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,�
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:
sales reps to provide one-on-one sales pitches, or "details," to
physicians about off-label uses of Neurontin;
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
(3) Paying doctors
to allow a sales rep to see patients with the doctor and to participate in
discussing the treatment plan;
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;
frequent teleconferences in which doctors were paid to speak about Neurontin on
off-label topics to other doctors; and
independent "medical education" events on off-label uses where there
was actually extensive input from the company on topics, speakers, content, and
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.
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.
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."
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
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
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.
show, the DOJ says, that the company focused its attention on recruiting
doctors from major teaching hospitals to serve as "Neurontin
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
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
Evelyn Pringle is a
columnist for OpEd News and an investigative journalist focusing on exposing corruption in government.