Thank you, and good morning.
I'm a family doctor and researcher at St. Michael's Hospital in Toronto and a lecturer in the Department of Family and Community Medicine at the University of Toronto.
Before I begin my remarks, I would like to register my support for the suggestions made by my colleagues in British Columbia and by Dr. Kahan.
Pharmaceutical companies produce medications that can improve and save lives. Sometimes the inappropriate marketing of potentially beneficial medications results in great harm to patients.
One pharmaceutical company, Purdue Pharma, has admitted to illegally mismarketing opioid pain medications in the United States. I am going to discuss one important similarity between the illegal and harmful marketing described in the agreed statement of facts in Purdue Pharma's American guilty plea and the marketing that's in place here in Canada.
The similarity is the claim that new opioid formulations have a lower abuse potential than older opioid medications. Health care providers want to help patients who are in pain. Opioids can be effective at alleviating pain that lasts a few hours or days, and they are commonly used in hospitalized patients, for example in patients who have undergone surgery.
In the 1980s physicians were reluctant to prescribe opioids to patients with mild or persistent pain because of the abuse potential. The tendency for opioids to be abused or harmfully used has been known since the first synthetic opioid, diacetylmorphine, was marketed in the late 19th century. Diacetylmorphine is now known as heroin, and in some countries it is still prescribed by physicians, mostly for pain near the end of life.
In the 2007 agreed statement of facts, Purdue Pharma admitted it attempted to counter the bad reputation opioids such as heroin had by misleading physicians about the abuse potential of new opioid formulations such as OxyContin. Market research done by Purdue indicated that the abuse potential of opioids was a reason physicians hesitated to write prescriptions for these drugs. Product information for OxyContin, Purdue's eventual bestseller, included the false claim that the formulation of the drug was believed to reduce the abuse liability.
Purdue sales representatives were instructed to visit physicians and tell them that these opioids—I'm again quoting from the agreed statement of facts signed by Purdue—had less addiction potential, had less abuse potential, and even could be used to “weed out” people who are addicted to opioids.
The sales representatives were also instructed to boast that OxyContin was more difficult to use intravenously than other medications, even though Purdue's own studies indicated that most of the drug could be extracted simply by crushing tablets and stirring them in water prior to injection.
These claims that newer opioid formulations had a lower abuse potential were known to be false at the time they were made. In fact, Purdue had requested permission from the United States Food and Drug Administration to make these claims, and those requests were flatly denied. There was never any evidence that these opioid formulations carried a lower abuse potential.
Unfortunately, similar false claims were made here in Canada. A reference book that was paid for and distributed by Purdue in Canada entitled Managing Pain contained the claim that new opioid formulations had a lower abuse potential. The book was distributed to clinicians by sales representatives, and it was even distributed to medical students. Purdue paid some physicians to deliver educational sessions throughout the country.
Inaccuracies and false claims were disseminated in print advertisements in medical journals, such as the Canadian Medical Association Journal, which is mailed to almost every physician in Canada. The ads were approved by the Pharmaceutical Advertising Advisory Board of Canada.
On September 30, 2010, I attended a lecture in Bowmanville, Ontario, given by an assessor for the College of Physicians and Surgeons of Ontario. The title of the talk was “Opioids and the College” and methods for record-keeping around opioid prescribing that would pass the college's standards were discussed. The talk was sponsored by Purdue Pharma. Sales representatives from Purdue Pharma were present and actively distributing promotional materials for Purdue products.
I have here a certificate I received that day that would have qualified me to receive continuing medical education credits from the College of Family Physicians of Canada for attending this pharmaceutical industry-funded talk.
Physicians as a group played an active role in unquestioningly accepting, acting on, and disseminating the misinformation that Purdue Pharma generated, even though less biased sources of information were readily available.
The present close ties between the pharmaceutical industry and the medical profession are inappropriate and completely unnecessary. Other health care industries such as the medical testing industry are profitable and provide good jobs for Canadians without engaging in aggressive or illegal marketing. In fact, these industries have little or no direct contact with physicians. Physicians generally obtain information about appropriate medical testing from sources more reliable than the companies that profit from them. The same should be true for medications.
At the time that all of this was happening in Canada, to my knowledge, no regulatory action was taken. Even in 2007 when Purdue Pharma pled guilty to fraudulently mismarketing practices in the United States, nothing happened in Canada. There was no investigation in Canada, no sanction in Canada, nothing. Prescription rates actually accelerated.
After the false and misleading marketing of opioids had taken place in Canada and in response to a complaint by a colleague and me, Health Canada acknowledged that the lower abuse potential claim was inappropriately made in Canada. Regarding the lower abuse potential claim in the 2002 edition of the Purdue's Managing Pain book, a letter from Health Canada dated May 25, 2012 stated:
Of course, should this issue had been brought to our attention back in 2002, Health Canada would have contacted Purdue Pharma to implement corrective measures.
Health Canada does not proactively monitor industry claims about their products so produced distortion of the addictive potential of newer opioid formulations went unrecognized and no action was taken. The exact number of Canadians who have died of an opioid overdose since 2002 is unknown. Health Canada does not track this. But estimates range from 5,000 to more than 10,000 deaths. Many more Canadians have been devastated by the non-fatal harms of opioids.
Is there a connection between the false “lower abuse potential” claim and the well-documented harms to Canadians? It is impossible to become addicted to a drug without exposure to it. There are countless people in Canada who never would have been exposed to opioids if physicians had not been misled about their abuse potential. Physicians would have continued to exercise the caution about opioid abuse that was revealed by Purdue's market research and subsequently targeted by Purdue's admittedly illegal marketing campaign.
In the United States the connection between the mismarketing and harm was established to the tune of more than $600 million that Purdue paid after pleading guilty. We would know if Purdue Pharma illegally marketed long-acting opioids in Canada if there was an investigation. There has apparently been no such investigation, criminal or otherwise, here in Canada, even though there is documentary evidence that false claims were made.
The government's role in curbing prescription drug abuse should include the effective regulation of pharmaceutical marketing in Canada. The comprehensive and protracted failure of Canadian regulators in the case of opioid marketing has had lethal consequences for Canadians. The difference between the actions of American regulators and the inaction of Canadian regulators should prompt drastic changes here.
In the future the Canadian government should: one, proactively regulate the marketing of medications that may be harmfully misused; two, closely monitor for harms associated with these medications; and most importantly, three, act decisively when inappropriate marketing or medication harms are detected.
I raise these concerns and suggestions today in the hope that this committee will resolve to make real changes that will protect Canadians from misinformation about medications, medications that can either harm or heal.