interesting article on risperodal

[Guest guest]

State's mental facilities duped into using drug, Abbott alleges

Lawsuit claims state official pushed drug, was rewarded with money.

By Embry, W. Gardner Selby

AMERICAN-STATESMAN STAFF

Saturday, December 16, 2006

A major corporation and several subsidiaries misrepresented the safety and

effectiveness of an anti-psychotic drug and unduly influenced at least one

state official to make it a standard treatment in public mental health

programs, according to a lawsuit the state has joined.

Attorney General Greg Abbott joined a lawsuit filed in County

district court by , a former investigator for the state of

Pennsylvania, against & Inc. and five related companies.

says in the lawsuit that he learned of payments to at least one Texas

mental health official in interviews he conducted as an investigator. No

official is named in the lawsuit.

The lawsuit, which came to light Friday, seeks to recover for the state

untallied alleged overcharges to the state's Medicaid program, which pays

for health care for low-income people.

' 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. 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.

" We allege it's a scheme whereby they passed off as medical science phony

representations and misleading facts about the efficacy and appropriateness

of these drugs, " said Melsheimer, a lawyer for .

Abbott's office declined to comment on the lawsuit, as did spokesmen for

& and the state's Health and Human Services Commission,

which oversees the Medicaid program. A commission spokesman did say Texas

paid 308,000 claims totaling $73.5 million for Risperdal in 2005.

Melsheimer described as a " classic whistle-blower " who filed the

lawsuit in 2004 on behalf of Texas to recover the companies' overcharges.

Because of his whistle-blower status, the lawsuit was sealed from public

view until Abbott joined it.

jembry@...; 445-3654

wgselby@...; 445-3644