An inside look at how Purdue Pharma pushed OxyContin despite
risks of addiction and fatalities.
By Fred Schulte JUNE
13, 2018
Purdue Pharma left almost nothing to chance in
its whirlwind marketing of its new painkiller OxyContin.
From 1996 to 2002, Purdue pursued nearly every
avenue in the drug supply and prescription sales chain — a strategy now cast as
reckless and illegal in more than 1,500 federal civil lawsuits from communities
in Florida to Wisconsin to California that allege the drug has fueled a
national epidemic of addiction.
Click here to dive into Purdue’s internal budget documents from
1996 through 2002, a 2001 sales bonus program and more.
Kaiser Health News is releasing years of Purdue’s internal
budget documents and other records to offer readers a chance to evaluate how
the privately held Connecticut company spent hundreds of millions of dollars to
launch and promote the drug, a trove of information made publicly available
here for the first time.
All of these internal Purdue records were
obtained from a Florida attorney general’s office investigation of Purdue’s
sales efforts that ended late in 2002.
I have had copies of those records in my
basement for years. I was a reporter at the South Florida Sun-Sentinel, which,
along with the Orlando Sentinel, won a court battle to force the attorney
general to release the company files in 2003. At the time, the Sun-Sentinel was
writing extensively about a growing tide of deaths from prescription drugs such
as OxyContin.
We drew on the marketing files to write two articles,
including one that exposed
possible deceptive marketing of the drug. Now, given the disastrous arc of
prescription drug abuse over the past decade and the stream of suits being
filed — more than a dozen on some days — it seemed time for me to share these
seminal documents that reveal the breadth and detail of Purdue’s efforts.
Asked by Kaiser Health News for comment on the
OxyContin marketing files and the suits against the company, Purdue Pharma
spokesman Robert Josephson issued a statement that
reads in part:
“Suggesting activities that last occurred more
than 16 years ago, for which the company accepted responsibility, helped
contribute to today’s complex and multi-faceted opioid crisis is deeply flawed.
The bulk of opioid prescriptions are not, and have never been, for OxyContin,
which represents less than 2% of current opioid prescriptions.”
The
marketing files show that about 75 percent of more than $400 million in
promotional spending occurred after the start of 2000, the year Purdue
officials told Congress they learned of growing OxyContin abuse and
drug-related deaths from media reports and regulators. These internal Purdue
marketing records show the drugmaker financed activities across nearly every
quarter of medicine, from awarding grants to health care groups that set
standards for opioid use to reminding reluctant pharmacists how they could
profit from stocking OxyContin pills on their shelves.
Purdue
bought more than $18 million worth of advertising in major medical journals
that cheerily touted OxyContin. Some of the ads, federal officials said in
2003, “grossly overstated” the drug’s safety.
The
Purdue records show that the company poured more than $8 million into a website
and venture called “Partners Against Pain,” which helped connect patients to
doctors willing to treat their pain, presumably with OxyContin or other
opioids.
It made
and distributed 14,000 copies of a video that claimed opioids caused addiction
in fewer than 1 percent of patients, a claim Food and Drug Administration officials
later said “has not been substantiated.”
Purdue
hoped to grow into one of the nation’s top 10 drug companies, both in sales and
“image or professional standing,” according to the documents; OxyContin was the
means to that end.
Purdue
first marketed the drug for cancer pain but planned to expand that use to meet
its multimillion-dollar sales goals. In 1998, the market for treating cancer
with opioids stood at $261 million, compared with $1.3 billion for treating
other types of pain, the Purdue reports note.
Purdue’s
OxyContin sales objectives were clearly stated in the earliest marketing plan
in the records, for 1996. It sought $25 million in sales and to generate
205,000 prescriptions. By the next year, its goals had tripled: $77.9 million
in sales and to generate 600,000 prescriptions.
Purdue bombarded doctors and other health
workers with literature and sales calls. Records show that in 1997 the company
budgeted $300,000 for mailings to doctors who prescribed opioids liberally,
based on sales data that drug companies purchase. The mailers recommended
OxyContin for “pain syndromes,” including osteoarthritis and back pain. It
added $75,000 for mailings “to keep in touch with our best customers for
OxyContin to ensure they continue prescribing it.”
Sales agents made thousands of visits to
general practice doctors and others who had little training or experience using
potent opioids, according to a 2003 Government Accountability Office audit. The
OxyContin slogan in 1999 was: “The One to Start With and the One to Stay With.”
OxyContin earned Purdue about $2.8 billion in revenue from the start of 1996
through June 2001, according to the Justice Department.
In May 2000, Purdue’s hope to conquer the
arthritis market hit a snag when the FDA criticized an ad for OxyContin in the
New England Journal of Medicine. The FDA said the ad, which Purdue Pharma
agreed to stop using, overstated the drug’s benefits for treating all types of
arthritis without pointing out risks.
News reports of abuse and overdose deaths also
were surfacing. Purdue’s 2001 marketing document noted that OxyContin had
“experienced significant challenges” the year before because of abuse and
unlawful diversion in Maine, Ohio, Virginia, Louisiana and Florida.
OxyContin pills contain oxycodone, an opioid
as potent as morphine and maybe more so. Abusers quickly figured out they
could crush the pills and snort or inject the dust
In response, Purdue’s 2001 marketing budget
included funding to help doctors recognize patients who were in need of
“substance abuse counseling” and do more to “prevent abuse and diversion.” It
added $1.2 million in spending for what it called “anti-diversion” efforts in
2002, according to the internal records.
Potent Sales Force
In 2002, The Florida attorney general’s office
was one of the first law enforcement agencies to investigate Purdue. The state
ended its probe after Purdue agreed to pay Florida $2 million to help fund a
data system to monitor narcotics prescriptions. It did not admit to any
wrongdoing in the settlement.
Yet handwritten notes of a state
investigator’s interview with a former Purdue sales manager for West Virginia
and western Pennsylvania named Bill Gergely, then 58, suggested otherwise. The
notes were part of the documents released by the state.
Gergely, who worked for the company from 1972
until 2000, said Purdue executives told sales staff at a launch meeting that
OxyContin “was non-habit forming,” according to the undated investigator’s
notes. Gergely said Purdue gave its sales force material — some of which was
not approved by the FDA — for “education,” the notes show. He told the
investigator that Purdue had a bonus system and paid well; the last year he
worked for Purdue, Gergely earned $238,000.
As Purdue charged ahead with OxyContin,
prescription pills overtook illegal drugs like heroin and cocaine as killers in
Florida, according to medical examiner files. In May 2002, the South Florida
Sun-Sentinel documentednearly 400 pill deaths in three
South Florida counties the previous two years, based on an examination of
autopsy and police records.
Half the deaths involved drugs that contained
oxycodone, according to medical examiner records. But it was not always clear
in these records that it was OxyContin because oxycodone was an ingredient in
many other narcotic pills. In 70 of the deaths, however, police or medical
examiner records specifically identified OxyContin as one of the drugs. Though
some people who died bought pills on a thriving black market, many were under
the care of doctors for what appeared, at least at some point, to be legitimate
injuries, according to medical examiner files.
Purdue did not challenge the accuracy of the
newspaper’s reporting. It countered that the articles “did a disservice” to the
company and patients who take their medicine “according to the directions of
their doctors.” While the company said its executives “deeply regret the tragic
consequences that have resulted from the misuse and abuse of our pain medicine
… advances in the treatment of pain should not be limited or reversed because
some people illegally divert, abuse or misuse these drugs.”
To its sales force, the internal Purdue
records show, Purdue blamed bad press for cutting into sales. “The media’s
attention to abuse and diversion of OxyContin tablets has provided state
Medicaid plans and some HMOs, concerned about the effect the product is having
on their budget, an excuse to look for ways to limit the prescribing of
OxyContin tablets,” the 2002 marketing document said.
But five years after its legal battle with
Florida officials, Purdue made a startling admission in federal court in
Virginia. The company pleaded guilty in 2007 to felony charges of “misbranding”
OxyContin “with the intent to defraud or mislead.” The company paid $600
million in fines and other penalties. Among the deceptions it confessed to was
directing its salespeople to tell doctors the drug was less addictive than
other opioids.
Three Purdue Pharma executives pleaded guilty
to misdemeanor criminal charges for their roles in the marketing scheme. The
three men paid a total of $34 million in fines and penalties, court records
show. Accepting Purdue’s plea deal, U.S. District Judge James P. Jones noted
that federal prosecutors believed the Purdue case of 2007 would send a “strong
deterrent message to the pharmaceutical industry.”
A Costly Reckoning?
Ten years on, the 1,500-plus lawsuits, filed
mostly on behalf of cities, counties and states, could prove to be a costly
reckoning for the opioid industry. The suits are demanding payback from Purdue
and other drugmakers for the sky-high costs of treating addiction and other
compensation, much as the litigation against Big Tobacco in the late 1990s.
Other drug makers named as defendants in most
of the suits include those that Purdue considered to be its top competitors in
the pain sector: Janssen Pharmaceuticals, Teva Pharmaceutical Industries, Endo
International PLC and Mallinckrodt PLC.
Federal officials estimate the economic cost
of opioid abuse topped $500 billion in 2015 alone. Since 1999, at least 200,000
people have died in the U.S. from these overdoses, according to the Centers for
Disease Control and Prevention. More than 52,000 of those died in 2015 alone,
more than were killed in car crashes and gun homicides combined, the suits
contend.
A case filed in April by Baltimore County in
Maryland makes an argument common to many of the suits:
“From the mid-’90s to the present, manufacturing
defendants aggressively marketed and falsely promoted liberal opioid
prescribing as presenting little to no risk of addiction, even when used long
term for chronic pain. They infiltrated academic medicine and regulatory
agencies to convince doctors that treating chronic pain with long-term opioids
was evidence-based medicine when, in fact, it was not.
“Huge profits resulted from these efforts — as
did the present addiction and overdose crisis.”
Purdue has not yet filed a response to the
allegations in the suit.
Other drug manufacturers “emulated Purdue’s
false marketing strategy” and sold billions of dollars of prescription opioids
“as safe and efficacious for long term use, knowing full well that they were
not,” Wisconsin’s Oneida County alleges in its November 2017 federal court
suit. Purdue also has not yet filed a response to the allegations in this suit.
But Purdue spokesman Josephson told KHN: “We
share public officials’ concern about the opioid crisis, and we are committed
to working collaboratively toward meaningful solutions. We vigorously deny
these allegations and look forward to the opportunity to present our defense.”
One California doctor who was sentenced to 25
years in prison for overprescribing OxyContin is also suing Purdue. Masoud
Bamdad alleges that the company’s representatives made sales calls and gave him
“deceitful, misleading and over-hyped information,” which he relied on to
prescribe the drug, in some cases with deadly consequences for his patients,
according to the suit, which is pending. Purdue has asked that the case be
stayed while judges decide if it should be consolidated with others filed
against the company. In February, Purdue announced that it would no longer
promote opioids to doctors.
Because the lawsuits from across the U.S.
contain similar allegations, many of them have been consolidated in Ohio – as a
multi-district litigation. Some days, federal court dockets log a dozen or more
new cases. Many of the suits run a hundred pages or more and allege that
deceptive opioid marketing schemes continue to this day.
The manufacturers, in a joint court motion
late last year, contend that opioids “serve a critical public health role in
providing relief to patients suffering from pain that is often debilitating”
and that they are being wrongly blamed.
They also point out that the FDA approved all
of their products as “safe and effective.”
This month, the manufacturers filed motions to
dismiss several of the cases, arguing that the county governments lack a legal
basis for their claims. In seeking to blame the drugmakers, these lawsuits
ignore “the criminal acts of third parties, the crucial role of health care
providers, and the thorny public policy questions surrounding the problem of
opioid abuse,” reads a motion to dismiss a case filed by Monroe County, Mich.,
against Purdue Pharma and other drug companies.
Dan Polster, the federal judge handling the
cases, told an overflow crowd in his courtroom that the opioid epidemic has
become so severe, that it is cutting the average life expectancy of Americans.
“I’m pretty ashamed that this has occurred
while I have been around,” he said in January, adding “I think we all should
be.”
KHN’s
coverage of prescription drug development, costs and pricing is supported in
part by the Laura and John
Arnold Foundation.
Fred
Schulte: fschulte@kff.org,
@fredschulte
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