Purdue faces hundreds of lawsuits, and has filed for bankruptcy protection, because of its aggressive marketing and sales of OxyContin (Drew Angerer) |
In 2002,
Andrew Kolodny, a resident in psychiatry, attended a training session on pain
treatment in Philadelphia.
Seventeen
years later, he still shakes his head over the surprising enthusiasm of the
lecturer, an authority on the topic, for prescribing opioids.
"The
message was that people are suffering because of an overblown fear, and the
correct and compassionate way to treat pain is to prescribe aggressively,"
Kolodny recalled.
The
lecturer, Thomas McLellan, had shown the class a short film examining the case
of a man seeking relief from chronic back pain.
The patient
had been prescribed a strong regimen of OxyContin, the pain medication produced
by Purdue Pharma -- but he wanted more, complaining of crippling agony.
After the
film, McClellan asked the doctors in the class for their diagnosis.
"For
me and for most of the people in the room, the obvious diagnosis was that this
patient became addicted to their medicine," said Kolodny, who is now the
co-director of opioid policy research at Brandeis University's Heller School in
Boston.
"The
surprise was that the person teaching the class said it's not true addiction.
It's a pseudo-addiction."
McLellan
insisted the problem facing the seemingly addicted patient was that he was not
getting enough drugs, Kolodny recalled.
At the
time, the concept of "pseudo-addiction" was being advanced by Purdue
Pharma and other laboratories to promote their opioid products.
OxyContin,
an anti-pain medication similar to morphine, was introduced to the American
market in 1996 with a campaign that swept aside years of caution on the use of
opioids, previously reserved for the gravely ill because of their highly
addictive nature.
The
campaign featured deceptive marketing, controversial sales practices and
endorsements from eminent physicians generously remunerated by Purdue Pharma.
But as a
result of the singularly aggressive promotion of the prescription drug, both
Purdue and the Sackler family, which owns the firm, now face more than 2,300
lawsuits in the United States.
They stand
accused of having provoked the nationwide opioid crisis.
Opioids are
blamed for more than 400,000 deaths by overdose since 1999, according to recently
published data, and on average for more than 130 deaths a day.
Contacted
by AFP, Purdue Pharma declined to comment.
A green light
Opioid
painkillers like these are linked to thousands of overdose deaths
in the US
(Eric Baradat)
|
A green light
The origins
of OxyContin, which has generated more than $35 billion in sales for Purdue,
date to 1990.
The laboratory,
based in the northeastern US state of Connecticut, was looking for a successor
to its popular analgesic MS Contin, a morphine-based medication prescribed
mainly to cancer patients but which was facing growing competition from generic
drugs.
Purdue developed
a painkiller based on oxycodone, a semi-synthetic opioid first concocted in
Germany in 1916, with effects comparable to those of MS Contin.
Opioids
posed well-known risks of dependence, but the laboratory had an answer: the new
drug's beneficial effects would last 12 hours, twice as long as similar
medications, meaning a patient would take fewer pills and face reduced danger
of addiction.
But even
before it reached the market, tests showed that OxyContin's effects did not
last as long as originally thought, the Los Angeles Times found in a 2016
investigation.
Still, in
December 1995, the US Food and Drug Administration (FDA) gave Purdue a green
light to market OxyContin for the treatment of moderate to severe pain,
authorizing its use for a range of ailments, many less serious than cancer.
"At
the time of approval, FDA believed the controlled-release formulation of
OxyContin would result in less abuse potential, since the drug would be
absorbed slowly and there would not be an immediate 'rush' or high," an
agency spokesman told AFP.
The FDA's
approval drew growing criticism after Curtis Wright, a doctor who led the
agency committee that authorized OxyContin, left to take a senior position with
Purdue in 1998.
Another
troubling development: once the drug was being marketed and aggressively
promoted, OxyContin generated a huge black market that Purdue, critics say,
ignored or minimized for far too long.
Quantities
of pills were procured -- stolen from pharmacies or obtained from unscrupulous
doctors -- and ground into powder to be inhaled, which multiplied their
euphoric effects, according to a confidential US Justice Department report
cited by The New York Times in 2018.
The
80-milligram pills, the most common dose, sell for $65 to $80 on the black
market, compared to $6 in pharmacies, according to several doctors questioned
by AFP.
An
explosion in sales
Despite the
warning signals, Purdue continued to present OxyContin as being less addictive
than other opioids.
The
company's advertising budget surged from $187,500 in 1996 to $4 million in
2001, according to internal documents.
Purdue also
built up a so-called "speakers' bureau" -- mainly physicians highly
remunerated for attesting to the "miracle" qualities of OxyContin.
Sales
exploded -- rocketing from $80 million in 1997 to $2.1 billion only four years
later, internal documents showed.
Purdue also
enlisted the help of the American Academy of Pain Medicine (AAPM) and the
American Pain Society (APS), two respected professional organizations
specializing in pain treatment, to support its campaign to destigmatize
opioids.
Purdue
helped finance both organizations, and several of their members worked as
consultants for the laboratory.
Underscoring
the close relationship, David Haddox, who headed an APS committee that endorsed
the increased use of opiates, was hired by Purdue in 1999, where he remained
until earlier this year.
Purdue's
sales pitch to physicians was probably helped by the fact that pain treatment
has long been a neglected branch of medicine, said Gregory Terman, director of
the Acute Pain Service at the University of Washington and the APS president
from 2015 to 2017.
"Until
the opioid crisis, NIH (the National Institutes of Health) had never spent more
than one percent of their budget on pain -- the most common reason people go to
doctors -- let alone chronic pain, which troubles more than 100 million
Americans," he said.
The APS,
facing lawsuits over its promotion of opioids and unable to pay its lawyers,
filed for bankruptcy in late June.
Primary
care doctors "have little training in addiction or pain, and many of them
believed the promises" made by Purdue, Stanford University psychiatry
professor Keith Humphreys said.
Legal
problems mount
In 2006,
the medical world finally awoke to the dangers of OxyContin, jolted by an
article by Leonard Paulozzi of the Centers for Disease Control and Prevention
(CDC), who reported that deaths linked to opioids had exploded by 91 percent
from 1999 to 2002.
In 2007,
for the first time, Purdue Pharma and three of its executives pleaded guilty,
in Virginia, to having deceived physicians, patients and regulatory authorities
about the risks posed by OxyContin of dependence or abuse. They agreed to pay
$635 million in fines.
Yet when
Purdue's legal problems grew in the United States and OxyContin sales fell in
2010, the company simply turned to its international subsidiary Mundipharma to
promote sales in other parts of the world.
In Europe,
where drug ads targeting the general public are banned, Mundipharma aired one
in Spain in 2013 drawing attention to the problem of chronic pain and
encouraging people to see a doctor and demand treatment.
Asked about
that, a Mundipharma spokesperson said only: "We no longer have any such
activity today."
The group
has also financed seminars for physicians in other countries -- notably Brazil
and China -- to promote opioids as effective pain treatment, the Los Angeles
Times reported in 2016.
Joseph Pergolizzi,
a Florida doctor who the newspaper said had lectured in 2016 at a
Mundipharma-sponsored conference in Brazil, rejected any suggestion of
deceptive marketing.
"I was
invited to a cancer pain conference," he told AFP, adding that he had
spoken about "severe cancer pain treatment and what the options are."
Pergolizzi
said he had severed all ties to Mundipharma two years ago.
Purdue
files for bankruptcy
Purdue has
repeatedly stated that OxyContin is only one of several opioid medications on the
market, and that it now fights actively against the abuse of such drugs.
It sought
bankruptcy protection in mid-September and is now urging the states and cities
suing it to agree to its transformation into a trust, with any future profits
to be used to alleviate the harm caused by the opioid crisis.
The
laboratory has said it is ready to make payments to the plaintiffs totaling $10
billion to $12 billion -- with $3 billion coming from the Sackler family -- if
they drop all legal action.
But nearly
25 states, including New York, have rejected the proposal.
The offer
from Purdue and the Sacklers falls far short of paying for "the death and
destruction they inflicted on the American people," said New York Attorney
General Letitia James.
In the US, drug deaths have overtaken homicide, suicide and motor-vehicle accident fatalities since 1999 pic.twitter.com/5xfwIUZZrc— AFP news agency (@AFP) 18 oktober 2019
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