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Nearly 75% of the people we surveyed believe the guideline should be withdrawn or revoked.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.)

Patients Say CDC Opioid Guideline Made Their Pain Worse

By Pat Anson, PNN Editor

Nine out of ten pain patients say their pain levels and quality of life have grown worse since the Centers for Disease Control and Prevention released its 2016 opioid guideline, according to a large new survey by Pain News Network. Over half say they were taken off opioids or tapered to a lower dose against their wishes.

Nearly 4,200 people in the U.S. participated in the online survey, including 3,926 who identified themselves as chronic, acute or intractable pain patients.

The CDC’s controversial guideline discourages doctors from prescribing opioids, particularly in doses that exceed 90 morphine milligram equivalents (MME) per day. Although voluntary and only intended for primary care physicians, the guideline has had a sweeping effect on virtually every aspect of pain management, with many of its recommendations adopted as the standard of care by doctors, pharmacies, insurers, regulators and law enforcement.

Asked what has happened to their opioid prescriptions since the CDC guideline was released, one in four patients said they are no longer prescribed opioids and nearly 56% said they are getting a lower dose.

“These CDC rules are cruel and abusive to patients like myself. I never have even 5 minutes without debilitating pain now because I’m not allowed to have the dosage I need to be comfortable. I do cry a lot and pray that God will end my suffering,” said one patient.

“My pain meds have been reduced by about 70% and I am in much more pain now. It is hard for me to eat and I have lost about 30 pounds and severely underweight,” said another.

“I have had no quality of life since my pain specialist took me off the meds 5 years ago. Now my life consists of sitting in a recliner all day long, with nothing to look forward to except weight gain,” a patient wrote.

WHAT'S HAPPENED TO YOUR OPIOID PRESCRIPTIONS SINCE 2016?

Opioid prescriptions were declining before the CDC guideline was released and now stand at their lowest level in 20 years. But reduced prescribing has had negligible impact on the overdose crisis – drug deaths are at record levels – and it’s come at significant cost to patients. Over 92% say their pain levels and quality of life have grown significantly worse or somewhat worse in the last five years.

“It has made my life hell. I can barely stand or walk. Every day is an endurance test. It is clear how much opiates worked for me,” a patient wrote.

“The effects on my physical, mental health and quality of life have been devastating. I can't take care of my home, I can't regularly do grocery shopping, attend my kids extra curricular events or have any form of family fun without immense suffering,” said another patient.

“These guidelines are destroying the lives of chronic pain patients! We didn't do anything to deserve the loss or great reduction of our medications, and we are losing quality of life and the ability to function,” a patient said.

WHAT'S HAPPENED TO YOUR PAIN AND QUALITY OF LIFE SINCE 2016?

“It’s astounding that in a theoretically free country that people who have committed no crime are sentenced to life sentences of intolerable pain that prevents us from working, driving any distance, visiting friends or family and being forced to expend funds and effort to see our pain doctor monthly to hopefully have our prescription renewed,” said another patient.

Many patients report that effective pain treatment is increasingly hard to find:

• 59% were taken off opioids or tapered to a lower dose against their wishes

• 42% had trouble getting an opioid prescription filled at a pharmacy

• 36% were unable to find a doctor to treat their pain

• 29% were abandoned or discharged by a doctor

• 27% had a doctor who stopped prescribing opioids

• 19% had a doctor close their practice or retire unexpectedly

• 13% had a doctor investigated by DEA, law enforcement or state medical board

“My life has been significantly changed for the worst since my doctor was unjustly arrested, and the government continues to delay his trial. I have complicated medical issues and can find no one to prescribe what I need,” a patient said.

“When the DEA raided my physiatrist's office and suspended his DEA and medical licenses, pending the outcome of their B.S. investigation, and I began to search for a new one, I learned that all of my doctor's patients (myself included) had been blacklisted by most of the remaining physiatrists and anesthesiologists or pain specialists in the state! Whenever a receptionist or nurse asked me who my previous physician was and I answered them, the phone call basically ended right there,” another patient wrote.

“This entire mess has caused massive suffering to chronic pain patients, worsening health, dangerous side effects from being forced to take other dangerous medications not made to treat pain, and numerous suicides,” another patient said. “Good doctors are now terrified of being wrongly targeted by the DEA, resulting in massive suffering and diminished patient care, and even doctors offices closing entirely.”

‘Please Give Me My Life Back’

Only about two percent of patients said they’ve found better alternatives to opioids. With effective pain care difficult to obtain, some patients are having suicidal thoughts or using illicit drugs.

• 35% have considered or attempted suicide due to poorly treat pain

• 10% have obtained prescription opioids from family, friends or the black market

• 9% have used illegal drugs for pain relief

“As a pain patient of over two decades I never had a problem until the CDC guidelines came out, since then I've had to see a psychiatrist, pain psychologist, endure nasty forced tapering, wrote suicide notes and caught myself walking out the back door to kill myself,” a patient said. “When will these losers understand nobody in their right mind wants to take opioids? The only reason pain patients take opioids is because we don't have anything else that works.”

“I started going to the methadone clinic. I couldn't find a doctor for my pain meds nor my nerve meds. I started using heroin as did my longtime girlfriend who fatally overdosed in 2019 amongst many other friends and family members and the methadone is not working for my pain,” another patient said.

“My daughter is 28 and has severe pain. The last two pain specialists she had quit due to the guidelines and now she can't find anyone who will help her. She is very suicidal and I know I will not have her much longer as she is extremely depressed,” a mother wrote. “The CDC guidelines will most likely kill my daughter. She has already attempted suicide.”

“I blame our governmental agencies for my suffering. I have thought about suicide and yet I'm a board member of our local Suicide Prevention Council. And as I sit here promoting wellness and suicide prevention, I can't help the physical and emotional pain that is ripping out my soul. It really pisses me off because I know my life doesn't have to be this way,” said another pain patient. ”Please give me my life back where I was able to function with my pain medicine.”

“The CDC has ruined my life,” said a patient who has had five back surgeries and needs a hip replacement. “Most of us in chronic pain contemplate committing suicide all the time. We are not addicts, we aren't getting high, we are trying to survive and be parents or productive members of society.”

Ironically, the risk of addiction and overdose appears to be low in the pain community. Only 8% of patients who participated in our survey said they’ve been given a referral or medication for addiction treatment. And less than one percent (0.55%) have suffered — and survived — an opioid overdose.

(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.)

Patients and Providers Want CDC Opioid Guideline Revoked

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

Overdoses Rising

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

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

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

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

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

HAS THE CDC GUIDELINE REDUCED OPIOID ADDICTION AND OVERDOSES?

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

‘Throw the Whole Mess Out’

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

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

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

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

WHAT SHOULD BE DONE WITH CDC GUIDELINE?

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

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

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

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

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

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

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

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

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

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

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

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

CDC Won’t Say Who Is Writing Update of Opioid Guideline

By Pat Anson, PNN Editor

When the Centers for Disease Control and Prevention released the draft version of its opioid prescribing guideline in September 2015, the agency was roundly criticized for its secrecy and lack of transparency.

There were no public hearings. The CDC initially refused to identify who wrote the guideline or who its advisors were. And the public was given just 48 hours to comment on the guideline after a botched online webinar that presented only a summary of the recommendations.     

After a congressional investigation and threats of a lawsuit for “blatant violations” of federal laws, the CDC changed course and opened up the guideline to public scrutiny and a 30-day comment period. After a few minor changes, the guideline was released in March 2016.

Five years later, after a tsunami of complaints that the guideline’s recommended dosage limits have been harmful to patients and failed to reduce opioid addiction and overdoses, the CDC is now in the process of rewriting the guideline.

There’s more transparency this time around. The public was given an early invitation to comment and nearly 5,400 people wrote to the CDC about their concerns.  The agency also released the names of the “Opioid Workgroup,” a diverse group of physicians, academics and patients that is advising the agency as it updates the guideline.     

But one thing hasn’t changed: the CDC won’t identify who is writing the guideline update.

“Primarily CDC scientists are involved in drafting the update,” Courtney Lenard, a CDC spokesperson, explained in an email to PNN. “Many CDC staff are working on the process of updating the 2016 Guideline, including reviewing the scientific evidence; analyzing patient, caregiver, and provider input gathered during the public comment period and conversations held earlier in 2020; and drafting its content.”

The updated guideline will be only reviewed by the Opioid Workgroup, which has been given no direct role in writing it or in making revisions. The workgroup is expected to give its recommendations to the Board of Scientific Counselors at the CDC’s National Center for Injury Prevention and Control sometime this summer.

“At that time the authors of the draft Guideline will also be announced,” said Lenard, adding that the public likely won’t see the draft until late 2021, when it is published in the Federal Register.

Potential Conflicts of Interest

Only after another round of public comments will the revised guideline finally be released in 2022 – a full six years after the initial guideline. Some patient advocates worry about a lack of urgency at CDC and that too much is occurring behind closed doors.  

“I remain concerned about an ongoing lack of transparency in the development of an update to the CDC Pain Guidelines,” said Dr. Chad Kollas, a palliative care specialist in Florida. “There will be no disclosure about the authorship of the revised guidelines until their release, which effectively eliminates the opportunity to challenge any of their authors’ potential conflicts of interest proactively.”

“The CDC has put together a writing team without addressing transparency or conflicts of interest to our satisfaction,” says Terri Lewis, PhD, a patient advocate and researcher. “This is unacceptable and nonresponsive to the concerns that have been so clearly expressed by both the patient community and the medical communities since 2016.”  

The CDC’s evasive response about who is writing the update raises the possibility that the three authors of the original 2016 guideline are working on the revision: Deborah Dowell, MD; Tamara Haegerich, PhD; and Roger Chou, MD.

In 2019, the trio penned an awkward defense of the guideline in The New England Journal of Medicine, in which they admitted the “misapplication” of guideline was causing harm to patients, but deflected taking any responsibility for it.

Chou’s involvement in the updated guideline would be particularly alarming to critics, because of his advocacy for opioid tapering and collaboration with Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

“I'd give long odds that Roger Chou is a member of the current CDC writers group,” says Richard Lawhern, PhD, a prominent advocate in the pain community. “Talk about giving the fox the keys to the hen house!” 

In addition to his work on the 2016 guideline, Chou has authored numerous articles on pain management in peer-reviewed medical journals, many of them critical of opioid prescribing.

Chou is listed as an “external reviewer” on a PROP guide promoting “Cautious, Evidence-Based Opioid Prescribing” that at one time was posted — unedited — on the CDC’s website.

In 2019, Chou co-authored an article 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.”

And in 2011, Chou co-authored another op/ed with PROP founder Dr. Andrew Kolodny and PROP vice-president Dr. Michael Von Korff, calling for a major overhaul of opioid guidelines, which were then primarily written by pain management specialists.

“Guidelines for long-term opioid therapy should not be developed by the field of pain medicine alone. Rather, experts from general medicine, addiction medicine, and pain medicine should jointly reconsider how to increase the margin of safety,” Chou and his co-authors wrote, a call to action that came to pass five years later at CDC with a guideline that he helped write.

“I do not believe the CDC should be writing opioid guidelines,” says Dr. Lynn Webster, a PNN columnist and past president of the American Academy of Pain Medicine.  

“The authors of the CDC guideline should not have been tasked with creating the guideline for a few reasons. First, this was outside their areas of expertise. Second, they failed to understand how misguided arbitrary limits of morphine milligram equivalents were in recommending dosing to people in pain. Third, they lacked compassion for people in pain and an understanding that, for some patients, opioids were the only effective, available treatment.”  

Should Chou Be Recused? 

Chou is a primary care physician who heads research at the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University. He was the lead investigator for a recent report by the Agency for Healthcare Research and Quality (AHRQ) that found opioids have only “small beneficial effects” when prescribed for chronic pain and “do not appear to be superior to nonopioid therapy.”

Chou’s report, along with four other AHRQ reviews of pain therapies, were commissioned by the CDC. The reports are being used as key resources by the agency as it updates and possibly expands the opioid guideline to include recommendations for opioid tapering, short-term acute pain, migraine and other pain conditions. 

Some advocates believe Chou is so biased against opioids he should be recused from any further work on the guideline.

“I agree with that. He’s clearly published things and said things. He is not objective on dealing with people who need high dose opioids. It’s just as simple as that. He’s going to oppose anything that allows people to take opioid drugs,” says Forest Tennant, a PNN columnist and intractable pain expert. “They never put people on there who are for opioids. It’s always against.”

“Absolutely he should (be recused). Dr Chou is in the position of being given an opportunity to defend his earlier misdirected, unscientific, and ethically unsound work by influencing the revised guidelines to confirm his earlier positions. This is a ‘professional’ self-interest at least equally as meaningful of any financial relationship,” said Lawhern. 

“The harm the 2016 guideline caused should be sufficient reason to find a new group of individuals to work on the updated recommendations. Having the same authors work on the same guidelines makes it almost inevitable that the same mistakes will be made,” says Webster.

“To paraphrase Albert Einstein, it is insanity to do the same thing again and expect different results. If you want better results, you have to do something differently. I can see that the updated guideline will lack consideration for patients as individuals, just as the 2016 guideline did.”

For much of the past year, the CDC has been preoccupied dealing with fallout from the COVID-19 pandemic. The agency’s once-sterling reputation has been damaged by political interference and shifting recommendations on how to control the virus. The agency’s focus in 2021 is likely to remain on COVID-19.

Pain sufferers and their advocates worry that revising the opioid guideline will not be a top priority at CDC, and that many of the same mistakes made five years ago are being repeated.    

“There is no indication that CDC is treating this with the respect it deserves or with the scientific rigor it demands in spite of mounting evidence that the management of prescription opioids in the USA is 'going off the rails' and that very real systemic and structural harms are accruing to patients and the health care delivery system in general,” says Terri Lewis. 

“I think it fair to say that we all fear that, based on what we are aware of at the moment, this next round of 'revision' will simply amount to an 'expansion' into territory for which there is almost no verifiable evidence and very weak support in the existing literature.”

How Should the CDC Opioid Guideline Be Changed?

By Pat Anson, PNN Editor

It was five years ago today – March 15, 2016 – that the Centers for Disease Control and Prevention released its controversial opioid guideline, which discourages doctors from prescribing opioids for chronic pain.   

“This guideline is intended to improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death,” the CDC said.

Although voluntary and only intended for primary care physicians, the guideline soon became the “standard of care” in the United States, with many states, doctors, insurers, pharmacies and regulators adopting its recommendations, such as limiting opioid doses to no more than 90 morphine milligram equivalents (MME) per day.

Soon after the guideline was released, the CDC was warned by its own consulting company that “some doctors are following these guidelines as strict law rather than recommendation, and these physicians have completely stopped prescribing opioids.” Over three hundred healthcare professionals also warned that forced opioid tapering was causing “an alarming increase in reports of patient suffering and suicides.”

A PNN survey two years ago found that over 85 percent of patients believed the CDC guideline made their pain and quality of life worse, significantly reduced their access to pain care, and drove some to alcohol and illegal drugs for pain relief.

Not until 2019, however, did then CDC Director Robert Redfield acknowledge the guideline was causing problems and pledged to “clarify its recommendations to help reduce unintended harms.”

Two years later, the CDC is still in the process of revising and possibly expanding the guideline, with the goal of releasing an update for public comment late this year.

Should the guideline be changed? Has it been successful in improving pain treatment? Did it reduce addiction, overdose and death?

We thought this would be a good time to conduct another survey of patients and healthcare providers, to see what changes they’d recommend to the CDC and the “Opioid Workgroup,” a panel of experts that is advising the agency.

Among the questions we’re asking is whether the recommended dose limit of 90 MME/day should be scrapped; if the guideline should be expanded to include treatment of short-term acute pain; and whether the CDC should give advice on treating specific conditions, such as low back pain or fibromyalgia.

Click here to take the survey. It should only take a few minutes to complete. Your identity and any personal health information will be kept confidential.

CDC Is Prioritizing Politics Over Science

By Dr. Lynn Webster, PNN Columnist

For most of my career, I have revered the Centers for Disease Control and Prevention (CDC). I believed it had the best scientists in the world, and that we could and should believe everything they said.

Not anymore. Unfortunately, the CDC has devolved into a partisan mouthpiece for politicians and people with agendas not supported by science.

The Academy Award-winning documentary Under Our Skin first showed me how politics can influence decisions at the CDC. The film illustrates how chronic Lyme disease (CLD) can cause a great deal of suffering, including chronic pain and fatigue. But the medical community has been unwilling to respond appropriately because the government has determined that CLD is a "controversial" diagnosis.

As a result, patients with Lyme disease often go undiagnosed and untreated until their symptoms worsen. The ongoing "Lyme wars" make it difficult for them to get testing and treatment.

Contagion is a theatrical movie about a pandemic that shows the CDC making decisions based on the political aspirations of key CDC officers. But this fictional story about a pandemic and the power-seeking nature of CDC officials was unfortunately prescient.

CDC Has Done Better

We have seen the tremendous work the CDC can do worldwide. The Ebola virus was contained, and potentially millions of lives were saved, because of the stellar work of enormously talented and dedicated CDC scientists.

The CDC activated its Emergency Response Center to protect the United States and its territories from the threat of the Zika virus, which can cause birth defects and Guillain-Barré Syndrome. My childbearing-age daughter cancelled trips to areas that the CDC warned posed a high risk.

The agency conducted more than 160,000 Zika virus tests, created registries to track pregnant women who were known to be infected with the virus, and provided $251 million in grants to state and local health departments. Their ongoing efforts to minimize the damage from Zika demonstrates the exemplary work the CDC can perform.

CDC's Politicization Is Not Partisan

The politicizing of the CDC is nothing new. During the Obama administration, the CDC became a tool of anti-opioid zealots. Republican Rep. Harold (Hal) Rogers of Kentucky is a senior member of the House Appropriations Committee. You may have heard his name recently, because he helped determine the amount of the CDC's emergency funding for the coronavirus.  

President Obama joined Rogers at the National RX Drug Abuse and Heroin Summit in 2016 to support increased funding to address prescription drug abuse. That action ignored the larger problem of illicit drug abuse and the fact that the opioid crisis has been mischaracterized as a prescription drug problem.

CDC Harmed Millions With Its Opioid Guideline

When Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group, was unable to get what they demanded from the FDA through a citizen petition, they turned to the CDC, where they found political allies. This led to the now infamous CDC Guideline for Prescribing Opioids for Chronic Pain in 2016. 

The guideline has caused enormous harm to millions of Americans. Recently, the American Medical Association implored the CDC to significantly change the guideline "to protect patients with pain from the ongoing unintended consequences and misapplication of the guidance." Even the guideline’s authors have backpedaled, acknowledging it has been misapplied to withhold opioid medication from patients who need it.

Yet the harm continues. Alarmingly, the Department of Justice interprets the guideline as a mandate, warning and sometimes prosecuting doctors who do not follow its voluntary recommendations. Dozens of states have blindly adopted the guideline in a naïve attempt to address the rising number of drug overdose deaths, either not understanding or ignoring the fact that most overdoses are due to illicit, rather than prescription drugs. 

COVID-19 Flip Flops

Now we see the CDC yo-yoing with their recommendations regarding COVID-19. Initially, the CDC said that masks were not necessary, except for those who were sick or taking care of someone who was sick. Now they recommend that everyone wear a mask. The Trump administration wants to leave that decision up to individuals, so they have not issued a federal mask mandate. This is contrary to the advice of most experts.

The CDC has also stated that testing for COVID-19 is important. But when the administration apparently pressured the CDC to change their position and recommend that asymptomatic people who were exposed to the virus not get tested, they did so, allowing politics to trump (no pun intended) science. CDC Director Dr. Robert Redfeld has now reversed his position and said COVID-19 testing is important for those who have been exposed to the virus, even if they are asymptomatic.

I agree with Dr. Leana Wen, a well-recognized authority on public health, who wrote in The Washington Post that the CDC’s testing guidance was “nonsensical.”

"I worry that this CDC change is part of a larger pattern of diluting recommendations when the federal government can’t do its job properly," Wen wrote.

Perhaps we all should worry. Who and what are we to believe? I, for one, can no longer believe what the CDC says unless it is verified by non-partisan scientific bodies.

This is a sad time. Our health is being played with as if it were a game. I feel like a commoner in Game of Thrones, as the kings fight for power and ignore their people. We, the commoners, should insist that the CDC become an independent agency no longer headed by a political appointee, so it would be unassailable by politicians who are more interested in controlling messages than diseases. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find him on Twitter: @LynnRWebsterMD.

CDC Seeking Comment from Pain ‘Stakeholders’

By Roger Chriss, PNN Columnist

The Centers for Disease Control and Prevention has made an unusual request for public comment about the use of opioids and the management of acute and chronic pain.

In a notice published last week in the Federal Register, the CDC said it wants to “obtain comment concerning perspectives on and experiences with pain and pain management, including but not limited to the benefits and harms of opioid use.”

Comments are being sought from patients with chronic or acute short-term pain, their family members, caretakers and healthcare providers – what the agency bureaucratically calls “stakeholders.”

“Public comment will help CDC's understanding of stakeholders' values and preferences regarding pain management and will complement CDC's ongoing work assessing the need for updating or expanding the CDC Guideline for Prescribing Opioids for Chronic Pain,” the agency said.

To leave a comment in the Federal Register, click here.

The CDC doesn’t always seek comments from the public. The agency’s 2016 opioid guideline was initially drawn up without any public hearings or input from patients. It was only after a public outcry that hearings were held and comments were sought in the Federal Register. Over 4,000 people responded, most of them opposing the guideline.

Since then, the federal government has continued to get an earful from patients, providers, medical organizations and various panels about how harmful the guideline has been for pain sufferers and why a “one-size-fits-all approach” to pain management doesn’t work.

For instance, in May 2019, the Pain Management Best Practices Inter-Agency Task Force issued a long-awaited report on pain management, emphasizing the “importance of individualized patient-centered care in the diagnosis and treatment of acute and chronic pain.”

In December 2019, the National Academies of Sciences, Engineering, and Medicine issued another report outlining “a framework for prescribers and others to develop their own plans for acute pain.”

At present, the National Institute of Health’s HEAL Initiative is developing web services for chronic pain management, along with working on research to predict pain.

Moreover, physicians like Dr. Stefan Kertesz have written about the need for nuance in pain management. And pain psychologist Dr. Beth Darnall has written about the need for patient-centeredness in chronic pain, while also working on clinical best practices at the Patient-Centered Outcomes Research Institute.  

Patients themselves have drawn attention to the problem, from TED talks by advocates like Kate Nicholson to nationwide rallies by the group Don’t Punish Pain.

Nearly one year ago, the CDC finally recognized that the opioid guideline was being widely misapplied and issued a long-overdue “clarification” urging policymakers to stop treating its voluntary recommendations as law.

The American Medical Association said it was about time.

“The guidelines have been treated as hard and fast rules, leaving physicians unable to offer the best care for their patients,” said AMA President Patrice Harris, MD. “The CDC’s clarification underscores that patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than the guidelines or thresholds put forward by federal agencies, state governments, health insurance companies, pharmacy chains, pharmacy benefit managers and other advisory or regulatory bodies.”

Patients and providers have been sharing their perspective and experiences for years, with little evidence to suggest that the CDC has been paying much attention. Not a word of the guideline has changed, although the agency is working on an “update” that may be done in late 2021.

As the number of pain stakeholders continues to rise and their care is complicated by COVID-19, the CDC needs to look seriously at the many years’ worth of clearly expressed “values and preferences.” If the CDC needs even more information, so be it. But it’s hard to figure out how much more clearly all the stakeholders can speak.

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.

What Is CDC Trying to Hide?

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention made little attempt at openness and transparency when it released a draft version of its controversial opioid guideline in September 2015.

No public hearings were held. Only a select audience was invited to a secretive online webinar in which CDC officials hurriedly outlined the guideline and then refused to answer any questions about it. The guideline wasn’t posted on the CDC website and no copies were made available.

Even more puzzling is that the CDC refused to disclose who wrote the guideline or served on advisory panels such as the so-called “Core Expert Group” that played a key role in drafting the recommendations. Their names leaked out anyway.

What was the agency trying to hide?

Those issues were important five years ago, just as they are today.  While the opioid guideline was only intended as a recommendation for primary care physicians treating chronic pain, it has effectively become the law of the land for all doctors in every specialty – and adopted as policy by states, insurers, pharmacy chains and law enforcement agencies.

As a result, in the name of preventing addiction, millions of pain patients have been cut off from opioids and gone without adequate pain treatment, with an untold number of suffering souls committing suicide.

Only when threatened with a lawsuit and a congressional investigation of the guideline process did the CDC back down, delaying the release of the guideline for a few months. Hearings were held, public comments were accepted, and CDC revealed the names of its experts and outside advisors, including some who had strong biases against opioids.

Five were board members of Physicians for Responsible Opioid Prescribing (PROP), a small but influential advocacy group founded by Dr. Andrew Kolodny, a psychiatrist who was then-medical director of Phoenix House, an addiction treatment chain. PROP President Jane Ballantyne, MD, and Vice-President Gary Franklin, MD, were members of the Core Expert Group, while board member David Tauben, MD, served on the CDC’s peer review panel. PROP member David Juurlink, MD, and Kolodny himself were part of a “Stakeholder Review Group” that provided input to the CDC.

Concerned about the apparent one-sided approach to the guideline, a bipartisan group of congressmen on the House Oversight and Government Reform Committee wrote a letter to then-CDC director Thomas Frieden, a longtime associate of Kolodny.

“We expect CDC’s guidelines drafting process to seek an appropriate balance between the risk of addiction and the need to address chronic pain,” wrote Chairman Jason Chaffetz (R-Utah). “The CDC has utilized a ‘Core Expert Group’ in the drafting and development of opioid prescribing guidelines, raising questions as to whether CDC is complying with FACA (Federal Advisory Committee Act).”

Chaffetz and his colleagues asked Frieden to supply documents and information about the guideline process “as soon as possible.”

‘Some Information Was Withheld’

We were curious about Frieden’s response and filed a Freedom of Information Act (FOIA) request with the CDC last year, asking for “copies of all documents, emails, memos and other communications” that the agency sent in response to Chaffetz’s letter.

The CDC’s reply, received a few weeks ago, is just as puzzling and secretive as the agency’s actions in 2015.  Nearly 1,500 pages of documents provided to PNN were heavily redacted or scrubbed of all information. As a result, over 1,200 pages were completely blank.

“We located 1,449 pages of responsive records and two Excel workbooks (108 pages released in full; 103 pages disclosed in part; 1,238 pages withheld in full). After a careful review of these pages, some information was withheld from release,” Roger Andoh, who heads the CDC’s FOIA Office, wrote in a letter to PNN.

Andoh cited two FOIA exemptions to justify withholding the information. The first exemption protects material under a broad declaration of “deliberative process privilege.” Material that’s in draft form, including a reviewer’s comments and recommendations, can be withheld by the government because they are “predecisional and deliberative.”

The second FOIA exemption cited by Andoh protects information that is private because releasing it would be “a clearly unwarranted invasion of personal privacy.”  

The privacy exemption was applied often to documents from a June 23, 2015 meeting of the Core Expert Group. We can see from the agenda that it was an important meeting, with clinical evidence about opioids reviewed in the morning, followed by a lengthy panel discussion in the afternoon. But we don’t know who said what because the minutes from that meeting have been deleted.

Whenever you see the notations “(b)(5)” or “(b)(6)” appear means that some information was withheld.

SOURCE: cdc foia office

The privacy exemption was also applied to the financial conflict of interest statements filed by all 17 members of the Core Expert Group (CEG). Their names and signatures were redacted, so we have no idea who they were or what conflicts they declared.

One CEG member checked a box indicating they did consulting work for “a commercial entity or other organization with an interest related to controlled substances.” Opioids are a controlled substance and so is Suboxone, an addiction treatment drug. It would be important to know who that person was, but their name was redacted, along with name of the organization they worked for.

The same individual also checked a box indicating they “provided an expert opinion or testimony.” But because the information was redacted, we don’t know if the person was paid for their testimony and, if so, who they were paid by and what the amount was.

Information was also withheld about other CEG members who were given grants, honoraria, and reimbursement for travel and lodging by organizations with an interest in controlled substances. One CEG member was actually employed by such an organization, but we don’t know who that was or who they worked for..

In short, several members of the Core Expert Group had a financial conflict of interest and disclosed it to the CDC, but the agency has decided – five years later -- that information should not be made public.

‘There Was a Cover-Up Here’

We asked three advocates in the pain community to review the documents CDC provided to PNN. All three were puzzled why so much information was withheld.

“I think what they sent is an embarrassment. There is no reasonable or rational explanation to redact any part of a suggested guideline process especially since the CDC admits the guidelines were misapplied and misinterpreted,” said Julie Killingworth, a disabled activist. “I believe the ridiculously heavy number of redactions is a clear admission of guilt. The CDC has committed at least one or multiple federal crimes and the House Oversight Committee needs to closely revisit their December 18, 2015 letter of concern to Dr. Tom Frieden.”

“There was indeed a cover-up here, grounded primarily on the escape clauses in the FOIA enabling legislation which exempts the government from revealing its internal processes or consultations to the public,” said Richard “Red” Lawhern, PhD, who heads the Alliance for the Treatment of Intractable Pain. “Unfortunately, this broad exception to full public disclosure permits agencies to hide their own biases, failures of transparency, or arbitrary decisions.    

“Masking the identities of individuals who contribute to policy can also make it practically impossible to assess bias, conflict of interest, or outright misrepresentation. The extensive redacting of documents raises concern that the reviewing office has engaged in a broad cover-up by masking the identities and professional or personal affiliations of those who contributed to the CDC Guidelines." 

“It could well be that there would be nothing surprising or unseemly in the redacted information. But if you don't want people to think you are trying to hide something nefarious, then the old saying that sunlight is the best disinfectant certainly would seem to apply here,” said Bob Twillman, PhD, a former executive director of the Academy of Integrative Pain Management, who was also a member of the CDC’s Stakeholder Review Group. 

“It's mystifying and sad to me that CDC will not reveal who was involved in the deliberations that led to the issuance of its opioid prescribing guideline, even though they have publicly revealed much of this information elsewhere.” 

Twillman points out that the identities of the Core Expert Group, as well as other advisors and contributors to the guideline, were all published in a JAMA article and by the CDC itself when the final guideline was released in 2016.  

Redacting their names and conflicts of interest, as well as minutes and notes from their deliberations, is likely to fuel long-standing suspicion in the pain community that the guideline process was tainted by bias and that much of the clinical evidence was cherry-picked.

“What's worse for me is the refusal to help people understand the deliberative process that went into drafting the recommendations in the guideline,” says Twillman. “An interesting issue that is probably covered by the redacted material is the decision to reject any evidence except RCTs (randomized controlled trials) when evaluating benefits of opioids, but to accept weaker types of evidence when evaluating harms of opioids. Why did the group decide this was acceptable, and not insist on a level playing field for evidence regarding these two questions?” 

The CDC recently announced plans to update and expand its opioid guideline, most likely to include the treatment of short-term, acute pain. Whether the agency will use more transparency and openness in that process remains to be seen. The updated guideline is expected in 2021.

Rising Overdoses Show CDC Guideline Not Working

By Pat Anson, PNN Editor

Rising suicides and drug overdose deaths led to another decline in U.S. left expectancy last year, according to two sobering reports released by the Centers for Disease Control and Prevention.

Americans born in 2017 are expected to live 78.6 years, about one month less than those born in 2016. Life expectancy has fallen or remained flat in the U.S. for three consecutive years. The UK is the only other country in the industrialized world where life expectancy is dropping.

“Tragically, this troubling trend is largely driven by deaths from drug overdose and suicide. Life expectancy gives us a snapshot of the Nation’s overall health and these sobering statistics are a wakeup call that we are losing too many Americans, too early and too often, to conditions that are preventable,” CDC director Robert Redfield, MD, said in a statement.

Redfield, who almost lost a son to a drug overdose, has been nearly invisible since becoming CDC director in March. He has previously called the opioid epidemic “the public health crisis of our time” and pledged to “bring this epidemic to its knees.”

So far, the CDC’s strategies, including its controversial 2016 opioid prescribing guideline, are not working. As PNN has reported, the guideline may even be contributing to the rising number of suicides and overdoses.

Over 70,200 people died of a drug overdose in 2017 – the highest number on record and nearly a 10 percent increase from 2016. Deaths involving illicit fentanyl and other synthetic, mostly black market opioids surged 45 percent, while deaths involving natural or semisynthetic opioids, mostly painkillers such as oxycodone and hydrocodone, remained flat.  The rate of heroin deaths also remained unchanged.

SOURCE: CDC

CDC researchers noted that their data is flawed. Drug overdose deaths often involve multiple drugs, and “a single death might be included in more than one drug category.” A death “involving” a specific drug also doesn’t mean that drug was the cause of death. It only means the drug was present at the time of death.  The competency of medical examiners and coroners who complete death certificates can also vary widely from state to state.

The CDC reported that over 47,000 people committed suicide last year, nearly 4 percent more than in 2016. Suicide is the 10th leading cause of death among all age groups – and the 2nd leading cause of death among adolescents and young adults aged 10 to 34.

Reports Ignored Role of Antidepressants, ADHD Drugs

The CDC reports did not explore the role of drugs used to treat depression, anxiety and attention deficit hyperactive disorder (ADHD) in either suicides or overdoses.

According to a recent study by the Substance Abuse and Mental Health Services Administration (SAMHSA), Xanax, Valium, Adderall and other psychotherapeutic drugs were involved in more overdoses in 2016 than prescription opioids.

A report this week from the Research Abuse Diversion and Addiction Related Surveillance System (RADARS), which tracks illicit drug use nationwide, underscores that emerging trend. RADARS found that the abuse of ADHD stimulants now exceeds the abuse of prescription opioids by Americans aged 19 or younger. The rising trend in “intentional exposures” to stimulants – which includes suicide – began in 2010 and is accelerating.    

PEDIATRIC CASES OF UNINTENTIONAL EXPOSURE (SOURCE: RADARS)

“There have been more pediatric exposures involving stimulants than pediatric exposures involving natural/semi-synthetic opioid analgesics in every quarter since 4th quarter 2014. The increase appears to be driven by exposures where the intent of the patient was suicide,” the RADARS report found. 

“Multiple factors may contribute to the observed increase in suspected suicide exposures. The increase may reflect overall increases in suicides in the United States. It may also be a result of increases in stimulant misuse.” 

In the 2nd quarter of 2018, there were 822 reported cases of intentional exposure to stimulants among young people, while there were 503 cases involving opioid analgesics.

CDC: 50 Million Americans Have Chronic Pain

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention and other federal agencies have faced a fair amount of criticism over the years for adopting insensitive policies and guidelines that are often harmful to the pain community. But there are growing signs the CDC and other agencies are starting to listen to or at least better understand pain patients.

Today the CDC released a new report estimating that 50 million Americans – just over 20 percent of the adult population – have chronic pain. About 20 million of them have “high-impact chronic pain” -- pain severe enough that it frequently limits life or work activities. The estimates are based on the 2016 National Health Interview Survey of over 33,000 adults.

“Pain is a component of many chronic conditions, and chronic pain is emerging as a health concern on its own, with negative consequences to individual persons, their families, and society as a whole,” reported James Dahlhamer, PhD, of the CDC's Division of Health Interview Statistics.

Dahlhamer and his colleagues found that women, unemployed older adults, adults living in poverty, rural residents and people without public health insurance are significantly more likely to have chronic pain, while the risk of pain is lower for people with a bachelor’s degree.

“Socioeconomic status appears to be a common factor in many of the subgroup differences in high-impact chronic pain prevalence,” they found. “Education, poverty, and health insurance coverage have been determined to be associated with both general health status and the presence of specific health conditions as well as with patients’ success in navigating the health care system. Identifying populations at risk is necessary to inform efforts for developing and targeting quality pain services.”

Different Estimates

Last week the National Institutes of Health (NIH) released its own research on high impact chronic pain (HICP), estimating that 11 million American adults have it -- about half the CDC’s estimate.

Both the NIH and CDC are part of the Department of Health and Human Services (HHS). It was not immediately clear why the two estimates are so far apart – or why two government agencies in the same department were studying the same thing at the same time.  

It’s certainly not the first time researchers have disagreed on the number of people in pain. In 2011, the Institute of Medicine released a landmark report claiming at least 100 million Americans have chronic pain, an estimate that one critic said was a “ridiculous number.” Other estimates range from 39 to 70 million.

“The multidimensional nature of chronic pain is not reflected in commonly used operational definitions… resulting in inordinately high prevalence estimates that limit our ability to effectively address chronic pain on a national level,” said Mark Pitcher, PhD, a visiting fellow at the National Center for Complementary and Integrative Health (NCCIH).

Like their counterparts at the CDC, NIH researchers found that socioeconomic factors play a significant role in high impact chronic pain. HICP sufferers not only have more severe pain, they are more likely to have mental and cognitive health issues, as well as substantially higher healthcare costs. About 83 percent of people with HICP are unable to work and one-third have difficulty with simple activities such as bathing and getting dressed.

“By differentiating those with HICP, a condition that is associated with higher levels of anxiety, depression, fatigue, and cognitive difficulty, we hope to improve clinical research and practice,” said co-author M. Catherine Bushnell, PhD, scientific director at NCCIH.

The concept of HICP was first proposed by the National Pain Strategy to better identify patients with pain severe enough to interfere with work and life activities. It also helps distinguish HICP from other types of chronic pain that are less impactful and more easily treated.

“It is crucial that we fully understand how people’s lives are affected by chronic pain. It will help improve care for individuals living with chronic pain and strategically guide our research programs that aim to reduce the burden of pain at the population level,” said Linda Porter, PhD, director of the Office of Pain Policy at the National Institute of Neurological Disorders and Stroke. 

The Food and Drug Administration has also recently taken steps to better understand the chronic pain population. In July, the FDA held a day-long public hearing and heard from dozens of pain patients and advocates. Some fought back tears as they testified about the lack of access to opioid medication and the deteriorating quality of pain care in the U.S.

Former CDC Director Arrested for Sexual Misconduct

By Pat Anson, Editor

Dr. Thomas Frieden, the former director of the Centers for Disease Control of Prevention, has been arrested on sexual misconduct charges in New York City.

Frieden turned himself in to police in Brooklyn Friday morning after being charged with forcible touching, harassment and third degree sex abuse, all misdemeanors. The charges stem from a complaint filed in July by a 55-year old unnamed woman who alleges the 57-year old doctor grabbed her buttocks without permission in his apartment last October. 

According to STAT, Frieden later apologized to the woman -- a longtime family friend -- and "tried to manipulate her into staying silent by citing his position and potential to save lives around the world."

Fried was arraigned Friday afternoon and released without bail, after a judge ordered him not to contact his accuser and to surrender his passport. He's due back in court October 11.

Frieden did not enter a plea. A spokesperson released a statement saying the incident "does not reflect Dr. Frieden’s public or private behavior or his values over a lifetime of service to improve health around the world.”

Frieden led the CDC from 2009 to 2017 and championed the agency’s controversial opioid prescribing guideline -- calling it an "excellent starting point" to prevent opioid abuse.

Although voluntary and only intended for primary care physicians, the guideline has been widely adopted by insurers, states and healthcare providers – resulting in many chronic pain patients losing access to opioid medication.

“This crisis was caused, in large part, by decades of prescribing too many opioids for too many conditions where they provide minimal benefit," Frieden wrote in a commentary published by Fox News.  “There are safer drugs and treatment approaches that can control pain as well or better than opioids for the vast majority of patients."

DR. THOMAS FRIEDEN

Frieden currently heads Resolve to Save Lives, a program of Vital Strategies, a non-profit health organization that is trying to improve public health worldwide.

Vital Strategies released a statement saying Frieden informed the organization in April about the misconduct allegation. His accuser does not work for Vital Strategies, but the organization hired an investigator to interview employees about Frieden. No inappropriate workplace behavior or harassment was found, according to Vital Strategies CEO Jose Castro.  

“I have known and worked closely with Dr. Frieden for nearly 30 years and have seen first-hand that he has the highest ethical standards both personally and professionally. Vital Strategies greatly values the work Dr. Frieden does to advance public health and he has my full confidence,” said Castro.

Frieden has an extensive background in epidemiology and infectious diseases, and his tenure at the CDC was marked by major efforts to combat the Ebola virus, fungal meningitis, influenza and the Zika virus.

Before his appointment as CDC director, Frieden was New York City’s health commissioner, where he led efforts to ban public smoking and remove unhealthy trans fats from restaurants. Frieden is married and has two children.

CDC Report Ignores Suicides of Pain Patients

By Pat Anson, Editor

The suicide rate in the United States continues to climb, with nearly 45,000 people taking their own lives in 2016, according to a new Vital Signs report by the Centers for Disease Control and Prevention.

The suicide rate in the U.S. is so high it rivals the so-called “opioid epidemic.” The number of Americans who died by suicide (44,965) exceeds the overdose deaths linked to both illicit and prescription opioids (42,249).  The nationwide suicide rate has risen by over 30 percent since 1999.

“Unfortunately, our data shows that the problem is getting worse,” said CDC Deputy Director Anne Schuchat, MD. “These findings are disturbing. Suicide is a public health problem that can be prevented.”  

Contrary to popular belief, depression is not always a major factor in suicides. The report found that less than half of the Americans who died by suicide had a diagnosed mental health issue. Substance abuse, physical health problems, and financial, legal or relationship issues were often contributing factors. So was the availability of firearms, which were involved in nearly half of all suicides.

But while CDC researchers can go into great detail about the methods, causes, demographics, ethnicity and even the drugs used by suicide victims, they did not investigate anecdotal reports of a growing number of suicides among pain patients.

“Our report found that physical health problems were present in about a fifth of individuals as circumstances considered to lead up to suicide," Schuchat said in a conference call with reporters. "That doesn’t differentiate whether it was intractable pain versus other conditions that might have been factors.”

Asked directly if lack of access to opioid medication may be contributing to pain patient suicides, Schuchat said that federal agencies were “working on comprehensive pain management strategies,” but they were not investigating patient suicides, such as the recent tragic death of a Montana woman.

“We don’t have other studies right now. But I would say that the management of pain is a very important issue for the CDC and Health and Human Services,” she said.

PNN asked a CDC spokesperson if the agency was conducting any studies or surveys to determine whether the CDC's 2016 opioid guideline was contributing to patient suicides, and what impact it was having on the quality of pain care. The boilerplate response we received essentially said no, and that the CDC was only tracking prescriptions. 

"Through its quality improvement collaborative and its work with academic partners, CDC is evaluating the impact of clinical decisions on patient health outcomes by examining data on overall opioid prescribing rates, as well as measures such as dose and days’ supply, since research shows that taking opioids for longer periods of time or in higher doses increases a person’s risk of addiction and overdose," Courtney Leland said in an email.

As PNN has reported, the CDC’s guideline may be contributing to a rising number of suicides in the pain community.  In a survey of over 3,100 pain patients on the one-year anniversary of the guideline, over 40 percent said they had considered suicide because their pain was poorly treated.

Most patients said they had been taken off opioids or had their doses reduced to comply with the  CDC guideline, which has been widely adopted throughout the U.S. healthcare system. Many patients say they can’t even find a doctor willing to treat them.

‘Making Plans to End This Life’

“I am scared to death as pain for me is unbearable. If I cannot get a prescription for relief I will probably be one of those (suicide) statistics because as far as I'm concerned, my quality life would be gone and no longer worth living. I will be sure to leave a note telling the CDC to go to hell too,” one PNN reader said.

“If my life is reduced to screams of agony in my bed while my father has to watch, if that happens and I can’t take anymore suffering, I will leave a note (probably a very long one), and in it I will say that the people who are making these guidelines into law, should be charged with my homicide,” another patient wrote.

“My suicidal ideation has increased exponentially. I have now resorted to cutting and punishing myself in order to distract from the physical chronic pain I suffer with,” said another patient. “I am struggling terribly and can’t even get sleep. I have been making plans to end this life and if the pain continues without treatment, it will not be hard to do.”

“My wife has been talking about suicide as the only option to escape her chronic pain and migraine headaches. I am starting to think the same thoughts,” wrote a man who also suffers from chronic pain. “Many chronic pain patients left without a doctor or opiate painkillers will commit suicide to escape the pain and suffering. My wife and I included.”

British Columbia Revising Its Guideline

The Canadian province of British Columbia was one of the first to adopt the CDC guideline as a standard of practice for physicians. In April 2016, British Columbia declared a public health emergency because overdose deaths from illicit fentanyl, heroin and prescription drugs were soaring. In response, the College of Physicians and Surgeons of British Columbia released new professional standards and guidelines that were closely modeled after the CDC’s.

Two years later, the British Columbia guidelines are now being revised because too many patients were being denied care or abandoned by doctors fearful of prescribing opioids.

“Physicians cannot exclude or dismiss patients from their practice because they have used or are currently using opioids. It’s really a violation of the human rights code and it’s certainly discrimination and that’s not acceptable or ethical practice,” college registrar Heidi Oetter told The Globe and Mail.

Under the old guidelines, British Columbia doctors were strongly encouraged to keep opioid doses below 90 milligrams of morphine a day – the same recommendation as the CDC’s. Now they’re being told to use their own discretion and to work with patients in finding an effective dose.

“Hopefully it’s clear to physicians that the college is really expecting that they exercise good professional discretion, that they are really engaging patients in informed consent discussions and that patients are really aware of the potential risks that are associated with opioids, particularly if they’re taking them in conjunction with alcohol or sedatives,” Oetter said.

Not only were the old guidelines harmful to patients, they were ineffective in reducing overdoses. British Columbia still has the highest number of overdoses in Canada, with 1,448 deaths last year.

Overdoses also continue to soar in the United States – mostly due to illicit fentanyl and other street drugs. Will the CDC change its guideline -- as promised -- because it is harming patients and failing to reduce overdoses?

"CDC will revisit this guideline as new evidence becomes available," the agency said in 2016. "CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.”

Today’s report on suicides indicates the agency has no plans to do either.

CDC Blames Fentanyl for Spike in Overdose Deaths

By Pat Anson, Editor

The Centers for Disease Control and Prevention released a new report today estimating that 63,632 Americans died of a drug overdose in 2016 – a 21.5% increase over the 2015 total.  

The sharp rise in drug deaths is blamed largely on illicit fentanyl, a powerful synthetic opioid that has become a scourge on the black market. Deaths involving synthetic opioids doubled in 2016, accounting for about a third of all drug overdoses and nearly half of all opioid-related deaths.

For their latest report, CDC researchers used a new “conservative definition” to count opioid deaths – one that more accurately reflects the number of deaths involving prescription opioids by excluding those attributed to fentanyl and other synthetic opioids. Over 17,000 deaths were attributed to prescription opioids in 2016, about half the number that would have been counted under the “traditional definition” used in previous reports.

CDC researchers recently acknowledged that the old method "significantly inflate estimates" of prescription opioid deaths.

The new report, based on surveillance data from 31 states and the District of Columbia, shows overdose deaths increasing for both men and women and across all races and demographics.  A wider variety of drugs are also implicated:

• Fentanyl and synthetic opioid deaths rose 100%
• Cocaine deaths rose 52.4%
• Psychostimulant deaths rose 33.3%
• Heroin deaths rose 19.5%
• Prescription opioid deaths rose 10.6%

The CDC also acknowledged that illicit fentanyl is often mixed into counterfeit opioid and benzodiazepine pills, heroin and cocaine, likely contributing to overdoses attributed to those substances.

2016 DRUG RELATED DEATHS

West Virginia led the nation with the highest opioid overdose rate (43.4 deaths for every 100,000 residents), followed by New Hampshire, Ohio, Washington DC, Maryland and Massachusetts.  Texas has the lowest opioid overdose rate.

‘Inaccurate and Misleading” Overdose Data

The CDC's new method of classifying opioid deaths still needs improvement, according to John Lilly, DO, a family physician in Missouri who took a hard look at the government’s overdose numbers. Lilly estimates that 16,809 Americans died from an overdose of prescription opioids in 2016.

“Not all opioids are identical in abuse potential and likely lethality, yet government statistics group causes of death in a way that obscures the importance of identifying specific agents involved in deadly overdoses,” Lilly wrote in a peer reviewed article recently published in the Journal of American Physicians and Surgeons..

Lilly faults the National Institute on Drug Abuse (NIDA) -- which relies on a CDC database -- for using “inaccurate and misleading” death certificate codes to classify drug deaths. In its report for 2016, NIDA counted illicit fentanyl overdoses as deaths involving prescription opioids. As a result, deaths attributed to pain medication rose by 43 percent, at a time when the number of opioid prescriptions actually declined.

“That large an increase in one year from legal prescriptions does not make sense, particularly as these were being strongly discouraged,” Lilly wrote. “Rather than legal prescription drugs, illicit fentanyl is rapidly increasing and becoming the opioid of choice for those who misuse opioids... Targeting legal prescriptions is thus unlikely to reduce overdose deaths, but it may increase them by driving more users to illegal sources.”

Some researchers believe the government undercounts the number of opioid related deaths by as much as 35 percent because the actual cause of death isn’t listed on many death certificates.

“We have a real crisis, and one of the things we need to invest in, if we’re going to make progress, is getting better information,” said Christopher Ruhm, PhD, a professor at the University of Virginia and the author of a overdose study recently published in the journal Addiction.

Ruhm told Kaiser Health News the real number of opioid related deaths is probably closer to 50,000.

Kratom Linked to Salmonella Outbreak

By Pat Anson, Editor

Kratom just can’t get a break. In recent weeks, the herbal supplement used by millions of Americans to treat chronic pain, depression and addiction has been blamed by federal agencies for dozens of fatal overdoses and even been called an opioid.

Now the Centers for Disease Control and Prevention has linked kratom to a salmonella outbreak and is recommending that people "not consume kratom in any form."

The bacterial infection has sickened 28 people, eleven serious enough to be hospitalized, but there have been no deaths. The outbreak began in October 2017 and has reached 20 states scattered around the country, which are highlighted in the map below.

“Epidemiologic evidence indicates that kratom is a likely source of this multistate outbreak,” the CDC said in a statement.

“In interviews, ill people answered questions about the foods they ate and other exposures in the months before they became ill. Eight (73%) of 11 people interviewed reported consuming kratom in pills, powder, or tea. No common brands or suppliers of kratom have been identified at this time."

The CDC statement did not say that Salmonella bacteria had actually been found in any samples of kratom. Nor did it explain how kratom use in 8 out of 28 cases establishes a link or proves that it was "a likely source."

The only "epidemiologic evidence" that investigators have established is that when they compared bacteria samples from people who were infected, they found the bacteria were closely related genetically.

"This means that people in this outbreak are more likely to share a common source of infection," the CDC said. "At this time, CDC recommends that people not consume kratom in any form. The investigation indicates that kratom products could be contaminated with Salmonella and could make people sick."

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Salmonella causes an estimated one million food-borne illnesses a year in the United States, with 19,000 hospitalizations and 380 deaths.

In the current outbreak, the CDC says there could be more cases than the 28 reported, because salmonella infections typically take 2 to 4 weeks before the illnesses are confirmed.

salmonella bacteria

It was a July 2016 report from the CDC that claimed kratom was linked to several overdose deaths and was “an emerging public health threat” that led the Drug Enforcement Administration to attempt to schedule kratom as an illegal controlled substance. Kratom supporters said the CDC research was amateurish and flawed, and a public outcry and lobbying campaign eventually forced the DEA to suspend its scheduling decision.

Earlier this month, the Food and Drug Administration released a computer analysis that found kratom contains over two dozen opioid-like substances – a report that critics say was biased and amounted to “junk science.” The computer analysis and a recent FDA public health advisory may indicate the federal government is planning another attempt at scheduling.

Kratom comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries for its medicinal properties.

CDC: Opioid Prescribing Peaked in 2010

By Pat Anson, Editor

The Centers for Disease Control and Prevention admitted something today that most doctors and pain patients could have told the agency several years ago: prescriptions for opioid painkillers are declining.

In its newest Vital Signs report, the CDC analyzed prescription drug data compiled by QuintilesIMS from 2006 to 2015, and found that opioid prescribing in the U.S. peaked in 2010.  More recent data indicates the downward trend continued in 2016.

The CDC's new report undermines one of the main reasons behind the agency’s 2016 opioid prescribing guidelines, which falsely claimed that “opioid prescriptions per capita increased from 2007 to 2012,” when, in fact, they actually declined (see chart below).  

“Overall, opioid prescribing in the United States is down 18 percent since 2010,” said CDC Acting Director Anne Schuchat, MD.  

But even with that downward trend in prescribing, the CDC maintains opioid doses are still too high and contributing to the nation’s overdose crisis.

“Despite these overall declines, the bottom line remains we still have too many people getting opioid prescriptions for too many days at too high a dose,” said Schuchat. “In addition, the dramatic increase we’ve been seeing in heroin overdose is another tragic consequence of exposing too many people to prescription opioids, since most people who use heroin started off with misusing prescription opioids.”

Schuchat did not explain how her theory could account for the fact that heroin overdoses were increasing at a time when opioid prescriptions were declining. The association between heroin use and prescription painkillers is a common misconception at best, and a misleading half-truth at worst.

While many heroin users start out with painkillers (as well as tobacco, marijuana, alcohol and other drugs), most obtain their opioids illegally through friends, relatives and the black market. Heroin use by patients who are legally prescribed painkillers is actually quite rare, although the CDC's acting director makes it sound like one of the leading causes of overdoses.

"We're now experiencing the highest overdose drug death rates ever recorded in the United States, driven by prescription opioids and illicit opioids like heroin and illicitly manufactured fentanyl," Schuchat said.

Contrary to its own prescribing guideline, the CDC found that the average per capita daily morphine equivalent dose (MME) has been in decline for nearly a decade, from 59.7 MME per capita in 2006 to 48.1 MME in 2015.

The latter dose is well below the highest recommended limit of 90 MME in the CDC guidelines.

AVERAGE DAILY PER CAPITA MORPHINE EQUIVELANT DOSE (MME)

Source: CDC/QuintilesIMS

The CDC also found a wide variation in prescribing practices around the country, with six times more opioids per resident dispensed in the highest-prescribing counties than in the lowest-prescribing ones.

Many of the high-prescribing counties are in rural, economically depressed areas such as Appalachia, where there are high rates of disability, suicide and unemployment; suggesting that the so-called "opioid epidemic" is actually more of an epidemic of despair. Other factors associated with high rates of opioid prescribing are a high percentage of white residents, high rates of uninsured or Medicaid recipients, and high rates of patients with diabetes and arthritis.