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Editorial Commentary on "Torsade de pointes associated with very-high-dose methadone" (New: Sept 6) By Robert Newman, MD A just-published paper entitled "Torsade de pointes associated with very-high-dose methadone" (Krantz MJ et al, Annals of Internal Medicine 2002; 137:501-504) permits few if any conclusions, but will create much anxiety. With regard to the inability to draw conclusions: 1. The failure to define "very-high-dose" is compounded by the enormous variation in dosage (mean 397, ±283). No hint is given as to the population from which the 17 patients with the condition came: how many "very-high-dose" patients were there in the addiction treatment facilities and in the pain management practice, and how did those with Torsades compare to those without - by age, concomitant and/or underlying illness, concurrent use of other mediations/drugs, etc.? 2. No indication is given as to how these patients were identified, other than to say that their diagnosis was reached "fortuitously"; but why did they (and apparently not other patients) receive EKGs? True, "the manufacturer of methadone does not require this screening [by EKG]," but a manufacturer's "requirement" is rarely the only indication for performing this or any other test. 3. Two (pain management) patients were excluded because of "inadequate documentation of arrhythmia"; if the arrhythmia couldn't be documented, how could one conclude they might have belonged in the sample in the first place? 4. Although all patients "survived," there's no indication of just what it is they survived, or for how long; case identification began in 1996 and continued to 2001 - thus the period of observation was a few months, or up to six years. One might anticipate that some of the subjects in the pain management as well as opioid addiction treatment group would have died of something, or been lost to contact, or . . . 5. Two patients who were excluded from the study had "begun receiving substantially higher methadone doses 48 hours before their death;" even though "substantial" is a relative term - and another one that is undefined in this paper - "substantial increase" over a 48 hour period demands explanation, most particularly since at the end of the 48 hours these two patients died. The authors' discussion of the "many limitations" of their report doesn't go nearly far enough. Thus, they acknowledge they can make no "definitive statements about a true causal association." "Definitive" and "true" would seem to be serious understatements. It would be more accurate, I believe, to state that no conclusions whatsoever, not even the most tentative, can be drawn. An equally egregious understatement is the comment, "We cannot estimate the actual incidence of torsades de pointes in methadone-treated patients" - no, neither "the actual" nor the most wildly speculative incidence. Perhaps the most misleading disclaimer of all is the "caution" that "our report should not be interpreted to suggest that high-dose methadone cannot be used safely." Indeed it can't, because (among other reasons), while "high-dose" is defined by the authors as being above 60 mg, they make it clear that this rubric is distinct from "very-high-dose." As such, "high-dose" methadone treatment was not received by a single one of the subjects discussed here. The concern that the paper will cause anxiety among patients who receive methadone and those who prescribe it surely is self-evident. It is particularly sad, however, that this unnecessary additional burden is imposed on a medication that is already reviled by many health care providers and by a large majority of the public at large (and the elected and appointed officials who determine whether and how it may be prescribed). To see the journal annals Click Here
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