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State joins antipsychotic drug lawsuit

Kickbacks alleged in nursing home use

By Kay Lazar
Globe Staff / March 11, 2010

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Attorney General Martha Coakley’s office joined a federal lawsuit yesterday that contends that Johnson & Johnson paid tens of millions of dollars in kickbacks to get its drugs, especially the powerful antipsychotic Risperdal, prescribed in nursing homes.

The action was taken as Coakley’s office disclosed that it is also scrutinizing companies that market antipsychotics to Massachusetts nursing homes. These drugs are widely used in some homes for residents suffering from dementia, a condition that puts them at greater risk of death when given antipsychotics.

Antipsychotics were approved to treat people with severe mental illnesses, such as schizophrenia, but it is legal for physicians to prescribe them “off label’’ to treat people with dementia. Pharmaceutical companies are prohibited from marketing or promoting off-label uses of their products.

“The inappropriate off-label marketing of antipsychotic drugs to nursing homes is a significant health and safety issue for our seniors,’’ Coakley said in a statement released by her office. “We have taken strong action on this issue in the past and are continuing to monitor it very closely moving forward.’’

Coakley’s office declined further comment, citing the pending litigation.

The Globe reported Monday that 28 percent of Massachusetts nursing home residents were given antipsychotics last year.

Of that group, 22 percent, or 2,483, did not have a medical condition that calls for such treatment. That rate was 12th highest in the nation, according to federal data.

The lawsuit against Johnson & Johnson — filed in January by the US attorney in Boston, Carmen M. Ortiz — alleges that the drug company paid millions to Omnicare, the nation’s largest provider of drugs to nursing homes, to get the company to intensively push the antipsychotic Risperdal between 1999 and 2004, using rebate programs and other incentives.

That campaign nearly tripled sales of J&J products to Omnicare, from approximately $100 million to over $280 million, with annual purchases of Risperdal alone rising to over $100 million, the suit contends.

Omnicare then filed for reimbursement for these purchases, seeking payment from Medicaid, the joint federal and state health program for the poor, which pays for nursing home care for many seniors.

The attorney general’s office is joining the suit against Johnson & Johnson to ensure that the state shares in any financial settlement for the Medicaid payments.

Omnicare agreed in November to pay $98 million to settle federal charges it took kickbacks.

Johnson & Johnson spokeswoman Carol Goodrich said in a statement yesterday that “airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate.’’

“We look forward to the opportunity to present our evidence in court,’’ Goodrich said.

The federal lawsuit details an elaborate program by Johnson & Johnson and Omnicare to allegedly convince nursing home physicians to prescribe Risperdal. The suit contains internal company documents and e-mails, including one from 1999 in which Omnicare offered J & J’s sales team a list of nursing home physicians who had been resistant to prescribing the antipsychotic.

“These names were provided to the sales force in an effort to increase the call frequency on these resistant prescribers and to eventually influence them to use more Risperdal in the elderly demented patient,’’ the e-mail said.

Another internal Johnson & Johnson document, from 2003, said that physicians accepted prescribing recommendations from Omnicare’s force of 900 consultant pharmacists more than 80 percent of the time.

Kay Lazar can be reached at klazar@globe.com.

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