"Prescription drug abuse is not so much about the prescriber as it is about demand. There will always be a prescriber to fill the demand."
~Dr. Lynn Webster

"...When you think about the fact that he's had multiple deaths in his clinic from overdose, it suggests that the system he is teaching is seriously flawed."
~ Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing

June 21, 2015
The Honorable Rona Ambrose, P.C., M.P. Minister of Health
Brooke Claxton Building, 16th Floor Tunney’s Pasture
Health Canada Ottawa, ON K1A 0K9

Copy to: Provincial Ministers of Health RE: Pharmaceutical marketing and their conflicts of interest in Canada

Dear Minister Ambrose,

Get Prescription Drugs off the Street Society is writing you due to our concerns regarding the conflicts of interest that are evident in the pharmaceutical industry, particularly opioid manufacturers and the promotion of their products. The influence pharmaceutical companies have on our physicians, prescribing guidelines and regulatory bodies is troubling.

Minister as you know, OxyContin was approved for introduction into the Canadian market by Health Canada in 1996. Since OxyContin’s approval and aggressive marketing campaign rates of opioid addiction, overdose, and death have soared. While OxyContin is not the only prescription opioid contributing to deaths and addiction in Canada, Purdue Pharma’s aggressive marketing campaign and involvement in physician education is a clear example of how physicians can be influenced to prescribe products that may not be beneficial to their patient.

In the United States, Purdue Pharma and three current and former executives pleaded guilty in 2007 to criminal charges that they misled regulators, doctors and patients about the drug’s risk of addiction and its potential to be abused. _i

When pharmaceutical companies such as Purdue overstate their product’s benefits while minimizing the risks, physicians prescribing can unintentionally cause harm to their patients. Doctors who are not prescribing with good intentions also have the resources to defend their prescribing practices with pharma influenced prescribing guidelines or educational material. Each of the described prescribing scenarios often end in patient harm or diversion.

You can find Purdue Pharma and other opioid manufacturer’s influence across Canada in a variety of ways.

The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain Advisory Panel consists of 49 physicians, 17 of which have financial disclosures from Purdue Pharma. One physician disclosed 1 million dollars in competing interests, $200,000 directly from Purdue Pharma in relation to Financial/Material Support for operating costs of a Pain Clinic. _ii These guidelines also include an “opioid risk tool” to assist Canadian doctors in assessing a patient’s risk if they are prescribed opioids.

This tool was developed by Dr. Lynn Webster._iii Dr. Webster came under DEA investigation in 2013 after 20 opioid overdose deaths occurred at his Utah Pain Clinic. _iv In addition Dr. Webster was also investigated in 2012 by the Senate Finance Committee for payments made to him from opioid manufacturers. _v

These details of our Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain seem to be overlooked but are extremely troubling when these documents are recognized as "evidence based" and used by doctors across the country to prescribe opioids.

The University of Toronto pain management curriculum was criticized and investigated in 2010 after a complaint that students were provided a book by a lecturer who is member of Purdue’s speaker’s bureau.

The book "Managing Pain: The Canadian Health Care Professionals Reference" was copyrighted by Purdue Pharma. The public also learned from 2002 to 2006, the pain course was funded by donations, including $117,000 in unrestricted educational grants from four drug companies Merck-Frosst, Purdue Pharma, Pharmacia Canada and Pfizer. _vi

A study published in 2013 reported the majority of Canadian medical schools (12 of 17) have generally weak or non-existent COI policies "The faculty and student relationships with industry are very poorly regulated," said study author Adrienne Shnier, a PhD candidate at York University’s School of Health Policy and Management.

"This means that industry has the ability to influence the resources that are provided to medical students, and influence the information that is taught to medical students." _vii

Dr. Navindra Persaud also expressed concern in a similar study stating "The management of conflicts of interest is particularly important for controversial clinical topics where marketing has the potential to shape the later practices of medical students in the absence of a clear evidence base. A notable example is the use of opioids for the management of chronic non-cancer pain. Recent guidelines have highlighted the morbidity associated with chronic pain and the lack of evidence supporting the use of opioids for this indication."_viii

Minister as you know, on October 30th 2013, the House of Commons Standing Committee on Health agreed to undertake a study on the federal government’s role in addressing prescription drug abuse.

The Committee heard that:

• Due to an overall lack of control systems in place regarding the marketing of pharmaceuticals in Canada, physicians faced some fraudulent and aggressive marketing practices from some of the manufacturers of these drugs, which led to inappropriate prescribing practices. Consequently, one witness recommended that a “firewall” be put in place between industry, prescribers and patients.
• In Nova Scotia, prescription opioids contributed to 74% of overdoses between 2007–2012.
• In Ontario, admissions to publicly funded substance abuse centres rose by 129% between 2004 and 2011. In Nova Scotia, there was a 112% increase over this period in the number of people undergoing withdrawal management for opioid dependency.

After listening to testimony the committee made several recommendations, one being Health Canada review, in cooperation with stakeholders, inappropriate marketing practices that have an effect on prescribing practices.

In recent years the Federal Government has made commitments on a variety of levels to address the issue of prescription drug abuse. There is one key message throughout the governments many initiatives that has been lost or ignored: patients do not need to "abuse" opioids to have a negative outcome especially when prescribed for chronic non cancer pain. With current pharmaceutical marketing practices and prescribing guidelines patients are having negative outcomes in opioid therapy simply by taking their medication as prescribed. Until that fact is acknowledged not only will irresponsible prescribing continue to occur but so will deaths, overdose, and addiction.

Get Prescription Drugs off the Street Society encourages both Federal and Provincial Governments to seriously consider examining the current relationships between the pharmaceutical industry, medical communities and regulatory agencies within Canada. Legislators must establish better policies to protect doctors, patients, and the public from being influenced by aggressive and fraudulent marketing practices.

The Canadian Government must first acknowledge that prescription drugs such as opioids are not always safe as prescribed and harmful exposure to opioids could be minimized by improving the regulation of pharmaceutical marketing. We have also copied Provincial Ministers of Health as positive changes can be made by various levels of government.

Thank you for your time and we look forward to further discussion.

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