read the whole script…

Posted on Friday 4 November 2011


The Texas Medication Algorithm Project:
Development and Implementation of the Schizophrenia Algorithm

[full text on-line]
by John A. Chiles, M.D., Alexander L. Miller, M.D., M. Lynn Crismon, Pharm.D., A. John Rush, M.D., Amy S. Krasnoff, M.A. and Steven S. Shon, M.D.
Psychiatric Services 1999 50:69-74.

The Texas Medication Algorithm Project is a program designed to improve the quality of care of persons with serious mental disorders across sites in the Texas public mental health system and to create a uniform clinical environment from which cost estimates can be made. This paper describes the process of developing a pharmacological treatment algorithm for schizophrenia that addresses use of antipsychotics as well as other medications for side effects and co-existing symptoms. Input from clinicians, consultants, and consumers informed development of the algorithm, which was based on existing expert consensus guidelines. Information about the project can be found on the Internet at www.mhmr.state.tx.us/meds/tmap.htm. The authors present and describe the original and current versions of the algorithm, outline the feedback process by which it will be refined, and discuss how new medications will be incorporated as they enter the market.

When the Texas Medication Algorithm Project was introduced in 1996, I doubt that many people outside of the Texas public mental health system thought much about it. Here’s how it was described in the above article published three years later:
    In brief, TMAP is a public-academic collaborative endeavor to develop, implement, and evaluate medication treatment algorithms for public-sector patients in three diagnostic groups—those with schizophrenia, major depression [including psychotic depression], and bipolar disorder. The institutions involved are the Texas Department of Mental Health and Mental Retardation; the departments of psychiatry at Texas Southwestern Medical College, the University of Texas Health Science Center at San Antonio, and the University of Texas Medical Branch in Galveston; and the College of Pharmacy at the University of Texas at Austin. The schizophrenia algorithm was initially implemented at five sites within the Texas public mental health system
Had I run across the article [unlikely, considering where it was published], I probably would’ve skipped it. I knew the term algorithm from my programming days [a procedure for solving a mathematical problem in a finite number of steps that frequently involves repetition of an operation; a step-by-step procedure for solving a problem or accomplishing some end especially by a computer]. I even knew it was named after an ancient Arabic mathematician. Had I thought about it, I might have seen it as an odd word usage, because algorithms are ways to solve problems. This wasn’t a solution. It was more like recommended guidelines than a solution, but I doubt that I would have even had that thought without being prodded. Had I read the article, curious about where the guidelines/algorithms came from, I’d have found this:
    Most of these facts are implicitly incorporated into the tri-university group’s expert consensus guideline on schizophrenia, which is based on a survey of experts in the treatment of schizophrenia. This work was fundamental to our project and was presented at the initial TMAP meeting for the schizophrenia algorithm in September 1996. Participants—clinicians, consultants, and consumers—spent a full day discussing, digesting, and prioritizing the information on which the algorithm would be built…
Followed by a long discussion of the process they went through to arrive at their own algorithm. The "tri-university group’s expert consensus guideline on schizophrenia" they started with had been published in 1996 [and updated in 1999] in Journal of Clinical Psychiatry Supplements, a compilation of experts responding to a questionnaire collated by representatives from Duke, Columbia, and Cornell. Here are the first steps of the Texas Algorithms as they evolved over seven years as more of the atypical antipsychotics were approved by the FDA [NGA = new generation antipsychotic]:
1996 and even 1999 were more innocent times, or so they seemed. Nowadays, I would look at this through a different pair of glasses. I’d pay attention to the acknowledgements and wonder about the industry funding, and about the Robert Wood Johnson Foundation. I’d probably run down the tri-university guidelines and find out who financed that effort. It would likely register that the conventional antipsychotics were quickly dropped, and that expensive new atypicals were added as soon as they came out. Surely I would notice that guidelines in public systems are usually designed to minimize costs, and these did the opposite – insisted that the most expensive in-patent drugs be used. I might even look up the Texas public medicine population and realize that it is huge. But back then it wouldn’t have occurred to me to do those things that now come immediately to mind. Like I said, it seemed a more innocent time – but that was an illusion.
Now, fifteen years after TMAP was launched, all those things that got overlooked and more are about to become exhibits in a courtroom in Austin Texas later this month when whistle-blower Allen Jones and the State of Texas take Johnson & Johnson and subsidiaries to court alleging that TMAP was part of a fraudulent marketing scheme that ultimately spread to a third of our States and to the Federal government. This is what I wrote about the story when it was scheduled for trial in June [coming this month: TMAP finally goes on trial…] before being postponed.

The volumes of treachery and intrigue in the psychopharmaceutical industry of our time might rival the shelf space of Zane Grey’s stories of the old west, and the Texas Medication Algorithm Project tale stands above all the others – a truly Texas-sized story. Risperdal [Risperodone] is an antipsychotic drug introduced as a step forward in the treatment of Schizophrenia – a limited market of patients primarily treated in the public sector. When introduced in 1993, there were hopes that it would be more efficacious and less toxic than the first generation antipsychotics of the previous forty years. TMAP was a joint venture among academia, industry, and the State of Texas to select by expert opinion the medications used in its vast public system [prisons, clinics, Medicaid, etc.]. Starting with Consensus Guidelines prepared from afar, the TMAP group arrived at its own algorithms, then repeatedly revised them as new drugs became available [above]. TMAP went on the road, sending emissaries to other States and abroad – ultimately engaging multiple other States to set up similar programs. An enthusiastic Texas Governor Bush took the program to Washington when he was elected President in 2000.

When Allen Jones in the Pennsylvania Office of the Inspector General found improprieties in travel vouchers connected to Pennsylvania’s dealings with TMAP and began to look around, his superiors tried to wave him off the case. When he persisted, he found himself on the sidewalk with the contents of his desk in a cardboard box, out of a job. On the long road to Austin, he won his suit against his former employers and the offending official ended up a convicted felon. Tracing the improprieties back to Texas and TMAP, he filed a whistle-blower suit against Johnson & Johnson in 2004 in Texas, later joined by the State of Texas in 2006. From what is available publicly, it appears that J&J had its fingers in and financed every piece of this story – those Guidelines from afar, the Texas Medication Algorithm Project experts, the wandering Texas emissaries, the traveling Pennsylvanians, etc. What makes this story stand out from all the other pharmaceutical misadventures is that it involved charity patients treated in a public system paid for by Medicaid funds using the most expensive possible medications with no scientific verification that they were more effective [and came close to bankrupting the taxpayer financed Texas Medicaid system].

The TMAP story isn’t the only volume on the shelf involving Johnson & Johnson’s stealth contracts with academic medicine. Recall the children’s story of Harvard’s Dr. Joseph Biederman and Mass General’s J&J Center for Pediatric Psychopathology [bipolar kids: harvard for sale…].
Research Center Tied to Drug Company
New York Times

By GARDINER HARRIS
November 24, 2008

When a Congressional investigation revealed in June that Dr. Joseph Biederman, a world-renowned child psychiatrist, had earned far more money from drug makers than he had reported to his university, he said that his interests were “solely in the advancement of medical treatment through rigorous and objective study.” Court documents reveal that Dr. Joseph Biederman, a renowned child psychiatrist, pushed Johnson & Johnson to fund a research center whose goal was “to move forward the commercial goals of J&J.”

But e-mail messages and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to finance a research center at Massachusetts General Hospital, in Boston, with a goal to “move forward the commercial goals of J.& J.” The documents also show that the company prepared a draft summary of a study that Dr. Biederman of Harvard, was said to have written.

Dr. Biederman’s work helped to fuel a fortyfold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotic medicines in children. Although many of his studies are small and often financed by drug makers, Dr. Biederman has had a vast influence on the field largely because of his position at one of the most prestigious medical institutions…
Through the Texas Medication Algorithm Project, Johnson & Johnson raided Medicaid and other public funds. Johnson & Johnson’s deal with Biederman involved giving children potentially toxic drugs to expand its customer base. Sometimes, it’s easy to get caught up in the intricacies of a story, and miss the essence of what happened. Johnson & Johnson lost all sight of the business they’re allowed to be involved in – stealing from the public coffers and over-medicating children to inflate corporate profits.

To my way of thinking, one of the more important outcomes of the TMAP proceedings would be the full release of the discovery documents and trial transcripts. This is not a story that needs to be sealed in the restricted stacks of some courthouse basement or inaccessible law library. It was our tax dollars being diverted into J&J’s bank account through TMAP. It was our children being medicated based on Dr. Biederman’s expert opinion. It’s our medical care system and our practitioners that were being played like pieces in some oversized Monopoly game by the J&J’s wheelings and dealings. It was our innocence and naivete that Johnson & Johnson knowingly preyed on – our assumption that matters medical were governed by an ethical code. So if we are to be the characters in their story, we have the right to read the whole script…
  1.  
    November 5, 2011 | 1:24 PM
     

    You wrote:

    “… algorithms are ways to solve problems. This wasn’t a solution.”

    You echo the feelings of many of us in reference to pharmacological psychiatry: We were taught that “medicine” promotes healing. Psychiatric drugs do nothing of the sort…

    And so, a growing number of us are left shaking our heads, dumbfounded… while those who continue to drink the Kool-Aid call us “scientologists” or worse.

    Duane

  2.  
    Brenda A. Durant
    November 5, 2011 | 10:34 PM
     

    Why is there no mention of the elderly in nursing homes being harmed and killed with the same drugs. I provided Allen Jones with documentation which clearly proved that TMAPS was being utilized by Texas DHS. The state victimized me for daring to notice and complain. The nursing home chain, Mariner (also known as Living Centers of Texas) owned the pharma service provider company contracted with the state to self police, and the state did everything to help protect the nursing homes and the pharmaceutical companies. Disgraces in care and protection!

  3.  
    November 5, 2011 | 10:44 PM
     

    Brenda, that’s an excellent point! I did pull out children with Dr. Biederman’s contribution, but I failed to fractionate the TMAP impact which involved children, adults [even those with non-psychotic illnesses], and the elderly – a large target population for the Risperdal [and other Atypicals]. The drugs now carry a warning of dire side effects including death in the elderly. That’s another exaple of drug sales trumping patient safety and care. Thanks for the reminder…

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