Psychiatr News February 2, 2007
Volume 42, Number 3, page 30
© 2007 American Psychiatric Association
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
TMAP.
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
algorithms.
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.
More information on TMAP is posted at
<www.dshs.state.tx.us/mhprograms/TMAPtoc.shtm>.
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