A federal decision to back away from the former Conservative government's plans to make one type of opioid tamper resistant is setting off a contentious battle between the government, a major player in the narcotic-painkiller market and chronic pain specialists, many with ties to that company.
Tamper resistance is when drug manufacturers make opioids harder to crush, dissolve or otherwise manipulate for purposes of abuse. Last year, the Conservative government introduced regulations to require one type of opioid, oxycodone, to be tamper resistant.
Earlier this month, Health Canada announced that the government would no longer be going through with the proposed new rules because the move would drive low-cost drugs from the market and have "little to no effect in the fight against problematic opioid use," according to a notice on the department's website.
"The evidence shows that isolating one drug class can cause abusers to move to a new drug, and that this is already happening, as we have seen so tragically with fentanyl in our communities," Health Minister Jane Philpott said in a statement Friday.
Purdue Pharma, a leading opioid manufacturer, holds the patent on tamper-resistant oxycodone with its OxyNEO drug, an updated version of OxyContin. The rule change would have forced generic oxycodone off the market and granted Purdue a monopoly. Purdue Pharma said in a news release that the company is "disappointed" by the move and urges Dr. Philpott to "reconsider this decision of regulatory inaction."
A coalition of chronic pain and addiction specialists sent a letter to Dr. Philpott this week asking her to change her mind and move forward with tamper-resistant regulations for oxycodone. The letter notes "impressive evidence" showing that OxyNEO helps reduce misuse of the drug. The letter suggests "a small segment" of the population abuses opioids and that they have created "significant harms" as a result.
A Globe and Mail analysis found that more than 60 per cent of the nearly 40 signatories have declared financial ties on various websites to Purdue Pharma as consultants, speakers or researchers. The author of the letter, pain specialist Roman Jovey, for instance, has a long-standing relationship with the company. He faced widespread criticism in 2010 when it was revealed that he taught lectures to medical students at the University of Toronto that included course material copyrighted and paid for by Purdue.
In an e-mail, Dr. Jovey wrote: "Just because a physician interacts in some manner with a pharmaceutical company, does not mean that he/she endorses 'indiscriminate' prescribing of opioids for pain."
He added that the people endorsing the letter are experts "who are out there treating real patients with pain and/or addictions."
Purdue declined an interview request. In a statement, the company said Health Canada's rationale for not adopting tamper resistance for oxycodone is "fundamentally flawed." It also said that any company is free to develop its own tamper resistant technology and that health care practitioners "have a right to independently express their opinions on important public health issues, irrespective of their involvement with government, industry, or academic."
David Juurlink, an opioid-addiction expert in Toronto, said that for too long, vested interests have influenced public policy over opioids.
"It's time we stopped listening to pain specialists. Their messages, which were wrong, got us into this mess in the first place," Dr. Juurlink said in an e-mail. "Many of these physicians are deeply in the pockets of the companies that make opioids and that stand to profit immensely from the sale of these new products."
He said that while he supports the concept of tamper resistance, the majority of patients who misuse opioids do so by simply swallowing the pills. Targeting oxycodone for tamper resistance wouldn't have accomplished anything other than allowing one company greater control over the market. "There's a lot of money to be made from the sale of these products," Dr. Juurlink said.
Pamela Leece, with Toronto's Dalla Lana School of Public Health, wrote an article in the Canadian Medical Association Journal last year criticizing the plan to make oxycodone tamper resistant. Targeting one drug in a large category doesn't address the underlying problem, which is that too many people are being prescribed opioids, she wrote.
In an interview, she said there is a need to be wary of individuals with conflicts of interest and that to solve the problem, Canada needs to focus on better treatment options for chronic pain, among a host of other measures. "I think we can all agree we need to put the interests of patients … ahead of the interests of pharmaceutical companies," she said.