1270 trauma, toxins and exposure to viral infections [9,10], and disturbances in the sleep/waking patterns in the brain [11]). It is admirable that Wolfe et al, even after having developed the above-mentioned criteria, continue to consider and update the wide range of fibromyalgia symptoms, emphasizing the continued presence of an undefinable entity whose initiating cause and mechanisms previously seemed understandable. Fibromyalgia has been proven to be markedly difficult to classify because of its intrinsic comorbidities and symptoms, as well as its polysymptoms, which can appear in distinct ways from one patient to the next, leading it to become an extremely subjective disease. Another complicating factor is that pain is not easy to ascertain, again because of its subjective nature and the lack of objective measurement tools that must be independent from the person making the evaluation. Functional magnetic resonance imaging studies have been undertaken to attempt to identify a pain signature, but these studies remain in the research stage (12). In the near future, we might identify a fibromyalgia signature that can serve as a biomarker of fibromyalgia, along with the changes in central sensitization, neurotransmitter levels, and alpha– delta sleep (13,14). A better understanding of the underlying etiology of fibromyalgia will be an essential and prominent issue. Although technological advances can offer important tools for the evaluation, elucidation, and even diagnosis of fibromyalgia, the human factor remains crucial in the diagnosis and treatment of certain diseases. To respect the patient as a whole, consideration of the psychic and somatic aspects of the disease, as well as the full spectrum of the potential disease severity, may be more useful than a precise diagnosis. As mentioned by the authors, the approach toward and understanding of a disease are much more important than making an assertive diagnosis. Therefore, it is necessary to augment the search for new technological tools that allow us to quantify pain and monitor interventions in fibromyalgia without losing sight of the fact that the human care factor is irreplaceable. Cristina Frange, PT Helena Hachul, MD, PhD Sergio Tufik, MD, PhD Monica L. Andersen, PhD Universidade Federal de Sa˜o Paulo Sa˜o Paulo, Brazil 1. Wolfe F, Walitt BT, Hauser W. What is fibromyalgia, how is it diagnosed and what does it really mean? Arthritis Care Res (Hoboken) 2014;66:969 –71. 2. Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, et al. The American College of Rheumatology 1990 criteria for the classification of fibromyalgia: report of the Multicenter Criteria Committee. Arthritis Rheum 1990;33: 160 –72. 3. Wolfe F, Clauw DJ, FitzCharles MA, Goldenberg DL, Katz RS, Mease P, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken) 2010;62: 600 –10. 4. Wolfe F, Clauw DJ, FitzCharles MA, Goldenberg DL, Hauser W, Katz RS, et al. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the

Letters

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6. 7. 8. 9. 10. 11.

12. 13. 14.

ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol 2011;38:1113–22. Ferrari R, Russell AS. A questionnaire using the modified 2010 American College of Rheumatology criteria for fibromyalgia: specificity and sensitivity in clinical practice. J Rheumatol 2013;40:1590 –5. Katz DL, Greene L, Ali A, Faridi X. The pain of fibromyalgia syndrome is due to muscle hypoperfusion induced by regional vasomotor dysregulation. Med Hypotheses 2007;69:517–25. Baranauskas G, Nistri A. Sensitization of pain pathways in the spinal cord: cellular mechanisms. Prog Neurobiol 1998;54: 349 – 65. Vierck CJ, Wong F, King CD, Mauderli AP, Schmidt S, Riley JL III. Characteristics of sensitization associated with chronic pain conditions. Clin J Pain 2014;30:119 –28. Clauw DJ. Fibromyalgia: an overview. Am J Med 2009;122 Suppl:S3–13. Bradley LA. Pathophysiology of fibromyalgia. Am J Med 2009; 122 Suppl:S22–30. Moldosfky H. The significance of the dysfunctions of the sleep/waking brain to the pathogenesis and treatment of fibromyalgia syndrome. Rheum Dis Clin North Am 2009;35: 275– 83. Wager TD, Atlas LY, Lindquist MA, Roy M, Woo CH, Kross E. An fMRI-based neurologic signature of physical pain. N Engl J Med 2013;368:1388 –97. Hauri P, Hawkins DR. Alpha-delta sleep. Electroencephalogr Clin Neurophysiol 1973;34:233–7. Roizenblatt S, Moldofsky H, Bendito-Silva AA, Tufik S. Alpha sleep characteristics in fibromyalgia. Arthritis Rheum 2001; 44:222–30.

DOI 10.1002/acr.22356

Who decides if research will be published, authors or sponsors? Comment on the article by Curtis et al To the Editor: I read with interest the article by Curtis et al published in Arthritis Care & Research (1). The authors reported that patients with rheumatoid arthritis were less likely to be tested for hyperlipidemia, and that tumor necrosis factor inhibitors led to modest increases in all lipid parameters in a retrospective analysis of a large data set. A disturbing aspect of the article appeared at the end, where under the Author Contributions it states that “all authors were involved in drafting the article or revising it critically for important intellectual content, and all authors approved the final version to be published. Dr. Curtis had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.” Right below the Author Contributions, under the Role of the Study Sponsor, it states that “Genentech participated in the study design, data interpretation, and editing of the manuscript, and approved the content of the submitted manuscript. United BioSource Corporation participated in writing of the manuscript. Publication of this article was contingent on the approval of Genentech.” This seems to be a contradiction of terms. If the sponsor had the final approval for content and publication, what difference does it really make how much control the authors had over the final version? Of course, the main issue is publication bias and how pharmaceutical companies

Letters distort the medical literature by overwhelmingly publishing only positive results and not negative ones, of which there are plenty of disturbing examples (2–5). In both the US and Europe, there are efforts to have all data from clinical trials available to the public within a certain time period after a study has been completed (6). Selective reporting of results affects individual studies, and because meta-analyses are dependent on the published trials and studies, if negative results are left out, then the conclusions reached by the meta-analysis also become unreliable (7). There already is distrust among physicians regarding publication of research funded by pharmaceutical companies (8). An editorial in the same issue as reference 8 suggested we should believe the data regardless of the funding source (9); however, this is hard to do given what we currently know, namely that the drug companies can suppress data and articles and decide what can and cannot be published. The Trial and Experimental Studies Transparency Act (10) has been proposed as a way to make all trial results, of approved or unapproved products, whether conducted in the US or overseas, publicly available. Finally, it is concerning that Arthritis Care & Research, one of the most highly cited journals in rheumatology, would publish an article that explicitly stated that the pharmaceutical sponsor had the final say whether the study would be published. I would like to think this decision is still between the authors (who somehow agreed to this arrangement for an article where they analyzed the data and wrote the manuscript) and the journal reviewers and editors. The buck should stop, as it were, with the journals that are the real arbiters of what and how articles get published. I believe the rheumatology community is owed an explanation as to how this was allowed to happen. Dr. Yazici has received consultancy fees and/or honoraria (less than $10,000 each) from AbbVie, Bristol-Myers Squibb, Celgene, Genentech, Pfizer, and UCB.

Yusuf Yazici, MD New York University Hospital for Joint Diseases New York, NY 1. Curtis JR, John A, Baser O. Dyslipidemia and changes in lipid profiles associated with rheumatoid arthritis and initiation of anti–tumor necrosis factor therapy. Arthritis Care Res (Hoboken) 2012;64:1282–91. 2. Dyer O. GlaxoSmithKline faces US lawsuit over concealment of trial results. BMJ 2004;328:1395. 3. Tanne JH. GSK is accused of trying to suppress editorial on rosiglitazone. BMJ 2010;340:c2654. 4. Scherer RW, Langenberg P, von Elm E. Full publication of results initially presented in abstracts. Cochrane Database Syst Rev 2007;2:MR000005. 5. Thomas K. Study of drug for blood clots caused a stir, records show. The New York Times 2014 February 6; Sect. B:1. 6. Goldacre B, Heneghan C. Improving, and auditing, access to clinical trial results. BMJ 2014;448:g213. 7. McGauran N, Wieseler B, Kreis J, Schuler YB, Kolsch H, Kaiser T. Reporting bias in medical research: a narrative review. Trials 2010;11:37. 8. Kesselheim AS, Robertson CT, Myers JA, Rose SL, Gillet V, Ross KM, et al. A randomized study of how physicians interpret research funding disclosures. New Eng J Med 2012;367: 1119 –27.

1271 9. Drazen JM. Believe the data [editorial]. New Eng J Med 2012; 367:1152–3. 10. Drazen JM. Transparency for clinical trials: the TEST Act [editorial]. N Eng J Med 2012;367:863– 4.

DOI 10.1002/acr.22354

Reply To the Editor: I would like to thank Dr. Yazici for his letter raising this important topic. It is a truism that promoting objectivity and transparency in the scientific literature is a laudable goal, hence the importance of disclosing the role of the sponsor with respect to any publication. Despite efforts to be transparent, incomplete information regarding the role of the sponsor may be conveyed because, for some journals, the standard disclosure language choices do not reflect the role of the sponsor with sufficient precision. That was the circumstance for our article, and I therefore appreciate the opportunity for clarification. A common requirement for any employee of a commercial entity or federal agency, such as the Food and Drug Administration or Centers for Disease Control and Prevention, is to obtain clearance from their employer to be permitted to serve as a coauthor. The manuscript is reviewed at the agency or company, often following a peerreview process conducted by scientific experts, and may yield valuable feedback to the coauthor team. Such feedback is typically nonbinding, as was the case in the article in question. If other coauthors do not believe that the manuscript should be modified based upon the suggestions given, and if the sponsor will not clear the manuscript without it being modified, then the author list can be revised and coauthors who do not obtain their employer’s approval can withdraw from coauthorship and be listed only in an acknowledgment section. This withdrawal from being a coauthor would occur despite the fact that such individuals otherwise met all International Committee of Medical Journal Editors requirements (1). The decision to publish and the responsibility for the final content thus rests with the remaining coauthors, as it did in the case of our article. We work in an era where there is an increased effort to share data (not simply results), where collaborations to improve science and innovation are increasingly the norm, and where partnerships between industry and academic scientists are commonplace and viewed in many sectors as being valuable as long as appropriate safeguards are in place (2,3). I would encourage journals to consider these complexities and, for example, to revise their policies to provide more guidance on this topic of industry scientists as coauthors. It would be helpful for journals to allow authors, when submitting a manuscript, to disclose that a sponsor had the final say about a manuscript only inasmuch as it could disallow its employees from being listed as coauthors, but that the sponsor neither exerted final control over the decision to publish nor influenced the final content. This suggestion aside, I concur with Dr. Yazici that it is journal editors, peer reviewers, and ulti-