When Do Guidelines Become Guidelines?

By Marvin Ross, Guest Columnist

Blaming doctors for failing to prescribe to guidelines that did not exist is the latest in the strange research coming out on the use of opioid pain medication.

That was the case for a recent study led by Dr. Tara Gomes, Dr. David Juurlink and others at the Institute for Clinical and Evaluative Studies (ICES) in Toronto, Canada. Both of these authors have a long list of research reports on opioids and Juurlink was one of the central players in the development of the Canadian guidelines for prescribing opioids for non-cancer pain. Juurlink is also a board member of Physicians for Responsible Opioid Prescribing (PROP), which is notorious for their anti-opioid views.

This particular study, called “Clinical indications associated with opioid initiation for pain management in Ontario, Canada,” is published online in the journal Pain. Gomes and Juurlink set out to evaluate prescribing patterns for patients who are “opioid naïve” to see if their prescriptions complied with guidelines adopted in the U.S. and Canada. In many cases, they did not.

The U.S. and Canadian clinical guidelines for prescribing opioids for chronic non-cancer pain suggest that doctors should avoid initiating opioids at daily doses above 50 MME,"  Gomes is quoted saying in an ICES press release.

"Our study found that nearly one-quarter of Ontarians taking an opioid for the first time received a daily dose exceeding this threshold, and for certain indications such as knee, hip and shoulder surgeries and Caesarean sections, the dose was even higher.”

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Here is the problem with their work. Gomes and Juurlink looked at prescription opioid claims for over 650,000 people in Ontario from April 1, 2015 to March 31, 2016 and compared them to guidelines that did not exist during the study period.

They defined as inappropriate any initial opioid dose that exceeded 50 MME (milligram morphine equivalent) or had a duration exceeding 7 days’ supply.  According to their findings, 17 percent of the opioid prescriptions were for periods longer than 7 days and almost one quarter (23.9%) were for dosages over 50 MME. This prescribing, they said, was not in line with North American guidelines.

By guidelines, they mean the Centers for Disease Control and Prevention guidelines that were released on March 18, 2016 --- two weeks before the end of the study period. The U.S. guidelines have never been formally accepted in Canada, although they were used to help shape the Canadian opioid guidelines that were released in 2017, a full 13 months after the study period.

How can one say that doctors were not compliant with prescribing guidelines when those guidelines did not exist at the time they prescribed? Doctors may be very clever, but I do not know of any who are capable of abiding by guidelines that only exist in the future

Aside from the study being biased and wrong, the misleading findings were picked up and portrayed by several Canadian news outlets as another example of doctors fueling the so-called opioid crisis. The Ottawa online policy paper Ipolitics ran a story with the headline, “A quarter of prescription drugs in Ontario exceeded dosage guidelines.”

Dr. Gomes also appeared on a popular radio show in Toronto saying, “We’re not really aligned right now with the guidelines in Canada.”

I have filed a formal retraction request with Dr. Michael Schull, the CEO of ICES. Schull referred my complaint to Gomes herself, who replied via e-mail on May 17 with:

“Your point regarding the timing of the guidelines in contrast with the timeframe of our study is an important one, and one that we made sure to address through our communications related to this study. In particular, in our study, we speak to the evidence related to harm associated with opioid doses above 50MME as being a core reason why attention should be paid to the high proportion of new opioid patients who are exceeding these doses. It is not simply that these doses exceed thresholds now recommended in guidelines, but that they have been shown in the literature to be associated with considerable risk of harm. We therefore need to consider how to mitigate this harm whenever possible.”

I pointed out in my reply that neither the media reports nor the press release cautioned about the discrepancy between the study period and the release of the guidelines, and I requested a public clarification and retraction. Schull replied that you cannot retract a study just because someone disagrees with it.

This is more than a simple disagreement. You cannot compare apples to oranges as they did. Schull’s final e-mail to me was we will agree to disagree, and I should take it up with the editors of Pain. Francis Keele, the editor in chief of Pain, informed me via e-mail on May 26 that they will be looking into the matter.

Broadcaster Roy Green, who has taken up the defence of chronic pain patients in both the U.S. and Canada through his syndicated radio show, offered Gomes the opportunity to bring with her 3 medical doctors to have an on-air debate on her research with him and me. So far, she has refused to respond.

I did point out to her boss that she works at the expense of taxpayers and since she is willing to discuss her work with a journalist who knows little or nothing of the topic, she has an obligation to talk to us.

I am not holding my breath.

(Update: Mr. Ross has been informed by the editor of Pain that the Gomes study has been revised to clarify to that the CDC and Canadian opioid guidelines were not in effect during the study period.) 

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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.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

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.