The Pfizer case broke new legal ground by recovering losses to Medicaid resulting from the illegal off-label promotion of a drug for uses other than those approved as safe and effective.

At the time of the settlement in May 2004, Pfizer's drug, Neurontin, ranked ninth among all drugs sold in the US, with annual sales of $2.7 billion, according to IMS Health, �Leading 20 Products by U.S. Sales, Moving Annual Total, June 2004,� www.imshealth.com.

The whistleblower, David Franklin, a former medical liaison for Parke-Davis, who filed the FCA lawsuit, received a $24.6 million settlement, when Warner-Lambert agreed to plead guilty to two felonies to settle charges that it fraudulently promoted Neurontin for a wide variety of unapproved uses.

Among the tactics the DOJ found the company using to achieve its goal of increasing off-label use of Neurontin were the following:

(1) Encouraging sales reps to provide one-on-one sales pitches, or "details," to physicians about off-label uses of Neurontin;

(2) Utilizing medical liaisons, who represented themselves, often falsely, as neutral scientific experts on Neurontin, to promote off-label uses, working in tandem with the sales reps to directly sell Neurontin to physicians for off-label uses;

(3) Paying doctors to allow a sales rep to see patients with the doctor and to participate in discussing the treatment plan;

(4) Paying physicians, through both direct payments, and trips, hotel rooms, dinners and other benefits, to attend meetings termed �consultant� or �advisory� meetings or �speaker bureau trainings� in which doctors received listened to presentations about off-label uses;

(5) Implementing frequent teleconferences in which doctors were paid to speak about Neurontin on off-label topics to other doctors; and

(6) Sponsoring independent "medical education" events on off-label uses where there was actually extensive input from the company on topics, speakers, content, and participants.

"Neurontin was marketed for four broad categories of unapproved use: pain, psychiatric

use, monotherapy and dosage," the DOJ stated. In fact, the company promoted the drug for so many unapproved uses, the DOJ said, "some employees referred to the list of these uses as the 'snake oil' list."

In the settlement agreement, the company admitted that it aggressively marketed the drug by illicit means for unapproved uses including pain, bipolar disorder, migraines, and drug and alcohol withdrawal.

The prosecutors described the harm that resulted from the off-label scheme as: (1) health care reimbursement programs such as Medicaid paid more in reimbursement; (2) consumers paid for ineffective, experimental use and may have been improperly medicated; (3) improper medication could have resulted where Neurontin was not as effective as another approved drug; and (4) unnecessary exposure of patients to adverse side effects of Neurontin.

The prosecutors said Warner-Lambert turned Neurontin into a blockbuster drug with promotional tactics like paying doctors "honoraria" to listen to sales pitches on the off-label use of the drug and by treating physicians to luxury trips to Florida, Hawaii, and Atlanta for the 1996 Olympics.

According to court documents filed in the case, doctors were paid honoraria to listen to presentations that took place at: �Bus to Yankee Stadium,� �World Yacht Cruise� and �Braves Stadium.�

On one weekend in April 1996, the DOJ discovered that Warner-Lambert had arranged two weekend �consultant� meetings, one at the Jupiter Beach Resort in Palm Beach, Florida, and the other at the Ritz-Carlton in Aspen, Colorado. Both were three-day affairs, for which each attendee received a $250 cash payment, plus airfare, and all other expenses paid at the resort, and the doctors who acted as faculty were also paid between $1,500 and $2,000.

According to the DOJ, the total cost for the Jupiter Beach weekend was approximately $361,000 for about 100 doctors, meaning the price per doctor was about $3,000, and the cost of the Aspen weekend ran about the same.

Documents showed that both meetings included presentations on off-label topics such as �Neurontin: Use as Monotherapy,� and �Reduction of Pain Symptoms During Treatment with Gabapentin,� that were designed to present information to the attendees, rather than to receive information from consultants.

One advisory board was treated to an extravaganza at the 1996 summer Olympics in Atlanta, Georgia. Along with free Olympics tickets valued at $650 each, the company staged an Epilepsy Advisory Meeting, at the Chateau Elan Winery and Resort in Atlanta.

The brochure for the event describes the resort as: "Chateau Elan has made a name for itself as a fine winery. It is now earning a reputation as a one-of-a-kind resort . . . Here, you�ll enjoy all the comforts and amenities you�d expect of a fine resort, mellowed by the warm ambiance of a French country inn."

"During your meeting breaks," the brochure says, "you will have the opportunity to play a round at one of three accessible golf courses, swim, play tennis, explore the Georgia hill country by foot or by horseback, or escape to Chateau�s European style spa for a pampering body treatment. . . ."

For this event, records show the company paid all expenses for 18 advisers and their spouses, and each adviser was given $750 in cash for spending. In planning the Olympics advisory board meeting, a company document obtained by the DOJ, referred to the cost of the event as a �$3 million investment.�

Another example of the lavish meetings doctors attended for free, was the Western Advisory Board Meeting, held at the Grand Wailea Resort, Hotel & Spa in Maui, Hawaii in April 2000.

Only one of the attendees resided in Hawaii and the company paid for all of the others to fly to Hawaii for a two-night stay at the resort to attend only three hours of meetings, all on off-label uses of Neurontin, according to the DOJ.

In planning this meeting, the company targeted doctors whose uses for Neurontin were only off-label and "evidence shows this event was promotional, not an independent, scientific meeting," according to the DOJ's sentencing memorandum.

The DOJ said Parke-Davis held hundreds of meetings where doctors were paid to attend, and paid even more to speak and that Parke-Davis was especially interested in two types of physicians: (1) those who prescribed large amounts of anticonvulsants; and (2) those who had a prominent reputation.

These doctors were often referred to as the �movers and shakers� or �thought leaders� because of their influence, and were recruited as spokespersons on behalf of Neurontin.

Parke-Davis paid key �thought leaders� well who could be counted on to deliver a strongly favorable message on off-label use. At least 20 of these doctors, the DOJ said, were paid more than $50,000 over time for speaking on the company�s behalf. In fact, some received in excess of $250,000.

Corporate documents show, the DOJ says, that the company focused its attention on recruiting doctors from major teaching hospitals to serve as "Neurontin champions."

For example, documents show that Dr Steven Schachter, a professor at Harvard Medical School and a physician at Beth Israel Deaconess Medical Center in Boston received $71,477 between May 1994 and September 1997, and a Dr B.J. Wilder, a former professor of neurology at the University of Florida, was paid more than $300,000 for speeches given between 1994 and 1997. Six other doctors, including some from top medical schools, the DOJ said, received more than $100, 000 each.

The most common forums for speakers were consultant and advisory board meetings, where doctors were gathered to listen to a presentation. Parke-Davis justified holding these meetings, because it entered into pro forma consultant agreements with the physician attendees and doctors were paid anywhere from $250-$2,500 to serve as consultants or advisers.

In one six-month period alone, the DOJ said, Park-Davis held over 50 meetings and despite being called �consultant� meetings, the actual objective was to provide off-label information to the doctors rather than to receive information from the consultants.

During its investigation, the DOJ discovered that doctors were misled into believing that educational programs they attended were independent programs when they were actually led by the drug maker. For example, prosecutors found a Ward-Lambert relationship with a company known as Physicians World, where Warner-Lambert employees transferred to Physicians World to run the company's speakers bureau.

Part 3: Pfizer embroiled in massive lawsuit suit over off-label use of Neurontin