Canada’s health minister says she cannot delay or block the approval of generic OxyContin on the premise that some could misuse and become addicted to it.

In a letter to her provincial counterparts, Health Minister Leona Aglukkaq said that there’s nothing in the Food and Drugs Act that indicates she could withhold the approval of generic Oxy if the formula is considered “safe and effective” when taken as recommended.

Her remarks bear significant weight in the debate over whether Health Canada should allow drug companies to manufacture alternative versions of the powerful time-release painkiller.

Last September, Aglukkaq’s provincial counterparts had asked her to intervene and delay the approval of a generic form of OxyContin to allow for more research on the discontinued drug.

Reaffirming a position she’s held throughout the generic Oxy debate, Aglukkaq said politicians should not weigh in on decisions that should be made by medical experts.

“While intentions may be noble in this circumstance, what stops future politicians from caving into public pressure and allowing unproven, unsafe drugs on the market once political pressure starts to mount?,” Aglukkaq said in her letter.

OxyContin was developed by Purdue Pharma Canada to alleviate chronic pain by releasing a dose of oxycodone into the body over several hours. The drug, however, became popular among addicts who crushed the tablets into a fine powder that could be injected or snorted.

The original drug was discontinued early this year and replaced with a drug called OxyNEO.OxyNEO tablets are said to be tougher to crush and extract oxycodone from, but as Aglukkaq notes, the drug cannot bill itself as being “harder to abuse” or “tamper-proof.”

Meanwhile, Purdue Pharma’s patent on the original OxyContin formula expires on Nov. 25.

Ontario Health Minister Deb Matthews was among the provincial health ministers championing calls to block the production of generic forms of OxyContin. In her view, the emergence of an Oxy alternative would be “tragic,” leading to widespread abuse all over again.

Responding to concerns about the potential emergence of Oxy generics, Aglukkaq said banning alternative versions of the powerful painkillerdoes not solve the overarching issue of prescription drug abuse in Canada.

There nearly 100 drugs in Canada in the same class of drugs as OxyContin, she said. If generic Oxy is allowed to hit the market, it will be available by prescription only and up to provinces, territories and medical professionals to regulate use of the drug.

“If the country is ‘flooded’ with prescription drugs, it can only be in part because some medical professionals are making it possible,” Aglukkaq said in her letter.

She announced that Ottawa would be introducing new licensing rules to “clamp down” on the misuse of prescription drugs. Manufacturers of time-release oxycodone drugs are now subject to new rules under Health Canada,requiring them to report any sharp increases in sales or changes in distribution.

Previous requirements, which still stand, just required companies to report loss and theft.

The idea that prescription drug abuse represents a failure at the regulatory level has been disputed by many, including the Ontario Pharmacists’ Association, which advocated Monday for the deferral of Health Canada’s generic Oxy decision.
“While the drug-approval process is designed to ensure that a product is safe and effective, it cannot protect patients against any product’s eventual misuse and alteration, or illicit potential,” the association said in a statement.

Though Aglukkaq has asked provinces and territories to consider what they can do to combat prescription drug abuse, she has also said that she will consider more federal oversight.

But additional oversight, she warned, could make it more difficult for patients with chronic pain to access pain-relieving drugs.

“I want to make sure that whatever we do to crack down on prescriptiondrug abuse does not have unintended negative consequences on those who need this medicine to maintain a reasonable quality of life,” said Aglukkaq.

For more on this story go to: http://www.ctvnews.ca/health/ottawa-won-t-intervene-in-generic-oxycontin-decision-1.1044216#ixzz2Cld9L8y8

See also this story from BBC

OxyContin abuse hits Canada First Nations communities
By Linda Pressly

Addiction to prescription drugs is devastating Canada’s First Nations peoples. Fort Hope, almost a three-hour flight north of Toronto, is one of the worst-affected communities.
Dave Waswa is a talented artist. He carves eagles from moose antlers. If he sold his art to a dealer he could make good money. But Mr Waswa has a serious addiction, and he uses his art to feed it.
One carving will get him five or six OxyContin pills – and in Fort Hope, home to the Eabametoong First Nation, just one 80mg tablet sells for between $400 and $600 (£250 and £376).
“It makes everything go away,” Mr Waswa says of the prescription-only painkiller. “You don’t have no feeling. You just want to stay high… But I’m tired of it. I lost a buddy last summer. He was 38 years old and took an overdose, went into a coma and never got up.”
OxyContin is said to be as potent as heroin and twice as addictive. If it is prescribed by a doctor for the relief of chronic pain, it is taken orally and absorbed in the body over 12 hours. But people who abuse it, like Dave Waswa, crush the pill, then smoke, snort or inject it to get an immediate high.
Purdue Pharma, the makers of OxyContin, has recently stopped manufacturing the drug for Canada and replaced it with a formulation supposed to be more difficult to tamper with. The province of Ontario, in which Fort Hope is located, has also imposed tighter controls on prescriptions.
Meanwhile, it has been estimated that up to 80% of the working age population of Fort Hope is abusing the drug. Mr Waswa has been hooked for seven years. Now he wants out.
“I’m sick and tired of what Oxy’s doing to me. It’s taken a lot away from me. My kids, my parents, girlfriend, friends. I hurt a lot of people because of my addiction, and I’d like to try and change it,” he says. “I’d like to see what it’s like getting clean.”
He is hoping to get help at the detox centre set up in Fort Hope by the local chief and council. It prescribes Suboxone, a drug used to wean addicts off OxyContin in the same way methadone is prescribed to heroin addicts. But the facility only has four beds, and there are 70 people on the waiting list.
Chief Harry Papah is worried. In 2010, Fort Hope declared a state of emergency as a result of the surge in addiction and the crime wave that followed, including two murders and 49 arson attacks.

“It was the first step we took to expose what we are going through, and it brought the community together,” says the chief. “And it’s not just us who are affected. So many other First Nations are dealing with the same issues.”
Addiction to prescription drugs is a problem across Canada. But Chief Papah says First Nations communities are especially vulnerable.
“We’re very isolated up here, and there are deep-rooted issues people are dealing with like abuse – in our families, or because we went to residential schools,” he says, referring to the government-sponsored schools that separated aboriginal children from their parents in an effort to assimilate them.
The desire for the drug has had repercussions across the community. “People will do whatever they can to get that drug. They are stealing or selling off their own appliances,” Chief Papah says.
“There are homes here that are empty: no TV, no furniture, and sometimes the kids are going hungry. We want parents to care for their children but they don’t because they are hooked on OxyContin.”
That lack of parenting means some young people are out of control, and the fallout is in evidence all around Fort Hope. Arson attacks have continued. The shell of a burnt-out police vehicle sits behind the police station. Buildings are blackened by the attempts to set them on fire, and house lots are often empty because a home has been razed to the ground.
Fort Hope’s state of emergency brought in a temporary increase in police resources from the Ontario Provincial Police. Detective Staff Sgt Chris Lawrence, who heads up the force’s Organized Crime Enforcement Bureau, believes far-flung First Nations communities like Fort Hope are being targeted by drug dealers.
“In cities like Toronto you can buy a hundred OxyContin pills for around $40 each. But if you get those up to Fort Hope, you can sell each one for around $500 or $600,” he says. “The profit margins are ridiculous and organised crime groups recognise that.”
OxyContin is a drug that is very difficult to give up.

For more on this story go to:
http://www.bbc.co.uk/news/magazine-17516230