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but also of falls among older patients with use of dabigatran compared with warfarin; hip and vertebral fractures should be analyzed separately because most vertebral fractures occur without falls in contrast to hip fracture. Furthermore, a 2016 study reported a similar rate of fractures due to fall- ing with edoxaban, another NOAC, and warfarin in older patients at increased fall risk,5 and therefore the compari- son among different NOACs might be clinically meaningful.
Toshihiro Sugiyama, MD, PhD
Author Affiliation: Department of Orthopaedic Surgery, Saitama Medical University, Saitama, Japan.
Corresponding Author: Toshihiro Sugiyama, MD, PhD, Department of Orthopaedic Surgery, Saitama Medical University, 38 Morohongo, Moroyama, Saitama 350-0495, Japan (tsugiym@saitama-med.ac.jp).
Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
1. Lau WC, Chan EW, Cheung CL, et al. Association between dabigatran vs warfarin and risk of osteoporotic fractures among patients with nonvalvular atrial fibrillation. JAMA. 2017;317(11):1151-1158.
2. Veronese N, Bano G, Bertozzo G, et al. Vitamin K antagonists’ use and fracture risk: results from a systematic review and meta-analysis. J Thromb Haemost. 2015;13(9):1665-1675.
3. Sugiyama T, Kono Y, Sekiguchi K, Kim YT, Oda H. An evidence-based perspective on warfarin and the growing skeleton. Osteoporos Int. 2016;27(9): 2883-2884.
4. Sugiyama T, Oda H. Edoxaban versus warfarin: bone fractures due to falling. J Am Coll Cardiol. 2017;69(4):466-467.
5. Steffel J, Giugliano RP, Braunwald E, et al. Edoxaban versus warfarin in atrial fibrillation patients at risk of falling; ENGAGE AF-TIMI 48 analysis. J Am Coll Cardiol. 2016;68(11):1169-1178.
In Reply Dr Sugiyama suggested some possible mechanisms for our results and directions for further research. We agree that it is worth investigating whether dabigatran could reduce the risk of falls in future studies. We were unable to look in detail at hip and vertebral fractures separately because of the small number of events; even the composite outcome was rare (<1.0 per 100 person-years). Additional studies that examine the risk of falls, as well as fall-related and fall-unrelated fractures, are therefore warranted to evaluate the possible roles of dabigatran and warfarin in association with fracture risk, especially among patients receiving short-term treatment (<1 year).
Although the lower risk of fractures with short-term treatment may be less likely to result from changes in bone fragility, we think that this might not necessarily preclude any biological effects of dabigatran or warfarin on bone because we also observed a lower risk for long-term use (≥1 year). Further, an animal study reported that dabigatran use was associated with higher bone volume, reduced tra- becular separation, and lower bone turnover rate compared with warfarin use.1 It would be useful to determine the effect on bone, together with the risk of falls and individual types of fractures, with the use of dabigatran vs warfarin in future studies.
Although some studies suggest that warfarin may not cause fragility fractures,2 previous evidence was mainly derived from studies using untreated or unmatched patients as the com-
parator with warfarin, and so the potential for confounding by indication cannot be ignored.2 However, at the time the stud- ies were conducted, no comparator with similar indications ex- isted because warfarin was the only treatment choice avail- able. With the availability of NOACs, there will be opportunities for reliable comparisons with warfarin with respect to frac- ture risk. Further comparisons between different NOACs, as suggested by Sugiyama, will provide further insights into any mechanistic differences between NOACs with respect to frac- ture risk, as well as inform the choice of oral anticoagulant pre- scribed in clinical practice.
Wallis C. Y. Lau, BSc Ian C. K. Wong, PhD Esther W. Chan, PhD
Author Affiliations: Department of Pharmacology and Pharmacy, The University of Hong Kong, Pokfulam, Hong Kong (Lau, Chan); Research Department of Practice and Policy, UCL School of Pharmacy, London, United Kingdom (Wong).
Corresponding Author: Esther W. Chan, PhD, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 21 Sassoon Rd, L02-08, 2/F, Laboratory Block, Faculty of Medicine Bldg, Pokfulam, Hong Kong (ewchan@hku.hk).
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs Wong and Chan reported receiving research funding from Bristol-Myers Squibb, Pfizer, Janssen, the Hong Kong Research Grants Council, and the Hong Kong Health and Medical Research Fund. No other disclosures were reported.
1. Fusaro M, Dalle Carbonare L, Dusso A, et al. Differential effects of dabigatran and warfarin on bone volume and structure in rats with normal renal function. PLoS One. 2015;10(8):e0133847.
2. Veronese N, Bano G, Bertozzo G, et al. Vitamin K antagonists’ use and fracture risk: results from a systematic review and meta-analysis. J Thromb Haemost. 2015;13(9):1665-1675.
The Joint Commission and the Opioid Epidemic To the Editor The Viewpoint on the history of The Joint Com- mission’s pain standards1 presented 4 lessons the organiza- tion learned to help address the current opioid epidemic. However, we believe that these lessons do not go far enough in evaluating The Joint Commission’s involvement in the opioid epidemic.
First, Dr Baker stated that The Joint Commission’s 2000 standards for pain management “were a bold attempt to address widespread underassessment and undertreatment of pain.”1 However, there was no clamor within the health care community for such a regulatory-based approach to pain management.
Second, Purdue Pharma, the manufacturer of OxyCon- tin, was 1 of 2 drug companies that provided funding for The Joint Commission’s pain management educational programs.2
Purdue also distributed videos and monographs about pain management on The Joint Commission’s website.2 We be- lieve that accrediting organizations should not partner with pri- vate pharmaceutical companies on issues that appear to be a conflict of interest.
Third, once the opioid epidemic was recognized, The Joint Commission did not take steps to address this problem in a timely manner, as the epidemic has progressed for more than 18 years.
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Fourth, by making pain control a patients’ rights issue, The Joint Commission emphasized symptomatic treatment of pain over clinical investigation of the causes.3
The Joint Commission did not follow the principles of evi- dence-based medicine in enacting its pain management guide- lines and did little to prevent or decrease opioid use once the epidemic became apparent.
Neeraj Chhabra, MD Jerrold B. Leikin, MD
Author Affiliations: Toxikon Consortium, John H. Stroger Jr. Hospital, Chicago, Illinois (Chhabra); NorthShore University HealthSystem, Glenview, Illinois (Leikin).
Corresponding Author: Jerrold B. Leikin, MD, NorthShore University HealthSystem, 2150 Pfingsten Rd, OMEGA, Ste 3000, Glenview, IL 60026 (jleikin@northshore.org).
Conflict of Interest Disclosures: Both authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Leikin reported receiving fees for providing expert witness testimony on medical malpractice and impairment issues involving drugs; and owning several mutual funds that include stocks in the pharmaceutical industry. No other disclosures were reported.
1. Baker DW. History of The Joint Commission’s pain standards: lessons for today’s prescription opioid epidemic. JAMA. 2017;317(11):1117-1118.
2. US General Accounting Office. Prescription drugs: OxyContin abuse and diversion and efforts to address the problem. http://www.gao.gov/new.items /d04110.pdf. Accessed May 4, 2017.
3. Phillips DM. JCAHO pain management standards are unveiled. JAMA. 2000; 284(4):428-429.
In Reply I agree with Drs Chhabra and Leikin that The Joint Com- mission should have examined ways to address the opioid epi- demic earlier, and the organization should learn from this ex- perience. Past criticism of the pain standards may have caused some reluctance to tackle the emerging opioid epidemic.
Their letter incorrectly states there was no “clamor” for standards. After several national and international guide- lines failed to improve the severe undertreatment of pain that was prevalent at the time and numerous articles showed per- sistence of the problem, Max1 wrote in 1990 that education was not enough and recommended a different and more aggres- sive approach. Even the US Congress joined the call, passing a bill in 2000 that established the “Decade of Pain Control and Research.”2 The Joint Commission’s pain standards were de- veloped with funding from the Robert Wood Johnson Foun- dation (the only organization that provided funding), which shows that this philanthropic organization saw the standards as a way to address a public health priority.
The authors used information selectively from a US Gen- eral Accounting Office study of OxyContin and Purdue Pharma to imply that Purdue had a close relationship with The Joint Commission.3 The US General Accounting Office report actually said, “From 1996, when OxyContin was introduced to the market, to July 2002, Purdue has funded over 20,000 pain-related educational programs through direct sponsorship or financial grants.” The Joint Commis- sion was only 1 among thousands of organizations that received funds to develop educational programs. Like the others, we were unaware that the science behind their
claims and the advice of experts in the field were erroneous. Even the US Food and Drug Administration accepted Pur- due’s claims, approving labeling saying that iatrogenic addic- tion was “very rare” and that the delayed absorption of Oxy- Contin reduced the abuse liability of the drug.4 The US Food and Drug Administration removed these unsubstantiated claims from OxyContin’s labeling in 2001. However, the con- cept that iatrogenic addiction was rare and that long-acting opioids were less addictive had been widely repeated, and studies refuting these claims were not published until sev- eral years later. After this experience, The Joint Commission established much stricter processes to review any corporate sponsorship of educational programs and to ensure that our technical expert panels and other advisory group members are free from conflict of interest.
More information on the history of The Joint Commis- sion’s pain standards is available on our website, including data showing a continuously rising trend in opioid prescriptions dur- ing the decade before and after the standards were released.5
The website includes many references, and I encourage oth- ers to read the primary literature on this topic and come to their own conclusions. As I wrote in my Viewpoint, it is vital to “care- fully review the primary literature on issues of critical impor- tance and do not simply repeat the claims of experts in previ- ous articles.”6 This admonition applies equally well to claims about The Joint Commission’s role in the opioid epidemic. We will continue to work to address the opioid epidemic with our new standards and maintain efforts to ensure that patients get appropriate pain management.
David W. Baker, MD, MPH
Author Affiliation: Division of Healthcare Quality Evaluation, The Joint Commission, Oakbrook Terrace, Illinois.
Corresponding Author: David W. Baker, MD, MPH, Division of Healthcare Quality Evaluation, The Joint Commission, 1 Renaissance Boulevard, Oakbrook Terrace, IL 60181 (dbaker@jointcommission.org).
Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
1. Max MB. Improving outcomes of analgesic treatment: is education enough? Ann Intern Med. 1990;113(11):885-889.
2. Brennan F. The US congressional “Decade on Pain Control and Research” 2001-2011: a review. J Pain Palliat Care Pharmacother. 2015;29(3):212-227.
3. US General Accounting Office. Prescription drugs: OxyContin abuse and diversion and efforts to address the problem. http://www.gao.gov/new.items /d04110.pdf. Accessed May 1, 2017.
4. Van Zee A. The promotion and marketing of OxyContin: commercial triumph, public health tragedy. Am J Public Health. 2009;99(2):221-227.
5. The Joint Commission. Pain management. https://www.jointcommission.org /topics/pain_management.aspx. Accessed May 1, 2017.
6. Baker DW. History of The Joint Commission’s pain standards: lessons for today’s prescription opioid epidemic. JAMA. 2017;317(11):1117-1118.
Physicians Interrupting Patients To the Editor Mr Mauksch’s discussion1 of interruption tech- niques for the busy physician is problematic. Specifically, he put the focus on the needs and emotions of the physician. Phy- sicians must recognize that during each patient encounter, at- tention must center on the patient. Physician stress should
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