Dr. Irfan Dhalla, who has studied the opioid-addiction problem, is skeptical about Purdue Pharma’s marketing claims that switching from OxyContin to OxyNEO will result in fewer misuse and abuses of the potentially lethal drugs.
More than two months after one of the most abused drugs in modern medicine – OxyCon-tin – was taken off the market, there are signs that Canadian drug users are trying to adapt and to fill the void that’s been left.
On websites, drug users are sharing recipes on how to crack the code for OxyNEO – a new version of the drug – which is designed to turn gel-like when dissolved in liquid so it can’t be pulled into a syringe.
In Toronto, public health officials say they are trying their best to encourage clients not to try to break OxyNEO down, “because we don’t really know what the impact is of injecting a gel formulation into someone’s veins,” says Dr. Rita Shahin, an associate medical officer of health with Toronto Public Health.
In Ottawa, where police believe the street supply of OxyContin is drying up, use of fentanyl – a heavy hitter opi-oid stronger than oxycodone, the active ingredient in Oxy-Contin, that has always been a part of the city’s drug-trade equation – is growing.
“We’ve seen an increase in the number of seizures, particularly at the street level, and a lot of trafficking in fentanyl patches,” says Ottawa Police Staff Sgt. Mike Laviolette.
What there hasn’t been, how-ever, is the all-out health disaster predicted by many.
CALM BEFORE THE STORM
There is no evidence yet of mass withdrawal some had feared would unfold in First Nations communities in Northern Ontario – where leaders say staggering numbers of people are addicted to opioids, from seniors to 11-year-old children.
Provincewide weekly surveillance in Ontario has so far found no sudden significant run on detox or addiction treatment services, or increases in overdoses. There are anecdotal reports suggesting some people are switching to fenta-nyl, as well as heroin, “but it’s not significant, it’s not a major increase just yet,” a health ministry spokeswoman said.
Some fear this could be just the calm before the storm. They say that if the lessons learned from the abuse of OxyContin aren’t implemented, the same problems could play out once more.
Advocates of the drug’s replacement, OxyNEO, say it is the figurative tamper-proof cap that was needed. They say it will dissuade people from the two most self-destructive behaviours associated with OxyContin abuse – snorting and injecting, which deliver heroin-like hits to the brain and a potentially higher risk of fatal respiratory arrest along with it.
But there are worries, too, that the new “tamper-resistant” formulation could create a false sense of security – that some doctors will believe that OxyNEO can’t be misused or abused, a situation that could lead to more liberal prescribing of the powerful opioid.
OxyNEO has the same analgesic properties as OxyContin. It still can be abused simply by swallowing heavy doses – something one doctor suggested many addicts will do, rather than trying to follow the complicated online instructions for extracting the oxycodone for the purpose of injection.
And while OxyNEO tablets were hardened to make them more difficult to crush, snort and inject, many people who are addicted to OxyContin or other prescription opioids simply swallow the tablets whole.
“And if you’re swallowing the tablet whole,” says Dr. Irfan Dhalla, a general internist at St. Michael’s Hospital in Toronto, “it really won’t make any difference whether you’re swallowing OxyContin or OxyNEO.”
Initially, OxyContin was marketed as having a lower risk of abuse than other opioids.
Prescriptions and sales soared, and the more prescriptions were filled, the more leaked to the streets.
The drug has been implicated in playing a role in an increase in overdoses and deaths and a “public health crisis” involving what became, according to the College of Physicians and Surgeons of Ontario, one of the most easily obtained prescription opioids on Toronto’s street drug scene.
Observers say the new formulation – which becomes gel-like in water so that it can’t be pulled into a syringe – may lessen the risk of overdose due to tampering.
But, according to Health Canada, no available evidence exists to show that these “abuse-deterrent formulations” lead to less drug abuse and related harm.
An official said OxyNEO hasn’t been allowed to claim that it is less abusable than other extended-release opioid formulations.
Purdue Pharma says it con-ducted a number of studies before OxyNEO was launched. “Most of the misuse and abuse of long-acting prescription opi-oids is about defeating the con-trolled-release formulation,” said Randy Steffan, vice-president of corporate affairs for the pharmaceutical company.
OxyNEO tablets were tested “after various physical manipulations,” he said, including being crushed with a hammer.
“OxyNEO may be the first of a new generation of controlled-release opioids designed to help discourage misuse and abuse of prescription opioids,” Stef-fan said.
OPIOID USE IN CANADA
He added that Purdue “is committed to collecting post-marketing data in Canada.”
Some observers want Health Canada to do its own monitoring for the prevalence of abuse and diversion as OxyNEO replaces OxyContin on the Canadian market. They also want strict controls over how the drug is marketed to doctors.
“So far Health Canada doesn’t really seem to have learned any lessons from OxyContin,” says Dr. Joel Lexchin, an emergency room physician and professor in the School of Health Policy and Management at York University in Toronto.
In a recent article in the International Journal of Risk and Safety in Medicine, Lex-chin and co-author Jillian Clare Kohler [an expert witness on OxyContin marketing practices for a Nova Scotia law firm involved in an OxyContin class-action lawsuit], describe how the company’s U.S. branch pleaded guilty to the “misbranding” of OxyContin.
Sales representatives gave false information about the drug to some doctors, they wrote, claiming that because it was long-acting it would produce less of a “high,” and thus was less likely to be abused. Purdue paid more than $600 million in fines – one of the largest payouts of its kind.
Lexchin says Health Canada has the power under the Food and Drugs Act to require that Purdue have a prominent statement in all of its promotions of OxyNEO warning of the potential for abuse, and that drug company sales reps should be required to deliver the same message to doctors.
The company says warnings are prominently contained in OxyNEO’s monograph – the official product information document for doctors – that all information in its promotional materials is consistent with the monograph and approved by the Pharmaceutical Advertising Advisory Board, and that company representatives “comply with the requirement of delivering full and factual information on products” in accordance with the industry’s code of ethical practices.
Experts say the issue is wider than a single drug. Canadians are among the highest users of prescription opioids in the world. In the past decade alone, our opioid consumption has more than doubled.
“It goes beyond just chronic pain – it involves people being sent home from hospital with large amounts of painkillers, or people going to the dentist to get a tooth pulled and sent home with 38 Tylenol No. 3s,” says Dr. Peter Selby, clinical director of the addictions pro-gram at the Centre for Addiction and Mental Health.
“What happens to all these opioids? Who else has access to them when the person dies? How are they keeping [the drug] in the home?”
There’s nothing inherently evil about opioids, Selby says. “It’s how we deliver them and how we use them that got us into trouble.”
STATE OF EMERGENCY
Perhaps nowhere is that more true than in First Nations com-munities. In January, Chief Matthew Keewaykapow of Cat Lake First Nation in northwest-ern Ontario declared a state of emergency, saying the opioid addiction rate was approaching 70 per cent of his community members.
In February, Nishnawbe Aski Nation [NAN] Deputy Grand Chief Mike Metatawabin warned First Nations com-munities to brace for a health catastrophe – a mass, involuntarily opiate withdrawal due to the replacement of the “ultra-addictive” OxyContin.
So far, it hasn’t been what he expected.
“We’re just seeing trickles now – some abuse of alcohol, some reports of withdrawals,” Metatawabin said this week.
But “right now the under-ground supply [of OxyCon-tin] is still there,” he said, “so we haven’t seen what we were anticipating yet.”
“I was told it would maybe occur sometime in April or May. We’re into May now. I’m going to see what happens this month,” he said. “If it happens, it’s going to hit hard.”
In a move to restrict diversion and abuse, six provinces have decided to remove Oxy-NEO from their drug benefit formularies and to approve new requests on a case-by-case basis only.
“It’s going to be very difficult to prescribe,” says Dr. Edward Sellers, who chaired a Health Canada scientific advisory panel on opioid abuse. “The hoops to go through to get that – most physicians just won’t be prepared to do that.”
The OxyNEO formulation has been available in the U.S. for almost two years. According to Sellers, the initial data from the drug company “are more or less showing what one would expect – you make a hard formulation that is hard to crush, and you can’t inject it, then there is going to be less tampering.” Presumably, he said, less tampering will mean fewer deaths.
“Can OxyNEO be abused or is it addictive? Well, it’s got an opiate in it, of course it can be,” said Sellers. However, he said, many of the risks associated with the original product have been “substantially mitigated.”
Preliminary data from three ongoing studies released by Purdue Thursday at the American Pain Society’s annual scientific meeting in Honolulu show a reduction in the street price of the new formulation of Oxy-Contin across the U.S., a drop in OxyContin-related reports to poison control centres and a 50 per cent decrease in Oxy-Contin abuse rates among opi-oid addicts entering treatment since the new formulation was introduced in 2010, the company said in a statement. During the same period there was a 134 per cent increase in abuse of the painkiller, Opana.
The company says further analysis showed a 74 per cent drop in abuse through “no-oral routes” -injecting, snorting and smoking – as well as a 30 per cent decrease in oral abuse. Dhalla, of St. Michael’s Hospital in Toronto, who has also seen some of the preliminary data, isn’t convinced that simply replacing OxyContin with OxyNEO will result in fewer deaths. According to an FDA spokeswoman, the agency has not conducted an independent study or review.
“I’m skeptical of anything that is put out by a [drug] manufacturer, particularly if it hasn’t appeared in a top-ranked peer-reviewed journal,” says Dhalla, an assistant professor in medicine and health policy, management and evaluation at the University of Toronto.
In a recent editorial published in the British Medical Journal, Dhalla says that opioids carry significant risks that aren’t completely known.
“-[W]e don’t really know what the benefit-to-harm ratio is – we don’t really know whether benefits outweigh risks, or vice versa, when these drugs are used for years at a time, as they quite frequently are,” he said.
“Hopefully we’ll eventually get through this problem, and we’ll look back on this period and say, ‘Whoa, that was a strange and unfortunate episode in the history of medicine.’”