Thought I had stopped thinking about that trial in Texas? Not hardly. These are the transcripts [including the video depositions]. Obviously, they don’t contain the exhibits, but most of the important parts of the email chains, the call-notes, the memos, etc. were read into the record. It’s an enormous amount of material and it reads like transcripts read – slowly. But you might want to look over Mr. Melsheimer’s Opening Statement, Allen Jones’ testimony, and the deposition of Dr. Steven Shon. At some later point, I’ll try to synopsize the essential pieces, but for the moment, this simple index was quite enough for my afternoon.
The point of this trial was to get an accurate picture of how extensively J&J [Janssen] disregarded the FDA, the State governments, and any minimal version of medical ethics in the service of an extensive marketing program with Risperdal. It’s a dark picture that needs the light of day. And financial penalties alone are not the solution. Hopefully studying what happened here will point us along the way to a saner, safer, and more ethical future.
| STATE OF TEXAS and ALLEN JONES v. JANSSEN et al |
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| DATE | WITNESS | DESCRIPTION | |
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| State v. Janssen Vol 1 | |||
| State v. Janssen Vol 2 | |||
| 01/10/2012 | Cynthia O’Keeffe | The Opening Statement for the State of Texas Civil Medicaid Fraud Division. |
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| 01/10/2012 | Tom Melsheimer | The Opening Statement given by by Whistleblower Allen Jones’ Lawyer. |
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| 01/10/2012 | Steve McConnico | The Opening Statrment for the defendents – Janssen Pharmaceutica et al. |
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| 01/10/2012 | Thomas Anderson | Mr. Anderson was a Product Manager at Janssen during the time Risperdal was "launched" in 1993. |
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| 01/10/2012 | Margaret Hunt | Ms. Hunt is a fraud investigator for the Civil Medicaid Fraud Division of the Texas Attorney General’s Office. | |
| State v. Janssen Vol 3 | |||
| 01/11/2012 | Alexander Miller | Dr. Miller is in the Department of Psychiatry at the San Antonio Texas Health Science Center – a member of the TMAP team. | |
| 01/11/2012 | Steven Shon | Dr. Shon was Medical Director of the Texas Department of Mental Health Mental Retardation – an integral part of TMAP. | |
| 01/11/2012 | Gary Leech | A Janssen employee who was the medical science liaison for Texas, Oklahoma, Arkansas, Louisiana, and New Mexico[95 – 03]. |
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| 01/11/2012 | James Van Norman | Dr. Van Norman is a public psychiatrist currently with Austin Travis County Integral Care, a community mental health center. | |
| State v. Janssen Vol 4 | |||
| 01/12/2012 | Nancy Bursch-Smith | Janssen employee from the Department of Reimbursement Management. |
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| 01/12/2012 | Bill Struyk | Former Janssen employee from the Department of Reimbursement Management [1996-1997]. | |
| 01/12/2012 | Allen Jones | Pennsylvania Investigator who blew the whistle on TMAP and filed this suit. |
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| 01/12/2012 | Laurie Snyder | Janssen employee in the Department of Public Health Systems & Reimbursement management. | |
| 01/12/2012 | Susan Stone | Dr. Stone worked at the TDMHMR at the time the Texas Medication Algorithm Project [TMAP] was started. |
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| 01/12/2012 | Steven Schroeder | He is the president of the Robert Wood Johnson Foundation and CEO of the Robert Wood Johnson Foundation. |
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| 01/12/2012 | Percy Coard | Janssen employee who was a District Manager for hospital sales and later a Public Health Systems & Reimbursement manager. | |
| State v. Janssen Vol 5 | |||
| 01/13/2012 | Arnold Friede | An expert witness from New York testifying for the plaintiff, specializing in FDA Law. |
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| State v. Janssen Vol 6 | |||
| 01/17/2012 | Tiffany Moake | Ms. Moake was a Sales Rep for Janssen from 2002-2004 in the San Antionio area. |
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| 01/17/2012 | Shane Scott | Mr. Scott was a Janssen employee and was Ms. Moake’s District Sales Manager. |
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| 01/17/2012 | Bruce Perry | Dr. Perry was an expert witness for the Plaintiffs – a Child Psychiatrist with Baylor Medical School. | |
| 01/17/2012 | Tone Jones | Mr. Jones was Janssen’s District Sales Manager for the Houston area. |
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| State v. Janssen Vol 7 | |||
| 01/18/2012 | Tone Jones | [continued] | |
| 01/18/2012 | Billy Milwee | Dr. Milwee is in charge of the Texas Medicaid Formulary Program. |
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| 01/18/2012 | Valerie Robinson | Dr. Robinson worked as a Child Psychiatrist in Fort Worth TX, working with Foster Children. |
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| 01/18/2012 | Sharon Dott | Dr. Dott is a psychiatrist in the Galveston area working in public facilities. |
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| 01/18/2012 | Scott Reines | Dr. Reines is an MD/PhD Janssen scientist who was in charge of Clinical Trials and FDA submissions. |
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| 01/18/2012 | Joseph Glennmullen | Dr. Glenmullen was an expert witness for the plaintiff – on the faculty of Harvard University. |
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FANTASTIC thank you!
this article seems related to the pharmaceutical situation in psychiatry
The idolatry of the surrogate
BMJ 2011; 343 doi: 10.1136/bmj.d7995 (Published 28 December 2011)
Cite this as: BMJ 2011;343:d7995
OPEN ACCESS: All research articles are freely available online, with no word limit. Find out more about the BMJ’s open access policy. Submit your paper.
Analysis
The idolatry of the surrogate
BMJ 2011; 343 doi: 10.1136/bmj.d7995 (Published 28 December 2011)
Cite this as: BMJ 2011;343:d7995
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John S Yudkin, emeritus professor of medicine1,
Kasia J Lipska, Robert Wood Johnson clinical scholar2,
Victor M Montori, professor3
Author Affiliations
Correspondence to: J S Yudkin, London N7 0AG, UK j.yudkin@ucl.ac.uk
Easier to measure surrogate outcomes are often used instead of patient important outcomes such as death, quality of life, or functional capacity when assessing treatments. John Yudkin, Kasia Lipska, and Victor Montori argue that our obsession with surrogates is damaging patient care ”
Much of the evidence for clinical interventions is based on their effect on surrogate outcomes rather than those that matter to patients such as quality of life or avoidance of vision loss or renal failure. Moreover, because these “hard†end points generally show much smaller responses to interventions than surrogate markers, many of the widely accepted strategies for diabetes may be based on artificially inflated expectations.
Hours of fun!
This caught my attention (from the testimony of Allen Jones):
Q.“…who did Janssen state they were going to send the check to the attention of?
A. To the attention of Steve Fiorello.
Q. Okay. And what did Janssen state was the reason for supporting this program?
A. Pennsylvania Office of Mental Health to meet with TIMA group, specifically Dr. Trivedi to assist on implementation of algorithm.
Q. And what did Janssen state was the deliverable?
A. Successful implementation of PennMAP…â€
This is one load of work… thank you, Mickey.
@ Jamzo:
Thank you for bringing attention to the use of surrogate outcomes as failing patients relative to quality of life, adaptation to health insults and function. In professional nursing (not that it still exists), those are/were precisely the areas of interest that nurses attended to – or were supposed to attend to.
If one reads the nursing research literature, the outcomes primarily be concerned with patient perceptions of self-mastery, global function and optimal adaptation.
My understanding is that medicine primarily concerned itself with the mitigation and cure of disease states. Perhaps this is why it is easier to fall into the trap of using intermediate goals as endpoints in this profession’s research. And of course, aided, abetted and encouraged by pharma/device makers – the stakeholders with the most to gain from doing so.
Dr. Nardo, thanks for providing all of these documents. Please consider teaming up with the likes of Dr. Carroll and Dr. Balt, not to mention Dr. Lindeman, to serve as the catalyst for a 21st C Flexner Report.
I wonder if Donald Berwick might not be a critical supporter. The IHI should be interested in this as it addresses patient safety and patient outcomes as a primary organizational area of concern.
Thanks so much for making all this info available in one place.