $4,936,882
Research Payments   $43,373,464
2013 (Aug-Dec)
General Payments       $1,270,471
Research Payments   $12,726,998
2013 (Aug-Dec)
General Payments       $1,148,818
Research Payments   $14,262,452
Emory University Hospital has involved itself
in drug-company payments
during Aug2013-Dec2016 totalling

$89,933,303
openpaymentsdata.cms.gov
Dana-Farber Cancer Institute has involved itself
in drug-company payments
during Aug2013-Dec2016 totalling

$154,865,743
openpaymentsdata.cms.gov
CAUTION!

"The transparency display of transactions from applicable manufacturers and group purchasing organizations to physicians and teaching hospitals does not necessarily mean any of the reported financial relationships are improper."  openpaymentsdata.cms.gov

"Sharing information about financial relationships alone is not enough to decide whether they’re beneficial or improper.  Just because there are financial ties doesn’t mean that anyone is doing anything wrong."  cms.gov/OpenPayments

"If you are a physician who served as a principal investigator on a research study, you may see the payments associated with that research study listed under your name.  This does not necessarily mean the payments are attributed to you."  FAQ #12224  cms.gov/OpenPayments

The ASCO DISCLOSURES, FOURTH VERSION below now adds the insight that Drs Lonial and Richardson not only may be inhibited to speak critically of drug-compan products by the large drug-company payments they have involved themselves in (and which involvement they may fear losing), but may be inhibited also by the large drug-company payments that their hospitals have involved themselves in (and which involvement the hospitals may fear losing).  The drug-company payments involving doctors and hospitals are so large as to more strongly invigorate the hypothesis that the ASCO video shows not at all a discussion between two scientists, but only a drug-company-scripted promo recited by two salesmen.

ASCO DISCLOSURES, FOURTH VERSION

Dr Lonial, working as "Consultant", Aug2013-Dec2016
involved himself in payments totalling  $2.8 million  made by

Bristol-Myers Squibb, Celgene, Novartis, Millennium           , Janssen               , Onyx
and whose Emory University Hospital involved itself in payments totalling  $89.9 million
from drug companies over the same interval


Dr Richardson, Member of Advisory Committee, Aug2013-Dec2016
involved himself in payments totalling  $19.6 million  made by

Bristol-Myers Squibb, Celgene, Novartis, Millennium Takeda, Johnson & Johnson
and whose Dana-Farber Cancer Institute involved itself in payments totalling  $154.9 million
from drug companies over the same interval





OBLIGATION TO INFORM

Dr Richardson, I submit for your consideration the proposal that you have an obligation to inform not only the patients you treat, and not only the subjects you run in clinical trials, but also general audiences who watch your presentations — an obligation to inform all these that over the most recently-documented three-year-five-month interval, you have involved yourself in drug-company payments totalling $19.6 million, and the Dana-Farber Cancer Institute that you are affiliated with has involved itself in drug-company payments totalling $154.9 million.

I propose that the criterion triggering this obligation to disclose is the possibility that the information might affect the patient's or the subject's willingness to participate, or might affect a general audience's willingness to themselves rely on the promoted drugs should fate ever cast them in the role of patient or subject.

If your opinion is that you are free of any obligation to disclose OpenPayments data, then I further propose that you are still bound by an obligation to disclose your refusal to disclose your involvement — obligated to declare, essentially, that drug company payments passing through your hands are nobody else's business.  And you would in this case be obligated to give your patients or subjects time to consider the implications of what you have just said before they decide whether they will allow you to treat them or experiment on them.

I wonder, finally, whether you would care to comment on the possibility that your patients and subjects may feel aggrieved to discover that they placed themselves under your care when the conflict-of-interest disclosure that you had given them was a pseudo-disclosure, and with the result that the consent your patients and subjects gave you was a misinformed consent?

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