Wednesday, December 20, 2006

TMAP: Part 1

Janssen (owned by Johnson & Johnson) and a few other companies are being sued for defrauding the Texas public mental health system. How could a company do a thing like that? Well, let’s start with a quote from a Texas newspaper:

“Jones' lawsuit alleges that the companies launched a drug named Risperdal in 1994 to treat schizophrenia. About the same time, the state was developing a protocol, or treatment guidelines, for which drugs should be used in public mental health programs. [This is the Texas Medication Algorithm Project.] The defendants "provided substantial financial contributions to and improperly influenced the development" of the protocols, the lawsuit said, and Risperdal took precedence in the protocols over cheaper, equally effective medicines.

The drug later received recommendations as the medicine of choice in the state's mental health protocol for treating children and adolescents, even though it lacked a Food and Drug Administration indication for those age groups, the lawsuit says. It says side effects and health risks include increased chance of stroke, renal failure and hyperglycemia.

The companies pushed Risperdal in other states through paid consultants on expert panels, peer-to-peer marketing strategies and "administrative decisions made by a select few public officials," the lawsuit says. The companies sent an unnamed Texas official around the country as a spokesman for the drug, and they hired third-party contractors to conceal their control and funding of medical education programs, speakers' bureaus and clinical research that promoted the benefits and safety of Risperdal, the lawsuit says.

The lawsuit says at least 17 states, including Texas, have implemented the protocol or are doing so.”


“A commission spokesman did say Texas paid 308,000 claims totaling $73.5 million for Risperdal in 2005.”

That hopefully piqued your interest. Essentially, Texas and several other states developed guidelines which laid out a prescribing algorithm for patients in public mental health programs. The catch is that the recommended first-line medications are nearly all in the newest, most expensive classes. Take a look for yourself at the TMAP algorithms. While this is allegedly based on research, there was no research conducted (at least not to my knowledge) that directly tested the recommended line of medications (i.e., SSRIs before tricyclics for depression or atypical antipsychotics before conventional antipsychotics for schizophrenia) in any systematic manner. We are certain that TMAP recommends expensive meds, but are they the most effective? Hmmm…

The plot thickens. In Pennsylvania, a state official (Steven Fiorello) who was on a committee that helped decide which meds would get used for mental health treatment in state hospitals was charged criminally. Why? Because he had received honoraria and other income from drug companies and failed to disclose these conflicts of interest. My earlier post (Bribery Pays) tells a little more about his story. Why is this relevant? Because the program in Pennsylvania was similar to TMAP – it was an algorithm-based program that allegedly placed a higher priority on newer, more expensive meds for people receiving state mental health care.

So what about TMAP and money? Oh, right, the lawsuit. That’s coming in my next post…

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