by Kelly_Bourdet on Tuesday, Sep 18, 2012 - Mother Board
Frank Morris was only 23 when he ended up in
rehab. But he was already a full-blown junkie, smoking crack on the
streets of San Francisco, and nearly losing his left arm after
accidentally pumping a full shot into his artery. He tells me the drug
that led him down this path — that helped him accelerate from a teenager
smoking pot in his parent’s basement to a young man shooting heroin in a
filthy apartment — was OxyContin, a pain medication that has proved
dramatically helpful to those in pain, and dangerously addictive too.
Matthew began taking painkillers –
Percocet, then OxyContin – as a
teenager. His father was battling cancer, so narcotics were readily
available in the house. While vacationing in Florida, he was unable to
take the number of pills his body had become dependent upon. At the peak
of his addiction, Matthew was taking nine 80mg pills a day, for a
combined 720mg. He bought them off of a local friend who was prescribed
300 per month for her
Fibromyalgia,
a syndrome in which a person has long-term, body-wide pain and
tenderness in the joints, muscles, tendons, and other soft tissues. He
told me about his confusion at his typical withdrawal symptoms –
vomiting, aches, sweating, headaches. He thought he had a bad flu.
He
went to the hospital because he felt so ill, though he didn’t honestly
answer doctors’ questions about his drug use. Doctors were confused by
his symptoms, even giving Matthew a spinal tap to investigate. After
leaving the hospital, he took some pills and his horrible “flu symptoms”
miraculously disappeared.
Courtney, 28, was already a seasoned drug addict at age seventeen.
When she left a treatment facility after overcoming a methamphetamine
addiction, she tried OxyContin, thinking it would be easier to control.
She immediately liked it. Within two months she was taking it everyday –
and getting extremely dope-sick when she couldn’t find it. In a
familiar sequence of events, she went from snorting to shooting Oxy, and
then shooting heroin when she couldn’t find any Oxys. She bought blank
prescription pads on the black market, forging OxyContin prescriptions
to fuel her habit. She was eventually caught trying to fill a fake
prescription at a local pharmacy. She eventually detoxed in a jail cell.
Next April, the patent on the original formulation of OxyContin
expires; what happens next depends upon, to a large extent, what’s
already happened. And it’s been a mess.
The active ingredient behind the drug,
oxycodone, isn’t new. The compound was originally synthesized
in Germany
in 1916. The patent on the medication had expired well before
Purdue
Pharma, a Stamford, Connecticut-based pharmaceutical company and the
industry leader in pain medication, released it under the brand name in
1996. The genius of Purdue’s continued foray into pain-management
medication – they had already produced versions of
hydromorphone,
oxycodone, fentanyl, codeine, and
hydrocodone – was twofold. They not
only created a drug from an already readily available compound, but they
were able to essentially re-patent the active ingredient by introducing
a time-release element. Prior to the 1990s, strong opioid medications
were not routinely given for miscellaneous or chronic, moderately
painful conditions; the strongest classes of drugs were often reserved
for the dying.
But Purdue parlayed their time-release system not only
into the patent for OxyContin. They also went on a PR blitz, claiming
their drug was unique because of the time-release element and implied
that it was so difficult to abuse that the risk of addiction was “under
1%.”
To cement the brand’s reputation among doctors, Purdue conducted more
than 40 national pain-management and speaker-training conferences at
resorts in Florida, Arizona, and California between 1996 and 2001. They
invited over 5,000 physicians, pharmacists, and nurses to these
all-expenses-paid symposia.
Many were recruited and trained for Purdue’s national speaker bureau.
Purdue offered starter coupons offering a free 7-30 day trial of their
medication, a practice that’s common among pharmaceutical companies for
everything from skincare medicine to contraceptives. OxyContin became an
instant hit among doctors, many of whom saw it as a wonder drug in the
battle against the debilitating effects of chronic pain. As the good
news spread sales of the drug mushroomed, rising from $40 million in
1996 to more than $1 billion in 2001, outstripping even Viagra.
Meanwhile, Purdue’s campaign to extend the use of powerful narcotics to
ordinary chronic ailments – for which the drug has been well documented
to help – proved highly successful. By 2003, over half of the OxyContin
prescriptions written in the United States
were written by a primary care physician.
Anyone who has ever had to face the sad reality of being close to a
drug addict or alcoholic quickly learns an important lesson. Namely,
that when it comes to getting and using mind-altering substances, active
drug addicts are among the most resourceful, ingenious, and crafty
humans on the planet. I’ve known people who drank hairspray in detox
units to get a buzz. So how difficult was it to circumvent the
time-release element of the original OxyContin?
“The fact that I could freebase it the way that I did,” Frank says, “is really freaky.”
See, the proprietary time-release mechanism was essentially a waxy
coating that could be peeled off using a razor blade or dissolved using
water or saliva. Turning the “safe” version of OC into a highly-abusable
form was about as difficult as peeling a tiny apple. The death rate
from overdoses of opioids in 2007 was roughly three times that of 1991.
In 2008, deaths from opiate overdose surpassed the combined overdose
deaths of cocaine and heroin. This year
the CDC says that, “opioid overdose resulted in 14,800 deaths, accounting for 73.8% of all prescription overdose deaths.”
Young Markets
Many safety trials for pharmaceuticals do not test children under the
age of sixteen. To combat the rampant prescription of adult drugs to
kids by pediatricians, the Food and Drug Administration offers
incentives for companies who design tests specifically for children. One
of these incentives is a six-month patent extension.
Sometime this year, Purdue Pharma
began paying
dozens of clinical sites around the country to document what happens
when OxyContin is given to children. This wasn’t the first time the
company had conducted pediatric trials of OxyContin: they initiated
tests on children in 2004,
but halted the study citing financial constraints.
That year, a federal District Court in Manhattan found the company
guilty of deliberately misleading federal officials in order to retain
exclusive patents and prevent cheaper generic versions of OxyContin from
hitting the market.
When Purdue’s new trials were reported this year by
The Daily,
critics and especially addiction specialists, concerned about
administering a highly addictive drug to children, wondered if the tests
had something to do with the expiration date of Purdue’s patent for the
drug: April 2013.
“[Purdue is] doing [the pediatric trial] for patent exclusivity,
there’s no doubt about it in my mind – not out of largesse,” Dr. Elliot
Krane of Stanford University’s Lucile Packard Children’s Hospital told
The Daily in July. “That’s important for their bottom line.” In 2004,
Purdue Pharma reported $1.7 billion in gross sales of OxyContin. Last
year, Purdue saw $2.8 billion in sales of the drug.
Still, Purdue said that “resources” were an issue. “We reinitiated
the remaining pediatric trials once we had the necessary resources to
continue them,” said James W. Heins, a company representative. “These
trials are challenging to conduct and can take years to complete.”
20mg and 80mg OxyContin pills (via)
However ulterior Purdue’s motives are, and however risky testing
OxyContin on kids might sound, the trials aren’t without basis. Despite
the skepticism of critics, Purdue says it doesn’t plan to attempt to
market its drug to pediatricians, a shift that would require rigorous
FDA
review. But doctors already regularly prescribe Oxy for children
suffering conditions of moderate or severe pain, a practice that’s
accompanied by little to no data predicting how it might affect them and
what their long-term outcomes might be. This phenomenon is called
“off-label use,” one
defined as
the practice of prescribing pharmaceuticals for an unapproved
indication or in an unapproved age group, unapproved dose or unapproved
form of administration."
Pharmaceutical companies can’t officially promote their drugs for the
treatment of any conditions for which it has not received formal
FDA
approval. But that doesn’t stop off-label prescribing from happening
all the time. In the United States, physicians are granted generous
leeway in prescribing drugs for uses and patients other than their
intended ones. Last month, GlaxoSmithKline, the British multinational
pharmaceutical maker, was slapped with a $3 billion fine, the largest in
the industry’s history,
for promoting the off-label use of the antidepressants Wellbutrin and Paxil.
Kids are a popular audience for off-label drugs. A 2008 study published in the journal
Academic Pediatrics
found that 62 percent of pediatric outpatient visits resulted in the
prescription of a drug for off-label use. When you look at only the
prescription of pain medications, the number jumps to 86 percent. Tests
on children then are a good thing: without them, we might not know what
the drugs we’re already prescribing to them might actually be doing to
them.
By their end, the pediatric trials will have included approximately
150 children aged 6-16, all of whom are already taking opioid
medications to treat moderate to severe pain. Of course, the costs of
such tests on brains that aren’t fully developed aren’t yet well
understood. One study from 2005, by a professor from the University of
Michigan, found that children who are prescribed opioids are more likely
to abuse painkillers in later life.
The Fine Points of Misbranding
Even after a barrage of criticism over it’s marketing, Purdue Pharma,
per industry norms, continues to fund a dubious advertising campaign in
the form of a “public service” program called “Partners Against Pain."
Aimed at consumers and physicians, the 17-year-old “resource” for
doctors is one of the company’s foremost marketing tools, extolling the
virtues of opioid pain medication for chronic non-malignant pain while
minimizing the risk of addiction. Today it centers around public
endorsements – actress Jennifer Gray is its latest spokesperson, and has
appeared on
local TV newscasts to promote the program – and a website that’s been
a goldmine of spin. It’s impossible to fully stress how misleading some of its “facts” have been over the years. To wit:
While opioids can be abused and may be habit forming, clinical
experience shows that ‘addiction to opioids legitimately used in the
management of pain is very rare… In trials in almost 25,000 patients
with no history of drug dependence, there were only 7 cases of
iatrogenic drug addiction.
Pretty impressive, right? As a general practitioner considering
prescribing opioid drugs for chronic non-malignant pain, wouldn’t an
approximately 0.028 percent addiction rate strike you as an extremely
low risk?
Well, if you trace this claim back to the original literature, you
find that this “information” is culled from three “studies.” The first
of which was not even a study. It was a letter to the editor of the
New England Journal of Medicine
written in 1980, reporting that in 11,882 hospitalized patients who
received at least one narcotic, there were only four cases of
“reasonably well documented addiction.” Note that administration of
narcotic painkillers took place in a hospital setting for acute pain,
and so including this statistic in resources designed to inform on
long-term, non-hospital prescription of narcotics is inherently
misleading. (Despite being cited in academic journals an impressive 635
times, no abstract was available for this correspondence in the online
U.S. National Library of Medicine.)
Another of the sources summarized here,
Drug Dependency in Patients with Chronic Headaches,
was a review of 2,369 patients experiencing headaches. Only 62 patients
were actually included in the drug dependency study, however, as they
had been taking medications frequently for at least six-months. Of these
62, only 23 were taking narcotics. Of these 23, three were thought to
be abusing their narcotic medication.
In reviewing the website for the
FDA, Dr.
Art Van Zee concluded in 2001 that Purdue had “over-sold the benefits of
opiod therapy for chronic non-malignant pain, while providing false
reassurance about what the real risks are of addiction for patients
taking opiods for chronic non-malginant pain.” It’s hard to overstate
the negative effects of misinformation on the prescribing habits of
physicians naïve about certain classes of drugs. A resource produced by
Purdue Pharma claimed to represent addiction rates in almost 25,000
patients. In reality, only 23 of the patients were taking narcotics
outside of a hospital setting, and for what could be termed chronic
non-malignant pain (headaches). In this extremely small sample,
approximately 13 percent were believed to be abusing their narcotic
medication. These studies were cited not only on their website, but also
in literature given to both physicians and to patients taking
OxyContin.
In 2007, Purdue Pharma and three of its top executives
were ordered to pay $634 million as a penalty for misbranding OxyContin.
In court, Purdue Pharma admitted that “with the intent to defraud or
mislead” it promoted OxyContin as a safer, less-abusable opioid drug.
Documents filed by prosecutors in the Abingdon, Virginia, District Court
demonstrated that, beginning in 1996, Purdue had waged the most
aggressive marketing campaign ever for a narcotic medication, promoting
OxyContin to general practitioners, lauding its safety, and encouraging
its use for ailments like arthritis and back pain, maladies for which
treatment with opioids of this strength would have been unthinkable only
a decade prior.
All the while, representatives for the company proclaimed that
“delayed absorption as provided by OxyContin Tablets is believed to
reduce the abuse liability of the drug.” The “believed” statement was
reinforced by sales officials, who were found to have fabricated phony
scientific charts and to have suppressed certain findings about the
drugs addictive effects. Three top executives, who pleaded guilty to
misdemeanor charges of being liable for misleading regulators, the
public and doctors about the risk of addiction, were fined a combined
total of $35 million. None faced prison. And while the larger $600
million fine was one of the largest ever levied against a pharmaceutical
company, it represented less than half of Purdue Pharma’s annual
OxyContin sales.
Frank
Like many people, Frank Morris’ parents caught him smoking weed in
high school. He had developed a bit of a pot habit by around age 18, but
with his parents keeping a close eye on him, he quit smoking weed and
snatched a few of his mother’s Vicodin pills instead. Within a year and a
half he began trying OxyContin. Frank’s life deteriorated quickly.
Almost immediately he started using daily. Six months later, he
freebased the drug for the first time. Six months after that he shot Oxy
intravenously for the first time. After another six months he shot
heroin intravenously for the first time.
Some eighteen months after his introduction to Oxy, Frank was strung
out, a junkie. Soon enough he was jailed for attempting to purchase
heroin on the streets of San Francisco.
Street heroin (via U.S. Drug Enforcement administration)
For much of the time he was using OxyContin, Frank, who is now 27 and
living in New York City, had a legitimate prescription from a doctor.
His physician prescribed him 280 80mg pills per month for his migraines.
After all, this is the drug that Purdue Pharma represented as a safe
alternative to fast-acting narcotics, bragging that a patient only
needed two pills per day, with a 12-hour release mechanism, to achieve
around-the-clock pain management. Frank was prescribed enough of one of
the highest doses of the medication to take roughly nine per day. At $40
to $50 a pill, the street value in 2006 of this number of 80mg
OxyContin pills was $11,200 to $14,000. Frank sold enough of the pills –
roughly a quarter of them – to cover his $11-per-pill cost at a local
hospital pharmacy. He pocketed the rest. By the end of his opioid
addiction, he switched to shooting black tar heroin. It was cheaper.
How could a doctor have legitimately prescribed so much Oxy for
migraines? Wouldn’t a young man filling this outlandish prescription
month after month at a hospital pharmacy raise some red flags? The same
off-label prescribing guidelines in place for the prescription of drugs
to children also applies to prescription for adults. Clinical trials
might only test for the safety and efficacy of, say, two pills per day,
but physicians are able to interpret this information any way they see
fit. Over-prescription of this kind is undoubtedly morally questionable.
It’s not, however, illegal.
“It Brought Me To My Knees”
There was a salient thread connecting all the OxyContin addicts I spoke with, and that’s how
fast
they all said it happens, how quickly they all became addicted, and how
surprised they were at their physical dependence. Each of them recited a
litany of opioid substances that they had abused in various
combinations: Methadone, heroin, Diuladid, Percocet, Suboxone, Vicodin,
and Morphine. They swallowed, snorted, shot, and free-based the pills,
sometimes even mixing them with crack. But they all told me that the
first opioid that really got them, the one that was easiest to get and
gave the most powerful high, was OxyContin.
Original Oxy and new formula (via)
Frank told me he was once driving through central California going
into heavy withdrawal. When he pulled over at a gas station to fill up,
he saw a guy with telltale scratches on his face – opiate addicts often
feel phantom itches while high and will scratch their faces, arms, and
legs until they bleed. Frank approached the guy, asking if he knew where
he could score some Oxys. The guy pulled two huge bottles out of the
trunk of his car; he could get them right there.
None of the men and women I spoke with used street heroin before
taking OxyContin. All of them used it after using OxyContin. In fact,
since Purdue Pharma introduced a reformulated OxyContin in 2010
containing chemical safety-nets meant to render it less easily abused —
the pills no longer dissolve in water, making them more difficult to
cook and shoot intravenously — the number of addicts switching to heroin
has skyrocketed.
In
a study
of 2,500 OxyContin addicts followed from July 2009 until March 2012,
researchers found a 17 percent drop in OxyContin abuse. The study found
that almost one-fourth of participants were able to abuse OxyContin
despite the reformulation. Sixty-six percent switched to heroin. Many
have also latched onto to
Opana,
another painkiller. But according to the National Association of Drug
Diversion Investigators, OxyContin’s falling street price is a sign that
the $100 million reformulation is working at thwarting abuse of the
drug. Getting high on the new Oxy requires swallowing three or four
pills rather than one, but abusers are still finding unusual ways to
break down their safety mechanism, through microwaving and freezing, as
well as carefully filing them down to powder.
A fourth recovering addict I spoke with, Richard, a 29-year-old
living in New York, seemed near tears when describing his addiction. “It
brought me to my knees,” he said. When I mentioned that Purdue would be
testing the safety of their drug on children, he seemed horrified. “I
wouldn’t wish [OxyContin] on anyone.” Richard also watched his father’s
difficult journey quitting OxyContin after being prescribed the drug.
His grandfather is currently an addict after he was prescribed OxyContin
for pain.
After the Backlash
Make no mistake: OxyContin is a powerful treatment for people
suffering from severe and chronic pain. Users say it has changed their
lives, and anyone suffering from the effects of back surgery or a
violent accident can attest to the relief that opioids bring. And
addiction is a complex beast, one whose roots lie far beyond a simple
pill, no matter how addictive it may be.
But having heavily promoted a drug so easily abused while downplaying
the danger of that abuse – and having come under heavy criticism from
regulators – Purdue Pharma has in recent years changed its approach to
marketing OxyContin. After being fined for their fraudulent claims,
Purdue invested in several informational sites and programs to educate
doctors, pharmacists, and patients on prescription drug addiction.
Rxsafetymatters.org
is mainly geared towards the parents of teens abusing prescription
drugs. It offers links to resources for addicted persons, tips for
parents on storage and disposal of commonly abused drugs, and the signs
of symptoms of addiction. Purdue financially supported The Partnership
at drugfree.org in their production of
Time to Get Help, a resource for parents seeking addiction treatment for drug- and alcohol-abusing children.
Additionally, Purdue provides training and information to pharmacists
and law enforcement on safety and proper protocol during pharmacy
heists. The number of armed robberies on pharmacies in the United States
rose 81 percent between 2006 and 2010, concurrent with the rise of
opioid abuse and addiction. Purdue launched
Rx Patrol
as a resource for pharmacists.
They provide up-to-the-minute crime
statistics — as of September 16, 2012, there have been 2,527 robberies
and 1,541 burglaries at pharmacies since the site began compiling data
in 2002 — and offer a reward of $2,500 to anyone providing a tip leading
to arrests in a “significant pharmacy crime.” They also provide a “Tip
of the Month” in thwarting theft. In August Purdue advised pharmacists
to, “determine whether [their] building provides easy access to the
roof, which is a popular entry for more seasoned criminals.”
Some pharmacies, after repeated robberies, have stopped carrying the
stuff. They display signs, “No OxyContin Here,” alerting would-be
robbers that holding them up wouldn’t be worth the effort.
Some pharmacies have stopped stocking Oxy to drive away robbers (via)
One wonders whether Purdue’s efforts to educate pharmacists on safety
measures, though doubtless partially motivated by concern, also
functions as a way to soothe pharmacists who might be coming to the
conclusion that stocking the drug is more trouble than it’s worth. After
all, most pharmacists didn’t anticipate a career filled with the threat
of gun-wielding, ski-masked thieves and
Mission Impossible
-style burglars cracking the roof and shimmying down the ventilation
ducts. The more prescription drug abuse creates desperate addicts, the
more the pharmacy staff unwittingly fulfills the role of a drug cartel’s
security, guarding a shipment of drugs prior to distribution.
The End of Oxy
Addiction to and abuse of prescription drugs will exist no matter
what pharmaceutical companies do. It’s impossible to know the number of
addicts directly “created” by any drug, legal or illegal, and there is
likely some proportion of society that would fall prey to drug addiction
or abuse regardless of the specific substances involved. The crucial
question surrounding OxyContin is, how many inadvertent addicts has the
drug and its marketing created? Opioids in general are highly addictive –
that’s not alarming. It’s not news that Purdue admittedly defrauded the
public concerning the safety of their drug. What’s disturbing is that
the practice of deception and data suppression, physicians and
regulators acknowledge, is common throughout the industry.
Perhaps one of the most intriguing aspects to the OxyContin story is
that it asks what, exactly, we expect from pharmaceutical companies.
Purdue Pharma knew, on some level, that the amount of OxyContin they
were selling absolutely couldn’t all have been used for legitimate pain.
The
CDC famously reported that enough painkillers were sold in 2010 to medicate every adult in America, around the clock,
for one month. We can’t all be in that much pain.
Purdue had to have known it was profiting off of addiction and
dependence. If it didn’t, I question why the company would’ve waited for
such extreme social pressure to create a less abusable form of their
drug. Maybe they really did believe they had found a magic bullet, an
opioid medication with the power to “cure” pain without cultivating
dependence. We’ll never really know. But now that their drug is
practically synonymous with addiction and crime, now that so many
exposés have explored both their marketing practices and the personal
stories of addicts, now maybe we can all look more clearly and
critically at a culture that reveres pharmacological solutions.
Purdue’s patent for the original formulation of OxyContin is almost
up, but the era of pushing Oxy as a drug
safe-for-management-of-chronic-conditions isn’t quite over. The company
is
now fighting
to protect its reformulated version of OxyContin, which has patent
protection until 2025, by lobbing 16 patent-infringement lawsuits
pending against 10 generic-drug manufacturers. And unless Purdue can
manage to keep its original patent, cheaper generic versions of Oxy will
begin to arrive in pharmacies next year. Regulators are already
worried. In a June 6
letter,
Ontario’s Minister of Health, Deb Matthews, asked her federal
counterpart not to approve generic versions of the drug, stating that
“Ontario believes that the costs to society of the reintroduction of the
more-easily abused version far outweigh the financial benefits that
would accrue from the reduced price.”
I didn’t even have to cook it to shoot it. I could just drop it in some water and pump it right into my arm
_
The drug industry is based around the concept of making us “well”. We
get sick, and they make us better. But there are a host of medications
and disorders – the use of narcotics for some types of pain and the use
psychiatric drugs for some disorders – that are often dubiously thrust
into this paradigm. Since all pain and psychiatric disorders exist on a
spectrum, there is a danger in overmedicating those in the middle, those
who might not need it and who might not take drugs if they were aware
of all the possible negative outcomes related to doing so.
Drugs aren’t always necessarily making people better, though they
might make things easier (in some ways, for some time). Through its
aggressive marketing,
Purdue Pharma pushed the concept of more liberal narcotics prescribing
behavior as a human rights issue. People deserve to not be in pain. They
have the right to not be in pain. This is a seductive argument
and it fits neatly into the current paradigm of what we expect from
drugs and the medical community. But they buried the counterargument to
making people’s pain easier: It’s not always easy to put down the thing
that takes away your pain.
In a society where direct-to-consumer marketing of many
pharmaceuticals is legal, where pharmaceutical companies are legally
allowed to entice physicians with all manner of incentives and perks,
and where we elevate the power of drugs to near-mythic levels, it’s no
surprise that drug companies are able to write their own narrative on
sickness, cures, and risk. And we believe them, on some level, just like
an entire generation believed that a powerful opioid medication wasn’t
addictive or easily abused. We believe them until we reach the end of an
era, until the data and stories and robberies pile up so high that we
can’t ignore the fact that we were duped. As a generation of Oxy addicts
suffers, as Purdue continues to make billions a year in sales of the
drug, and cheaper versions are bound for pharmacies next year, what have
the rest of us learned? When the next miracle pill comes along, with
all its easy promises and assurances, how low will the highs go?
When I asked Frank about his thoughts on Purdue and their business
practices, he was ambivalent. “I always knew I was a drug addict, so I
don’t blame them for that,” he admits. Besides, it was easy: “I didn’t
even have to cook it to shoot it. I could just drop it in some water and
pump it right into my arm.”
But in a telling, almost poignant admission, Frank says he’s actually
happy that Oxy was available to him simply because it hastened the sink
to rock bottom. He even goes so far to say that Oxy has “in a weird
way” granted him a life he never could’ve imagined. What disappoints
him, though, is that Purdue
had to know “what the deal was”
with Oxy. “They just had to know what was capable with it, due to the
fact that they must go through strenuous testing,” he continues. “So,
its a little disheartening that this company would knowingly produce
pills like that, and just say that it wasn’t so bad.”
