Tuesday, May 01, 2007

TeenScreen's Evil Sister in HOT WATER

Psychiatric News
Legal News
Company Accused of Improprieties in Marketing Risperdal Jim Rosack 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 Johnson and
Johnson 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 Allen Jones, a former employee
in Pennsylvania's Office of the Inspector General (OIG). as an OIG
investigator, Jones had investigated allegations of impropriety during
Pennsylvania's efforts to implement PENNMAP, a slightly modified version of

As a result of Johnson and Johnson'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 Johnson and Johnson 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 Johnson and Johnson 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."

Stephanie 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 Johnson and Johnson.

Development of TMAP cost the state of Texas a reported $5.6 million;
however, the Robert Wood Johnson Foundation (founded by a Johnson 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

In addition to those grants, the lawsuit alleges, Johnson and Johnson
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.

Johnson and Johnson 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.

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