Makes it into the American Psychiatric Association's Psychiatric News

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http://www.ethicscommittee.ca/science/article.php?id=356609 & group=sci.me

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Psychiatr News February 2, 2007

Volume 42, Number 3, page 30

© 2007 American Psychiatric Association

Legal News

Company Accused of Improprieties in Marketing Risperdal

Jim ck

The Texas attorney general says TMAP was just one part of an elaborate

marketing scheme to increase psychotropic drug sales.

The Texas state attorney general joined a whistleblower lawsuit this

past December accusing the pharmaceutical and consumer goods giant

and inc. of exaggerating the benefits and minimizing

the known adverse effects associated with its second-generation

antipsychotic Risperdal (risperidone), marketed by subsidiary Janssen

L.P.

The suit further alleges the company and its subsidiaries " improperly

influenced " at least one Texas state mental health program official

through the payment of " substantial financial contributions " aimed at

ensuring a preferred position for Risperdal during the development and

implementation of the Texas Medication Algorithm Project (TMAP).

The lawsuit was originally filed in 2004 by , a former

employee in Pennsylvania's Office of the Inspector General (OIG). as

an OIG investigator, had investigated allegations of impropriety

during Pennsylvania's efforts to implement PENNMAP, a slightly

modified version of TMAP.

As a result of and 's alleged improper influence of

state officials through illegal payments of significant sums of money,

the lawsuit claims that Risperdal became a widely prescribed

" preferred " first-line medication in the TMAP and PENNMAP algorithms

for the treatment of schizophrenia.

To assure Risperdal a first-line spot in the algorithms, the suit

alleges that and overstated Risperdal's effectiveness

in treating patients with schizophrenia and downplayed the drug's side

effects. The suit states that the company also manipulated data

collected during development of TMAP, so that Risperdal would appear

to be more effective and safer than it actually was.

As a result of Risperdal's preferred position in TMAP, the state

mental health and Medicaid programs were said to have paid " dollars

per pill " for Risperdal when it could have paid " pennies per pill " for

generic first-generation antipsychotics that were equally effective.

Neither and nor Janssen responded to inquiries by

Psychiatric News for this article.

Texas Attorney General Greg Abbott was quoted by the Austin American-

Statesman newspaper as saying, " We believe Texas has been defrauded of

some money, and we're going to be looking to get our money back. "

Goodman, a spokesperson for The Texas Health and Human

Services Commission, defended TMAP's development and implementation.

The TMAP algorithms, she said in a prepared statement, are " firmly

grounded in the latest research and science. "

The central issue in the lawsuit is the pharmaceutical company's

alleged improper involvement in the development and implementation of

TMAP.

Developed in 1997, TMAP is composed of a series of flow charts that

lead physicians through evidence-based decision trees to help them

determine which psychotropic medication is most appropriate for

patients with specific mental illnesses (Psychiatric News, August 6,

2004). As a result of a series of consensus conferences that included

noted experts in each field, separate TMAP algorithms were developed

for adult patients with schizophrenia, bipolar disorder, and

depression.

After the adult algorithms were completed, Texas state employees began

development of the Texas Children's Medication Algorithm Project,

which the lawsuit alleges was also unduly influenced by and

.

Development of TMAP cost the state of Texas a reported $5.6 million;

however, the Wood Foundation (founded by a

family member and a former comapny executive) gave the state $1.8

million in the form of " unrestricted educational grants " toward the

development of the algorithms.

In addition to those grants, the lawsuit alleges, and

improperly influenced an unnamed " Texas mental health program decision

maker " by paying that individual to promote the placement of Risperdal

as a first-line medication in the TMAP schizophrenia algorithm.

and allegedly also paid the state official to further

promote the TMAP program by funding trips to various states, including

Pennsylvania, to promote the adoption of TMAP. As a result of those

activities, the suit claims, 16 other states, in addition to Texas,

formally adopted TMAP or a closely related version of the algorithms.

The lawsuit asks for a jury trial. No trial date has been set.

http://pn.psychiatryonline.org/cgi/content/full/42/3/30