Following months of controversy and complaints about lack of transparency, Centers for Disease Control and Prevention (CDC) has published an online draft of Guidelines for Prescribing Opioids for Chronic Pain.
According to the CDC, “This guideline provides recommendations for primary care providers who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care”. 1 The draft guideline is available on the federal register and is open for comments until January 13th 2016. As of December 25th 2015, there are 957comments received by the CDC.
At first, the guideline was going to be published without outside comments. The American Medical Association (AMA) released a statement in October stating that this move is “disappointing, given the stature of the CDC as a public agency, the serious nature of the problem, and likely impact of the specific guidance that may be released”. 2 In turn, the CDC plans to consult with a stakeholder review group, only two of which represent patients, the American Chronic Pain Association and the American Cancer Society (ACS). Cancer Pain? With so many patient focused pain support groups, why ACS? – The guidelines were written for noncancer pain as noted above.
Several patient groups should have a voice in these guidelines. There are support groups for fibromyalgia, arachnoiditis, medullary sponge disease, Ehlers-Danlos syndrome, various forms of arthritis, chronic back pain, and countless others. In this blog, we ask that all of you come forward and provide the name of your group and links to your websites!
The Executive Director for Physicians for Responsible Opioid Prescribing (PROP) Dr. Andrew Kolodny, who is believed to have input on the CDC opioid guidelines, called opioids heroin pills in this C-SPAN interview (see time stamps 23:00, 41:10, 40:21) and also stated that patients may not be able to trust doctors who prescribe them and many patients taking opioids for chronic pain mistakenly believe the drugs are helping them, when the vast majority of them are not doing well.3 While PROPagandists continue this rhetoric and criticize chronic opioid therapy for lack of supportive long-term evidence, they shamelessly use lack of evidence as evidence of absence.
Speaking of quality evidence, the CDC guidelines are based on evidence that is “low quality” or “very low quality” yet assigned strong recommendations to the statements.4 “Evidence cited to support the guidelines “is low to very low and that’s a problem”, said Sharon Hertz, the FDA’s director of the Division of Anesthesia, Analgesia and Addiction Products.5 As a matter of fact, all of the 12 recommendations are based case series (level 3 evidence) or expert opinion (level 4 evidence) yet listed as strong recommendations (grade A). “This is a ridiculous recommendation from my perspective. Very low quality of evidence, yet a strong recommendation. How do you possibly do that?” stated Richard Ricciardi, PhD, of the Agency for Healthcare Research and Quality.6
The American Medical Association (AMA) released a statement in July 2015 stating “America’s patients who live with acute and chronic pain deserve compassionate, high-quality and personalized care and we will do everything we can to create a health care response that ensures they live longer, fuller and productive lives”. 7 However, these CDC guidelines prove otherwise, and if implemented, could have a dreadful impact on pain patients and their loved ones. In a survey of over 2,000 patients by Pain News Network, “over 90% said the guidelines were discriminatory and would be more harmful than helpful to pain patients”.8
If implemented, these guidelines could drastically reduce the prescribing of opioids for chronic and acute pain. The CDC guideline states that prescribers “should generally avoid increasing dosage to ≥90 MME/ day”.
Morphine 90mg equivalents based on what evidence? And, whose equivalence recommendations do we use? In 2013, paindr.com posted The Answer is Morphine 100mg Equivalent – Morphine Jeopardy where this was clarified. In November 2015 an article was published in Pain Medicine that solidified the fact that there is no acceptable morphine equivalence, and if there were, it still wouldn’t account for individualized patient variability and drug interactions.9 We wonder if the psychiatrists aligned with PROP and those advisors on the CDC panel would use the same antidepressant at the exact same dose, with a ceiling cut-off for every patient. And if a patient didn’t respond to that cut-off, if suicide from unresponsive antidepressant therapy would be an acceptable outcome – we don’t believe that is an acceptable outcome for pain and/or depression. It’s just not that simple.
“Who drafted these controversial opioid guidelines” was a question raised by many including The U.S. Congress.10 This was followed by a
Congressional letter to the CDC Director demanding full disclosure and transparency to identify the Core Expert Panel no later than January 5th 2016. The letter stated “to date, the CDC has not identified the group’s 17 members”. Of particular interest is that PROPagandists are quick to criticize Big Pharma and various well-respected clinicians who advise them as paid consultants. The reason anyone even knows of their relationship with Big Pharma is because these renowned experts have been wholly transparent and are required by the Sunshine Act to disclose such potential conflicts – they are the honest ones with high integrity, not the villains that PROP followers would lead you to believe. But, the very PROP folks that have criticized their honesty have been protecting their own dark secret conflicts within PROP and collaborating with the CDC.
The recommendations in the guidelines are mostly based on “expert” opinions, but it begs the question; who are the experts and what is their expertise? Pain News Network disclosed on September 18, 2015 that out of “15 people in the Core Expert Group, only one of which is a physician with expertise in pain management”.11 There were also no patients on the panel. There is not a single practicing pharmacist on the Core Expert Group, a panel that is bantering around issues related to drugs. That’s sort of like talking about feet without a podiatrist or orthopedist specializing in foot surgery.
There are up to 100 million patients living with daily chronic pain who deserve “compassionate and high quality care” according to the AMA.7 Placing drastic limits on opioid prescribing is not the solution to the overdose pandemic, and could have a harsh impact on their wellbeing.
We need to promote safe opioid prescribing instead of incorrectly sensationalizing opioids as “heroin pills”, and labeling patients with legitimate pain as “drug addicts”.
We need to improve awareness opioid overdose risk instead of claiming that the risks outweigh the benefits of opioids. According to a recent study by Dasgupta’s and colleagues, of 2,182,374 patients prescribed opioids, 478 overdose deaths were reported (0.022% per year).12 Pretty incredible right?
According to yesterday’s PROP and the ‘Opioid Lobby’ post by Pat Anson, “Over 600 comments have been received since the comment period opened on December 14 and many of the recent ones apparently are from PROP supporters. They often parrot instructions made by Kolodny in his newsletter.”
If you are a patient reading this blog, we ask you to write a response from your heart to the CDC, not a canned prewritten cut and paste that comes from PROP as outlined in above. We ask that you encourage others to do so by any social media platform at your fingertips (ie. Twitter, Facebook, Google, LinkedIn) and to encourage your advocacy groups to do the same. This is your chance to be heard!
Comment and provide the website of your support group and
A special thanks to coauthor Mena Raouf, a 2016 PharmD Candidate at the Albany College of Pharmacy and Health Sciences, with a concentration in Nephrology. Mena moved from Egypt 5 years ago to start pharmacy school and career in the U.S. He hopes to complete PGY1 and PGY2 Pharmacy Residency and practice as a clinical pharmacist specialist. He completed an advanced practice rotation in pain management under the mentorship of Dr. Jeffrey Fudin.
- Rennick A, Atkinson TJ, Cimino NM, Strassels SA, McPherson ML, Fudin J. Variability in Opioid Equivalence Calculations. (2015) Pain Medicine.
- Dasgupta N, Funk MJ, Proescholdbell S. et al. Cohort Study of the Impact of High-dose Opioid Analgesics on Overdose Mortality. Pain Medicine 2015