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.

The Opioid Blame Game

By Roger Chriss, Columnist

Nearly 40 years after it was published, a short letter to the editor in The New England Journal of Medicine is today being blamed by various media outlets for having “kicked off” or “fueled” or “sparked” the opioid epidemic.

The one paragraph letter, written by researchers at Boston University Medical Center, has attracted media attention because of a new letter to the editor by Canadian academics Pamela Leung, Erin Macdonald, MD, PhD, Irfan Dhalia, MD, and David Juurlink, MD, PhD. They claim that the 1980 letter “was heavily and uncritically cited as evidence that addiction was rare with long-term opioid therapy.”

The authors are not the first to notice this. The New Yorker made the same claim in 2013, to little effect.

Now, however, the media has latched onto the 1980 letter’s statement that “addiction is rare in medical patients with no history of addiction,” by declaring it to be the spark that ignited an explosion of opioid overdoses and deaths.

If only it were that simple.

The opioid epidemic has already been blamed on OxyContin and Purdue Pharma, drug seeking pain patients, physician overprescribing and pill mills, and even a small study by Russell Portenoy, MD, in 1986.

But conspicuously absent are many other contributing factors, including:

  • Managed healthcare looking for cheap treatment options
  • Health insurers pushing to reduce healthcare costs
  • Employers expecting workers to return to work sooner
  • Patients wanting a quick pain cure

Another commonly cited villain is the campaign to treat pain as the "5th Vital Sign.” But that did not occur in a vacuum. The rise of chronic pain paralleled increasing levels of acute pain, for reasons such as:

  • Better trauma care for car crash and gunshot victims
  • Early and aggressive cancer care
  • Increasing rates of diabetic neuropathy and amputation
  • More injection therapy and surgery to treat damage and deterioration in the spine and joints

Medical care improved in many important ways in the 1980’s, including the advent of minimally invasive surgery and chemotherapy for a wide variety of cancers, as well as the discovery of drugs that turned once deadly diseases like AIDS and leukemia into chronic conditions that could be medically managed. There have also been many well-intentioned attempts to treat increasingly common degenerative diseases and disorders that may have caused more pain in some patients.

In other words, there is plenty of blame to go around. But media coverage ignores these larger issues.

Instead, CNN draws a parallel between the 1980 letter and a lawsuit filed last week by Ohio’s Attorney General against five opioid manufacturers. And the CBC’s coverage includes a link to a 2011 YouTube video produced by the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), perhaps because David Juurlink himself is on the PROP Board of Directors. An old lecture on the evils of opioids is beside the point here

The real question here is: Does finger pointing at a NEJM letter from 1980 help people today who are suffering from opioid addiction?

The research literature on opioid addiction in the 1970’s and 80’s strongly resembles today’s efforts. Even high school health classes back then discussed methadone clinics and medication-assisted treatment, the importance of long-term maintenance therapy, and the value of safe injection sites and needle exchange programs for heroin users.

This leads to a far more important question: Why aren’t we using these treatments more widely?

This blame game isn’t helping opioid addicts. As media reports identify the 1980 letter as another target of blame for the opioid crisis, we should be asking why we’ve made so little progress since then in treating addiction.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.