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Prescription pills containing oxycodone and acetaminophen are shown in this June 20, 2012, photo. Health Canada’s recent decision to approve yet another addictive, generic form of the popular painkiller oxycodone is raising questions about the federal department’s approval process. (GRAEME ROY/THE CANADIAN PRESS)
Prescription pills containing oxycodone and acetaminophen are shown in this June 20, 2012, photo. Health Canada’s recent decision to approve yet another addictive, generic form of the popular painkiller oxycodone is raising questions about the federal department’s approval process. (GRAEME ROY/THE CANADIAN PRESS)

Oxycodone decision puts Health Canada’s drug-approval process under scrutiny Add to ...

Health Canada’s recent decision to approve yet another addictive, generic form of the popular painkiller oxycodone is raising questions about the federal department’s approval process.

Drug approval is based on clinical trials performed by the pharmaceutical companies themselves, with no independent review. Those manufacturers often only compare their products to sugar pills, not painkiller alternatives, one expert says.

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Health Canada says it “rigorously” assesses the safety and efficacy of all drugs before deciding whether to approve them, with a primary focus on the needs and safety of patients.

But David Juurlink, a clinical pharmacologist and drug safety researcher at Sunnybrook Health Sciences Centre in Toronto, calls Health Canada’s criteria for green-lighting drugs “inscrutable,” given they’re not subject to external analysis.

What little is known about how drugs are given the okay would alarm Canadians dependent upon them, and even the doctors prescribing them, he said Thursday.

“Everything we know on Day 1 of a drug’s licensure in Canada, as patients and as doctors, is the rosiest possible picture of its benefits and risks,” he said. “When it comes to opioids, this can’t be overstated.”

Drug companies testing opioids understandably don’t include patients with addiction tendencies in their clinical trials, Juurlink pointed out, which skews the findings on safety risks.

And when compared to a placebo or sugar pill, any patient in pain is going to report a marked improvement after taking opioids, he added.

“They’re studied in as close to an ideal situation as possible, and consequently they offer a less-than-accurate depiction of the safety profile,” Juurlink said.

“No pharmaceutical company has ever taken their opioids and compared them head-to-head against an anti-inflammatory drug for a year or two to see what patient does better in a real-world scenario and that’s because, firstly, the government doesn’t require it, and secondly, they know they’d find something unflattering for their product.”

The Conservative government is on the hot seat for Health Canada’s recent approval of two generic, addictive formulations of oxycodone manufactured by Ranbaxy, an Indian drugmaker.

The green light for the drugs came despite suggestions from Health Minister Rona Ambrose earlier this fall that the Conservative government was weighing pleas from the United States to follow its lead in outlawing oxycodone.

Studies have shown that Canadian generic forms of oxycodone are migrating south of the border, where tens of thousands of people die every year from prescription painkiller abuse. The director of the White House Office on Drug Control Policy wrote Ambrose earlier this month reminding her of the dangers posed by the opioids and urging Canada to take action.

Wayne Kalinski, a deputy police chief in Orangeville, Ont., said Thursday the federal government has been receptive to calls from the Ontario Association of Police Chiefs to ban oxycodone.

“The response thus far has been positive, but we haven’t seen the change yet,” Kalinski said. “Oxycodone continues to be abused not only for recreational purposes, but by addicts as well.”

The government defended itself on Thursday in the House of Commons.

“We have implemented strict controls in the public drug plan run by Health Canada, including maximum monthly and daily drug limits, monitoring the usage of certain drugs, and real-time warning messages to pharmacists at point of sale,” said Eve Adams, Ambrose’s parliamentary secretary.

Former Liberal leader Bob Rae is among those predicting that Health Canada’s approval of the Ranbaxy drugs will be particularly devastating for Canada’s First Nations. An estimated 70 to 80 per cent of aboriginals on Ontario reserves struggle with prescription painkiller addiction.

But Ontario regional Chief Stan Beardy said it makes little difference whether generic forms of oxycodone are banned. Addicted natives are going to get their hands on the drugs one way or another, he said.

“Regardless of what is on the market or not on the market, the people that are addicted to these drugs will always find a way to feed their addiction,” Beardy said.

First Nations addicts often obtain drugs by ordering them online from other countries, something a federal ban couldn’t combat, he added.

What’s truly needed from federal and provincial governments are community-based efforts that address the systemic issues at the root of drug addiction in aboriginal communities – issues that are unique to First Nations.

“The dysfunction will continue regardless, whether these drugs are banned or not banned. That’s why we need support from governments in terms of mental well-being strategies that are community-based.”

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