Saturday, December 30, 2006

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

http://www.statesman.com/search/content/news/stories/local/12/16/16drugs.html

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

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


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 Travis County district court by Allen Jones, a former investigator for the state of Pennsylvania, against Johnson & Johnson Inc. and five related companies. Jones 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.

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. 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 Thomas Melsheimer, a lawyer for Jones.

Abbott's office declined to comment on the lawsuit, as did spokesmen for Johnson & Johnson 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 Jones 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  (at) statesman.com; 445-3654

wgselby  (at) statesman.com; 445-3644

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