Canada Takes a Cautious Approach to Unapproved COVID-19 Drugs as Others Prescribe Wide Use

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A guest doctor on Fox News called it “the beginning of the end of the pandemic.” President Donald Trump has said it could be a game-changer, and the U.S. Food and Drug Administration has given doctors a qualified green light to use it on COVID-19 patients.

Hydroxychloroquine, a malaria drug, is a hot topic in the United States, adopted by the country’s top politician and by many members of the medical community, despite minimal evidence that it helps those affected by the disease. new coronavirus.

India and Brazil have also doubled the use of drugs to treat the pandemic virus.

But this is another story in Canada, where hydroxychloroquine and other potential COVID-19 drugs have more cautious interest than unbridled enthusiasm.

Canadian researchers are actively involved in several malaria studies and others, with the federal government spending millions to support them.

But unlike the FDA, health organizations here have discouraged their use except for these clinical trials – studies designed to carefully assess the effectiveness of the drugs 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 determine whether they work or not.

“When people get very sick … your impulse is to try anything that could help, and that has sparked the response in some places,” said Lynora Saxinger, infectious disease specialist at the University of Alberta. “But while people have turned their heads around the data behind these drugs, it’s really pretty thin on the ground. “

Dr. Salim Yusuf, a professor at McMaster University in Hamilton and a leading clinical trial expert, is helping to design an accelerated study of hydroxychloroquine. He said he understands the urge to try unproven treatments but is concerned about the consequences.

This could cause damage

“A prospect is” We are in a period of despair and are throwing everything we can to save people’s lives. “I understand that,” he said. “The danger is not objective. It could cause harm. “

Just as the scientific community has entered an extraordinary and accelerated race to develop a vaccine against the virus that causes COVID-19, it is rapidly testing whether a number of new drugs or those used for other conditions could help the minority of patients seriously affected by the pathogen.

Health Canada alone has approved eight separate COVID-19 trials.

The malaria drug has attracted the most attention in the world, first due to a small French study that appeared to show that its association with the antibiotic azithromycin had some efficacy against the coronavirus.

Trump gave his approval, and then it became a political problem, with opponents of the president seemingly impatient to see him demystified, supporters making drugs a miracle cure.

And on Monday, the FDA made its surprise statement, saying it was worth the risk of trying an unproven cure for critically ill patients.

Canadian physicians, like their American counterparts, are legally authorized to prescribe approved “off-label” drugs for uses other than those specified in their licenses.

But Health Canada did not follow the American example by encouraging them to do so with hydroxychloroquine.

Meanwhile, the B.C. The Center for Disease Control recommended in a lengthy March 30 report not to use any of the many potential COVID-19 drugs, except in clinical trials.

The National Institute of Excellence in Health and Social Services in Quebec said in a statement on Thursday that treatment of patients with coronavirus with antimalarial pills should “be done within the framework of research protocols”.

Researchers at the University of Minnesota set up an automated liquid handler at the start of a trial to see if hydroxychloroquine, an antimalarial treatment, can prevent or reduce the severity of COVID-19.


Craig Lassig / Reuters / File

And the guidelines developed by the intensive care physicians at the University of Toronto also say that experimental therapies should only be used in clinical trials, or after consulting an infectious disease specialist and obtaining informed consent from the patient.

Saxinger said she agreed with this advice, although she said exceptions may need to be made in small centers where there is no chance of a patient joining a clinical trial.

After hearing positive reports about some of the drugs, patients may be reluctant to participate in a clinical trial, in which half would not receive the drug, said Dr. Gordon Rubenfeld, intensive care physician at Sunnybrook Health Sciences Center in Toronto. But before we use treatments widely, “we need to know if they work.”

The accelerated effort to conduct these studies is remarkable, said Yusuf. Researchers typically take two or more years to study a drug and then set up the trial. Her group’s trial on hydroxychloroquine was launched two weeks ago and, pending approval from Health Canada, aims to begin enrolling patients in approximately one week.

“It’s unprecedented … at least in my lifetime. “

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