Posted on Wednesday 15 June 2011

The whistle-blower suit filed against Johnson & Johnson by Allen Jones and the State of Texas was recently postponed until November, but some of the information from the case is publicly available at the Travis County, Texas courthouse. This post is from a Report I obtained through a contact in Austin who went to the courthouse and simply requested a photocopy. It’s an expert opinion filed by the plaintiffs but included in a later filing by the defense.

The Texas Medication Algorithm Project has been the subject of many of my recent posts [links below for background]. It essentially prescribed that psychiatrists in the public sector in Texas treat schizophrenia using the then new Atypical Antipsychotics rather than the older drugs – a move that cost the State of Texas megabucks. The project was ultimately incorporated by about 30% of our other States. When Allen Jones, a Pennsylvania OIG investigator, discovered that Johnson & Johnson was funding the spread of this program by Texas officials, Jones was waved off the case and later fired. His whistle-blower suit was filed in Texas in 2004 and joined by the State of Texas in 2006.

This report addresses many  things, but I want to highlight the Tri-University Guidelines published in supplements in the Journal of Clinical Psychiatry in 1996 and updated in 1999. These Guidelines were used to create the TMAP Algorithms. The Guidelines were funded by a grant from Johnson & Johnson and not publicly connected to the Texas project. These Guidelines were step one in the process. Here’s what the expert who had access to the primary discovery documents had to say about the Tri-University Guidelines [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."
So these guidelines were constructed not as an academic exercise, they were a part of J&J’s marketing plan for their then new Atypical Antipsychotic, Risperdal, aimed at a "target audience."
    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 "target audience" was Texas and the TMAP project, headed by Dr. A.J. Rush. That’s just the beginning of the revelations in this Report. J&J appears to have been in the driver’s seat of TMAP and the efforts to sell the program to other States – an effort that involved Texas State officials and UT Medical School faculty. And the Report doesn’t stop there. The Report goes on to suggest multiple cases of ghost-written articles – academic misbehavior beyond any nailed down so solidly before. This looks like it was a massive stealth campaign to sell Risperdal to the public mental health market. I’ll try to summarize the various points in later posts, but I’d suggest saving the report to your own computer, printing it out, and digesting it yourself. It’s a lot to digest.

Many of us have spent a lot of time and energy trying to hone in on the depth of the Pharmaceutical Industry’s penetration into academic psychiatry. One would think it would be confirming to read a Report like this  – one that actually seems to document our worst suspicions. Guidelines for treatment written by prominent academics being willingly co-opted by the marketing needs of a drug company; State officials involved in the State formulary medication choices profiting from their drug company affiliations; State and University officials actually marketing their tainted  program to other States on a pharmaceutical company’s nickle; articles being professionally written and "guest authored" by academics chosen after they were written – flooding our journals. But it was still deeply disturbing for me to read this Report, even though I’d suspected many of the revelations for a while.

This looks to have been a concerted effort by Johnson & Johnson to assure that their Atypical Antipsychotic would be the first-line drug in the treatment of schizophrenia in the public sector where most of the afflicted wind up being treated. The scientific evidence did not support that designation, so it appears they made it happen by methods I thought I would never see operating in the world of medicine. Judge Couch used the word "detestable" in his South Carolina decision against J&J. It was a good choice of words. I hope that all of the primary information that informs this Report sees the light of day. This should never have happened in the first place, but now the imperative is to be sure it never happens again.

I apologize for the poor quality of the PDFs. I’m afraid that home-made rural Georgia pdfs aren’t as good as our biscuits:
Previous TMAP Posts on 1boringoldman:
    June 15, 2011 | 11:45 AM

    TMAP was a model of pharmaceutical corporate corruption which continues to be honed, refined, and used repeatedly today (aka DSM-5, Bio-markers, preemptive asymptomatic intervention Blah Blah Blah).

    Unfortunately we can’t put this Nasty Genie back in the bottle…

    Thank you for this great series of informative post…

    June 15, 2011 | 2:45 PM

    Like you, even after following your research and revelations on this, the boldness and blatantness of this is appalling.

    Thanks for keeping on this. I wouldn’t have known about it otherwise/

    Nancy Wilson
    June 15, 2011 | 10:47 PM

    I last saw John Rush at UT Southwestern in December 2009. He was standing alone outside the auditorium, where he was scheduled to talk about his experiences in Singapore. As I walked by, I thought, if I can make eye contact with him, I will stop and tell him about the negative impact he had on my life. As soon as I caught his eye, though, he dropped his head and looked at the floor. I got the impression he was sorry for what he had done. Now I know better.

    What baffles me is that Rush and his colleagues are still employed in academic settings.

    June 16, 2011 | 3:35 AM

    Great coverage. Keep on keeping on brother.

    June 16, 2011 | 1:42 PM

    EKS expert knowledge systems guidelines online at

Sorry, the comment form is closed at this time.