Recall of High Dose Opioids Proposed in Canada

Marvin Ross, Guest Columnist

A citizen’s petition filed last year by Physicians for Responsible Opioid Prescribing (PROP) and other anti-opioid activists tried to get the FDA to ban high-dose opioid medications. Although the FDA has yet to decide on the petition’s merits, the very same proposal is now being made in Canada in an editorial in the Canadian Medical Association Journal (CMAJ).

Dr. David Juurlink, a Toronto physician and board member of PROP, penned the editorial with Matthew Herder, a lawyer from Dalhousie University in Halifax, Nova Scotia. They claim that high dose pills – such as those containing 100mg of morphine or 80mg of oxycodone -- are too risky and should be pulled off the market.

"There is little sign that the (opioid) crisis is abating in Canada," they wrote. "Ministerial recall of the most hazardous opioid formulations is a powerful regulatory tool that should be deployed to address one aspect of the crisis: the excessive prescribing of opioids for chronic pain."

Juurlink and Herder point to Vanessa's Law, which empowers the Canadian Minister of Health to recall drugs from the marketplace when they pose “a serious or imminent risk of injury to health.”

Vanessa's Law was introduced into Parliament in 2014 by Trevor Young, a government member, when his 15-year-old daughter tragically died from heart failure after taking a stomach drug called Prepulsid (Cisapride). That same year, Health Canada removed the drug, as did the EU and the UK. It is only available in the U.S. under special conditions.

Health Canada has always had the power to pull drugs off the market and issue safety alerts. As for Vanessa’s Law, Health Canada told me it “has not encountered a situation where it has been necessary to use its authority to order a mandatory recall.”

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Obviously, there have been no valid safety reasons to limit high dose opioid prescriptions or it would have been done by now.

The CMAJ editorial claims that high dose opioids are potentially dangerous and that they increase the risk of accidental overdose, falls, fractures, cognitive impairment, worsening pain, motor vehicle accidents, and dependence. Of the five academic papers cited as evidence, four are authored by Juurlink himself or his research colleague at the Institute for Clinical and Evaluative Studies in Toronto. One of their papers was reported by this author in PNN as being erroneous and in need of correction. It was corrected, but it should have been retracted.

When the FDA sought public input into PROP’s petition, it received opposition from hundreds of patients and such groups as the American Academy of Pain Medicine (AAPM), the American Medical Association, the American Society of Anesthesiologists, and the American Pain Society. The AAPM said several of the petition’s underlying premises “are either false, misleading or speculative.”

“Perhaps the most serious problem with the petition is its cavalier assumption that in those patients in whom high doses are required, the change would be ‘unlikely to result in a significant inconvenience or hardship.’ Nothing could be farther from the truth. It is undisputed that many end-of-life patients require and benefit from opioid doses that are often quite high,” the AAPM said.

Other critics pointed out that taking high dose pills off the market would result in more lower dose pills being prescribed and stored in medicine cabinets, where they could potentially be stolen or diverted. It also raises the risk of a patient taking too many or too few low dose pills to get pain relief.

Dr. Juurlink has previously claimed that the long-term use of opioids results in an increase in pain called opioid induced hyperalgesia (OIH). He wrote about hyperalgesia in an earlier article in CMAJ, saying pain patients may think opioids are helping them, when they’re not.

“Why might some of these patients not be doing as well as they or their doctors perceive?” Dr. Juurlink asked.

Well, the answer is that Dr. Juurlink knows better. He knows better than the patient and he knows better than their doctor. He knows that they are not doing well. What can anyone say to that level of arrogance?

I did write a reply to his arguments in CMAJ and pointed out that his concept of hyperalgesia is simply a theoretical construct with no solid evidence in the research literature.

It is truly unfortunate and criminal that the response from some “experts” and politicians to the rising deaths we are seeing from overdoses is directed at pain doctors and their patients, when there is little evidence they are the main cause of the opioid problem.

As I pointed out in my last PNN article, the Minister of Health continues to blame the wrong people and is incapable of providing any evidence for her position. The coroner in British Columbia has already put out data on the source of opioids involved in overdose deaths. Fentanyl was involved in 3 out of 4 deaths and its source was illegal, not prescribed.

A very recent investigation by Global News Network in Canada found that the smuggling of illicit fentanyl into Canada via BC is the responsibility of a Chinese gang called the Big Circle Boys. The billions of dollars of profits they make is laundered through casinos in that province and to buy property in Vancouver. The police are aware but simply do not have the resources to counter any of this.

Instead, officials go after doctors and patients. One pain patient I am in contact with just e-mailed me that his doctor continues to reduce his opioids to the point that he is ready to leave this world.

“I can’t understand the thought process of my pain doctor who continues to taper away at my meds,” he wrote.

And neither can I.

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Marvin Ross is a medical writer and publisher in Dundas, Ontario. He has been writing on chronic pain for the past year and is a regular contributor to the Huffington Post.

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The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.