IN RESPONSE:
Dr. Wolfe is surprised that I did not mention his study (1), but my review focused on controlled trials. Although Wolfe and colleagues' study yielded important information, the authors stated that they did not test specific treatments in fibromyalgia and that the patients' conditions may have worsened over time had the patients not sought conventional treatment. Additionally, concern should be raised on how information on treatment failures at tertiary care centers gathered by fibromyalgia experts translates to patient responses in community settings.
Dr. Wolfe indicates that I do not define "what works" and that it is "fundamentally wrong to extrapolate short-term data to long-term outcomes." This is a problem common to therapeutic trials for most chronic conditions. I agree that uniform criteria for improvement must be established for fibromyalgia clinical trials. Up to this point, however, this has not occurred. As a review of the available literature, my paper relied on definitions of improvement as given by the researchers and as approved by the journals publishing these studies. I endorse the idea that an organization such as the American College of Rheumatology establish and validate uniform criteria for improvement in fibromyalgia. I acknowledged in my review that in fibromyalgia, "pharmacologic therapies show only limited success ... ."
Dr. Wolfe states that physicians who attempt to treat patients with fibromyalgia are "responsible for creating ... illness." The purpose of my review was to help clinicians distinguish therapeutic interventions that have been evaluated scientifically from those for which the experience is anecdotal. Until evidence shows that all patients meeting the clinical definition of fibromyalgia are malingering or feigning their suffering, and until there are better suggestions on how to help these patients, we must help them by using agents evaluated in a controlled fashion.
Given the increasing industry support for medical research, I understand Dr. Huppert's and Mr. Muilenburg's sensitivity to pharmaceutical company influences. I do not, however, believe I expressed more enthusiasm for tramadol than for other interventions requiring further study. Tramadol is the only currently available agent, marketed as an oral "analgesic," shown to be potentially beneficial in fibromyalgia. Ortho-McNeil Pharmaceutical was unaware that my review was being prepared. Honoraria received by my division from pharmaceutical companies for speaking engagements are used to help offset secretarial costs incurred by manuscript preparation. It is unfortunate that my review does not coincide with Huppert and colleagues' experience, as expressed in their discussion.
Finally, I hope that Mr. Muilenburg's opinions are not influenced by any incentive to limit access to medications he considers "too expensive."