A Former Federal Peer Reviewer’s Analysis of the Draft CDC Guidelines

A Former Federal Peer Reviewer’s Analysis of the Draft CDC Guidelines

Brooke Keefer

Brooke Lee Keefer

In my former life prior to chronic pain and illness I had many important and fascinating jobs.  One was as a peer reviewer for the United States National Institutes for Health (NIH), Center for Mental Health Services (CMHS), and Substance Abuse and Mental Health Services (SAMHSA); and New York State’s Education Department, Office of Mental Health, and Office of Alcohol and Substance Abuse Services.  I reviewed multi-million dollar grants, provided consumer input to agencies, and served on publication committees and focus groups.  When the opportunity arose to comment on the draft “CDC Guideline for Prescribing Opioids for Chronic Pain”, I looked forward to reawakening my peer reviewer skills to objectively identify the strengths and weaknesses of the document.

Unfortunately, I found it near impossible and beyond frustrating to review this document in an objective manner.  The guideline is not organized like a typical guideline or tool kit.  It is nothing more than a literature review of the harms and risks of opioids.  It is not objective, therefore, I found it impossible to be objective.  It was biased which made me completely biased (in the other direction).  Reading this document left me scared—really scared.  It left me wondering what happened to the United States and to the rights of patients?  How could this be?  No consumer groups or chronic pain patients were included in their peer review or “experts” process.  A huge no no.  Here is the comment I posted on the CDC site (I omitted my introduction):

As a consumer and citizen, I request you halt further activity regarding these guidelines until a consumer board can be developed—one that is solely made up of chronic pain patients who have experienced primary care access issues to opioid medication.  I also request you conduct focus groups of chronic pain patients who are on opioids.  Only then will you have guidelines that serve the public, the primary care doctors, and the chronic pain patients.

It is imperative a section in the guideline be created detailing how adequate pain control is a fundamental right of every patient.  Point to the Joint Statement from 21 Health Organizations and the Drug Enforcement Administration, “Promoting pain relief and preventing abuse of pain medications: A critical balancing act” which states “Effective pain management is an integral and important aspect of quality medical care, and pain should be treated aggressively… Preventing drug abuse is an important societal goal, but it should not hinder patients’ ability to receive the care they need and deserve” (http://www.deadiversion.usdoj.gov/pubs/advisories/painrelief.pdf).  In addition, in this section provide a thorough review of the risks of untreated chronic pain, i.e. suicides, depression, unemployment, lower quality of life, etc.

Throughout this document it is mentioned there are no adequate long term studies that prove opioid medication is effective, leading the reader to believe opioid medication never helps patients long term, which is not true.  If you conducted a focus group of chronic pain patients you would understand the complexities of opioid pain management and long term effect.  It became clear to me this document was written in a biased manner when I read the “Effectiveness of Alternative Treatments” section.  It boasted these treatments effective under 6 months.  Nowhere in this document did I see a similar positive citation for opioid treatment for short term use though hundreds exist.  The writers excluded the fact these alternative treatments, like opioids, had no proven long term benefits.  Furthermore, the alternative pharmacological agents, i.e. gabapentin, SSRIs, NSAIDs, etc. are touted as excellent treatments with little to no risks.  The writers should have included information on the hundreds of possible side effects, some very serious, each of these drugs carry.  The risk of death, overdose and suicide is very real for some of these medications and literature citations stating as such was discluded.

The statistics in the Background section do not delineate criminal activity from actual chronic pain patients in a pain management type setting.  It also does not define whether in overdoses there were additional drugs or alcohol contributing to the overdose (polydrug overdose) and whether these overdoses were legitimate pain patients or illegally obtained prescriptions.  These guidelines should not include such statistics.  This is not a paper about criminal activity and misuse.  Only statistics for actual pain patients should be included.

Information must be included describing the fact primary care doctors may be the only opioid prescriber in their area as most pain management doctors no longer manage chronic pain with opioids and specialists refuse to prescribe.  Primary care doctors have by default become pain management doctors.  As such, pain patients should not be punished for this trend.  I did like that you included a few sentences encouraging physicians to be compassionate.  Please expand on this.  Most of us are treated like a nuisance and criminal.  Include information on the difference between physical dependence, tolerance, and addiction/misuse of opioid medications.

Information about actual pain conditions is slim, which is disconcerting.  The fact you include cataracts as a painful condition and not severely painful conditions like chronic pancreatitis, complex regional pain syndrome, shingles, back and spine issues, trigeminal neuralgia, endometriosis, adhesion pain, kidney stones, and more shows the lack of familiarity of the team of writers with true chronic pain populations.

Teach patients basic opioid safety—keeping the opioids locked away and out of teenagers’ hands.  Many patients are naïve to think their teens would never consider experimenting with their meds or visitors won’t snoop through a medicine cabinet.  Providing real-world information will prevent unnecessary overdoses NOT limiting chronic pain patients their pain medication.  Also, the naloxone section should be removed or limited to a sentence.  True chronic pain patients rarely experience overdose and should be dealt with by emergency personnel.

—End of comment—

The CDC is clearly not the appropriate agency to spearhead opioid prescribing guidelines.  They are good at authoring literature reviews on ebola and trying to find cures for diseases.  They are NOT equipped to publish guidelines of this manner.  This is not an epidemic and they are incapable of being objective.  A document like this must be objective and unbiased.

Brooke Keefer is a mom to three sons ages 28, 19, and 4 and has a 2 year old granddaughter. Brooke has a Bachelor of Science degree in Mathematics from the State University of New York at Albany. For over 15 years she worked as a not-for-profit director, lobbyist, advocate, and a grants writer, manager, and reviewer in the field of children’s mental health. Brooke suffers from several painful conditions—sphincter of oddi dysfunction (a defect in the pancreatic/biliary valves), chronic pancreatitis, and fluoroquinolone toxicity syndrome (long term adverse reaction of the nervous system to Levaquin). Though these have disabled her, she writes health articles, advocates for patient rights, and runs the Sphincter of Oddi Dysfunction Awareness and Education Network website, www.sodae.org.

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Authored by: Brooke Lee Keefer

There are 15 comments for this article
  1. Dr. Jeffrey Fudin at 2:06 pm

    Brooke, Nicely written – this is an excellent review! Please consider writing a guest blog for paindr.com On that site, you will find a link to my email address. Thank you for this wonderful contribution!

  2. Heather at 5:13 pm

    Thank you so much for writing! I’m glad we have you to add your voice to ours. You are well-spoken and thoughtful and make excellent points. I do hope we genuinely are listened to, but I am skeptical.

  3. Marty at 2:26 am

    Great article Brook Thank you so much for taking the time to share it. It’s people like yo that give the rest of us hope.

  4. Anne at 7:56 pm

    Definitely make sure to forward a copy of your comments to your senators, representatives, and the committee investigating the guidelines.

  5. Anne at 7:52 pm

    Brooke, thank you so much for taking the CDC to task and explaining WHY these edicts are not a guideline. I was a registered nurse and worked in mental health and hospice care. You’re absolutely right that this is little more than a biased review of low quality evidence. Medicine and nursing are both science and art. Biased scientific work isn’t scientific in nature. Guidelines are based on scientific evidence. There is consensus from differing viewpoints. Each side makes concessions. The CDC guidelines were developed by people who shared the same viewpoints and counter viewpoints were not represented at all. Essentially this is similar to an invading country that seeks to impose its will on the invaded people.

  6. Shari Noland at 6:31 pm

    As a RN and a chronic pain patient, who is disabled due to a genetic metabolic disease that causes neuromuscular loss, autonomic dysfunction, and shut down of GI system, this is a topic my doctor and I have discussed often. The government has not considered patients like me who have progressive diseases that causes severe pain. I would be unable to enjoy my family. I work hard to keep my doses low and still have pain, but my life would be intolerable without the meds that keep the pain at a tolerable level. I know that most doctors in our area no longer prescribe any pain meds at all. I find that cruel. How can any doctor see patients who have conditions known to cause pain and tell them they will not help them.

  7. Linda F. Nolan at 6:07 pm

    Excellent comment to the CDC! Thank you, I have made my comment as well. We surely need knowledgeable like you that can speak their language. Much appreciated.

  8. Brooke Keefer at 11:32 am

    I’d like to respond and comment on a few comments thus far. Mona, which comments are you concerned the CDC will exclude? Now you have me thinking. Of course we can’t trust the process so I want to be sure my comments are considered. I emailed my Congressman, Paul Tonko, and would be surprised if I heard back. I will follow up though in a week or two with this question to ensure my comment is included in their review. Louis VA, don’t discount the fact you are an expert in your own right as a chronic pain patient. We are experts of our bodies and experiences and need to be represented as such in any process concerning our population. Doc Anonymous, funny you mention the DEA removed this document. The original url for it led me to an error page. The fact it is on their website means they still endorse it. I would like to think it would be impossible to remove themselves from a document they developed in collaboration with 21 health organizations after the fact.

    -Brooke Keefer

  9. Carla Cheshire at 10:25 am

    Brooke, thanks so much for writing and explaining the process and your findings on these “Guidelines.” I read through them and the Stakeholders paper in which it seems many are questioning the processes in which they gleaned information, the lack of scientific evidence and the apparent bias of the findings. Like you I was scared when I read this.

    NPR’s “All Things Considered” is featuring the CDC Guidelines for Prescribing Opioids for Chronic Pain on its show yesterday and again today. There is a written transcript of the radio show followed by some good comments. I urge all of the pain patients reading this to go to: http://www.npr.org/2015/12/29/461409296/draft-of-cdcs-new-prescribing-guidelines-stirs-debate to read and comment. Anytime we can get our voices out there and tell our side of the story we need to take advantage of it.

  10. Kristine (Krissy) at 10:07 am

    Great article, Brooke. So glad to see this today, and hope it spreads widely! Thanks for all you do for those of us in pain, and I know your comment to the CDC will help many others.

  11. LouisVA at 9:45 am

    Great comment to the CDC, Brooke. I am a chronic pain patient and wish that I had something more to offer other than the following – my support to the cause. I returned to college in 1993 as a non-traditional adult student and graduated with a BS in Geography in 1996 at the ripe young age of 46. One of the things that I valued learning about, and am still fascinated by today, is the ‘scientific method.’ This farce from the CDC falls short by a mile.

  12. Mona Twocats-Romero at 9:32 am

    I just noticed the following statement on the page where comments have been submitted. According to the site there have been more than 1200 comments so far, BUT:

    ” This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.”

    Does this mean we have to worry about our submissions being withheld?

  13. Mona Twocats-Romero at 9:18 am

    Thank you for your comments to the CDC. I would like to encourage everyone reading this to submit their comments before the deadline on January 13,2016. Without your comments, you are effectively acquiescing to the CDC nightmare. Use your voice, speak out! If you are unable to write comments by yourself, get the help of someone close to you and tell them about your condition and all the things that the CDC needs to know about chronic pain in your particular case. The more comments, the better.

  14. Scott michaels at 7:39 am

    great comment. thank you. please stay involved.

  15. Doc Anonymous at 7:19 am

    Excellent comments. I am intrigued by the reference to and link to the DEA paper: “Promoting pain relief and preventing abuse of pain medications: A critical balancing act”. If I am not mistaken, it seems that the DEA actually withdrew its support of this article back in 2001 when it was first drafted. Shortly after their withdrawal of their support of this document (or a very similar document) they dramatically escalated their attack on doctors who dared to prescribe opioids for any significant numbers of chronic pain patients. Over the next decade, opioid prescribing docs had their offices and homes raided and all of their medical records seized for copying by the Feds. Over the ensuing 10 years, the medical community got the message loud and clear: Prescribe opioids at your own risk. That decade of attacks on opioid prescribers cultivated the soil that gave rise to organizations like PROP….and to an unfettered growth of injections for all kinds of pain. The growth of the injection industry also gave rise to companies like NECC that sold contaminated medicine for profit that resulted in more than 770 injured and 76 deaths…..all affecting ONLY people with chronic pain.

    The re-appearance of this article is perhaps a glimmer of light that the climate may be changing. But history tells us to be wary of the DEA when it comes to their approach to chronic pain. Thus the need to continue the battle.