I made an earlier analogy that the
STAR*D story is like falling down Alice’s rabbit hole. But that metaphor hasn’t held up under scrutiny. A rabbit hole is enclosed.
STAR*D just won’t fit. It keeps on growing. It needs a bigger place – like… well, sort of like the wide open spaces of Texas. As a matter of fact, whistleblower,
Allen Jones, opened his statement about TMAP [the Texas Medication Algorithmic Project] with something he called the “A Texas Primer”:
• Texas is uniquely suited for the pharmaceutical industry to develop a marketing scheme of the depth and proportion of TMAP. The industry needed to create an aura of legitimacy and a body of favorable data to advance its marketing aims. It needed universities, prisons and hospitals. The industry also needed a friendly Legislature to initiate such an extensive program….
• …one former Texas legislator, Tom Robbins, was annoyed that his colleagues seemed to pass legislation that they had not even read, let alone understood. To prove a point he introduced a resolution to honor Albert de Salvo.
“This compassionate gentleman’s dedication and devotion to his work has enabled the weak and the lonely throughout the nation to achieve and maintain a new degree of concern for their future. He has been officially recognized by the state of Massachusetts for his noted activities and unconventional techniques involving population control and applied psychology.”
The Resolution passed with a unanimous vote. Albert de Salvo was, of course, the Boston Strangler…
• Texas Governor George W. Bush supported Texas Mental Health Parity legislation in 1997 that required private industry to provide increased insurance coverage for mental health treatment, including mental health drugs. Texas passed legislation expanding Medicaid coverage of mental health drugs to persons who would not otherwise qualify under Medicaid guidelines…
• TMAP opened the doors of the Texas prison system, juvenile justice system and Texas state mental health hospitals to the unlimited influence of major pharmaceutical companies in expanding the usage and marketing of their most expensive drugs…
Of course the forces behind
STAR*D didn’t arise with the Texas Medication Algorithmic Project, but Texas did provide the climate and the space they needed to flourish. Where else, but a State that would mindlessly honor the Boston Strangler, would anyone overlook a program that was so obviously a scheme to sell expensive drugs to a public health-care system? conceived and financed by the people who made the drugs?
[see the singapore sojourn? ask Alice…]John Rush was the TMAP Project Director and Madhukar Trivedi was the Major Depressive Disorder Module Director, both in the Department of Psychiatry at The University of Texas Southwestern Medical Center at Dallas. Their algorithms embraced Risperdal, Zyprexa, Seroquel, Geodon, Depakote, Paxil, Zoloft, Celexa, Wellbutrin, Zyban, Remeron, Serzone, Effexor, Buspar, Adderall, and Prozac – and avoided the generics.
[ref]
For Medicaid in Texas, TMAP meant crippling health care costs. Medicaid spending on five antipsychotic drugs skyrocketed from $28 million in 2002 to $177 million in 2004—almost $700 million combined. That did not include care for those who are in state institutions. According to Alan Jones, by early 2001, TMAP and TCMAP had bankrupted the Texas Medicaid program and the budgets of the state’s mental health and prison systems.
In this version of evidence-based medicine, diagnosis was by DSM/SCID, treatment was directed by TMAP/TCMAP/TIMA algorithms, initialed rating scales were the coming way to follow patients [analogous to "lab work" in mainstream medicine]. It’s hard to know whether the push towards treatment of the mentally ill by Primary Care Physicians arose independently within the TMAP/Dallas group, or whether it was inserted by the campaigns within industry [Lilly’s Viva Zyprexa, GSK’s Nemeroff/Shatzberg textbook, etc]. Whichever the case, that was definitely on the table in the STAR*D protocols.
These days, it’s becoming fashionable to consider many of the Y2K psychopharmacology-types as only shills for PHARMA, but I’m not sure that’s right. I think they really believed the atypical antipsychotics [SGAs] were the new solution to psychosis, and that some version of the new antidepressants [SSRIs, etc] were the solution to depression, and also they became willing shills for the Pharmaceutical Industry. In Texas, those beliefs became public policy under Governor Bush connecting a two-way spigot between government and PHARMA via TMAP [more one way than the other]. John Rush’s Co-Director Steven Shon hit the road and sold the idea to 16 other States [traveling on PHARMA’s nickle, as it turns out]. Meanwhile, in 2001 the idea went to Washington with President Bush as the New Freedom Commission and TeenScreen.
The NIMH funded two ambitious studies around Y2K to look at the SGAs and the AntiDepressants – CATIE and STAR*D. By my read, CATIE was a study that tested a hypothesis, STAR*D was a polemic that chased a conclusion. The difference was apparent in the subtext of their acronyms.
Training residents in the 80s, I noticed that many went through a moral period when they were angry at the patients’ poor compliance with neuroleptics. I used to say, "You know, Schizophrenia isn’t a Haldol deficiency. You try some yourself and let me know how it goes [they never did]." CATIE started there and measured "take-ability" – a wise decision. The SGAs were no more "take-able" than CATIE‘s sole FGA. Around the same time, the reports began to mount that the SGA’s decreased incidence of old side effects [EPS, TD] was offset by their new problem – the metabolic syndrome. But I’m getting ahead of myself.
When Rush and Trivedi conceived the STAR*D trial, they incorporated the whole TMAP gestalt – permissive enrollment, primary care facilities [18/41], treatment with complex layers of simplistic algorithms, follow-up with an "E.T. phone home" rating scale [created for the occasion and validated in the 11th hour]. It was as big as the State of Texas where it originated and as brash as the Governor they sent to Washington. But in the seven years it took to do that study, things began to change. During the STAR*D study, TMAP came under fire when Allen Jones blew his whistle in a 2004 lawsuit in Texas. By 2006, TMAP Evangelist Steven Shon hit the road again – this time allowed to resign rather than be fired. TMAP got quiet and TCMAP was disbanded. Suits against the drug companies for suppressing dangerous side effect data and deceptive marketing were gathering steam. Kingpin Psychiatrists like Charlie Nemeroff were beginning to be exposed and there was a groundswell of anti-psychopharmacology sentiment arising from multiple foci. The climate was changing when STAR*D was finally published in 2006.
As for the STAR*D study itself, I think I’ve said all I know to say and gone as far as old man in a cabin in the woods can go [with only the Internet, an Ovid account, and some more informed new friends pointing the way]:
But I’ve gone far enough to know that STAR*D was expansively planned, poorly executed, and deceptively reported. It was bad science because instead of starting with a question, it set out to prove an answer that was built on a set of unproven hypotheses and grandiose wishes – making things worse by using an idiosyncratic methodology that was equally speculative. And what they reported to the scientific community was just plain wrong.
Texas itself seems to have recovered. TMAP is long gone. They still talk about
alogorithms, but in a different way. Texas Medicaid pays for
rational, generic medication and you have to get the expensive drugs pre-approved. The whole agency that housed TMAP has been reorganized. Even the old TMAP procedure manuals seem to have have recently disappeared from sight [at least from the web
site]. In 2008, the Dallas Psychiatry Chairman headed back east and TMAP/
STAR*D guru John Rush fled to Singapore to further the CRO’s meme to globalize clinical trials [rather than figure out how to do them]. Steven Shon is practicing in a suburb of Vegas and Allen Jones’
suit has recently broken out of a bottle-neck and is proceeding. Maybe Texas will get a rebate after all. And Senator Grassley’s investigations may have toppled only a few of the most egregious, but the ripples are still being felt. Even Governor/President George Bush is finally back in Texas clearing away the brush on his ranch.
Should we let STAR*D slink into the shadows like TMAP? or Bush? If anyone asks my opinion, I’ll say that I don’t think so. That major report in the American Journal of Psychiatry [Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report] remains on the books, as does the editorial [STAR*D: What Have We Learned?]. And their reported results continue to influence practice broadly in physician’s offices all over America [update: see here]. Pharmaceutical advertisements still promise more from the antidepressants and "augmentation" strategies than these medications really have to offer.
If Dr. Francis Collins of the National Institute of Health and Dr. Tom Insel of the National Institute of Mental Health are really the scientists they were hired to be and stand behind the names of the organizations they lead, they shouldn’t allow STAR*D to stand as an unfinished symphony. If its now defunct originating group won’t publish the promised results, then they should order a thorough investigation of the study and its primary data. After all, they own it. They paid for it to the tune of $35 Million. And if the American Journal of Psychiatry is to remain the primo scientific resource for the organization it represents and members it informs, it should join in that investigation and retract both the STAR*D report article and the editorial if they turn out to be as flawed as they appear to be. There’s no shame in going back and setting the record straight. The word "ignorance" is derived from the verb "to ignore." STAR*D is way too important to just ignore…
The unfortunate reality is that it pays huge dollars to ignore the past & wear blinders. Many would like to believe the tide is turning against this kind of bastardized science. I personally believe that view/analysis maybe something to the order of living in a fantasy world.
If anything, the foundations of false & corrupted science are now the ordained & indoctrinated marble statues used today as support pillars to continue this juggernaut onslaught of the pharmaceutical transformation ongoing related to our basic human condition.
Once more we see the same conflicted players & pharmaceutical insider shenanigans working at the FDA as they once more approved another atypical anti-psychotic for use in children today.
“Antipsychotic INVEGA approved for use in kids age 12-17 for Schizophrenia based on a 6 wk study” http://tinyurl.com/3jo2cmw
It would nice to think we are moving forward, making some healthy headway, & are starting to right these so many insidious wrongs. But the data, sales figures, and damage being done seems to tell us we are actually accelerating this phenomena much like a run away locomotive moving in the other direction.
Have we come to a time & place when only the most extreme & catastrophic derailment of this modality is the one deemed possible intervention?