Mr. Chairman, and members of the committee, good afternoon and thank you for the opportunity to provide testimony.
My name is Ada Giudice-Tompson. I am vice-president of Advocates for the Reform of Prescription Opioids, and I serve as a member of CCSA's National Advisory Council on Prescription Drug Misuse that developed Canada's strategy “First Do No Harm”.
However, I am also here as a bereaved mother of a wonderful young man, my son Michael, who died in 2004 from an opioid prescribed by his physician. I speak both as an advocate and as a person who has lived the personal pain of seeing someone die from the effects of prescription opioids, drugs that are too often deemed "safe as prescribed", but which are, in my view, anything but.
Indeed, if I had been provided with accurate information about Percocet, I would not have filled my son's first prescription, and I would not be here today. My son Michael died within two years of that initial prescription.
Like many other Canadians, I had no idea legally prescribed drugs, those coming from a physician, dispensed by a pharmacist, and approved by Health Canada are as dangerous as such illicit drugs as cocaine, heroin, or crystal meth. In fact I believe they are more dangerous, because when a drug receives approval from Health Canada, Canadians accept the premise that the drug is safe, or at the very least, safe as prescribed. My story could be anybody's story; thousands of Canadians have been prescribed into addiction and overdose death.
The current scope and risk associated with prescription opioid drugs is significantly underestimated. The Centers for Disease Control and Prevention has stated that the epidemic of addiction and overdose death has increased in parallel with the prescribing of opioids. The CDC has acknowledged they have an epidemic, the worst in U.S. history. Yet Canada and the U.S. continue to be the top per capita consumers of opioids worldwide, and Canada's consumption has increased faster than that of the U.S.
At risk is any Canadian who is exposed to opioids, with or without a prescription. Additionally, with each passing year we are presented with more and more evidence of safety issues, and that opioid misuse is becoming increasingly common among chronic pain patients. Indeed, this should come as no surprise, given the lack of clinical trials for the use of opioids long term.
Advocates for the Reform of Prescription Opioids is a binational organization in the U.S. and Canada composed of people whose lives have been destroyed by the massive over-prescribing of opioids. ARPO represents what happens in the real world, and our mission is to end the epidemic of death and addiction caused by prescription opioid drugs by ensuring opioids are regulated, prescribed, and used in an evidence-based manner.
ARPO has studied this problem alongside Physicians for Responsible Opioid Prescribing, PROP. We believe prevention of prescription drug misuse cannot be studied in isolation from the systems that sanction drugs of abuse. In addition our understanding must come from science not misinformation. By looking at both the process and content we are able to find gaps starting with the regulatory approval of drugs right through to prescriber practices and patient use of legally sanctioned drugs that act on the body in very much the same way heroin does.
History reveals the truth. If we look at the successful court actions against drug companies, the misleading marketing of morphine, heroin, oxycodone slow release tablets, abuse deterrent formulations, and the ongoing United States Senate finance committee investigation into the financial ties between the pharmaceutical makers and groups that advocated broader use of opioids, we begin to see a clearer picture. What we see is a picture of misrepresentation of the drugs' safety and efficacy, as well as conflict of interest and influence.
The message for broader use of opioids was not based on scientific evidence so much as it was on the desire to maximize sales. Many well-meaning physicians have advocated for broader use of opioids because they wish to relieve pain, yet the sad reality is that the drugs don't work nearly as well as physicians have been told. In fact, pain sensitivity is often increased when patients are on opioids in the long term.
Misinformation has framed our laws, regulations, policies, and the practice of medicine. Pharmaceutical manufacturers, health care providers, and others have told us many myths about opioids, but unfortunately, our main regulatory agency, Health Canada, accepts as gospel the clinical trial information provided by drug companies, without any further checks and balances.
This in turn has implications for marketing, product monographs, labelling, prescribing, and, ultimately, patients and their families. Health Canada must acknowledge that the regulatory role impacts on clinical practice, and they should be required to review how they are arriving at the approval of opioid drugs, or frankly, any drug in Canada that has a high abuse potential and/or can lead to abuse, misuse, or dependence.
Many Canadians say that we have an epidemic of prescription drug abuse. This is not quite the right way to describe the problem. Yes, abuse is part of the problem, but typically this behaviour is not how an individual starts down this road.
The focus is always on abuse because it is to the advantage of many if we neatly categorize people into being either legitimate patients or abusers. This is a false dichotomy. It also perpetuates the stigma of people who develop addictions. Indeed, the product monograph for oxycodone states that drug abuse is usually “not a problem in patients with pain in whom oxycodone is appropriately indicated”. This claim continues to reinforce the fallacy that addiction is rare in pain patients and speaks to the extent of industry rhetoric and influence.
Presently, the Food and Drugs Act does not permit approval of a drug to be withheld on the basis of misuse. This is extremely worrisome, given the non-transparent manner of the drug approval process and the fact that use can lead to misuse. This is so important that it bears repeating. Many people start using prescription opioids as prescribed and then later begin to misuse or abuse their prescriptions. After all, opioids are highly addictive narcotics, so perhaps we should not be all that surprised by this. The Minister of Health should be empowered to reject the approval of a new drug if there is high potential for it to be misused or abused.
Further, in September 2013, the FDA requested that opioid manufacturers update the language on product monographs, labelling, and patient counseling information to improve warnings and precautions. One example was provided by the FDA, “Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse. and misuse that can lead to death.” Health Canada should request similar warnings.
Prescribers need accurate information on which to base patient care decisions. Emphasis on prevention should occur before drugs are approved, not after patients have been harmed by their use. A committee of experts on drug and patient safety should be established at the federal level, independent of industry, to assist Health Canada with drug approval and/or recall. Prevention must begin with the regulatory agency, and it must have the authority to fully recognize its mandate of patient safety.
Regulators need to stop listening to people who have a vested interest in the sale of opioids and start listening to patients, families, health care providers, and Canadians nationwide who want to see a full scale change in how drugs are being brought to market. Your role as legislators can do much more than mitigate harm. It can prevent it in the first place.
Formularies at the federal and provincial level should provide coverage for non-opioid drugs and other forms of therapy to assist with pain management.
Just to be perfectly clear, I am not suggesting that opioids should never be used. There is no question there is a need for opioids in appropriate clinical situations. When we have all the facts, we may better determine the clinical situations in which we are willing to put patients at risk with an opioid.
This epidemic has resulted in countless deaths and destruction to patients, families, and communities. The status quo cannot continue. We need those who have moral, legal, and regulatory accountability to accept their responsibilities and bring about change.
Thank you.