Reply to Sayeed Et Al’s Reply to Reply

Reply: We are somewhat perplexed by Sayeed et al’s1 most recent “reply” to our “reply” to their “reply” regarding our ACOEM Guideline publication.2 At this point, these authors from the Spinal Intervention Society (formerly ISIS) have left argument for polemic, abandoning the scholarly vein intended in our work. Grievances are revisited again and again with no new evidence. For 2500 years, the rhetorical style of aggrieved repetition has been considered the weakest form of argument. And so it is today. However, their persistence is disturbing. It attempts to foist bromides and pseudoscience to the pinnacle of clinical research in a manner perhaps deceptive to readers. As such, it becomes a danger to the injured worker, to our patients, and misleading to clinicians. Reluctantly, we fear this needs to be bluntly addressed. Each and every point in their new “reply” has already been addressed in our previous iterations.2,3 We still maintain that: yes, RCT’s may vary in quality; no, high quality research is not typical in small observational studies; yes, syndromes with variable natural histories need rigorous controls; no, robust placebo responses cannot be ignored, and yes, institutionally/financially sponsored papers, such as the SIS promoted publications, have long been proven prone to bias. Are these facts actually in dispute? Especially important, we hazard to note that the 2013 Bogduk book “Practice Guidelines. . .”4 (Sayeed et al’s touchstone citation) is neither a Euclidian proof nor the divine decalogue. This 9-year-old SIS publication was not independently peer-reviewed and is neither definitive, externally vetted, nor of course, without conflicted interest (publisher: SIS; editor: Past President, Founding Member; Standards Division Head SIS; price: $400 USD; https://www.spineintervention.org/store/View-Product.aspx?id=3177246). And unlike virtually every other citation in modern publications, it is not available to any reader or reviewer online, has no library digital access and is neither in stacks nor loan status at the largest university medical library in the western United States. (Lane Medical Library, Stanford University.) Having this self-published book function as the axis mundi of one’s relentless argument is not merely poor scholarship but effectively precludes critical review. But then, perhaps that is the point. Yet Sayeed et al specifically reference this as the authoritative, undisputed citation that unimpeachably guides “precision” patient selection. And Bogduk guidelines allegedly directed the patient selection in the three foundational works on which Sayeed et al rely to validate their argument: Dreyfuss et al,5 Ghahreman et al,6 andMacVicar et al.7 Yet inexplicably, Dreyfuss et al was published 13 years before the Bogduk’s “Guidelines,” Ghahreman et al was performed 6 years earlier and the MacVicar study was begun more than 3 years before the Bogduk book appeared. Supernatural prescience aside, Sayeed et al refer to these studies as “high quality” and “benchmark” evidence supporting their proposition and that each followed Bogduk’s “rigorously applied selection criteria.’ But reader beware: in no two of these papers is the selection method the same. Sayeed et al hold up the Ghahreman et al6 trial as that which best “reflects” the apogee of “current clinical practice.” At best, correcting for the documented robust response of control subjects, Ghahreman still finds most patients failed to receive even 1 month pain relief from TFSI. And can this be their “best evidence?” Are we not reasonably unmoved when TFSI remains unlikely to work, despite purported, “precision” selection and “rigorous” application? They further neglect to mention that while somehow following the still unwritten Bogduk guidelines, Bogduk was also an author in each of the three “high quality” “benchmark studies”5–7 and, to complete the circular logic of their argument, Bogduk was also reported to be both the collector of data6 and the sole “independent assess[or] and analyz[or]” of the data7—which he found, unsurprisingly, supported his own thesis. This arrangement would not pass the chuckle test of serious scientists. Sayeed et al sadly end in an ad hominum attack on our Guideline committee members for lacking expertise in, nor apparent conversion to, the Bogduk book of revelations concerning precision diagnosis and treatment. Only the believer or converted need apply. This hermetic approach suggests scientific advancement by cabal as opposed to reason, verification, corroboration, and independent analysis. Comparing the outcomes of completely different clinical practices (as does Bogduk in MacVicar et al7) is just poor science; basing treatment “efficacy” on an uncontrolled 15 subject cohort (as does Bogduk in Dreyfuss et al5) is ill-considered enough to flunk any medical school course on clinical research methods; and acting as both data collector and sole “assess[or] and analyz[or]” supporting one’s own proposition (as does Bogduk above), is to step backward to the time medieval star-chambers validated “truth” by inquisition. In perusing our costly copy of Bogduk’s book, we find endless contradictions, baseless speculation, tautology and similar promotion of the lowest form of clinical investigation. It should be observed that Bogduk’s guidelines extoll another of his own works in which the designers of a “precision diagnosis” study also wrote the IRB, had livelihoods that heavily relied on the technique, and, incredibly, served as both injectionists and subjects all the while “blinded” to the “intention” of the very study they designed. Then as the piéce de résistance, the self-same designers, interventionalists, subjects and “blinded” controls also authored the publication.8,9 Despite combining prescience, amnesia, and self-promotion in one go, this too is purported to be the highest standard of clinical investigation. Mirabile dictu. Nevertheless, the SIS group appears mortified by minor issues in independent double-blind clinical trials used in our decision making. Perhaps the SIS group can be gently reminded of the biblical admonition: “why worry about a speck in your friend’s eye when you have a log in your own?” [Matt 7:3]. Shall we go on? We think not. We suggest the page be turned on this tedious and increasingly embarrassing chapter. Eugene J. Carragee, MDGunnar B.J. Andersson, MD, PhDRoger M. Belcourt, MD, MPHMarjorie Eskay-Auerbach, MD, JDMichael Goertz, MD, MPHScott Haldeman, MD, DC, PhDKurt T. Hegmann, MD, MPHJames E. Lessenger, MDTom Mayer, MDKathryn L. Mueller, MD, MPHDonald R. Murphy, DCWilliam G. Tellin, DCMatthew S. Thiese, PhD, MSPHRussell Travis, MDMichael S. Weiss, MD, MPHJeffrey S. Harris, MD, MPH, MBA