Category Archives: Pain

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.

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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

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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

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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)

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.

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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

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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

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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 Two

 

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

We now know the names of the seventeen members of the Core Expert Group.[18, 19] Among these core experts is the president of Physicians for Responsible Opioid Prescribing (PROP), which her own biographical sketch calls “an advocacy group that lobbies government agencies concerning regulation for medical use of opioids.”[20] PROP is a political advocacy[21] program of Phoenix House[22] Foundation, Inc., which, in turn, runs more than one-hundred thirty “drug and alcohol addiction treatment” programs.[23] She is an author of at least two other guidelines on the use of opioid analgesics for chronic pain,[24, 25] including guidelines which were not only partially sponsored by PROP, but largely authored by persons associated with it.[25] In the past, she recognized that opioid therapy “can relieve pain and improve mood and level of functioning in many” of those “patients with chronic pain not associated with terminal disease,”[26] but her current position has been characterized as a “former believer turned crusading reformer.[27] She, along with another core expert from PROP and with one of the stakeholder reviewers from PROP, equates physical dependence (unpleasant physical symptoms upon abrupt discontinuation) with addiction (compulsive use in spite of evidence of harm).[28] She shares the CDC’s[13] and other of its “core experts’” peculiar concern with fractures due to opioid analgesics.[29, 30] She has received personal income from a pharmaceutical company as an “Expert Panel/Advisory” for an opioid analgesic,[24] and her pain unit was the recipient of a $1.5 million dollar educational and research grant for another pharmaceutical company’s opioid analgesic. She is a paid consultant to Cohen Milstein Sellers & Toll,[19] which brings lawsuits against pharmaceutical companies for their opioid marketing,[31, 32] has been criticized for accepting cases from states’ attorney generals to whose campaigns it had contributed,[32] as well as for other ethically suspect practices,[32, 33] and which stands to gain, in the form of more cases from states’ attorney generals and enhanced lawsuits against pharmaceutical companies, from guidelines for opioid analgesics. She advocates education by regulation and more opioid controls.[34] She is one among seven contributors to the CDC’s guidelines who is also a signatory to a letter, on PROP stationary, demanding that the FDA discriminate against “non-cancer pain” according to the degree of pain and the dose and duration of therapy. In particular, that letter demands that opioid-therapy of “non-cancer pain” be limited to low doses for severe pain” for a maximum of ninety days, because there are no long-term efficacy and safety studies.[35] Of course, not only have such studies never been done, but they can never be done, as she, herself, has recognized.[36] (Apart from the insurmountable ethical and logistical barriers to conducting long-term studies comparing opioid analgesics to “dummy” treatments in patients with “severe” pain, who would ever pay the multiple billions of dollars to conduct such studies? Certainly not the anti-opioid activists who insist that they are necessary.)

Another of the core experts[37] who contributed to the CDC guidelines gave the Food and Drug Administration (FDA) this advice for opioid analgesics: “We need to think about how we would construct a REMS [risk evaluation and mitigation strategy] if we were going to be marketing heroin.”[38] Lest his implication be missed, he is also coauthor, with one of the CDC guidelines outside reviewers,[39] of a paper equating prescribers with illegal drug cartels and street dealers,”[40] thus implying that the prescribing of opioid analgesics should be prohibited. He is also a signatory of the logically, scientifically, and ethically questionable PROP letter to the FDA demanding that opioid analgesics for “non-cancer pain” be limited to low doses forsevere pain” for a maximum of ninety days.[35]

Another core expert[40] shares the CDC’s,[13] and some of its other core experts, peculiar preoccupation with fractures associated with opioid analgesics.[34, 41] As a member of the Washington State Interagency Guideline on Opioid Dosing Panel[41] and a signatory to PROP’s logically, scientifically, and ethically questionable letter to the FDA demanding that opioid analgesics for “non-cancer pain” be limited to low doses for severe pain” for a maximum of ninety days,[35] he clearly has predefined views on the use opioid analgesics for chronic pain. He is among the seven contributors to the CDC guideline who is also an author of a guideline partially sponsored, and largely authored, by PROP[25]. He along with at least one other core expert from PROP and one stakeholder reviewers from PROP, equates physical dependence (unpleasant physical symptoms upon abrupt discontinuation) with addiction (compulsive use in spite of evidence of harm).[28]

While not as overtly hostile to opioid analgesics as most of the other authors of those PROP guidelines[25], another core expert[42] seems biased against them. Interestingly, she multiplied 0.00148 overdoses per person per year of opioid treatment by one hundred-thousand, in order to graph as much larger numbers and to present them as overdoses per one hundred-thousand person-years[43]—a minuscule unit that sounds huge.

Yet another core expert[44] is an author, along with two other core experts, of a paper crediting the guidelines partially sponsored by PROP, and largely authored by persons associated with it,[25] as having reduced mortality from opioid overdoses 50%[45] (Maybe so, but similar reductions have been seen elsewhere, prior to the existence of those guidelines.[46, 47]). She is among the seven contributors to the CDC’s guidelines who is also a signatory to the logically, scientifically, and ethically questionable PROP letter which demanded that the FDA limit opioid analgesics for “non-cancer pain” to low doses for severe pain” for a maximum of ninety days.[35]

One core expert[48] was an unspecified “leader”[49] in developing Ohio’s Emergency and Acute Care Facility Opioids and Other Controlled Substances Prescribing Guidelines (Emergency Guidelines).[50] However, the development that she led was merely a modification, based uponfeedback from Ohio emergency departments,[51] of the same guidelines[25] that have previously been noted as partially sponsored by PROP and largely authored by persons associated with it.

Another core expert‘s[52] bias may be seen from the fact that she is the first author of a paper (whose senior author is a PROP member and signatory to the PROP letter to the FDA[53]) illogically condemning physicians for not performing “risk reduction strategies”[54] for which she had already published that there is “lack of evidence”[55] to justify their use.

The only connection that I can find between one core expert[56] and opioid analgesics is his conclusion that opioid prescriptions for those 65 and older have increased[57]which reveals nothing about how—or whether—they ought to be prescribed. Tellingly, however, he has a history of manifest hostility toward the pharmaceutical industry, as an expert witness,[58] as co-creator of a database to be used against pharmaceutical companies,[59] and as author of many of articles attacking the pharmaceutical industry.[58]

Yet another’s[60] relevant experience seems to be limited to having chaired a position statement on prescription drug abuse. It said little more than that the American College of Physicians was against such abuse, perhaps because, ironically, it was authored by a lawyer and two other non-physicians.[61]

Another core expert’s[62] interest in opioids seems to be limited to naloxone treatment of overdoses[63] and to social, sexual, and racial “disparities” in overdose deaths[64]—as if we should be ensuring social, sexual, and racial equality in overdose deaths, too.

So far as I can tell, another core expert‘s[65] expertise is solely based upon being unspecified “staff” for the Oklahoma Injury Prevention Advisory Committee, from the Oklahoma State Department of Health, Prevention & Preparedness Administration.[66] One would expect the CDC to supply its own “staff” and not to rely upon them for its “Core Expert Group.”

Another[67] was an author of Arizona’s guidelines, which were developed by the department for which she is Deputy Medical Director.[68] These appear to be independent of the PROP guidelines[25].

One core expert[69] was a member of the steering committee[70] that developed the Tennessee Clinical Practice Guidelines For Management of Chronic Pain.[71] It is clearly independent of the PROP guidelines[25] and is noteworthy for requiring documentation in the medical record that the patient was “counseled that the goal of chronic opioid therapy is to increase function and reduce pain, not to eliminate pain.”[71]

Another core expert[72] who offers an alternative to CDC Director Tom Frieden’s views chaired the American Association of Family Practitioners’ (AAFP) guidelines, which stress that the AAFP opposes any actions that limit patient access to physician-prescribed drugs.”[73] Rather than targeting prescribers, as do Frieden and almost all of the other contributors, he promotes Project Lazarus, which he says successfully reduced “overdose deaths down to basically zero,”[74] while broadening “awareness of the extent and seriousness” of chronic pain.[75]

Another[76] core expert whose views may be an alternative to Frieden’s is an author for a paper which finds that the increase in deaths from prescription opioids was primarily due to just one drug, methadone.[46] It also showed not only that “Opioid drugs…can be used safely with only 0.64% of opioid prescriptions associated with a fatality,” but that the rate declined “dramatically” from 2002 through 2010.[46] This occurred prior to the guidelines to which three other core experts credit[45] reductions in overdose deaths. However, she has been partially funded by the CDC,[47] and so has a financial conflict of interests in helping to develop CDC guidelines.

In spite of the widespread preoccupation with overdoses from “prescription painkillers,” another of the core experts[77] has shown that overdose deaths from prescribed opioids are actually rare[78] and that nonmedical opioid overdoses are strongly correlated with pain and apparent self-medication.[79]

(Continued)

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

 

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

The recently released Centers for Disease Control and Prevention (CDC) draft guidelines for the use of opioid analgesics[1] make a mockery of the National Academy’s Institute of Medicine’s (IOM) standards for clinical guidelines.[2] In addition, not only do they violate the standards posted by the CDC, according to which the guidelines these guidelines should be excluded from the National Guidelines Clearinghouse,[3] but they do not even so much as meet the IOM’s definition for “clinical practice guidelines.”[2]

Such strong charges must be backed by arguments from strong evidence, which unfortunately means that these comments will not be brief.

Under a mandate from the Medicare Improvements for Patients and Providers Act of 2008[4], the IOM, in conjunction with the Agency for Healthcare Research and Quality,[5] developed Standards for Systematic Reviews[6] and Standards for Developing Trustworthy Clinical Practice Guidelines (CPGs).[2]

As defined by the IOM, “Clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”[2; emphasis in original]

According to the IOM’s Standard “4.1 CPG [clinical practice guidelines] developers should use systematic reviews that meet standards set by the IOM’s Committee on Standards for Systematic Reviews of Comparative Effectiveness Research.”[7]

The CDC’s own posting says that, “To be trustworthy, guidelines should…Be based on a systematic review of the existing evidence,” and declares that, “Guidelines that have not included a thorough SR [Systemic Review] of the relevant scientific evidence base should be excluded from the NGC [National Guidelines Clearinghouse].”[8] However, the CDC’s description of the review process that it used for its guidelines either fails to document compliance with, or actually documents violation of, most of the IOM’s standards[9] for systematic reviews. For example, “CDC excluded all studies outside the United States.”[10] Why? Even the Food and Drug Administration is legally required to “accept data from clinical investigations conducted outside of the United States.”[11] When data is limited,[12] arbitrarily restricting it further is inexcusable. By its own description, the only portion of CDC’s review that was systematic dealt exclusively with harms, and, astoundingly, its “benefits” analysis focused on “overdose, cardiovascular events, motor vehicle crashes, and fractures.”[13] “Search terms also focused on opioids and chronic pain and their relation to overdose, cardiovascular events, motor vehicle crashes, and fractures (for benefits and harms)….”[13] The CDC justified these separate, nonsystemic, “rapid reviews” of “overdose, cardiovascular events, motor vehicle crashes, and fractures,” for the “Benefits and harms of opioid therapy,” by the need to “streamline” development of prescribing guidelines,[13] but then excluded even them from its strength-of-evidence analysis: “Given the nature of the studies, the purpose that contextual evidence serves, and the short timeline for developing the guidelines, CDC did not conduct rigorous evidence grading of the findings from the rapid reviews”[14] These behaviors, which violate the standard published by the CDC, requiring a “thorough and unbiased review of existing knowledge,”[15] represent a clear pattern, as may be seen from the fact that a study of practice guidelines singled out the CDC “in particular” for compliance that was “substantially worse than that of other organizations” for IOM standards for “Data Collection Method Given” and “Quality of Evidence Rated.”[16]

Although, according to its own posting, standards “Require transparency,”[15] the CDC was secretive[17, 18] about the members responsible for both the review and the guidelines, as well as how they were selected.[18]

(continued)