(Note: The endnotes which provide the references for this critique have been collected into this final part of this document.)
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4. Public Law 110-275, July 15, 2008, Section 304. https://www.gpo.gov/fdsys/pkg/PLAW-110publ275/pdf/PLAW-110publ275.pdf
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6. Richard N. Shiffman. Recognizing Trustworthy Guidelines: The New IOM Standards. p. 34. http://www.cdc.gov/od/science/quality/docs/trustworthy_gls.pdf
7. Institute of Medicine of the National Academies. Clinical Practice Guidelines We Can Trust: Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs), p. 2. http://iom.nationalacademies.org/~/media/Files/Report%20Files/2011/Clinical-Practice-Guidelines-We-Can-Trust/Clinical%20Practice%20Guidelines%202011%20Insert.pdf
8. Richard N. Shiffman. Recognizing Trustworthy Guidelines: The New IOM Standards. p. 34. http://www.cdc.gov/od/science/quality/docs/trustworthy_gls.pdf
9. Jill Eden, Laura Levit, Alfred Berg, and Sally Morton, Editors; Committee on Standards for Systematic Reviews of Comparative Effectiveness Research; Board on Health Care Services; Institute of Medicine. Finding What Works in Health Care: Standards for Systematic Reviews. The National Academies Press, Washington, D.C.: 2011, pp. 84-85. http://www.nap.edu/read/13059/chapter/5#85
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11. 21 U.S. Code § 360bbb–8b – Use of clinical investigation data from outside the United States. https://www.law.cornell.edu/uscode/text/21/360bbb%E2%80%938b
12. CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016. Online Appendix 2: Contextual Evidence Review, pp. 2, 4, 10, 11, 13. www.regulations.gov/contentStreamer?documentId=CDC-2015-0112-0004&disposition=attachment&contentType=pdf
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35. Jane C. Ballantyne, Miles Belgrade, Russ Carlisle, Roger Chou, Edward C. Covington, Robert W. Day, Richard A. Deyo, Irfan Dhalla, Thomas A. Farley, Gary M. Franklin, Stephen G. Gelfand, Stuart Gitlow, Roland W. Gray, Erik Gunderson, W. Michael Hooten, David Juurlink, Andrew Kolodny, Thomas R. Kosten, Kurt Kroenke, Eric B. Larson, Petros Levounis, Elinore F. McCance-Katz, Lewis Nelson, Rosemary Orr, William Phillips, Charles Reznikoff, Roger Rosenblatt, Nirav R. Shah, Harris Silver, Kurt C. Stange, Jon Streltzer, Mark Sullivan, Barbara J. Turner, Judith Turner, Michael Von Korff, Sidney M. Wolfe, Art Van Zee. Letter, Dockets Management Branch, Food and Drug Administration, July 25, 2012. http://paindr.com/wp-content/uploads/2012/08/2012-07-25_FDA-letter-from-physicians-for-responsible-opioid-prescribing.pdf I have written a separate commentary (available upon request) regarding the ethical breaches that these demands represent, and the FDA’s scientific rebuffs were withering: (1) The FDA repudiated the spurious distinction between “cancer” and “noncancer pain:” “It is FDA’s view that a patient without cancer, like a patient with cancer, may suffer from chronic pain, and PROP has not provided scientific support for why labeling should recommend different treatment for such patients. In addition, FDA knows of no physiological or pharmacological basis upon which to differentiate the treatment of chronic pain in a cancer setting or patient from the treatment of chronic pain in the absence of cancer, and comments to the Petition docket reflect similar concerns. FDA therefore declines to make a distinction between cancer and non-cancer chronic pain in opioid labeling.” (2) The FDA rejected PROP’s unscientific dose ceiling: “For the reasons discussed in further detail below, the scientific literature does not support establishing a maximum recommended daily dose of 100 mg MED [morphine equivalent dose]. Further, creating a maximum dose of 100 mg MED, or another dose ceiling, could imply a superior opioid safety profile under that set threshold, when there are no data to support such a conclusion. The Agency therefore denies PROP’s request that opioid labeling specify a maximum daily dose.” (3) It rejected PROP’s duration demands, noting that the evidence PROP used “did not suggest that chronic opioid therapy causes addiction, or vice versa. Both addiction and chronic opioid therapy were measured at one-point in time, so it is unknown which happened first: addiction or chronic opioid therapy.” “The cited literature does not identify a duration threshold beyond which the risk of addiction outweighs the benefits of opioid treatment. PROP has selected a 90-day limit, but provides no evidence that addiction (however it is defined) increases significantly after 90 days of use such that it would support a labeling change.” (4) While granting PROP’s request to remove “moderate pain” from opioids labeling, the FDA refused to restrict them to “severe pain,” using the PROP letter as the occasion to actually liberalize opioid labeling. The new labeling substitutes language that “underscores that patients in pain should be assessed not only by their rating on a categorical pain intensity scale, but also based on a more thoughtful determination that their pain—however it may be defined—is severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate. This framework better enables prescribers to make decisions based on a patient’s individual needs…[and] allows prescribers to make an assessment of pain relative to a patient’s ability to perform daily activities or enjoy a reasonable quality of life, not only on where a patient’s pain falls on an intensity scale.“ (Janet Woodcock. Letter, Andrew Kolodny, MD, President, Physicians for Responsible Opioid Prescribing, September 10, 2013. http://paindr.com/wp-content/uploads/2013/09/FDA_CDER_Response_to_Physicians_for_Responsible_Opioid_Prescribing_Partial_Petition_Approval_and_Denial.pdf)
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92. http://feduprally.org/study-opioid-overprescription-a-problem-for-all-doctors/ accessed December 23, 2015. Note that this study used to support this claim actually showed only that opioids are prescribed exactly the same way other medications are, rather than by outlying physicians (“pill mills”): Jonathan H. Chen, Keith Humphreys, Nigam H. Shah, Anna Lembke. Distribution of opioids by different types of Medicare prescribers. Journal of the American Medical Association Internal Medicine, December 14, 2015. http://archinte.jamanetwork.com/article.aspx?articleid=2474400 Neither the study design nor the Medicare database is capable of showing whether opioids are over- or under- or appropriately prescribed.
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99. In NM, a state with unusually high rates of addiction, from 1990 through 2005, the rates of unintentional overdose deaths related to heroin were 2.4 times as high as those related to prescription opioids, even though deaths that could not be definitively attributed to heroin were categorized as “opioid-related” due to morphine. (Nina G. Shah, Sarah L. Lathrop, R. Ross Reichard, Michael G. Landen. Unintentional drug overdose death trends in New Mexico, USA, 1990–2005: Combinations of heroin, cocaine, prescription opioids and alcohol. Addiction, 2007;103:126–136. http://www.ihra.net/files/2010/08/23/Shah_-_Unintentional_Drug_Overdose.pdf)
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124.This would only be true if the tapering were performed too quickly.
125.Richard C. Dart, Hilary L. Surratt, Theodore J. Cicero, Mark W. Parrino, S. Geoff Severtson, Becki Bucher-Bartelson, Jody L. Green. Trends in opioid analgesic abuse and mortality in the United States. New England Journal of Medicine, January 15, 2015;372:241-248. http://www.nejm.org/doi/full/10.1056/NEJMsa1406143#t=articleResults In a study of heroin users, 94% responded to open-ended questions by saying that they used it because prescription opioids were much more expensive and difficult to obtain: Theodore J. Cicero, Matthew S. Ellis, Hilary L. Surratt, Steven P. Kurtz. The changing face of heroin use in the United States: A retrospective analysis of the past 50 years. Journal of the American Medical Association Psychiatry, July 2014;71(7):821-826. http://archpsyc.jamanetwork.com/article.aspx?articleid=1874575
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141.“The term “dangerous drug” means a controlled substance, as defined in section 802 of title 21.” 42 USC 5117aa-21: Definitions. http://uscode.house.gov/view.xhtml?req=%28dangerous+drug%29&f=treesort&fq=true&num=90&hl=true&edition=prelim&granuleId=USC-prelim-title42-section5117aa-21 “'[D]angerous drug’ means a narcotic drug, a controlled substance, or a controlled substance analog (as defined in section 102 of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. 802))” 46 U.S. Code § 2101 – General definitions. https://www.law.cornell.edu/uscode/text/46/2101 A search of state laws (December 21, 2015) showed that AZ follows these definitions, but CA, GA, NM, NV, OH, OK, and TX define “dangerous drug” to mean any substance that requires a prescription (This definition appears to modeled after the 1952 Prescription Drug Amendment to the Federal Food, Drug, and Cosmetic Act, for which see: Edward B. Williams. Federal law of prescription drugs. Notre Dame Law Review, May 1, 1952;27(3):377-404. http://scholarship.law.nd.edu/cgi/viewcontent.cgi?article=3744&context=ndlr.).
142.Report of the International Narcotics Control Board for 2004 (E/INCB/2004/1), p. 31. http://www.incb.org/documents/Publications/AnnualReports/AR2004/AR_04_English.pdf As commonly observed by others, people view pharmaceuticals as safer and more predictable than nonpharmaceutical drugs.
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