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canada takes cautious approach to unapproved covid-19 drugs

'one perspective is "we’re in a time of desperation and let’s throw anything we can at it." i understand that. the danger is ... it could result in harm'

by tom blackwell, national post

apr 4 2020
read time 3 minute read
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a doctor guest on fox news called it “the beginning of the end of the pandemic.” president donald trump said it could be a “game changer,” and the u.s. food and drug administration gave physicians a qualified green light to use it on covid-19 patients.

the malaria drug hydroxychloroquine is a hot item in the united states, embraced by the highest politician in the land and many in the medical community, despite minimal evidence that it helps those stricken by the novel coronavirus.
india and brazil have similarly doubled down on using the drugs to treat the pandemic virus.
but it’s a different story in canada, where hydroxychloroquine and other potential covid-19 medicines are being met more with a cautious interest than unbridled enthusiasm.
canadian researchers are actively involved in several studies of the malaria drug and others, with the federal government spending millions to support them.
but in contrast to the fda, health organizations here have discouraged their use except as part of those clinical trials — studies designed to carefully assess the drugs’ effectiveness and possible harmful side effects.
and some experts warn that widespread use outside of studies — which typically include a control group of patients who don’t receive the drug — could make it difficult to ever determine whether they work or not.
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“when people become very ill … your impulse is to try anything that might help, and that’s driven the response in some places,” said dr. lynora saxinger, an infectious disease specialist at the university of alberta. “but as people have been wrapping their heads around the data underpinning these drugs, it’s really pretty thin on the ground.”
dr. salim yusuf, a professor at hamilton’s mcmaster university and leading clinical-trials expert, is helping design a fast-tracked hydroxychloroquine study. he said he understands the urge to try unproven treatments but worries about the consequences.
“one perspective is ‘we’re in a time of desperation and let’s throw anything we can at it to save people’s lives.’ i understand that,” he said. “the danger is it’s not objective. it could result in harm.”
just as the scientific community has entered an extraordinary, expedited race to develop a vaccine for the virus causing covid-19, it is rapidly testing whether a number of new drugs or ones used for other conditions might help the minority of patients made critically sick by the pathogen.

health canada alone has approved eight separate covid-19 trials.

the malaria drug has drawn the most attention worldwide, initially because of a small french study that seemed to show that combining it with the antibiotic azithromycin had some effectiveness against the coronavirus.

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trump gave his endorsement and then it became a political issue, with opponents of the president seeming eager to see it debunked, supporters trumpeting the drugs as a miracle cure.

and on monday, the fda made its surprise pronouncement , saying it was worth the risk of trying an unproven remedy for seriously ill patients.

canadian doctors, like their american counterparts, are legally allowed to prescribe approved medicines “off-label” for uses other than those specified in their licences.
but health canada has not followed the u.s. lead by encouraging they do so with hydroxychloroquine.

meanwhile, the b.c. centre for disease control recommended in a lengthy march 30 report against using any of several potential covid-19 drugs except as part of clinical trials.

quebec’s national institute of excellence in health and social services said in a news release thursday that treating coronavirus patients with the malaria pills should “be done within the framework of research protocols.”

and guidelines developed by university of toronto-based critical care doctors also say experimental therapies ought to be used only as part of clinical trials, or else after consulting an infectious-disease specialist and getting the patient’s informed consent.

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saxinger said she agreed with such advice, though she said exceptions may have to be made in smaller centres where there’s no chance of a patient joining a clinical trial.
having heard positive reports about some of the drugs, patients might balk at being part of a clinical trial, where half would not receive the medicine, said dr. gordon rubenfeld, a critical-care doctor at toronto’s sunnybrook health sciences centre. but before using the treatments widely “we should find out whether these work.”
the accelerated effort to conduct those studies is remarkable, said yusuf. researchers would typically take two or more years first to study a drug and then set up the trial. his group’s trial involving hydroxychloroquine was launched two weeks ago and, pending health canada approval, aims to start enrolling patients in a week or so.
“this is unprecedented … at least in my lifetime.”
• email: tblackwell@postmedia.com | twitter:

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