Solving the painkiller crisis: It’s in the hands of doctors

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Somewhere in Canada this year, a car accident claimed the life of someone who was taking eight different kinds of potent painkillers. We don't know the person's name, age, gender or even where the crash took place – just that he or she is one of the nearly 2,500 such death reports sent to Health Canada's "adverse drug reaction" database.

Some who died took their own lives, while others had used the pills to get high. But many were people who had received a prescription from their doctor: a 49-year-old man with heart problems, a 51-year-old woman who overdosed, perhaps forgetting that her dosage had gone up, a 69-year-old man simply in "pain."

The entries are voluntary and imprecise (some deaths appear more than once), but the database is the closest the federal government comes to tracking the body count in the nation's pitched battle with painkillers.

Doctors are supposed to "do no harm." Yet, they now order enough opioid painkillers – compounds descended from the opium poppy – each year to give a dose to every single Canadian between ages 20 and 60.

The national consumption has risen so rapidly that Canada now ranks second per capita only to the United States, where painkillers take more lives than heroin and cocaine combined.

But the U.S. is beginning to turn the tide. This week, the prestigious American Academy of Neurology, whose members specialize in pain treatment, became the first major medical organization to oppose the long-term use of opioids for most types of chronic pain.

As well, the National Institutes of Health (NIH) – Washington's primary medical research agency – held a two-day session where experts concluded that over-prescribing is a major threat.

The issue also was on the agenda when provincial health ministers met this week in Banff, but the Ebola outbreak in West Africa and other concerns dominated the session. Canada's public officials have yet to grasp the full extent of the opioid crisis.

A report released last month reveals that high-dosage prescriptions – which greatly increase the risk of accidental overdose and death – rose by nearly 25 per cent between 2006 and 2011.

One expert calls the practice "quite possibly the most dangerous thing that doctors are doing in Canada right now."

Opioids have long been used immediately after surgery, for a severe injury or in cancer patients. More recently, they have become the treatment of choice for chronic pain, the kind that may never go away, even though they are addictive and deadly. Physical dependence often takes hold within weeks, bringing with it the danger of a fatal overdose.

And despite the fact that thousands of Canadians now take opioids for chronic pain, there is little hard evidence they actually work long-term – and mounting proof they can, in fact, begin to cause pain themselves.

There are no fewer than 38 types of opioids now in use, but the notoriety surrounding OxyContin – the first of the high-powered slow-release varieties – has linked them all in the public mind with "hillbilly heroin."

But illegal drug use is not the only reason for the rising rates, says Tara Gomes, the high-dose study author and a scientist with the Li Ka Shing Knowledge Institute at St. Michael's Hospital in Toronto. "A lot of it," she says, "is people receiving legitimate pain prescriptions."

The nearly 20 million opioid prescriptions dispensed from Canadian pharmacies in 2013 (almost three million more than just four years earlier) were worth nearly $800-million, according to IMS Brogan, a firm that tracks pharmaceutical sales. Taxpayers picked up the tab for any covered by provincial drug plans.

Although deaths related to opioids are not being tracked, experts estimate there are as many as four a day. In 2012, the toll in Ontario – which has the highest rate of high-dose opioid prescriptions in the country – was nearly 600, or more than 11 a week, according to the provincial chief coroner's office. A recent study in the journal Addiction found that opioids account for one in every eight deaths among Ontario young people.

"When you give somebody a drug that's exactly the same thing as heroin, we shouldn't be surprised that bad things ensue," says David Juurlink, head of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre in Toronto.

He argues that "we have ... helped at least 10,000 Canadians directly or indirectly to an early grave. Doctors need to be ashamed."

And now a new, more powerful member of the opioid family is waiting to join those already on the market.

The federal government has long been criticized for dragging its heels on opioids. It has, unlike the U.S., undertaken no formal investigation of how they are marketed, nor has it forced manufacturers to make products that resist abuse by recreational users.

Now, however, Health Minister Rona Ambrose appears to be making the issue a personal cause, revealing to The Globe and Mail that she has friends who became addicted while suffering pain "that you could probably have taken a Tylenol for." Alberta, her home province, is second only to Ontario in per capita consumption.

She has certainly grown increasingly vocal on the subject – telling the annual conference of the Canadian Medical Association in August that "too many people are abusing prescription drugs; too many people are suffering and dying as a result" and issuing a national call for ideas on how to improve the situation.

But with little obvious success.

Ms. Ambrose hasn't ruled out adopting a new U.S. requirement that high-dose opioids be "tamper resistant" – less easily crushed for recreational use. But her only concrete action so far has been to announce that soon the medication will carry tougher warning labels.

"Doctors don't read labels," replies Dr. Juruulink, insisting that only a drastic reduction in the number of prescriptions can have a real impact.

Ms. Ambrose says that, despite her cabinet post, she is handicapped: "I'm trying to do everything I can ...," she tells The Globe and Mail, "but the most obvious issue to deal with is prescribing, and I have no control over that – I can't control how somebody writes a prescription."

Recently, she adds, a senior representative of Canada's doctors told her that her criticism has " 'really touched a nerve with our organization and we don't feel that we're to blame.' My message back was … 'This is real and we need to tackle it,' " she says. Doctors "can and should take a leadership role on this."

Meanwhile, in the past five years, her department has approved about two dozen new versions of the opioids oxycodone, fentanyl and hydromorphone.

There has been very little scientific research on how opioids affect people who take them for long periods of time, and the few studies there are raise serious doubts. The Cochrane Collaboration, an international network of medical experts, reviewed 22 studies involving nearly 8,300 patients and concluded that placebo pills were almost as effective – with far fewer side-effects.

The AAN's decision this week to advise against opioids for most chronic conditions was bold move, but this lack of evidence, combined with the overwhelming proof they cause harm, left it with no other choice, says Gary Franklin, who wrote the academy's position paper.

Half of patients who take opioids for three months are still on them five years later and risk doing so for the rest of their lives, says Dr. Franklin, a research professor at the University of Washington School of Public Health in Seattle.

Nav Persaud, a family physician and researcher also at St. Michael's, says reliance on opioids has got to the point that "most people actually overlook that one very important question, which is why are these medications being prescribed? For other medications, we would say, if there isn't evidence, we shouldn't prescribe them."

So, what is motivating doctors? Some experts chalk it up to a perfect storm: suffering patients, the tendency to rely on pills to treat a complex physical problem, and the lack of alternatives.

Others see darker forces at work. "I think we have been misled," says Dr. Irfan Dhalla, opioids researcher and a vice-president of Health Quality Ontario, an independent provincial government agency.

"I think physicians want to help and there's no doubt that patients are suffering … but that doesn't mean the benefits of long-term opioid therapy outweigh the harms."

In fact, such therapy can also cause pain rather than relieve it – a condition known as opioid-induced hyperalgesia. For reasons scientists don't fully understand, the central nervous system becomes overly sensitive.

When patients complain that their pain hasn't subsided, or is worsening, unsuspecting doctors assume the body has begun to tolerate it – and increase the dosage.

After all, that's what they learned in med school.

"I think that one of the saddest things about the opioid epidemic ... is that physicians have played a large role in the problem," says Dr. Persaud, who five years ago stumbled on one reason that may be the case.

He was working as a medical resident in a Toronto hospital when he noticed something strange. A patient had overdosed on acetaminophen tablets (which can be extremely toxic) and the student doctor he was supervising wanted to prescribe Percocet, unaware the painkiller also contains acetaminophen.

When asked why, the student said that's what she had been taught in a mandatory course on pain management at the University of Toronto's medical school.

He asked for her notes and was surprised to see a guest lecturer not only refer to drugs by brand name (rather than active ingredient) but describe oxycodone, the active ingredient both in Percocet and OxyContin, as relatively weak, with little potential for abuse, neither of which is true.

Dr. Persaud, also a U of T grad, then looked at his own notes and realized that he'd had the same lecture.

Alarmed, he investigated and discovered that both the guest speaker and a supplementary textbook students received had been subsidized by Purdue Pharma – the manufacturer of OxyContin.

Fearing that "most patients would find [this potential conflict] unacceptable," he pursued the matter until his alma mater changed the course and dropped the textbook.

He also asked officials to contact all former students who had attended the lectures; instead, they sent out a notice asking current students to consult up-to-date guidelines for best practices in pain management.

Aggressive marketing aside, doctors are often grateful to have something, anything, that promises relief.

Anyone suffering from chronic pain – typically longer than three to six months – knows that others rarely appreciate how debilitating it can be.

But because it is hard to see or measure, chronic pain does not attract much research money (just a quarter of 1 per cent of federal spending on health research, according to a 2009 study). The bulk of what does come is often from the makers of opioid drugs.

Alternative treatments, such as physiotherapy, can be highly effective, but Dr. Persaud says many patients go to a doctor's office expecting to be given a pill.

"The issue is that we don't really have much else," says Benedikt Fischer, director of the Centre for Applied Research in Mental Health and Addictions at Simon Fraser University.

"But the absence of better tools doesn't necessarily mean what we have is the best or optimal."

When OxyContin was approved for sale in the mid-1990s, its manufacturer went to great lengths to persuade doctors and patients that a slow-release all-day pill was just what they needed.

As well as the usual tactics – sending out sales reps and placing ads in medical journals – Purdue commissioned focus groups, only to learn that doctors were worried about Oxy's addiction potential.

The company came up with a response that a decade later led to it and three top executives pleading guilty to misleading regulators, doctors and patients. It also agreed to pay a fine of more than $600-million U.S., one of the largest ever imposed on a drug maker.

Investigators found that Purdue had instructed its sales force to claim, much like the guest lecturer told Canadian medical students, not only that OxyContin was less addictive and prone to abuse than other opioids, but that it didn't produce the euphoria that was to attract recreational users or cause withdrawal symptoms. Rather than "the result of good science," the lead prosecutor told one interviewer, "OxyContin was the child of marketers and bottom-line financial decision-making."

Canada, however, made no attempt to follow the U.S. lead, doing little before Ms. Ambrose's labelling announcement about opioids or the way they are marketed. Last year, Purdue gave grants to 30 pain-management centres, hospices, advocacy groups and medical organizations across he country.

Lucy Lai, communications manager at Purdue Pharma Canada, says the company is committed to supporting the community and finding ways to help patients. Declining a request for an interview, she says by email that, when donating, Purdue follows guidelines created by an industry association.

Still, the fact that it is also among the sponsors of a course offered by the Canadian Medical Association raises some eyebrows. It promises to teach CMA members how to apply national guidelines for using opioids and how to identify patients who can benefit from them.

But Amy Graves, who launched a campaign against opioids after her brother died of an overdose in Halifax three years ago, says she can't help but wonder: "What kind of information are these doctors getting?"

Published in 2010, national opioid prescribing guidelines were supposed to provide some clarity.

In response to growing concerns, the provincial colleges that regulate the medical profession assembled a 49-member advisory panel to help draft the policy, only to have nearly half of them declare a potential conflict of interest. Purdue had paid 17 of the 49 for speaking engagements and work on clinical trials and, in one case, contributed $200,000 to a pain-management clinic.

Of the 24 recommendations that resulted, 18 were based at least in part on the opinion of the panel, which makes people like Dr. Juurlink (who began his career as a pharmacist) uneasy. "I would say, if people have accepted money from the pharmaceutical industry ... it makes it very difficult for them to be truly objective," he says.

For example, to determine a patient's optimal dosage, doctors are advised to start low and gradually increase – even though doing so can raise the risk of dependence dramatically.

Some U.S. agencies now actively discourage this approach. The Group Health Co-operative, which serves 600,000 people in Washington state, has launched a program to combat addiction by keeping patients on low doses and monitoring them carefully, says Michael Von Korff, a researcher at the co-operative.

Some research was used to determine the Canadian guidelines, but it often compared opioids with a placebo, which doesn't accurately portray how they stack up against other painkillers. And no study that supports using them to treat back or neck pain, osteoarthritis or a host of other conditions lasted longer than three months – the bare minimum for pain to be considered chronic.

But Andrea Furlan, a specialist in chronic pain at the U of T medical school who played a lead role in drafting the guidelines, dismisses the notion that they are suspect simply because some on the panel accepted money from drug companies.

Mary Lynch, a panel member and director of research at the pain-management unit at Queen Elizabeth II Health Sciences Centre in Halifax, insists that her corporate contact has had no impact on her work or findings. She also argues that, despite the statistics that dispensing is rising, doctors are becoming so hesitant to prescribe opioids that many people with chronic pain can't get the medication they need.

"That has been a real problem for us out in the field of pain management," she says.

For example, the 1,965,000 prescriptions filled in 2009 for hydromorphone (also known as Dilaudid) alone nearly doubled to 3,529,000 last year.

One solution being proposed by the industry is Zohydro, designed for what the U.S. Food and Drug Agency describes as "pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatments options are inadequate."

Recently approved over the objection of the FDA's own advisory board, Zohydro has sparked an outcry from politicians and public-health experts, as well as concern that it may appear in Canada.

Philip Berger, chief of family medicine at St. Michael's, says he fears that its marketing would target doctors in the same way OxyContin's once did.

"It would be safer if the drug was silently put on the market," he says. "Let physicians determine if it's a reasonable choice or a necessary choice."

But adding a 39th opioid to the roster would absolutely send the wrong signal, say those desperate to see a dramatic scaling-back.

"We use and dispense way too many of these drugs," says Dr. Juurlink, who calls the rising tide "quite possibly the most dangerous thing that doctors are doing in Canada right now."

Chris Simpson, president of the Canadian Medical Association, is much more cautious. The head of cardiology at Queen's Hospital in Kingston, Ont., he agrees that doctors should be better educated on how to prescribe opioids safely, but he warns that, by the same token, they need to have something to give patients in pain.

"I'd hate to move to an environment where we demonize opioids," Dr. Simpson says. "They certainly have a place. We work in a world of incomplete evidence all the time."

He calls it "encouraging" to see the federal health minister talking publicly about this problem, but he hopes "this isn't more plan development without execution on the plan."

Barb Moran, director of prescription-drug abuse for Health Canada, says the department is keenly aware of the problem and has been working with provinces to improve surveillance. She says that finding a solution also will require the co-operation of law enforcement and the drug industry, but offers no indication of what that may entail.

The provincial colleges of physicians and surgeons also seem reluctant to take concrete steps. Many focus on monitoring programs aimed at identifying patients who try to get multiple prescriptions.

This can help to pinpoint people who are breaking the law – from recreational drug users to addicts who engage in "doctor shopping." But it doesn't address the vast majority of people who have proper prescriptions.

Gus Grant, registrar and CEO of the College of Physicians and Surgeons of Nova Scotia, says doctors must balance the obligation to patients in pain with the potential risks of addiction, while Alberta's regulator is focused on better monitoring and education efforts, says Susan Ulan, its senior medical adviser.

On Sept. 23, the Nova Scotia college unveiled a new awareness campaign designed to help patients talk to their doctors about different pain management strategies. But in the accompanying press release, Dr. Grant insists that opioids will not be cast side. "In many cases, they are the right tool for the job."

Ontario registrar Rocco Gerace says that, like Dr. Lynch in Halifax, he believes doctors are already prescribing less often. If so, why is consumption going up? Perhaps, he sugests, because aging baby boomers are falling prey to chronic pain.

But some doctors feel their profession's regulators are paying lip service to the problem. Dr. Berger, for example, says the Ontario college "has utterly failed in its duty to protect the public by not scrutinizing the prescribing practices of physicians years ago."

Dr. Franklin of the AAN says he is astounded that the public isn't already up in arms. "If these were salmonella deaths, our health authorities would be jumping into action. But I think it's because organized medicine has done this – it's not easy to buck that."

Dr. Juurlink agrees, saying that putting away the prescription pad is the only way to ease the problem and save lives – yet something even he admits is "going to be a very tall order."

But it is possible, if the country's doctors, their regulatory bodies and the federal government are willing to act.

The changes he and other experts seek rest on three essential measures:

A real-time monitoring system for prescriptions;

Comprehensive tracking of opioid-related deaths;

A massive re-education program for medical practitioners.

The monitoring system would allow doctors and pharmacists to see at a glance if a patient has already filled another prescription down the street.

Tracking the deaths (which the U.S. now does) would reveal the true scope of the opioid problem and allow the impact of improvements to be measured accurately.

And the education program would allow regulatory colleges to impress upon doctors exactly why opioids can and should be prescribed for patients who are in extreme pain, suffering from cancer or dying.

There will always be a need for opioid drugs to treat severe pain. But it's time to do away with, once and for all, the idea these troublesome drugs are the answer to chronic pain.

"I think some doctors are hearing that message," Dr. Juurlink says. "But many others are not."

WHO TAKES WHAT

Doctors across Canada write millions of prescriptions for high-dose opioids, but some parts of the country take a lot more of them than others.

The nation

961: The number of high-dose opioids prescribed for every 1,000 people in 2011 (up from 781 five years earlier)

By province

Ontario: 1,382 (from 1,111 in 2006)

Alberta: 1,133 (from 1,066)

Newfoundland and Labrador: 937 (up 85 per cent from 507)

New Brunswick: 902 (from 687)

Nova Scotia: 839 (from 719)

Manitoba: 743 (from 518)

British Columbia: 739 (from 682)

Prince Edward Island: 556 (from 388)

Quebec: 368 (from 283)

Source: IMS Brogan Canada