Where is CDC’s Guidance About Its Opioid Guideline?

By Carol Levy, PNN Columnist

By happenstance, I recently came across the CDC's 2022 revised opioid prescribing guideline. Too many doctors and states saw the agency’s original 2016 guideline as being written in stone -- not the voluntary set of recommendations they were intended to be.

To their credit, the CDC tried to address that misconception in its updated guideline:

“Recommendations are voluntary and are intended to support, not supplant, individualized, person-centered care. Flexibility to meet the care needs and the clinical circumstances of a specific patient is paramount.”

The CDC also acknowledged the damage done by its 2016 guideline, when many pain patients were forcibly tapered or cutoff from opioids, regardless of their diagnosis or condition. 

Some patients were abandoned by doctors who no longer wanted to risk going to prison for prescribing opioids. Other physicians retired or closed their offices, sometimes without warning. And several states passed legislation limiting how many days initial opioid prescriptions could be written for.

It is always hard to put the genie back in the bottle. Two years after the revised guideline was released, about 90% of patients still have trouble getting their opioid prescriptions filled at pharmacies. Others have to fight with their insurance company to get opioid medication covered.

Patients are still being forced into withdrawal and disability, despite a history of taking opioids safely and responsibly. Some will have to leave jobs they could only perform with the help of opioids. Others can’t play with their kids, walk the dog or even get out of bed, because they are no longer able to get the medication that helped them lead relatively normal lives.

It should not have taken CDC six years to revise the opioid guideline, to make clear that they were only recommendations and never a mandate.

Is there a way to undo the damage? For the doctors who closed their practices or stopped treating pain, it is probably too late. For the patients who chose suicide because they could no longer get opioids, it is definitely too late

But maybe, just maybe, we can persuade doctors, pharmacists, lawmakers and insurers to take another look at the revised opioid guideline and convince them they are out of line.

It would be helpful if the CDC joined in an effort to fix the mess that it helped create.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here. 

New CDC Guideline: Too Little, Too Late for Chronic Pain Patients

By Sam Whitehead and Andy Miller, Kaiser Health News

Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain.

“A lot of them are straight-up insulting,” said the 40-year-old, who lives in Dallas. “They say things like ‘We don’t treat drug addicts.’”

Layman has tried a host of non-opioid treatments to help with the intense daily pain caused by double scoliosis, a collapsed spinal disc, and facet joint arthritis. But she said nothing worked as well as methadone, an opioid she has taken since 2013.

The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won't do the same. “If something should happen to him, there's nowhere for me to go,” she said.

Layman is one of the millions in the U.S. living with chronic pain. Many have struggled to get opioid prescriptions written and filled since 2016 guidelines from the Centers for Disease Control and Prevention inspired laws cracking down on doctor and pharmacy practices. The CDC recently updated those recommendations to try to ease their impact, but doctors, patients, researchers, and advocates say the damage is done.

“We had a massive opioid problem that needed to be rectified,” said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that analyzes prescription drug pricing. “But the federal crackdowns and guidelines have created collateral damage: patients left high and dry.”

Born of an effort to fight the nation’s overdose crisis, the guidance led to legal restrictions on doctors’ ability to prescribe painkillers. The recommendations left many patients grappling with the mental and physical health consequences of rapid dose tapering or abruptly stopping medication they’d been taking for years, which carries risks of withdrawal, depression, anxiety, and even suicide.

Opioid Guideline Revised

In November, the agency released new guidelines, encouraging physicians to focus on the individual needs of patients. While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use.

But some doctors worry the new recommendations will take a long time to make a meaningful change — and may be too little, too late for some patients. The reasons include a lack of coordination from other federal agencies, fear of legal consequences among providers, state policymakers hesitant to tweak laws, and widespread stigma surrounding opioid medication.

The 2016 guidelines for prescribing opioids to people with chronic pain filled a vacuum for state officials searching for solutions to the overdose crisis, said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School.

The dozens of laws that states passed limiting how providers prescribe or dispense those medications, she said, had an effect: a decline in opioid prescriptions even as overdoses continued to climb.

The first CDC guidelines “put everybody on notice,’’ said Dr. Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force. Physicians reduced the number of opioid pills they prescribe after surgeries, he said. The 2022 revisions are “a dramatic change,” he said.

The human toll of the opioid crisis is hard to overstate. Opioid overdose deaths have risen steadily in the U.S. in the past two decades, with a spike early in the covid-19 pandemic. The CDC says illicit fentanyl has fueled a recent surge in overdose deaths.

Taking into account the perspective of chronic pain patients, the latest recommendations try to scale back some of the harms to people who had benefited from opioids but were cut off, said Dr. Jeanmarie Perrone, director of the Penn Medicine Center for Addiction Medicine and Policy.

“I hope we just continue to spread caution without spreading too much fear about never using opioids,” said Perrone, who helped craft the CDC’s latest recommendations.

Christopher Jones, director of the CDC’s National Center for Injury Prevention and Control, said the updated recommendations are not a regulatory mandate but only a tool to help doctors “make informed, person-centered decisions related to pain care.”

Multiple studies question whether opioids are the most effective way to treat chronic pain in the long term. But drug tapering is associated with deaths from overdose and suicide, with risk increasing the longer a person had been taking opioids, according to research by Dr. Stefan Kertesz, a professor of medicine at the University of Alabama-Birmingham.

He said the new CDC guidance reflects “an extraordinary amount of input” from chronic pain patients and their doctors but doubts it will have much of an impact if the FDA and the Drug Enforcement Administration don’t change how they enforce federal laws.

Patients Still Not Getting Needed Medication

The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. The DEA, which investigates physicians suspected of illegally prescribing opioids, declined to comment.

The DEA’s pursuit of doctors put Danny Elliott of Warner Robins, Georgia, in a horrible predicament, said his brother, Jim.

In 1991, Danny, a pharmaceutical company rep, suffered an electric shock. He took pain medicine for the resulting brain injury for years until his doctor faced federal charges of illegally dispensing prescription opioids, Jim said.

Danny turned to doctors out of state — first in Texas and then in California. But Danny’s latest physician had his license suspended by the DEA last year, and he couldn’t find a new doctor who would prescribe those medications, Jim said.

Danny, 61, and his wife, Gretchen, 59, died by suicide in November. “I’m really frustrated and angry about pain patients being cut off,” Jim said.

Danny became an advocate against forced drug tapering before he died. Chronic pain patients who spoke with KHN pointed to his plight in calling for more access to opioid medications.

DANNY AND GRETCHEN ELLIOT

Even for people with prescriptions, it’s not always easy to get the drugs they need.

Pharmacy chains and drug wholesalers have settled lawsuits for billions of dollars over their alleged role in the opioid crisis. Some pharmacies have seen their opioid allocations limited or cut off, noted Ciaccia, with 3 Axis Advisors.

Rheba Smith, 61, of Atlanta, said that in December her pharmacy stopped filling her prescriptions for Percocet and MS Contin. She had taken those opioid medications for years to manage chronic pain after her iliac nerve was mistakenly cut during surgery, she said.

Smith said she visited nearly two dozen pharmacies in early January but could not find one that would fill her prescriptions. She finally found a local mail-order pharmacy that filled a one-month supply of Percocet. But now that drug, along with MS Contin, are not available, the pharmacy told her.

“It has been a horrible three months. I have been in terrible pain,” Smith said.

Many patients fear a future of constant pain. Layman thinks about the lengths she’d go to in order to get medication.

“Would you be willing to buy drugs off the street? Would you be willing to go to an addiction clinic and try to get pain treatment there? What are you willing to do to stay alive?” she said. “That is what it comes down to.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

CDC Revises Opioid Guideline, But Can It Undo the Damage to Pain Care?

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has released a long-awaited final update to its controversial opioid prescribing guideline, expanding the recommendations to include patients suffering from short and long-term pain, while at the same time giving doctors more flexibility when prescribing opioids.

Although voluntary and only intended for primary care providers treating chronic pain, the original 2016 guideline was adopted as a mandatory opioid policy by many states, insurers, medical societies and even law enforcement agencies, resulting in millions of patients being reduced to lower ineffective doses or taken off opioids and forced into withdrawal. The newly revised guideline is intended to end the “one-size-fits-all” approach to pain care and a public health experiment gone wrong.

“Fundamentally, the framing of the guideline is that pain happens in many different ways, in different intensities, and patients respond to different treatments in different ways. And so it is paramount that clinical decisions are based on the individual needs of the patient,” said Christopher Jones, PharmD, Acting Director of CDC’s National Center for Injury Prevention and Control and a guideline co-author.

“In some cases opioids, even opioids at high doses, are the right thing to do for the patient. It’s more about working with the patient to set expectations and goals and look at the full range of treatments. And if opioids are the right thing or opioids plus non-pharmacological treatments, or opioids plus NSAIDs, if that’s the right thing and the patient is doing well and meeting their goals, this guideline supports that. It doesn’t dictate any particular type of care that any particular patient has to receive.”

Benefits vs Risks

To be clear, the revised guideline still takes a dim view of opioid pain medication and its potential to result in addiction and overdose. Doctors are advised to “maximize” the use of non-opioid drugs and non-pharmacological treatments, and should “only consider initiating opioid therapy if expected benefits for pain and function are anticipated to outweigh risks to the patient.” When opioids are prescribed, it should be at the “lowest possible effective dose.”   

Other notable changes in the guideline:

• A more cautious, slower approach to opioid tapering that strongly encourages patient buy-in before doses are reduced

• Drug testing only recommended when “appropriate.” Doctors should first “consider the benefits and risks of toxicology tests”

• Instead of “extreme” caution about taking opioids with benzodiazepines and other anti-anxiety drugs, “particular” caution is recommended

• Patients should not be dismissed for failing a drug test or because of information found in prescription drug databases (PDMPs)

Importantly, the revised guideline also removes a recommendation in the 2016 guideline that daily opioid doses not exceed 90 MME (morphine milligram equivalents), which was widely seen as a hard limit. It is replaced with cautionary language about doses above 50 MME being “more likely to yield diminishing returns.”  

“There are tweaks, but I think they are tweaks that are meaningful. That doesn’t mean its not still built on a rotten core,” says Kate Nicholson, Executive Director of the National Pain Advocacy Center (NPAC), who belonged to an independent advisory panel that advised the CDC to drop all references to MME.

Nicholson is concerned the 50 MME threshold – which is mentioned two dozen times in the revised guideline – will be misapplied as the new hard limit.

“They still overly focus on MME’s,” she told PNN. “They do qualify it whenever they mention it, but it’s still there, it’s there a lot, and it’s aligned strongly with risk. My concerns are misapplication, even though they say repeatedly ‘Do not apply this as a strict threshold.’”

Nicholson is also concerned about the guideline’s expansion beyond chronic pain (pain lasting three months or more) to include people with short-term acute pain from trauma or surgery, as well as “sub-acute” pain lasting one to three months.

“It’s good to cover all pain and not just single out chronic pain. So in theory I think it’s fine, but in practice, given that they acknowledge again and again the problems of the 2016 guideline. Usually, you check your safety features on the airplane before you expand the fleet. And they didn’t. They did it all at once,” she said. “I also have concerns that it’s a clinical practice guideline written mostly by non-clinicians and by people who are not experts in pain. And it’s now going to cover how all pain should be treated?”

For some patient advocates, no amount of revisions are acceptable. They want the CDC guideline revoked.

“False claims of one-size-fits-all dose thresholds are alive and well in this final draft. More than ever, I am convinced that the CDC must be restricted by law from issuing practice guidelines of this type,” says patient advocate Richard “Red” Lawhern. “It doubles down on lies and cherry-picked research intended to further suppress opioid prescribing at the expense of undertreating patients and driving clinicians out of pain management practice.”

Most of the mainstream media coverage of the revised guideline portrayed it as a weaker or softened version of the 2016 guideline. That is puzzling to Andrew Kolodny, MD, founder and president of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), who believes the new guideline is “much stronger” than the original.

“Press coverage of the CDC opioid guideline is wacky,” Kolodny wrote on Twitter. “CDC issued a guideline much stronger than the 2016 version (high dose defined as 50 MME/day instead of 90) but press headlines say CDC softened guideline.”

Reversing the Damage

Many patient advocates believe it will be hard to unwind the damage caused by the 2016 guideline to patients, pain management practices, and the healthcare system in general.

“Many laws, regulations, and policies were implemented from the rigid application of the 2016 opioid dosage thresholds. I believe this means many physicians may remain reluctant to prescribe opioids when indicated for chronic pain, and patients may continue to find access to treatment a challenge,” said Dr. Lynn Webster, Senior Fellow at the Center for U.S. Policy and past president of the American Academy of Pain Medicine

“To reverse the damage, the CDC could take an active and vocal public role in publicizing the statements about the guideline not being a law, regulation or policy. The agency should make sure that governmental and enforcement entities know there’s a new CDC statement on these matters.”

Chris Jones said the CDC would monitor how the revised guideline is implemented by states, insurers and others to prevent further misapplication. But he was vague about how it would be done, saying it needs to be handled on a case-by-case basis and while recognizing that “states do what states do.” The CDC has no legal authority to enforce its recommendations.

 “As with any clinical practice guideline, the work doesn’t stop today. It really starts as we engage with the clinical community, as we engage with patient organizations with educational opportunities. Certainly engaging with insurers and others to say, ‘Here’s the latest evidence about the range of treatment options that can be effective,’” he told PNN. “But we’re still working through, from a policy perspective when we see misapplication, how to respond to that.”

Jones said he would be speaking next month to the National Conference of State Legislatures about the revised guideline and to reinforce the need for individualized patient care. He and the other guideline co-authors also published an op/od in The New England Journal of Medicine that cautions providers about misapplying the CDC’s recommendations.

Webster thinks the CDC’s efforts to combat addiction and overdoses should be refocused on illicit fentanyl and other street drugs, which are involved in the vast majority of drugs deaths. In 2021, nearly 108,000 Americans died from overdoses, a record number.

“I think it is important to remember that the goal of the guideline was to reduce the number of overdose deaths by reducing the opioid supply or amount prescribed. It hasn’t worked out that way,” Webster said. “Over the past decade, opioid prescribing has plummeted, but the number of overdoses has skyrocketed. The CDC should now focus on the cause of most opioid-related overdose deaths, which is to bring attention to the social and economic factors that create the demand for so many Americans to escape the pain of living.” 

Evidence Used to Justify CDC Opioid Guideline ‘No Longer Present’

By Pat Anson, PNN Editor

Anti-opioid activists and public health officials have long argued that opioid “overprescribing” fueled the overdose crisis in the United States, causing drug deaths to surge to record levels.

“This rise is directly correlated with increased prescribing for chronic pain,” Dr. Jane Ballantyne, then-president of Physicians for Responsible Opioid Prescribing (PROP), wrote in a 2015 letter to the National Institutes of Health.

That claim was repeated the following year by the CDC when the agency released its controversial opioid guideline. “Overprescribing opioids – largely for chronic pain – is a key driver of America’s drug overdose epidemic,” then-CDC director Dr. Thomas Frieden said in a news release.   

But a new analysis debunks the overprescribing myth, finding the “direct correlations” cited by Frieden, Ballantyne and others are no longer valid, if they ever were.

In a study recently published in Frontiers of Pain Research, independent researchers Larry Aubry and B. Thomas Carr examined opioid prescribing trends and overdose deaths from 2010 to 2019, using the same data sources that the CDC guideline is based on.

“The direct correlations used to justify the CDC guideline… are no longer present,” they reported.

Aubry and Carr found that opioid prescribing, when measured in morphine milligram equivalents (MME), was in steep decline years before the guideline was even released. That trend accelerated even further when regulators, insurers and healthcare providers started following the CDC’s recommendations.

If the overprescribing theory were true, you would expect drug deaths to go down as opioid sales did. But in subsequent years, overdoses linked to prescription opioids stayed flat and drug deaths surged even higher. In research terms, that is known as a “negative correlation” -- a trend not supported by facts.

Looking at data from all 50 states, Aubry and Carr found “significant negative correlation” in 38 states between overdoses and prescription opioids, and a positive correlation in only 2 states. In 10 states, there appeared to be no relationship at all. That calls into question ones of the primary recommendations of the CDC guideline; that daily opioid doses not exceed 90 MME.

“This recommendation is not supported by the available data. Regression analyses of (total opioid deaths, opioid overdose deaths, opioid treatment admissions, and prescription opioid sales) among patients receiving doses of at least 90 MME/day show significant negative relationships, indicating that lower (prescription opioid sales) in this high-dosage cohort do not correspond to lower death rates,” Aubry and Carr reported.

The CDC estimates that over 107,000 people died of overdoses in 2021, well above the 63,600 drug deaths reported in 2016, the year the guideline was released.

Negative Correlation Between Overdoses and Opioid Prescribing

sOURCE: FRONTIERS OF PAIN RESEARCH

Patient Outcomes Not Being Monitored

Even more concerning is that the CDC does not appear to be tracking the impact of its 2016 guideline on pain patients, even as it prepares a long-delayed update to the guideline. As PNN has reported, the CDC ignored warnings from its own consultants that the agency “should consider conducting more research” on patients, many of whom were abruptly tapered or abandoned by their doctors after the guideline’s release.

“Reasonable judgment would dictate tracking and reporting of chronic pain patient outcomes (deaths, suicides, returns in benefits, reported pain, function, etc.) for individuals since the guideline or the guideline update. However, there appears to be no publicly available evidence that a monitoring process is required or is planned to measure and confirm outcomes,” Aubry and Carr wrote.

PROP is not following the data either. In a recent debate, PROP board member Adriane Fugh-Berman claimed that pain patients addicted to prescription opioids were still fueling the overdose epidemic, even though illicit fentanyl and other street drugs are linked to the vast majority of deaths.

“Those patients went to the street. They got addicted to heroin. The reason those deaths went up is because the illicit supply of opioids has become laced with fentanyl and has become highly dangerous,” Fugh-Berman said, without citing any evidence. “It’s not that prescription opioids have nothing to do with it.  Many patients started on prescription opioids ended up on the streets looking for heroin. They’re dying because the illicit opioid products have become extremely dangerous. That’s what’s killing people.”

Fugh-Berman is not an unbiased observer. She and at least five other PROP board members have testified as paid expert witnesses in opioid litigation cases, making as much as $850 an hour for their testimony blaming drug makers for the opioid crisis.

A recent analysis of overdose deaths in 2020 found that prescription opioids ranked well behind illicit fentanyl, alcohol, cocaine, methamphetamine and heroin as the leading cause of drug deaths.   

At least one critic of opioid prescribing feels it’s time to change the focus on why so many Americans are overdosing. Beth Macy, who wrote the best-selling book “Dopesick,” says drug use has changed. 

“At this point, too much attention is focused on stemming the oversupply of prescription opioids. We now have a generation of drug users that started with heroin and fentanyl.”

— Beth Macy, author of "Dopesick"

“At this point, too much attention is focused on stemming the oversupply of prescription opioids,” Macy writes in her new book, ‘Raising Lazarus.’ “We now have a generation of drug users that started with heroin and fentanyl.”

As for the CDC, a spokesperson tells PNN the agency won’t publish its guideline revision until late this year, nearly seven years after the original guideline was released. 

“CDC is currently in the process of revising the draft update to the 2016 Guideline based on comments received during the public comment period and peer review. We anticipate the final Guideline will be released later this year,” the spokesperson said.

I’m Living Proof That Effective Pain Management Can Heal

By Heather Grace

My journey into what would become debilitating pain began at age 19, when my neck was injured in a head-on collision caused by a drunk driver. Being a backseat passenger in an older car meant there were no headrests.

I healed as best I could after the accident with chiropractic care and exercise. I was young and told myself I’d be fine, but sensed I wasn’t quite the same as before.

Nearly a decade of work in the IT field worsened the severity of my injury, due to faulty ergonomics. Between the severe pain and the horrors of the workers compensation system, it began to feel like I was in free fall. At my first visit with a prominent pain management specialist, I was told, “Normal is out the window for you.”

It was the worst thing I’d ever heard, so I began sobbing. What he said wasn’t actually cruel, it was honest. He could see that my body was broken by work comp care that included two botched neurosurgeries and one spinal discectomy-fusion surgery that came far too late to be a good thing. 

I was left with intractable pain and nerve damage, which would be diagnosed as Complex Regional Pain Syndrome (CRPS) Type II. The CRPS is not regional at all, but spread to the whole body, thanks to the impact on my spinal column and brain.

I would later also learn that I was born with Ehlers-Danlos Syndrome, a progressive connective tissue disease.

HEATHER GRACE

Intractable Pain Syndrome (IPS) isn’t well understood in mainstream medicine because it’s not very common. In fact, even after working in Continuing Medical Education for 10 years, I’d never heard of IPS until I was diagnosed with it. I didn’t know that it was possible to be in severe unceasing pain.

People with IPS experience major health problems throughout their lives because of the physical and psychological toll that pain takes on the brain and body. Treatment for this complex and disabling condition must be taken seriously and done correctly.

A New Future

After all this was explained to me by my doctor, I realized that to move forward with my life, I had to stop pinning my hopes on returning someday to “normal.” I had to grieve the loss of my former life. Once I did, a door was opened to a meaningful future for me.

Thanks to amazing treatment with a physician who also helped me focus on the future, I’m living again in a way I didn’t think was possible when I first sat down with my doctor in 2006. He found the right treatments for me, which included opioid pain medication.  

I’ve reduced my medication dose slowly over the years. I’m now taking less than one sixth the pain medication I started with. That’s because I’ve experienced neurogenesis, a form of healing in my nervous system.

It is possible for people like me to heal, albeit very slowly over time when they get the care that they need. Despite the severity of my conditions, I’m doing well. Contrary to popular opinion, patients who get the proper dose of pain meds don’t always require more and more medication. While some patients’ dosages stay the same, some of us are able to lower our doses when our health improves.  

I’ve come so far. In 2004, when I left the job I loved awaiting two major surgeries, I thought I’d never work again. But I was able to obtain a full-time job (with benefits!) in 2020. It required a major effort, but I got here because I had a good foundation of long-term effective pain management, which lessened the impact of pain on my overall wellness.

Opioid medication does not define my care, nor my life. Pain meds are merely a tool I’ve used to get well. Every patient should have access to individualized pain care with the treatment options that best work for them. It’s crucial for patients if they’re ever going to see their health improve.

I won’t lie, it’s been a struggle and I have had my share of setbacks too. Yet I know without question that pain medication was required in my case. It made a serious difference in my overall health and paved the way to my future too.  

Effective pain management for someone with IPS is as vital as care for any other serious illness. You’d never tell a diabetic that an arbitrary maximum dose of insulin was all they were allowed to have. Why are pain patients any different? None of us asked for the pain, nor do we like having to take a prescription drug that’s so socially maligned. These judgments exist nowhere outside of pain management. Why are people in pain treated so differently and with such suspicion?  

The fact is, when the CDC’s opioid prescribing guideline was released in 2016, the consequences were far-reaching and dire. Countless patients have needlessly suffered and died because they lost access to opioids or were tapered, based on the guideline’s recommendations. Many of those deaths have been due to the pain finally overtaking the body. Other patients have chosen to end their pain via suicide. Imagine being so ill that you were forced to make such a choice!  

Without access to effective individualized treatment by physicians whose options aren’t stifled by a system that doesn’t understand pain, many more people with serious diagnoses will develop intractable pain.

Those outside the treatment setting have no business undermining patients’ pain care protocols. They simply don’t have the knowledge to be involved on that level. That goes for the CDC, DEA, state medical boards and insurance companies — along with anyone else who gets in the way of pain patients having effective care. 

Sadly, I know it’s the workers compensation system that led to the severity of my illness. I got an extensive education on how an overburdened system not designed for people with serious healthcare needs can result in disability.  

Please don’t jeopardize the future of an entire branch of medicine any further. There are human lives on the line. Everyone knows someone living with chronic pain. Make the changes needed to continue treating people like me — people whose lives don’t have to end because they have a serious injury or illness. It’s crucial to roll back the damage done by the CDC guideline before we all lose access to pain management forever.

Heather Grace is a patient, advocate and member of For Grace’s Board of Governors. She’s worked for health-focused nonprofits most of her career & developed Continuing Medical Education (CME) for nearly a decade. Heather lives with Complex Regional Pain Syndrome II and the genetic condition Ehlers-Danlos Syndrome. Heather has a website on pain issues called Intractable Pain Journal.

Class Action Lawsuit by Pain Patient Against CVS Moves Forward

By Pat Anson, PNN Editor

A federal judge has ruled that a class action lawsuit against CVS may continue over the pharmacy chain’s refusal to fill high dose opioid prescriptions for a Florida woman.

Edith Fuog, a breast cancer survivor who lives with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions, filed suit against CVS in 2020, alleging the company discriminated against her and violated the American with Disabilities Act (ADA). Her complaint was filed in federal court in Rhode Island, where CVS has its corporate headquarters.

The lawsuit alleges that CVS pharmacists refused to fill her opioid prescriptions nearly 30 times because the daily doses exceeded 90 morphine milligram equivalents (MME), a threshold considered risky under the 2016 CDC opioid guideline. Although the guideline is voluntary, many healthcare providers have adopted it as a mandatory policy.   

This week Judge William Smith rejected a CVS motion to dismiss the lawsuit, essentially ruling that because Fuog needed a higher dose to treat pain from her medical conditions, she was legally qualified as a disabled person.

“Ms. Fuog has pleaded sufficient facts for the Court to conclude that it is plausible that prescriptions over the threshold are generally denied meaningful access to this benefit, and also disproportionally or predominantly disabled,” Judge Smith wrote in his opinion.

“She has alleged a specific dose-and-duration threshold and provided well-pleaded facts supporting a strong correlation between those over the threshold and disability. While she will have much to prove as the case progressed, these pleadings push past the plausibility bar.”

Judge Smith agreed to drop CVS Caremark as a defendant in the lawsuit, saying there wasn’t a clear enough allegation against the company’s pharmacy benefit manager. But the rest of the potentially precedent setting case will continue.   

“He basically said there’s no doubt that she’s disabled. And there’s no doubt that there’s discrimination going on,” Fuog told PNN.  “It’s a huge step. And we’ve got all this in his own words, telling us this is real, it’s happening, it’s unfair and it’s discrimination.”

“We are very pleased with the Court’s ruling and look forward to moving ahead and litigating the claims on Edith’s behalf,” said Scott Hirsch, Fuog’s lawyer. “We are always happy to speak with other individuals who are being denied the filling of their legitimate opioid prescriptions. They can go to the website we have setup and get more information.”

Longtime Problem for Patients

Pain patients across the U.S. have complained for years about pharmacies refusing to fill their opioid prescriptions or reducing them to lower doses. It’s also not uncommon for patients to encounter delays and flimsy excuses about not filling a prescription, such as a pharmacist claiming a particular opioid was out of stock.

The CVS case and a similar lawsuit against Walgreen’s in California are believed to be the first class action cases to address the problem. Class action suits allow plaintiffs to prosecute a case in civil court and receive compensation for their injuries on behalf of others.

“I was thrilled with this opinion. I think it’s very well-reasoned and applies the ADA appropriately,” said Kate Nicholson, a civil rights lawyer who at one time worked for the Justice Department and helped draft federal regulations under the ADA. She is now Executive Director of the National Pain Advocacy Center (NPAC).

“I mean it’s ridiculous that this woman went to 30 different pharmacies and couldn’t get her prescription refilled. That is highly problematic,” Nicholson told PNN.

Ironically, CVS and several other pharmacy chains face multiple lawsuits for filling too many opioid prescriptions and allegedly contributing to the nation’s opioid crisis. CVS recently reached a $484 million settlement with the state of Florida to end opioid litigation there.

Pharmacists have a legal right to refuse to fill prescriptions they consider suspicious or inappropriate, but should first take steps to verify whether a prescription is legitimate and medically necessary, such as calling the prescribing doctor. Fuog’s lawsuit alleges that CVS pharmacists refused to call her doctor or even look at her medical records.

“Which is why I think the judge was very careful on this case to say CVS has a perfectly legitimate basis for looking at high dose prescribing,” said Nicholson. “They just can’t do it in this arbitrary way.”

Drug Addiction Is the Problem, Not Prescription Opioids

By Christine Kucera, Guest Columnist

The Centers for Disease Control and Prevention (CDC) is the leading national public health institute of the United States. The agency is responsible for protecting the public from health and safety threats. 

In my opinion, the CDC has no business writing clinical guidelines! Medical guidelines for healthcare/disease management, medication management, and clinical decision making should be developed, reviewed and approved by a diverse team of clinical subject area specialists and key stakeholders, including medical specialists, medical groups, advisory teams, advocates and patients. Not regulatory agencies!

The 2016 CDC opioid guideline, as currently written, has harmed and damaged millions of lives, and caused unspeakable suffering. In effect, the CDC sanctioned torture by failing to promptly address and correct the negative impact of its guideline on individual patient care, addiction and pain management treatment and resources.

The CDC has clearly overstepped its authority by creating a guideline meant to regulate the use of prescription opioids. Any regulatory measures which prevent patients from accessing prescription opioids as indicated for their health and well-being are unethical and should be reconsidered, if not totally withdrawn.

The CDC continues to propagate the false narrative that any patients requiring prescription opioids for any type of pain are or will become addicts. And it continues to claim — without any evidence — that if opioid prescriptions are limited in quantity, type, duration and dose, there will be a reduction in addiction, overdose and death. The facts indicate otherwise. Overdoses are at record high levels.

The True Causes of Addiction

Substance addiction exists because our government has failed to address its true causes, which include poor access to addiction treatment, unethical pain treatment, lack of quality care standards across medical institutions, and lack of legislative laws that protect patients from suffering needlessly. 

Addiction is caused by preventable and manageable health disparities, untreated and undertreated mental and physical suffering, genetic metabolic variability, lack of resources, lack of all-inclusive healthcare insurance, lack of provider managed pain care, lack of treatment centers, lack of access to appropriately prescribed medications, lack of drug monitoring systems, lack of access to mental health and pain care providers, lack of timely access to a comprehensive network of providers, and lack of individualized care. 

Maybe if the CDC actually focused on the above health and safety issues, we would have guidance on solving the real problems. The CDC has failed miserably to recognize that individual pain care is as unique as the patient who is suffering in pain. Every single person that has pain seeks relief.

Relief comes in many different forms, both healthy and unhealthy. These forms of relief may be self-directed and/or medically managed by clinical staff and providers, and includes exercise, yoga, rest, mobilization, heat/ice therapy, massage, mindfulness, acupuncture, Chinese herbal medicine, bio-feedback, diet, weight loss, surgeries, water therapy, bicycling, strength/weight training, martial arts, immunotherapy, TENS, anti-inflammatories, anti-seizure medication, muscle relaxants, antidepressants, biologicals, medical/recreational cannabis, CBD, kratom, prescription opioids, illicit/illegal drugs and alcohol — to name a few. 

Every Patient is Different

The journey each patient in pain takes is individual. The pain you've experienced and lived with is different from mine and everyone else’s.  

The terms “acute pain” and “chronic pain” are also misleading and are part of the false narrative. Pain is a symptom. Its management depends on its physical and/or mental cause, not how long it lasts. Pain is the body's way of sending up a red flag that something is not right.

Duration means nothing in the world of pain, as every minute of the day is different in type, in location and in intensity. Pain goes through cycles, and no person experiences pain the same way.  

Until the individuals who wrote this God awful, evil guideline experience pain that is unrelenting, agonizing, non-stop, 24/7 for their entire life, they should back off the false narrative, go back into their non-medical cave, and leave the medical decision making up to the actual physicians who are trained to manage pain with all the tools available and at any quantity required by a patient.  

What the CDC should be addressing are the sources of suffering, identifying at-risk individuals and providing a framework for implementing resources and systems of care that are fluid and adaptive to the unique circumstances of each individual.  

There are too many outstanding questions and issues which also continue to impact patients and providers. What are the FDA and DEA’s roles and responsibilities? How do their policies meet the objectives of the CDC guideline to reduce addiction, overdose and death? What impact do they have on medical providers treating patients in pain? 

Addiction is the public health issue requiring CDC input, not the utilization of prescription opioids for pain treatment. 

Christine Kucera is an intractable pain patient survivor of over 30 years. She lives with reactive psoriatic arthritis, spondylitis, polyarthritis, sacroiliitis, degenerative disc disease, dermatomyositis, mixed connective tissue disease, psoriasis, lupus, spinal radiculopathy, thoracic outlet syndrome, endometriosis stage IV, and other painful conditions.

Prior to becoming disabled, Christine was a healthcare research systems developer and analyst for federally funded CMS, AHRQ, and NIH grants and programs. 

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.  

Too Little, Too Late: Patients and Providers Say Changes to CDC Opioid Guideline Inadequate

By Pat Anson, PNN Editor

Proposed changes to the CDC’s opioid prescribing guideline are inadequate and will not undo the damage caused to patients and the practice of pain management, according to a large new survey by Pain News Network.

The Centers for Disease Control and Prevention released a long-awaited draft revision of its 2016 guideline in February, giving healthcare providers more flexibility in how they manage pain with opioids. Although voluntary, the original guideline was widely misapplied as a rigid “standard of care” by many states, insurers, doctors and law enforcement, causing millions of patients to be taken off opioids or tapered to lower doses.

The revised guideline states that “opioids can be essential medications for the management of pain” and encourages doctors to use their own best judgement when prescribing them. But many patients and providers believe the changes don’t go far enough and may even make the crisis in pain care worse.

“Appreciate the effort, but too little too late. These revisions are like trying to prevent disaster by course correcting the Titanic after it hit the iceberg,” one patient told us. “The revisions offer no protection against overzealous DEA interference and prosecution, and are meaningless in court. Until the draconian laws spawned by the guidelines are changed, things will only continue to get worse.”

“I believe it is a small step in the right direction, though the damage has already been done. The doctors who truly care about their patients and would like to help them are still terrified of the potential repercussions from the governing bodies,” another patient said.

“In 45 years of treating patients with pain, I have never seen it so difficult for patients to have their reports of pain taken seriously and get access to pain treatment,” a doctor said. “Patients often feel treated like addicts, and have had many professionals and family members supporting that erroneous and stigmatizing label.”

‘I Barely Leave the House’

Over 2,500 patients, providers and caregivers in the U.S. responded to PNN’s survey, the vast majority (94%) identifying themselves as patients with either chronic or short-term acute pain.

Over half the patients (57%) rated the quality of their pain care as poor or very poor. Only one in five (20%) rated it good or very good.

This was the fifth survey we’ve conducted on the CDC guideline. Like the others, people expressed strong opinions about the agency’s recommendations and how they’ve impacted pain care.

“My pain medication was involuntarily reduced by 75% since the the last guideline was published,” a patient told us. “Now I barely leave the house. I can't do my physical therapy due to excessive pain.”

HOW WOULD YOU RATE THE CURRENT QUALITY OF YOUR PAIN CARE?

“The 2016 guidelines caused me to have to go on disability, spend 20 hours a day in bed due to severe back pain, and sell a bank consulting company that I had run successfully for 20 years. The CDC needs to get out of pain medicine,” another patient said.

Should CDC Have Opioid Guideline?

When asked if the CDC should even have guidelines for pain management and opioid prescribing, eight out of ten respondents (84%) said no. Many said the agency overstepped its authority.

“It is outside the CDC's charter and purpose to publish opioid guidelines. If an opioid guideline is needed, that would be the FDA's responsibility. Why is our government even allowing the CDC to do this? They are expending resources on something that is unnecessary and outside of their area of responsibility,” a patient wrote.

“The "D" in "CDC' is for "disease." Pain is not a disease. CDC should stick to its mission,” said another patient. 

“The CDC should not be allowed to regulate pain medications. The CDC conveniently made a disease to justify getting involved in an area that was not their area to regulate. The guidelines were biased against chronic pain. The (guideline) panel was biased by people with preconceived ideas,” a provider wrote. 

‘Made Each Day a Living Hell’

Asked if the 2016 opioid guideline improved the quality of pain care or made it worse, nearly nine out of ten respondents (88%) said pain care in the U.S. was significantly worse. Only 2% believe the guideline improved pain care. 

“I had a friend that was seeing a pain management physician, and he was on high dose opiates for 10 years due to a car accident, and because of the 2016 guidelines, his doctor became very fearful and took him off his meds,” a patient told us. “That person committed suicide.”

“CDC regulations may have saved the lives of some addiction-prone people, but it's made each day a living hell for millions of us with progressive chronic pain,” another patient said.

“The damage has been done. Patients are still dead, physicians are still terrified, and these deaths and loss of practice were totally unnecessary. It is a disgusting example of ill-informed government over reach,” said another.

DID 2016 GUIDELINE IMPROVE PAIN CARE OR MAKE IT WORSE?

‘Pain Drove Me to Street Drugs’

Perhaps the most damning assessment of the 2016 guideline is that it made the opioid crisis worse – an opinion shared by nearly eight out of ten survey respondents (78%). When denied access to opioids, some patients have turned to street drugs.

“Chronic pain drove me to use street drugs, including fentanyl, when all I needed was a doctor to prescribe a safe medicine for me,” a patient told us. “It's messed up I have to do this for relief.”

“Patients know about their pain, doctors know their patients, the CDC does not know individual patients. Making it harder to get much needed medications is what causes people to try and obtain opioids illegally,” said a patient.

“People in chronic pain who cannot get relief from doctors are turning to street drugs - and THEN getting hooked. The CDC is CAUSING drug addiction,” wrote another patient.

“The people who benefit from the CDC guidelines are lawyers, politicians and drug dealers. The drug dealers can sit back and rake in the money while the CDC, lawyers and politicians do their work for them.”

DO YOU THINK THE 2016 GUIDELINE MADE THE OPIOID CRISIS WORSE?

 ‘Revoke the Guidelines’

What should be done with the 2016 guideline? Should it be revised? Can it be fixed? Nearly two-thirds of respondents (63%) believe it should be completely revoked or withdrawn. About 36% believe changes are needed to make opioid medication more accessible.

“The CDC needs to completely revoke the 2016 guidelines and let trained professionals treat their patients for pain. Unfortunately, some of the damage that was done is irreversible and some patients have lost their lives as a consequence, and that lies squarely on the shoulders and consciousnesses of the CDC,” a provider told us.

“DESTROY IT NOW! No updates are needed,” a patient wrote. “Just get rid of these guidelines completely and get out of the middle, coming between a doctor and his pain patient, as well as the patient and their pharmacy.”

“Revoke the guidelines and revoke the CDC’s ability to have anything to do with medications, leave that to the FDA and doctors. Also revoke the DEA’s ability to prosecute and/or harass doctors and make them focus on drug dealers and cartels,” another patient wrote.

WHAT SHOULD BE DONE WITH 2016 GUIDELINE?

‘CDC Has Lost All Credibility’

Given all the problems created by the 2016 guideline and the lengthy delay in revising it, many people have lost faith in the CDC — once one of the most trusted government agencies in the U.S. Asked if the CDC could be trusted to handle the revision of the opioid guideline in an unbiased and scientific manner, nearly 96% said no.

“I do not and will never trust them. This revision is nothing more than putting lipstick on a pig,” a patient said.

“The CDC has lost all credibility with me. They lie, falsify records to suit their argument, pick and choose things in studies to support their argument, and they have anti-opioid zealots writing these guidelines. Clear conflict of interest! CDC and DEA need to get the hell out of my doctor-patient relationship!” said another patient.

“The CDC were warned their Guidelines would harm patients, and they moved forward anyway. They refused to monitor harm to patients or acknowledge it. The CDC's unethical behavior continues over and over at shocking levels. They have broken the public trust over and over. Nothing they've written can be trusted after these deliberate and intentional unethical choices,” a patient wrote.

For more survey findings, including what respondents think about the CDC’s new guidance about doses, click here. You can see the full survey results here.

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.

CDC Censoring Public Comments About Revised Opioid Guideline

By Pat Anson, PNN Editor

The U.S. Centers for Disease Control and Prevention has censored over a dozen public comments about its revised opioid guideline to remove negative references to Dr. Roger Chou, one of the guideline’s co-authors.  

Chou is a controversial figure in the pain community. A prolific researcher and an outspoken critic of opioid prescribing, Chou heads the Pacific Northwest Evidence-based Practice Center (EPC) at Oregon Health & Science University.

Over the last five years, the university has received nearly $2 billion in contracts from the CDC and other federal agencies, much of it going to the EPC to support Chou’s research. That research, which generally discourages the use of opioids, is cited over 100 times in the revised CDC guideline.

The CDC published the revised draft in the Federal Register last month and invited the public to submit comments, with the agency cautioning posters that it “may choose to redact, or withhold, submissions containing private or proprietary information.”

Of the 2,600 submissions received so far, over 280 have been edited in some way, mostly to remove personal information about the poster or their medical provider

SOURCE: REGULATIONS.GOV

But at least 15 comments critical of Chou’s research and his role in writing the opioid guideline have also been edited to remove his name, even though much of the information they contain is already public and not proprietary.

Chou’s name is redacted four times from this post by Emma W:

“I think it’s reasonable for them to redact private information, physicians’ names, clinic names, etc. I’m all for protecting privacy. But it makes no sense to me that they would redact the names of guideline authors and/or the authors of research papers they directly cite as evidence,” said Emma, who asked that we not use her last name. “I did not personally make any offensive, rude, or vulgar remarks about him in my comment, so I’m still at a loss as to why I and some others were singled out.”

In addition to being a co-author of the revised guideline, Chou was one of the authors of the original 2016 guideline, which led to significant cutbacks in opioid prescribing nationwide. He also continues to serve on the CDC’s Board of Scientific Counselors, despite admitting to a financial conflict-of-interest (COI) at a board meeting last year.

“Since CDC funds Chou’s research, which supports their guidelines, my guess is that they’re going above and beyond to protect him from criticism,” Emma told PNN. “I suppose I should’ve expected this, considering absolutely nothing has been done about his continuing involvement in these guidelines despite his COIs.”

“It is outrageous but I’m not surprised,” said Julie Killingworth, whose comment was edited 6 times to remove the names of Chou and others.

“I thought my comment would be removed because I stopped appeasing the CDC with politeness long ago. I’m not surprised the CDC is silencing people they have cruelly targeted to be tortured,” Killingworth told PNN. “The CDC does not deserve the national respect they feel entitled to receive.” 

To be clear, not every post that references Chou has been edited. PNN identified 5 posts where his name has not been redacted. Those comments are also critical of Chou’s extensive involvement researching, developing and writing the guideline.

“I am concerned about the legality of redacting public comments. This in my experience is quite irregular,” says Terri Lewis, PhD, who co-authored a 2021 paper that looked into Chou’s conflicts of interest. “It doesn't change what are legitimate concerns about what are very real conflicts of interest and the failure to disclose same, especially in light of other historical facts that are emerging.”

In addition to the Chou redactions, the CDC has censored several comments that mention Dr. Andrew Kolodny by name and other members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that Kolodny founded.

Chou has collaborated on several occasions with PROP, including a 2019 op/ed he co-authored with PROP President Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to consider tapering “every patient receiving long term opioid therapy.”

(3/31/22 Update: Nearly three weeks after we asked CDC why the names of Chou and others are being redacted, we received this reply from a spokesperson:

“Our approach with comments on this FRN (Federal Register Notice) was to redact all individuals’ names to protect privacy. With so many comments, there have been a few that were not redacted in line with this approach, but the intent was to redact names of any and all individuals.”

The spokesperson said the CDC may also “redact or withhold certain submissions” that contain private or proprietary information, inappropriate language, or duplicated public comments that could indicate a mass-mail campaign.)

The CDC will continue to accept public comments about the revised guideline until April 11. Click here to make one.

Ironically, the revised guideline has generally been received favorably by the pain community because it gives doctors more flexibility in prescribing opioids. Some patients and advocates are leery, however, that the revisions won’t restore access to opioid medication or fix all the other problems the original guideline created, such as patients being forcibly tapered or reduced to ineffective doses.

More Than Just CDC Opioid Guideline Needs Changing

By Roger Chriss, PNN Columnist

The CDC’s draft revisions to its 2016 opioid guideline are generally seen as an improvement by pain management experts because they give doctors more flexibility to prescribe opioids. But how much will prescribing really change?

Forty states have enacted laws that limit the supply or dose of opioid prescriptions, according to the Pew Charitable Trust. Some states may resist making changes.

“For the eased guidelines to have their intended effect, states would need to amend or repeal existing statutes that limit opioid prescriptions to three to seven days and set ceilings on the daily dose doctors can prescribe,” Stateline reported.

The reasons are simple. Amid a deteriorating drug overdose crisis and a complex prescribing landscape, the proposed changes in the CDC guideline are likely to be seen at the state level as a negative for public health. There’s a tangled mess of different opioid regulations that vary from state to state.

“Relaxing those regulations now would wreak havoc on states. They won’t know what to do,” says Gary Franklin, MD, who is Vice-President of State Regulatory Affairs for Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

“We’ve made quite a dent in prescription painkiller use,” Franklin told EMS1. “But we’ve still got a lot of work to do.”

Lewis Nelson, MD, Chair of Emergency Medicine at Rutgers New Jersey Medical School, is concerned about plans to drop the guideline’s recommended dose limit of 90 morphine milligram equivalents (MME) per day. Nelson says the CDC’s “watered down recommendations” will lead to more addiction and overdoses.

“By removing this recommended cap … prescribers may feel it is appropriate to prescribe longer initial prescriptions to their patients,” Nelson told The Daily Targum, a student newspaper at Rutgers. “This is one of the key factors that created the opioid crisis in the early 1990s that lasted through today.”  

Nelson and Franklin were both key advisors to the CDC during the drafting of its 2016 guideline, serving on a panel known as the “Core Expert Group.” They did not have a similar role in the drafting of the revised guideline.

Federal Agencies and States Do Their Own Thing

Because they are controlled substances, prescription opioids are not regulated the same way as other medications. Manufacturing levels are determined by the DEA, which annually determines production quotas for opioids based on input from the FDA, CDC, Centers for Medicare and Medicaid Services (CMS), and individual states. The DEA has been steadily reducing production quotas for prescription opioids for almost a decade and seems unlikely to change course anytime soon.

Drug approval falls to the FDA, which says one of its “highest priorities” is reducing the number of Americans addicted to opioids. “This may be achieved by ensuring that only appropriately indicated patients are prescribed opioids and that the prescriptions are for durations and doses that properly match the clinical reason for which the drug is being prescribed in the first place,” the FDA says on its website.

Federal programs like Medicare, Medicaid and VA/Tricare, as well as private insurers and pharmacies, exert considerable influence on clinical practice via formularies, guidelines, and prior authorizations.

States ignore the CDC, FDA and other federal regulations when it suits their ends, as seen with Florida’s new “Buck the CDC” effort against federal mask mandates and covid guidelines.

States also set their own regulations for legalizing cannabis or decriminalizing hallucinogens.

When it comes to healthcare and public health, each state does its own thing, even if they conflict with federal policy and are detrimental to other states.

Patient advocate Richard “Red” Lawhern deftly summarizes the many nuances of the CDC’s draft guidance with “the devil is in the details.”  And the National Pain Advocacy Center has a detailed analysis of the draft, with suggestions for further advocacy.

The CDC has been a convenient scapegoat for the rapid opioid tapering, patient abandonment, and even suicides that have occurred in recent years. But the reality of regulating prescription opioids and treating chronic pain is complex. Even if CDC does finalize the proposed changes in its draft guideline, there is still a long way to go to restore some semblance of order and stability in pain management.

The CDC is one part of a much larger system that probably needs to change as much as the 2016 guideline need to be updated.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research. 

Medical Societies Have New Advice for Treating Surgery Pain in Patients Taking Opioids

By Pat Anson, PNN Editor

The American Medical Association and 14 other medical societies have released new advice for physicians managing surgical pain in “complex patients” who have chronic pain, substance use disorders, or those taking opioid medication prior to surgery.

The seven guiding principles emphasize the coordination of pain care with other providers, and that patients taking opioids be allowed to stay on them before, during and after surgery.  

“Every surgical patient deserves adequate pain relief that aims to prevent opioid reliance, chronic pain and other negative outcomes, but it may be more challenging to achieve this in certain patient populations,” Randall Clark, MD, President of the American Society of Anesthesiologists (ASA), said in a statement.

“The new principles were created to build upon an original set established last year during our first pain summit, but specifically address patients undergoing surgery with chronic pain, those taking opioids preoperatively, and those with substance use disorders.  The new principles give the perioperative care team more guidance to care for these particularly complex patients.”

The new principles come at a time when many U.S. hospitals are reducing the use of opioids for surgical pain. As result, some people in pain have postponed or cancelled surgeries because they fear their postoperative pain would be poorly treated or their current opioid therapy would be disrupted.

For patients on long-term opioid therapy, the principles urge physicians to “continue the baseline opioid dose” and to provide “supplemental analgesia” for postoperative pain. The additional pain treatment should be the coordinated with the patient’s opioid-prescribing clinician, with the goal of returning to “the preoperative dose or lower as soon as possible.”

“This really is meant to be a patient-centered document that says we should invest in making sure these patients have a good experience,” said David Dickerson, MD, chair of the ASA’s Committee on Pain Medicine. “A lot of people don’t even get their baseline meds continued during their surgery. They don’t even get their home meds. And so this now creates a principle that says you need to have a really good reason why you’re going to withhold those meds.

“In our health system, if someone has pre-op opioid use, we know that they’re going to need more opioids in the wake of their surgery or they’re going to need more anesthetic even while they’re on the table having their care,” said Dickerson, an anesthesiologist who is section chief for pain medicine at the NorthShore University HealthSystem in Chicago.

In addition to the ASA and AMA, these medical organizations have adopted the new guiding principles:

• American Academy of Orthopaedic Surgeons

• American Academy of Otolaryngology-Head and Neck Surgery

• American Association of Neurological Surgeons

• American Association of Oral and Maxillofacial Surgeons

• American College of Obstetricians and Gynecologists

• American College of Surgeons

• American Hospital Association

• American Society of Addiction Medicine

• American Society of Breast Surgeons

• American Society of Plastic Surgeons

• American Society of Regional Anesthesia and Pain Medicine

• American Urological Association

• Society of Thoracic Surgeons

‘CDC Guideline Falls Flat’

Dickerson emphasized the new guiding principles are only meant as a resource for physicians managing surgical pain and are not intended to be a guideline or standard of care. He also expressed concern about some of the proposed changes to the CDC’s opioid prescribing guideline, which now includes recommendations for treating postoperative pain.

“I think that the CDC guidelines, as they are proposed in their draft format right now, is not an incredibly functional document. It doesn’t really shape what great pain care looks like. All it talks about really is mitigating the effects of opioid injury. It offers up ideas, but I don’t think it’s a comprehensive summary of what we do for patients,” Dickerson told PNN.

The CDC’s draft revision is actually quite similar to the medical societies’ new principles for treating surgery pain. It allows for patients on long-term opioid therapy to get additional opioids “for the duration” of their postoperative pain, with a return to their baseline doses as soon as possible.  

But Dickerson says there are many different types of surgery that require different forms of pain control, and some complicated patients may need more pain relief and different therapies than others. He thinks medical societies should set their own guidelines for their own specialties, and not rely on the generic advice of the CDC.

“I think that societies when they come together to do things like this are really best-tasked as experts to do this. To expect primary care physicians to write a guideline about how to manage surgical populations is limited from the start,” he said. “I think the CDC guideline falls flat.”

The Devil in the Details of Revised CDC Opioid Guideline

By Richard Lawhern, PNN Contributor

Last month, the U.S. Centers for Disease Control and Prevention circulated a revised and greatly expanded draft update to its 2016 guideline on prescribing opioids to adults with chronic non-cancer pain. The new version expands to include short-term acute and “subacute” pain, and it acknowledges some of the harms done by the “misapplication” of its predecessor. 

The draft also proclaims that clinicians and their patients should be free to tailor pain therapy to the needs and circumstances of each individual, rather than applying the guidelines as a mandatory or legal standard of care. 

Many media commentators have focused on the easing of restrictions on opioid pain therapy. But as often happens, the devil is in the details -- which many commentators have either not read or paid appropriate attention to. In my view, the revised draft is simply version 2.0 of the same “Little Shop of Horrors: published in 2016. 

The authors of the revised guideline set out to deceive the public with the appearance of giving doctors more discretion in prescribing opioids. But that new “flexibility” is overwhelmed by wording that subtly informs doctors that they may risk sanctions if they prescribe opioids to anyone, at any level above 50 morphine milligram equivalents (MME) dose per day.

The underlying bias and predetermined agenda of the CDC writers is apparent in the wording of the draft:

• The words “risk” or “risks” appear 512 times, while “benefits” appears 167 times. Clinicians are repeatedly admonished to evaluate “risks versus benefits” of opioid therapy when deciding to prescribe opioids or increase the dose. But the draft acknowledges that “there is no validated, reliable way to predict which patients will suffer serious harm from opioid therapy and no reliable way to predict which patients will benefit from opioid therapy.”  In more accurate words, clinicians are on their own when they prescribe these medications.

• “Taper” or “tapering” or “tapers” are mentioned 200 times. Although “abrupt discontinuation” of opioids is discouraged, clinicians are still advised to “appropriately taper and discontinue opioids” for patients on high doses.

• The writers repeat their false claim from 2016, that opioids are not a proven long-term therapy because there are few long-term randomized double-blind trials for opioids versus placebo. They ignore the fact that the rarity of long-term trials reflects high dropout rates among patients who experience breakthrough pain when treated with placebos.  This error can be corrected by the use of enriched enrollment trials, which is unmentioned in the draft.

• The writers also assert that “additional dosage increases beyond 50 MME/day are progressively more likely to yield diminishing returns in benefits relative to risks to patients.” However, they offer scant scientific evidence for this assertion. They fail to reference case reports from patients who do well on high doses exceeding 1000 MME.

• Most fundamentally, the entire CDC draft is organized around the concept of “Morphine Milligram Equivalent Dose” – which is now known to be junk science unsupported by any real data.

Errors and distortions of the CDC draft are also apparent in the wording of their 12 recommendations:

• Seven of the recommendations are identified as “Category A recommendations [which] indicate that most patients should receive the recommended course of action.” Any reasonable clinician will recognize these words as a standard of practice that they violate at their own peril. 

• The 2nd recommendation is that “nonopioid therapies are preferred for subacute and chronic pain.”
  Ignored in this phrasing is the fact that several of the CDC referenced studies on non-steroidal anti-inflammatory drugs (NSAIDs) employed deeply flawed protocols. Likewise, there have been no trials of non-drug therapies as substitutions for opioids in moderate to severe pain. Thus, non-opioid therapies cannot possibly be “preferred.”

• Also glossed over by the draft writers is the strength of evidence supporting seven of the recommendations is rated as “type 4 evidence” (clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations). Freely translated, this level of evidence simply represents the opinions of the writers, rather than any general consensus among actual practitioners. 

The revised guideline is almost as interesting for what it does not discuss as for what it does. Missing from the draft is any mention of the World Health Organization’s “Pain Ladder.” First published in 1986 and oriented to cancer pain, it is now widely used in both doctor training and common practice for all types of pain.

• The first level of the ladder is Tylenol (ibuprofen) and other NSAIDs -- which are used in the short term for mild to moderate pain.

• Second level of the ladder is weak opioids like tramadol, used in longer lasting or more intense moderate to severe pain.

• Third level is strong opioids like hydromorphone or medical fentanyl, used in very severe or treatment-resistant pain.

• Non-drug treatments like acupuncture or massage can be integrated with pain therapy at any level of the ladder, to assist patients in managing pain and increasing function. These are not, however, replacements for drug treatment.

• Interventional treatments like nerve blocks, epidural corticosteroid injections, spinal cord stimulators or fusion surgery may be used when pain is resistant to drug therapy. 

The rationale for excluding discussion of this framework from the CDC guideline is nowhere made clear in either the 2016 or 2022 documents.  The implied reason for this policy choice seems to be that prescription opioid analgesics were assumed by the writers to carry significant danger of addiction and misuse, even when administered at low doses and for short periods. 

It is now clear, however, that such reasoning is seriously wrong on facts. Prescription opioids did not cause and are not sustaining America’s so-called “opioid crisis.”  That distinction belongs to illegal street drugs, notably illegal fentanyl.

Given the many failings of the Little Shop of Horrors 2.0, it is reasonable to ask, “What should be next?”  In my opinion, it is time to burn this shop to the ground and start all over.

The development of practice standards for pain treatment should be taken entirely out of the CDC and allocated to medical specialty boards and academies whose members are practicing clinicians -- rather than public health bureaucrats who have never treated patients face-to-face.

Richard “Red” Lawhern, PhD, has for over 25 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids. Dr. Lawhern has written or co-authored over 150 papers and articles published in medical journals and mass media.

Revised CDC Opioid Guideline a ‘Band Aid for a Stab Wound’

By Emily Ullrich, Guest Columnist

After years of state sanctioned torture, people in pain have finally received a small reprieve from the Centers for Disease Control and Prevention, in the form of a revised draft of the agency’s opioid prescribing guideline.

In the new draft, the CDC acknowledges some of the harm inflicted by its 2016 guideline, by adding language that gives doctors more flexibility in prescribing opioids and encourages them to practice “individualized patient centered care.”

While this perspective is a welcome departure from the original guideline, we need to go further. As a disabled chronically ill patient, I have personally experienced the stigma and misinformation that comes with being prescribed opioids. As a patient advocate, I’ve also watched in horror as an untold number of suffering patients deprived of opioids committed suicide.

There are four main issues that still need to be addressed by the CDC. The first is that many patients on long-term opioid therapy have rare diseases such as Complex Regional Pain Syndrome (CRPS) and Ehlers-Danlos syndrome. Because these and other incurable illnesses aren’t even mentioned in the guideline, it is assumed that most pain patients have treatable conditions such as low back pain or acute injuries that will improve with time. This is not the case. There is a large segment of the patient population that cannot be cured. For them, symptom management with opioid medication is their only option.

Second, it’s important to emphasize that all patients are different. Individual factors like genetics, metabolism, tolerance and more can determine how opioids affect a patient.  A dose that may be “a lot” for one patient might be very ineffective and too low a dose for others.

Third, because of the harms that have been imposed upon pain patients, it is extremely important that providers be advised to treat them with compassion and respect.  Stigma, shame and puritanical morals-based thinking that paints people with pain as having “character flaws” only inflicts more harm and makes it more difficult for them to get help.

Finally, although the CDC has abandoned its previous recommendation that daily opioid doses not exceed 90 morphine milligram equivalents (MME), I can't help but notice new language in the guideline draft that cautions doctors about exceeding 50 MME, a dose that is low for many patients. I fear that 50 MME will be taken above all the other verbiage of the 2022 guideline and be enforced as the new hard limit.

The revised guideline is a small step in the right direction, but patients need more than a band aid for a stab wound.

Emily Ullrich lives with CRPS, Sphincter of Oddi Dysfunction, Carpal Tunnel Syndrome, endometriosis, Interstitial Cystitis, migraine, fibromyalgia, osteoarthritis and chronic pancreatitis.