The recent announcement by federal health minister Leona Aglukkaq that she will not interfere with the approval of generic OxyContin is just the latest development in what has become a major public health crisis.
In Canada, overdose deaths involving prescription medications now vastly outnumber deaths from HIV. By some estimates, prescription drug overdoses have killed 100,000 North Americans over the past 20 years. Astonishing though that may seem, these deaths are just the tip of the iceberg. For each one, there are hundreds of people whose lives have been ravaged by addiction to prescription drugs.
Much of this toll involves opioids -- painkillers including codeine, morphine and oxycodone, the active ingredient in OxyContin. Closely related to heroin, opioids produce euphoria, are highly addictive, and can be fatal at high doses or when combined with alcohol or other sedating drugs.
Until the 1980s, physicians prescribed opioids primarily for acute pain (e.g., from a broken bone) and pain related to cancer. But today, opioids are more commonly prescribed to patients with chronic conditions like back pain and arthritis, often at doses that would have been viewed as unimaginably high 25 years ago.
When someone has high blood pressure, there is good evidence that prescribing a drug for many years is beneficial. But with chronic pain, the prescribing of opioids for long periods of time (or at high doses) is not supported by good evidence.
Comprehensive reviews of the scientific literature suggest that in many conditions -- arthritis, for example -- the dangers likely outweigh the benefits.
Nevertheless, aggressive marketing by pharmaceutical companies has convinced hundreds of thousands of physicians that long-term treatment with opioids is safe and effective, with little risk of addiction. Some aspects of this marketing campaign have been so misleading that in 2007 the manufacturer of OxyContin pleaded guilty in United States federal court to felony charges of "misbranding" and was fined $634 million.
OxyContin was designed so that the active ingredient would be released in stages over 12 hours, but the controlled-release mechanism was easy to defeat. People seeking a quick high could simply chew the tablets or crush them. For this reason, the manufacturer of OxyContin withdrew the drug from the Canadian market earlier this year and replaced it with OxyNEO. (It is worth noting that this move has also allowed the manufacturer to continue to sell its product at brand name prices for many more years.) OxyContin and OxyNEO have the same active ingredient, and when swallowed whole the two drugs are considered equivalent. OxyNEO, however, is more difficult to misuse because it is harder to crush or dissolve.
All opioids -- not just OxyContin -- can be misused, and the federal health minister is correct when she says that the law does not permit her to withhold approval of a generic formulation just because of the risk of misuse. But when the legal and regulatory framework results in a situation in which more than a dozen Canadians die each week because of an accidental prescription drug overdose, that framework needs to be changed.
How can we start to undo the damage? A critical first step is to acknowledge the extent of the problem, recognizing that for every celebrity death (Heath Ledger and Derek Boogaard, for example) there are thousands whose deaths do not make the front page. The misuse of prescription drugs and addiction remain taboo topics in our society. This must change. And while recognizing that untreated pain also remains a problem, it is time to stop heeding pleas for continued unfettered access to prescription opioids.
Physicians should re-evaluate how freely we prescribe these drugs for chronic pain, how readily we increase the dose, and we must abandon the widespread perception -- implanted in our psyche over many years by the pharmaceutical industry and its agents -- that opioids are safer and more effective than other pain relievers. We now know otherwise. Finally, we must become more comfortable treating patients who have become addicted to prescription drugs.
Governments at all levels also need to collaborate on a co-ordinated national approach. The federal government should pass a law requiring that all opioids be manufactured in a manner that makes them difficult to tamper with. It should also review whether opioids are being marketed for too broad a range of problems. Provincial governments should do their part too. For example, they need to move far more quickly in developing online databases so that physicians and pharmacists can see whether their patients are trying to acquire opioids from multiple prescribers.
We don't need generic OxyContin in Canada. The federal government should still try to find a way to keep it off the market. But more importantly, governments at all levels need to work with doctors to do more to reduce the number of overdose deaths and the burden of addiction to prescription drugs.
Irfan Dhalla is an expert advisor with EvidenceNetwork.ca and both Dhalla and David Juurlink are physicians and researchers at St. Michael's Hospital and the Sunnybrook Health Sciences Centre respectively. Dhalla was and Juurlink continues to be, a member of the Ontario committee to evaluate drugs.