Janssen Pharmaceutica misled Government officials

The Philadelphia Inquirer
Suit: Janssen Pharmaceutica misled Texas officials on drug
By: Rob Waters, Bloomberg News

Unsealed documents in a whistle-blower lawsuit allege that drugmaker Janssen Pharmaceutica, of Titusville, N.J., misled Texas officials about an antipsychotic drug to increase prescriptions.

The lawsuit claims that Janssen, a subsidiary of Johnson & Johnson, of New Brunswick, N.J., caused Texas to overspend last year on Risperdal, a top-selling schizophrenia drug.

The case, one of several against makers of antipsychotics in several states, centers on Texas prescription guidelines that require doctors to give priority to newer, more expensive drugs in state-funded treatment of mental-health patients.

The Texas guidelines have been adopted by several other states, including Pennsylvania. The complaint was initiated in 2004 by Allen Jones, a former investigator for Pennsylvania’s Office of the Inspector General. Jones was fired after questioning the Pennsylvania system and divulging information about his investigation without permission.

Texas court records unsealed Dec. 15 allege that the Texas guidelines and Janssen’s “deceptive” marketing techniques had boosted sales of Risperdal, raising costs for Texas and endangering patients.

Under Texas law, the whistle-blower suit would have been dismissed if the attorney general had not joined it. The state is seeking unspecified damages. Jones would collect 15 percent to 25 percent of any damages, his attorney said.

U.S. sales of Risperdal totaled $10 billion from 2001 through 2005, according to IMS Health Inc., a Plymouth Meeting industry information firm.

“This is a case about sales and marketing trumping medical science,” said Thomas Melsheimer, a plaintiff attorney.

Johnson & Johnson responded that it does “not promote our products for off-label use,” said Ambre Morley, a company spokeswoman. J&J does not comment on litigation, she said.

Tom Kelley, a spokesman for Texas Attorney General Greg Abbott, declined to comment yesterday on the lawsuit.

Nationwide, several lawsuits accuse drug companies of engaging in deceptive marketing by overstating effectiveness and understating risks of newer antipsychotics. The suits also claim companies promoted the drugs for unapproved uses.

Mississippi, Louisiana, Alaska and West Virginia sued Eli Lilly & Co. this year on behalf of their Medicaid health programs for the poor. They said the company fraudulently touted the antipsychotic Zyprexa for unapproved uses. Indianapolis-based Lilly settled about 8,000 personal-injury complaints for $700 million in 2005, and faces 4,000 more claims.

Lilly spokesman Phil Belt said Lilly was “committed to being transparent about the risks of Zyprexa.” He declined to comment on specific cases.

London-based AstraZeneca P.L.C., maker of the third-best-selling antipsychotic, Seroquel, stands accused in more than 200 federal and state lawsuits of concealing the diabetes risk faced by users. AstraZeneca, whose U.S. headquarters are near Wilmington, is “vigorously defending” the cases, spokesman Jim Minnick said in an e-mailed statement.

The Texas program began in 1996 as a way to standardize prescribing of medication to state mental patients, led by University of Texas academics and Steven Shon, then medical director for behavioral health for the Texas health department.

Shon also had consulted for Janssen, an arrangement the department was unaware of and would not have approved, said Ted Hughes, a spokesman for the Texas Health and Human Services Commission.

Shon resigned effective Oct. 31. His boss, Charles Bell, acting health commissioner, requested Shon’s resignation after being briefed on the whistle-blower lawsuit by the Attorney General’s Office, Hughes said.

Shon did not respond to requests for comment.

Jones’ complaint alleges that the Texas health department received as much as $6 million in contributions from Janssen and other parties to implement the treatment guidelines under the Texas Medication Algorithm Project, known as TMAP.

The largest contributors, according to the lawsuit, were Janssen and the Robert Wood Johnson Foundation, the Princeton-based charity endowed by J&J’s cofounder that operates independently of the company.

The foundation provided three grants totaling $2.8 million to evaluate TMAP as part of an effort “to improve treatment of chronic disease,” foundation spokesman David Morse said.

After the guidelines were adopted, Janssen “experienced a significant increase in sales of Risperdal” in Texas and worked to bring the program to other states, the suit alleges.

State officials “traveled extensively, at the expense of defendants, to tout the wonders of the new drugs,” the complaint says.

Janssen “improperly influenced state decision-makers with trips, perks, travel expenses, honoraria,” and paid state officials “to speak in their official capacities” to promote the drugs, the complaint says.

In Pennsylvania, allegations about drug-company influence over Medicaid policy resulted in ethics charges against Steven J. Fiorello, of Palmyra, former chief pharmacist for the Public Welfare Department.

Fiorello was fined more than $27,000 last year and fired for using his position to earn extra income from two drug manufacturers, including Janssen. Fiorello also faces criminal charges.

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