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US Filing Backs Suit Against Drug Firm

Federal prosecutors: Epilepsy medication was illegally marketed

May 28, 2003 | The Boston Globe

The US attorney's office in Boston said in court documents that the drug company Parke-Davis, now Pfizer, gave illegal kickbacks to doctors, including trips to Puerto Rico and tickets to the 1996 Summer Olympics, to prescribe what has become the nation's best-selling anticonvulsant, Neurontin.

The Boston office, the country's most aggressive prosecutor of healthcare fraud, has refused to comment on a civil whistle-blower lawsuit filed more than six years ago against Parke-Davis by David Franklin, a former employee. But by filing a ''statement of interest'' in the case Friday, federal prosecutors for the first time outlined their support of Franklin's case and their belief in his allegations that the company engaged in an illegal marketing scheme to increase sales of its epilepsy drug.

Federal prosecutors yesterday declined to comment on the significance of the filing or whether they are planning to file criminal charges against the company. According to documents filed previously in the Franklin case, the US attorney's office in Boston is negotiating a settlement with Pfizer, which purchased Parke-Davis in 2000. Pfizer executives yesterday declined to comment on the government's filing.

Federal and state prosecutors, angry over the soaring costs of prescription drugs to the state and federal Medicaid program, 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 with $3 million just three years ago.

Most of these payments were not for prescriptions for epilepsy, but for ''off-label'' uses not approved by the US Food and Drug Administration such as bipolar disease and certain types of pain. It is illegal for a pharmaceutical company to promote its drugs for unapproved conditions, though it is not illegal for physicians to prescribe drugs for off-label uses.

In settlement negotiations, prosecutors would aim to recover some of these expenditures under the False Claims Act making fraudulent claims for payment to the government and the Anti-Kickback Statute.

In the filing Friday, federal prosecutors said Franklin and his attorney, ''presented evidence of an illegal off-label marketing scheme that is rife with false statements and fraudulent conduct all of which had one intended purpose and result increasing sales and, therefore, the claims for off-label uses of Neurontin submitted to Medicaid.''

The filing was to oppose Pfizer's request for summary judgment a ruling in its favor without a trial in the case.

Prosecutors said Parke-Davis misled doctors into believing that programs discussing uses for Neurontin were independent educational programs when they actually were marketing efforts led by Parke-Davis. For example, prosecutors said, Parke-Davis joined in an undisclosed relationship with a company known as Physicians World where Parke-Davis employees transferred to Physicians World to run Parke-Davis's speakers bureau.

At the same time, prosecutors said, a division of Physicians World, known as Professional Post-Graduate Services, purported to be an independent medical education provider that created a program on anticonvulsants for pain, but did not say that Parke-Davis staff planned and developed the program. Thousands of US doctors took the classes.

The US attorney's office said the company gave doctors kickbacks in the form of lavish trips and tickets disguised as educational or consulting payments. In one instance, prosecutors said, Parke-Davis paid for doctors to stay five days in Atlanta during the 1996 Summer Olympics. The doctors stayed at the Chateau Elan Resort and Winery, and the company covered their meals, use of the resort, and motorcoach travel to the games. Agendas for the meeting listed 10.5 hours of business meetings, including one session devoted to off-label uses for Neurontin, prosecutors said.

The government argued that in setting up the Medicaid program, Congress depended on the integrity of doctors' decisions in prescribing drugs, and that it is vital the process ''be untainted by self-interest or improper inducement.''

''For the programs to function in the best interests of public welfare individual patient health as well as the continued fiscal viability of the programs they must function free of the insidious effects of kickbacks and related financial conflicts of interest,'' wrote US Attorney Michael Sullivan and Assistant US Attorney Sara Miron Bloom.

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