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Ruling Sought Against Pfizer: Federal Prosecutors Say Anticonvulsant Marketed Illegally

May 18, 2003 | The Boston Globe

Federal prosecutors yesterday accused drug company Parke-Davis, now Pfizer Inc., of a widespread and fraudulent scheme to persuade doctors to prescribe what has become the country's top-selling anticonvulsant, Neurontin.

Assistant US Attorney Sara Miron Bloom's comments came during a hearing yesterday in US District Court in Boston and represent the government's growing interest in a civil whistle-blower lawsuit filed more than six years ago against Parke-Davis by David Franklin, a former employee.

Bloom said Franklin and his lawyers had presented substantial evidence that the company made false statements to doctors, including telling them that federal regulators had approved Neurontin for stand-alone treatment for epilepsy when regulators had in fact rejected the drug for that use. Neurontin is approved only as an add-on drug for epilepsy and for a certain type of pain.

Bloom asked US District Judge Patti Saris to reject Pfizer's request for summary judgment a ruling in its favor without a trial in the case. The US Attorney's Office in Boston is currently in settlement negotiations with the company to recoup money the state and federal Medicaid program spent on Neurontin for Medicaid recipients.

Franklin's attorney, also asked the judge to rule against Pfizer.

But Pfizer attorneys argued that the whistle-blower had not made his case, saying that even though Greene showed that nine doctors increased their Neurontin prescribing for unapproved uses after they attended Parke-Davis dinners or trips, he did not interview the doctors or prove the company's event caused them to prescribe more of the drug. The company's attorneys also said Greene failed to prove that the payments to doctors for consulting and other services were kickbacks specifically intended to sway them into using more Neurontin, and have in previous court filings denied the allegations in the case.

Bloom, however, said the company continually promoted the drug to doctors for unapproved uses which is not allowed under federal law by paying them to attend meetings as consultants, through sales representatives in their offices, by sponsoring continuing medical education courses without disclosing the company's financial backing, and by inviting physicians on ''trips and boondoggles.'' She said this off-label promotion resulted in increased payments for the drug by the state and federal Medicaid program for the poor.

Physicians recorded many of the sales representatives' statements about unapproved uses in slips they filled out for a company called Verispan, which tracks the effectiveness of sales calls for pharmaceutical companies including Parke-Davis.

Federal and state prosecutors, angry over the soaring costs of prescription drugs to Medicaid, are increasingly investigating and bringing charges against companies that allegedly market drugs illegally. Costs for Neurontin, in particular, have grown dramatically for Medicaid programs, which provide health insurance to the country's poorest residents. Ohio Medicaid spent $24 million on the drug last year, twice what it spent in 2000. Florida's expenditures tripled to $15 million between 1998 and 2001. And Massachusetts spent $25 million on Neurontin last year, compared to $3 million three years ago.

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