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A criminal investigation into opioid marketing would expose larger systemic rot

Last Updated May 12, 2018 at 8:50 am PDT

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Summary

Health Canada won't give a yes or no as to whether Ottawa will launch a criminal investigation amidst the opioid crisis

A closer look at who is to blame as the number opioid overdoses continues to rise nation-wide

TORONTO, ON. (NEWS 1130) – Whenever Canada’s opioid crisis is discussed, the focus invariably falls at the end of the drug supply chain — on the “abuser,” on illicit use, on bootleg fentanyl, on debate over supervised consumption sites, on criminality, on devastated families. This isn’t surprising given the country’s status as the world’s second-highest per-capita user of prescription painkillers, behind the United States. More than 20,000 Canadians are estimated to have died of opioid overdoses in the past 20 years, with the toll rising annually: at least 2,923 Canadians died of apparent opioid-related deaths between January and September 2017, according to the latest stats from the Public Health Agency of Canada. A study published last month in the Journal of Addiction Medicine found one in every 133 deaths in Ontario was related to opioids; one of every six deaths among young adults involved the drugs. Even though the risk of opioid addiction and overdose is well-publicized, a staggering number of Canadians are filling prescriptions for the drugs: in Ontario alone, close to two million people — some 14 per cent of the population — did so in the 2015-16 year.


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Now a group of prominent doctors, lawyers and academics want to redirect the conversation to the beginning of the opioid pipeline: to the manufacturer, to marketing of the drugs and to the risks of opioids taken exactly as prescribed. Their first letter, sent last month to the federal attorney general and minister of health (and also forwarded to the Prime Minister’s Office) called for the government to launch a “criminal investigation into the marketing of opioids,” pointing to Purdue Pharma (Canada), the manufacturer of OxyContin, an extended-release version of oxycodone, approved in 1996 by Health Canada. The drug — which has up to twice the potency of morphine — was vigorously marketed to medical students and doctors as safer and less addictive than other opioids, as well as a means to reduce distress and improve function in patients with chronic, non-cancer pain. In 2012, more than a decade after OxyContin was known to be over-prescribed and widely abused, it was taken off the market in Canada and replaced by OxyNEO, a formulation that can’t be crushed or injected.

The letter also called on the government to “directly compensate victims of the opioid crisis with funds recovered from opioid manufacturers with new legislation,” a reference to Protecting Canadians From Unsafe Drugs Act, a 2014 amendment of the Food and Drug Act dubbed “Vanessa’s Law” passed unanimously by the House of Commons and Senate. The bill imposed more stringent pre- and post-marketing drug monitoring in Canada, called for seismic change in reporting adverse drug reactions, enabled swifter regulatory action such as a product recall or label change, and also introduced stiffer fines and even litigation for non-compliance (the previous maximum of $5,000 per offence to was raised to $5 million per day of contravention and/or two years in jail; if the offence involves “knowingly or recklessly causing a serious risk of injury to human health,” the fine is left entirely to the discretion of the court, with no cap). “The Government of Canada can divert funds from opioid manufacturers who continue to profit from the crisis to the victims of the crisis,” the letter reads, going on to note that similar legislation is in place for tobacco companies “and the victims of their inappropriate marketing practices.”

A second letter sent by the group last week provided “supporting facts,” including testimony from doctors and ads Purdue placed in medical journals, including a 2001 OxyContin spot in the Canadian Medical Association Journal featuring a photograph of a fit jogger, with the tag line “one to start and stay with.”

So far the group has received back “a generic statement from the government saying they are going to take it into consideration,” Nav Persaud, a family physician and drug researcher at Toronto’s St. Michael’s Hospital who is a signatory of the letter, tells Maclean’s.

That’s not a shocker. Any such investigation would also force the lens on a drug regulatory system that has come under repeated fire for lack of transparency, alliance with industry, and, more recently, for “gutting” Vanessa’s Law. It could also remind the nation that the transition to OxyNEO was made without any strategy to support those who had become hooked on OxyContin, despite the problems seen two years earlier in the US when the drug was taken off the market that would, in time, lead to a heroin crisis.

Any deep dive into opioid marketing would also cast light on the pharmaceutical industry’s influence on medical education and medical guidelines. Twelve of 49 experts on an advisory panel that produced 2010 practice guidelines on using opioids to treat non-cancer pain, for instance, disclosed that they received speaking or consulting fees of more than $5,000 a year from Purdue, or Purdue and other companies. The divide between the U.S. and Canada on the opioid file, and drug regulation, would also be laid bare. In 2007, Purdue Pharma pleaded guilty in the US to misleading marketing, paying $600 million in criminal and civil settlements; three executives pleaded guilty as individuals to the criminal violation of “misbranding” and were fined another $34.5 million. The company since has paid out hundreds of millions to American governments and slashed half its US sales force. In February 2018, Purdue announced it will stop advertising opioids to doctors in the US.

Meanwhile, in 2007 in Canada, the same year as the US judgment, the Ontario government, then led by Dalton McGuinty, pledged $4.9-million toward a $32-million expansion of Purdue’s Pickering, Ont. facility. Canadians patients, and their families, were left on their own to file a $20-million class action suit winding through the courts since 2007 (of that amount, $2-million would be earmarked for provincial health insurers, with the remainder split among claimants, minus some $4.5-million in legal fees). In March, Saskatchewan judge Brian Barrington-Foote put a pause on the suit, ruling the $20-million settlement inadequate.

The pause presented the last chance for criminal prosecution, says Persaud. “Once the settlement is approved, there wouldn’t be any further opportunity for provincial governments to intervene because they would receive a small amount and that would likely tie their hands.”

Like his co-signatories, Persaud has been raising red flags about opioid risk and the marketing of opioids for years. Writing in the Journal of Medical Ethics in 2013, he outlined how a Purdue-sponsored medical school lecture on pain management delivered false information about the risks. “None of purported benefits of long-acting opioids was based in reality,” Persaud tells Maclean’s. “It was all good marketing.” The following year, Purdue sponsored a continuing education program for doctors titled “Optimizing Pain Relief While Reducing Risk: Finding Your Comfort Zone.”

By then, Purdue’s strategy of enlisting doctors as “key opinion leaders,” funding pain clinics, and producing textbooks used in medical schools that downplayed risk had been well-reported. In 2012, Toronto physician Brian Goldman, host of CBC radio’s White Coat, Black Art, wrote an op-ed expressing regret for taking money from Purdue to speak to other doctors about pain management. “In recent years, I’ve seen doctors overprescribe opioids to patients without screening or monitoring them for addiction,” he wrote. “I’ve seen doctors prescribe powerful narcotics in assembly-line fashion at walk-in clinics.”

The opioid crisis was caused by the drugs taken exactly as prescribed, says Persaud: “We didn’t have an opioid crisis in the 1980s and ’90s even though we had lots of opioid products — morphine, oxycodone, hydromorphone. The rise in deaths beginning in the late ’90s and early 2000s is related to the availability of these [newly available] medications,” he says acknowledging the black market for the drugs in terms of pills diverted or inadvertently taken or used in ways not recommended by a healthcare provider. “But the bottom line is it’s related to the availability of these medications; it’s impossible for anyone to get addicted to a substance they haven’t been exposed to.”

Steps taken by the government, such as earmarking $231-million in the 2018 federal budget to improve access to overdose treatments such as naloxone (a drug also produced by Purdue), are necessary, Persaud says, but treat the problem “downstream:” Naloxone is only helpful, he says, “when someone is not breathing, near death. Obviously we would want to intervene sooner and address the origin of the problem — opioid prescribing. Relatively little attention has been paid by authorities to that.”

No one is holding their breath for the government to act. Health Canada, which regulates the approval and marketing of drugs, has not fined a single drug company since the ’70s for the way that it promoted prescription drugs, Joel Lexchin, professor emeritus of health policy and management at York University, writes in an article, “How Big Pharma deceives you about drug safety.” In theory, Health Canada has the power to regulate drug companies, writes Lexchin, who is also an associate professor of family and community medicine at the University of Toronto, and who signed the letter; in practice, day-to-day regulation of promotion has been handed over to “to a combination of industry, as represented by its lobbying arm Innovative Medicines Canada, and an independent external group with strong industry representation, the Pharmaceutical Advertising Advisory Board (PAAB),” whose Code of Advertising Acceptance is “deeply flawed.”

The system prosecutes people not companies, Matthew Herder, an associate professor of medicine and law, and the director of the Schulich School of Law’s Health Law Institute at Dalhousie University, tells Maclean’s: “A lot of discourse [around the opioid crisis] is around personal culpability, on personal failures, on people who are addicted and who made bad decisions. This is the line not only from Purdue but from some health care providers and members of public.” The real problem is “upstream,” he says, “on the supply side, on the lack of enforcement by the regulator.” Herder points to another imbalance: “Thousands, if not tens of thousands, of people across the country have gone to jail because of opioid-related diversions and abuse issues which are the sequela of overprescribing these drugs. The number of prosecutions brought against corporate persons? Zero.”

Even when its own rules were breeched, Health Canada didn’t act. In 2015, the regulator and the Canadian Institutes of Health Research (CIHR) jointly awarded a $618,248 grant to McMaster’s Michael G. DeGroote National Pain Centre to update national prescribing guidelines on opioid use. One provision was that no one voting could have financial ties with Big Pharma. After a Globe and Mail review found one-third of the 28 medical experts, academics and patient advocates had in fact received remuneration from drug companies, Health Canada entrusted the CIHR, a co-funder that reports to Health Canada, to conduct an “independent” investigation. Published in 2017, it determined no conflict of interest occurred; newly appointed federal Health Minister Ginette Petitpas Taylor expressed satisfaction with the findings.

Despite campaigns for transparency, doctors and institutions in Canada aren’t required to report payment from industry. In the US, under the Physicians Payments Sunshine Act, doctors and institutions must report funding over $10. We know big money was spent in this country by opioid manufacturers. In 2013, a year after OxyNEO came to market, Purdue spent more than $3-million promoting it in Canada, an effort that included 143 pages of advertising in Canadian medical journals; its sales representatives made 17,000 office visits to doctors. Purdue was one of the 10 pharmaceutical companies that voluntarily disclosed its 2016 payments to doctors in Ontario ($2.06 million), without naming the doctors who received the money. Last week, the Toronto Star revealed Purdue paid Canadian doctors nearly three and a half times more per capita than they did US prescribers.

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When asked by Maclean’s if the government plans to launch a criminal investigation, Health Canada spokeswoman Maryse Durette did not respond with a yes or no: “The Government of Canada recognizes that the high level of opioids historically prescribed in Canada has contributed to the devastating impacts of the current opioid crisis,” she wrote in an email, adding, “The Government of Canada is exploring all options to address this crisis.” If Health Canada determined “that an advertisement poses a significant safety concern or is in contravention of the Food and Drugs Act (FDA) or its Regulations, the Department would take prompt and appropriate actions,” she writes. (On Friday, the group also received an email from the Prime Minister’s Office saying it had received the “correspondence regarding the opioid crisis” and that the email had been “carefully reviewed” and the Prime Minister “will leave the matter to be considered by [Health] Minister Petitpas Taylor.”)

The government “closely noted the proceedings and outcomes” of the Purdue 2007 US lawsuit, Durette writes, noting that, “had charges against Purdue been pursued under the [Canadian] Food and Drugs Act at the time of the alleged inappropriate marketing practices, the maximum penalty that the courts could have imposed upon conviction was a fine of $5,000 per offence.” More stringent penalties could not be applied to situations that arose before the changes in the law, she said, adding “Health Canada will not hesitate to address advertising and marketing abuses using the new powers at its disposal.”