As CDC Guidelines Approach One-Year Anniversary, Questions Loom
“Next month will mark the one year anniversary of opioid guidelines released by the Centers for Disease Control and Prevention – guidelines that discourage primary care physicians from prescribing opioids for chronic non-cancer pain,” writes Pat Anson in the February 15, 2017 edition the Pain News Network newsletter.
My Expectations for CDC Opioid Guidelines One Year Ago
As I explained in my April 20, 2016 blog, Will the New Opioids Restrictions Help to Reduce Overdoses?, politicians and some government officials told us at the time that the new CDC opioid guidelines would reduce deaths due to overdoses. Based on the early evidence, I thought it was unlikely that the CDC’s guidelines would accomplish this goal. It was my belief that the guidelines would not help solve the opioid crisis. However, they would place people with pain at higher risk of suffering.
Unfortunately, I believed that under the CDC’s prescribing guidelines, pain patients would find it far more difficult to find doctors and pharmacists who would provide them with the medication they needed. People with pain would then have a choice between trying to endure their pain without adequate treatment, or finding illegal drugs such as heroin or fentanyl (the drug that killed pop singer Prince) on the streets.
In my blog, I said, “The problem is more complex than the lawmakers, CDC, and regulators would have us believe. Simply reducing the amount of opioids prescribed will not necessarily affect overdose death rates as you might expect. In fact, it might do just the opposite.”
My Concerns About CDC Opioid Guidelines Remain
Almost a year after the guidelines were implemented, my previous comments have eerily become true. We have seen roughly a 25% decline in opioid prescribing between 2012 and 2015. Hydrocodone short acting (SA) prescribing decreased 33% from 2011, and Methadone prescribing decreased 28% from 2010 – 2015. However, deaths from illegal opioids have continued to climb.
Yet we still have many unanswered questions. For example, as Anson asks in his Pain News Network article, “Are the CDC guidelines voluntary or mandatory?” The guidelines appeared to be voluntary, but state legislators are attempting to codify what were intended to be only guidelines.
In effect, healthcare professionals were asked to cut down on prescribing opioids without regard to the needs of individual patients. As I said in my blog, “Denying prescriptions to people who have been benefiting from opioids is a misguided attempt to save the lives of people with opioid addictions at the expense of people with pain.”
Outstanding Questions About CDC Opioid Guidelines
Other outstanding questions Anson raises about the CDC’s guidelines are: “Have they improved the quality of pain care? Are patients being treated with safer and better alternatives? Most importantly, are soaring rates of opioid abuse and addiction finally being brought under control?”
To get answers, the Pain News Network and the International Pain Foundation (iPain) have created a CDC survey. Anson explains that the survey is “intended to measure the impact of the guidelines on patients, doctors and other healthcare providers. We will be asking a series of multiple choice questions that should take you only a few minutes to complete.”
Link to CDC Survey for Patients and Healthcare Providers
As Barby Ingle, president of iPain and a Pain News Network columnist tells Anson, “I strongly believe that as these guidelines are implemented by doctors and hospitals around the country there are important lessons to learn from those who are affected by them….I hope that pain patients and providers participate in this survey so that we can begin to show how deep the impact actually is to the chronic pain community one year later.”
Because I share Ingle’s goals, I’m providing the link to the CDC survey here and asking patients, doctors, and other healthcare providers to consider completing it. I appreciate your participation and greatly value your input.
Purchase my book, The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us (available on Amazon), or read a free excerpt here.
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Copyright 2017, Lynn Webster, MD
I am a chronic pain patient along with over 116 million other Americans and I think most Physicians & medical staff are out of touch with what’s really going on with chronic pain patients or they just don’t care and the CDC the DEA and the FDA & the politicians are practicing medicine but know nothing about it the truth be told Physicians don’t know as much about chronic pain and addiction as they try to convince you that they do there has been very little study on it and they received very little education about it but I guess you gotta know about something before you teach it right ? they’re out of touch with the real reality of what’s going on and I’m not sure if they realize or even care that day personally each and every one of them are responsible for every death of a chronic pain patient that committed suicide or died from an overdose of street drugs because they were forced to turn to turn to the streets for relief cuz of untreated or undertreated pain that they could no longer bear ! I am very disappointed in the medical community I understand they don’t want to lose their license or be prosecuted but some actually believe this crock of crap that the media keeps reporting & data the CDC released then later admitted was not correct ! its heroin that is killing most people but all opioid deaths including heroin is listed under the same code by the coroner’s even if it was a combination of other drugs if they have opioids in their system they are listed as an opioid overdose none of that data is reliable but everyone is acting like it’s the gospel ! Instead of the medical community coming together standing up for their patients and their right to practice medicine as they were trained to do and how they see fit ( within reason of course) they stick their tail between their legs and turn their backs on their patients !!! what happened to the oath of Do No Harm ? what happened to compassion & morals ? As soon as a Dr realizes a patient is on any narcotic med their whole attitude changes suddenly you are the enemy ,you are an addict ! They get tunnel vision which puts many patients at risk cuz they do not listen to their patients, they have created a hostile environment & in many cases because they now look at us as addicts thay feel they have the right to yell & talk down to us insist we submit two procedures that are risky as well as withhold treatment , at times serious conditions are overlooked and people are sent home only to return to their local ER in even more serious condition . And now they are pushing injections some that are not even approved by the FDA (not that I have much faith in them anymore either ) that specifically states it is not recommended for injections in the spine but they can charge a lot of money for 5 or 10 minutes of work it’s like an assembly line , I had injections before that I believe caused more pain and did nothing to help but was subjected to even more ,although I don’t deny some people claim that it helps them and that’s wonderful but they are risky and many times patients are not notified about the risks I wasn’t . humans are not one-size-fits-all , in my experience there was an unspoken threat that if you did not consent to all the expensive injections they would no longer keep you on as a patient & there just aren’t enough pain management practices but all of them seem to be doing the same thing anyway, matter of fact many doctors were just walking out abandoning their patients others chose to close their pain management practice and go into addiction treatment cuz of course it’s all about the money right ! it is never okay to demand anyone to submit to anything that they don’t want to do just like if a doctor recommends a hysterectomy , is that woman required to get that hysterectomy NO that is her choice it is her body but chronic pain patients appear to have lost all their rights & their privacy. do you know what it’s like to have somebody watch you use the restroom & the DEA has access to our medical records, NKU no what it’s like to be a patient with a health problem and be treated like a criminal , a lowlife piece of crap ? I do and more often than not I think about walking out in front of a train all hope has been lost I have become isolated and spend more time down in bed now that my medications have been cut and will continue to be cut I was a productive functioning woman but not anymore , it’s become extremely difficult and even dangerous for me to drive anymore, I am very stressed and have developed anxiety and panic attacks as many chronic pain patients now have now it goes along with the territory of being in constant pain but also more so with the added stress brought on by what they are doing to one group based on what another group has done ! Dr want to act having anxiety or panic attacks or depression or being emotional are red flas for addiction with a bunch of other ridiculous so-called signs which in reality are side effects to this opioid Hysteria and chronic pain itself . Unless you suffer from chronic pain you haven’t a clue how it impacts every aspect of your life ! I could write a book on it . We are patients not addicts , we are not criminals , an addict shouldn’t be treated as criminals but at times are but they all seem to have more compassion for addicts then they do legitimate responsible pain patients , they all created this heroin epidemic in the first place with the way they handled the situation !
As a chronic pain patient, and a support group director, I have seen the devestation in patients whose medications were suddenly restricted, reduced or discontinued by the “law” as stated to them. Maybe the doctors called it law, seeing where these guidelines were heading. The worst part of witnessing these changes, are the indigent who suffer with serious pain issues but are categorized by the medical community, as seekers! I’ve watched a good friend reduce from a viable member of our group, to a depressed, suicidal pain patient cause the doctor she’s forced to see, claiming they can’t prescribe opioids any longer due to “law”. No human should have to suffer, because a doctor fears restriction or loss of licensure. We have not moved forward, but drastically, to the dark ages!
Compounding the distortions and frauds of the CDC Guidelines, these atrocious and restrictive prescription standards are now proposed for integration into reimbursement criteria for Medicare and Medicaid. The following is copied from letters that I have sent to the healthcare legislative assistants of 25 US Senators. I suggest that anyone reading this thread can and should make known their own objections at the CMS correspondence gateway AdvanceNotice2018@cms.hhs.gov
Dear [name], Legislative Director to Senator [name]
The HHS Centers for Medicare and Medicaid Services are accepting public input through March 3rd, 2017, on a proposal to integrate the CDC Guidelines on prescription of opioids to adults with non-cancer chronic pain, into their criteria for insurance reimbursement. I believe on the basis of extensive research and contacts with hundreds of pain patients and medical professionals, that such a step will be a uniform disaster for pain patients across America. It must NOT be allowed to happen until major errors and scientific frauds incorporated into the Guidelines are corrected.
I urge the Senator to join in authoring legislation or other effective action to stop the CMS process, pending an unbiased review and correction of the CDC Guidelines by a reconstituted working group led by board certified pain management specialists and including pain patient advocates.
Please review the background paper I have developed on this issue, and brief your Senator on the points you find most pertinent.
Sincerely,
Richard A “Red” Lawhern, Ph.D.
Patient Advocate
=======================
Edited from input sent February 7, 2017 to AdvanceNotice2018@cms.hhs.gov
To whom it may concern,
I write to strongly oppose the proposed alignment of practice standards at the US Centers for Medicare and Medicaid Services, with the Centers for Disease Control and Prevention March 2016 guidelines on prescription of opioids to adult non-cancer chronic pain patients.
On multiple grounds, the CDC guideline is an ongoing disaster for both pain patients and medical professionals. The guidelines must be immediately withdrawn and rewritten by an unbiased body of consultants including as key members, board certified specialists who are active in the community practice of pain management, as well as chronic pain patients themselves.
– The CDC Guidelines are already having an enormous negative impact on the lives of tens (possibly hundreds) of thousands among the 100 Million+ chronic pain patients in America.
— Doctors – both general practitioners and specialists – are leaving pain management practice in droves, fearing malicious and arbitrary prosecution by DEA for “over-prescription” of opioids — against a standard of prescription which is ill-supported by the medical evidence.
— Patients who have long been successfully managed on high doses of opioids are being outright deserted, in many cases without withdrawal assistance or oversight, and uniformly without access to effective alternative means for maintaining the quality and functionality of their lives.
— Many among those deserted are lapsing into disability, losing their ability to sustain former employment or family relationships that have benefited from treatment of pain with opioids.
— Some patients have already committed suicide, overcome by agony imposed on them by their physicians. More are likely to suicide as this crisis continues and deepens.
– Even in its own published content, the CDC Guidelines acknowledge that recommendations are grounded upon very weak medical evidence.
— Conclusions were drawn which substantially exceeded the content or clarity of the available medical evidence.
— Conclusions were drawn which contradicted or omitted previous research published in FDA and NIH studies. Particularly damning are published CDC workshop findings that confirm the existence of a substantial cohort of patients among whom opioid treatment is both appropriate and an only resort after the failure of all other therapies.
— Extended commentary submitted on the draft Guidelines by the American Academy of Pain Management appears to have been largely ignored — with neither explanation nor rationale.
— It appears that public health statistics were misinterpreted and may have been deliberately distorted to support a largely fictitious “epidemic” of deaths mis-attributed to opioids prescribed to pain patients.
— Although opioid-related deaths are a serious public health issue, they are for the most part not being caused by drugs prescribed to legitimate pain patients. Research published by the CDC itself reveals that death statistics are dominated by illegally imported Fentanil, Heroin, Methadone, and opioids diverted by theft or fraud to the street.
– There is now incontrovertible proof that the CDC Consultants Working Group which wrote the Guidelines deliberately biased their consideration of medical research to unfairly disadvantage and discount the effectiveness of opioids in treating chronic pain. They also substantially inflated the perceived risks of opioid prescription by ignoring multiple confounding factors in the studies used to support their Guidelines.
– There is credible evidence that key figures associated with the CDC attempted to write Guidelines which would divert research and treatment funds to professionals in addiction psychiatry, to the disadvantage of professionals in chronic pain. The guidelines process up to December 2015 was dominated by participants who had vested financial and professional interests in this diversion of resources. That process was also largely closed to the public until challenged by Congressional overseers.
– Especially disqualifying is the fact that the CDC Guideline fails to acknowledge a number of key facts widely accepted in the practice of pain management.
— Nowhere in the Guideline are genetic factors acknowledged which create wide variability in opioid metabolism and drug tolerance among the patient population. This variation directly contradicts most of the dose limit rationale embedded in the Guideline.
— Nowhere in the Guideline are controversies acknowledged with pertain to Morphine Milligram Equivalent Dose determination. Estimated MMED is considered by many practitioners to be a to be a matter of mythology and opinion, not science.
— The Guideline appears to parrot an unproven assertion that drug tolerance and “hyperesthesia” are universally experienced among chronic pain patients — which is deeply contradicted by some published studies and by widespread reports of patients themselves. Hyperesthesia appears to be relatively rare among chronic pain patients, though no reliable statistics are available on its incidence.
– The CDC Guidelines were originally phrased as advisory for general practitioners and subject to tailoring for each individual patient — not mandatory for all physicians or applied as a one-size-fits-all restrictive edict. If made mandatory, the 90 MMED upper limit on opioid dose levels will effectively destroy the lives of many tens of thousands of chronic pain patients who have been maintained at stable doses above 100 MMED (often above 400 MMED) for years.
The CMS system MUST NOT accept the CDC Opioid Guidelines as a basis for mandatory practice standards. These Guidelines are scientifically invalid, biased by professional self-interest among addiction treatment specialists, and highly destructive in their effects on chronic pain patients. As support for this position, I encourage you to read some of the many references cataloged here: https://edsinfo.wordpress.com/2017/02/01/evidence-against-cdc-opioid-guidelines/ “Evidence Against CDC Opioid Guidelines”.
I am available for follow-up discussions, should that input be desired. I write as a non-physician author and advocate for chronic pain patients, with over 20 years experience in peer-to-peer support groups, Internet forums, and analysis of the medical literature. I have no financial conflicts of interest in that I am retired and working solely without direct or indirect reimbursement, as a volunteer.
============================
Richard A. -Red- Lawhern, Ph.D.
(803) 566-8011 (South Carolina)
Twitter: @lawhern1, #SpotsOfLight
Personal Website: http://www.lawhern.org
“Giving Something Back” g
Mr. Lawhern: May i copy parts of your letter above on my Facebook page to give my friends an idea of what to say when they contact CMS? thank you so much for your advocacy. My life is about to get more difficult and i am really worried about it. And ready to fight. thank you, Pam
Thank you for publishing this letter. With your permission, I would like to copy this and send it to my own legislators.
Although the CDC ‘guidelines’ were supposed to be voluntary and targeted at primary care doctors, people are finding that even Pain Management specialists are so frightened that they are using them as an excuse to stop prescribing. I think that this is what the CDC wanted. Sadly, it makes me question their stated goals.
I am not a drug addict, but am treated as one because of needing narcotic drugs. I am living in nerve pain 24/7 even with some
help of medication. I get more terrified every day that the rest will be taken away. I know in my heart that I will have to do something that I really don’t want to do——–suicide! I am a nurse from the 60’s and I know I would never have let my patients be in the pain that those of us are in today. I would have begged, borrowed or stolen anything I could get for them!! Don’t you people have any heart, have any of you even experienced a “headache”, because I doubt it! In my shoes and those of others you people would probably be the first one’s to commit suicide if you were in our shoes and deprived of proper pain care! Stop taking such good care of street drug addicts——-start taking care of us and the wonderful doctors that want to treat us, but you have tied their hands!! P.Jackson
I am 25 with chronic illness and have a life to live riddled with pain.
If you are going to restrict pain medications for chronically ill patients, at least have the humanity to make assisted suicide legal and accessible.
If I die early, it will be by my own hand. I will be choosing to finally release myself from living in a body that is my prison.
What happened to my comment???????
Please feel free to use any part of this comment:
I have several spinal cord injuries that are undebatable on diagnostic imaging and physical exam, and I have a rare disease destroying tissue in my cervical spine. After having seven spinal surgeries, my physicians warned me that more surgery would be too dangerous, and I should resign myself to permanently depending on opiates. My physician carefully developed a regimen of medications that I was able to use consistently for 15 years with minimal side-effects. During that time, I had no medication-related complications and was able to pursue my career as a Ph.D. Clinical Psychologist, conducting research about childhood trauma, practicing psychotherapy, and teaching university undergraduate and graduate students. I maintained an active social life and often traveled to see my daughter.
However, my ability to maintain a satisfactory life has been shattered during this past year when my long-time physician retired about the time that the CDC Guidelines were released. For several months, I have been unable to obtain prescriptions for the the medications that permit me to function because they are about 300% the (arbitrary) “MME” that the CDC incorporated into its rules for acute pain. Over the past months, I spoke with at least ten pain physicians in Colorado. Some were honest and explained they (or the rules of their clinics) were reacting to the DEA’s recent prosecutions of pain physicians, and self-preservation required that they follow the CDC Guidelines for acute pain, although they acknowledged my pain would not be controlled by those limits. Other physicians pretended that there is “science” that demonstrates that I would overdose on the regimen which I had taken without problems for 15 years. It is shocking how quickly a whole field of physicians has deteriorated under governmental pressure. One physician stated that pain has been the one domain in which medications have been employed in spite of their being “harmful;” apparently this physician forgot about chemotherapy and other domains in which physicians and patients weigh the advantages and disadvantages of treatment. About half of the physicians I saw only looked at my list of medications and then talked about their pain clinic’s need to reduce patients to the CDC’s limits – without a bit of attention to the severity or number of pain generators.
The CDC “guidelines” do include an “Introductory” statement about chronic pain patients urging physicians to collaborate with them to weigh the (dis)advantages of taking opiates versus suffering uncontrolled pain. However, given fear evoked by DEA actions, apparently every pain clinic in Colorado is applying the CDC’s rules for “MME” doses for acute pain to all patients. In sharp contrast to my experiences before the CDC Guidelines, not one pain physician acknowledged that patients have any right to weigh the (dis)advantages of opiates versus uncontrolled pain nor even that uncontrolled pain is dangerous, which is revealed by many well-designed studies. When I mentioned the CDC’s advise abut discussing these matters with chronic patients, without fail, the pain physicians pointed out that this paragraph would not protect them if they surpassed the “MME” rules.
Because my own research concerns posttraumatic stress, I am aware that uncontrolled pain evokes Autonomic Nervous System reactions like those induced by traumatizing stressors. (For example my blood pressure has increased from normal to 190/120 during the past year, with my pain out of control.) Probably because of my specialization, my patients tend to include many with acute pain. During the first few months of this past year, for the first time in my experience, I encountered patients who suffered because they were apparently under-medicated for control of acute papin. I am aware f two cases in which patients attempted suicide post-surgery because they were overcome and traumatized by pain. I never previously encountered such experiences in my forty years of practicing in Colorado, and attribute these events to the CDC Guidelines. It must be remembered that the “MME” limitations were based on an arbitrary cut-off point at which death might result from over-dosing; it is not surprising that insofar as patients have more medication available, they are more likely to successfully kill themselves. However, that cut-off is unrelated to a criterion about an opiate dose for controlling pain post-injury (or -surgery).
Although the “MME” was proposed by the CDC for acute pain, it was incorporated by Colorado State into reimbursement rules for Medicaid, which in turn was then incorporated into rules for all pain clinic patients. The attraction to using this numeric limit is that if a physician to be prosecuted by the DEA, they could point to following a minimum prescription set by some federal agency. Although the CDC may not be responsible for DEA action, they must consider how their “Guidelines” will actually be employed by physicians in their actual contexts, and therefore how patients will be affected.
At present, four pain physicians have suggested that I seek an intra-thecal pump. However, very few (no?) pain physicians are actually doing trials of pumps in Colorado, apparently because of fears that the DEA will investigate even the relatively small absolute amounts of medication employed in them. Without the pump, the options are apparently suicide or leaving the U.S. I have been warned that the pain I am currently experiencing will dill me I I cannot find a solution soon.
I do not understand why either the DEA or the CDC has accomplished their goals by preventing me from being successfully employed as I was months ago. It is not surprising that the rate of over-doses has continued to increase, although the rate of opiate prescriptions has dropped by 25%. The increasing over-doses are likely due to pain patients’ suicides, due to untreated pain. This obvious hypothesis has apparently not been investigated in relevant research, but it certainly should be before the CDC Guidelines are made permanent.
I exist with RSD/CRPS, Auto Immune Disease, PTSD and Chronic Depression. I am fortunate that today I can refill a pain prescription of Opiates that allows me to exist and get through another day.
However, if you continue on this path of your shotgun approach to handling the abuse of opiates, you will be forcing many suicides, because a denial of medication equals intolerable pain with no possible relief in sight and by step therapy that is a failure.
May God have mercy on you for your actions.