"From the start, the [Tri-University
Schizophrenia Practice Guidelines] project subverted scientific
integrity, appearing to be a purely scientific venture when it was
at its core, a marketing venture for Risperdal."
The case filed against Johnson & Johnson by Allen
Jones and the State of Texas was recently postponed until November. But
some of the documents from the case are now publicly available at the
Travis County, Texas courthouse.
The confidential Expert Witness Report by Dr. David
Rothman of Columbia University (March 22, 2011), is the most damning
document that we've seen in which not only is J & J's "detestable"
conduct--as described by Judge Couch who presided over the court
decision against J & J in South Carolina--laid bare, but Rothman's
report also describes the shameless active collaboration by prominent
academic psychiatrists--including the Chairman of the DSM-IV.
The prominent academic psychiatrists who were paid by Johnson & Johnson
to formulate the Tri-University Guidelines are: Dr. Allen Frances,
Chairman of the Dept. of Psychiatry, Duke University; Dr. John P.
Docherty, Professor and Vice Chairman of Psychiatry, Cornell
University; and David A Kahn, Associate Clinical Professor of
Psychiatry, Columbia University; who took the lead in designing and
developing the Tri-University Guidelines as a marketing strategy
designed to elevate their then new so-called, Atypical Antipsychotic,
Risperdal, to first-line treatment.
The report describes how these prominent
psychiatrists developed commercially driven prescribing algorithms that
they helped masquerade as legitimate, science-based medication
prescribing guidelines.
"Not only were Frances, Docherty, and Kahn ready to violate
standards of conflicts of interest in mixing guideline preparation
with marketing for J&J, but also in publicizing the guidelines in
coordination with J&J. The three men established Expert Knowledge
Systems [EKS]. The purpose of this organization was to use J&J money
to market the guidelines and bring financial benefits to Frances,
Docherty, and Kahn.
Dr. Rothman's report states that the 1995 Tri-University
Schizophrenia Practice Guidelines was the first of subsequent
psychotropic drug prescribing guidelines formulated by prominent
academic psychiatrists at the behest of Johnson & Johnson. The best
known of these Guidelines was the Texas Medication Algorithm Project (TMAP),
which adopted the Tri-University Guidelines en masse.
Excerpt describing the inception of the Tri-University Guidelines,
page 14: [link]
"As one of its first activities, and in disregard of professional
medical ethics of principles of conflict of interest, in 1995 J&J
funded a project led by three psychiatrists at three medical centers
[Duke, Cornell, and Columbia] to formulate Schizophrenia Practice
Guidlines. From the start, the project subverted scientific
integrity, appearing to be a purely scientific venture when it was
at its core, a marketing venture for Risperdal. In fact, the
guidelines produced by this project would become the basis for the
TMAP algorithms, giving a market edge to the J&J products in Texas.
Three psychiatrists, Dr. Allen Frances, Chairman of the
Department of Psychiatry, Duke University, Dr. John P. Docherty,
Professor and Vice Chairman of Psychiatry, Cornell University and
David A Kahn, Associate Clinical Professor of Psychiatry, Columbia
University, took the lead in designing and developing the
Tri-University Guidelines. The project would employ three
questionnaires to establish the guidelines: one went to academic
experts, one to clinicians, and one to policy experts. Including the
third group was in all likelihood J&J’s idea as witness to the fact
that Frances wrote J&J: "This is new to us and requires additional
discussion. The panel members would include mental health
commissioners, community mental health directors, NAMI
representatives, experts in pharmacoeconomics, and so forth."
These were precisely the constituencies that J&J was eager to
influence. J&J was the exclusive supporter of the project, dividing
an "unrestricted" grant of $450,000 among the three schools. It
further agreed to a $65,000 bonus incentive payment if the team was
timely with its product. The team met the requirement, requested the
additional payment, and received it.
The guideline team promised wide distribution of its product,
including publication in a journal supplement. The team was prepared
to have J&J participate in its work, not keeping the company even at
arms length. With a disregard for conflict of interest and
scientific integrity, the group shared its drafts with J&J. On June
21, 1996, Frances wrote Lloyd: "We are moving into the back stretch
and thought you would be interested in seeing the latest draft of
the guideline project… Please make comments and suggestions." So
too, the group was eager to cooperate with J&J in marketing
activities. Frances wrote without embarrassment or equivocation: "We
also need to get more specific on the size and composition of the
target audience and how to integrate the publication and conferences
with other marketing efforts."
Indeed from the start J&J had made it apparent to the team that
this was a marketing venture. In a letter to Frances, Lloyd set
forth what he called an "aggressive time line" for the project, and
added: "There are a number of other Treatment and Practice
Guidelines for schizophrenia being developed or published during
this same period that may well serve our marketing and
implementation needs at a substantial lesser cost."
"Not only were Frances, Docherty, and Kahn ready to violate
standards of conflicts of interest in mixing guideline preparation
with marketing for J&J, but also in publicizing the guidelines in
coordination with J&J. The three men established Expert Knowledge
Systems [EKS]. The purpose of this organization was to use J&J money
to market the guidelines and bring financial benefits to Frances,
Docherty, and Kahn.
EKS wrote to Janssen on July 3, 1996 that it was pleased to
respond to its request to "develop an information solution that will
facilitate implementation of expert guidelines." It assured the
company: "We are also committed to helping Janssen succeed in its
effort to increase its market share and visibility in the payor,
provider, and consumer communities." Now that the "first phase" was
completed, with guidelines created, "EKS is now ready to move
forward in a strategic partnership with Janssen." The strategy will
allow Janssen to influence state governments and providers… Build
brand loyalty and commitment with large groups of key providers
around the country."
EKS also promised "rapid implementation," with particular
attention to having an impact on Texas decision making. "It is our
intent to work with the State of Texas immediately in implementing
this product in a select number of CMHC’s with the assistance of A.
John Rush, MD." Again, EKS emphasized: "It is essential for Janssen
to distinguish Risperidone from other competitors in a timely and
creditable way." In its Summary of the document, EKS wrote: "Your
investment in the development of state of the art practice
guidelines for schizophrenia is already beginning to pay off in
terms of positive exposure in the Texas implementation project."
The costs for these various activities included: $250,000 for
"educational conferences;" and dissemination of publication at
$177,659. J&J agreed to them. So all told, J&J paid at least
$942,659 on the production and marketing of the Tri-University
guidelines.
The report is posted at: http://boringoldman.com:
pp.1-20; pp.
21-42; pp.43-65
; pp.
66-86
Vera Hassner Sharav |