Kolodny: Critics of CDC Opioid Guideline ‘Twisting the Facts’

By Pat Anson, PNN Editor

The founder of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP) says his organization played only a minor role in drafting the CDC opioid guideline and claims much of the controversy over the guideline was stirred up by pain organizations funded by the pharmaceutical industry.

“Not every group that has harmful advocacy is funded by industry, but the vast majority are. The ones that are not funded by industry work arm-in-arm with industry funded groups,” said Dr. Andrew Kolodny. “They have an agenda. A lot of individuals, journalists, organizations that have weighed in on the opioid crisis have an agenda. And they will try and twist the facts to fit their agenda.”

Kolodny spoke for over an hour Tuesday during a webinar hosted by PharmedOut, a program at Georgetown University that seeks to expose deceptive marketing in healthcare. The webinar was billed as an effort to refute “False Narratives & Manufactured Controversies about the Opioid Crisis,” but it turned into a rambling dialogue by Kolodny that gaslighted pain sufferers, doctors, patient advocates and anyone else critical of the CDC guideline.

“Much of the controversy or the critique of the guideline, almost all of it, was focused on the secretive way in which the guideline had been drafted, not on the actual recommendations. They seemed to stay clear from attacking recommendations, almost all of which were pretty benign,” said Kolodny.

Although voluntary and only intended for primary care physicians, the CDC guideline has become the “standard of care” in the United States for treating pain, with millions of patients taken off opioids or reduced to lower doses in the name of preventing addiction and overdoses.

Many patients say their pain and quality of life are now significantly worse, they have a hard time finding doctors, and some have turned to alcohol and illegal drugs for pain relief. The opioid crisis also continues to grow worse, with a record number of fatal overdoses last year – most of them caused by illicit fentanyl and other street drugs, not prescription opioids.

Even the CDC has recognized that its 2016 guideline has caused “unintended harms,” and the agency is now in the process of updating and possibly expanding its recommendations.

Kolodny brushed aside many of those concerns and instead focused on deflecting attention away from PROP –- at various times blaming Purdue Pharma, the Koch brothers and the Washington Legal Foundation for “manufacturing a controversy around the CDC recommendations.”

“To try and make the guideline controversial, the messaging came out that the guideline has been secretly written by PROP. We started to see mentions in social media and publications describing PROP as a fringe group or as anti-opioid zealots. So the messaging was that the CDC relied on this fringe, anti-opioid zealot group to secretly write the guideline,” Kolodny said. 

As PNN has reported, the CDC guideline was in fact drafted in secret, with no public hearings and little input from patients or pain management experts. Only when threatened with a lawsuit by the Washington Legal Foundation and a congressional investigation did the CDC open up the guideline process to public scrutiny and disclose the identities of its advisors and consultants.

At least five PROP board members were involved in drafting the guideline, although Kolodny claimed there were only three in Tuesday’s webinar.  PROP President Jane Ballantyne and Vice-President Gary Franklin were members of a key advisory panel; David Tauben was on the guideline’s peer review panel; and Kolodny and David Juurlink were on a stakeholder review group.

While technically true that PROP did not write the guideline, PROP had input and key relationships within the CDC. Dr. Roger Chou, one of the guideline authors, has collaborated with PROP members on several occasions, such as writing an op/ed with Ballantyne that encouraged doctors to consider tapering “every patient receiving long term opioid therapy.”

Koldony is also a longtime associate and friend of then CDC Director Thomas Frieden, and has co-authored op/eds with Frieden, including one that recommended taking all high-dose opioid medications off the market.

On September 14, 2015, two days before the first draft of the CDC guideline was even made public, Frieden wrote an email to Kolodny thanking him for his role in preparing it. The email was then forwarded by Kolodny to other PROP members

“I want to personally thank you and your organization’s leadership for serving as members of the Stakeholder Review Group,” Frieden wrote. “We greatly appreciate not only your engagement in this process, but also your willingness to do so within the allotted timeframe. Given the public health toll, we have undertaken a process that will expedite publication while maintaining fidelity to the scientific process.”

We may never know the full extent of Kolodny and PROP’s relationship with the CDC, because the agency has refused to disclose key material about its guideline deliberations. The CDC’s response to a Freedom of Information Act (FOIA) request from PNN was to send us nearly 1,500 pages of documents that were heavily redacted or scrubbed of information. Over 1,200 pages were completely blank, including some of the conflict of interest statements of CDC advisors like Kolodny.

The agency cited “deliberative process privilege” and “personal privacy” as reasons to withhold the information

(Update: In 2022 testimony in West Virginia, Kolodny testified that he started working on opioid litigation in 2012 with Linda Singer from the law firm Cohen Milstein. It’s unknown if he disclosed that relationship to the CDC on his conflict of interest statement. In 2017, Singer joined Motley Rice, yet another law firm involved in opioid litigation.) .

Friendly Questions

Kolodny took only a handful of friendly, softball questions during the PharmedOut webinar, most of them from students at Georgetown University who are interning at PharmedOut. Several pain patients also submitted more critical questions, but they were not passed on to Kolodny.

Although opioid prescriptions in the U.S. have been declining since their peak in 2011, Kolodny says they need to go down further, even though nearly 85% of overdose deaths in the U.S. involve illicit fentanyl and other street drugs.

“We continue to massively overprescribe,” he said. “Opioids are not good treatments for chronic pain. It’s not true that more cautious prescribing somehow jeopardizes compassionate care for chronic pain. Compassionate care for chronic pain really demands more cautious prescribing.”

Kolodny is quick to blame “industry funded groups” for opposition to the CDC guideline, but PROP has remained secretive about its own funding. PROP uses a loophole in IRS regulations that allows it to hide behind front organizations such as the Steve Rummler Hope Network as its “fiscal sponsor.” Because it is not registered as a nonprofit — although it sometimes claims to be one — PROP has never filed a federal or state tax return and is not required to disclose anything about its funding or spending.

Kolodny currently works in opioid research at Brandeis University, but has a lucrative sideline testifying as an expert witness in opioid litigation and malpractice lawsuits. He was paid $725 an hour for his testimony during Oklahoma’s lawsuit against Johnson & Johnson, and may have collected as much as $500,000 for that case alone.

Dr. Adriane Fugh-Berman, who is a PROP board member and Director of PharmedOut, is also a paid expert witness and earned $500 an hour for her testimony in another trial involving Johnson & Johnson. She reportedly received about $120,000 for her work in that case. Like PROP, PharmedOut does not disclose its funding or donors.

DEA: Drug Cartels Targeting Pain Patients as Potential Customers

By Pat Anson, PNN Editor

The Drug Enforcement Administration’s “National Drug Threat Assessment” is an interesting annual report that gives insight into drug trafficking and drug abuse trends in the United States that you don’t often see in the mainstream media..

The DEA’s 2020 report, released this month, is no exception. One hundred pages long, it covers a broad range of “unclassified” information about drug cartels, counterfeit medication and emerging trends in drug abuse.

“Although we have made progress in driving down the abuse of controlled prescription opioids, the United States continues to face challenges from both new and persistent threats,” said acting DEA Administrator Christopher Evans.

According to the DEA report, the diversion and abuse of opioid painkillers and other controlled prescription drugs (CPDs) are at their “lowest levels in nine years.”

While opioid pain relievers remain the most commonly abused type of prescription drug, most people don’t take them to get high.

The DEA said nearly two-thirds (64%) of drug users “identified relieving pain as the main purpose” for their misuse of painkillers – a staggering statistic that may say more about the poor state of pain care in the U.S. than anything else.

Ironically, the second most widely abused opioid medication was buprenorphine, which is combined with naloxone in addiction treatment drugs such as Suboxone and Zubsolv. The National Forensic Laboratory (NFLIS) reports that buprenorphine is abused far more often than methadone or hydrocodone, and appears poised to soon replace oxycodone as the most commonly abused prescription opioid. 

“Drug data reveals that buprenorphine reports from all participating federal, state, and local laboratories increased each year except a minor drop from 2018 to 2019. (NFLIS) reported a 50 to 67 percent decrease of hydrocodone, methadone, and oxycodone reports from 2014 to 2019, so the 27 percent increase of buprenorphine during that time frame was significant,” DEA said.     

Fentanyl Laced Counterfeit Pills

Not surprisingly, the DEA said illicit fentanyl was “primarily responsible for fueling the ongoing opioid crisis,” with Mexican drug cartels controlling most of the supply for the potent synthetic opioid. With hydrocodone, oxycodone and other legal opioid medications in short supply — and a lot of people with poorly treated pain — the DEA believes drug cartels are actively targeting pain sufferers as potential customers for counterfeit medication.

“The spread of fentanyl-laced counterfeit pills in the United States is likely due to Mexican TCOs (Transnational Criminal Organizations) seeking to further distribute fentanyl into prescription opioid user populations,” the DEA said. “The increasing number of counterfeit pills resembling prescription medications and users who may be pivoting to abusing illicit substances with waning CPD availability may prove to be a significant threat into 2021.”  

The counterfeit pill of choice for the drug cartels are fake 30mg oxycodone tablets, stamped with an “M” on one side and “30” on the other.

Known on the street as “Mexican Oxy” or “M30s,” the DEA says the blue tablets “demonstrate that traffickers are taking advantage of an established market for these pills.”

Illicit fentanyl tablets appear to be getting more lethal, with laboratory tests showing 26 percent of them containing a potentially fatal dose of fentanyl in 2019, compared to just 10 percent in 2017.

In one chilling paragraph, the DEA seemed to acknowledge it was losing the war on drugs to Mexican cartels and local criminal gangs.

“Barring significant, unanticipated changes to the illicit drug market, Mexican TCOs will continue to dominate the wholesale importation and distribution of cocaine, heroin, marijuana, methamphetamine, and fentanyl in U.S. markets. No other criminal organizations currently possess a logistical infrastructure to rival that of Mexican TCOs. Mexican TCOs will continue to grow in the United States through expansion of distribution networks and continued interaction with local criminal groups and gangs,” the agency warned.

Sometimes what is not disclosed in the DEA’s report is just as revealing as what is actually said. For example, while the DEA officially lists kratom as a “drug of concern” and even tried to ban the herbal supplement in 2016, the agency has never said a word about kratom in its annual threat assessment. Not in 2020. Not ever.  

Why is that? Is kratom not addictive or dangerous, despite all the public hand-wringing over the years by the Food and Drug Administration? In a 2018 letter to the DEA recently made public, federal health officials quietly withdrew their request to schedule kratom as a controlled substance because of “lack of evidence” it can be abused or posed a public health threat.

How You Can Change the Public Conversation About Pain

By Richard Lawhern, PhD, PNN Contributor

Because I am highly visible as a healthcare writer and advocate for people in pain, I receive many inquiries from people who have been deserted by their doctors and denied effective treatment.  Many ask me, “What can I do?” 

My answer is that many of our problems with pain treatment began with the guideline on opioid prescribing for chronic non-cancer pain, published in 2016 by the U.S. Centers for Disease Control and Prevention. The CDC is currently updating its recommendations, with the goal of releasing a revised guideline for public comment late this year. Without major change or outright repeal of the guideline, nothing will change and much may grow worse.

CDC management knows that they messed up -- they’ve been told so repeatedly over the last five years by both doctors and patients.  But still they dither and delay, and refuse to act on behalf of millions they have harmed.

Congress has added insult to injury with misdirected legislation blaming doctors for the substance abuse of people who never saw a doctor for pain.  And the Drug Enforcement Administration continues to drive doctors out of pain practice by targeting and persecuting those who prescribe opioid medication for people in agony.   

We can no longer depend on the CDC and DEA to do the right thing. They are too concerned with defending their earlier and ongoing misbehavior.  Instead, we’re going to have to change a lot of minds in Congress, the Executive Branch, and at the state level to force change by legislation. Thousands of patients, caregivers and doctors must lobby if change is to happen.  

How Do We Lobby Effectively? 

We don’t have the money to hire lobbyists. Law firms won’t sue without millions of dollars in retainers up front.  Most legislators don’t actually read emails, even from their own constituents, and increasingly they lock out emails from anyone who doesn’t vote in their districts. Petitions don’t work either, even when we have 100,000 signatures behind them.   

So what can we do? We can phone our legislators to demand change, and we can reach out to editors, publishers, radio and TV news anchors to ask that they show the public “the other side” of the opioid crisis.

It may seem that one person acting alone can’t do much.  But thousands of people acting consistently sometimes can.  We need patients, caregivers and medical professionals to contact their legislators and regulators.  Not just once, but every week.  Your congressional representatives in the U.S. House and Senate, as well as state legislators, can all be candidates for a phone call.  

To learn their names, first do a Google search for “legislators” plus your zip code. You might need to explore several “hits” to find the phone numbers for local congressional offices and the offices of your state legislators. Other possible contacts to explore:  

• U.S. National Office of Drug Control Policy 

• Office of the Governor  

• State Health Department

• Executive Director of your State Medical Board 

• State office of the Drug Enforcement Administration 

• State Attorney General 

Two important websites may reduce the burden of multiple Google searches to locate these people. The Chronic Illness Advocacy & Awareness Group (CIAAG) has links to a national directory of legislators and regulators by state; a library of resources and research; “How to” advocacy guides; and templates for calling and meeting with legislators. Similar resources can be found at Pain Warriors Unite, which also has a large archive of related information and advocacy guides.  

What Should We Tell Them?

When you locate the phone numbers of legislators and regulators, the next task is to phone their offices and talk to them or their staff. 

When you call, you might find that the office isn’t answering their phones.  If you can leave a message, then state your name and callback number. Tell them you are a voter in their state or district, and you want to talk with their healthcare policy staffer about how bad policy and restrictions on pain treatment are destroying your life. Hang up politely.

If you reach anyone in real time, it will almost always be a staffer.  As you speak, try to listen for their responses and be respectful.  Here is a possible script.  Practice it aloud before you make your calls, so you are comfortable with what you want to say: 

“Good morning” (or Good afternoon). My name is ___________ and I vote in ______ (State or District number).

“May I ask your name, please?”   [Make a note for later follow-up]

“I’ve been a chronic pain patient for __ years and under doctor’s care for several complex pain issues.  Right now, my life is a wreck because doctors have been terrorized by government authorities. Nearly half of primary care clinics in the U.S. are refusing to accept new patients on opioid pain relievers, even though pain is the number one reason why people see a doctor.  Many practices that still treat pain are rapidly force-tapering patients off opioids, or below effective treatment levels.”

You should include some personal details about what your life is like without adequate pain management. An example might be:

“I literally cannot get out of bed many days, because I am in agony from under-treatment of my pain. I can’t work, do simple chores, or leave the house for basic necessities without help. 

The so-called ‘prescription opioid crisis’ is bogus.  Doctors prescribing opioids for their patients didn’t create our public health crisis with addiction and overdose deaths. Pain patients almost never become addicted. For millions of us, opioids are the only thing that gives us any quality of life.”

End with a call for action. Ask them to do something with the information you give them.

“People like me need your boss to sponsor legislation to fix this mess.  We need him (her) to help stop the widespread persecution of doctors who prescribe medical opioids for people like me.

Restrictions on access to effective pain care are driving thousands of us to buy street drugs for relief or to even consider suicide. If your boss doesn’t act to stop this disaster, then he (she) will become an accessory to it.”

End the call by asking the staffer to add notes from the call to their office phone logs, and to brief the office Chief of Staff or legislator. Ask for a call-back from that individual, confirming that they got the message and are working on your behalf. Be sure to leave a call-back number if they don’t ask for one.

Richard “Red” Lawhern, PhD, has for over 20 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 100 papers and articles published in medical journals and mass media.

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.

VALUE Study Seeks Patient Perspective on Long-Term Opioid Use

By Pat Anson, PNN Editor

In 2011, the Institute of Medicine released its landmark report, “Relieving Pain in America,” an ambitious project aimed at improving pain care, education and research in United States.

One of the report’s co-authors was Stanford University’s Dr. Sean Mackey, who remembers telling colleagues at the time that more research was needed on the long-term use of opioid pain relievers.     

“One of the questions I put forward to the group was, ‘One of the biggest questions that we need to answer is do opioids help relieve chronic pain for some people?’ Do they actually work? And if so, for whom do they work?” Mackey recalls.

“And surprisingly, ten years later, here we are in 2021 and I would submit to you that we still don’t know the answer to that question. We still do not know how well long-term prescribing of opioids work for chronic pain and for which person they work for. We understand much better who they don’t work for. But we don’t know the flip side.”

Mackey is now leading a study aimed at finally answering the question. The VALUE study is designed to give patients a voice in determining whether opioids can be a safe, effective and long-term treatment for chronic pain.

Mackey and co-investigator Beth Darnall, PhD, along with a team of patient advocates, hope to get up to 500 chronic pain sufferers to enroll in their year-long study. Patients will be asked to participate in three online surveys and three phone calls, answering questions about their pain, symptoms, mood, sleep, quality of life, and whether they encountered any problems or stigma from using opioids.

Long-Term Studies Lacking

Many doctors, regulators and opioid critics claim – disingenuously – that there is no evidence supporting the long-term use of opioids. But the truth is the same could be said for all pain relievers, including non-opioids. Few placebo-controlled studies have been conducted on the long-term use of any pain medication -- simply because it would be unethical to subject a participant to untreated pain for a lengthy period.

That leaves it to patients to share their own experiences with opioids, and a shrinking pool of doctors like Mackey who are not afraid to prescribe them.

“In my caring for people who suffer from pain and for whom it takes a big toll, I have clearly seen a subset of people for whom they do work,” Mackey told PNN. “What we’re trying to do here is transcend what has become a one-size-fits-all approach to patient treatment and the issue of opioids. We’ve become rather guideline-based and we treat all people as if they were an average in a clinical trial. I don’t treat averages. I treat people.

“Everybody is unique and deserves to be treated as an individual. That doesn’t mean that we can’t be guided by those research studies and averages, but we need to get at a more personalized approach. We need to recognize, at least in many of our experiences, there are sub-groups of people who respond to opioids. The problem is we don’t have good data on who they are.”

People who volunteer for the VALUE study should be prepared to spend a fair amount of time answering questions. Each survey will take about 45 minutes to complete. Participants will complete the first survey when they enroll, the second one after 6 months, and the third survey after one year. For each completed survey, patients will be compensated with an Amazon or gift card.

All information collected will be confidential, and won’t be shared with doctors, regulators or insurers. Participants can even use a pseudonym if they don’t feel comfortable using their real names. The VALUE study website has a list of other frequently asked questions.

People interested in participating should contact study coordinator Hannah Cunningham by email at hcunning@stanford.edu or by calling 1-833-668-0277.

“We believe our findings will have broad policy indications at local, state and national levels that will hopefully make opioid prescribing guidelines more patient centered, more effective and safer,” says Mackey.

New European Guideline Says Opioids ‘Do Not Work’ for Many Types of Chronic Pain

By Pat Anson, PNN Editor

Calling opioid medication a “two edged sword,” the European Pain Federation (EFIC) has released new guidelines that strongly recommend against using opioids to treat fibromyalgia, low back pain, migraine, irritable bowel syndrome and other types of chronic non-cancer pain.

“The new recommendations advise that opioids should not be prescribed for people with chronic primary pain as they do not work for these patients,” the EFIC said in a statement.

However, the guideline states that low doses of opioids may be suitable for treating “secondary pain syndromes” caused by surgery, trauma, disease or nerve damage, but only after exercise, meditation and other non-pharmacological therapies are tried first.

“Opioids should neither be embraced as a cure‐all nor shunned as universally dangerous and inappropriate for chronic noncancer pain. They should only be used for some selected chronic noncancer pain syndromes if established non‐pharmacological and pharmacological treatment options have failed,” the guideline states. “In this context alone, opioid therapy can be a useful tool in achieving and maintaining an optimal level of pain control in some patients.”

Opioid pain relievers are not as widely used in Europe as they are in the United States or Canada. The EFIC said it was trying to “allay concerns over an opioid crisis” developing in Europe, as it has in North America.       

“As the leading pain science organisation in Europe, it is crucial that EFIC sets the agenda on issues such as opioids, where there are growing societal concerns. These recommendations clarify what role opioids should play in chronic pain management,” EFIC President Brona Fullen said in a statement.

The guideline’s lead author, Professor Winfried Häuser, said he and his colleagues tried to strike a middle ground on the use of opioids.

“The debate on opioid-prescribing for chronic non-cancer pain has become polarized: opioids are either seen as a dangerous risk for all patients, leading to addiction and deaths, or they are promoted as most potent pain killers for any type of pain,” said Häuser, who is an internal medicine specialist in Germany.

“Opioids are still important in the management of chronic non-cancer pain – but only in some selected chronic pain syndromes and only if established non-pharmacological and non-opioids analgesics have failed or are not tolerated.”

PROP Consulted for European Guideline

The guideline was developed by a 17-member task force composed of European experts in pain management, including 9 delegates selected by EFIC’s board “who advocate and who are critical with the use of opioids.” Only one delegate from Pain Alliance Europe represented patients.

The recommendations developed by the task force were reviewed by five outside experts, including Drs. Jane Ballantyne and Mark Sullivan, who belong to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group in the U.S.  Ballantyne is PROP’s President, while Sullivan is a PROP board member. Several changes suggested by the outside experts were adopted.

Coincidentally, Ballantyne, Sullivan and three other PROP board members were involved in the drafting of the opioid guideline released in 2016 by the U.S. Centers for Disease Control and Prevention. That controversial guideline is now being rewritten by the CDC after voluminous complaints from patients and doctors that the recommendations led to forced tapering, withdrawal, uncontrolled pain and suicides.

Sullivan and two other PROP board members were also involved in drafting Canada’s 2017 opioid guideline, which was modeled after the CDC’s and provoked similar complaints from Canadian pain patients.

90 MME Recommended Limit

The CDC and Canadian opioid guidelines appear to have been used as resources by the EFIC task force, which adopted many of the same recommendations, even while acknowledging the low quality of evidence used to support them.   

One recommendation is straight out of the CDC guideline, advising European doctors to “start low and go slow.” Prescribers are urged to start patients on low doses of 50 morphine milligram equivalents (MME) or less a day and to avoid increasing the dosage above 90 MME/day.

One significant difference with the North American guidelines is that the EFIC recommends that opioids not be prescribed for fibromyalgia, migraines and other chronic “primary pain” conditions for which there is no known cause – suggesting those disorders have an emotional or psychological element that will lead to opioid abuse.

“Prescription of high doses of opioids to patients with primary pain syndromes might have been a factor driving the opioid crisis in North America,” the EFIC guideline warns.

“This was further compounded by patient characteristics that included physical and psychological trauma, social disadvantage and hopelessness that served as a trigger for reports of pain intensity prompting prescriptions of more opioids.”

Secondary pain conditions for which opioids “can be considered“ include multiple sclerosis, stroke, restless leg syndrome, Parkinson’s disease, rheumatoid arthritis, phantom limb pain, non-diabetic neuropathy, spinal cord injuries and Complex Regional Pain Syndrome (CRPS). 

Unlike the North American guidelines, the EFIC acknowledges that there are physical and genetic differences between patients. Some patients who are rapid metabolizers “might require higher dosages of opioids than the ones recommended by the guidelines.“

EFIC GRAPHIC

The EFIC also warns that its guideline should not be used to justify abruptly tapering or discontinuing opioids for anyone already prescribed at higher dosages. The recommendations are also not intended for the management of short-term acute pain, sickle cell disease or end-of-life care.

Individualized Pain Care After Surgery Raises Patient Satisfaction

By Pat Anson, PNN Editor

An opioid prescribing guideline tailored to a patient’s specific needs – that doesn’t take a one-size-fits-all approach – resulted in high patient satisfaction rates and reduced the use of opioids after surgery.

The post-operative pain management guideline was developed by surgeons at Dartmouth-Hitchcock Medical Center in New Hampshire, who based the number of opioid pills sent home with patients on how many they needed the day before they were discharged from the hospital. Other guidelines typically base the number of pills on the type of operation that was performed and do not take into account a patient’s individual needs.

“In this new prospective study we found that 93 percent of patients had their post-surgery opioid needs satisfied,” said lead author Richard Barth Jr., MD, section chief of general surgery. “This finding means that this guideline can be used for a wide variety of operations to guide surgeons on how many opioids to prescribe when sending patients home after surgery.”

Barth and his colleagues enrolled 229 patients in the study who had elective general surgery, including colorectal, gynecological, thoracic and urological operations. Upon discharge, patients received prescriptions for acetaminophen and ibuprofen, as well as opioids, based on the guideline.

If they needed no opioids the day before discharge, they were sent home with the morphine milligram equivalent (MME) of five oxycodone 5mg pills. If they took one or three pills, they were given a prescription for 15 more. And if they needed four or more pills, they were given a prescription for 30 pills.  

Patient satisfaction was highest among those who needed the fewest number of pills. Despite being given an opioid prescription, 73 percent of the patients who were prescribed five pills used no opioids at home, and 85 percent used two pills or less.

In all, 60 percent of patients in the study had leftover opioid pills, according to findings published in the Journal of the American College of Surgeons. They were given instruction on how to dispose of them safely.

Barth says surgeons played a pivotal role in minimizing opioid use by talking to patients before surgery and setting their expectations for pain management. They told patients they were likely to be discharged with either no opioids or a small amount based on their opioid use in the hospital.

“The other part of that discussion involves letting patients know that they should expect some pain, that our goal isn’t to get rid of every last bit of their pain,” Barth said. “That was something that surgeons tried to accomplish years ago, but that’s not what we’re aiming for now. A low level of discomfort is acceptable, and patients need to have that expectation.”

That process also including prescribing, not just recommending, over-the-counter pain relievers.  

“By prescribing non-opioid analgesics, the surgeon sets the expectation that they should be used,” he said. “It’s a big difference if a surgeon prescribes non-opioid analgesics compared with just recommending that a patient take acetaminophen or ibuprofen that they might have at home.” 

In recent years, many U.S. hospitals have adopted policies that reduce or completely eliminate the use of opioids after surgery. Those policies unfairly leave some patients in pain, according to a recent study presented at the annual meeting of the American College of Surgeons. Researchers found that about half of patients need opioid medication after major surgeries.

“Our goal is to give them the exact right amount so that we limit the number of un-used opioids in our community while also making sure we don’t reduce it down too far and then leave them in pain,” said lead author Cornelius Thiels, DO, a surgical oncology fellow at Memorial Sloan Kettering Cancer Center.

“The right answer may be more non-opioid based pain medications, better patient education and setting of expectations, or in some cases patients may actually require slightly more opioid medications, and that is OK.”

Abuse of Rx Opioid Painkillers Unchanged During Pandemic

By Pat Anson, PNN Editor

An alarming spike in U.S. overdose deaths during the COVID-19 pandemic does not appear to be fueled by increased abuse of opioid painkillers, according to a new nationwide analysis of urine drug tests.

The Drug Enforcement Administration approved an exemption last year allowing patients to connect with doctors via telehealth – without a physical examination -- to get prescriptions for opioids and other controlled substances. While the relaxed rules made it easier for patients to get pain medication during the pandemic, they have not resulted in more diversion or abuse of oxycodone and hydrocodone, according to the Millennium Health Signals Report. Urine positivity rates for the two opioids remained flat during 2020.

“Despite the hardships faced during the pandemic, it is encouraging to see that positivity rates for non-prescribed use of hydrocodone and oxycodone have not changed,” said Michael Parr, MD, an addiction treatment specialist and consultant to Millennium.

“Patients requiring opioids for the treatment of pain have faced difficulty obtaining medications, as well as stigma, before the pandemic. Perhaps this data will reassure clinicians who have taken additional steps to safely prescribe these medications during the pandemic.”

There was an uptick in positivity rates for non-prescribed tramadol, a weaker opioid, particularly in Ohio, Tennessee and Kentucky. Millennium said there were more cases of people with substance use disorders using tramadol as their “drug of preference.”

Millennium researchers also found that positivity rates for non-prescribed gabapentin (Neurontin) showed little change in 2020 – but they remain at levels nearly three times higher than positivity rates for oxycodone, hydrocodone and tramadol. The abuse of non-prescribed gabapentin did rise significantly in Ohio and Virginia.

POSITIVITY RATES FOR NON-PRESCRIBED PAIN MEDICATIONS

SOURCE: MILLENNIUM HEALTH

The abuse of gabapentin has been going on for years, but with little public attention. Gabapentin is a non-opioid nerve medication increasingly prescribed for pain, despite the fact many patients say it doesn’t help and has too many side effects. Drug abusers, however, have found that gabapentin can heighten the effect of heroin and other street drugs.

While positivity rates for non-prescribed pain medication were mostly unchanged during the pandemic, they soared for illicit fentanyl and methamphetamine, increasing 78% and 29%, respectively.

After initially increasing in the early stages of the COVID-19 crisis, Millennium found that positivity rates for cocaine and heroin soon returned to pre-pandemic levels.

Another encouraging sign is that positivity rates for carfentanil, a deadly fentanyl analogue, have flatlined to nearly zero. It is unclear why carfentanil abuse has fallen so sharply, but Millennium said it may be because the pandemic has disrupted manufacturing and supply routes from China.     

Opioid Promotion Cited in FDA Warning Was Stopped in 2019

By Pat Anson, PNN Editor

A California pharmaceutical company that received a warning letter from the Food and Drug Administration over its promotion of a controversial opioid painkiller stopped using the marketing material over a year ago.

The FDA sent the warning letter to AcelRx Pharmaceuticals last week. The agency told the company to stop making “false and misleading claims” about Dsuvia, a potent opioid tablet used to relieve acute pain in hospital settings.

The “Tongue and Done” banner ads and tabletop displays emphasized how easy Dsuvia is to administer by using a plastic applicator that releases a single tablet directly into a patient’s mouth. The FDA said the promotions were misleading and dangerous.

“AcelRx has disseminated promotional communications that undermine key prescribing conditions required for the safe use of this opioid product. Dsuvia was approved with special restrictions requiring that it only be prescribed in a certified medically supervised setting by health care practitioners trained to properly administer it,” the FDA said in a statement.

“This promotion dangerously undercuts FDA-required conditions on the proper administration of the drug, which requires particular diligence to minimize the risk of serious or even fatal adverse events.”

The letter warns AcelRx to either stop using the marketing material or cease distributing Dsuvia. It gave the company 15 days to respond or face “further regulatory action.”    

ACELRX PROMOTION

But in a filing with the Securities and Exchange Commission, AcelRx said it could “easily address” the FDA’s concerns because it stopped using the “Tongue and Done” promotions in late 2019.

“The Company intends to respond to the FDA within the timeframe requested in the Letter and seek guidance and clarification from the FDA on the concerns raised in the Letter,” the SEC filing states. “The Company cannot give any assurances, however, that the FDA will be satisfied with its response to the Letter or that such response will resolve the issues identified in the Letter.”

Few Adverse Events Involve Dsuvia

The FDA approved the use of Dsuvia in 2018 over the objections of anti-opioid activists who said it was a “dangerously unnecessary opioid medication" that would be diverted, abused and lead to more overdoses. There is little evidence any of that has occurred.

Dsuvia contains sufentanil, an opioid 10 times stronger than fentanyl. It was developed to fulfill an unmet need in military and civilian hospitals, where patients need quick relief from acute trauma pain and can’t wait for opioids to be administered intravenously. Each Dsuvia tablet comes in a single dose applicator. The tablets quickly dissolve under the tongue and are not available for home use.

Those safety measures appear to be working. The FDA’s Adverse Events Reporting System lists only six cases involving Dsuvia in 2019 and 2020. There were no deaths and none of the cases were considered serious.

AcelRx recently published the results of a clinical study that showed surgery patients treated with Dsuvia used significantly fewer opioids than those treated with traditional IV opioids. They were also discharged sooner.

The FDA’s belated warning letter to AcelRx about its Dsuvia marketing comes as the agency faces renewed scrutiny for its regulation of opioids.

Acting FDA Commissioner Dr. Janet Woodcock is reportedly under consideration by President Biden for a formal nomination to the job, which has drawn the ire of some anti-opioid activists. A letter sent to the Acting Secretary of Health and Human Services accuses Woodcock of “dereliction of duty” for failing to address the opioid crisis by halting the approval of new opioids. Woodcock has been Director of the FDA’s Center for Drug Evaluation and Research for over 25 years.

Would Drug Legalization Reduce Overdoses?

By Roger Chriss, PNN Columnist

As the overdose crisis worsens, public health data and biostatistics become more important. Debates about opioid prescribing and drug legalization often center on two key concepts: incidence and prevalence as applied to drug use, substance use disorder (SUD) and overdoses.

Brandeis University researcher Andrew Kolodny, MD, recently argued against drug legalization on Twitter.

“Some critics of reducing Rx opioids don't believe that repeated use of highly addictive drugs cause addiction and/or they believe all drugs, including heroin & cocaine should be available over the counter. They don't believe that easy access can increase prevalence of SUD,” said Kolodny, who founded Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

Conversely, Columbia University professor Carl Hart, the author of “Drug Use for Grown-Ups,” believes legalizing recreational drugs would help reduce overdoses by making the drug supply safer.

“A large proportion of these deaths are caused by adulterated substances purchased on the illicit market. A regulated market, with uniform quality standards, would virtually put an end to contaminated drug consumption and greatly reduce fatal accidental drug overdoses,” Hart told Columbia Magazine.

Both claims hinge on a proper understanding of incidence and prevalence. In epidemiology, incidence is the rate of new-onset diagnosis of a medical condition. It is measured over a given period of time -- typically a year -- though sometimes the time period is shortened to a week for an urgent problem, such as a viral pathogen like the coronavirus.

By contrast, prevalence measures the total number of people in a population who have a specific medical condition. For prevalence, the duration of the condition is important. For an infectious disease, it may be brief. But for cancer, SUD and many other chronic conditions, it may last a lifetime.

For instance, the incidence of opioid use disorder (OUD) among people who are on long-term opioid therapy is 8-12%, according to the National Institutes of Health. But unlike claims frequently made by PROP, only a small fraction of patients who abuse prescription opioids start using heroin, less than 4% over a five-year period. So, making a clear distinction between OUD involving prescription opioids versus heroin becomes important.

The prevalence of OUD is a cumulative total of all people with OUD over time. This is because OUD and other substance use disorder diagnoses are lifetime diagnoses that remain on a person’s medical records forever. When we count people with OUD, we are counting everyone ever diagnosed with the condition, though in practice sometimes the OUD diagnosis is dropped due to administrative error, poor record-keeping or deliberate obfuscation.

This means that OUD prevalence can go up over time even when the incidence of OUD is going down. In fact, that is what is happening at present.

A recent report from the Substance Abuse and Mental Health Services Association showed modest declines for both prescription opioid misuse and heroin use. This came at a time when U.S. drug deaths were rising, fueled primarily by overdoses involving illicit fentanyl.

These counterintuitive trends make for intense debate about the success or failure of the 2016 CDC opioid guideline and state laws restricting prescription opioid use. A recent study from Indiana University concluded that limits on legal opioid prescribing may have actually driven more people to illicit drugs.

"Our work reveals the unintended and negative consequences of policies designed to reduce the supply of opioids in the population for overdose. We believe that policy goals should be shifted from easy solutions such as dose reduction to more difficult fundamental ones, focusing on improving social conditions that create demand for opioids and other illicit drugs," said co-author Brea Perry, PhD, a professor of sociology at Indiana University.

Even if drug legalization were to reduce drug risks, an increase in the number of drug users could lead to more harms. For instance, if an illicit drug harms 10% of users and there are 1 million users, that results in 100,000 people harmed. If that drug is then legalized and made safer, harming only 1% of users, that seems like an improvement. But if the number of users rises to 15 million, then 150,000 people would be harmed.

Since we don’t know how these numbers would change under a legalized drug regime, any claims about changes in incidence or prevalence are speculative at best.

What is counted and how it is expressed are very important in debates about the role of prescription opioids or drugs in general in SUD and overdose deaths. A failure to be specific about methodology or using data that is not well-founded can result in specious or even deceptive claims. And counterintuitive results are possible, as we are seeing at present in the ever-evolving overdose crisis.

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.

AMA Scolded for Seeking Changes in CDC Opioid Guideline

By Pat Anson, PNN Editor

Eight months after the American Medical Association told the CDC that its controversial opioid guideline has “harmed many patients” and needs to be revised, an anti-opioid activist group has accused the AMA of employing false moral arguments to justify using opioid medication to relieve human suffering.

The letter from Physicians for Responsible Opioid Prescribing (PROP) to AMA President Susan Bailey, MD, takes issue with the AMA’s position that the U.S. “no longer has a prescription opioid epidemic” and instead faces an overdose crisis fueled by illicit fentanyl and other street drugs.

“These statements send a strong message that opioid prescribing for pain is no longer problematic, and that the CDC’s recommended guardrails are no longer needed. Nothing could be further from the truth,” says the PROP letter, which was signed by the organization’s board of directors.

“There is compelling evidence that many of those currently struggling with opioid dependence and addiction were introduced to opioids through use of medically prescribed opioids used to treat chronic pain. Medically prescribed opioids remain a common gateway to illicit opioid use and are themselves frequent causes of opioid addiction and overdose, even if illicit opioids currently cause the greater number of deaths.”

The CDC’s 2016 guideline was only intended for primary care physicians treating chronic pain, but its voluntary recommendations on opioid prescribing have been widely adopted as policy by federal agencies, states, insurers, pharmacies and doctors of all specialties. The guideline has not only failed to reduce drug deaths – which now stand at record highs – but federal health experts admit that widespread misuse of the guideline has caused “serious harm” to patients, including forced tapering, withdrawal, uncontrolled pain and suicide.    

PROP’s letter to the AMA goes even further than the CDC recommendations, suggesting that opioid medications should only be used for short-term acute pain and end-of-life care.  

“All moral, ethical, regulatory, legal and political arguments that opioids are needed so that people do not suffer needlessly should apply specifically to short-term pain management where there is proven benefit, and not to long term pain management where evidence of benefit is largely anecdotal, and there is compelling evidence of harm,” PROP said.

“Why then is the AMA applying the moral argument to the false premise that people will suffer needlessly if they do not have unrestricted access to opioids? By all means apply moral arguments and principles to make sure opioids are available for the right indications, but it makes no sense at all to suggest that removing guidance on opioid dose and duration is needed so that people with chronic pain do not suffer.”

AMA: ‘Misguided Focus’ on Opioids Harms Patients

To be clear, opioid addiction is rare in patients and the AMA never said that people should have “unrestricted access to opioids.” The AMA called for balanced and individualized care based on patient need, not one-size-fits-all guidelines that dictate dosages or the type of treatment everyone should get.    

In a February 19th letter to PROP, AMA President Dr. Susan Bailey said the group mischaracterized the AMA’s position on opioid treatment.

“When policies or organizations focus only on the restriction of a legitimate pharmacologic option to help patients with pain, they miss the chance to address the complexity of policies needed to truly help patients with pain. That misguided focus also has led to harmful stigmatization and other stressors,” Bailey said.

“That is why the AMA provided comprehensive recommendations on the 2016 CDC Guideline and why we continue to advocate for policies that support comprehensive, multidisciplinary, multimodal pain care, including opioid therapy when appropriate.”

“Patients with chronic pain and patients with substance use disorder both need access to multimodal treatments for their medical care,” said Dr. Chad Kollas, a palliative care specialist who is an AMA delegate and Secretary of American Academy of Hospice and Palliative Medicine (AAHPM).

“AMA and AAHPM have recognized the importance of pursuing balanced opioid policy, policy that protects access to opioid analgesics for patients with medically legitimate needs for those medications, while also protecting the public safety and reducing potential harms of prescribed medications.”

Kollas said PROP’s belated response to the AMA’s position may be an attempt to deflect attention away from a recent report that found deaths due to illicit fentanyl soaring, while overdoses involving prescription opioids remained flat.  The research adds to a growing body of evidence suggesting the CDC opioid guideline was ineffective and misdirected.

Although opioid prescribing is at 20-year lows, PROP founder Dr. Andrew Kolodny has said prescriptions “still have a very long way to go” and should be reduced even further. Kolodny recently advised the World Health Organization in the development of a new guideline for treating chronic pain in children, which recommends that opioids only be given to children who are dying or in palliative care.

Slow Progress on Guideline Update

Faced with growing criticism of its own guideline, the CDC announced in 2019 that it was working on an update or possible expansion of its recommendations. Progress has been slow since then.  An advisory group appointed by the agency last summer has had only two preliminary meetings and will not review suggested changes to the guideline until next month, according to an update given Tuesday to the CDC’s Board of Scientific Counselors (BSC).

Draft guidelines are not expected to be available for public comment until the end of this year, meaning any revisions will likely not be finalized until 2022. Patient advocates told the BSC they were disappointed by the lack of progress.

“I would like to urge the members of this panel to please take seriously the issue of timely revision of the CDC guidelines for chronic pain. We have a catastrophe welling out across the country in a wholly marginalized and invisible group. On top of that, we are losing working physicians at a steady rate,” said Terri Lewis, PhD, a patient advocate and rehabilitation specialist. “Everybody is in the gun sights of policy that is not working for anybody. I beg you to please make this an urgent priority.”

Mexicans ‘Dying in Pain’ Because Rx Opioids Limited in U.S.

By Pat Anson, PNN Editor

Efforts to limit opioid prescribing in the United States are driving some Americans across the border to Mexico to purchase opioid medication, according to a new study that found shortages of painkillers in some of Mexico’s poorest regions.  

Mexico, along with many other third-world countries, have relatively low rates of opioid prescribing. Faced with international criticism that pain was going untreated, the Mexican government launched an initiative in 2015 to improve access to opioids for terminally ill patients in palliative care.

Doctors were allowed to write more prescriptions and there was expanded insurance coverage of opioids, which led to a steady increase in opioid dispensing in Mexico over the next few years – a period when opioid prescribing in the U.S. was falling sharply.

A team of researchers at UCLA, with funding from the U.S. National Institutes of Health, looked at prescription drug data in Mexico from 2015 to 2019. They found a steady increase in opioid dispensing nationwide, but the growth was concentrated in wealthier Mexican states and major metropolitan areas, particular those along the U.S. border. The research findings, published in The Lancet Public Health, suggest that some of the opioids intended for Mexican citizens wound up in American medicine cabinets.

"People in the poorest areas of Mexico are dying in pain," said lead author David Goodman-Meza, MD, an assistant professor of medicine at the David Geffen School of Medicine at UCLA. "A lot of work needs to be done to increase access to opioids for those who have a medical need for them in Mexico.”

Goodman-Meza and his colleagues found the highest opioid prescribing rates in Baja California, Mexico City, Nuevo Leon, Sonora and Jalisco. Fentanyl was the most frequently dispensed opioid medication, followed by methadone, morphine, tapentadol, oxycodone and hydromorphone.

Baja California, Nuevo Leon and Sonora all border the United States, and have a “heavy concentration of pharmacies” just a few miles away from San Diego, El Paso and other U.S. cities. The researchers noted that many of these pharmacies had an increase in opioid dispensing during the study period.

Although they did not examine cross-border purchase data, researchers believe “medical tourism” by Americans probably contributed to more opioid prescriptions being filled in Mexico.

"As the U.S. has tried to curb the epidemic related to prescription opioids by instituting structural mechanisms such as closing 'pill mills' and instituting prescription drug monitoring programs (PDMPs), individuals may be getting around them by going to Mexico to get opioids," Goodman-Meza said. "Continued surveillance at border crossings is necessary to avoid unmonitored entry of opioids into the U.S."

Unintended Consequences of PDMPs

Another unintended consequence of U.S. policy to limit opioid prescribing is that it may be forcing some patients to turn to illicit drugs.

A new study published in JAMA looked at state efforts to combat the opioid epidemic by using PDMPs to track opioid prescriptions. A team of Indiana University researchers found that while opioid misuse and “doctor shopping” by patients declined, drug deaths continued to increase, fueled largely by overdoses linked to illicit fentanyl, heroin and cocaine.    

“Heightened demand for diverted and illicit drugs might arise from limiting the supply of prescription opioids under certain conditions. These unintended consequences may occur if the fundamental causes of demand for opioids are not addressed and if the ability to reverse overdose is expanded without increasing treatment of opioid overdose,” researchers found.

“We believe that policy goals should be shifted from easy solutions (eg, dose reduction) to more difficult fundamental ones, focusing on improving social conditions that create demand for opioids and other illicit drugs.”

A 2019 study of PDMPs was more explicit, finding there was a “consistent, positive, and significant association” between them and heroin overdoses. A study conducted the previous year also found an increase in heroin deaths associated with PDMPs, along with a decline in overdoses linked to prescription opioids.  

CDC Focused on Rx Opioids While Fentanyl Deaths Soared 1,040%

By Pat Anson, PNN Editor

A new report from the Centers for Disease Control and Prevention documents an alarming increase in overdose deaths and how the agency’s 2016 prescription opioid guideline failed to stop the drug crisis from growing worse.

The study looked at fatal overdoses from 2013 to 2019, a period when U.S. drug deaths rose by over 56 percent, culminating with 70,630 Americans dying from overdoses in 2019.  

Deaths involving prescription opioids remained relatively flat during that period, while overdoses involving other substances rose, led by an astounding 1,040% increase in deaths linked to illicit fentanyl and other synthetic, mostly black market opioids. Overdoses involving heroin, cocaine and stimulants such as methamphetamine also rose.

DRUGS INVOLVED IN U.S. OVERDOSE DEATHS (2013-2019)

“Sharp increases in synthetic opioid- and psychostimulant-involved overdose deaths in 2019 are consistent with recent trends indicating a worsening and expanding drug overdose epidemic. Synthetic opioids, particularly illicitly manufactured fentanyl and fentanyl analogs, are highly potent, increasingly available across the United States, and found in the supplies of other drugs,” researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

“Similarly, psychostimulant-involved deaths are likely rising because of increases in potency, availability, and reduced cost of methamphetamine in recent years. The increase in synthetic-opioid involved deaths in the West and in psychostimulant-involved deaths in the Northeast signal broadened geographic use of these substances.”

The new CDC study adds to a growing body of evidence suggesting that the agency’s controversial opioid guideline has been ineffective and misdirected. While the guideline helped reduce the already shrinking supply of opioid medication – prescription opioid use is now at 20-year lows – drug deaths linked to illicit fentanyl and other substances kept rising. Overdoses hit a record high last spring.

"This represents a worsening of the drug overdose epidemic in the United States and is the largest number of drug overdoses for a 12-month period ever recorded," the CDC said in a recent health advisory.

‘I Don’t Really Want to Die’

Many pain patients – including those who have used opioids safely and responsibly for years – now have difficulty obtaining opioid analgesics and live with untreated or poorly treated pain. A recent study found that nearly half of primary care clinics in the U.S. are unwilling to accept new patients on opioids, because they had either stopped prescribing them or feared scrutiny by law enforcement and regulators if they did.

“Why am I treated like a criminal for needing opioids? For 26 years opioids are the only treatment that allows me to have a life,” a pain patient recently told PNN. 

“My doctor stopped prescribing my pain medication without my consent, leading to rapid tapering and abrupt discontinuation. No medication and haven't heard from her since. She won't return my calls,” another patient said.  

“I'm at a very desperate point in my life,” said a patient with Complex Regional Pain Syndrome (CRPS). “The meds don't address my needs and I'm at my end. If something doesn't give right away, I will be gone! I don't really want to die but I feel that it is the only option left.” 

Some anti-opioid activists have turned a blind eye to pleas from patients and want opioid prescriptions reduced even further.

“Opioid scrips have been trending in a more cautious direction, (though we still have a very long way to go) while opioid OD deaths have soared. Some see this as a policy failure. They may not realize the main goal of more cautious Rx opioid use is to reduce incidence of OUD,” Dr. Andrew Kolodny, founder of Physicians for Responsible Opioid Prescribing (PROP), wrote in a recent Tweet.

But when asked by another poster if there have been declines in OUD — opioid use disorder — because fewer opioids are being prescribed, Kolodny said he didn’t know.

“OUD incidence isn't tracked. We're 25 years into an epidemic of OUD but still have lousy surveillance. So no hard data but if fewer people are exposed to a highly addictive drug, it's a safe bet that fewer people will become addicted,” Kolodny replied.

The CDC is currently working on an update and possible expansion of its opioid guideline – with the goal of releasing a revised guideline late this year. The agency’s Board of Scientific Counselors is holding a public hearing this Tuesday, February 16th to get an update from an “Opioid Workgroup” that is considering changes to the guideline. People interested in listening to the meeting online can register clicking here.

Acetaminophen Better Than NSAIDs for Acute Trauma Pain

By Pat Anson, PNN Editor

Acetaminophen (Tylenol) is superior to non-steroidal anti-inflammatory drugs (NSAIDs) in treating acute pain in patients recovering from arm and leg trauma, according to new research published in the journal Academic Emergency Medicine. It’s the latest in a string of studies that recommend the use of non-opioid pain relievers for acute pain after discharge from a hospital.

The research is based on a study of 1,500 adults in the North African nation of Tunisia, nearly half of whom had bone fractures. Upon discharge from a hospital emergency department, the patients received either acetaminophen, a high-dose NSAID, or a combination of the two. Acetaminophen is commonly called paracetamol outside the United States.

After seven days, researchers found that nearly two-thirds (61.8%) of patients receiving paracetamol alone were “satisfied” or “very satisfied” with their pain relief. Only 11.4% required another oral pain reliever. The other two groups had similar satisfaction scores, but had lower rates of medication adherence. Side-effects such as vomiting and gastrointestinal pain were also more common in patients who received NSAIDs.  

“This study found that the combination of a high‐dose NSAID with paracetamol does not increase the analgesic effect compared to paracetamol alone. We also found that paracetamol alone is superior to high‐dose NSAID alone for post-traumatic extremity pain,” wrote lead author Mohamed Amine Msolli, MD, an emergency room physician at Fattouma Bourguiba University Hospital in Tunisia.

“Taking into account its superior efficacy and tolerability, paracetamol appears to be the most suitable first‐line therapy for managing mild to moderate posttraumatic extremity pain after discharge from the ED.”

Opioid analgesics are not widely available in Tunisia and most other Middle East countries, and were not included in the study. Nevertheless, the study findings are being cited as evidence that paracetamol is superior to both NSAIDs and opioids in treating acute trauma pain.

“The surprising efficacy of paracetamol over an NSAID, as shown by a 6.4% lower need for additional oral analgesics, may impact prescribing practices,” Andrew Chang, MD, a professor of emergency medicine at Albany Medical Center, said in a statement.

“Many ED patients who have a contraindication to NSAIDs but require analgesics upon ED discharge might be prescribed an opioid. Given the ongoing opioid epidemic, this study lends evidence to support the use of acetaminophen alone in such patients."

But the risk of long-term opioid use after an emergency room visit is actually quite low. A large 2017 study by the Mayo Clinic found that only about one percent of emergency room patients given an opioid prescription progressed to long term use.

Acetaminophen also has risks that are not acknowledged in the Tunisia study. Excessive use of acetaminophen can lead to liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

WHO Guideline Only Recommends Opioids for Children Who Are Dying

By Pat Anson, PNN Editor

The World Health Organization (WHO) has released new guidelines on the treatment of chronic pain in children, recommending that prescription opioids only be used for children who are dying or seriously ill and not expected to recover.

The 56-page guideline calls access to pain management a “fundamental human right,” while at the same time warning that “evidence of the effectiveness and safety of opioids is completely lacking in children.”

The guideline emphasizes the use of physical and psychological pain therapies, while taking a cautious approach to opioids. Morphine is only recommended for children in palliative care and those with “life-limiting” conditions for which there is no cure and “an early death is expected.”

“Children who are appropriately prescribed morphine for chronic pain in the context of end-of-life care or in children with life-limiting conditions, may require morphine for the management of intercurrent, acute or breakthrough severe pain,” the guideline states.

“Time-limited use of morphine in these contexts should be at the lowest appropriate dose and duration possible and must be regularly reviewed in order to ensure the fewest possible adverse events. Healthcare providers and caregivers need to perform frequent and repeated reassessments of pain and other symptoms, and the principles and relevant guidelines for acute pain management should be followed, including having an opioid stopping plan.”

The new recommendations for children between 0 and 19 years of age are a marked departure from previous WHO guidelines for chronic pain, which said that opioids “are known to be safe and there is no need to fear accidental death or dependence.”

Those guidelines were withdrawn in 2019, after two U.S. congressmen accused the United Nation’s health agency of being “corruptly influenced” by opioid manufactures.  A coalition of palliative care organizations objected, saying WHO caved-in to political pressure.

“We are extremely concerned that the withdrawal of these guidance documents will lead to confusion and possible extreme measures that will hinder access to patients with legitimate medical needs,” the coalition said in a joint statement. “Lack of availability and limited access to these medications for legitimate medical treatment is a human rights violation.”

‘Very Low Certainty’ of Evidence

Most of the recommendations made by a WHO advisory panel – the Guideline Development Group (GDG) — are vague, conditional and based on “very low certainty” of evidence. One of GDG’s members was Andrew Kolodny, MD, a psychiatrist and addiction specialist who founded Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

Despite an admitted “paucity of high-quality research” on how to treat pain in children, the GDG recommended that children be treated from a “biopsychosocial perspective” that incorporates physical therapy and psychological interventions such as cognitive behavioral therapy.  

“Children with chronic pain and their families and caregivers must be cared for from a biopsychosocial perspective; pain should not be treated simply as a biomedical problem,” the GDG said.

There is surprisingly little discussion in the guideline about the risks and benefits of non-opioid drugs such as acetaminophen. Some of the recommendations border on platitudes, such as treatment being “child and family-centered” and “tailored to the family’s values, cultures, preferences and resources.”

One area where the GDG is adamant is the importance of treating childhood pain to prevent it from becoming a lifetime problem.

“Exposure to chronic pain in early life may have implications for the incidence, severity and duration of chronic pain, and may be associated with long-term, maladaptive neurological changes,” the guideline warns.

“Chronic pain in childhood is associated with progression of pain into adulthood and potentially predisposes these children to other chronic health problems in later life. The negative impacts of chronic pain also extend to family members who report a higher burden of care and a detrimental effect on family function. As such, chronic pain during childhood has a very significant negative impact on the child over their life course as well as their wider family unit, making appropriate diagnosis and management essential.”  

The GDG said large, multi-center trials are needed to examine the safety and efficacy of virtually all pain management therapies. Additional research is also needed for children suffering from cancer pain and those with developmental and intellectual disabilities.

Former President Trump withdrew the United States from WHO last year in a dispute over its handling of the COVID-19 pandemic. President Biden reversed that decision on his first day in office.