Texas Medication Algorithm Project (TMAP)

From Health Care Renewal

Wednesday, December 20, 2006

Guidelines in Whose Interest? - Pharmaceutical Companies and the Texas Medication Algorithm Project (TMAP)

Out of Texas comes a story with allegations of pharmaceutical industry involvement in the crafting of state mandates for the treatment of psychiatric illness. Per the Dallas Fort Worth Star Telegram (edited, and re-ordered):

A recently unsealed lawsuit accuses Johnson & Johnson and related companies, including Janssen Pharmaceutical, of conning the state of Texas into spending millions of dollars on costly psychiatric drugs.

The suit targets a controversial state program that instructs doctors at state-funded healthcare facilities about which medicines to prescribe for a variety of mental illnesses.

The suit was filed in 2004 in Travis County by Allen Jones, a former employee of the Pennsylvania Office of Inspector General who investigated drug companies' ties to his state's officials. In the process, he learned of allegations related to Texas. The Texas attorney general's office has joined the lawsuit.

While the suit does not name a "state mental health program decision-maker" who it alleges received payments and other benefits, a spokeswoman for the Texas Health and Human Services Commission confirmed that the lawsuit refers to Dr. Steven Shon, who managed the program. Shon took more than 80 trips throughout the country and abroad to promote it, with his expenses often underwritten by drug companies.

Shon, who left the Department of State Health Services this fall while the investigation was ongoing, said he has not received money from drug companies in connection with his work for the state. Money paid for his travel expenses or to reimburse taxpayers for his time away from the office, he said.

'These assertions are really ridiculous, he said.

However, Shon said he received a few thousand dollars from Janssen several years ago for consulting work unrelated to his state job. He said he got approval from the department's legal staff, but commission spokeswoman Stephanie Goodman said the agency was unaware of payments and would not have approved them.

The lawsuit alleges that Johnson & Johnson and its subsidiaries misled state officials about the benefits of the antipsychotic drug Risperdal, including promoting it for treating children when the drug had not been federally approved for such use. The company's influence led the state to purchase the expensive brand-name drug instead of cheaper generic alternatives, according to the lawsuit. The result, it alleges, was that the state paid excessive amounts in claims for Medicaid, which covers medical costs for low-income people.

A major portion of the lawsuit focuses on the Texas Medication Algorithm Project, which Shon coordinated. That program offers a series of treatment plans, or algorithms, for various mental illnesses, including which drugs to use. In many cases, the plans recommend the newest drugs, which are the most expensive and are not available in generic form.

Such drugs generate much income for pharmaceutical companies. In a recent three-year period, more than $190 million was paid in Texas for outpatient Medicaid claims for Risperdal alone, according to the state Health and Human Services Commission. During those same years -- 2002 to 2005 -- almost $700 million was spent on all antipsychotic medications combined. That does not include care for those who are in state institutions.

Drug companies, including Janssen, gave the state more than $1 million to help promote the plan. And the Robert Wood Johnson Foundation, established by the founder of Janssen parent company Johnson & Johnson, gave $2 million. A company spokesman previously said the foundation is independent of the company.

The exact amount donated by the companies remains unclear. Shon has acknowledged that his agency did not always seek required approval from the department's governing board before accepting donations.

Shon left his job with the state in October.

Shon said he was given the option of resigning or being terminated, and he chose to leave.

In addition, per a reporter for an Austin television station,

Shon spent a great deal of his time traveling around the country promoting the TMAP treatment guidelines.

Shon made at least 84 trips. Many of the trips were courtesy of the drug companies whose drugs are specified in TMAP and have a financial interest in getting other states to adopt the program.

'So when ever you were going on trips to speak on behalf of this and the money was coming from the pharmaceutical companies were you ever aware that it might look like a conflict of interest,' CBS 42’s Nanci Wilson asked.

'I think that it possible could, but I thought that given the fact that this is how conferences and education works, I didn't think that this was really any different then what was going on anywhere else,' Shon said.

But Shon's trips to Pennsylvania weren't business as usual.

'The check originated as an unrestricted educational grant from Janssen to the Harrisburg State Hospital here in Pennsylvania,' Allen Jones said. 'However, the check was deposited to an off the books account and a separate check written out to Shon in the exact amount of the unrestricted educational grant. And while they called it an unrestricted grant, the supporting documentation clearly, clearly established that the purpose of the monies was to bring Shon to Pennsylvania to sell the TMAP program to Pennsylvanian officials.'

Before commenting, I need to acknowledge that the story above is based only on allegations, so far. The law-suit has not gone to trial, and there may be more than one side to this story.

Nonetheless, the allegations are striking. We have previously posted on allegations of attempts to influence guidelines by those trying to sell drugs, devices, or services that such guidelines may support. However, in the current case the allegations were of attempts to influence state mandated treatment algorithms (the Texas Implementation of Medication Algorithms, or TIMA), not mere guidelines. (As best as I can tell from the TMAP web-site, particularly its FAQ section, these algorithms are mandatory for all state mental health outpatient facilities.)

If nothing else, this reinforces the need for physicians, health care professionals, and patients to be extremely skeptical about how guidelines are written, and who has influenced their writing.

Parenthetically, note that this skepticism should extend to guidelines labelled as "evidence-based." The TMAP algorithms are described as evidence based, but I can find nothing on the TMAP web-site that explains how the process used to develop them fit this definition.

ADDENDUM (12/20/2006): See also these posts (here and here) on Clinical Psychology and Psychiatry.

From Clinical Psychology & Psychiatry

Thursday, March 08, 2007

TMAP and Bipolar: Where's the Beef?

Much has been made of the Texas Medication Algorithm Project. I have written about it earlier (1, 2), as have others (3). A lawsuit has been filed alleging that TMAP was a sneaky way to convince state mental health programs to switch their patients to newer, much more expensive medications. TMAP defenders, on the other hand, say that TMAP was simply allowing patients access to the state of the art, most effective medications.

What is TMAP? Essentially, TMAP is a program that used “expert consensus” to develop treatment guidelines for patients (depression, bipolar, and schizophrenia) in the public mental health system. On one hand, I can see why care should be improved – not many people seriously argue that patient care is very good in most public mental health systems.

According to the TMAP model, medication treatment is provided in stages according to these guidelines. If you are not responding to treatment #1, then you move to treatment #2, and if that does not work, then to treatment #3, and so on. Naturally, the “objective experts” who developed said guidelines stuck the newer, more expensive medications on the top of the list for treatments, especially as the guidelines have been revised during the past couple of years.

TMAP was unfurled in the mid 1990’s and similar programs have since been sweeping across many states.

Was this a way to backdoor newer medications onto patients? Well, I think that is probably the case, but the issue I am going to address here is one that I think is even more important…

Does TMAP Work? Do TMAP patients show more improvement than patients who were not on the TMAP treatment regimen? The TMAP team has produced some evidence in which they claim that TMAP treatment works better than “treatment as usual,” which was standard state mental health care. In this case, we’ll discuss TMAP for bipolar patients.

The Study: Some patients received TMAP, which included both a standardized medication algorithm as follows:

Manic:
Stage 1 – Depakote or Lithium or Tegretol
Stage 2 – Depakote + Lithium OR Tegretol + Lithium
Stage 3 – Depakote + Lithium OR Tegretol + Lithium
Stage 4 – Depakote + Tegretol
Stage 5 – Add atypical antipsychotic to mood stabilizer
Stage 6 – ECT
Stage 7 – Other (e.g., Lamictal, Neurontin)

Depressed:
Stage 1 – Wellbutrin or SSRI + mood stabilizer
Stage 2 – Wellbutrin or SSRI or Effexor or Serzone + mood stabilizer
Stage 3 – Mood Stabilizer + two antidpressants
Stage 4 – Mood Stabilizer and MAOI antidepressant
Stage 5 – ECT
Stage 6 – Other (e.g., Lamictal)

Note that in the 2005 revision of this standard, atypical antipsychotics are featured much more prominently. But when the study on bipolar patients was conducted, this was not the case.

Those who received “treatment as usual” (TAU) received whatever care they would normally receive.

The Results: On some measures, TMAP patients did modestly better than TAU patients. This could be interpreted as evidence that these strict treatment algorithms that involve a high frequency of prescribing Depakote and Tegretol, and to a lesser extent, newer antipsychotics, are a good idea for patients. However, one would be fooling oneself to buy this conclusion. Why?

The (Huge) Caveat: The TMAP patients all received: Group education, consumer to consumer discussion groups, individual patient education from the physician, referrals to therapy groups and more. These interventions were rolled out exclusively for the TMAP group. Why does this matter? Well, patients in the TMAP group were likely getting more time with their physician, which is likely going to boost their relationship with the physician, which will likely lead to better outcomes regardless of the medication taken. In addition, the patient education groups provide additional support for patients, which has been shown to improve outcomes.

Even the study authors, to their credit, admit this is a gigantic potential issue:

At this time, the relative contributions of different elements [i.e., medication versus the extra patient care] of the “disease management package” to the obtained results has not been evaluated.

A Better Idea for TMAP: If you wanted a study that would have compared the effects of a) extra patient education and support, b) use of medication algorithms that favored use of newer medications and c) “treatment as usual” – regular care in the state mental health system, then why not have a study that looks like this:

A) Treatment as usual (No extra patient support)
B) Extra Patient Support + TMAP Algorithms
C) TMAP Algorithms (No extra patient support)
D) Extra Patient Support + Treatment as usual

If C’s outcomes are better than A’s outcomes, then you can shout about the evidence base of your algorithms. If B is greater than D, then you can also do your evidence-based practice speech. However, the TMAP bipolar study as was actually conducted was A versus B, – that is a pretty lame comparison. Was it the patient support (which is my guess) or was it the algorithms?

Why Was TMAP Investigated This Way? This is where it gets interesting but murky. Could such a study have been designed because it was biased to find favorable results for the TMAP intervention (due to TMAP patients receiving extra support not received by treatment as usual)? Then, finding positive results, it becomes a lot easier to sell the program to other states because TMAP is now “evidence based”. Maybe I’m off in Conspiracyville, but one has to admit this is pretty weird stuff.