May 25, 2006 at 17:01:18

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Neurontin Deal - Slap On The Hand To Pfizer

By Evelyn Pringle (about the author)     Page 7 of 12 page(s)

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"Indeed," the prosecutor wrote, "in one study ... the placebo was as effective or more effective than was Neurontin."

Moreover, the DOJ found the company paid no attention even when the FDA did refuse to approve an additional use. For instance, Parke-Davis sought approval for use as a monotherapy on September 16, 1996, but because one of 2 clinical trials submitted with the application showed no demonstrable monotherapy efficacy, on August 26, 1997, the FDA rejected the application.

Nonetheless, the DOJ found that Parke-Davis had actively promoted the drug for monotherapy before it applied for approval, and after the FDA rejected its application right through at least 2000, when slides, lecture summaries and audiotapes obtained by the DOJ demonstrate that Parke-Davis continued to promote Neurontin for monotherapy without ever mentioning the fact that the FDA had rejected its application.

Documented examples listed by the DOJ, of statements made after the FDA's non-approval include a marketing event in 1998, where Parke-Davis went so far as to state that Neurontin was “now approved as monotherapy for seizures.”

In his whistleblower lawsuit, Mr Franklin explained how Warner-Lambert had hired two marketing firms to write favorable articles about the unapproved uses of Neurontin and to find doctors willing to sign their names as the authors. The marketing firms, he said, were paid $12,000 for the articles and the doctors were paid $1,000 for signing off as authors.

The off-label scheme proved to be highly successful. By government estimates, citing company documents and independent market research, by 2002, 94% of Neurontin's sales were for off-label use, up from 40% in 1995.

At the time of the settlement in 2004, Vermont Attorney General, William Sorrell, noted that a 30-day supply of Neurontin at a common dose sold for $205.

Under the terms of the settlement agreement, Pfizer agreed to:

(A) plead guilty to inadequately labeling of Neurontin and to introducing Neurontin into interstate commerce for unapproved purposes, which, by virtue of its prior violation of the Food, Drug & Cosmetic Act, constitute felony violations of the Act, and to pay a $240,000,000 criminal fine;

(B) settle its False Claims Act and other civil liabilities and to pay the Government $83,600,000, plus interest, in civil damages for losses suffered by the federally funded portion of the Medicaid program as a result of off-label promotion of Neurontin;

(C) settle its civil liabilities to the 50 states and the District of Columbia in an amount of $68,400,000, plus interest, in civil damages for losses suffered by the state-funded portion of the Medicaid program as a result of off-label promotion of Neurontin;

(D) settle its civil liabilities to the Consumer Protection divisions of 50 states and the District of Columbia state attorney general's offices in an amount of $38,000,000, plus interest, in civil damages for losses suffered by consumers and to fund a remediation program designed to offset the impact of the improper marketing of Neurontin; and

(E) comply with the terms of an amendment to the corporate compliance program of its parent, Pfizer, which, among other things, proscribes off-label marketing and requires training of employees and audits of its marketing practices.

At the time of the settlement, Pfizer issued a statement that said the illegal practices took place before Pfizer acquired Warner-Lambert in 2000. However, even if true, sales figures reveal that Pfizer was still reaping the benefits of the scheme at the time of the settlement.

For instance, on August 19, 2004, USA Today noted that: "Pfizer's confession that the success of one of its top drugs was built partly on fraud may have been humbling, but it isn't hurting the bottom line. Neurontin sales last quarter rose 32% from a year ago, and 2004 sales should pass last year's $2.7 billion."

"With few exceptions," USA said, "state Medicaid programs pay for Neurontin just as before and so do major insurers."

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