Recently investigators working at the Minneapolis VA Hospital conducted a study examining the efficacy of nonopioids vs opioids in a “pragmatic randomized trial” in knee and low back pain. After considerable angst and restraint, I teamed up once again with Dr. Morty Fein to clarify significant and glaring inconsistencies inherent to this study and how it can only serve to mislead lay press journalists, politicians, and even clinicians that are naïve to sound scientific research and what constitutes validity.
In general, a study like the one above is difficult to conduct, with considerable challenges in enrolling and retaining subjects. The authors are to be commended for taking this study on and for completing it, but that’s about all the kudos they get. Like many studies of its kind, it has many warts and indeed it is tremendously flawed in some ways. That is forgivable. What is not, is the misinterpretation and misstatement of the meaning of the results given how deeply defective this inquiry truly is.
The authors concluded that opioids work no better than nonopioids. They could not show that opioids were more harmful, but they jumped on the anti-opioid fame wagon nonetheless and intimated that opioids are much more harmful and had they had longer they would have demonstrated that too. If they had a modicum of humility, they would have concluded that the opioid algorithm they employed in this study is deeply flawed, and that it needs to be amended. And that when you enshrine and institutionalize non-individualized dosing and keep doses of opioid monotherapy really low, you can enshrine and institutionalize clinical mediocrity. In this way, this study continues a trend, inherent in the CDC guidelines that will ultimately render opioid therapy completely useless by separating out only the responders to the lowest of doses. And testing these doses with an enriched sample of non-opioid responders in one group and an unenriched sample in the opioid group is stacking the deck. Not just against opioids – against patients. Rather than further dignify these approaches, we start calling them “blind-leading-the-blind-lines.” We are creating an opioid strawman that limits the help opioids can afford people with these approaches, and all the while the opioid epidemic has moved on. So in effect, these blind-leading-the-blind-lines that violate every principle of good opioid therapeutics are willing to do so in a misguided effort to end a heroin and illicit fentanyl crisis.
Don’t get us wrong – the old opioid strawman, the “no ceiling, escalate to the stratosphere for every patient done by non-experts with no monitoring” strawman was no better and it caused much harm. We haven’t shown a willingness or ability as a field to really change the standard of care, utilize the tools and practices that have emerged in the interim and individualize care. Instead, we are in a phase of ascientific, watered down opioid therapy that also causes much harm and suffering. One set of bad practices doesn’t justify another, and we grow increasingly pessimistic that this world will ever be able to stop conflating bad opioid practices with bad opioid outcomes and ever have our patients realize what is the true safety and efficacy of opioid therapy when conducted in a more expert fashion.
We don’t know what a pragmatic randomized trial is. Pragmatic supposedly means useful, because this study will prove really useful to the anti-opioid propogandists. We think they meant pragmatic as in real world. But in the real world nobody that knows anything about opioid therapeutics practices like this. So it isn’t real world. The interpretation of this study by the authors, the journal reviewers and by local news talking heads is more like a reality show than real world. Borrowing Trump’s mantra from The Apprentice, study authors, JAMA, and CDC: You’re fired!
And here is the proof of the pudding. Had the results of this study been in favor of opioids there is no way the editors of JAMA would have accepted it and published it given the flaws. As authors and editors of various peer reviewed journals, we are certain of this. If they deny it, they are even more unaware of their anti-opioid bias then they know. Hey JAMA: you’re fired! Ah, if only we were younger the bar for a JAMA pub was this low.
Here’s some food for thought. This is the same VA that has already begun to minimize the findings coming out that their opioid guidelines and lowering of morphine equivalent daily doses (MEDDs) that has led to an increase in overdoses and suicides with a spike at 50mgs of MEDDs. God bless Dr. Stefan Kertasz for reporting these results in What’s Wrong With Just Counting the Patients on High Dose Opioids and Calling that Bad Care? (3 addiction docs respond to CMS). And why would that happen? Opioid mediocrity leads to people supplementing with illicit opioids and anything they can get and then when the “oxy” or heroin they think they’re buying turns out to be Chinese fentanyl it’s “zaijian”.
The non-opioid group in this study supplemented more with illicit drugs too…we wonder why. With no detail about the nature of the urine drug monitoring used and the frequency of use, we suspect that there was a lot more of this use than they even report out. If we had longer we might be able to prove that.
To have a shred for applicability, the research would need to include a cross-over study putting all of the opioid patients on non-opioids and all of the non-opioid patients on opioids to see if they maintain their same levels of pain. They also need to go out for more than 1-year to see how many patients on chronic NSAIDS end up with a GI bleed, heart failure, or kidney dysfunction and compare that against incidents of opioid-induced respiratory depression, and then look at drug related deaths from both groups.
We can drone on to enumerate a list as long as your arm of the methodologic flaws of the study. They may be forgivable. The misrepresentation of what they say are unforgivable. JAMA publishing this garbage is unforgivable. We are now clearly in a world of alternative opioid facts, an altered universe, virtual unreality – not the real world.
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