Below I’ve tried to limit this long discussion to its most meaningful statements. I spent much time highlighting and commenting on the most pertinent phrases, so I hope you find this post informative.
This discussion gives an interesting view of how pain and pain patients are viewed by these doctors.
Dr. Webster: The CDC says the “recommendations are intended to promote safer use of opioids to improve clinical practice, patient outcomes, and public health.”
To achieve safer use depends on mitigating many uncontrolled factors, such as whether a patient inappropriately self-medicates due to mental health disease or uncontrolled pain. I can’t see how the guideline will curtail unauthorized use of opioids or prevent opioids from being intentionally or unintentionally diverted, unless access is severely limited.
The very purpose of this guideline is dubious since it addresses neither pain nor the problem of diversion, perhaps due to the speed and prejudice with which it was slapped together.
The CDC seems to have merely rubber-stamped the views of PROP, using much of the same wording as PROP’s propaganda.
Thus, it appears the guideline is less about improving clinical care and more about trying to limit supply, which means some people with severe pain will struggle accessing opioids.
A public health perspective should address multiple reasons for overuse, including severe pain and emotional suffering.
Dr. Ballantyne: My sense is that the criticisms are based on an irrational fear of opioid restrictions.
If you had constant pain, you too would be afraid of losing the relief opioids provide.
The danger is that the detractors will succeed in blocking the guideline.
Since when are “detractors” seen as the enemy? This is supposed to be a consensus document and consider all different points of view.
Dr. Nelson: There are several guidelines for chronic opioid therapy already published, and most, if not all, of them were created by panels selected by professional organizations or other groups with an interest in the subject matter.
The key criticism of the CDC guideline, other than the composition of the panel, was that the strength of the recommendations was considered too great for the degree of strength of the evidence.
evidence-based medicine does not yet—and may never—produce sufficiently high-quality data to support every permutation of clinical care.
Dr. Twillman: I am hopeful that the criticisms will lead the CDC to greater inclusiveness of pain management specialists in the guideline’s development, and that the product resulting from that process will do a better job of addressing both of the related public health crises: prescription drug abuse and persistent pain. The discussion could have focused entirely on the merits from the beginning, had the CDC followed an appropriate process. Because they didn’t, they are having to redo a tremendous amount of work, and that is appropriate.
Dr. Argoff: Frankly, the manner in which the CDC opioid guideline was developed has poisoned and undermined the very reason why it was allegedly developed.
We could have thought they represented a nonbiased, patient-focused, humane effort. Instead, we were left wondering, “What were they thinking?” [and] “Were these developed by anyone who cares about patients?”—and questioning the extreme bias that went into their development.
Dr. Webster: A guideline offered by a federal agency is not ultimately going to be viewed as voluntary, and the proponents of the guideline are keenly aware of this.
Although the guideline is directed at primary care, it is likely to grow to have universal application, as payors and regulatory bodies begin to codify the recommendations. In fact, payors already are adopting them.
Plaintiff attorneys and attorneys general will use the guideline to evaluate appropriateness of prescribing. Medical boards will likely move to adopt the guideline.
This is how recommendations built on mostly low- to very low-quality evidence become the de facto standard of care.
Usefulness implies they would improve care for people in pain and reduce the abuse of opioids.
But I believe adoption of the sections of the guideline that treat all pain as if it were created equal would make it more difficult for millions of Americans to access necessary opioid therapy.
Again, the guideline seems to be more about trying to mitigate nonmedical use than about helping people in pain.
So, yes, the guideline will be useful to payors, plaintiff attorneys, and regulatory bodies, but not useful for patients whose experience of pain does not fit the CDC template of limits on intensity and duration.
Dr. Ballantyne: I think it should be voluntary;
Yet she’s totally aware that it will become mandatory.
nobody wants government agencies controlling medical practice,
Yet his is exactly what the guidelines are trying to do
nor do the agencies actually want to control practice.
This is laughable – of course the CDC wants to control practice! That’s the whole point and stated goal of these guidelines, so her denial is not only false but suggests a deep level of self-deception.
However, the CDC guideline will carry weight because of its central role in public health and because the third-party payors are likely to take their lead from the CDC.
This contradicts what she said before, claiming it’s just a voluntary guideline “suggesting” an approach to opioid prescriptions.
Dr. Craig: I do think that many state medical boards and licensing bodies will adopt them as a standard of care, which is likely to have much more of an influence than the guideline itself.
Dr. Nelson: I do not support the use of mandates to provide clinical care. Given the breadth and variety of patient pain relief needs, there will likely never be a one-size-fits-all answer to managing pain
Given the association of opioid toxicity [with] standard therapeutic use, as well as the high incidence of adverse effects and substance use disorder, some aspects of the guideline could be mandatory, such as the requirement to review and understand them. However, the details of prescribing should be left to the bedside clinician, in most cases in association with the patient.
Dr. Twillman: The guideline is only voluntary as long as it is not turned into something mandatory by state legislators and regulators. The content of the recommendations isn’t really different from what is found in numerous guidelines from professional organizations, but because this one comes from the CDC, state policymakers will assume it is completely valid.
Because of that assumption, I expect that it won’t be long before states start turning the recommendations into mandates.
Dr. Argoff: Whatever shape and content the guideline ultimately takes could strongly influence a provider’s ability to manage a person with chronic pain—when appropriate—on chronic opioid therapy.
Dr. Webster: It certainly will have a clinical effect, just as precursor guidelines have already had an effect. Patients are increasingly being denied care and viewed with suspicion, even if they have been stable and doing well on their medications
On the other hand, one result of the guideline should be less opioids diverted, since less will be prescribed.
The point is, if we want a public health policy that is best for all Americans, we must focus on improving care for people in pain while at the same time reducing harm from opioids.
We should not sacrifice the health and well-being of one group to help the other. I do not believe the guideline helps resolve this conflict.
Dr. Ballantyne: The guideline is not very different from all previous chronic opioid guidelines, except in two respects: There is dosing guidance, and the suggested dose is low; and there is guidance about how long to treat after uncomplicated acute pain.
This contradicts her previous statement that they are not trying to “control” doctors. These limits put a severe and unreasonable restriction on pain doctors, without any evidence at all to support the upper limits they are demanding.
Dr. Craig: I don’t think the guideline will improve the way that patients’ acute or chronic pain is managed, but I do think that many more people are now talking about, and [are] more interested in, how we improve the lives of those currently struggling to manage their chronic pain.
Dr. Nelson: I strongly support the use of guidelines, as mentioned above, to normalize practice.
When will these folks understand that medicine is individual and cannot be “normalized”. Individuals differ greatly in theri pain and their response to opioids, making standards not only useless, but damaging.
I think this guideline in particular will have an effect on improving the overuse and risks associated with this very complicated and dangerous class of medications. I am continually astonished by how many thoughtful and well-meaning clinicians are uninformed or illogical—not to mention complicit—in their prescribing of opioid therapy.
Dr. Twillman: We [the American Academy of Pain Management] have some problems with some of the specifics in the recommendations, and we have made those problems known to the CDC
The concern is that, as we have seen in states that have adopted guidelines, good content easily can be turned into bad practice that ends up restricting access to pain care.
Dr. Argoff: The CDC guideline could have a significant clinical effect regardless of its quality, and not necessarily a good clinical effect, because of the letters “CDC” and their potential effect on how various stakeholders [eg, state and hospital policymakers, payors] will react to them.
Because the CDC is in a unique position to influence health care policy, there should have been a list of recommendations for payors and Congress, perhaps even before the guideline was issued.
A poorly appreciated root cause of the opioid problem lies in a failed health care system for people in pain, and the payor community has significantly contributed to the problem.
If insurance companies were willing to pay for non-opioid, non-medication pain therapies, many pain patients would happily access them. However, for pain patients it is a hardship to travel, so multiple sessions of treatment each week might not be possible.
In a letter to the CDC, the American Medical Association suggested minimum benefits and noted alternatives to opioids; unfortunately, if payors don’t cover these services, they will be unaffordable for most patients, leaving patients with neither opioids nor affordable alternative therapies.
Another issue is methadone. The CDC reports that methadone is responsible for about one-third of all overdose deaths but represents only about 2% of all opioids prescribed
The CDC should recommend that the 34 states with preferred drug formularies, Medicare, workers’ compensation, and commercial payors remove methadone as a preferred drug
The CDC refused to recommend ADFs for lack of evidence, but the evidence of reduced harm with ADFs is stronger than the evidence on most other recommendations in the guideline, including the suggested dose limits. The CDC appears to be protecting payors from additional expenses.
The CDC did pick and choose what it used as evidence and none of it was conclusive, not for any of their suggestions.
But most importantly, the CDC should sow the seeds with the National Institutes of Health and Congress for a Manhattan Project–like commitment to research to develop safer and more effective analgesics.
Dr. Ballantyne: The problem of what to do with the thousands of patients who are already dependent on opioids, often at high doses, is not fully developed in the guideline.
It is a huge unsolved problem and may need its own guideline, and certainly needs some changes in availability of suitable treatments such as Suboxone [Indivior; buprenorphine and naloxone].
Again, she is talking about addiction, not pain relief, when she suggests Suboxone, buprenorphine, and naloxone. These are medications to help addicts resits opioids.
Dr. Craig: What is missing from the guideline is the patients’ voice and perspective.
Dr. Nelson:The management of patients with acute pain was not well covered, by design.
None of the CDC folks are concerned with pain, yet we are the people most affected by these guidelines.
Dr. Twillman: They didn’t address abuse-deterrent opioid formulations, for one thing
Finally, the guideline addresses the use of nonpharmacologic treatments, but what it doesn’t do is talk in adequate detail about the problems patients have in getting those covered by their insurance.
Dr. Argoff: The CDC opioid treatment guideline fails to comprehensively and appropriately address nonpharmacologic and nonopioid pharmacologic chronic pain treatments in general. In addition, mandating access to all appropriate nonopioid treatments, proven complementary approaches, and physical rehabilitation strategies is a concept that is absent from the guideline.
We are being pushed to use treatments that aren’t covered by insurance and we simply cannot afford that.
Dr. Webster: Yes, people are going to suffer and be denied treatment because of this guideline.
The prespecified doses and time limits are going to be inadequate for many people, particularly for those who have been on higher doses.
There is low to very low [quality] evidence for the dose limits suggested in the guideline.
The FDA completed a sophisticated and thorough review of the literature and concluded there was no scientific basis for certain requested limits to dose or duration of opioid therapy, but that was ignored in the CDC guideline
The guideline writers simply ignored anything that didn’t fit their goals, and instead included the most flimsy evidence supporting them.
The genetic variability in response to each opioid, along with differences in clinical needs, mandate an acceptable range much higher than stated in the guideline.
I had to wonder if the authors of the guideline appreciated genetic science or consulted any experts in the field regarding the pharmacogenetic differences in human response to opioids.
Because they were focused solely on addiction, such concerns were never addressed. Because these authors don’t believe in using opioids for chronic pain, they were completely unconcerned about the ramifications of the extremely low doses they were mandating.
Dr. Craig: Unfortunately, many cancer patients who I care for would likely be negatively influenced by this guideline. Many cancer survivors struggle with the ramifications of their past cancer treatments, like chronic pain. This guideline would have a negative effect for those cancer survivors who take chronic opioids.
I cannot believe they are actually denying opioids even to cancer patients these days. It’s like a return to the dark ages when pain was unavoidable.
Dr. Nelson: I do have this concern but not to the same extent as others
Nobody believes that they have been adversely affected by opioids, which can occur through the development of hyperalgesia, dependence, depression, or addiction, to name a few [factors].
Hyperalgesia has never been proven to exist in humans, only mice, and dependence on various substances is a simple fact of every living organism.The rest of these “adverse effects” result from uncontrolled pain, not opioids.
We have far too many people receiving opioids for chronic pain, and frankly they do not all require this dangerous, addictive class of medication. We need to better define who and what disease states really benefit from opioid therapy and not generalize the use of opioids to broad classes of human beings, who subsequently suffer only the risks without any real hope of benefit.
Yet, generalizing the denial of opioids is OK?
Dr. Twillman: If policymakers turn the content of the guideline into laws and regulations, then patients will be at much greater risk for having access to opioids restricted.
Dr. Argoff: Yes, this is an important and a realistic concern. Whatever is ultimately included could be used by those who pay for health care in such a manner that access to appropriate treatment may very well be prohibited.
Dr. Webster: First, there must be recognition that people in pain deserve to be treated with dignity and respect.
The CDC should declare pain an epidemic and devote as many resources to helping solve this epidemic as any other, because it affects more Americans than any other medical problem.
The CDC must become educated on this topic.
As things stand, the CDC is ignoring chronic pain in their zeal to choke of the opioid supply. This method of drug control has never, ever succeeded.
Dr. Ballantyne: I am a strong believer in the biopsychosocial model of chronic pain, which means that the best interventions are multimodal or interprofessional
This is the first true statement she has made, even if it is for the reason of denying opioids.
Behavioral and physical treatments win out over any medication known to date,
Really? I’d like her to try those treatments the next time she breaks a bone, suffers the need for chemotherapy, or gets crushed in an accident.
yet our current system is not set up with the right type of facilities, nor does it pay for these very valuable treatments. If that changed, then I think our overreliance on medication would go away.
Dr. Craig:We must not take the one-size-fits-all approach and [instead] strive for personalized and individualized pain care.
This is such an obvious statement, yet the CDC seems utterly unaware that humans come in a great variety.
Dr. Nelson:We need to rationalize expectations for pain relief. Very importantly, we need to assess and manage functional end points
He assumes there is a functional endpoint for pain, when we patients know darn well that there is not.
Chronic pain has always existed, although in far smaller numbers than today, and patients have always learned to cope with pain.
He seems unconcerned about how these patients “coped”; many may have killed themselves in “accidents”. Plus, he ignores the burden of chronic pain not just on the patient but on everyone around them, how it can drain and even destroy relationships and families.
But lifestyle change is inevitable for such patients and this will have to be accepted.
This guy really thinks we don’t have to change our lifestyle when we take opioids. He apparently has no idea how they work, that they don’t remove pain, but merely make it bearable.
The risk for developing life-altering opioid dependence, addiction, or of overdosing or dying are far too great to rely on the routine use of opioid therapy for the vast majority of pain.
Again, dependence is equated with addiction. The CDC ignorant of the difference. (See my page about Addiction, Dependence, and Tolerance
Dr. Twillman: We absolutely need to get policymakers to understand that opioids are used to such a great extent because they are often an easily accessed treatment option.
If we want to reduce the inappropriate use and overuse of opioids, then we need to be able to ensure that our patients have unfettered access to the other kinds of treatments that work for persistent pain.
We need to be unbiased regarding approaching our patients in such a manner that we work to comprehensively assess the person in pain;develop personalized treatment plans that may involve medical, cognitive-behavioral, interventional, rehabilitative, and complementary approaches, singly or in combination;
and we cannot apply a one-size-fits-all approach to people in pain (eg, all people getting prescribed opioids, all people having implantable devices, etc).
I cannot understand how intelligent people educated about modern science could possibly think that a “standard” can be applied to pain.
Below are the credentials of the doctors involved in the above discussion:
Lynn R. Webster, MD
Past President, American Academy of Pain Medicine
Vice President of Scientific Affairs
PRA Health Sciences
Salt Lake City, Utah
Editorial Advisory Board Member
Pain Medicine News
New York, NY
Jane Ballantyne, MD, FRCA
President, Physicians for Responsible Opioid Prescribing
Professor (retired), Anesthesiology and Pain Medicine
University of Washington
David Craig, PharmD
Director, Pain and Palliative Care Specialty Residency
H. Lee Moffitt Center and Research Institute
Lewis S. Nelson, MD
Professor, Ronald O. Perelman Department of Emergency Medicine
Vice Chair, Academic Affairs
New York University Langone Medical Center
New York, New York
Bob Twillman, PhD
Executive Director, American Academy of Pain Management
Chair of the Prescription Monitoring Program
Advisory Committee for the Kansas Board of Pharmacy
Charles Argoff, MD
Professor, Department of Neurology
Albany Medical College Albany, New York
Director, Comprehensive Pain Program
Albany Medical Center
Albany, New York
Editorial Advisory Board Member
Pain Medicine News New York, NY