Good, Bad, and Ugly of CDC Proposed Opioid Guidelines

Share with others

Anyone reading this is likely familiar with the “confidential” proposed CDC Guideline for Prescribing Opioids for Chronic Pain”. Before even reading the proposed guidelines, my initial inquest was to review the panel of 17 presumed expert panelists.  My reaction, much akin to almost every recent media post, was that the deck was stacked against fair balance.  One particularly glaring omission on the panel was lack of a single pharmacist, much less one with post-graduate training and expertise in pain pharmacotherapeutics.  To me, it seems that writing drug guidelines without a single pharmacist is like writing diagnostic guidelines without a single medical doctor.

More recently, the indignation among key opinion leaders and organizations within the pain space is attributable to the carelessness with which these “guidelines” were approached by a recognized government agency that heretofore was hailed as an organization to protect and serve the public.  In our minds, that includes patients that are suffering daily with pain syndromes who require chronic opioid therapy.

On October 20, 2015 Dr. Robert Twillman, Executive Director of the American Academy of Pain Management (AAPM), responded with a letter to Honorable Fred Upton, Chairman of the House Energy and Commerce Committee, United States House of Representatives.  Dr. Twillman and AAPM graciously agreed to share their perspective here.

But first, Dr. Twillman offers this summary…

Earlier this year, the US Centers for Disease Control and Prevention (CDC) requested assistance in developing an “evidence-based guideline” for opioid prescribing, with the intent of using this guideline to reduce the number of overdoses and deaths resulting from the use and misuse of opioid analgesics. They did this despite an NIH panel’s finding, only three months before, that, essentially, there is no credible evidence that a clinician can use to make any important clinical decision regarding the long-term use of opioids to treat chronic pain.

Throughout the guideline development process, CDC has attempted to maintain strict secrecy over the entire project, refusing to reveal the names of experts recruited to help them develop the guideline, the stakeholder groups asked to review their first draft, and the additional experts who will help develop a final draft after considering the comments received. They engaged in a “box-checking” exercise when they revealed the recommendations in this draft guideline during a bizarre webinar, giving participants only two days to file comments afterward. And, now that they have received comments, they are producing a revision that no one outside the agency will see until the final version is published most likely in January.

The complete lack of transparency in CDC’s process is unacceptable; to compound matters, the core expert group recruited by CDC to help develop the guideline is biased and has only one pain management specialist. It is clear to us that this is a guideline intended to reduce opioid prescribing, as opposed to one intended to help people use opioids more safely.

Below is a letter (pasted in) and hyperlinked HERE, that I sent to the Congressional committees with oversight responsibility for CDC, detailing the problems with this guideline development process. It details our concerns, and asks that Congress tell CDC to withdraw this guideline and start over, using a process that is transparent, unbiased, and consistent with the usual manner in which federal agencies develop rules and regulations.

As always, comments are encouraged and welcome!

R TwillmanDr. Bob Twillman is the Director of Policy and Advocacy for the American Academy of Pain Management.  In that capacity, Dr. Twillman is responsible for overseeing federal and state pain policy developments and advocating for those supporting an integrative approach to managing pain.  He also serves as Chair of the Prescription Monitoring Program Advisory Committee for the Kansas Board of Pharmacy.  Dr. Twillman received his Ph.D. in Clinical Psychology at the University of California in Los Angeles, and maintains a volunteer faculty appointment as Clinical Associate Professor of Psychiatry and Behavioral Sciences at the University Of Kansas School Of Medicine in Kansas City, KS.  Prior to taking his current position, Dr. Twillman was a full-time faculty member at the University of Kansas Medical Center, where he founded and directed the inpatient pain management program and was a co-founder of the hospital’s Palliative Care Team.  He has been actively involved in pain policy through his work with the Alliance of State Pain Initiatives and the American Pain Society for many years.

October 20, 2015

The Honorable Fred Upton
Chairman
House Energy and Commerce Committee
United States House of Representatives
Washington, DC

Dear Chairman Upton:

I am writing to you today on behalf of the American Academy of Pain Management (the Academy) to express our concerns about an effort underway by the US Centers for Disease Control and Prevention (CDC) to develop a guideline for prescribing of opioid analgesics to treat pain. While we have concerns about some of the content of the draft guideline that CDC has presented, the subject of this communication is the process that is being undertaken to develop that guideline. We are very concerned that this process is deeply flawed, and that any guideline developed as a result: 1) is in no way supported by current standards of chronic pain management; (2) will alter clinicians’ decision processes relative to their most difficult pain control challenges; and (3) will certainly have negative impacts on patients. Following are some of the key points of concern, which we would like to bring to your attention.

Summary of the guideline development process

On January 15, 2015, CDC issued a request for applications, seeking assistance in developing an evidence-based guideline for prescribing of opioids to treat chronic pain. CDC then revealed no further information about this process publicly until June 16, 2015, when it invited a limited number of stakeholders to review an anticipated draft guideline. It should be noted that the draft guideline document, when eventually released, stated that the draft had been reviewed by a group of federal partner agencies, but the timing for that review is unknown to us.

CDC followed these emailed stakeholder invitations with an email to a larger group on August 25, 2015, announcing that it would hold a webinar for a limited number of interested participants on September 16, 2015. This emailed invitation noted that comments on the draft guidelines could be submitted orally over the telephone during the webinar, by writing in real-time via the webinar portal, and by email for 25 hours following the webinar. CDC later extended the deadline for email comments to 49 hours, and was forced to re-run the webinar on September 17 due a technical problem on September 16.

Participants in the webinar noted that there was no response from the CDC staff presenting the webinar to any comments that were made during the webinar, nor was there an attempt to answer any questions posed by webinar participants.

In parallel with this, CDC released the draft guideline to the stakeholder review group on September 14, 2015, with a response deadline of October 1, 2015. Comments on the draft guideline were solicited in the form of a spreadsheet. CDC noted that it would compile comments from all sources, de-identify them in terms of their source, and post them on the CDC website on or around October 23, 2015. Stakeholders will be able to participate in a telephone review of this information on October 21, 2015.

Following compilation and consideration of the comments, a group of three physicians will advise CDC on revisions to the guideline. CDC anticipates issuing the final guideline in January, 2016.

An “evidence-based guideline” without an evidence base

On September 29 and 30, 2014, the National Institutes of Health held a Pathways to Prevention workshop on The Role of Opioids in the Treatment of Chronic Pain. Prior to this workshop, experts compiled the relevant available evidence through an exhaustive search of the literature. This compilation formed the basis for scholars who, at the workshop, reviewed the evidence of benefits and harms resulting from the use of opioid treatment for chronic pain. Following the workshop, an unbiased, independent panel developed a report summarizing the current state of affairs with respect to research into opioid treatment of chronic pain. Perhaps that report, released on October 2, 2015, is best summarized by this statement from its conclusion:

“What was particularly striking to the panel was the realization that there is insufficient evidence for every clinical decision that a provider needs to make regarding the use of opioids for chronic pain, leaving the provider to rely on his or her own clinical experience.”

Despite this statement from the panel’s report, we were struck by the fact that, only three months later, CDC issued its request for applications to develop “an evidence-based guideline”. We wonder how CDC could be calling for an “evidence-based guideline” when the National Institutes of Health, after a considerable investment of time and money, had just concluded that there was, in effect, no evidence. We also wish to note that a group of pain management experts, led by the Academy’s current executive director, worked with CDC employees in 2012 and 2013 to review existing opioid treatment guidelines, and concluded that all of them were based on very sparse evidence—that they represented “consensus” guidelines, not “evidence-based” guidelines, because there was insufficient evidence on which to base a guideline.

In its draft guideline, CDC acknowledges just how weak the evidence is. The draft guideline provides twelve recommendations for prescribers, and rates the evidence base for these twelve guidelines as being of “low quality” in five cases and as being of “very low quality” in seven cases. Yet, in another puzzling twist, the draft guideline also rates eleven of the twelve recommendations as “strong” and only one as “weak”. In our view, a recommendation based on “low” or “very low” quality evidence should hardly ever be a strong one, as it essentially represents an expert opinion, rather than a conclusion drawn from evidence.

Makeup of groups advising CDC on guideline development

Although CDC has not been transparent about the members of the Core Expert Group that helped it develop the initial recommendations, the Stakeholder Review Group, or the three experts who will assist it in developing a final draft, we are privy to this information because we are one of the stakeholder groups invited to review the draft. We find the makeup of these groups both puzzling and concerning. To wit:

Core Expert Group: This group of 17 individuals contains one person who is a bona fide pain management expert—Dr. Jane Ballantyne, a retired physician most recently from the University of Washington. The remaining members include five non-physicians and eleven physicians from a variety of medical specialties. For instance, one is a retired cardiologist who works for a state health department, while another is an emergency physician and medical toxicologist who, by virtue of his specialty, treats primarily acute pain and overdoses, rather than chronic pain. Another is a neurologist who is best known for his nationwide advocacy of efforts to markedly curtail opioid prescribing. In sum, this is a panel filled with individuals who are on the record as opposing the use of opioids to treat chronic pain in nearly all circumstances. By virtue of their work, they focus on the potential harms of opioid treatment without focusing on the potential benefits—which is not surprising, given that they come from backgrounds that do not expose them to people with pain who are successfully treated with opioids.

Stakeholder Review Group: Eighteen groups are identified as stakeholders, and each of those stakeholders has identified a point person. Here, the representation of pain management organizations is somewhat better: six of the 18 groups are specifically pain management provider organizations. Another nine groups represent various medical specialties in which pain is prevalent; two represent people who have chronic pain; and one is an organization that has been prominent in efforts to curb opioid prescribing across all patient groups.

Final Review Group: This group consists of three physicians, one of whom is a pain management specialist. The remaining two members are an expert in outcomes research and healthcare communication, and an emergency medicine specialist and medical toxicologist who has published extensively with the toxicologist previously identified as a member of the Core Expert Group. Interestingly, this individual’s website lists her research expertise as, “Evaluating methods to limit initiation of new opioid users and modify opioid misuse through interventions in the ED, regionally and nationally.” We are struck by two facts here: this has very limited applicability to the treatment of chronic pain, which is the supposed subject of the guideline; and that this is a public statement that the primary goal of her research is to reduce the total number of opioid prescriptions written, a fact that is inconsistent with the effort to develop a guideline addressing the prescription of opioids to manage chronic pain.

These groups, charged with developing a guideline on how best to use opioids to treat chronic pain, are overwhelmingly dominated by individuals with no apparent expertise in the subject, nearly devoid of groups representing and advocating for people with pain, and studded with a number of individuals who are publicly on record as opposing the use of opioids to treat most types of chronic pain. This leads us to our next source of concern.

Potential sources of bias in expert groups

In its draft guideline document, CDC describes at length the steps it took to seat an unbiased panel, stating that it considered not only bias associated with employment as a consultant by pharmaceutical manufacturers, but also public statements made by experts, and a number of additional sources of bias. CDC asserts that it has succeeded in identifying an unbiased panel.

Yet, in the disclosures found in the CDC document, it is noted that Dr. Ballantyne, the only pain management expert in the Core Expert Group, has served as a paid consultant to a law firm that has aggressively shopped, to various levels of government, lawsuits against opioid manufacturers, alleging that those manufacturers are responsible for substantial harms to those government entities, resulting from adverse effects of opioid treatment that, in turn, resulted from illegal and/or inappropriate marketing practices by those manufacturers. If the CDC was going to such great lengths to seat an unbiased panel, they should have easily identified that this law firm would undoubtedly be aided in litigating its cases by the establishment of a CDC clinical practice guideline recommending severe restrictions on the use of opioids.

Two members of the Core Expert Group, two designated reviewers in the Stakeholder Group, and one of the three experts assisting with the final draft of the guideline, all are members of the board of directors of an anti-opioid lobbying organization named Physicians for Responsible Opioid Prescribing. This group has been extremely active in attempts to limit opioid use, including a Citizen Petition effort to convince the US Food and Drug Administration (FDA) to change the label indications for extended release and long-acting opioids so as to limit their approved use to no more than 90 consecutive days and to doses at or below the equivalent of 100 mg of oral morphine daily, for all persons with non-cancer pain. It should be noted that FDA denied this Citizen Petition on the basis of its review of the scientific evidence, opting instead to make minor, but still significant, changes to those label indications. Specifically, FDA found no evidence supporting either a duration or dose limit on these medications. (A copy of FDA’s decision and its explanation is attached.) One of the recommendations contained in the draft guideline is that opioid doses above the equivalent of 90 mg of morphine daily be avoided.

It also should be noted that a long-time employee of the CDC’s National Center for Injury Prevention and Control, the home agency for this guideline, is a former member of the board of directors for Physicians for Responsible Opioid Prescribing; his name appeared on the letterhead used to submit the Citizen Petition to FDA. The extent to which this individual participated in the guideline development process is unknown.

It is our contention that, if CDC intended to exclude experts who may have displayed a bias through their public statements and professional activities, it failed. Several members of all three expert groups have written and spoken extensively and inaccurately about a supposed lack of utility for opioids in treating chronic pain, and several also have consulted with government agencies, non-governmental organizations engaged in addressing prescription drug abuse, and others, suggesting ways in which to limit opioid use. It is not known to us if any of these individuals might also have consulted with for-profit entities such as workers’ compensation insurance companies.

We remain concerned that the biases of expert consultants have not been fully disclosed, and that some members of these groups perhaps should have been excluded.

Unnecessary secrecy and extremely limited opportunities to provide comments

We acknowledge that, because the document in question is a guideline, and not a proposed rule, the ordinary standards for obtaining and considering feedback from anyone who wishes to comment do not apply. We also note that members of the Senate Health, Education, Labor, and Pensions Committee have very recently expressed concern about government agencies using a guideline development process as a means of circumventing the standard requirements for transparency and public comment (http://www.help.senate.gov/chair/newsroom/press/senators-challenge-department-of-labor-regulatory-actions). That said, we are at a loss to explain the extraordinary secrecy and extremely limited opportunities for comment attached to this guideline development process.

Within both the medical and regulatory fields, it is axiomatic that transparency and vigorous debate considering a wide variety of viewpoints produces the best results. To that end, when most government regulatory bodies propose new policies, they fully disclose the expert consultants advising them, and they accept comments from a wide array of sources, allowing at least 30, and more often 90, days to receive those comments. This allows all stakeholders concerned by the content of the proposed policy to a) be aware of the proposal so they can ensure that their concerns are communicated; and b) have time to carefully consider and discuss the proposals so that they can offer well-reasoned comments and suggestions for approval. Due to the strict secrecy and limited participation in the development process established by CDC in this case, neither of those was possible, except as it concerns the expert groups.

Consider:
• To this date, CDC has not publicly identified the members of any of the three expert groups
• Every communication we receive as a stakeholder group reminds us to maintain confidentiality with respect to the content of the draft guideline
• The comment period provided to webinar participants was extraordinarily limited, to such an extent that it was challenging even for experts in this arena to construct well-reasoned comments in time to submit them
• There will be no further review by stakeholders after the next draft of the guideline is written
• Comments received by CDC will be stripped of information identifying their source, and may also have their content edited so as to allow presentation of a summary of the comments, rather than the actual comments. This contrasts sharply with the practice of regulatory agencies that post all comments, with attribution, on their websites.

In the end, this guideline doesn’t give us anything we don’t already have

As our prior work with CDC demonstrated, there is no shortage of clinical practice guidelines, issued by a variety of professional organizations and regulatory bodies, with a variety of patient populations in mind. All of them are consensus guidelines, reflecting primarily the opinions of experienced clinicians because of the paucity of evidence regarding long-term use of opioids to treat chronic pain. The recommendations contained in the existing guidelines vary to some degree, but most of them are consistent with the recommendations in CDC’s draft guideline. So what have we accomplished, if CDC issues another such guideline? In one sense, we will have achieved nothing, because it won’t contribute something new to the discussion. In another sense, though, the potential for unintended negative consequences for people with pain is substantial. Experience with similar clinical practice guidelines has shown that many clinicians treat them as rules, not as guidelines, and that a substantial portion of primary care providers (the stated targets of this guideline) will simply opt to stop prescribing opioids to their patients with chronic pain. What will these people do to address their pain?

Our request

In light of the concerns we have detailed here, we respectfully request that your committee look into CDC’s actions with respect to this guideline development process. We think that questions need to be asked and answered, with respect to: the poor-quality evidence underlying these “strongly recommended” “evidence-based” guidelines; the process of selecting experts to participate in the various groups involved in developing these guidelines; potential sources of undisclosed bias from a variety of sources; the implications of CDC issuing a clinical practice guideline developed without the benefit of appropriate peer review, that could limit access to pain medications for people who benefit from them; and the reasoning behind the lack of transparency and opportunity for comment from the public found in this process. Unless these questions are adequately addressed, the organizations with clinicians who strive to treat chronic pain, and in fact do so with opioids, will not support them but will, by necessity, be forced to actively oppose them, ensuring that clinicians understand why.

As we mentioned above, we believe that this is a situation in which transparency and robust academic debate will produce the best outcome. We urge you to strongly encourage CDC to withdraw this draft guideline and, should they decide to start over, to engage in a process that is more transparent and inclusive of the needs and views of all clinicians and patients—both those with pain and those who misuse opioid pain relievers.

19 thoughts on “Good, Bad, and Ugly of CDC Proposed Opioid Guidelines

  1. I thank you doctor for your article. Finally some sound intelligence on this ridiculous and cruel subject!Here is the shortened version of my nightmare beginning on my early 20’s. Severely osteoarthritis of both TMJ’s. I was lucky to have one of best OMFS in Pittsburgh who spoke all over the world. He finally did a bilateral replacement with silastic proplast joints. Surprise they failed. I was one of my be first in this country to have the procedure and had them in 10 years. No idea others had them removed in 3 to 6 months!!! FDA finally recalled them and ensuing that notice I had five more surgeries one being fashioned by my ribs. In 2003 I received titanium implants and was told that I’d always have chronic pain since the first set sloughed off thousands and thousands of minuscule Teflon floating in my face. Also the developers of the initial joints declared bankruptcy, ran to Europe and sold them there!!!
    Back then Rheumatology dept at UPMC did a full work up telling me I am hypermobile and to stay strong and thin. Back then they did not call it Ehlers Danlos.
    So after living in Atlanta for the last 15 years all I wanted to do was move home. We did 10 months ago. I left my Atlanta pain team (whom I love) and moved to north of Pittsburgh. I have seen FIVE 5 so called pain doctors and have never in my life been treated with outright disgust! Never asked me how I was… nothing. One jag off looked at the meds me Atlanta docs had me on and told me to stop all of it. Then put me on the patch that did not help. Finally OxyContin 2x/day. Had one month of being comfortable. Then these idiots told me that thc kept showing up in my saliva!! I researched for a living and found out Advil, nsaids would show slightly above their threshold. I am smart enough to insist on a urine within ten minutes of the saliva. lol and behold completely CLEAN!!! I also had years of records from my Atlantadoc with drug screens 100%clean X8years!!! So they kicked me out rather than admit their saliva tests are faulty.
    So I sit here in extreme pain as I now have osteoarthritis in my back, ribs, foot etc. and let us not forget migraines and adrenal failure.
    I love my new home but can do zilch. So have s next doc on Wednesday is my last hope and I pray he does not prey on pain patients. I have always been so so strong but I am close to falling apart.
    Dr. Please, pleas stop this cdc jerks! So heir stats are wrong, their secretiveness is quite suspect! They even own rehab centers. It is always about the money. I want government out of my health. Lastly, they must STOP lumping chronic pain with addict deaths. I so want to go to Congress! Also heard the pharmacy across for the Capital send approx scripts to lawmakers predominantly pain meds and some aricept! This must be stopped an Kolodny needs to GO AWAY! Thank you.

  2. I am 38 and had radio frequency lesioning on my neck
    I went over a year thru management and before that was horrible
    I was in hospital every week headache due to trauma
    I also have anxiety and mannic depression and
    Adhd so my meds where a lot
    20 years continued pain and mental dr meds
    Fentanyl patches 4 years
    Oxy , percs , stadol,
    Antidepressants, Xanax 2 mg 4x daily
    Plus soma and adderal , and other meds also
    Several other surgeries but when my dr closed I moved north and they cut offf all my meds pretty much I became a addict almost died. Few times I need meds regulated I need help I’m not ok !
    I’ was off everything 8 months maybe little more , some things I can not live with out I would rather die !
    Help me I need help any dr anyware I don’t think I need all narcotic meds but yes some I have worked and still am but my patience is almost gone and next time I wish I don’t wake up!
    I never abused them ever!
    I need help!!

  3. It is transparently evident that the true intent of this was NOT to be transparent, NOT to listen to those in the pain management field with opposing viewpoints or to pain patients themselves and simply to bulldoze through legislation is a politically reactionary way to the crisis of opiod related deaths. This was done in an unscientific way because we did not even have good data at the time they were working on this as to how many of those deaths were related to legitimately prescribed pain medication and how much of it was related to street drugs! There is now emerging evidence from a couple of states that 90 percent of that is due to street drugs!!! That leaves the remaining question being that of those with legitimately prescribed prescriptions in what number of those overdoses were the medications taken as perscribed and without additional substance use such as ETOH. We do know that in a number of emergency room overdoses involving opiods alcohol or another illegal drug were also involved. It is bad enough to so egregiously put the needs of one community group ahead of those of another (the chronic pain population) but to do so not based upon scientific fact is especially reprehensible. In fact, we DO know that according to large research studies where they took care to exclude those with previous or current addictions as well as addictive behaviours the rate of addiction in with long term use of opiates is less then 1 in a thousand. While they have said these are “guidelines” they have in fact are being used on a state level, federal level, and by insurance companies and even pharmacies to deny pain medications to chronic pain patients. Ideally, all those pain patients would have access to a pain management doctor but in reality there are not enough to go around and even they are afraid of being prosecuted because of these “guidelines”. Shame on you CDC. I will forever have doubts about your intentions and objectivity from now on.

  4. Has anyone else not noticed that supportprop.org is registered by Domains By Proxy? Yet, the website states openly on their homepage: “PROP is a program of Phoenix House Foundation, Inc., a 501(c)(3) charitable organization. PROP’s education, advocacy and research are conducted without sponsorship from companies affected by those activities.”

    I’ve never taken a logic course, but would Phoenix House not be a company affected by PROP’s education, advocacy and research? Phoenix House is about neck and neck with Hazelden Betty Ford in revenue. Just read their annual report and read their publicly available Form 990 form! Just another little detail, but one that would probably fly over the head of someone like Senator Manchin or Governor Charlie Baker. I never cease to be amazed. Just gotta laugh, I suppose.

    Mark Twain on Politians
    “Suppose you were an idiot. And suppose you were a member of Congress. But I repeat myself.”
    “All Congresses and Parliaments have a kindly feeling for idiots, and a compassion for them, on account of personal experience and heredity.”

  5. I SURE HOPE SOMEONE IS IN A POSITION TO HELP US. ALTHOUGH MY.PLIGHT IS HORRIFIC. READING ABOUT THESE POOR PEOPLE IN WASHINGTON AND CONNETICUT WHOS DOCTORS ARE NOT PRECSRIBING ANY opioid PAIN MEDICATION. These people are turning to the streets, seeking out self medication thru heroin. The suicide rate is up as is heroi. Overdose
    Its not a coincidence that since people cant relieve pain they do what they can. Of course insurance companies are all for these inhumane tactics. This will save millions. In california , kaiser is jumping the gun. “You either reduce the dosage or leave kaiser” i was told after 6 years of 500 mg eq, i must go to 120.
    I am being treated as if i just walked in. My initial pain doctors put me through a barage of tests.,shots, epidurals physical therapy etc
    Finally opioid pain medication. It took a year and thousands of dollars to get the dose proper so i could go to work. I was bedridden, in such pain i couldnt lift my head or stand on my feet without screaming. I was able to drive, work, hike and even go on vacations. Now, Because my pain has progressed, this is what diseases do, tjey progress, the medication is not as helpful, but it still helps, what.my old doc would do.is switch.my meds so my body doesnt get used to 1 thing. At laiser, if i want to change anything theyll just stop prescribing. What bugs me the most is my primary care dr wants to help me. I see her all the time
    Its the so called pain dr that saw me 1 time 1 yr ago who is telling her what to do. He is 60 miles away. She even jokes and says this guy thinks the pain to go away by meditation. I said cant he read
    My mri, she said he is more concerned with the politics then the patients.
    I hope the nation not just t,he state says doctors are allowed to prescribe as they have been trained to do. Go ahead take urin tests every few months to make sure the patient is not selling his scripts or taking other medication. That is all the oversight.necesssary. nobody in this country should suffer from chronic pain as long opioid pain medication is available and the patient is willing to take a few tests a year.
    PLEASE DONT PUT ME BACK IN BED. I AM AFRAID I MAY SEEK RELIEF ANY WAY I CAN, IF I CANT find it, I DONT KNOW WHAT ILL DO.

  6. I am a podiatrist who is a chronic pain patient and who regularly treats the foot related pain for many patients, some with crps, nerve damage, various diabetic and non-diabetic neuropathy, etc. Suffering from pain myself I have become very compassionate and understanding of those in need of relief. Unfortunately, I see more MD’s and DO’s in my large urban setting who are refusing to prescribe narcotics and send them to me to manage their pedal pain that hasn’t responded to non-narcotic management. I have taken epidermal nerve study biopsies on patients indicating microscopic verification of severe neuropathy. Years ago, this same government wanted physicians to be tuned in to chronic and acute pain, to finally recognize that PAIN is the fifth aspect of a patient’s health to be addressed by the medical community (after blood pressure, pulse, respiration and temperature). Hospitals and facilities published numerous “patient’s rights to have pain management.” All of us know that the predominant problem with drug overdoses isn’t the legitimate pain patient taking their medications as prescribed; it’s the 80% of people who take other’s drugs or combining prescribed medication with illegal or non-prescribed medication. The prescription monitoring program has been a major asset, but I find it extremely frustrating that we, as physicians have no ability to report patients who test positive for illegal substances. I just had a methadone patient in my office whose urine drug test was positive for cocaine, marijuana, methadone and spice (who insisted she didn’t have a drug problem and insisted I should prescribe her percocet for her pedal neuropathy). Police have told me it’s not illegal to test positive for illegal substances, only if they posses it. They have no desire to know who these patients are and HIPAA makes it very questionable if we could report illegal behavior if there are no victims who are minors. I regularly report to Childrens’ Service those patients who test positive for illegal substances and overseeing children, even if their own.
    We have no resource to report these people who are making it impossible for legitimate pain patients (like myself) who only want to be able to have a close to normal quality of life, to work and enjoy their activities of daily living to the best of their ability. That’s what pain management is all about. Rather than attacking pain doctors and legitimate patients, why doesn’t this same government label those illegal drug seekers as to whom they are. Government regulates people who are not qualified to obtain a gun permit and if labelled, they have a right to appeal. Let’s start identifying those who abuse the system and permit those who are legitimately suffering to obtain their relief. I recently had a diabetic patient in my office who is a 30+ addiction specialist and counsellor, who has had partial pedal amputation in conjunction with osteomyelitis, neuropathy, etc., who is constructing apartment units limited to recovering addicts hoping to live in a sober environment. He is prescribed pain medication and is working 60+ hours per week and functioning excellently. (that’s our goal as when treating pain.) We were discussing as to what those patients like us who exceed the 90-100 daily morphine milliequivalents that the government states we have no need to exceed. I am personally over the limit. I don’t abuse illegal drugs nor will I. (i did use marijuana once in college and got drunk twice in my life before ever taking narcotics)
    I can see the government’s solution to the drug problem will worsen this crisis. Passing more laws to govern guns will never stopped criminals from obtaining weapons, it only made it more difficult for legitimate patients to obtain a gun. Passing these illogical laws to make it more difficult for legitimate pain patients to obtain relief will NEVER stop those who seek to illegally obtain narcotics from getting their high.
    What is the chronic pain patient who is currently well regulated, who has never failed a UDT, who has never failed a pill count, who works full time and functions in society to do? Are we pushing legitimate patients to seek remedies through illicit means? All people have their limits. Depression, anxiety and suicidal ideologies are some of the results when the pain controls the patient. Proper pain management means the the patient controls the pain.
    Our congressman (and woman) have unrestricted access to have gun carrying people to protect them and want to tell us we are safe without guns. Congress has exempted themselves from ObamaCare and it’s mandates. How many of our lawmakers will be willing to have themselves and their families live by the same guidelines they mandate for us if they or their family unfortunately become pain sufferers? We will force those patients seeking legal, proven remedies, many of whom who have gone beyond the magic 90 day proposed limit and 90-100 daily milliequivalents to look for dangerous, life threatening alternatives. Will they be pushed to become alcoholics, use sedatives or other inappropriate substances to treat their pain when contraindicated, hoping for relief? I bet the number of benzo’s will sky rocket if they pass their laws. Understandably, many of our pain patients will become very anxious.
    We continue to punish law abiding citizens so that lawmakers can campaign that they are “saving society from themselves.” Thank god that the government can tell me and others that are pain will be a 5/10 with a drastic reduction in their medication. Perhaps if we tell the diabetics that they don’t need more than a government delineated daily maximum of Insulin, it won’t affect their quality of life. The government believes if we reduce the pain medication then the pain will go away. Perhaps if we stop the diabetics from taking their insulin all together then their Diabetes will be cured.
    I have never blamed legitimate pain patients for the crime of illegal, immoral, illicit drug abusers and seekers. Why is the government harming only the legitimate pain suffers for the crimes of others? They are not stopping those who will find their high through other resources. I’m sure if we told many of those alcohol consuming congressman that they can only have a government regulated limit of alcohol/day they would be grossly offended that they are being punished for those who drive drunk, commit crimes, abuse their family, etc. and that government should punish those who abuse alcohol, drive drunk, promote domestic violence and abuse and not interfere with the rights of those to drink because others act criminally. (didn’t the government do that before with alcohol and look how well that worked out. They even passed a constitutional amendment to save people from their own ability to know better.)
    It’s amazing how in a few short years government went from carrying the flag to promote a patient’s right to have their pain managed to punishing patients who have done nothing wrong and doctors for trying to be faithful to the Hippocratic oath; to enhance the quality of life of patients who are suffering to the best of our ability.
    Lawyers regulating medicine is about as smart as doctors writing laws.
    Maybe if we have our patients stop taking anti-depressants then their depression will go away. Maybe if we stopped prescribing medication, diseases would go away.
    I bet if we went back through history, JFK would’ve been told he was exceeding the opioid maximum and wouldn’t be able to continue with his regiment. I’m sure he would’ve been happy to reduce his daily intake to comply with the law. Maybe he would’ve said “ask not what the government can do for you, but what the country can regulate for you.”
    Rather than punishing criminals, we are harming innocent victims of pain.
    Let’s punish criminals, let’s give counselling to those who need help with substance abuse, anxiety, depression, etc. People who are abusing drugs because of mental health issues desperately need help. Stopping all narcotics will not address their issues and they will seek other remedies if not properly obtaining mental healthcare. But the government should allow law abiding people who are suffering to have a relationship with their doctor to safely enhance their quality of life. The government has no right to tell a woman what to do with their body, but they have a right to tell a patient that they don’t need the pain medication that has helped you safely for years.
    A woman can legally have a partial birth abortion, but we may be willing to put a patient in jail for taking 120 mg/day of morphine equivalents where it’s not even questionable if there is another life involved. Some states have legalized doctor assisted suicide, but if a doctor prescribes 120mg/day of morphine equivalents to a patient so they can avoid depression/anxiety and/or suicide, to enhance their quality of life, permit them to work and perform their adl’s, then the physician can go to jail.
    So maybe we can legally encourage the patient to consider euthanasia because it’s illegal to increase their opioid to more than 120 mg/day or for more than 90 days, but not to increase their medication
    makes sense to me.

  7. When a group(person?) is threatening to sue and the truth is not debatable, one must wonder what this group is afraid of. It you’re stance is solid, fact-based and irrefutable, there should be no need to involve lawyers to maintain your standing. If you’re afraid the other party is getting somewhere, now it’s time to call the lawyers in. You two must have hit a nerve to be treated so imPROPerly.

    I know the CDC was convinced their method of holding a “secret” comment session, webinar style, was a clever way to sneak one past everybody. The idea to do this in such a nefarious way came from somewhere. Is this what allying yourself with an imPROPer group of advisors will do for you? I know I never raised an eyebrow before when the CDC was mentioned. Will I ever be able to say that again?

    1. A woman can legally have a partial birth abortion, but we may be willing to put a patient in jail for taking 120 mg/day of morphine equivalents where it’s not even questionable if there is another life involved. Some states have legalized doctor assisted suicide, but if a doctor prescribes 120mg/day of morphine equivalents to a patient so they can avoid depression/anxiety and/or suicide, to enhance their quality of life, permit them to work and perform their adl’s, then the physician can go to jail.
      So maybe we can legally encourage the patient to consider euthanasia because it’s illegal to increase their opioid to more than 120 mg/day or for more than 90 days, but not to increase their medication
      makes sense to me.

  8. Thank you, Dr. Twillman, for calling out the CDC. I was unable to listen to the webinar, but posted the link in my MSK group the night before it was scheduled to go live; as you said, not much notice at all. One of my fellow admins listened to some, but not all of it. Based on what I was told after the fact, I didn’t think it was that bad at the time. As you stated, a lot of what they suggest is already being implemented, so I was a little perplexed as to why the CDC was even getting involved. They just parroted everything that’s already been said. Then I found out one of the founders of PROP is involved, and that completely changed my attitude about the entire thing. Nothing that PROP has been involved with up until this point has had a good outcome for chronic pain patients, and they have made their stance against all chronic pain patients blatantly clear.

    As features on this topic have started to emerge online, it’s evident among the chronic pain community that these new guidelines are aimed directly at us – not at “helping” people. Kick us while we’re down. It’s already nearly impossible to get opioid pain medications because of the regulations that are in place; many, many doctors outright refuse to write for them now. If you do find a doctor that will prescribe, and you have to go to the ER for an emergency situation and tell them the truth, that you have pain that’s uncontrolled, you are automatically labeled as an addict because you already have a prescription and it “should” be working. I know this for a fact, it happens to hundreds of my patients on a weekly basis, and I’ve gotten the “looks” in the past as well, which is why I stopped taking them altogether two years ago. I’ve had four surgeries this year and was hospitalized for four days with an infection, and was prescribed a very limited supply of medications during those times, but I haven’t taken anything since then. My last surgery was in May.

    When you’re this sick every single day, it’s exhausting to jump through all of the hoops just to feel decent for 30 days and then worry that your doctor’s attitude or opinion may have changed in that 30 days, or that he or she is being pressured to prescribe less and will cut you back drastically or drop you altogether, or he or she will be investigated by the powers that be and that you may not be able to get them the next month. While I still believe in our rights to pain control and the medications that help, and I will continue to fight for that until my last breath, I do it while I’m personally suffering. If marijuana were legal in my state, I’d use it in a heartbeat, but it isn’t. So I just suffer with rocks in both kidneys and chronic cystitis that nobody can do anything about. I think this is exactly what PROP, the CDC, the FDA, and the DEA want, and it’s exactly what they’re getting.

    All the secrecy surrounding the CDC’s latest antics stems from the fact that they know we’re out there, and they knew there would be a sharp outcry from the chronic pain community, because we’ve been raising Cain for several years now. Not that it’s done us much good. They don’t want to hear it, they don’t care. We’re all just a bunch of junkies that are upset that we can’t get our next fix.

    Ironically, there were more ER visits for anti-anxiety and insomnia medications in 2013 than there were opioids, according to their own reports, but we’re just going to sweep that little fact under the rug and ignore it, because the war is on opioids right now. http://www.cdc.gov/drugoverdose/data/overdose.html. We’ll deal with the other drugs in 10-15 years when the focus has turned to them.

    Forty-four people die every day due to prescription opioid overdose, a total of 16,235 a year. Tragic, yes, but so is the millions of people that suffer with chronic pain every single day. Comparing the numbers, 16,235 is hardly an “epidemic”. Again, statistics that have been repeated over and over, but they don’t care about that, because again, the war is on opioids right now. I honestly think the end game here is to get all of the really sick people to just die off. It isn’t going to be long before they start getting their wish with the way things are going. A body can only endure so much before it reaches its breaking point.

    Mary Maston
    MSK Advocate

  9. This CDC “Opiate Guidelines” is almost Orwellian. It is almost as if they had bunch of random Dog Catchers or Cafeteria ladies create the “guidelines” . There is a pattern here and the main question should be, Who benefits? Chronic Pain patients have been maligned for years now, so there would be no problems with denying them basic care. the Media consistently misleads the public maligning the Chronic Pain patients, blaming them for the “Drug Epidemic”. There has been a long term swaying of public opinion and the Medical Industry to label Chronic Pain as a Mental Health issue. It serves the Drug and Insurance Industries to create further confusion about Chronic Pain. The current atmosphere is frightening, and it should be a wake up call. Medicine is no place for biases and opinion, especially when there are so many people whose quality of life is at stake.

    1. I agree with you, Cathy Kooper. Medical facts used to be simply that, “facts”. Now there’s room for debate based on who needs votes, whose PAC is supported by which Pharmaceutical Company, and therefore, whose products should be endorsed to get money, who is the easiest target to throw under the bus in order to achieve the results needed? The much maligned, already beat up and down, chronic pain patients make very easy targets. They’re a weight on society already, believe me I know, I am a chronic pain patient. They just want drugs, we’re making sure everyone KNOWS that, and worst of all, they have single handedly caused more people to die every year than die from car wrecks!

      It’s cruel and certainly not what people want to believe, but it’s happening. They are coming after chronic pain patients with both barrels as the sacrificial lambs in a political war on pain patients. We are losing ground on a daily basis, it seems, and we don’t seem to have the support to stop the bus!

  10. That 5 PROP members are involved in the drafting and reviewing of the guideline represents a clear conflict of interest; thereby, the guideline is an unethical one, and invalid. However, if the CDC added 5 PROMPT members (or any 5 non-anti-opioid zealots) to the committee(s), there would be a sense of balance. For the CDC to claim that the guideline is “scientific” is ludicrous. Unfortunately, we’re dealing not with the tyranny of the majority, but rather with the tyranny of the minority!

      1. Michael, I believe you are talking about our article, The damage done by the war on opioids:the pendulum has swung too far when we were threatened. Interesting the same person that threatened us told me and a group of pain colleagues that PROMPT, unlike PROP, isn’t a “real organization”. There’s been an awful lot of articles for a “fake” organization. Somehow it’s difficult to believe anything PROPagandists say. Can the CDC be that misinformed?

    1. Of course Kolodny. You are right–that says it all. Thanks to him and PROP even pain patients who CAN’T take opioids are being stigmatzed apparently just for claiming to be in pain. And I will accept that, and stand with those who could be helped with proper care, and fight the cruel discrimination the opiophobes have engendered against the vulnerable, who already need all their energy and resources just to get through a day. This insane opiophobic war is costing innocent lives, and they call it “unintended consequences.” Intended or not–and at this time I lean toward the former–people are dying in misery, needlessly, because we have the means to help them. Bless you, Drs. Fudin and Twilliman, for your consistent stand for what is moral and just. And thanks, too, to all the pain caregivers, especially those physicians who are not so self- righteous that they cannot tell a criminal from a sufferer; or a personal flaw from a disease. Thank God there are still people of integrity in this insane country.

Leave a Reply to Grant Cardane Cancel reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.