Deadline Nears for Public Comments on Revised CDC Opioid Guideline

By Pat Anson, PNN Editor

The public comment period on the revised draft of the CDC’s opioid prescribing guideline ends Monday, April 11th. So far, over 4,200 comments have been submitted in the Federal Register. You can leave a comment and read the ones already submitted by clicking here. A final revised guideline is not expected to be released by the CDC until late this year.

Like the original guideline, the revised version still maintains that opioids should not be used as a first line or routine therapy for pain, but takes a more flexible approach to dosing. Providers are urged to weigh the individual needs of each patient and not take a one-size-fits-all approach to pain care.

“It’s important to point out that the guideline is not final and the step that we’re at now is a real critical point in the process to wrestle with and get feedback,” Christopher Jones, PharmD, Acting Director of the CDC’s National Center for Injury Prevention and Control, told PNN in February.

“And that’s why it’s important that we hear from readers of Pain News Network to get feedback, to get that experience, so as we move toward a final guideline, we can incorporate that feedback. We hope that insurers, medical community, law enforcement and others will also review the guideline and provide feedback.”

Does 50 MME replace 90 MME?

Perhaps the most controversial change in the opioid guideline is the elimination of dose thresholds. The original guideline strongly encouraged providers not to exceed doses of 90 morphine milligram equivalents (MME) per day. That 90 MME limit has been dropped from the revised draft, but providers are still urged to be cautious about going over 50 MME because higher doses have “diminishing returns in benefits relative to risks.”

That change has led to significant confusion about what CDC is trying to do. Many patients are concerned that 50 MME will be seen as the new recommended limit, a dose they consider low for severe pain.

“Does the 50 MMEs replace the 90 MMEs? This is asking for more and more suicides. Much of the proposed guidelines are the same except you removed 90 MMEs and replaced it with 50 MMEs. Go back to the beginning and start over,” Pamela Hoard wrote in her comment.

“It is ridiculous to put a numerical number, such as 50 MME/day, to a risk/benefit outcome when there is no scientific evidence to support MME's,” wrote Joe Benotz, who said he was a pharmacist. “Using unvalidated MME to guide dosing opioid pain meds has in the past led to significant harms to pain patients. Continued use of MME numbers will cause more harm in the future.”

“I'm a doctor in Michigan who has lost his license because of the 90 MME requirement. It doesn't matter if you add caveats, prosecutors see a limit and it becomes the law. The 50 MME ‘suggestion’ is even worse,” wrote Jonathan Roberston.

The anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP) posted a letter in the Federal Register supporting many of the guideline changes, including the cautionary language about exceeding 50 MME. PROP continues to maintain that long-term use of opioids is too risky.

“Available evidence indicates modest benefits of opioids for acute pain relative to placebo, while benefits for chronic pain have not been shown,” PROP said. “New evidence also demonstrates significant risks of high dose opioids (>50 MME/day) and shows that alternatives to opioids often provide equal or superior benefit with a markedly better safety profile. These are important findings which PROP fully supports being widely disseminated to medical professionals and to the public.”

Medical Societies Weigh In

Other medical societies and physician groups generally support the guideline changes, but with important caveats. The American Society of Anesthesiologists (ASA) is concerned about the CDC making new recommendations for treating postoperative pain that are based on “inconsistent” evidence from a small number of clinical trials.

“The agency fails to recognize the complexities around the many different types of surgery that require different forms of pain control, especially that some patient populations may need more pain relief and different therapies than others,” the ASA said in a letter that basically told the CDC to stay in its lane.

“ASA recommends that the agency note in the updated Guideline that clinicians defer to professional medical society guidelines and standards of care for surgical procedures. Medical specialty societies, including ASA, are the experts in perioperative pain care, including postsurgical pain, and are best suited to develop clinical guidelines in this specific area.”

In a move apparently timed to preempt the CDC, the ASA recently joined the American Medical Association and 13 other medical societies in releasing new advice for managing postoperative pain in “complex patients,” such as those with chronic pain and those taking opioids prior to surgery. The societies said patients should be allowed to stay on opioids before, during and after surgery.

Other medical organizations urged the CDC to avoid the mistakes of the past, such as allowing insurers, states, regulators and law enforcement to adopt its voluntary recommendations as inflexible standards of practice.  

“It is imperative that the CDC assure the new guidelines emphasize not only support for safe, quality pain care, but also strive for clarity to prevent rigid application of the guidelines and prevent misunderstandings and misapplications that may result in substandard care and needless suffering by patients with unrelieved pain,” said Maureen Cooney, DNP, President of the American Society for Pain Management Nursing.

Other professional societies took offense that their particular specialties were omitted or only briefly covered in the revised guideline.

The American Society of Regional Anesthesia and Pain Medicine urged the CDC to include a “robust discussion” on the use of nerve blocks, epidural steroid injections and other interventional pain procedures.

The American Association of Neurological Surgeons said it was “disappointed” that the revised guideline “fails to adequately explore” implanted neuromodulation devices such as spinal cord stimulators.

And the American Psychological Association was offended by “the obvious, and unfortunate, omission of clinical hypnosis” from the guideline as an alternative pain therapy.

What Do You Think About Changes to CDC Opioid Guideline?

By Pat Anson, PNN Editor

Do you think the proposed changes to the CDC’s opioid guideline are an improvement over the original 2016 guideline? Will the changes make doctors more or less willing to prescribe opioids? Should the guideline be expanded to include recommendations for treating conditions like migraine and low back pain?

Those are some of the questions we’re asking in a new PNN survey on the long-awaited draft revision of the guideline that was unveiled last month by the CDC.  In addition to giving healthcare providers more flexibility in using opioid medication to manage chronic pain, some experts say the changes effectively transform the guideline into a national “standard of care” for pain management – one that would apply to most doctors and patients, regardless of the severity or duration of their pain.

While the guideline changes have been applauded by professional societies like the American Medical Association for removing “arbitrary doses thresholds” for opioids, some worry that the expansion goes too far and could harm patients -- like the original guideline did -- by depriving them of effective pain treatments.

“The CDC is outside its lane to be recommending how physicians should practice pain medicine. Would they recommend how to treat hypertension or diabetes? If they did, it too would be inappropriate, unless it was in collaboration with one or more of the medical professional societies devoted to those areas,” says Lynn Webster, MD, Senior Fellow at the Center for U.S. Policy and past president of the American Academy of Pain Medicine.

“I have a lot of concerns about the new version. It is better, but still terribly misleading and not grounded in science, which is terrible disappointing.” 

90 MME Threshold Dropped

Perhaps the biggest change to the 2016 guideline is the CDC’s decision to drop a recommendation that opioid doses not exceed 90 morphine milligram equivalents (MME) per day, which quickly became a hard limit for many providers, insurers, states and regulators.

While the CDC still recommends caution about doses exceeding 50 MME, that advice is not enough for Lewis Nelson, MD, a longtime critic of opioid prescribing who advised the agency when the original guideline was created. He thinks the 90 MME limit is based on sound evidence.

“There are good data to support that there is an inflection point at 90 MME. It’s clear that high-dose chronic opioid therapy is associated with a number of adverse consequences -- including addiction, unintentional overdose and potentially death,” says Nelson, the Chair of Emergency Medicine at Rutgers New Jersey Medical School. “In a way, it’s a race to the bottom in pain management, because if you’re not getting better with a reasonable dose of an opioid, there’s nothing to support that additional opioid is going to carry significant benefit and is known to markedly increase the risk.”

Dr. Webster says the use of MME to guide prescribing is misleading because not all opioids are the same or convert well to MME doses. Like others, he worries that 50 MME will become the new hard threshold for opioid doses.

“I think any reference to conversion tables and MME will be interpreted as validation of them. We saw that with the 2016 guideline,” Webster told PNN. “The CDC needs to explicitly state the lack of scientific basis for both and that their use could be dangerous in some cases. They should not cite 50 MME threshold anywhere, as it is meaningless, misleading and will lead to further misapplication of the recommendation. You would think that they would have learned that by the 2016 guideline.” 

Take Our Survey

This is the fifth survey PNN has conducted on the CDC guideline. All of them found that the vast majority of patients and providers believe the guideline was harmful, worsened the quality of pain care, and led some patients to contemplate suicide or turn to street drugs.    

For those who think surveys are a waste of time and the CDC doesn’t pay attention to them -- think again. On Page 53 of its revised opioid guideline, the agency cites PNN’s 2017 survey and has a footnote linking to it:

"An online (non-peer reviewed) survey of over 3000 patients 1 year after the release of the 2016 CDC Guideline found that 84% reported more pain and worse quality of life and 42% said they had considered suicide; however, the survey did not attempt to sample patients with chronic pain using a rigorous methodological approach.”  

It’s true the PNN survey was not peer-reviewed and that patients were not sampled with a “rigorous methodological approach.”  It’s also true that CDC has not conducted a large survey of its own to measure the impact of its guideline on patients. The agency has focused on counting opioid prescriptions — not patient outcomes — as a measure of whether its guideline is working.

To take our new survey, click here.

It should only take a few minutes to complete. We’ll share the results in mid-April.

'This is an opportunity for patients, caregivers, clinicians and others to share their impressions of the 2022 revised and expanded CDC practice guidelines for treatment of acute and chronic pain,” says patient advocate Richard “Red” Lawhern, PhD.

“This guideline will ultimately steer pain care for the foreseeable future, for better or worse. The more involved and informed every part of our community is, the more we can help shape its impact. This survey is one more way to get involved and help guide future efforts,” said Tamera Lynn Stewart, Policy Director for P3 Political Action Alliance.

You can read the revised draft of the CDC guideline and leave an online comment in the Federal Register by clicking here. Comments must be received by April 11.

Patients and Providers Want CDC Opioid Guideline Revoked

By Pat Anson, PNN Editor

The CDC opioid prescribing guideline has failed to reduce addiction and overdoses, significantly worsened the quality of pain care in the United States and should be revoked, according to a large new survey of patients and healthcare providers by Pain News Network. Over two-thirds believe the federal government should not have guidelines for opioid medication and that treatment decisions should be left to patients and doctors.

Nearly 4,200 patients, providers and caretakers participated in PNN’s online survey, which was conducted as the Centers for Disease Control and Prevention prepares to update and possibly expand its controversial 2016 guideline.

Although voluntary and only intended for primary care physicians, the guideline has become the standard of care for pain management in the U.S., with many doctors, insurers, pharmacies and regulators adopting its recommendations as policy, such as limiting opioid doses to no more than 90 morphine milligram equivalents (MME) per day. Some providers have gone even further and stopped prescribing opioids altogether, rather than risk scrutiny from law enforcement or state medical boards.

The stated goal of the guideline was to “improve the safety and effectiveness of pain treatment” and reduce the risk of opioid addiction and overdose. But survey respondents overwhelmingly believe the CDC failed to achieve its goals, and that its recommendations have stigmatized patients and reduced access to pain management. When asked if the CDC guideline has improved the quality of pain care, nearly 97% said no.

“They have done immeasurable damage to chronic intractable pain patients all across America. There have been suicides, people have lost their jobs and their entire quality of life because of them,” one patient told us.

“In 40 years as a pain specialist, I have never seen patients with pain (acute, chronic and cancer) so mistreated, abandoned and unable to access pain treatment as a direct result of the CDC Guidelines,” a doctor wrote.

“Due to inadequate pain control many chronic pain patients, including myself, attempted suicide to get relief of intolerable pain. I wish I had succeeded,” another patient wrote.

HAS THE CDC OPIOID GUIDELINE IMPROVED THE QUALITY OF PAIN CARE?

Overdoses Rising

Except for a brief decline in 2018, opioid overdoses in the U.S. have steadily risen since the CDC guideline was released. When all the data comes in, 2020 is expected to be the deadliest year on record for opioid overdoses, the vast majority involving illicit fentanyl and other street drugs, not pain medication.  

Survey respondents are well aware of that fact. When asked if the CDC guideline has been successful in reducing opioid addiction and overdoses, nearly 92% said no.

“I view the CDC guidelines to be a desperate attempt to control the opioid overdose crisis by curtailing the ability of doctors and pharmacists to provide adequate, legally-prescribed pain relief,” a patient said. “It’s net effect has resulted in the suffering of thousands of chronic pain patients, while doing nothing to curtail the sale and use of illegal street drugs.”

“The guidelines are barbaric! It's not stopped overdoses from drugs being brought in by cartels. It's only harmed patients,” another pain sufferer told us.

“I've know far too many people in my circle of extended friends and family who have died of unintentional overdose. Many had valid pain issues. Had been under the care of a doctor. Then, as these new rules changed the playing field, doctors arbitrarily reduced prescriptions,” a patient said.

HAS THE CDC GUIDELINE REDUCED OPIOID ADDICTION AND OVERDOSES?

The CDC has been aware of these problems since the guideline’s inception. But not until 2019 did the agency acknowledge the guideline was harming patients and pledge to “clarify its recommendations.” Two years later, the CDC is still working on its clarification, which may not be finalized until 2022.

‘Throw the Whole Mess Out’

Most survey respondents – nearly 75% -- believe the entire guideline should be withdrawn or revoked. Less than one in four (23%) believe changes can be made to make the recommendations more effective. And fewer than one percent (0.38%) believe the guideline should be left the way it is.

“These guidelines need to be repealed and government needs to get out of the confidential doctor/patient relationship now and forever,” a patient wrote.

“The CDC guideline is interfering with the ethical practice of medicine between patients and physicians. There is never a ‘one size fits all’ model in medicine, and trying to create one is, and has been, detrimental to the doctor-patient relationship, and more importantly, to quality patient care in an underserved and vulnerable patient population,” a provider wrote.

“These guidelines have done more damage to acute and chronic pain patients than I have ever seen in practice. This is a decision between providers and patients, and federal government needs to stay out of it,” another provider wrote.

WHAT SHOULD BE DONE WITH CDC GUIDELINE?

CDC ‘Didn’t Care’ About Guideline’s Misapplication

The survey found a significant amount of distrust in CDC. Asked if the agency could handle the revision of the guideline in an unbiased, scientific and impartial manner, over 89% said no.

“Throw the whole mess out! Let our doctors decided what works for each patient for gods sake. Before we lose more people. And stop demonizing safe medication and pushing dangerous ones so big pharma can profit even more,” a patient wrote. “We KNOW what's going on here and its disgusting.”

“These guidelines are clearly biased to the point of corruption, and it has caused terrible disruption in the lives of literally millions of patients,” another patient said.

"It is unbelievable that this horrific mistake has not been rectified; the possibility that they are using the same biased, corrupt, incompetent committee to write the updates is purely fraudulent.”

DO YOU TRUST CDC TO REVISE THE GUIDELINE IN AN UNBIASED, SCIENTIFIC MANNER?

“While it is clear the CDC didn't intend the guidelines be used as law, it is also clear they didn't care that the guidelines were being misapplied, misunderstood, misappropriated and maliciously used to further an agenda not to help anyone,” a patient wrote.

Less than 4% of respondents believe the CDC is best qualified to create a federal guideline for opioid prescribing. About 9% would prefer to have the Food and Drug Administration write the guideline. But nearly 68% believe there should be no federal guideline for opioid medication.

“Physicians should be able to manage their patients’ pain without fear of agencies monitoring and implementing guidelines that limit their ability to properly manage and treat and individuals pain. Chronic pain and acute pain is individually subjective and no ONE agency should be able to determine how or what manages an individuals pain,” a provider wrote.

“These guidelines are an unmitigated disaster for the last 5 plus years and those responsible for creating the mess should be held accountable for the damage they created and continue to create. How many suicides? How many overdoses from turning to the ‘street’ for relief from pain? How in hell did the CDC become the authority?” asked one patient.

Nine out of ten patients said their pain levels and quality have life have grown worse since the CDC guideline was released. For further details, click here.

(The PNN survey was conducted online and through social media from March 15 to April 17. A total of 4,185 people in the United States participated, including 3,926 who identified themselves as chronic, acute or intractable pain patients; 92 doctors or healthcare providers; and 167 people who said they were a caretaker, spouse, loved one or friend of a patient. There were no significant differences in responses between the three groups. Thanks to everyone who participated in this valuable survey. To see the full survey findings, click here.)