Posted by Kelly_Bourdet on Tuesday, Sep 18, 2012
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
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.
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.”