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OxyContin touted as virtually nonaddictive, newly released state
records show
By Fred Schulte
Staff Writer
Posted March 6 2003
A former OxyContin sales manager says he used misleading
marketing tactics to boost sales, including telling some
doctors that
the addictive narcotic was "non-habit forming."
William Gergely, Purdue Pharma's district manager for West
Virginia
and western Pennsylvania for 27 years until he was fired in
2000,
made the statements in an August interview with a Florida
Attorney
General's Office investigator, newly released records show.
"They told us to say
things like it is
`virtually'
non-addicting,"
Gergely told the
South Florida
Sun-Sentinel. "That's
what we were
instructed to do.
It's
not right, but that's
what they told us to
say."
His statement is
among the first to
surface alleging
Purdue Pharma
executives may have
played a role in
directing their sales
force to downplay addiction and safety concerns with the
drug,
which has been tied to hundreds of overdose deaths in recent
years.
"We were not aware of, nor have we seen, the record of the
interview of Mr. Gergely by the Florida Attorney General's
Office,"
said James Heins, the company's director of public affairs.
"As a
result, we cannot comment on any statements that he made in
the
interview."
Heins also declined to answer written questions the newspaper
posed about its marketing of OxyContin. He cited "proprietary
information that the company does not disclose for
competitive
reasons" and pending lawsuits.
Notes of Gergely's interview are among hundreds of pages of
documents released to the Sun-Sentinel after the newspaper
won a
lawsuit to make them public. Late last month, Florida
Attorney
General Charlie Crist released seven years of OxyContin
marketing
plans, which showed that Purdue Pharma drove sales from $25
million in 1996 to $1.2 billion last year by persuading
doctors to
prescribe it for ailments ranging from low back pain to
arthritis.
In his interview with the attorney general's office, Gergely
admitted
using marketing materials in sales calls to doctors' offices
that he
did not think met U.S. Food and Drug Administration standards
for
objectivity. He said the company supplied him with the
materials.
Gergely is the only person the state talked to on a list of
more than
100 former and current sales employees which Purdue Pharma
turned over to the state in July as part of an investigation
of
OxyContin marketing.
$2 million settlement
Then Attorney General Bob Butterworth ended the inquiry in
November when Purdue Pharma agreed to pay $2.1 million to
help
the state set up a computer databank to monitor prescription
drug
abuse.
OxyContin is a brand form of the narcotic oxycodone, a drug
similar
to morphine. Its time-release system allows pain release for
up to
12 hours with a single dose, far longer than competing drugs.
Pain management specialists have praised the drug,
particularly to
help cancer patients. But abusers have thwarted the
time-release
feature by crushing and either injecting or snorting the
pills. That
unleashes the full dose at once, causing euphoria and
sometimes
death.
Purdue Pharma spokesman Heins said the company has "very
clear
and strict" procedures that marketers must adhere to in
promoting
OxyContin. He said the company "has disciplined and
terminated"
sales people who violated these standards, but declined to
say how
many.
Gergely, whose sales turf included West Virginia, where abuse
of the
drug became so common it was nicknamed "Hillbilly heroin,"
said in
his statement that he "didn't know of anyone that has been
disciplined or terminated for using unauthorized sales
material."
Two other current or former sales employees interviewed by
the
Sun-Sentinel corroborated Gergely's account. All three
described a
feverish sales campaign. They said salespeople were regularly
sent
voicemails from the company's Stamford, Conn., headquarters
urging
them to shatter previous records, for which they could count
on
being among the best-paid sales force in the industry.
Gergely said he earned $238,000 in his final year -- a salary
of
$85,000 and the rest from bonuses, most of it tied to the
exploding
sales of OxyContin.
Gergely, who supervised about 10 sales reps, said he was
fired in
April 2000 after a dispute over alleged discrimination
against women.
The veteran salesman told state investigators that two top
Purdue
executives attended a "launch'' sales meeting for OxyContin
at
which attendees were advised the drug was "non-habit
forming." He
said Jim Lang, Purdue Pharma vice president for sales and
marketing
and Russ Gasdia, national sales manager, were there,
according to
the state investigator's notes.
Gergely also supplied the attorney general's office with a
copy of an
unapproved paper he said he used as part of his sales pitch.
It is
titled "The Role of Opiods in Chronic Pain: A Case for
OxyContin,"
and was written by Gregory Holmquist, a pharmacist in
Washington
state.
Holmquist told the Sun-Sentinel that he has given
presentations on
OxyContin to a number of groups that accepted grant money
from
Purdue Pharma, but had no knowledge of his work being used to
spur sales.
"If a sales rep was using this material he would have been
using it
on his own," he said. Gergely said the company encouraged
sales
agents to suggest that OxyContin's time-release feature would
prevent addiction, even though all narcotics cause dependence
over
time.
`It was deceptive'
"You'd tell the doctor there is a study, but you wouldn't
show it to
him," he said. "I think it was deceptive."
Other "patient education" materials Purdue Pharma turned over
to
the Florida Attorney General's Office appear to downplay
risks of
addiction.
One is a pamphlet printed by "Partners Against Pain," a group
funded
at least partly by $4 million from Purdue Pharma in the past
two
years. The pamphlet was written for doctors to hand out to
patients with questions about their use of OxyContin.
Concerns that the drug is addictive are answered with:
"Drug addiction means using a drug to get `high" rather than
to
relieve pain. You are taking opioid pain medication for
medical
purposes. The medical purposes are clear and the effects are
beneficial, not harmful," the brochure states.
Whether the brochure or other literature passed to patients
or
doctors complies with FDA regulations is unclear. The FDA
doesn't
require drug companies to gain approval of marketing
materials.
However, it can review sales guides and advertisements and
order
corrections.
In January, for instance, the FDA admonished Purdue Pharma
for
failing to point out "serious, potentially fatal risks" of
using
OxyContin in advertisements placed in medical journals, and
ordered
the ads pulled.
Purdue Pharma records show that in November 2001 the company
took action to discourage its sales staff from profiting off
doctors
who illegally or improperly prescribed OxyContin.
That month, the company told its sales force that any
commissions
from sales to a doctor who had been arrested or investigated
for
improper prescribing would be deducted from their bonuses.
Purdue Pharma's marketing of OxyContin, and its plans to
introduce
a new narcotic painkiller once the FDA clears it, also face
congressional scrutiny.
Last week, House Energy and Commerce Committee Chairman W.J.
"Billy" Tauzin, R-La, asked the company to turn over by March
21 a
wide range of marketing records, including court depositions
of
salespeople and records describing the sales bonus plan.
The committee also asked for Purdue Pharma's marketing plan
for
Palladone, a time-release version of the often-abused drug
hydromorphone, also known as Dilaudid.
Drug Enforcement Administration officials have told the FDA
that
abuse of Palladone could exceed OxyContin. Dilaudid has long
been
abused in South Florida, mostly because a small number of
doctors
have indiscriminately prescribed it to addicts.
Staff Writer Nancy McVicar contributed to this report.
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