In previous blogs, big pharma’s influence on trade deals like the TPP and the negative consequences for Canadians was uncovered. The topic is inherently broad and often quite technical, so as a result the downstream outcomes people face as a result of pharma policy tend to be obscured. The recent opioid epidemic destroying lives across Canada and the US serves as the clearest example of the influence of big pharma has physician prescribing habits. This epidemic serves as a heartbreaking reminder of what occurs when our government allows big pharma to undemocratically influence our policies.
Opioids include prescription narcotics, such as Oxycontin, hydromorph Contin and fentanyl (which is around 100 times stronger than morphine). Alan Cassels, a pharmaceutical policy researcher at the University of Victoria, has stated, “By all accounts, we are in the midst of a deadly drug epidemic so severe and widespread that few people in North America will remain untouched by it. In case you think I’m exaggerating, right now we have probably the highest rates of narcotic abuse and deaths in modern history... we have some of the highest rates of prescription-opioid consumption in the world. From 2006 to 2011, use of opioids in Canada rose by 32 per cent and that rise has continued unabated... It’s important to recognize that liberal prescribing of opioids is a recent problem and, since the mid-1990s, can be linked to the message-crafting activities of the pharmaceutical industry that helped shape both patient perceptions of pain and influence how doctors thought about the safety of these drugs.”
More specifically on the influence of drug companies, an opinion piece in the Toronto Star by health lawyer Matthew Herder and Dr. David Juurlink highlighted, “You only need to know the name of one company — Purdue Pharma — to understand why transparency is needed in the financial dealings between drug manufacturers and doctors. Purdue sells OxyContin and other products prescribed for the treatment of pain, one of the most common symptoms physicians encounter. As the U.S. company acknowledged, Purdue misled doctors about the safety and effectiveness of OxyContin, fuelling a public health crisis that now claims the lives of some 30,000 North Americans annually.”
To understand what these two public health advocates are talking about, a great place to start is an excellent article by the LA Times this month (which is truly worth a full read by anyone interested in the subject) that has exposed the unbelievable facts how the opioid epidemic has been driven by big pharma. The article begins with a marketing claim made two decades ago when drugmaker Purdue Pharma launched OxyContin, “one dose relieves pain for 12 hours, more than twice as long as generic medications... Patients would no longer have to wake up in the middle of the night to take their pills, Purdue told doctors. One OxyContin tablet in the morning and one before bed would provide smooth and sustained pain control all day and all night.” As a result, Purdue reaped $31 billion in revenue but, “But OxyContin’s stunning success masked a fundamental problem: The drug wears off hours early in many people... Purdue has known about the problem for decades. Even before OxyContin went on the market, clinical trials showed many patients weren’t getting 12 hours of relief,” yet, “The company has held fast to the claim of 12-hour relief, in part to protect its revenue. OxyContin’s market dominance and its high price — up to hundreds of dollars per bottle — hinge on its 12-hour duration. Without that, it offers little advantage over less expensive painkillers.Purdue tells doctors to prescribe stronger doses, not more frequent ones, when patients complain that OxyContin doesn’t last 12 hours. That approach creates risks of its own. Research shows that the more potent the dose of an opioid such as OxyContin, the greater the possibility of overdose and death.”
The result is that in the US more than half of long-term Oxycontin users are on doses that are considered dangerously high by public health officials (there have been more than 190,000 lives lost from overdoses involving OxyContin and other painkillers since 1999 in the US). Theodore J. Cicero, a neuropharmacologist and a leading researcher on how opioids affect the brain has highlighted that, “OxyContin taken at 12-hour intervals could be ‘the perfect recipe for addiction,’” and other experts have stated that, “when there are gaps in the effect of a narcotic like OxyContin, patients can suffer body aches, nausea, anxiety and other symptoms of withdrawal. When the agony is relieved by the next dose, it creates a cycle of pain and euphoria that fosters addiction.”
The LA Times article details how Purdue developed OxyContin as a cure for pain — and for a financial problem. Even though the drug demonstrated a lack of increased efficacy in treating pain compared to older medications, the company pushed its product with zeal. In a 1995 meeting, a marketing executive explained to employees planning the drug’s debut, “We do not want to niche OxyContin just for cancer pain.” According to recent court documents the company spent $207 million US on the launch, doubling its sales force to 600, and sales reps pitched the drug to family doctors and general practitioners to treat common conditions such as back aches and knee pain. Further, the company’s, “sales reps showered prescribers with clocks and fishing hats embossed with ‘Q12h.’ The company invited doctors to dinner seminars and flew them to weekend junkets at resort hotels, where they were encouraged to prescribe OxyContin and promote it to colleagues back home.” It has been reported that in the seven years after OxyContin’s approval by the FDA in 1995, the company sponsored some 20,000 pain ‘education programs’ in the United States at a cost of about $200 million, the company employed a legion of sales representatives to promote its products, paying them bonuses averaging $70,000, with some earning upwards of $250,000, and Purdue also spent huge amounts on ‘gifts’ and ‘swag’ for doctors, and distributed starter coupons entitling patients to their first OxyContin prescription free. At the same time Purdue simultaneously engaged several ‘key opinion leader’ ( a common practice by big pharma for new drugs) to tout OxyContin’s safety and effectiveness to the profession. By the fifth year after its launch, OxyContin was generating annual revenue of more than $1 billion US and 2010 sales were at $3 billion. The only slap on the wrist to occur as a result of this marketing campaign came as a warning from the FDA in 2003 over misleading advertisements.
When doctors began complaining OxyContin didn’t last patients the specified 12 hours, Purdue reps were told “to recommend increasing the strength of the dose rather than the frequency. There is no ceiling on the amount of OxyContin a patient can be prescribed, sales reps were to remind doctors, according to the presentation and other training materials.” Further, in the late 1990’s when doctors started prescribing at shorter intervals, Purdue executives mobilized, “hundreds of sales reps to ‘refocus’ physicians on 12-hour dosing. Anything shorter ‘needs to be nipped in the bud. NOW!!’ one manager wrote to her staff.” Other supervisors, like one in West Virginia told, “one of his highest performing sales reps in a 1999 letter that she could ‘blow the lid off’ her sales and earn a trip to Hawaii if she persuaded more doctors to write larger doses. In an August 1996 memo headlined ‘$$$$$$$$$$$$$ It’s Bonus Time in the Neighborhood!’ a manager reminded Tennessee reps that raising dosage strength was the key to a big payday.” An analysis of the medical records of more than 32,000 patients on OxyContin and other painkillers in Ontario, Canada, found that one in 32 patients on high doses fatally overdosed.
The state of Kentucky filed a lawsuit against Purdue Pharma alleging the company helped create a wave of addiction by improperly downplaying the addictive properties of its drug while aggressively marketing the drug to doctors. In December, the case was settled, with Purdue agreeing to pay the state $24 million. Yet, the settlement did not require Purdue to admit any wrongdoing or change the way it told doctors to prescribe the drug. The company said they, "planned to continue telling doctors OxyContin was a 12-hour drug. The lawyers gave a list of reasons: Purdue hadn’t submitted studies to the FDA to support more frequent dosing, the FDA had approved OxyContin as a 12-hour drug, and 12-hour dosing was more convenient for patients,” and, “their final reason: It was better for business.... ‘The 12 hour dosing schedule represents a significant competitive advantage of OxyContin over other products,’ the lawyers wrote.” Recently, a Kentucky judge ordered an important deposition from the case to be released to the public after a request by journalists. Purdue, for their part, are planning to appeal the ruling, and the documents are being withheld pending the outcome of an appeal. So stay tuned...
Overall, the result of situation outlined in the paragraphs above means more Americans are being prescribed opioids than is necessary. In 2012, it is reported that 259 million prescriptions were written for opioids — enough to give every American adult their own bottle of pills. Since 2000, the overdose death rate in the U.S. has risen by 200 per cent; nearly 19,000 opioid-related overdose deaths occurred in 2014. A recent survey in the US found 44% of respondents say they personally know someone who has been addicted to prescription painkillers, with about a quarter (26 percent) saying the person they know is an acquaintance, 21 percent saying a close friend, 20 percent saying a family member, and 2 percent saying themselves. In a New York Times op-ed, the former commissioner of the Food and Drug Administration. Dr. David A. Kessler summarized the situation stating, “Beginning in the late 1990s, pharmaceutical companies selling high-dose opioids seized upon a notion, based on flimsy scientific evidence, that regardless of the length of treatment, patients would not become addicted to opioids. It has proved to be one of the biggest mistakes in modern medicine.”
Most Canadians would likely assume our public health system would protect us from big pharma’s influence on doctor’s prescribing habits (usually through a process known as the ‘gift relationship’), yet we have less transparency the US. Until the mid-1990s, opioids were, “primarily prescribed to cancer patients and others suffering debilitating pain. But in 1996, Health Canada approved OxyContin, a brand-name version of oxycodone, to relieve moderate-to-severe pain, heralding a sea change in the treatment of pain. Purdue Pharmaceutical, the maker of OxyContin, launched sales campaigns promoting the benefits of the drug. Doctors started prescribing it for everything from backaches to fibromyalgia. OxyContin quickly became the top-selling long-acting opioid in Canada.”
The National Post has reported in the past that, “Purdue has a yearly promotional budget of $14-million in Canada for its painkilling products, according... As direct-to-consumer advertising of prescription drugs is all but banned here, virtually all those resources are targeted at the country’s physicians, the gatekeepers who make or break any new medication.” Along with sales visits to prescribing doctors, “the company ran ads in medical publications that depicted OxyContin as a seemingly benign drug with wide application. One published in the Canadian Medical Association Journal — distributed to virtually every doctor in the country”
Purdue also sponsored lectures for doctors at fancy hotels, lunches, dinners, and so on, with experts in the field (funded by the company). One of these included Dr. Brian Goldman of the CBC radio show White Coat, Black Art. To be fair to Goldman, since this time he has stated, “I no longer believe it to be possible for educational courses paid for by drug companies to be free of corporate bias. But the practice of recruiting and paying doctors to give company-sponsored talks is alive and well – and the practice doesn’t end with opioid pain relievers.” While the exact number of doctors Purdue reimburses for ‘education work’ is not clear, a 2011 article stated the company pays about 100 Canadian doctors to influence their colleagues.
A Purdue-funded speaker was also one of the teachers in the University of Toronto inter-faculty pain-curriculum course, and students for years had been receiving free copies of Pain Management, a textbook paid for and copyrighted to Purdue. By 2007, the amount of this funding from companies selling opioid analgesics to the university centre exceeded CAN $500 000. It wasn’t until years later when two physicians complained and the story became public that the university barred industry-linked speakers and ending distribution of the Purdue text (yet the Faculty of Medicine did not inform previous students of concerns about the content of the lectures or the reference book). A paper on the incident from 2013 highlights that, “Undergraduate medical education is relatively free of restrictions on industry involvement...Medical students received information about opioids in educational sessions that were developed using funding from pharmaceutical companies that sell opioids. The course material contained information that aligned with the interests of these companies by minimising opioid-related harms relative to those of other analgesics, overstating the evidence for their effectiveness, and in at least one instance, provided a potentially dangerous characterisation of the potency of a commonly used opioid... Opioid prescriptions and opioid-related deaths both also rose in Ontario during the period medical students were exposed to this information in an industry-supported lecture series.”
Documents obtained by The Globe through an access-to-information request show, “The Office of the Chief Coroner of Ontario raised concerns, noting in a 2004 report that deaths linked to oxycodone climbed steadily between 1999 and 2003... it is noteworthy that the increase in the prevalence of oxycodone findings in death investigations coincides with the introduction of Oxycontin [sic] to the Canadian market.” According to a 2014 report by the Canadian Drug Policy Coalition, Opioid overdoses were, “the third leading cause of accidental death in Ontario, according to a 2014 report by the Canadian Drug Policy Coalition. In Toronto alone, coroners' statistics cited in the same study said more than 200 people died of overdoses in 2012. The CBC reports that, “Ten per cent of Ontario high schoolers reported having used prescription opioids for non-medical purposes in 2015, according a study by the Centre for Addiction and Mental Health,” which is slightly down from more than 12% in 2013.
The consequence of the influence big pharma has on our governments, trade deals, the medical community and physician prescribing, trickles down and ultimately rests with the public. This year, the chief medical officer of health of British Columbia has declared B.C.’s first ever public health emergency in light of 200 opioid related death. Overall, the Globe reports, “illicit drug overdoses killed an average of 64 British Columbians in each of the first four months of 2016 – a dramatic increase over last year’s record-breaking tally.” In Alberta deaths from fentanyl (a more potent analgesics than OxyContin that has been around since the 1950’s but who current abuse correlates to the increase in opioid prescription) have increased by 4,500 per cent over the last five years, and in Ontario one out of every eight deaths among young adults is attributable to opioids. No country on a per-capita basis in the world consumes more prescription opioids than Canada. Yet, Canada does not have a national database tracking deaths from opioid overdoses.
The provincial and the federal government continue to not take the steps needed to stop doctors from overprescribing addictive opioids. In 2015, “doctors wrote enough prescriptions for one in every two Canadians. And addiction-treatment programs are few and far between – a legacy of the former Conservative government’s tough-on-crime policies.” Unlike the US, which has guidelines to advise doctors not to prescribe opioids for chronic pain in most situations, Canada has not revised its guidelines since 2010. As a result, opioid prescriptions totalled 19.1 million in 2015, up from 18.7 million the year before.
The result of Canada’s inaction affects every province and territory. In Alberta, the situation is particularly dire with fentanyl being found in the blood and urine of 392 fatal-overdose victims over the past two years. On the Blood Tribe reserve (Kainai Nation), in March of 2015, the local band council declared a state of emergency, making it the first community in the country to sound the alarm because of fentanyl (at the same time Health Canada told one of their deputy medical officers [who has now resigned] to stop speaking publicly about First Nations health in Alberta). Another physician, Dr. Esther Tailfeathers, a family physician from Blood Tribe stated, “People sold everything they owned to buy another pill... with some nursing a habit that cost as much as $300 a day,” and she, “visited homes where there was no food, no heat and no blankets. The four walls of one house were covered with writings about suicide,” declaring, “It’s like a natural disaster on the reserve.” Since 2104, there have been at least 20 overdose deaths in the small community, which reports saying, “Initially the victims were in their 20s and 30s, but now teens as young as 13 are using.”
*Federal lobbying by Purdue Pharma since the Liberal government was sworn in this past November
While Health Canada has dragged its feet and continued to allow drug companies to influence doctors to prescribe more opioids, people are dying. With this being said Health Canada, due largely to media attention recently decided, “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.’” Purdue Pharma holds the patent on tamper-resistant oxycodone with its OxyNEO drug, an updated version of OxyContin. In a news release the company stated it is “disappointed” by the move and urges Health Minister Philpott to “reconsider this decision of regulatory inaction.” So, if you’re following along, the same company which it could be argued largely created the opioid epidemic in Canada now wants rules in place to promote its tamper resistant version (which it has the patent rights for). Dr David Juurlink, an opioid-addiction expert in Toronto wisely explained the situation stating 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.” Further, rules to promote OxyNEO as a solution do not address the core problem, over prescribing by doctors of opioids.
This decision led to yet another example of how pervasive big pharma’s influence is on many doctors with the Globe and Mail reporting a, “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...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.” Dr Juurlink surmises 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... 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.” While Health Canada and the Health Ministers decision is to be commended, sadly if opioid-related deaths had not reached a crisis level in Canada (with many media reports) they probably would have went along with the drug company.
Another recent Health Canada decisions to allow, “doctors to apply for special access to prescribe [SAP] pharmaceutical-grade heroin to severe addicts... would overturn a ban imposed by the previous Conservative government,” is a positive step. The SAP considers, “requests for emergency access to drugs for patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable, or are unavailable.” The departments release highlights this practice is, “permitted in a number of other jurisdictions, such as Germany, the Netherlands, Denmark, and Switzerland, to support a small percentage of patients who have not responded to other treatment options, such as methadone and buprenorphine.” While this is a move in the right direction, we also need a serious commitment to intensive treatment programs from the federal and provincials governments if any progress is to be made.
Overall, despite some positive steps to address the opioid epidemic occurring in Canada there is a dire need to look at the root cause of the problem. The harmful influence big pharma has on doctor’s prescribing habits is one that can -and should be- eliminated in the name of public health. The research data is there to show this practice is dangerous and leads to the inappropriate prescribing of medications. The lived realities of people suffering from opioid addiction show what the outcome of our system ultimately leads to. While we have seen downstream reactions to the problem, unless our government starts to seriously address the upstream causes of prescription drug abuse we will continue to see more stories of lives ruined and communities devastated.