Leona Aglukkaq says her hands are tied: She cannot stop the approval of oxycodone, the generic version of the much-abused painkiller OxyContin.
“The law does not permit approval to be withheld on the basis of misuse,” the federal Health Minister said.
Her provincial counterparts, led by Deb Matthews of Ontario, asked Ottawa to refuse, or at least delay, the approval of the generic version, saying that the drug is not safe because it is being widely abused. In other words, she is arguing that safety should be determined not in the laboratory but in the real world.
There is an important legal and philosophical issue at the heart of this debate: What do we really mean when we say a drug is “safe,” and what is the best way to decide that in the public interest? A prescription drug may be safe when used as directed, but what if its misuse has become a public-health crisis?
The federal Food and Drugs Act calls for prescription drugs to be approved by Health Canada if they are safe – meaning that, on balance, they do more good than harm if used properly. When it comes to generics, drugs are to be approved if they are biologically equivalent to the brand name drug, once its patent expires. (Once drugs are approved, it is up to provinces to decide if they will cover them under drug plans.)
Some provinces decided to cover OxyNeo, a “tamper-proof” version of the painkiller, so the manufacturer stopped selling OxyContin in Canada. Now oxycodone is slated to return to the market on Nov. 25 as a much cheaper generic.
But there is an immediate problem: The abuse of prescription drugs, and painkillers like OxyContin in particular, is out of control. Addiction is commonplace and more than 1,000 people a year die of oxycodone misuse alone. If cheaper oxycodone is allowed on the market, there is no question the tragedy will grow worse. (Oxycodone is a slow-release drug, but addicts crush it to get a quicker, more powerful high. Tamper-proof versions make that more difficult.)
To throw up our hands and say patent laws prevent a drug from being banned, as the Health Minister has done, is a cop-out. The confrontational tone of her letter to provincial health ministers also distracts from the positive changes Ottawa is making.
No one is suggesting that the minister of health routinely decide what drugs come to market. But Oxycodone is an unusual case that requires exceptional action. We should have no illusions either that a ban on generic oxycodone will be a panacea.
Many more actions need to be taken – federally and provincially – to tackle the scourge of prescription drug abuse and to ensure, even more importantly, that those in pain get pain relief and that those with addictions get help.
For example, in no particular order:· better monitoring and regulation of opioid painkillers, which, to their credit, both Ottawa and the provinces have undertaken; more treatment programs for people addicted to painkillers which, again, both levels of government have promised; a crackdown on doctors who over-prescribe and mis-prescribe painkillers like oxycodone; better education for physicians and clear guidelines given the huge variations in prescribing practices; formulating a national pain strategy.
In short, both levels of government should be using their energies to find common solutions to this massive societal problem rather than spending so much time and effort sniping at each other in press releases. They should be joined at the table by physicians, pharmacists, pain and addiction specialists and law-enforcement officials.
As Ms. Matthews said: “National problems require a national solution.” The oxycodone discussion shouldn’t be about jurisdiction and legal technicalities, but about saving lives and alleviating pain.