Tag Archives: Analgesics

Critique of the CDC’s Draft Guidelines on the Use of Opioid Analgesics for Chronic Pain Endnotes

(Note: The endnotes which provide the references for this critique have been collected into this final part of this document.)

1. Deborah Dowell, Tamara M. Haegerich, Roger Chou. CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016. http://static1.squarespace.com/static/54d50ceee4b05797b34869cf/t/566f4391df40f39ea7ef24f7/145013236970

2. Institute of Medicine of the National Academies. Clinical Practice Guidelines We Can Trust: Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs). http://iom.nationalacademies.org/~/media/Files/Report%20Files/2011/Clinical-Practice-Guidelines-We-Can-Trust/Clinical%20Practice%20Guidelines%202011%20Insert.pdf

3. Richard N. Shiffman. Recognizing Trustworthy Guidelines: The New IOM Standards. p. 6. (Ellipses in original) http://www.cdc.gov/od/science/quality/docs/trustworthy_gls.pdf

4. Public Law 110-275, July 15, 2008, Section 304. https://www.gpo.gov/fdsys/pkg/PLAW-110publ275/pdf/PLAW-110publ275.pdf

5. 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, p. 18. http://www.nap.edu/read/13059/chapter/5#85

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

10. CDC Guideline for Prescribing Opioids for Chronic Pain–United States, 2016. Online Appendix 2: Contextual Evidence Review, p. 2. www.regulations.gov/contentStreamer?documentId=CDC-2015-0112-0004&disposition=attachment&contentType=pdf

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

13. CDC Guideline for Prescribing Opioids for Chronic Pain–United States, 2016. Online Appendix 2: Contextual Evidence Review, p. 1. www.regulations.gov/contentStreamer?documentId=CDC-2015-0112-0004&disposition=attachment&contentType=pdf

14. CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016. Online Appendix 2: Contextual Evidence Review, p. 2. www.regulations.gov/contentStreamer?documentId=CDC-2015-0112-0004&disposition=attachment&contentType=pdf

15. Richard N. Shiffman. Recognizing Trustworthy Guidelines: The New IOM Standards. p. 24 http://www.cdc.gov/od/science/quality/docs/trustworthy_gls.pdf

16. Justin Kung, Ram R. Miller, Philip A. Mackowiak. Failure of clinical practice guidelines to meet Institute of Medicine Standards: Two more decades of little, if any, progress. Archives of Internal Medicine, November 26, 2012;172(21):1628-1633. http://archinte.jamanetwork.com/article.aspx?articleid=1384245

17. Pat Anson. CDC maintains secrecy over opioid guidelines. Pain News Network, September 18, 2015.

18. Jason Chaffetz, Elijah E. Cummings, Jim Jordan, Matt Cartwright, Mark Meadows, Gerald E. Connolly. House of Representatives Committee on Oversight and Government Reform letter to Thomas Frieden, M.D., Director, Centers for Disease Control, December 18, 2015. https://oversight.house.gov/wp-content/uploads/2015/12/2015-12-18-JC-EEC-Jordan-Meadows-Cartwright-Connolly-to-Frieden-CDC-FACA-due-Jan.-5.pdf

19. Peter Pitts. At the CDC. Morning Consult, September 24, 2015. http://morningconsult.com/opinions/opioids-and-sunshine-at-the-cdc/

20. Jane Ballantyne, MD. COPE Faculty. http://www.coperems.org/cope-faculty/ accessed December 29, 2015. See also http://www.supportprop.org/board-of-directors/ accessed December 15, 2015.

21. http://www.supportprop.org/advocacy/ accessed December 23, 2015

22 http://www.supportprop.org/about-prop/ accessed December 15, 2015

23. http://www.phoenixhouse.org/about/ accessed December 15, 2015

24. Roger Chou, Gilbert J. Fanciullo, Perry G. Fine, Jeremy A. Adler, Jane C. Ballantyne, Pamela Davies, Marilee I. Donovan, David A. Fishbain, Kathy M. Foley, Jeffrey Fudin, Aaron M. Gilson, Alexander Kelter, Alexander Mauskop, Patrick G. O’Connor, Steven D. Passik, Gavril W. Pasternak, Russell K. Portenoy, Ben A. Rich, Richard G. Roberts, Knox H. Todd, Christine Miaskowski, for the American Pain Society–American Academy of Pain Medicine Opioids Guidelines Panel. Opioid treatment guidelines: Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. The Journal of Pain, February 2009;10(2):113-130. http://health.utah.gov/prescription/pdf/guidelines/ASP.AAPMguidelines.pdf

25. Jane Ballantyne, Randi Beck, Andrew Bertagnolli, Marie Boudreaux, Hannah Burdge, Mary Catlin, Roger Chou, Gary Franklin, Rivka Klaff, Andrew Kolodny, Erin Krebs, Tony Mariano, Deborah Nelson, Roger Rosenblatt, Grant Scull, Michelle Seelig, Mark Stephens, Mark Sullivan, David Tauben, Claire Trescott, Michael Von Korff. The National Summit for Opioid Safety. Principles for more selective and cautious opioid prescribing. Seattle Washington, October 31-November 1, 2012. http://depts.washington.edu/anesth/education/forms/pain/Principles_opioidPrescribing.pdf

26. Jane C. Ballantyne, Jianren Mao. Opioid therapy for chronic pain. New England Journal of Medicine, November 13, 2003;349:1943-1953. http://www.nejm.org/doi/full/10.1056/nejmra025411

27. Barry Meier. Pendulum swings against wide use of painkillers. The New York Times, Herald-Tribune, April 9, 2012. http://health.heraldtribune.com/2012/04/09/pendulum-swings-against-wide-use-of-painkillers/

28. Jane C. Ballantyne, Mark D. Sullivan, Andrew Kolodny. Opioid dependence vs addiction: A distinction without a difference? Archives of Internal Medicine, September 24, 2012;172(17):1342-1343. http://www.thblack.com/links/RSD/ArchIntMed2012_172_1342_DependVSAdict.pdf

29. Jane C. Ballantyne. “Safe and effective when used as directed”: The case of chronic use of opioid analgesics. Journal of Medical Toxicology, December 2012;8(4):417-423. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3550253/

30. Jane C. Ballantyne. What Is the Evidence for the Effectiveness of Opioid Analgesics for Chronic Pain From Clinical and Administrative Data, p. 11. http://www.fda.gov/downloads/Drugs/NewsEvents/UCM307844.pdf

31. Press Release. Cohen Milstein Sellers & Toll PLLC Announces the Investigation of Insys Therapeutics, Inc. June 5, 2014 8:00am EDT. http://www.reuters.com/article/dc-cohen-milstein-idUSnBw055260a+100+BSW20140605

32. Jessica M. Karmasek. Cohen Milstein law firm strengthening relationships with state AGs, earning millions. LegalNewsline.Com, April 21, 2015. http://legalnewsline.com/stories/510550711-cohen-milstein-law-firm-strengthening-relationships-with-state-ags-earning-millions

33. Eric Lipton. Lawyers create big paydays by coaxing attorneys general to sue. New York Times, New York edition, December 19, 2014, p. A1. http://www.nytimes.com/2014/12/19/us/politics/lawyers-create-big-paydays-by-coaxing-attorneys-general-to-sue-.html?_r=1

34. C.J. Ballantyne. Opioid controls: regulate to educate. Pain Medicine. April 2010;11(4):480-481. http://onlinelibrary.wiley.com/doi/10.1111/j.1526-4637.2010.00822.x/abstract

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)

36. Jane C. Ballantyne, Naomi S. Shin. Efficacy of Opioids for Chronic Pain: A Review of the Evidence. Clinical Journal of Pain, July-August 2008;24(6):469–478. http://chroniccare.rehab.washington.edu/chronicpain/resources/efficacyofopioidsforchronicpain.pdf

37. Lewis Nelson, M.D.

38. Susan Okie. A flood of opioids, a rising tide of deaths. The New England Journal of Medicine, November 18, 2010;363(21):1981-1985. http://www.nejm.org/doi/pdf/10.1056/NEJMp1011512

39. Jeanmarie Perrone, M.D.

40. Jeanmarie Perrone, Lewis S. Nelson. Medication reconciliation for controlled substances—an “ideal” prescription-drug monitoring program. The New England Journal of Medicine, June 21, 2012;366:2341-2343. http://www.nejm.org/doi/full/10.1056/NEJMp1204493

41. Mark D. Sullivan, M.D., Ph.D. Curriculum vitae, February 2010. http://depts.washington.edu/pbscifac/Sullivan_CV.pdf

42. Erin E. Krebs, M.D., M.P.H.

43. Erin E. Krebs. Unintended consequences: Current state of prescription opioid use and misuse in the US. April 14, 2012, p. 15. www.janussc.org/janus/docs/Janus-Opioid-Conference-Summit-Keynote-04142012.pptx A less sensational, but more easily grasped, way of expressing the same information is some degree of overdose in 3 of every 100 people treated for 20 years.

44. Judith Turner, Ph.D.

45. Gary M. Franklin, Jaymie Mai, Judith Turner, Mark Sullivan, Thomas Wickizer, Deborah Fulton-Kehoe. Bending the prescription opioid dosing and mortality curves: Impact of the Washington State opioid dosing guideline. American Journal Of Industrial Medicine 2012;55:325–331. http://www.ucdenver.edu/academics/colleges/PublicHealth/research/centers/maperc/online/online/Documents/Franklin%20et%20al.,%202012.pdf

46. Lynn R. Webster, Susan Cochella, Keri L. Fakata, Perry G. Fine, Scott M. Fishman, Todd Grey, Erin M. Johnson, Lewis K. Lee, Steven D. Passik, John Peppin, Christina A. Porucznik, Albert Ray, Sidney H. Schnoll, Richard L. Stieg, Wayne Wakeland. An analysis of the root causes for opioid-related overdose deaths in the United States. Pain Medicine 2011;12:S26–S35. http://painmedicine.oxfordjournals.org/content/painmedicine/12/suppl_2/S26.full.pdf

47. Christina A. Porucznik, Erin M. Johnson, Robert T. Rolfs, Brian C. Sauer. Specialty of prescribers associated with prescription opioid fatalities in Utah, 2002–2010. Pain Medicine, January 2014;15(1):73–78. http://www.thblack.com/links/rsd/PainMed2014_15_73_SpecialtyOpioidDocsAssoc-w-fatality.pdf

48. Bonnie Burman, Sc.D.

49. Ohio Emergency and Acute Care Facility Opioids and Other Controlled Substances (OOCS) Prescribing Guidelines. http://www.healthy.ohio.gov/ed/guidelines.aspx accessed December 25, 2015

50. Ohio Emergency and Acute Care Facility Opioids and Other Controlled Substances (OOCS) Prescribing Guidelines. http://www.healthy.ohio.gov/~/media/HealthyOhio/ASSETS/Files/edguidelines/EGs%20no%20poster.pdf

51. Ohio Emergency and Acute Care Facility Opioids and Other Controlled Substances (OOCS) Prescribing Guidelines http://www.healthy.ohio.gov/ed/guidelines.aspx accessed December 25, 2015

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54. Joanna L. Starrels, William C. Becker, Mark G. Weiner, Xuan Li, Moonseong Heo, Barbara J. Turner. Low use of opioid risk reduction strategies in primary care even for high risk patients with chronic pain. Journal of General Internal Medicine, September 2011;26(9):958–964. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3157518/#!po=58.9286

55. Joanna L. Starrels, William C. Becker, Daniel P. Alford, Alok Kapoor, Arthur Robinson Williams, Barbara J. Turner. Systematic review: Treatment agreements and urine drug testing to reduce opioid misuse in patients with chronic pain. Annals of Internal Medicine, 2010;152:712-720. https://www.researchgate.net/profile/Barbara_Turner/publication/44640932_Starrels_JL_Becker_WC_Alford_DP_et_al_Systematic_review_treatment_agreements_and_urine_drug_testing_to_reduce_opioid_misuse_in_patients_with_chronic_pain/links/00b4953319c816f965000000.pdf?inViewer=0&pdfJsDownload=0&origin=publication_detail

56. Michael A. Steinman, M.D.

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63. Phillip O Coffin. Academic Detailing Intervention for Opioid Safety: ADIOS. http://www.narcad.org/uploads/5/7/9/5/57955981/day_2_pres2_phillip_coffin_plenary.pdf

64. Adam J. Visconti, Glenn-Milo Santos, Nikolas P. Lemos, Catherine Burke, Phillip O. Coffin. Opioid overdose deaths in the City and County of San Francisco: Prevalence, distribution, and disparities. Journal of Urban Health, August 2015;92(4):758-772. http://link.springer.com/article/10.1007/s11524-015-9967-y

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78. Amy S. B. Bohnert, Marcia Valenstein, Matthew J. Bair, Dara Ganoczy, John F. McCarthy, Mark A. Ilgen, Frederic C. Blow. Association between opioid prescribing patterns and opioid overdose-related deaths. Journal of the American Medical Association, April 6, 2011;305(13 ):1315-1321. http://jama.jamanetwork.com/article.aspx?articleid=896182

79. Erin E. Bonar, Mark A. Ilgen, Maureen Walton, Amy S.B. Bohnert. Associations among pain, non-medical prescription opioid use, and drug overdose history. The American Journal on Addictions, January-February 2014;23(1):41–47. http://onlinelibrary.wiley.com/doi/10.1111/j.1521-0391.2013.12055.x/full

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81. Gary M. Franklin, MD, MPH. http://workerscompensationconference.com/wp-content/uploads/Franklin-Gary-bio.pdf

82. Washington State Agency Medical Directors’ Group. Interagency Guideline on Prescribing Opioids for Pain. June 2015. http://www.agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pdf

83. Gary Franklin, Jennifer Sabel, Christopher M. Jones, Jaymie Mai, Chris Baumgartner, Caleb J. Banta-Green, Darin Neven, David J. Tauben. A comprehensive approach to address the prescription opioid epidemic in Washington State: Milestones and lessons learned. American Journal of Public Health, March 2015;105(3):463-469. http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2014.302367

84. Strategies and Tools for More Cautious Use of Chronic Opioid Therapy. Group Health Cooperative National Summit on Opioid Safety. http://cdn.e2ma.net/userdata/1400496/assets/docs/nationalsummit_opioidsafety_program.pdf

85. Leonard Paulozzi, Grant Baldwin, Gary Franklin, R. Gil Kerlikowske, Neelam Ghiya, Tanja Popovic. CDC grand rounds: Prescription drug overdoses—a U.S. epidemic. Morbidity and Mortality Weekly Report, January 13, 2012;61(1):10-13. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm

86. Pat Anson. PROP helped draft CDC opioid guidelines. Pain News Network. September 21, 2015. http://www.painnewsnetwork.org/stories/2015/9/21/prop-helped-draft-cdc-opioid-guidelines

87. Andrew Kolodny, M.D. http://www.huffingtonpost.com/andrew-kolodny-md/ accessed December 16, 2015

88. Andrew Kolodny, David T. Courtwright, Catherine S. Hwang, Peter Kreiner, John L. Eadie, Thomas W. Clark, G. Caleb Alexander. The prescription opioid and heroin crisis: A public health approach to an epidemic of addiction. Annual Review of Public Health 2015;36:559–74. http://collierdc.com/wp-content/uploads/2015/10/Kolodny-2015-Rx-Opiod-Epidemic.pdf

89. Interview with Judy Woodruff. How should U.S. regulate powerful painkillers? PBS NewsHour, January 6, 2015. http://www.pbs.org/newshour/bb/u-s-regulate-powerful-painkillers/ See also: Dr. Andrew Kolodny on Combating Drug Abuse. C-Span, October 25, 2051, at 00:23:04. http://www.c-span.org/video/?328904-4/washington-journal-dr-andrew-kolodny-drug-abuse-us

90. http://feduprally.org/wp-content/uploads/2015/08/Bios_FED-UP-committee-members_2015.pdf accessed December 23, 2015

91. Presumably, then, physicians must also overprescribe cocaine (“Coke,” “Crack”), cathinones (“Bath Salts”), ethanol (alcohol), ketamine (“K,” “Special K,” “Vitamin K,” “Lady K,” “Jet,” “Super Acid,” “Bump,” “Special LA Coke,” “KitKat,” “Cat Valium”), methamphetamines (“Chalk,” “Chrissy,” “Crank,” “Crystal,” “Glass,” “Go,” “Hydro,” “Ice,” “Meth,” “Rock Candy,” “Speed,” “Whiz”), 3,4-methylenedioxymethamphetamine (“Ecstasy,” “MDMA,” “Molly”), phencyclidine (“Amp,” “Angel Dust,” “Animal Tranquilizer,” “Dips,” “Dust,” “Elephant,” “Embalming Fluid,” “Formaldehyde,” “Fry,” “Hog,” “Ozone,” “PCP,” “Peace Pill,” “Rocket Fuel,” “Sernyl,” “Sernylan,” “Super Kools,” “Tictac,” “Tranq,” “Water,” “Wet”), tobacco, toluene (toluol, methylbenzene, methyl benzol, and phenylmethane), alpha-pyrrolidinopentiophenone (“alpha-PVP,” “Flakka”), and (outside of “medical marijuana” states) marijuana (“Cannabis, “Pot,” “Reefer,” “Buds,” “Grass,” “Weed,” “Dope,” “Ganja,” “Herb,” “Boom,” “Gangster,” “Mary Jane,” “MJ,” “Sinsemilla,” “Shit,” “Joint,” “Hash,” “Hash Oil,” “Blow,” “Blunt,” “Green,” “Kilobricks,” “Thai Sticks”).

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.

93. http://feduprally.org/about-the-coalition/ accessed December 23, 2015

94. http://feduprally.org/calltoaction/ accessed December 23, 2015

95. Andrew Kolodny. Food And Drug Administration Center for Drug Evaluation and Research Drug Safety and Risk Management Advisory Committee, FDA White Oak Campus, Silver Spring, Maryland, Friday, January 25, 2013. http://www.supportprop.org/wp-content/uploads/2014/12/FDA-Testimonony-on-hydrocodone-combo-upscheduling-1-1-25-13-2.pdf

96. http://www.rxreform.org/about-us/medical-advisory-board/ accessed December 24, 2015

97. Prescription Opioid Narcotics and Heroin. http://www.rxreform.org/prescription-opioids/similarities-to-heroin/ accessed December 28, 2015

98. Peter W. Jackson, President, Advocates for the Reform of Prescription Opioids. Letter, Division of Dockets Management (HFA-305), Food and Drug Administration, November 27, 2011. http://www.rxreform.org/wp-content/uploads/2011/11/ARPO-Statement-on-FDA-Draft-Blueprint-112911.pdf

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)

100.http://www.phoenixhouse.org/team/andrew-kolodny/ accessed December 30, 2015

101.Kristina Cooke, Robin Respaut. Harsh treatment: How a respected drug-rehab program spun out of control. Reutgers Investigates, September 2, 2015. http://www.reuters.com/investigates/special-report/usa-rehab-phoenixhouse/

102.Other data supports declining use, as well: 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 Monitoring the Future Study: Trends in Prevalence of Various Drugs for 8th Graders, 10th Graders, and 12th Graders; 2012 – 2015 (in percent) http://www.drugabuse.gov/trends-statistics/monitoring-future/monitoring-future-study-trends-in-

103.Andrew Kolodny, David T. Courtwright, Catherine S. Hwang, Peter Kreiner, John L. Eadie, Thomas W. Clark, G. Caleb Alexander. The prescription opioid and heroin crisis: A public health approach to an epidemic of addiction. Annual Review of Public Health, March 2015;36:559-574. http://www.annualreviews.org/doi/full/10.1146/annurev-publhealth-031914-122957

104.Florence Yates Hann. The Story Of Chanticleer Adapted from the French of Edmond Rostand. Frederick A. Stokes Company, 1913, pp. 62-63. http://babel.hathitrust.org/cgi/pt?id=hvd.hnt6k8;view=1up;seq=93 Originally, Edmond Rostand. Chantecler: pièce en quatre actes, en vers, January 1, 1910, Fasquelle https://play.google.com/books/reader?id=tvGRAAAAIAAJ&printsec=frontcover&output=reader&hl=en&pg=GBS.PA65

105.David Juurlink, M.D., Ph.D.

106.http://www.supportprop.org/board-of-directors/ accessed December 15, 2015.

107.David Juurlink. Canada’s opioid crisis is fueled by doctors. Huffpost Canada Politics, September 7, 2014, updated November 7, 2014. http://www.huffingtonpost.ca/david-juurlink/opioid-crisis-doctors_b_5775274.html

108.Dr. Deborah Dowell. CDC Workshop: Drivers of Rx Drug Overdoses. National Rx & Heroin Drug Abuse Summit, http://nationalrxdrugabusesummit.org/biographies/dr-deborah-dowell/

109.Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Division of Unintentional Injury Prevention. When the Prescription Becomes the Problem. http://www.cdc.gov/drugoverdose/media/

110.Deborah Dowell, Hillary V. Kunins, Thomas A. Farley. Opioid analgesics—risky drugs, not risky patients. Journal of the American Medical Association, June 5, 2013;309(21):2219-2220. https://jama.jamanetwork.com/article.aspx?articleid=1686609 For an opposing perspective, see: Ronald T. Libby. Treating doctors as drug dealers: The DEA’s war on prescription painkillers. Policy Analysis, June 16, 2005;(545):1-27. http://object.cato.org/sites/cato.org/files/pubs/pdf/pa545.pdf

111.Li-Tzy Wu, George E Woody, Chongming Yang, Paolo Mannelli, Dan G Blazer. Substance Abuse and Rehabilitation, May 3, 2011;2:77–88. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3114372/#__ffn_sectitle “Heroin users reported a short mean interval from first use to onset of abuse (1.5 years) or dependence (2.0 years)…; the corresponding mean estimates for PO [prescription opioid] abuse and dependence among NMPOUs [nonmedical prescription opioid users] were 2.6 and 2.9 years, respectively….”

112.D. Paonek, D. Dowell, D. Heller. Preventing misuse of prescription opioid drugs. City Health Information, December 2011;30(4):23-30. http://www.nyc.gov/html/doh/downloads/pdf/chi/chi30-4.pdf

113.Thomas R. Frieden. Preventing prescription drug overdose: New challenges, new opportunities. National Rx Drug Abuse Summit, Operation UNITE, Atlanta, GA, April 8, 2015. http://www.slideshare.net/OPUNITE/wed-frieden-webversionrxod-unite-apr-8-videoexternal

114.Tamara M. Haegerich, Leonard J. Paulozzi, Brian J. Manns, Christopher M. Jones. What we know, and don’t know, about the impact of state policy and systems-level interventions on prescription drug overdose. Drug and Alcohol Dependence, December 1, 2014;145:34-47. http://www.drugandalcoholdependence.com/article/S0376-8716%2814%2901846-8/pdf

115.Jeanmarie Perrone, Matthew J. Bair, and David Tauben. Peer Review Plan for CDC Opioid Prescribing Guidelines for Chronic Pain. http://www.cdc.gov/injury/pdfs/fundedprograms/peer-review-plan-for-cdc-opioid-prescribing-guidelines-for-chronic-pain.pdf

116.Department of Emergency Medicine Leadership & Faculty: Jeanmarie Perrone, MD. http://www.med.upenn.edu/apps/faculty/index.php/g321/p1870

117.Jeanmarie Perrone. To curb prescription opioid abuse, physicians need to get with the program. MD, August 17, 2012, http://www.hcplive.com/journals/pain-management/2012/august-2012/To-Curb-Prescription-Opioid-Abuse-Physicians-Need-to-Get-with-the-Program

118.http://www.ncbi.nlm.nih.gov/pubmed?term=Matthew%20Bair

119.Matthew J. Bair. Barriers and Facilitators to Chronic Pain Self-Management: A Qualitative Study of Primary Care Patients with Comorbid Musculoskeletal Pain and Depression, p. 38. http://www.hsrd.research.va.gov/for_researchers/cyber_seminars/archives/sopm-011410.pdf

120.Matthew J. Bair. Barriers and Facilitators to Chronic Pain Self-Management: A Qualitative Study of Primary Care Patients with Comorbid Musculoskeletal Pain and Depression, p. 40. http://www.hsrd.research.va.gov/for_researchers/cyber_seminars/archives/sopm-011410.pdf

121.National Institutes of Health Interagency Pain Research Coordinating Committee. National Pain Strategy: A Comprehensive Population Health-Level Strategy for Pain (Draft) https://web.archive.org/web/20150706070945/http://iprcc.nih.gov/docs/DraftHHSNationalPainStrategy.pdf

122.David J. Tauben M.D. http://www.uwmedicine.org/Pages/bio.aspx?bioid=28139&redirect

123.Agency Medical Directors’ Group. Interagency Guideline on Prescribing Opioids for Pain, 3rd edition, June 2015, http://www.agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pdf

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

126.Richard N. Shiffman. Recognizing Trustworthy Guidelines: The New IOM Standards. p. 12. http://www.cdc.gov/od/science/quality/docs/trustworthy_gls.pdf

127.Richard N. Shiffman. Recognizing Trustworthy Guidelines: The New IOM Standards. p. 22. (emphasis in original) http://www.cdc.gov/od/science/quality/docs/trustworthy_gls.pdf

128.Institute of Medicine of the National Academies. Clinical Practice Guidelines We Can Trust: Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs), p. 1. http://iom.nationalacademies.org/~/media/Files/Report%20Files/2011/Clinical-Practice-Guidelines-We-Can-Trust/Clinical%20Practice%20Guidelines%202011%20Insert.pdf

129.Richard N. Shiffman. Recognizing Trustworthy Guidelines: The New IOM Standards. p. 8. http://www.cdc.gov/od/science/quality/docs/trustworthy_gls.pdf

130.Richard N. Shiffman. Recognizing Trustworthy Guidelines: The New IOM Standards. p. 11. http://www.cdc.gov/od/science/quality/docs/trustworthy_gls.pdf

131.Richard N. Shiffman. Recognizing Trustworthy Guidelines: The New IOM Standards. p. 13. http://www.cdc.gov/od/science/quality/docs/trustworthy_gls.pdf

132.Allan D. Sniderman, Curt D. Furberg. Why Guideline-Making Requires Reform. The Journal of the American Medical Association, January 28, 2009;301(4):429-431. http://jama.jamanetwork.com/article.aspx?articleid=183265

133.Tom Frieden. Johns Hopkins Bloomberg School of Public Health Convocation–May 19, 2015. Transcript. www.jhsph.edu/alumni/_docs/tom-frieden-convocation-speech-2015.doc

134.IBD Editorials. Budget ‘Cuts’ Aren’t Why CDC Fumbled Ebola. http://news.investors.com/ibd-editorials/101314-721520-cdc-failures-on-ebola-are-not-from-phantom-budget-cuts.htm

135.Centers for Disease Control and Prevention Budget Request Summary—Fiscal Year 2014. http://assets.bizjournals.com/atlanta/pdf/cdc%20budget%20req%20sum%202014.pdf

136.Centers for Disease Control and Prevention. CDC Grand Rounds: Prescription Drug Overdoses—a U.S. Epidemic. Journal of the American Medical Association, 2012;307(8):774-776. http://jama.jamanetwork.com/article.aspx?articleid=1356004

137.Matthew Perrone. Painkiller politics: Effort to curb prescribing under fire. AP: The Big Story, December 18, 2015. http://bigstory.ap.org/article/765439c771b649a7b6940fda87595735/effort-curb-painkiller-prescribing-faces-stiff-opposition

138.The Wizard of Oz. The Wizard of Oz, 1939. http://www.wendyswizardofoz.com/printablescript.htm

139.Terrence Shaneyfelt. In guidelines we cannot trust: Comment on “Failure of clinical practice guidelines to meet Institute of Medicine Standards” Archives of Internal Medicine, November 26, 2012;172(21):1633-1634. http://archinte.jamanetwork.com/article.aspx?articleid=1384244

140.Mark Curnutte. Who fueled the opioid explosion? Pharmaceutical and medical organizations may be responsible for the dual public health crisis–painkiller and heroin addiction. Cincinnati.com http://local.cincinnati.com/community/pages/painday3/

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.

143.Counterfeit Drugs. Institute for Effective Diagnosis. http://effectivediagnosis.org/counterfeit-drugs/ accessed December 23, 2015

144.Michael M. Vanyukov, Ralph E. Tarter, Galina P. Kirillova, Levent Kirisci, Maureen D. Reynolds, Mary Jeanne Kreek, Kevin P. Conway, Brion S. Maher, William G. Iacono, Laura Bierut, Michael C. Neale, Duncan B. Clark, Ty A. Ridenour. Common liability to addiction and “gateway hypothesis”: Theoretical, empirical and evolutionary perspective. Drug and Alcohol Dependence, 2012;123(Suppl 1):S3–17. http://www.drugandalcoholdependence.com/article/S0376-8716%2811%2900555-2/fulltext

145.Gillian Mohney. Heroin-related deaths quadruple as drug epidemic continues to impact U.S. ABC News, July 7, 2015. http://abcnews.go.com/Health/heroin-related-deaths-quadruple-drug-epidemic-continues-impact/story?id=32285495 In contrast, according to the CDC’s own National Institute on Drug Abuse, most heroin injectors did not use prescription opioids before heroin: Nearly half of young people who inject heroin surveyed in three recent studies reported abusing prescription opioids before starting to use heroin.” (National Institute on Drug Abuse. Drug Facts: Heroin. http://www.drugabuse.gov/publications/drugfacts/heroin accessed December 29, 2015)

146.United Nations Office on Drugs and Crime. The non-medical use of prescription drugs: Policy direction issues. September 2011, p. 29. http://www.unodc.org/docs/youthnet/Final_Prescription_Drugs_Paper.pdf

147.Steven J Baumrucker. Opioid Safe Prescribing: Intro to the TN Guidelines, p. 12. http://www.ouramazingworld.org/uploads/4/3/8/6/43860587/baumrucker_tennessee_chronic_pain_guidelines_and_the_effects_of_repealing_the_intractable_pain_act.pdf

148.For oxycodone in 2002.

149.Joranson DE, Gilson AM. Drug crime is a source of abused pain medications in the United States. Journal of Pain and Symptom Management, 2005;30(4):299-301. http://www.painpolicy.wisc.edu/sites/www.painpolicy.wisc.edu/files/05jpsm.pdf

150.They did not report the percentage of hydrocodone that was diverted, but noted that more than twice as many units of hydrocodone were diverted than the other six studied opioid analgesics combined.

151.John Glover. The Importance of On-Dose Technologies in the Fight Against Misuse, Abuse and Illegal Diversion of Opioids: A White Paper. http://capsugel.com/media/library/the_importance_of_on_dose_technologies_in_the_fight_against_misuse_abuse_and_illegal_diversion_of_opioids.pdf

152.Steve Wood. Combating pharmaceutical counterfeiting and diversion. Pharmaceutical Online, November 19, 2014. http://www.pharmaceuticalonline.com/doc/combating-pharmaceutical-counterfeiting-and-diversion-0001

153.David De Jean. Serialization To solve pharma counterfeiting, a $70 billion issue. Pharmaceutical Online, November 13, 2014. http://www.pharmaceuticalonline.com/doc/serialization-to-solve-pharma-counterfeiting-a-billion-issue-0001

154.The National Center on Addiction and Substance Abuse at Columbia University. Under the Counter: The Diversion and Abuse of Controlled Prescription Drugs in the U.S., July 2005, pp. iii, 63-71. http://www.casacolumbia.org/download/file/fid/1202

155.Olaf H. Drummer. Postmortem toxicology of drugs of abuse. Forensic Science International, June 10, 2004;142(2–3):101–113. http://www.fsijournal.org/article/S0379-0738%2804%2900103-3/abstract?cc=y=

156.National Highway Traffic Safety Administration. Drugs and Human Performance Fact Sheets: Morphine (and Heroin). http://www.nhtsa.gov/PEOPLE/injury/research/job185drugs/morphine.htm accessed December 25, 2015

157.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

158.Center for Health Statistics. Overdose deaths related to non-pharmaceutical fentanyl on the rise in New Jersey. CHS Briefs, December 2006. http://www.state.nj.us/health/chs/oisp/documents/fentanyl_06.pdf

159.Source intentionally omitted.

160.J.C. Torpey. Fake oxycodone pills contain fentanyl: Did fake Tennessee pills come from Alberta? Inquisitr, May 14, 2015. http://www.inquisitr.com/2090488/fake-oxycodone-pills-contain-fentanyl-did-fake-tennessee-pills-come-from-alberta/

161.Heroin-fentanyl mix plaguing many states: Two McKees Rocks men arrested in bust. Pittsburgh Post-Gazette, January 31, 2014. http://www.post-gazette.com/local/crime/2014/01/31/Two-McKees-Rocks-men-arrested-in-heroin-bust/stories/201401310142

162.T.S. Jones, L. Krzywicki, J Maginnis, N.L Jones, R. Weiskopf, M. Reid, C. Schmidt, J. Fiedler, J.M. Topolski, M. Graham, R. Psara, M. Case, S. McCune, S.M. Marcus, V.W. Weedn, K. Hempstead, S.J. Klein, G. Roseborough, S Alles, K. Nalluswami, S. Kelly, T. Zobeck, T. McCormick, D. Peters, M. Wilson, E. Regula, K. Hoffman, D. Lentine. Nonpharmaceutical fentanyl-related deaths—multiple states, April 2005—March 2007. Morbidity and Mortality Weekly Report, July 25, 2008;57(29):793-796. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5729a1.htm

163.Northern Border. USBorderPatrol.com http://www.usborderpatrol.com/Border_Patrol1920.htm accessed December 23, 2015

164.Julian Sher. OxyContin smuggling from Canada rises sharply. The Globe and Mail, November 14, 2011, last updated September 6, 2012. http://www.theglobeandmail.com/life/health-and-fitness/oxycontin-smuggling-from-canada-rises-sharply/article547508/

165.Robert G. Carlson, Ramzi W. Nahhas, Raminta Daniulaityte, Silvia S. Martins, Linna Li, Russel Falck. Latent class analysis of non-opioid dependent illegal pharmaceutical opioid users in Ohio. Drug and Alcohol Dependence, 2014;134:259–266. http://www.drugandalcoholdependence.com/article/S0376-8716%2813%2900415-8/pdf

166.Theodore J. Cicero, Matthew S. Ellis, Hilary L. Surratt, Steven P. Kurt. Factors influencing the selection of hydrocodone and oxycodone as primary opioids in substance abusers seeking treatment in the United States. Pain, 2013;154:2639–2648. http://cicero.wustl.edu/skip/publications/documents/Factorsinfluencingtheselectionofhydrocodoneandoxycodoneasprimaryopioidsinsubstanceabuserssee.pdf

167.Report of the International Narcotics Control Board for 2004 (E/INCB/2004/1), p. iii. http://www.incb.org/documents/Publications/AnnualReports/AR2004/AR_04_English.pdf

168.Bob Roehr. Controversial Tom Frieden named to lead CDC. Windy City Times, May 18, 2009. http://www.windycitymediagroup.com/gay/lesbian/news/ARTICLE.php?AID=21192

169.Manny Alvarez. Dr. Manny: CDC director Dr. Tom Frieden should resign. Dr Manny’s Notes, October 13, 2014. http://www.foxnews.com/health/2014/10/13/dr-manny-cdc-director-dr-thomas-frieden-should-resign.html

170.Ford Vox. Why CDC chief must go. CNNOpinion, October 16, 2014. http://www.cnn.com/2014/10/16/opinion/vox-frieden-should-resign/

171.Thomas Barrabi. Who Is Tom Frieden? CDC director faces calls for resignation amid Ebola missteps. International Business Times, October 16, 2014. http://www.ibtimes.com/who-tom-frieden-cdc-director-faces-calls-resignation-amid-ebola-missteps-1706175

172.Sean Piccoli. Ex-FEMA Chief Michael Brown: CDC’s Frieden should resign. Newsmax, October 17, 2014. http://www.newsmax.com/Newsmax-Tv/cdc-tom-frieden-michael-brown-fema/2014/10/17/id/601484/

173.Gary M. Franklin. Opioids for chronic noncancer pain: A position paper of the American Academy of Neurology. Neurology, September 30, 2014;83(14):1277-1284. http://www.neurology.org/content/83/14/1277.longThe ideal approach would be to prespecify an MCID [minimum clinically important difference] in both pain and functional outcome on the order of a 20%–30% improvement, and perhaps to use a composite measure including both measures.” I have consistently used this approach (but requiring evidence for at least a 30% improvement) in my own clinical practice.

Critique of the CDC’s Draft Guidelines on the Use of Opioid Analgesics for Chronic Pain Part Five

 

(Note: The endnotes which provide the references for this critique have been collected into the final part of this document.)

The curve of increasing overdose deaths was unchanged following “5th vital sign.”

Rather than blaming prescribers, as the CDC and most of the contributors to its draft guidelines do, the International Narcotics Control Board declares that “diversions of narcotic drugs and psychotropic substances mostly occur when consignments pass from the wholesale level to the retail level.”[142] Criticizing preoccupations with physician prescriptions, others point to robberies, break ins, and pilferage of as much of 22.4%[148] of total U.S. pharmaceutical production,[149] based upon data from the Drug Enforcement Administration (DEA).[150] The unchecked flow of pain medications diverted from nonmedical sources will not be addressed if diversion control focuses only on prescribers and patients.”[149] Moreover, such figures are likely to seriously underestimate the diversion problem, because criminals have penetrated the legitimate supply chain to divert legitimate product to illegitimate uses and have introduced illegitimate product into the legitimate supply chain”[151] with near impunity, avoiding detection by simply replacing the diverted pharmaceuticals with counterfeits.[152, 153] The controlled substances of all sorts that are readily available on the Internet require a credit card, not a prescription,[154] but these “credit card painkillers” inflate statistics on “prescription painkillers.”

More often than not, laboratory tests reveal the presence of one or more substances in addition to the opioid, suggesting that the depressant effects of alcohol or other drugs on the central nervous system were additive with those of the pain reliever in causing death.”[38]

Furthermore, the assumption that the finding of a “prescription painkiller” is due to a pharmaceutical product is often false.

Under the best of circumstances, drug testing after death is fraught with pitfalls.[155] “Identifying risk factors among opioid overdose decedents has been difficult due, in part, to the widely varying methods employed by state death investigators to collect mortality data and to report on drug involvement in overdose.”[46] Even in life, drug testing is complicated, for example, by the fact that heroin (and codeine) are rapidly converted to morphine in the body.[156] This is important, if for no other reason than that morphine, but not heroin, might be a “prescription painkiller.” Even though heroin is more commonly abused than morphine, the default assumption is to blame a prescription opioid: The finding of a morphine blood concentration in a decedent is classified as a morphine-caused death if the differentiation between heroin- and morphine-caused death is not definitive.”[157] Even when the drug is correctly identified, the practice of automatically attributing death to a drug found in the blood[157] is invalid, because no concentration of a drug of abuse can be interpreted in isolation without a thorough examination of the relevant circumstances and after the conduct of a post-mortem to eliminate or corroborate relevant factors that could impact on the drug concentration and the possible effect of a substance on the body.[155]

…the exact number of deaths remains unknown for several reasons: 1) lack of standardized national definitions among death investigators to interpret postmortem toxicology findings, 2) state-level variations in determining the manner of death (e.g., suicide vs accident vs undetermined), and 3) poorly defined toxicology categories used to classify deaths in the ICD-10.”[46]

Failure to distinguish between counterfeit and pharmaceutical versions of a drug also inflates the apparent rates of “prescription” drug abuse and overdoses. For example, fentanyl is a “prescription painkiller,” but not necessarily a pharmaceutical.[158] It is easily manufactured. One kitchen chemist provides detailed instructions for what he claims to be a greater than 80% overall yield of more than 99.5% pure fentanyl, which he cuts 1:100 with milk sugar and sells as “white heroin.”[159] Counterfeit “Percocet” (oxycodone), that is actually nonpharmaceutical fentanyl, is widely available,[160] and heroin laced with fentanyl is commonplace.[161, 162] Since illicit fentanyl tests the same as legitimate fentanyl, and since heroin rapidly converts into morphine,[99] without additional information, heroin and illicit fentanyl inflate statistics on “prescription painkillers.

Even if the product is a pharmaceutical, until the recent rescheduling of hydrocodone combination products, people could “get a doctor’s DEA number, call up a pharmacy, pretend to be the doctor, and get themselves a hydrocodone prescription with five refills on it.”[95] Likewise, a pharmaceutical opioid may never have been intended to fill a prescription in the United States. Considering the status of our border,[163] smuggling of pharmaceutical controlled substances from Canada, for example, is big, highly profitable,[154] and easy. These factors also inflate statistics on “prescription painkillers.”

Adding to the complication, one study found that one-in-six nondependent “nonmedical” users of pharmaceutical opioids reported exclusively using them to self-medicate pain.[165] Another study of 2262 opioid dependent substance abusers whose primary drug was a prescription opioid analgesic found, “Although getting high was the desire of nearly all users of both oxycodone and hydrocodone, 50–60% also indicated that the management of pain was an important factor.”[166]

The CDC‘s obsession with prescriptions also puts it at odds with the International Narcotics Control Board, which declares that “focus on supply…does not and cannot have a long-term effect.”[167]

Even before he began his tenure as Director of the CDC, Tom Frieden was criticized by those who knew him as “a vindictive man” with a “an authoritarian my-way-or-the-highway approach and an unabashed secretiveness undignified of a public servant.”[168] The secretiveness[17, 18] and the forced outcomes in the opioid analgesic guidelines developed under him are extensions of this pattern.

Unfortunately, Frieden’s incompetent Ebola leadership[169, 170, 171, 172] is not the only reason for him to go. His blatant biases, his presumptuous disregard for the opinions of those who are internationally-recognized experts in addiction and abuse, his indifference toward facts, and his heavy-handed violations of the public trust have made it impossible to have confidence in guidelines produced by the CDC, so long as it remains under his politicized control.

There is a better approach, such as the open and comprehensive National Pain Strategy.[121] Instead of applying generic restrictions prescriptions of opioid analgesics for chronic pain, we ought to be prescribing them to those patients who clearly demonstrate significant functional improvements because of them,[173] while we maximize alternative therapies. Whether the number of such patients will be many or few, patients and their physicians deserve guidelines that they can trust.

Until January 13, 2016, you may comment upon these guidelines by Internet (http://www.regulations.gov) or by mail (National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE., Mailstop F-63, Atlanta, GA 30341, Attn: Docket CDC-2015-0112).

(See Endnotes)

Critique of the CDC’s Draft Guidelines on the Use of Opioid Analgesics for Chronic Pain Part Four

(Note: The endnotes which provide the references for this critique have been collected into the final part of this document.)

The CDC, itself, has published standards requiring a balanced “guideline development group”[126] and a broad base of reviewers[15] comprising “a full spectrum of relevant stakeholders.”[127; emphasis in original] However, out of twenty-five contributors and reviewers: Seven have highly questionable credentials. Another ten are overtly hostile toward opioid analgesics, while there is indirect evidence for such hostility in three more (thirteen total). Only five have both credentials and points-of-view that are distinct from the public positions of the CDC’s director, Tom Frieden, but one of those five has a financial tie to the CDC, creating a conflict of interests. Two are from the CDC’s Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, which is promoting a social media campaign against prescription opioids, one of the two is “Team Lead” for its “Prescription Drug Overdose Team,” and neither is an independent voice from Tom Frieden. Two are medical advisors to ARPO. One is chief medical officer of Phoenix House. Five are officials of PROP, an agency of Phoenix House, and at least two others are members of it. One is a “committee member” of FED Up!, a political action organization that is sponsored by PROP, Phoenix House, and ARPO. Eight are signatories to the logically, scientifically, and ethically questionable PROP letter demanding that the FDA limit opioid analgesics for “non-cancer pain” to low doses for “severe pain” for a maximum of ninety days. At least nine are responsible for the PROP guidelines or a modification of it, or else have a public position in favor of it. At least eight were authors of other guidelines. Two of three authors and two of three outside reviewers already had public positions that opioid analgesics are harmful or without benefits. At least five contributors have significant financial conflicts of interests, and the activities or declared positions of nineteen create significant intellectual conflicts of interest.

Furthermore, if authoring guidelines counts as participation in an “advisory board” (as I believe it does), at least fifteen of the twenty-five appointments violate the IOM’s Standard 2.3: “Members of the GDG [Guideline Development Group] should divest themselves of financial investments they or their family members have in, and not participate in marketing activities or advisory boards of, entities whose interests could be affected by CPG [Clinical Practice Guideline] recommendations.”[128] Certainly, the interests of PROP, Phoenix House, ARPO, and FED Up!, the American Association of Family Practitioners, and even funding for the CDC’s Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, “could be affected by” the CDC’s clinical practice guidelines.

Worse, by the definition published by the CDC, itself, the activities of least fifteen (and arguably eighteen) of the twenty-four represent “Intellectual COI [conflicts of interests]: academic activities that create the potential for an attachment to a specific point of view that could unduly affect an individual’s judgment about a specific recommendation….”[129]

By the standards published by the CDC, “Members with COIs [conflicts of interests] should be a minority,[130] but they are the majority of this group. Those same standards note that mere disclosure of conflicts of interest, whether they be financial or intellectual, can actually promote biased advice, because of the phenomena of “Strategic exaggeration” (the “Tendency to provide more biased advice to counteract anticipated discounting”) and “Moral licensing” (“The often unconscious feeling that biased advice is justifiable because the advisee has been warned.”).[131]

Surely the CDC is aware that “what is to be decided is often already decided with the selection of the deciders.”[132] The agency that is vested in its #RxProblem campaign against opioid analgesics[109] clearly chose people with prejudged opinions against opioid analgesics for the same reason that it chose to conduct a one-sided (harms) review of the literature on opioid analgesicsto force the outcome, and provide them a chance to get through it what the FDA refused to give them.[35]

Under Frieden, the CDC ignored the IOM’s requirement[7] that guidelines be based upon a systematic review of the world literature, as well as the standards it has published, requiring “thorough and unbiased review of existing knowledge.”[15] Instead, the CDC only conducted systematic reviews for harms. For benefits, the CDC substituted “rapid reviews,limited to U.S. studies, and incongruously focused on “overdose, cardiovascular events, motor vehicle crashes, and fractures,” and then excluded the information from its strength of evidence analysis.[13] In other words, the CDC’s literature review was designed to find no benefits, but to thoroughly document harms. While the CDC posts that guidelines that are not based upon a thorough and systemic review of the scientific evidence are neither trustworthy nor should be included in the National Guidelines Clearinghouse,[8] it claims that its own guideline irregularities were justified by the need to “streamline.”[13] Streamline for what? Why did this streamlining specifically leave them “informed neitherby a systematic review of evidence” nor by “an assessment of the benefits and harms of alternative care options, so that they do not even so much as qualify as “clinical practice guidelines,” under the IOM’s definition.[2; emphasis in original]

The man who preaches “the importance of practicing interventional epidemiology” through political activism, who advocates science with a political agenda,[133] who poses with a congressman to campaign against opioid analgesics,[109] whose appointment and tenure solely depend upon the President of the United States, whose budget is political,[134, 135] and under whom the CDC targets physician prescribing, conducts its #RxProblemcampaign,[109] openly advocates enforcement as the solution to opioids,[136] and speaks approvingly of Washington State moving “aggressively” to curb opioid prescribing,[85] expects us to believe that the guidelines developed under him were apolitical.[137] If the guidelines were not political, then why, of the twenty five selected to have roles in these guidelines, were at least nineteen politically tainted? Sixteen contributors are known to engage in, or to advocate, political processes to impose upon others their own views about prescribing opioid analgesics, one of whom implies that opioid analgesic prescriptions should be prohibited, and two more at least have close ties with those in the political camp. Of the sixteen that are unambiguously politically active, six are members of the board of directors of an organization which its own president describes as a lobbying group,[20] of which three have leadership roles in two other political action organizations. No politics, indeed. Pay no attention to that man behind the curtain.”[138]

The question, in the letter from the House of Representatives Committee on Oversight and Government Reform, regarding the “efforts by the CDC to ensure that the composition of the ‘Core Expert Group’ was balanced in terms of points of view,”[18] can be answered by noting that at least ten of the contributors are active in campaigns against the use of opioid analgesics for chronic pain, that two are under CDC Director Tom Frieden, in the CDC‘s own Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, and that at least eleven (and arguably thirteen) are members of the same incestuously interlocking network. If Guideline panel membership is the main determinant of the trustworthiness of guidelines,”[139] these guidelines cannot be trusted.

This composition, like the one-sided literature review, perfectly reflects CDC Director, Tom Frieden‘s own agenda. Frieden says opioid analgesics should be “reserved for situations like severe cancer pain.”[140] Does Frieden think that pain in patients with cancer is a different kind than it is in those without cancer? Or does he, like PROP (but quite unlike the FDA)[35]—stand logic and ethics on their heads, by saying that pain which will be suffered for the rest of people’s lives should be treated for those people and pains that are expected be short-lived, but not for those people and those pains that are expected to last for years? Apparently so, because Frieden misleadingly refers to opioid analgesics by their legal classification[141] as “dangerous drugs,”[113] sensationally–but falsely[111]claiming that “just a few doses may lead to a lifelong struggle with addiction” and the “risk of injection drug use including heroin.”[113] In the later, Frieden disregards: (1) the FDA’s counter to PROP,[35] (2) the International Narcotics Control Board‘s opinion that pharmaceuticals are substitutes for illicit drugs with similar effects,[142] and (3) the Institute for Effective Diagnosis‘ observation that “prescription drugs are now being substituted for illegal drugs,because of a preference for the standardization, purity, and sanitation represented by drugs manufactured under the supervision of the Food and Drug Administration (FDA).[143] Tom Frieden treats the logically incoherent and scientifically untenable “gateway hypothesis”[144] as fact, connects the startling rise” in heroin use with prescriptions for opioid analgesics[145] by decree, and announces that people are primed for heroin use because they were addicted to an opioid painkiller.”[145] Frieden’s propaganda against prescriptions also puts him at odds with the United Nations Office on Drugs and Crime, which flatly states, Health-care professionals should not be blamed for the problem as a whole.”[146]

CDC Director Dr. Thomas Frieden and Congressman Hal Rogers

(Continued)