Blame it on the law. That’s what Canada’s Health Minister Leona Aglukkaq did when she announced that she could not halt the approval of the generic version of OxyContin, a routinely abused and sometimes lethal painkiller. The medical community and politicians responded with a cri de coeur of regret and disappointment. Rightly so; opioid abuse is one of Canada’s most pressing drug problems. But it’s not our only drug problem, and probably not even our deadliest.
Science-ish contacted leading researchers across the country to get their take on the minister’s announcement, and the other drug-related issues that threaten Canadian public health.
1. Opioid addiction: A health systems issue.
As Drs. Irfan Dhalla and David Juurlink point out in this Ottawa Citizen commentary, “By some estimates, prescription drug overdoses have killed 100,000 North Americans over the past 20 years,” and part of the death toll can be attributed to the misuse and abuse prescription painkillers. (Just look at the graphs in this article.) These physician-researchers have been leading voices on the need for stricter regulation of these highly addictive pharmaceuticals, and when Science-ish contacted them about the news, they both expressed disappointment. But they noted that while it’s true the law may have prohibited the feds from rejecting the application of generic OxyContin, blocking generics is only a small part of the solution.
“In her letter, (the minister) implies that the drug is being used off-label, being prescribed in a high dose,” explained Dr. Dhalla, “but the label doesn’t limit the dose, and doesn’t say that OxyContin should only be prescribed for specific pain conditions. In fact, I think most observers would say this problem has arisen in the context of OxyContin being prescribed in accordance with its label.”
There’s actually insufficient evidence for the use of opioids beyond the acute and cancer-related pain for which they were originally intended, and Dr. Dhalla has done a good job of outlining how marketing filled the evidence void and boosted prescribing of the drug. Stricter labelling—so OxyContin only be prescribed for severe pain, and for a limited period of time, in accordance with the evidence from clinical trials—would fall within federal jurisdiction.
Another way the feds could ramp up efforts to address the prescription drug problem would be through calling on the provinces for a pan-Canadian approach to systems that monitor prescribing practices.
UBC pharmaceutical policy expert Steve Morgan explained, “In B.C., every single prescription that’s dispensed goes into our PharmaNet system, which tracks prescriptions drugs used by patients, information about prescribers, and allows for active monitoring.” This real-time database even flags worrisome practices or drug interactions. But this type of IT infrastructure is not in place in every province.
“If I were (a provincial health minister),” said Morgan, “I might tell the feds: ‘You have said the solution to this problem is monitoring and local regulation of practice, so why doesn’t the federal government then help pay for PharmaNet systems across the country?” Of course, all this requires more co-ordination between the federal and provincial players on the health file, and more leadership on the part of Ottawa—another problem entirely.
2. Health Canada’s transparency problem.
“No one has any idea what’s happening behind the walls (at Health Canada),” said Dr. Juurlink, a physician and researcher at the Sunnybrook Health Sciences Centre. “There are elements of the U.S. and European (drug regulatory) processes that are unclear but no one holds a candle to Health Canada when it comes to the lack of transparency and how byzantine the whole process is.”
One of the well-documented issues is the lack of information doctors, independent researchers and patients have access to about the drugs on the market here. As it stands, the Canadian public and health professionals don’t have a true understanding of the risks and benefits associated with the drugs they are prescribing and using.
For example, drug regulatory expert Dr. Joel Lexchin explained that at the very least, a physician might want to know whether the people in a drug trial for a treatment he is considering were similar enough to his patient. As well, some other minimum details for evidence-based prescribing, such as how long the trial was run, whether the results were statistically significant, whether the drug was compared to a placebo or another drug, and how many people withdrew from the trial. In a forthcoming study, he looked at every drug decision Health Canada released between 2005 and 2012, and found that information was lacking on all of these questions.
For this reason, researchers have been calling on Health Canada to not only provide more information about drugs that hit the market, but even about drugs and their uses that are rejected. This is key because doctors sometimes prescribe “off label”—meaning they write prescriptions for drugs outside of regulated uses—and there could be evidence that suggests they shouldn’t be doing so, but they have no way of accessing that information.
3. Clinical trials gone missing?
As Science-ish has noted in recent weeks, Canada lags behind almost every developed country when it comes to mandating that all clinical trials in humans be registered. (See this open letter to the Federal Health Minister, subsequent letters from researchers, and this interview with Health Canada.) Trial registry is a way of keeping tabs of what studies are being done, so evidence doesn’t go missing and trial endpoints aren’t changed to make results look more favourable. Without this kind of oversight, Canada is contributing to the perversion of the global evidence base. The Standing Senate Committee on Social Affairs, Science and Technology recently recommended the Canadian government take immediate action to address this issue. Science-ish remains hopeful that action will be taken.
4. The failure of post-marketing surveillance.
When a drug is approved in Canada, it enters the marketplace, and said Dr. Juurlink, “This amounts to a mass experiment on the population.” That’s because the people who are enrolled in clinical trials are often different from the patients who are taking the drugs. As well, sometimes the design and duration of trials do not resemble the way drugs are used in real life. So the safety and efficacy of experiments is not always reflected in the real world, and that’s why we need what’s called post-marketing surveillance—or doing follow-up studies and tracking problems with drugs after they reach pharmacy shelves. While pharmaceutical companies in Canada are required by law to report safety information that comes to their attention, the custodians of Canadian health care—doctors and front-line health professionals—are not.
Dr. Juurlink put it this way: “Any self-respecting developed country has a system in place where health professionals have to report drug problems; there’s no reason why we should be allowed to be lackadaisical.” (Maclean’s writer Anne Kingston does a brilliant job of reporting on our embarrassing track record at post-marketing surveillance and other the troubles with the drug regulatory system.)
5. Our deadliest drug issue: Pharmacare, where art thou?
Did you know that Canada’s is the only health system in the OECD that is universal but excludes public and universal coverage for prescription drugs? And yet, we’re filling more prescriptions than ever, pharmaceuticals make up our second largest health-care cost, and we are second only to the U.S. when it comes to per capita spending on medicines.
According to UBC’s Morgan, this suggests there’s something rotten with our pharmaceutical policy. The provinces have come up with a patchwork approach to covering drugs for some citizens—mostly seniors and social assistance recipients. Employers fill in the gaps. If governments, unions and employers all negotiate drug benefits, Canadians lose out on the efficiencies and bargaining power that comes with a universal, single-payer system.
Worst of all, our so-called universal health system essentially ends for many people when they leave the hospital or the doctor’s office. There’s evidence Canadians who need drugs face financial barriers, even financial ruin, because of treatment costs. One study estimated that about 1 in 10 Canadians who receive a prescription don’t fill it because they can’t afford to.
If every other universal system in the OECD figured out a better way, we can too. “You either see prescription drugs as part of the health-care system, or you don’t,” says Morgan. He added that when Obamacare is fully implemented south of the border, “it’s likely more Americans will have prescription drug insurance than Canadians, so in a sense, we may become the worst country in the world on pharmacare.” Indeed, a pretty serious drug problem.
Science-ish is a joint project of Maclean’s, the Medical Post and the McMaster Health Forum. Julia Belluz is the associate editor at the Medical Post. Got a tip? Seen something that’s Science-ish? Message her at firstname.lastname@example.org or on Twitter @juliaoftoronto
Tuesday, November 20, 2012