Texas Attorney General Joins Whistleblower Lawsuit against J & J

1. The Texas Attorney General, Greg Abbott,  has joined a whistleblower's lawsuit against one of the giants of the pharmaceutical industry: Johnson & Johnson and five of the their subsidiaries–including Janssen Pharmaceutical, manufacturer of the antipsychotic, Risperdal (risperidone)–for bilking the state Medicaid / Medicare budget.

The attorney for Allen Jones, former investigator with the Pennsylvania Office of the Inspector General, said: "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."

This lawsuit will unravel fraud and corruption in the development, promotion, and implementation of the biggest prescription drug market expansion scam in history: TMAP–the Texas Medication Algorithm Project

TMAP is endorsed by President Bush's New Freedom Commission on Mental Health report. See: http://www.ahrp.org/cms/content/view/273/142/

TMAP will be unmasked as a product of collusion by drug industry giants, their paid "expert" psychiatrists from the University of Texas, who made up "expert consensus panels," and state officials. Together they concocted a marketing scheme that allowed manufacturers of expensive patented psychotropic drugs to profiteer.

The Texas Statesman reports that the lawsuit charges the defendants with having "provided substantial financial contributions to and improperly influenced the development" of the TMAP prescribing protocols. The TMAP guidelines ensured that Johnson & Johnson's expensive antipsychotic drug, Risperdal, "took precedence in the protocols over cheaper, equally effective medicines."
This has been documented by a $42 million government-funded antipsychotic drug outcome evaluation study, CATIE: http://www.ahrp.org/cms/content/view/400/94/

This lawsuit will likely have a domino effect inasmuch as TMAP has been exported to at least 16 other states where, like in Texas, it has wreaked havoc with the public health budget expenditure. "Bloomberg News reported: Newer drugs, such as Johnson & Johnson's Risperdal, Eli Lilly & Co.'s Zyprexa and AstraZeneca Plc's Seroquel, account for more than 90 percent of the $10.5 billion-a-year U.S. antipsychotic drug market, largely paid for by federal and state governments. "  See: http://www.ahrp.org/cms/content/view/400/94/

As the Statesman reports, Risperdal's side effects and health risks include increased chance of stroke, renal failure and hyperglycemia.

The TMAP "experts" nevertheless recommended the drug 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 fact that the FDA in 2006, approved Risperdal for use in agitation in autism in children–without so much as a public hearing–underscores the ubiquitous influence of drug companies on government regulators.  FDA is as corrupted by industry's influence–as the state officials who helped industry railroad the TMAP formularies as state prescribing guidelines. See, the harsh criticism leveled at the FDA by the Institute of Medicine, for the agency's failure to protect the public from unsafe drugs. See:  http://www.iom.edu/CMS/3793/26341/37329.aspx.

The FDA has been shown to help facilitate increased corporate profit margins by sacrificing lives.  http://www.ahrp.org/cms/content/view/58/27/

2. A complaint filed by Texas Comptroller, Carole Keene Strayhorn, with the Federal Office of Inspector General.

Ms. Strayorn issued a devastating updated report about prescription drug abuse–the mass exposure of children in foster care to highly toxic psychotropic drugs that harm children's physical and mental health.  See:  Foster Children: Texas Health Care Claims Study — Special Report is available as a PDF file (4.7 MB). See: http://www.window.state.tx.us/specialrpt/hccfoster06

"They're everybody's children, and nobody's children. They are the forgotten children in the Texas foster care system. This report reveals shocking evidence of the system's failure regarding the health care provided to our foster children. In addition, it raises many red flags pointing to areas of potential fraud and abuse that I am referring to the Office of Inspector General at the Health and Human Services Commission to investigate. This report, as the Forgotten Children report did, gives these children something they desperately need — a voice." 

Carole Keeton Strayhorn
Texas Comptroller of Public Accounts

[Strayhorn's earlier report, Forgotten Children Progress Report  A Special Report on the Texas Foster Care System. July 2004 at: http://www.window.state.tx.us/forgottenchildren/progress/ ]

Last month, the California chapter of the NAACP passed unanimously a resolution to end the abusive prescribing of psychotropic drugs for  children in foster care! http://www.ahrp.org/cms/content/view/382/31/

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

 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.
By Jason 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 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.

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.

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@statesman.com; 445-3654

wgselby@statesman.com; 445-3644

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