Today we bring you a PainDr.com version of the Twelve days of Christmas – but this time, it’s satirically based on the 12-CDC Guidelines and 12-catastrophic sequalae. In order to bolster your Christmas Spirit, I ask that you hum a few bars to the tune of the Twelve Days of Christmas using the following lyrics.
On the twelfth day of Christmas,
anew from Seedy Sea,
and an error query.
Now that I have your attention, if you want to review the history of the CDC Ghost of Christmas past and how this nightmare began, you can review the Christmas Blog from 2015 entitled CDC: All we want for Christmas is our two front Tweets which was followed by Seedy Sea or CDC in early January 2016 as the debacle continued to unravel.
Here to give you some background of the alternative facts and call your attention to newfound disasters that are resultant from these Seedy guidelines are colleagues Drs. Mena Raouf and Terri Lewis.
On March 10, 2016, the CDC released its Guidelines for Prescribing Opioids for Chronic Pain. The guideline provided 12 recommendations for “primary care clinicians prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care”. The guidelines have been met with dissension from many pain clinicians and professional pain organizations alike grounded on the content, scientific merit, and development process.
And the icing on the cake was the CDC opioid calculator. We encourage you all to read Safety concerns with the Centers for Disease Control Opioid Calculator that addresses major calculation flaws, which could cause harm or death. These flaws pose major safety concerns and may lead to under or overestimating dosing if used to transition between opioids, particularly methadone and tapentadol.
Here to refresh your memory on the history behind the guidelines is Dr. Mena Raouf…
History of CDC Guidelines:
On January 15, 2015, the CDC issued a call for applications to assist with developing “evidence-based” guideline for opioid prescribing in management of chronic pain. No public information was disclosed by the CDC until June 16, 2015 when a “stakeholder” group was invited by the CDC to review the draft guidelines. The CDC then hosted webinar for “limited” number of participants on September 15, 2015 to provide comments on the draft guidelines. The comments were required to be submitted orally over the telephone, through the webinar portal during the session, or emailed within 25 hours. Due to technical problems, the deadline for comments was extended to 49 hours and the webinar was rerun on September 17, 2015. The draft guideline was released to the stakeholder group for review on September 15, 2015, with a response deadline of October 1, 2015 and comments were solicited in a spreadsheet. A congressional letter was sent to the CDC demanding full disclosure of the Core Expert Group by January 5th, 2016. The panel included 17 members, only one of which has bona fide pain management expert, Dr. Jane Ballantyne who also was criticized due to significant unchecked conflicts of interest. Specifically, she “served as a paid consultant to the law firm Cohen Milstein, which was profiled by the New York Times late last year for its coaxing of state attorneys general to sign contingency agreements allowing the firm to file suit against potential targets it has identified by scouring the news media and public records.”
Reception of The CDC Guidelines
The process of developing the guideline and its scientific merit caused dissension among pain key opinion leaders. Dr. Robert Twillman, Executive Director of the American Academy of Integrative Pain Medicine (AAIPM), responded with a letter discussing concerns regarding the guideline development process to Honorable Fred Upton, Chairman of the House Energy and Commerce Committee, United States House of Representatives.
The guidelines violated standards of research. All 12 recommendations were assigned grade A strength (strong recommendation) based on level 3 (case series) or 4 (expert opinion) evidence. According to the National Guideline Clearinghouse, level A rating requires at least two consistent randomized controlled trials. Furthermore, the guidelines excluded studies with observation periods of less than 1 year and then used absence of evidence as evidence of absence stating “No evidence shows a long-term benefit of opioids in pain and function versus no opioids for chronic pain with outcomes examined at least 1 year later”. A systematic review of analgesic trial duration for opioids, antidepressants, anticonvulsants, nonsteroidal anti-inflammatory drugs, and behavioral therapy found that nearly all trials had active treatment period of 12 weeks or less. Tayeb et al wrote, “if a one year minimum threshold for duration of active treatment were required to justify using any of the major typical therapies for chronic pain, then none of these nonopioid therapies could be recommended.”
The great Mark Twain once said “there are 3 types of lies, damned lies, and statistics”. This is beautifully discussed in a must read editorial by Drs. Schatman and Ziegler, titled Pain management, prescription opioid mortality, and the CDC: is the devil in the data?
Fast forward to the end of 2018, what happened since the guidelines were launched. Here is Dr. Terri Lewis to share some data ornaments representing each of the TWELVE days of Christmas.
- A single (1) non-competed grant was awarded to Brandeis University’s Heller School to consolidate and report pharmacy patient prescription sales data from the states and territories. This prescribing data is reported back to states, prescribers, and agencies of the federal government for their evaluation and use. In keeping with overall trends involving digital surveillance, consumers are largely unaware of the uses of this information. This information is used to frame the current response to the ‘epidemic’ of addiction and the war on opiates.
- Two (2) branches of the legislature continue to manage drug policy laws and regulation with representatives from the Senate and the House of Representatives. This national drug policy task force, formed in 1996, has morphed into numerous adhoc committees and caucuses representing a variety of problem oriented activities. But all this sound and fury has accomplished little to improve access to care.
- Three (3) medications have emerged as the primary weapons used to address opiate abuse and overdose – Buprenorphine, Methadone, and Naloxone. But access to these medications is impaired by restrictive and ill-conceived state pain laws, lack of mental health parity, funding shortages, lack of insurance payor sources, and short-sighted conceptualization of their potential for use. Despite increasing evidence of effectiveness for some individuals, the use of medication assisted therapy (MAT) is still viewed as replacing one set of addictions for another. Users are routinely stigmatized and successful re-entry into community life is overwhelmingly impaired by implementation of a short term therapeutic course. As a result, many of the drug overdoses we see are the result of premature discontinuation of a therapeutic intervention or underutilization. And, we still have the problem of access to care for those who receive more benefit than harms for the use of opiates to palliate intractable pain.
- Four (4) meetings have been held by Governor Chris Christi’s White House Commission that have to date, generated a menu of recommendations for fighting the epidemic of addiction without addressing the impact on persons who need continuing care for progressive diseases and chronic and intractable pain. Missing from these recommendations are 4 issues of importance to people who are suffering from pain: People with pain remain invisible in the conversation even though they are the target of deprescribing language. There is no mention of non-pharmacologic treatments. There is no mention of the importance of a coordinated National Pain Strategy (NPS). And, there is no recommendation to surveil the disease burden associated with chronic pain.
- Five (5) is the current version of the Diagnostic and Statistical Manual (APA, 2013) which adopted revised definitions of opioid use disorder, while at same time, specifically excluding the diagnosis of opioid use disorder (OUD) from being applied to persons who are stable in a routine of opiate prescribing while under the care of a physician for chronic pain (ICD-10 R52). This fact is frequently omitted from the public discussion, and failure to account for this has installed a systematic error into the public policy conversation.
- Six (6) prescribing trends have emerged: Treat all pain like acute pain; fail to plan for post-surgical and post hospitalization pain care; ration access to prescription filling at the community level by days, number, MME, and type; reduce the number of available doorways for prescription filling; empower pharmacists to decide who will be served; and remove patient choice from preferred vendor relationships.
- Evaluation of risk of harms has become synonymous with intensive dose management of MME and involuntary taper no matter the disease progression, patient history, or results. The optimization of benefits has become conflated with seven (7) emerging practices: Accept your pain; adopt nonpharmacologic practices like yoga and meditation; insert nonmedical switching to other classes of potentially more harmful medications; increased utilization of interventional medical procedures even where they are not appropriate; choose one course of care – pain management or disease management but not both; engage in insurance roulette; and if all else fails, abandon the patient for failure to ‘cure.’
- Eight (8) federal agencies are involved in regulating and responding to federal drug policy – the White House (Office of National Drug Control Policy, State, USAID); Health and Human Services (4 subagencies – SAMHSA, CDC, HC FA, HIS); Education, Justice (7 Subagencies – DEA, FBI, Justice programs, Attorneys, Marshalls, Prisons, Immigration & Naturalization Service); Labor, Veterans, Treasury (ATF, Secret Service, Customs, and Financial Protection Bureau); Defense. Despite the flurry of activity directed at diversion, and targeting of physicians, the number of overdoses, drug poisonings, and suicides is steadily trending upward even as prescriptions are steadily decreasing.
- Consumer input has been removed from the design of algorithms incorporated into the data generated and reported by state PDMPs and policy construction. Patients report nine (9) problems associated with the implementation of these systems: Errors in data capture are frequent; patients have no access to their personal data and may remain unaware of errors in data collection; problems remain when traveling across state lines; use of the PDMP across health care systems may result in differing applications of rule-making across jurisdictions; pharmacy staff across locations may enter data inconsistently for the same medications; days to refill pose problems of access for the most impaired; some pharmacies now refuse to carry some medications, forcing patients to travel long distances for refills and raising arbitrary red flags; some patients may be forced to accept incomplete Rx fills which shortchanges therapeutic benefits; and some patients may be unnecessarily reflected as doctor shoppers or frequent fliers due to the nature of the unresolved problems within the prescribing context.
- Ten (10) is the factor we can apply to the increase of spending Since Richard Nixon declared a war on drugs in June 1971. In 1980, the United States had 50,000 people behind bars for drug law violations – in 2017 we have half a million, making the U.S. home to the world’s largest prison population, most of whom have been incarcerated for violations of drug policy.
- Urine drug monitoring has become the “11” snake eyes symbol, as these eyes have been likened to the snake’s association with treachery and betrayal. These urine drug screens are now synonymous with potential for Medicare and insurance fraud as physicians are now moving into monthly laboratory testing despite lack of evidence that it improves patient outcomes. More and more patients report treatment access problems associated with false positives, frequency and cost of testing, and the use of testing to terminate the treating relationship. But just this month, Pain Medicine published Rational Urine Drug Monitoring in Patients Receiving Opioids for Chronic Pain: Consensus Recommendations.
- Twelve (12) recommendations were contained in CDC’s Guidelines (March 2016). Intended for primary care physicians who are initiating care for opiate naïve patients, the guidelines have been installed by states without evidence of effectiveness or uniform metrics, weaponized by a federal judiciary system that conflates the dual missions of drug diversion and care for the most vulnerable among us, and adopted as a risk management strategy for reducing physician business risk rather than risk to patients. If we listen to the data we have available, it appears that we are further away from preventing harms than we ever have been since the implementation of CDC’s Guidelines.
All-in-all, it’s been quite a year following the initiation of the CDC Guidelines. And for Christmas dessert in 2017 is the CDC Calculator Fruit Cake as seen HERE that will no doubt result in harm or death for many unsuspecting patients that rely on inaccurate calculations. While the actions of CDC remain unconscionable, I thank my colleagues Drs. Mena Raouf and Terry Lewis for helping to bring a very long, but important CDC review to you this holiday season. Perhaps with all this continued activity, next year will bring 12 consecutive days of short blogs.
Happy Holidays to all and as always, comments are encouraged and welcomed!
Dr. Terri Lewis has extensive experience in the development and administration of community programs and systems of care for persons with disabilities and chronic health impairments. She has broad community rehabilitation industry experience, having collaborated extensively with local, state, and federal agencies to create community mental health and rehabilitation services for unserved and underserved persons with a wide variety of needs. At this time, she serves on the academic faculty for two universities. She collaborates with vocational programs in the USA and southeast Asia on the design of community based rehabilitation with special emphasis on Allied Health care coordination and personnel training.
Dr Mena Raouf, Pharm.D., is currently completing PGY-2 Pain and Palliative Care
residency at the Stratton VA Medical Center in Albany, NY. Dr. Raouf received his
PharmD from Albany College of Pharmacy and Health Sciences and completed
a PGY-1 residency at the VA Tennessee Valley Healthcare System in Nashville, TN.