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 Purdue Pharma's efforts came as the government pledged a new attack
on the county's deadly opioid crisis. The privately owned maker of
the blockbuster OxyContin pushed for a requirement that all
long-acting narcotic painkillers, known as opioids, be made tamper
resistant.
The company, which sells the only tamper-resistant, long-acting
opioids in Canada, met with 40 officeholders last year, up from
eight in 2015 and three in 2014, records show.
The rule it proposed could edge out companies that don't sell
tamper-resistant opioids, including Novartis’, Sandoz AG <Sandoz
AG>, Johnson & Johnson’s Janssen, Teva, Pharmascience and Apotex SA
<Apotex SA> and others. Purdue said other companies make
tamper-resistant opioids that they could seek approval for in
Canada.
Purdue's lobbying illustrates the stakes for drugmakers in efforts
to curb what policymakers have called North America’s biggest public
health crisis.
Deaths involving opioids - including prescription painkillers,
heroin and other street drugs - rose 38 percent in Ontario over the
last five years and almost doubled in British Columbia in last year.
More than 200,000 people have died in the U.S. epidemic.
Canada's $881-million annual opioid sales are dwarfed by the U.S.
market, the biggest in the world. Any action by Canada is likely to
attract interest south of the border.
Purdue said it was pushing for the rule to improve safety. Canadian
officials have passed on that proposal and instead are looking at
measures that could hurt sales of long-acting opioids, including
Purdue's best-selling painkillers.
Health Minister Jane Philpott said she would begin taking steps this
month to get cigarette-style warning stickers on all opioids and,
next month, to rewrite Canada’s definition of appropriate use for
long-acting opioids. [L1N1FD018]
An advisory group funded in part by Health Canada recommended in
January setting a daily dosage cap for long-acting opioids and
scaling back their use for chronic, non-cancer pain.
TAMPER-RESISTANCE DEBATE
Long-acting opioids contain high doses of narcotics designed to be
released over time. If crushed pills are snorted or injected, they
release their full dose all at once, which makes them dangerous and
valuable among addicts.
In 2012, Purdue replaced OxyContin with tamper-resistant OxyNEO in
Canada and now wants that standard mandated for all long-acting
opioids.
"The abundance of published peer-reviewed evidence of the positive
impact abuse-deterrent technologies have on public health supports
Purdue Pharma (Canada)’s view that making all prescription opioids
less vulnerable to misuse, abuse and diversion, while retaining
their safety and efficacy, is necessary,” spokesperson Sarah
Robertson wrote in an email.
Many experts and public health officials see the research
differently. They said there’s little evidence tamper resistance
reduces addiction or death and that it may even prompt doctors to
more readily prescribe opioids.
Research shows opioids are most often abused not by crushing but by
swallowing pills whole, said David Juurlink, a drug-safety
researcher at Toronto’s Sunnybrook Health Sciences Centre.
"It’s very easy to get the sense that this push in favor of
tamper-resistant opioids is rooted more in financial considerations
than in the public interest,” he said.
The company said it's only objective was safety.
[to top of second column] |
Purdue Canada also sells a crushable long-acting opioid. Hydromorph
Contin is a brand-name version of Canada's top-selling opioid
painkiller, hydromorphone, which has been involved in a growing
number of overdose deaths. Purdue declined to say whether it had
plans to make Hydromorph Contin tamper resistant.
Generics manufacturers said they do not view tamper resistance as
the answer.
“We believe that efforts should be made to address the main root
cause of opioid abuse and misuse, which appears to be
over-prescribing,” Jeff Connell, Canadian Generic Pharmaceutical
Association Vice-President, said in an email.
"There is no evidence that tamper-resistant formulations are
effective in reducing the level of abuse of opioids," a Sandoz
spokesperson wrote in an email. Sandoz sells a long-acting,
crushable oxycodone painkiller.
Health Canada issued a statement last April saying it had no plans
to require tamper resistance.
Purdue sent lobbyists on four occasions to Health Canada officials
last year, including a May meeting seeking an explanation for the
government's stance, department spokesperson Anna Maddison said in
an email.
Conservative Member of Parliament Kevin Sorenson revived the idea in
September with a bill to require all controlled substances be tamper
resistant.
Records show Sorenson met with Purdue representatives six days
before he introduced the bill and spoke with them again two days
before it went to second reading in November.
The lobbyists expressed Purdue’s support for the bill, Sorenson's
spokesman Dan Wallace said in an email.
The bill needs majority support in the House of Commons, including
at least eight members of the governing Liberals, to go to the
Senate.
In October, Purdue Canada Chief Executive Craig Landau met with
Public Safety Minister Ralph Goodale to discuss "efforts to combat
opioid abuse," said Scott Bardsley, a spokesperson for the minister.
Toronto-area Liberal Member of Parliament Jennifer O’Connell said
Purdue sent a representative to talk to her when she was a candidate
in 2015 and, records show, twice after she won.
“I found that interesting. I flat-out asked them, ‘Why is this in
Purdue’s interest?’ And they said it was very altruistic, wanting to
deal with the opioid crisis,” she said in an interview. “I did a
little more research, and I realized … if the federal government
were to regulate it for everyone else, they’d essentially have a
monopoly.”
(Editing by Amran Abocar and Lisa Girion)
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