Wednesday, March 14, 2012

Risperdal has role in J&J probe by U.S. By David Sell INQUIRER STAFF WRITER

One Pennsylvania doctor in 2008 wrote 1,913 prescriptions for the antipsychotic drug Risperdal - a bit more than 5.2 per day in that leap year, counting weekends and holidays - costing Medicaid $341,273.71.

The top 10 prescribers in Pennsylvania's system that year wrote 9,557 Risperdal scripts costing Medicaid $1.76 million, according to figures provided by a state official to U.S. Sen. Charles Grassley (R., Iowa), who has pushed for disclosure of such information and the relationship between doctors and pharmaceutical companies.

The numbers raised questions for Grassley, and Pennsylvania officials sent letters to scores of doctors emphasizing the need for safety in prescribing antipsychotic drugs. Twelve were suspended, dropped from Medicaid, or are under investigation, according to a copy of a letter to Grassley released Tuesday by the state welfare department.

The numbers also play a role in the U.S. Department of Justice's efforts to fight health care fraud. In the case of Risperdal, the Justice Department is negotiating with Johnson & Johnson, whose Janssen subsidiary makes the drug, to address allegations that the company illegally promoted it to doctors and through Medicaid programs.

Medicaid is the taxpayer-funded insurance plan for poor Americans and is administered by the federal and state governments.

J&J previously disclosed that it set aside money to settle criminal and civil charges in the Risperdal litigation, though it had not specified the amount.

Reports over the weekend from the Wall Street Journal and Bloomberg News said the Justice Department had demanded a payment of about $1.8 billion, an increase from the $1 billion figure reportedly negotiated by the U.S. Attorney's Office in Philadelphia in December.

Spokesmen for J&J, the Justice Department, and the U.S. Attorney's Office declined to comment.

The $1.8 billion figure would be the largest settlement for a case involving a single drug, but some of the other big settlements also involved antipsychotic drugs.

"Both Sen. Grassley and the Department of Justice are making great headway in the battle against Medicaid fraud," said Allen Jones, the former investigator for Pennsylvania's Office of Inspector General whose findings were ignored by state officials in 2004.

Jones was fired by state officials when he took the information to the New York Times, but his whistle-blower lawsuit resulted in J&J's paying $158 million to settle charges that it illegally marketed Risperdal through the Texas Medicaid system. Jones will get a portion of that settlement. He now works as an adviser to attorneys in related litigation.

Eli Lilly & Co. paid $1.7 billion to settle charges of illegal marketing of its antipsychotic drug Zyprexa. Pfizer Inc. paid $2.3 billion to settle charges of illegal marketing of several drugs, notably Bextra, but also its antipsychotic Geodon. Late in 2011, GlaxoSmithKline P.L.C. said it had reached a deal to pay $3 billion to settle charges related to several drugs, including Avandia, but the Justice Department has declined to comment on that one as well.

Jones provided The Inquirer with state figures sent to Grassley's office in 2010 by Michael Nardone, then an official with the Pennsylvania Medical Assistance Program.

New Jersey never responded to Grassley's 2010 request for information nor a follow-up letter dated Jan. 24. State officials could not be reached for comment Tuesday. Delaware Medicaid officials responded to Grassley in 2010 and again in February.

J&J's Risperdal lost patent protection at the end of 2007, so the 2008 figures were the beginning of the decline in costs as generic versions were used more often.

As a comparison, AstraZeneca P.L.C.'s antipsychotic, Seroquel, is just now losing patent protection on most versions.

In 2008, the top 10 prescribers in Pennsylvania wrote 18,705 prescriptions for Seroquel, costing Medicaid $3.67 million. State officials provided The Inquirer with the most recent response to Grassley. That letter says the top 10 prescribers wrote 17,692 scripts for Seroquel, costing Medicaid $5.73 million.

In 2010, AstraZeneca paid $520 million to settle charge of illegal marketing of Seroquel.

"I liken the DOJ effort to a storm surge building for a long time," Jones said, crediting Grassley and a few others in Congress for helping to push the issue. "They have a clear eye on the dirty ways of fraudulent marketing and are systematically exposing it. It is changing the way antipsychotic drugs are marketed in America."

Contact David Sell at 215-854-4506 or

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