NEW YORK, Oct 25, 2019 (AFP) – 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 –
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.