Mistrust Shadows CDC Over New Opioid Dose Guidance

By Pat Anson, PNN Editor

Pain patients and healthcare providers are giving mixed reviews to proposed changes to the CDC opioid guideline, according to a large new survey that found many are skeptical the revisions will make doctors more willing to prescribe opioids. Others fear the revised draft could lead to even lower and ineffective doses of opioids being prescribed.

Over 2,500 patients, providers and caregivers responded to PNN’s survey on the revised opioid guideline, which is intended to undo some of the damage caused by the agency’s 2016 guideline.

States, insurers, regulators and law enforcement made many of the original guideline’s voluntary recommendations mandatory, resulting in millions of patients being abruptly tapered or taken off opioids. Fearing scrutiny or even prosecution for “overprescribing” opioids, some doctors stopped treating pain altogether.

Like the original guideline, the revised draft still discourages the use of opioids, but clearly states the CDC’s recommendations are intended “to support, not supplant, clinical judgment” and “should not be applied as inflexible standards of care.”

When asked if the revised 211-page guideline is an improvement over the original, only four out of ten people (39%) said it was “improved” or “much improved.”  Most respondents said it was about the same or even worse.

“It is very long and involved but seems like a bait and switch. Starts out speaking to the damage done by 2016 guideline. Then seems to restrict needed medication even more,” a patient told us. 

“Both the original and the revised guidelines are fraught with politics. Nothing's changed. The guidelines are still as harmful as they were when they were published in 2016. No appreciable improvements have been made,” said another. 

IS THE REVISED GUIDELINE AN IMPROVEMENT OVER 2016 GUIDELINE?

“It looks like a step in the right direction, but I'm not sure. I don't think the CDC should be interfering between doctors and their patients,” another patient said.  “My current doctor had his practice raided in a Gestapo-like action that found zero violations. CDC and DEA need to back off and let doctors treat their patients.”

50 MME Perceived As New Hard Limit

The 2016 guideline strongly encouraged doctors not to write prescriptions that exceed doses of 90 morphine milligram equivalents (MME) per day. That 90 MME limit has been dropped from the revised draft, but doctors are still urged to be cautious about going over 50 MME because higher doses have “diminishing returns in benefits relative to risks.”

The language about 50 MME is essentially unchanged from the 2016 guideline, but many patients and providers are worried about it. Over 97% of survey respondents said they are “somewhat concerned” or “very concerned” that 50 MME will be seen as the new hard limit for doses, a level many consider inadequate for pain relief.

“The CDC is assuming that, by reducing the misapplied 90 MME standard to 50 MME, it will reduce misapplication of the standard. Faulty logic. It will, in fact, make it even harder for pain patients to be prescribed more than 50 MME, and the result will be more people in more pain and an increase in pain patient suicides,” one patient told us.

“There should be NO MME! It is too specific to use for everyone. We shouldn't be treated all the same. Each person's pain is different. It was bad enough when it was 90, to now reduce it to 50 MME is just awful,” another patient wrote.  

“50 MME will be the new 90 MME. That’s the crux of it, despite the flowery fenestration and hollow words that 2016 gave the wrong impression. They are merely patronizing us, while lowering the guidelines for how much doctors will actually prescribe,” said another.

ARE YOU CONCERNED 50 MME WILL BE SEEN AS THE NEW HARD LIMIT FOR OPIOIDS?

“There should be no specific numbers concerning daily dosages. This should be between a patient and their doctor. All of the state laws that control opioid medications need to be overturned and the CDC needs to stop attempting to practice medicine,” a patient said.

‘Leave Pain Management to the Experts’

People are also skeptical that the revisions will ease doctors’ concerns about prescribing opioids. Nearly two-thirds (61%) said the changes won’t make doctors more willing to prescribe the drugs. 

“I'm glad they are changing, but I think the damage has already been done. My doctor took me off pain meds completely and life has been a living hell! Now that he's done that, I don't think he will be open to prescribing them again no matter how many chronic pain issues I have!” said a patient. 

“My doctors took me off pain meds because they were afraid of losing their license and they still are. I sent (them) the link to the new guidelines and they still will not do anything for my pain,” another patient said. “One doctor said, ‘If we give pain meds to our patients who need it, CDC will still be after us for giving pain meds so we can’t take that chance.’” 

DO YOU THINK REVISIONS WILL MAKE DOCTORS MORE WILLING TO PRESCRIBE OPIOIDS?

“I think the CDC needs to keep his nose out of providers business. I’ve been practicing pain management for 22 years,” a doctor told us. “The CDC guidelines of 2016 have ruined untold lives because they stuck their nose somewhere they shouldn’t have. Leave pain management to the experts and let them decide what each patient needs based on their individual condition.” 

Guideline Expansion

Patients and providers are a bit more receptive about the guideline being expanded to include recommendations for treating short-term acute pain (55%), as well as a handful of specific pain conditions, such as low back pain and migraine (53%).  

Patients with severe constant pain — known an intractable pain — feel left out of the guideline. The word “intractable” is not even mentioned in the draft revision. While some types of severe pain, like cancer pain and sickle cell pain, are specifically excluded from the guideline, others are not.

“I wish that consideration would be given for patients who have intractable pain and have already jumped through the hoops of therapy and other treatments and have found that they didn’t help. It is beyond discouraging to have to repeat trials of treatments that never work for that particular patient,” said one patient.

“There is no difference in cancer and non-cancer pain. Pain is pain. If they’re going to include any conditions (which I don’t think they should) they should recognize rare and incurable illnesses, not just low back pain, sickle cell, and cancer,” another patient wrote. 

End Mandatory Policies

Large majorities also think the CDC needs to do a better job tracking the impact of its guideline on patients (95%) and making sure it is not used to create mandatory policies (96%).

The American Medical Association has even recommended that the CDC undertake a “a national marketing and communications campaign” to make clear to law enforcement and healthcare providers that the revised guideline should not be used like its predecessor to adopt rules that replace individualized patient care. 

Many of our survey respondents agree. Without the elimination of laws and policies that dictate how pain should be treated, no amount of revisions to the guideline will not undo the damage the CDC’s recommendations have already caused. 

“It should be made clear to the doctors willing, but currently afraid, to prescribe opioids now for fear of fines, loss of income and even jail, that they won't be penalized for properly caring for their patients,” said one patient. “These doctors feel their livelihood has been threatened just for doing their job, which is to help people in pain. They are no longer doing that.” 

For more survey findings, including whether respondents think the CDC guideline should be revised or revoked, click here. You can see the full survey results here.

The CDC recently close a public comment period on the guideline revisions. Over 5,400 comments have been received and publicly posted, which you can read here. The CDC is not expected to adopt the final version of its revised guideline until late this year.  

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.

Pain Patients Worried About CDC Expanding Opioid Guideline

By Pat Anson, PNN Editor

 “These guidelines have been a disaster for people with chronic pain.” 

“The guideline is flat out wrong on facts, wrong on science and wrong on medical ethics.” 

“The CDC has no qualifications or authority to develop pain management guidelines, especially those pertaining to opioid therapy.” 

Those are just a few of the comments we received from nearly 4,200 pain patients and healthcare providers who participated in PNN’s survey on impending changes to the CDC's opioid prescribing guideline. 

“It has been misunderstood, misapplied, bastardized and weaponized to use against chronic pain patients,” is how one pain sufferer put it.  

People obviously have strong opinions about the CDC guideline. Can it be changed and made more effective? Or should the entire guideline be thrown out? 

Nearly 75% of the people we surveyed believe the guideline should be withdrawn or revoked. That’s not likely to happen, however, as the CDC completes a lengthy review and update of the guideline that started two years ago.

If anything, the agency seems intent on expanding the guideline to include specific recommendations for treating short-term acute pain, migraine and possibly other pain conditions such as fibromyalgia. 

That’s the route recently taken by two advisory panels in Europe, which released guidelines that are even stricter on the use of opioids than the CDC’s.

WHAT SHOULD BE DONE WITH CDC OPIOID GUIDELINE?

This month the UK’s National Institute for Health and Care Excellence advised doctors not to prescribe opioids or any other pain reliever for fibromyalgia, chronic headache, musculoskeletal pain and other types of “primary chronic pain” for which there is no known cause.

In March, the European Pain Federation (EFIC) released similar guidelines, saying “opioids should not be prescribed for people with chronic primary pain as they do not work for these patients.”

At least two members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group, served as consultants to the EFIC in making its recommendation. PROP has long urged the CDC to make a similar statement in its guideline.

“This recommendation should explicitly state that opioids should be avoided for fibromyalgia, chronic headache and chronic low back pain,” PROP’s board wrote in a 2015 letter to the CDC’s Dr. Deborah Dowell, one of the co-authors of the 2016 guideline. “We are suggesting this change because evidence-based reviews and expert consensus have found the long-term use of opioids is likely to be counter-productive for fibromyalgia, chronic headache and chronic axial low back pain.”

PROP didn’t get its explicit statement in 2016, but it may be getting another chance as the CDC revises and possibly expands its guideline.

Little Support for Guideline Expansion

In our survey, patients and providers seem to be wary about expanding the guideline to include treatment recommendations for specific conditions. Only about 40% support guidelines for low back pain, fibromyalgia and short-term acute pain. Many believe the CDC has already gone too far and some wonder where the agency gets the regulatory authority to create guidelines for medical conditions.    

“CDC should never have developed and issued opioid prescribing guideline, as such work falls outside CDC's mission and expertise. If guidelines are needed, FDA should write,” one respondent said.

“The CDC guideline would be fine, if if were not being weaponized. There is nothing wrong with having guidelines for non-specialists. However, insurance companies have grabbed hold of it and are now using it to deny coverage of what they think is outside the guidelines,” said another.  

“Pain and it’s treatment should have a guideline but with the acknowledgment that its never one size fits all,” a patient wrote. “Some standardized measures are useful to help physicians make decisions in acute, cancer, non-cancer pain, and non-narcotic options should be sought first.”

SHOULD CDC MAKE RECOMMENDATIONS FOR TREATING LOW BACK PAIN, FIBROMYLAGIA AND OTHER PAIN CONDITIONS?

Strong Opposition to 90 MME Limit

If there’s anything that patients and providers want changed, it’s the guideline’s recommended dose limit of 90 MME (morphine milligram equivalent). Although voluntary, the daily dose limit has been rigidly applied by many doctors, pharmacists, insurers and regulators. As a result, patients who’ve taken higher doses of opioids for years — and done it safely — suddenly found themselves being tapered to 90 MME or less.

“My spouse has Ehlers Danlos Syndrome. Her chronic severe pain kept her bedridden for years until a doctor found an opioid regimen that worked. She had her life back and was able to function out of bed. This worked for over 12 years,” one man told us.

“Now, the CDC guidelines have caused local practitioners to require cutting her MME equivalent per day from about 300 to 90. They fear liability. When they discuss tapering and are confronted with the question, ‘But this is a genetic tissue disorder, it is not going to taper away,’ they have nothing to say except to point the finger at the CDC and say they are afraid of being sued. This is going to put her back in bed and, I'm afraid, kill her.”

Asked what changes should be made to the CDC’s recommended dose limit of 90 MME, nearly 87% said there should be no limit on opioid dosages.

“My doctor drastically reduced my medication and I suffer for it. Can hardly walk, can't function like I want to, no one cares as long as its 90 MME. Doesn't matter if I require higher dose and have tolerated it just fine for years,” a patient said.

“I was force tapered in 2016. I've been unable to fill legitimate prescriptions several times and denied meds by my insurance unless I use what they say is equivalent,” a patient told us.

“I was forced tapered from 550mg down to 90mg without my consent,” another patient wrote.

“Pretty much told that I would either take the lower prescribed dose or suck it up without pain relief,” said another.

WHAT CHANGES SHOULD BE MADE TO CDC'S DOSE LIMIT OF 90 MME?

“All of a sudden you can't have your regular prescription. Doesn't matter if it effects my health adversely. Blood pressure through the roof, NEVER had that problem before with it, but keep that 90 MME no matter what. Doctors sympathize but they are too scared to help you,” another patient said. “This rule doesn't help chronic pain patients at all and it doesn't stop overdoses. It needs to change.”

“My physician has been told by the hospital board that they have to reduce the amount of pain medication to ALL patients to an equivalent of 90mg. I have been taken off 70mg of my pain medications that I have taken for over 20 years,” wrote yet another patient.

“The doctor has told me he must continue to taper me more. He knows I am suffering but his hands are tied. The CDC must allow physicians that are experts in the pain management field to treat their patients as individuals. I have a lot more to say but can not type anymore as it causes me great amount of pain to use my hands and fingers.”

We received thousands of comments like these from patients, doctors, caretakers, spouses and loved ones.

One of the more poignant ones came from an intractable pain patient who considers herself lucky to have a doctor who slowly tapered her down to 90 MME. That doctor has now retired. She fears for her future and those of other patients.

“It’s my feeling we’ll look back on all this one day and realize this was in every aspect of the word a genocide; an attack on the weakest of us, the ones who most needed protection, but were mercilessly denied it.”

— Intractable Pain Patient

“I’ve managed to get to 90 MME from a dose much higher, as I was most definitely a high dose patient, but it only happened because I had good care for all those years,” she said. “I experience more nerve pain now than ever before, and I still very much fear being cut off.

“God bless any doctor or human being who’s willing to support us during this terrible most tragic of times. We’re being put in a position to lose all semblance of pain management for good if this downward spiral is allowed to continue. That’s such an inhumane and ugly thing to do, after countless lovely vibrant lives have been snuffed out by the lack of it already. It’s my feeling we’ll look back on all this one day and realize this was in every aspect of the word a genocide; an attack on the weakest of us, the ones who most needed protection, but were mercilessly denied it.”

(PNN’s 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. Thanks to everyone who participated in this valuable survey. To see the full survey findings, click here.)