Forced Opioid Tapering Is Risky and Unethical

By Roger Chriss, PNN Columnist

Prescription opioid use has come way down from its peak in 2012. Fewer people receive an initial opioid prescription, pill counts have been lowered, and more people are being taken off opioids.  The American Medical Association recently reported that there was a 37% decrease in opioid prescribing from 2014 to 2019.

The goal of this was to reduce the harms associated with opioid pain medication amid an ongoing drug overdose crisis. But there is no justification for forced opioid tapers. As PNN reported last year, outcomes for patients taken off opioids are not necessarily good. And despite an ongoing focus on reducing prescription opioid use, there is still no established deprescribing strategy or method.

A new study looked at a dozen randomized controlled trials for deprescribing opioids for chronic non-cancer pain. Researchers found that reducing or discontinuing treatment did not reduce opioid use in the intermediate term. It also didn’t increase the number of patients who stopped taking opioids.

After looking at the evidence, the authors of the systematic review concluded that the were unable to draw “firm conclusions to recommend any one opioid-analgesic-deprescribing strategy in patients with chronic pain."

Ethically Unjustified

But even if we knew how to taper patients on prescription opioids, it would still not be ethical to do so. Forced tapers offer relatively few benefits for the patient and may carry serious harms. Policies promoting opioid tapering have nonetheless proliferated in recent years, including one in Oregon that was tabled after a public outcry.

In a recent paper in The Journal of Law, Medicine & Ethics, physicians Stefan Kertesz, Ajay Manhapra, and Adam Gordon argued against the forced tapering policies being promoted by public agencies.

“Neither the 2016 Guideline issued by the Centers for Disease Control and Prevention nor clinical evidence can justify or promote such policies as safe or effective,” they said.

Specifically, Kertesz and his colleagues said “the provider is trained never to treat a patient as merely a means to an end.” In other words, involuntary tapers with the goal of satisfying prescribing metrics or state-mandated statistics are unethical.

A more detailed analysis of the ethics of deprescribing is taken up by Travis Rieder, PhD, author of the book, “In Pain: A Bioethicist’s Personal Struggle with Opioids.” In a new commentary in the AMA Journal of Ethics, Rieder concludes that nonconsensual tapering is “clinically and ethically wrong” because it exposes so-called legacy patients who are dependent on opioids to uncontrolled pain and withdrawal.

“Forcibly tapering otherwise stable patients off high-dose, chronic opioid therapy reveals that this practice might have an effect that is the opposite of what public health is calling for: it may be a harm expanding intervention, exposing those who have long received opioid medications variously to worsened pain, withdrawal, social instability amidst untreated dependence, or loss of medical care relationships,” Rieder said.

“Taking such risks into account, continuing to prescribe high-dose opioid therapy for a legacy patient does not clearly constitute ethical or legal misprescribing.”

‘Large-Scale Social and Medical Experiment’

There is little doubt that prescription opioids involve serious risks and lead to harm for some patients. In some urgent cases, a forced taper may be justifiable in light of specific risks to an individual. But in general, forced tapers not only introduce new risks and create new harms, but they also damage the doctor-patient relationship and deny the patient’s status as an individual.

Stanford pain psychologist Beth Darnall, PhD, calls forced tapering a “large-scale social and medical experiment” being conducted without sufficient evidence on how to do it the right way.

“You may have a patient that has been on a stable dose of opioids for 10 years, and then you start de-prescribing. We are now exposing them to new risks for opioid overdose, for suicidality, for actual suicide, for withdrawal symptoms, for increased pain,” Darnall told The Guardian.

It's worth noting that both Darnall and Rieder were recently named to a new CDC panel that will advise the agency as it prepares to update its 2016 opioid prescribing guideline.

Physicians already have a wide variety of tools to reduce risk and improve outcomes without resorting to the ethically unjustifiable approach of forced tapers. It’s time to emphasize those tools and underscore the ethical importance of patient outcomes.

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. 

UK Guideline Warns Against Using Opioids and Most Other Drugs for Chronic Pain

By Pat Anson, PNN Editor

The United Kingdom may be on the verge of adopting even more stringent opioid guidelines than the United States and Canada.  

The UK’s National Institute for Health and Care Excellence (NICE) has released a sweeping guideline drafted by an expert committee that recommends opioid medication not be prescribed for chronic primary pain at any dose due to lack of evidence and risk of addiction.

“Based on their experience, the committee agreed that even short-term use of opioids could be harmful for a chronic condition. The lack of evidence for effectiveness of opioids, along with evidence of long-term harm, persuaded the committee to recommend against opioid use for people with chronic primary pain,” the guideline states.

The NICE guideline doesn’t stop there. It recommends against the use of virtually every other medication commonly used to treat chronic pain, including gabapentinoids, benzodiazepines, acetaminophen (paracetamol), non-steroidal anti-inflammatory drugs (NSAIDS), ketamine, corticosteroids, and antipsychotics. According to NICE, these non-opioid pain relievers may be addictive, have risky side effects and do more harm than good.

“The committee agreed that not commenting on these medicines could result in their continued use in practice, which would be inappropriate given the lack of evidence and possible harms, so they recommended against the use of these treatments,” the guideline says.

The guideline is the first by NICE to address “chronic primary pain” — a vague term used to describe pain conditions that last longer than 3 months, and cause significant emotional distress and disability, such as fibromyalgia, Complex Regional Pain Syndrome, chronic musculoskeletal pain and symptoms that “can’t be accounted for by another diagnosis.”

NICE said the new guideline “should be used alongside” existing recommendations it has already issued for headache, low back pain and sciatica, rheumatoid arthritis, osteoarthritis, spondyloarthritis, endometriosis and irritable bowel syndrome.

The draft guideline recommends that people with chronic primary pain get physical therapy, acupuncture, psychological therapy and regular exercise. Several other alternative therapies, including transcutaneous electrical nerve stimulation (TENS) and manual therapies such as chiropractic care, are not recommended due to lack of evidence.

Surprisingly, the only class of medication that was recommended for chronic primary pain is anti-depressants such as duloxetine (Cymbalta) and fluoxetine (Prozac), even though their use would be off-label.

Most Treatments Don’t Work

In short, the NICE guideline states that few treatments work for chronic primary pain and most should be avoided.

“There is no medical intervention, pharmacological or non-pharmacological, that is helpful for more than a minority of people with chronic pain, and benefits of treatments are modest in terms of effect size and duration. Additional morbidity resulting from treatment for chronic pain is not unusual, so it is important to evaluate the treatments we offer for chronic pain, to focus resources appropriately and to minimise harm,” the guideline warns.

The draft guidance is open for public comment until September 14.

The head of a large association of UK primary care physicians said the NICE recommendations are welcome, as long as the alternative therapies are made widely available.

“Most patients in pain do not want to take medication long-term, and GPs do not want this either, but sometimes medication has been the only thing that brings relief. As such these new guidelines, which focus on alternative therapies, have the potential to be beneficial for patients - but they will need to be guaranteed appropriate access to them,” Professor Martin Marshall, Chair of the Royal College of General Practitioners said in a statement.

“We should also be mindful not to disregard some medications completely as a lack of evidence may be due to a lack of high-quality research, particularly for older drugs, such as paracetamol.”

NICE estimates that chronic pain may affect between one-third and one-half of the UK population. Almost half of people with chronic pain have a diagnosis of depression and two-thirds are unable to work because of it.

The guideline emphasizes that physicians communicate and work collaboratively with patients to understand the symptoms and causes of their pain.  

“Understandably, people with chronic pain expect a clear diagnosis and effective treatment. But its complexity and the fact GPs and specialists alike find chronic pain very challenging to manage, means this is often not possible. This mismatch between patient expectations and treatment outcomes can affect the relationship between healthcare professionals and patients, a possible consequence of which is the prescribing of ineffective but harmful drugs,” Nick Kosky, a psychiatrist and chair of the NICE guideline committee said in a statement.

“This guideline, by fostering a clearer understanding of the evidence for the effectiveness of chronic pain treatments, will help to improve the confidence of healthcare professionals in their conversations with patients. In doing so it will help them better manage both their own and their patient’s expectations.” 

Misleading Data and Bias in Canadian Opioid Reporting

By Marvin Ross, Guest Columnist

It is sometimes said that there are lies, damned lies and statistics. That prophetic statement, often mistakenly attributed to British Prime Minister Benjamin Disraeli, explains the complete confusion in the minds of the public about the use of opioid medication.

By conflating data on prescribed opioids with illicit opioids – an apples to oranges comparison -- the average person has no real understanding of the value of opioid pain relievers. How often do we hear people say they refuse to take pain medication for fear of becoming addicted?

One Canadian agency that confuses, conflates and even admits that its data is misleading is the Canadian Centre on Substance Use and Addiction (CCSA). The reports they publish suggest that prescribed opioids are a major problem to be avoided. They are out of step with some of the provincial coroners and federal agencies such at the Public Health Agency of Canada and Health Canada.

Let's first look at what these other agencies report.

Last month, British Columbia reported its highest number of illicit drug deaths ever, nearly 6 deaths per day, with the vast majority involving fentanyl and its analogues. In neighboring Alberta, 127 of the 142 deaths in the first quarter of 2020 involved fentanyl. Neither province talks about deaths from prescribed opioids, as the main issue is illicit drugs.

While fentanyl is a prescribed drug and has many legitimate uses, only 5% of all opioids prescribed in Canada is fentanyl. Given its frequency in overdoses, it must come from illegal sources.

The Public Health Agency divides their overdose statistics into those involving patients with prescribed opioids and those with substance abuse problems.  Prescribed opioids accounted for 0.02% of total hospitalizations, while for the substance abuse population it was 0.04% of hospitalizations.

There are distinct differences in age between the two groups. People in the prescribed group were usually men and women aged 60 and older. For those with substance abuse problems, the most prevalent age group is 20 to 39 years of age. It is well known that illicit drug use is more prevalent in younger people, as this data demonstrates.

Health Canada tracks reported adverse drug reactions for prescriptions and finds that analgesics are the least likely drugs to result in an adverse event. Only 1.8% of all adverse reactions involve pain medications.

Confusing Illicit Opioids with Legitimate Opioids

These statistics all demonstrate that the problem is illicit drug use and not valid prescribed opioids given to patients in pain. In contrast, the CCSA conflates legitimate and illicit opioids, and provides a totally biased picture of what is happening.

Their July 20 report is entitled “Prescription Opiods” with no mention of illicit opioids. But then they provide data that really pertains to the illicit kind.

In 2017, 11.8% of Canadians were prescribed opioids, down from 13% in 2015. Little changed was the proportion of patients who used their prescriptions for non medical uses, which is 3 percent. So, 97% of patients prescribed opioids used them properly.

Despite that, Canada, like the United States, introduced draconian prescribing guidelines to control the 3% and, of course, that negatively impacted the 97%.

There were nearly 16,000 overdose deaths in Canada between 2016 and 2019, according to the CCSA report, with emergency room visits for opioid poisoning doubling for the 25-44 age group. Given this is a report about prescription opioids, the impression the naive reader would get is that deaths and hospital visits all pertain to legally prescribed opioids.

Next, the CCSA points out that, while the number of opioid prescriptions in Canada has fallen, 5.5% of those taking them can still become addicted. That estimate for addiction is low, but there is other research suggesting that it is even lower. In keeping with their anti-opioid bias, they state that prescription “opioids can also produce a feeling of well-being, relaxation or euphoria (“high”).”

What people who take opioids for pain experience is a decrease in pain or no pain at all, if they are lucky. That's it – there’s usually no high and no euphoria. Addicts take these drugs for its high.

They then move on to talk about the healthcare costs associated with the use of opioids, but again do not differentiate between prescribed and illicit. This leaves the reader with the impression that anyone who takes opioids for any reason is costing the health system extra for adverse events, hospitalizations, overdoses and deaths.

In fact, they are mostly talking about illicit uses as the data they provide is not dissimilar to the data provided by the Public Health Agency or Health Canada. To hammer home the CCSA’s deception, the very next section deals with driving under the influence of prescription drugs.

In 2018, two prominent health experts completed a review of all the independent health agencies funded by Health Canada and recommended that three of them had outlived their usefulness. One of those was the Canadian Centre on Substance Use and Addiction, which they recommended be abolished. For some reason, it still exists.

I asked CCSA to explain their misleading statistics and it took them almost three weeks to respond. Research and policy analyst Samantha King, PhD, admitted the data is misleading unless readers take a deep dive into the footnotes.

“We are aware that for some of the data captured in the summary, including hospitalizations due to opioid poisonings and opioid-related deaths, there is no ability to differentiate between legal or illegal sources of opioids that are causing these harms. For this reason, these sections only refer to opioids in general and contain footnotes where appropriate, highlighting the limitations of the data,” King wrote to me in an email.

So, why call the report “Prescription Opioids” when, unlike coroners and other federal agencies in Canada, you cannot differentiate between illicit opioids and legitimate ones? All I can say is that it is fortunate that Canada's handling of the Covid-19 Pandemic is being handled by the Public Health Agency and not CCSA.

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He is a regular contributor to the Huffington Post.

Over-the-Counter Pain Relievers Involved in Growing Number of Suicides

By Pat Anson, PNN Editor

One of the reasons opioid prescriptions have been reined in over the last few years is concern that some patients may use the drugs to take their own lives. One study estimates that up to 30% of fatal opioid overdoses are suicides.

But the risk of suicide is greater with over-the-counter (OTC) pain relievers. According to an analysis of nearly 550,000 calls to U.S. poison control centers from 2000 to 2018, the number of suicide calls involving acetaminophen, ibuprofen and other OTC analgesics rose 57 percent.

Children between the ages of 6 and 19 accounted for about half of those calls, and females represented 73% of cases among individuals of all ages.

“Because they are easy to purchase and can help alleviate a variety of symptoms, many families have over-the-counter pain relievers readily available in their homes, often in large quantities,” said Alexandra Funk, PharmD, co-author of the study and director of the Central Ohio Poison Center at Nationwide Children’s Hospital.

“Unfortunately, the easy access to these medications is likely a big part of the reason that they are used in suicide attempts and deaths. The fact that they are being used more often with more serious outcomes is cause for concern.” 

The study, published in Pharmacoepidemiology and Drug Safety, found that nearly half (48%) of the OTC analgesic calls to poison control centers involved acetaminophen alone, followed by ibuprofen (33%), and aspirin (19%). Acetaminophen accounted for nearly two-thirds (65%) of the 1,745 deaths that were reported.

Rates of suicide-related cases involving acetaminophen and ibuprofen increased significantly during the study period, while the rate of aspirin cases decreased. About a third of the calls involved exposure to multiple substances, and those cases were twice as likely to result in hospitalization or death.

“The top three substance categories associated with suicide-related exposures in the US are antidepressants, OTC analgesics, and antipsychotics, and of these, OTC analgesics are the only one readily available without a prescription or other restrictions,” researchers found. “With suicide-related exposures involving OTC analgesics increasing in the US, more effective interventions are clearly needed to reduce injuries and deaths from this cause.”

One way to reduce the risk if suicide is to regulate the sale of OTC pain relievers by requiring single dose packaging – also known as blister packs. Rather than emptying a bottle of pills, each individual tablet would have to be punched out of the package.

“Because suicidal ingestion is often a highly impulsive act, this would deter overdoses by limiting the amount of medication that can be extracted at one time,” said Gary Smith MD, senior author of the study and director of the Center for Injury Research and Policy at Nationwide Children’s Hospital. “In addition, the U.S. should follow the lead of other countries that have successfully reduced suicidal ingestions of these medications by limiting the package size and quantity that can be purchased by an individual at one time.”

According to another recent study of calls to poison control centers, gabapentin (Neurontin) and the muscle relaxer baclofen are also involved in a growing number of suicides and attempted suicides.  

Suicide is the 10th leading cause of death in the U.S. Over 48,000 Americans took their own lives in 2018.

‘First, Do No Harm’ Doesn’t Mean ‘No Rx Opioids’

By Dr. Lynn Webster, PNN Columnist

Many physicians say their ethical duty is to "First, do no harm." This principle is often mentioned in the context of prescribing opioids. Some people even believe that prescribing opioids to treat people in pain violates the Hippocratic Oath, because, they say, a doctor’s first obligation is not to do anything that could make things worse for a patient.

However, that is a flawed oversimplification of the "First, do no harm" directive.

As N.S. Gill writes in Thoughtco, many people believe that “First, do no harm” is a quotation from the Hippocratic Oath. They are mistaken. More importantly, the creed does not say that doctors must never provide a clinical intervention that might trigger some degree of harm. If physicians had to live by such a code of ethics, they would be unable to offer almost any medical treatment, since they all carry some risk of harm.

As the Harvard Health Blog points out, ensuring that you always "do no harm" would mean no one would ever have lifesaving surgery. Doctors wouldn’t be able to order CT scans, MRIs, mammograms, biopsies or other tests that can turn up false positives; draw blood for fear of bruising or provide vaccines that may cause side effects. Even aspirin is a potentially dangerous treatment for some people. To avoid risk altogether, doctors would have to limit themselves to Band-aids and soothing words.

The Double Effect Philosophy 

“First, do no harm” isn’t about standing by helplessly while someone suffers needlessly. It is an ideal that is better explained by the principles embedded in the philosophy of the Double Effect. 

According to the Stanford Encyclopedia of Philosophy, the Double Effect doctrine means that an action is acceptable if harm occurs in the course of trying to make a positive difference. An intent to do good or help must be the underlying motive. However, the intention to do good by itself is insufficient. The possible good from the action must sufficiently outweigh the potential for harm. 

Often, the Double Effect guideline is used to explain why physicians prescribe opioids even knowing they can pose risk to patients. Doctors prescribe opioids -- sometimes at very high doses -- with the intent to relieve pain (which is “to do good”), because there are few other options available or affordable, and the risk of harm is manageable for most patients. 

This trade-off in decision-making is true for all medications and interventions, not just for opioids. Opioids are not evil agents, despite their checkered reputation among some laypeople, physicians and lawmakers. 

Not Using Opioids Can Causer Harm

Most patients nearing the end of their lives, their families and clinicians who treat terminally ill patients place a priority on a peaceful, pain-free death. Opioids are frequently necessary to fulfill that desire, despite their potential to hasten death. 

Providing opioids to ease end-of-life suffering passes the Double Effect test, but it is still controversial. Furthermore, end-of-life-care is only one area for which some experts question the use of opioids. Some people believe that opioids should never be prescribed because of the harm they may cause, regardless of their potential benefits to patients. 

But not using opioids can also cause harm. In an American Journal of Law and Medicine scholarly essay this month, Kate Nicholson and Deborah Hillman argue that there is a special duty to a subgroup of patients who are already receiving opioids: doctors must not harm them with forced tapering.  

There is also harm, Nicholson and Hillman say, in not treating pain in patients. Based on a Human Rights Watch study, they believe that doctors who deny patients the care they need "in an effort to protect their licenses or stay under the radar of law enforcement" may be violating their patients' human rights. 

Nicholson and Hillman point out that "First, do not harm" has a different meaning for policymakers than for physicians. Policymakers have a responsibility to ensure that society isn't harmed by opioids. However, the authors contend that policymakers have an even greater duty to "do no harm" by respecting the doctor/patient relationship when considering the societal impact of opioid prescribing.  

The patient's need for pain medication, they believe, should be prioritized over society's need for protection against the harm that misused or diverted opioids can cause. 

Our Ethical Responsibility to Patients 

As physicians, we are trained to heal. We become healthcare professionals because we want to provide compassionate care to the sick, the frail, and the dying. We swear an oath to use our best judgment to evaluate the risks and potential benefits in all interventions. Intending to do good, even knowing that adverse effects can occur with every intervention, is our ethical responsibility. 

A mischaracterization of the phrase “First, do no harm” must not prevent providers from caring for people, or prevent policymakers from allowing physicians to treat their patients. That treatment must include providing patients with medication that can adequately provide pain relief with acceptable risk.  

The physician's ethos must always be based on what is best for the patient when all factors are considered -- not on arbitrary guidelines that impose a one-size-fits-all philosophy.  

This column has been revised and updated from a version that appeared in the Salt Lake Tribune on December 10, 2017.

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.” You can find Lynn on Twitter: @LynnRWebsterMD

CDC Appoints New Opioid Workgroup for Guideline Update

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has named a diverse group of physicians, academics and patients to an “Opioid Workgroup” that will advise the agency as it works on an update and possible expansion of its controversial opioid prescribing guideline. Several advisors on the 23-member workgroup also advised the agency during the 2015-2016 guideline process.

Notably lacking on the new panel are any members of Physicians for Responsible Opioid Prescribing (PROP), a small but influential group of radical anti-opioid activists who played an outsized role in drafting the original guideline.

Although voluntary and only intended for primary care physicians treating chronic pain, the guideline’s recommended limits on opioid prescribing were quickly adopted as policy by other federal agencies, dozens of states, insurers, pharmacies and doctors of all specialties.  As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses, leading to uncontrolled pain, withdrawal and, in some cases, suicide.

Not until last year did the CDC publicly acknowledge the “misapplication” of the guideline and promise to make changes – although the process is unfolding slowly. An update to the guideline is not expected until late 2021, nearly six years after the initial guideline was released. It is expected to include new recommendations for the treatment of acute, short-term pain.  

‘Opioids Gave Me a Life’

There are two pain patients in the workgroup, who have contrasting experiences with opioid medication.

One is Kate Nicholson, a civil rights lawyer and patient advocate who took opioids for several years while disabled with severe back pain. Nicholson declined to talk with this reporter about her appointment to the workgroup, but shared her personal experience with the medical use of opioids in a 2017 PNN guest column.

“As soon as I took opioids, I improved. I wasn’t foggy or especially euphoric. In fact, the opposite happened, space opened in my mind and I could work again.  I also never developed a tolerance, requiring more medication for the same level of pain relief,” Nicholson wrote. “Opioids did not heal me. Integrative treatment over a long period of time did.  But opioids gave me a life until I could find my way to healing. Importantly, they allowed me to continue to work.”  

In a 2019 op/ed in The Los Angeles Times, Nicholson said the CDC guidelines should be revised because they were being treated  as “one-size-fits-all mandates” that were harmful to patients.

“The agency needs to revise its guidelines to recommend that physicians not abandon pain patients or engage in ‘forced tapering.’ The CDC should also study and address any unintended consequences of its 2016 guidelines, as it promised to do,” she wrote.

The other patient on the panel is Travis Rieder, PhD, Director of the Bioethics Masters Program at Johns Hopkins University. Rieder severely injured his foot in a motorcycle accident in 2015 and became dependent on opioids while recovering from surgery.

Rieder has written a book and several articles on his experience with chronic pain and the difficulty he had getting off opioids. He also became frustrated with the healthcare system and how it often abandons patients to pain, addiction or both.

“I represented one of the medical community’s most distressing dilemmas: a patient in obvious severe pain but begging for medication that is killing tens of thousands of people a year. The fact that different doctors, in different moments, treated me in radically different ways is completely unsurprising. Because no amount of public hand-wringing or blunt policy tools is going to make it clear what to do with patients like me. We’re a problem, and there’s no obvious solution,” Rieder wrote in his book, “In Pain: A Bioethicist’s Personal Struggle with Opioids.”

‘Clear Need’ for More Specific Guidelines

The other 18 members of the workgroup bring a mix of mostly academic and medical experience to the table.

At least five members of the panel advised the CDC during the drafting the 2016 guideline. They include the chair of the workgroup, Christina Porucznik, PhD, a professor of public health at the University of Utah, who chaired the opioid workgroup in 2016. Chinazo Cunningham, MD, Anne Burns, RPh, and Mark Wallace, MD, are also returning members of the workgroup. They are joined by Jeanmarie Perrone, MD, was a peer reviewer for the 2016 guideline.

In 2018, Perrone called for even more prescribing guidelines.

“There is a clear need for further impactful guidelines similar to the CDC guidelines that outline more specific opioid and non-opioid prescribing by diagnosis," said Perrone, a professor of Emergency Medicine and director of Medical Toxicology at Penn Medicine.

A new addition to the workgroup is Beth Darnall, PhD, a pain psychologist at Stanford University, who has drawn some controversy in the pain community for her studies about “catastrophizing” — a clinical term used to describe patients who are anxious, angry or feel helpless about their pain. She recently began an effort to find another term for catastrophizing.

Darnall, who has advocated against forced opioid tapering, expressed concern about the misapplication of the CDC guideline in a 2019 op/ed published by The Hill.

“Health-care organizations and states have cited the CDC guideline as a basis for policies and laws that extend well beyond its intended purpose. The guideline has been wrongly cited to substantiate proposed dose-based opioid prescribing policies that fail to account for the medical circumstances of the individual patient,” wrote Darnall. “We need flexible policies that provide meaningful access to comprehensive pain care and do not myopically focus on opioid dose reduction policies.”

‘Vast Improvement’ Over Previous Workgroup

The fact that we even know who is on the new workgroup is a small step forward in transparency for the CDC, which refused to disclose the names of any of its advisors when a draft version of the opioid guideline was released in 2015.

Only when threatened with a lawsuit and a congressional investigation did the CDC make the names public. They included Dr. Jane Ballantyne, President of PROP, along with PROP board members Dr. Gary Franklin and Dr. David Tauben. PROP founder and Executive Director Dr. Andrew Kolodny and PROP member Dr. David Juurlink also participated in a “Stakeholder Review Group” for the CDC.

“This group is a vast improvement over the 2016 Guideline group. There are several people here who I know, and who I trust to act as strong patient advocates,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management. “All in all, this is a much better panel, and I'm confident it will produce a much better result for people with pain.”

Twillman cited Burns, Darnall, Wallace and Christine Goertz as workgroup members who would “keep patients in the center of the discussion.”

“The only other member I really know is Jeanmarie Perrone, who, while not a member of PROP, certainly could be. She and I have shared presentation opportunities a couple of times before, and she is very much in the anti-opioid crowd,” said Twillman.

“The new Workgroup constitutes a major improvement over the workgroup involved in drafting the 2016 guideline. That group included a number of well-connected people passionately opposed to the use of opioids in management of chronic pain,” said Stephen Nadeau, MD, a professor of Neurology at the University of Florida College of Medicine.

“Although the new Workgroup membership does not include such people, one could well question the inclusion of several people academically invested in pharmacological or non-pharmacological alternatives to opioid treatment, particularly in the complete absence of comparative effectiveness studies of such treatments.  One could also question the inclusion of surgeons, emergency room physicians, and pharmacists, who do not manage chronic pain.”

More Stakeholders Sought

CDC is seeking additional input from pain patients, caretakers and healthcare providers who will serve as “stakeholders” during the guideline development process. The agency is planning to speak with 100 stakeholders by phone or online for 45-60 minutes “to listen to personal perspectives and experience” related to pain care. The CDC has already obtained written comments from nearly 5,400 people, most of them pain patients.

If you’re interested in being a stakeholder, further information can be found here. The CDC is taking applications until August 21.

The CDC has also funded a series of new studies on opioid and non-opioid treatments for chronic pain. The report on opioids was released in April by the Agency for Healthcare Research and Quality. It concluded that opioids were no more effective in treating pain than nonopioid medication, and that long-term use of opioids increases the risk of abuse, addiction and overdose. At least three PROP members served as experts and peer reviewers during the drafting of that report.

U.S. Pain Foundation Pockets $210,000 from Insys Therapeutics

By Pat Anson, PNN Editor

The U.S. Pain Foundation has decided to keep over $210,000 leftover from a controversial co-pay prescription drug program funded by Insys Therapeutics, a disgraced Arizona drug maker blamed for the overdose deaths of hundreds of pain patients.

The funds have been designated as “unrestricted grant revenue” by the Connecticut based-charity, which at one time claimed to be the nation’s largest non-profit advocacy group for pain patients. The decision to keep the money, which was being held in an escrow account, reverses a previous pledge by U.S. Pain in 2018 that it “will not accept funding from Insys going forward.”

“It has been determined that the funds may be used for charitable purposes consistent with the tax-exempt purpose of USPF in assisting people living with chronic pain. Going forward these funds will be allocated for such purposes,” U.S. Pain disclosed in a recent audit statement. “The escrow reserve of $210,974 was reversed in 2019 and the unrestricted funds were recorded as unrestricted grant revenue.”

Insys and U.S. Pain launched the “Gain Against Pain” program in 2016 with $2.5 million donated by the company. The stated goal of the co-pay program, which was administered by NeedyMeds, was to help patients obtain medication for breakthrough cancer pain.

But the program was apparently only used to generate prescriptions for Subsys, an expensive and potent fentanyl spray that was Insys’ flagship product. A four-day supply of Subsys can cost nearly $24,000.

The Gain Against Pain program was shut down in 2018 after Insys executives were charged with racketeering, fraud, bribery and other criminal charges over their marketing of Subsys. Insys filed for bankruptcy in 2019 and its founder sentenced to 66 months in prison.

Controversy over the co-pay program and other financial irregularities also led to the resignation of Paul Gileno, the founder and CEO of U.S. Pain. Gileno later pleaded guilty to charges of fraud and tax evasion, and served a few months in federal prison.

“We now know that Insys Therapeutics advanced this program using predatory practices and were assisted in doing so by U.S. Pain Foundation via access to the vulnerable populations served by that organization,” said Stefanie Lee Berardi, a patient advocate and grant writer who worked in nonprofit management.

“Nonprofits receiving large charitable donations have a duty to ensure the source of those funds is both legal and ethical before those funds are accepted. Once the funds are accepted, it is very difficult to give those funds back.”

The $210,000 in leftover co-pay funds would be a significant amount of money for most charities. U.S. Pain had over $1.4 million in revenue according to its 2019 tax return, about 30% less than the year before. The charity also disclosed in its audit statement that it received $92,805 this year from the federal government’s Payroll Protection Loan Program.

Questionable Spending

Under Gileno’s leadership, there was virtually no oversight of spending at U.S. Pain, which used donated funds to pay for highly questionable purposes, such as operating a money-losing bakery, loans to Gileno’s brothers and a family vacation to Universal Studios in Florida. The charity now has a chief financial officer and a new board of directors, and says it has other safeguards in place to prevent further fraud.

U.S. Pain CEO Nicole Hemmenway, who was vice-president and board chair under Gileno, did not respond to a request for comment for this story.

The charity’s audit statement indicates the $210,974 was received in two checks from NeedyMeds and had not been spent or earmarked for any program. Classifying the funds as unrestricted grant revenue means they can be used for any purpose – not just helping cancer patients.

“What I am really not understanding is why U.S. Pain chose to accept these as unrestricted funds, rather than to a restricted fund that would help individuals and families who were harmed by Insys’ co-pay program,” Berardi said in an email.

“Given that they haven’t yet done so, it is now imperative that they clearly define how those monies will be used. It is still possible for them to do the right thing. Should they choose to, they may find that they can mitigate the reputational harm sustained as a result of unethical and illegal business practices for which their CEO went to prison and an irresponsible board of directors who failed to meet their duty of care.”

Another critic believes U.S. Pain should donate the money to another charity.

“Given what has come out about both Insys and the U.S. Pain Foundation, the ethical thing to do would have been to give the money to a nonprofit organization that provides treatment for opioid use disorder,” said Adriane Fugh-Berman, MD, Director of PharmedOUT, a program at Georgetown University that seeks to expose deceptive marketing in the healthcare industry.

Co-pay prescription drug programs – also known as co-pay charities – are ostensibly designed to help needy patients pay for prescription drugs. But in recent years, several major pharmaceutical companies have paid heavy fines to settle fraud allegations that they used co-pay programs to steer Medicare patients to their high-priced drugs.

The assistance programs typically pay only a small amount for the prescriptions, with the rest of the cost picked up by Medicare. Federal anti-kickback laws prohibit drug companies from making any kind of payment to induce Medicare patients to purchase their drugs.

The High Cost of California's Death Certificate Project

By Dr. Denise Phan, Guest Columnist

Even as the Covid-19 pandemic occupies the nation’s attention, most of my work as a primary care doctor still revolves around other chronic diseases.  

Every day, people are still giving birth, still getting sick, still dying from terminal diseases, still getting hurt and still having pain. Yet more and more, physicians’ hands are tied when it comes to prescribing opiate medication to reduce their patients’ pain and suffering, especially now that surgeries, physical therapy and injections are discouraged due to social distancing guidelines.

Last year, a patient came to me with a letter from her previous doctor explaining that he is no longer able to prescribe any opiates. The local pain specialists he recommended in his letter were either not taking new patients on opiates or would not prescribe the dosage of oxycodone needed to control her pain.

Several months ago, another patient came in complaining that his pain specialist had cut his dosage down so quickly that he now resorts to street heroin to control the pain and withdrawal.

Yet another patient asked me a few months ago to stop the chemotherapy for his lung cancer and put him in hospice care so he can get adequate pain control.

And just last month, a patient told me she can no longer bear to attend her online fibromyalgia support group because five people in the group had killed themselves in the past few years.

Recently, a frustrated nurse in the oncology/orthopedic ward asked me, “What is it with you doctors? Are you all going to let people scream themselves to death from pain? "

DR. DENISE PHAN

A cardiologist friend of mine remarked, “Ten years ago you could get sued for not prescribing pain meds to patients, now you can get sued just for writing one."

Project Targets ‘Inappropriate’ Prescribing

One of the causes for this sad state of affairs in California is the state medical board’s “Death Certificate Project.” The board investigated the overdose deaths of 450 patients who may have received “inappropriate” opioid prescriptions and sent warning letters to their physicians. Disciplinary action was taken against dozens of them.

The Death Certificate Project sounds like a well-meaning idea, but in practice it has decimated the field of pain management and brought tremendous suffering to patients living with real legitimate pain.

The most egregious of the project's many faults is the decision to pull death certificates from 2012-2013, and then use the state’s prescription drug database to identify "overprescribers." The deaths occurred years before the medical board adopted tougher guidelines on the prescribing of opiates in 2015 and the CDC released its opioid guideline in 2016. 

By this irrational act, the project targeted hundreds of primary care doctors and pain management specialists who were caring for the high-risk populations of chronic pain patients, and were following previous California guidelines to treat pain aggressively and with opiate medications if necessary.  

To date, the board has filed accusations of negligent prescribing against 66 physicians. Forty-eight of them have faced discipline such as license surrender, public reprimands and probation. Some were forced into early retirement. Eighteen doctors are still awaiting hearings or trials. The vast majority of them are responsible physicians who have had no other complaints lodged against them. 

Throughout the Covid-19 pandemic, standards of care and public policies have been rapidly evolving, even flip-flopping from week to week, some causing and some preventing thousands of deaths along the way. It is incredibly irrational to retroactively penalize doctors for following the previous standards of care during a epidemic. Yet this is precisely what the Death Certificate Project is doing by focusing on overdoses in 2012-2013, when the opioid epidemic had not even been recognized or publicized by the medical board itself. 

Imagine going to work every day on the frontline of an epidemic, knowing that the state or federal government can change their policies at any time; and that they can go back and prosecute you for the deaths that resulted from their previous policies.  As we watched our colleagues in the field falling like dominoes one by one, can you blame the doctors for running scared?

The primary result of the Death Certificate Project has been the effective removal of dozens of frontline doctors amid a decades-long shortage of primary care physicians and on the eve of a pandemic. The secondary result of this program is the refusal of terrorized remaining physicians to prescribe any pain medications at all or to drastically reduced the dosages. This has caused a marked increase in pain, suffering and suicide rates in the legitimate pain and addiction patient populations, as well as the subsequent rise in the use of street opioids and thus opioid deaths overall.

The data on California and national overdose deaths shows that prescription opioid overdoses have declined since 2014. Overall drug deaths spiked up sharply in 2017-2018 – but this was mainly due to street heroin and illicit fentanyl. This shows how sadly unnecessary and harmful the project is.

Beside the human and societal costs listed above, this project is costing California millions of dollars annually in funding for administrative, consulting and legal fees. This is not counting the immeasurable cost to the medical system from the loss of physician resources during the biggest pandemic of our time. 

When a medication or treatment does not work as intended and causes many harmful side effects, we need to stop it. If you are a resident of California, please join me in a letter writing campaign to end this irrational, unnecessary, harmful and costly Death Certificate Project at the Action Network website

Dr. Denise Phan is an Internal Medicine physician in Los Angeles. She works in private practice in the San Fernando Valley and is on staff at Valley Presbyterian Hospital. Dr. Phan is active in the annual missions of the mobile health units of the Social Assistance Program for Vietnam and the International Humanitarian Mission. 

Gabapentinoids Involved in a Third of Overdoses in Scotland

By Pat Anson, PNN Editor

A new study in Scotland is shining more light on the risks of overprescribing gabapentin (Neurontin) and pregabalin (Lyrica). The two drugs belong to a class of nerve medication called gabapentinoids, which are increasingly prescribed in Western nations to treat chronic pain.

In 2018, there were 1,187 accidental drug-related deaths (DRDs) in Scotland – the highest overdose rate in the European Union — and gabapentinoids were involved in about a third of them.

According to research published in the British Journal of Anaesthesia, gabapentin was implicated in 15.2% of fatal overdoses in Scotland, while pregabalin was linked to 16.5% of drug deaths. That’s up from 3% and 1% of fatal overdoses, respectively, in 2012.

Researchers say deaths involving gabapentinoids are rising because they are frequently co-prescribed with opioids and other medications that depress the central nervous system and raise the risk of overdose. Drug diversion also plays a role.

“Gabapentinoid prescribing has increased dramatically since 2006, as have dangerous co-prescribing and death. Older people, women, and those living in deprived areas were particularly likely to receive prescriptions. Their contribution to DRDs may be more related to illegal use with diversion of prescribed medication,” wrote lead author Nicola Torrance, PhD, Senior Research Fellow at the School of Nursing & Midwifery, Robert Gordon University, in Aberdeen, Scotland.

From 2006 to 2016, the number of pregabalin prescriptions in Scotland rose by an astounding 1,600 percent, while prescriptions for gabapentin quadrupled. About 60% of the time, gabapentin was co-prescribed with an opioid, benzodiazepines or both.  

Gabapentinoids are also showing up in Scotland’s illicit drug supply. Drug users have found they can heighten the effects of heroin, marijuana, cocaine and other substances. In the Scottish region of Tayside, gabapentinoids were involved in 39% of drug deaths. About three out of four of those overdose victims did not have a prescription for the drug.

In addition to overdoses, gabapentinoids have also been associated with increased risk of suicidal behavior, accidental injuries, traffic accidents and violent crime. UK health officials were so alarmed by misuse of the drugs and the rising number of deaths that gabapentin and pregabalin were reclassified as controlled substances in 2019.

Gabapentin is not currently scheduled as a federally controlled substance in the United States, but pregabalin is classified as a Schedule V controlled substance, meaning it has low potential for addiction and abuse.  

A 2019 clinical review found little evidence that gabapentinoids should be used off-label to treat pain and that prescribing guidelines often exaggerate their effectiveness. The U.S. Food and Drug Administration also recently warned that serious breathing problems can occur in patients who take gabapentin or pregabalin with opioids or other drugs that depress the central nervous system.

The CDC, Opioids and Cancer Pain

By Roger Chriss, PNN Columnist

In 2016, the Centers for Disease Control and Prevention issued its controversial opioid prescribing guideline. Insurers, states and other federal agencies soon followed with mandatory policies and regulations to reduce the use of opioid pain medication. All this was supposed to exclude cancer-related pain care, but in practice that’s not what happened.

Dr. Judith Paice, director of the Cancer Pain Program at Northwestern University’s Feinberg School of Medicine, told the National Cancer Institute in 2018 that the opioid crisis “has enhanced fear — fear of addiction in particular” among both patients and doctors.

“Many primary care doctors no longer prescribe opioids. Oncologists are still prescribing these medications, but in many cases they’re somewhat anxious about doing so. That has led some patients to have trouble even obtaining a prescription for pain medication,” Paice said.

In 2019, the Cancer Action Network said there has been “a significant increase in cancer patients and survivors being unable to access their opioid prescriptions.” One out of four said a pharmacy had refused to fill their opioid prescription and nearly a third reported their insurance refused to pay for their opioid medication.

That same year, CDC issued a long-awaited clarification noting the “misapplication” of the guideline to patients it was never intended for, including “patients with pain associated with cancer.”  

Long Term Use of Opioids Uncommon

Cancer pain management in the U.S. has been severely impacted by the CDC guideline, even though rates of long-term or “persistent” opioid use are relatively low and stable:

• A major review of over 100,000 military veterans who survived cancer found that only 8.3% were persistent opioid users. Less than 3% showed signs of opioid abuse or dependence.

• A study of older women with breast cancer who were prescribed opioids found that only 2.8% were persistent opioid users.  

• A study of 276 patients with head or neck cancer found that only 20 used opioids long-term – a rate of 7.2 percent.

• And a study of nearly 23,500 women with early-stage breast cancer who had a mastectomy or mastectomy found that 18% of them were using opioids 90 to 180 days after surgery, while 9% were still filling opioid prescriptions 181 to 365 days later.

While any sign of opioid abuse or addiction is concerning, these studies show that long-term use of opioid medication is relatively uncommon among cancer survivors. The American Cancer Society says opioids are “often a necessary part of a pain relief plan for cancer patients” and “can be safely prescribed and used” for cancer pain.

Cancer patients and their doctors have been successfully managing opioid risks long before the CDC guideline or associated state laws and regulations. Perhaps it is time for lawmakers, regulators, insurers and pharmacies to learn from the cancer community rather than getting in the way of clinical best practices.

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. 

Researchers Developing Safer Version of Acetaminophen

By Pat Anson, PNN Editor

Researchers at Louisiana State University have created a new type of analgesic that is similar to acetaminophen but can relieve pain and reduce fever without the risk of liver or kidney damage.

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. Over 50 million Americans take acetaminophen each week, many unaware that excessive use can cause 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.

Researchers at LSU Health New Orleans created 21 chemical compounds that are structurally similar to acetaminophen, but did not cause liver or kidney toxicity in tests on laboratory rodents. Their findings are published online in the European Journal of Medicinal Chemistry.

"The new chemical entities reduced pain in two in models without the liver and kidney toxicity associated with current over-the-counter analgesics that are commonly used to treat pain -- acetaminophen and NSAIDs. They also reduced fever in a pyretic model,” said senior author Nicolas Bazan, MD, Director of the LSU Health New Orleans Neuroscience Center of Excellence.   

The intellectual property behind the acetaminophen analogs has been licensed to South Rampart Pharma. The company expects to file an investigational new drug application with the Food and Drug Administration in the third quarter 2020, which would pave the way for clinical studies.

"Our primary goal is to develop and commercialize new alternative pain medications that lack abuse potential and have fewer associated safety concerns than current treatment options,” said Bazan. "Given the widespread use of acetaminophen, the risk of hepatotoxicity with overuse, and the ongoing opioid epidemic, these new chemical entities represent novel, non-narcotic analgesics that exclude hepatotoxicity, for which development may lead to safer treatment of acute and chronic pain and fever.”

Bazan said the development of safer pain relievers and fever reducers is particularly important because of the COVID-19 pandemic. Current treatments have led to kidney and liver disease in critically ill SARS-CoV-2 patients.

Acetaminophen is a key ingredient in hundreds of over-the-counter pain relievers and cough, cold and flu medicines – from Excedrin and Tylenol to Theraflu and Alka-Seltzer Plus. It’s also used in opioid pain medications such as Vicodin. Nearly two-thirds of the world’s supply of acetaminophen comes from China.

Gabapentinoids Ineffective for Pain Relief After Surgery

By Pat Anson, PNN Editor

Would you want to take Lyrica (pregabalin) or Neurontin (gabapentin) for pain relief after a major surgery? Both drugs belong to a class of nerve medication called gabapentinoids that are increasingly being prescribed to patients perioperatively (after surgery) as an alternative to opioid medication.

But gabapentinoids also have risks and there is little evidence to support their use for postoperative pain relief, according to a large new study by a team of Canadian researchers.  

“No clinically significant analgesic effect for the perioperative use of gabapentinoids was observed. There was also no effect on the prevention of postoperative chronic pain and a greater risk of adverse events. These results do not support the routine use of pregabalin or gabapentin for the management of postoperative pain in adult patients,” wrote lead author Michael Verret, MD, a resident at Laval University in Quebec City.  

Verret and his colleagues conducted a meta-analysis of 281 clinical trials involving nearly 25,000 patients undergoing a wide range of surgeries, including orthopedic, spinal and abdominal operations.

Their findings, recently published in the journal Anesthesiology, indicate that the analgesic benefits of pregabalin and gabapentin after surgery are negligible, regardless of the dose or type of operation. Gabapentinoids were also ineffective in preventing chronic pain from developing after surgery, one of the primary justifications for using the drugs postoperatively.

“Gabapentinoids were also associated with a greater incidence of adverse events, namely dizziness and visual disturbance, while other major adverse events such as respiratory depression and addiction are not reported or are underreported,” said Verret.

The findings contradict guidelines published by the American Pain Society (APS) in 2016,  which advocate “around the clock” use of gabapentin, pregabalin and other nonopioid drugs both before and after surgery.

“The panel recommends use of gabapentin or pregabalin as part of a multimodal regimen in patients who undergo surgery. Both medications are associated with reduced opioid requirements after major or minor surgical procedures, and some studies reported lower postoperative pain scores,” the APS guideline states.

“The panel suggests that clinicians consider a preoperative dose of gabapentin or pregabalin, particularly in patients who undergo major surgery or other surgeries associated with substantial pain, or as part of multimodal therapy for highly opioid-tolerant patients.”

‘Evidence of Harm’

Although opioid addiction is relatively rare after surgery, dozens of U.S. hospitals followed the lead of the APS and other medical guidelines by stopping the use of opioids for certain surgeries.

Cleveland Clinic Akron General Hospital, for example, adopted a policy of only using gabapentin and other non-opioid analgesics for colorectal operations.

“It is now clear that over the past two decades, evidence of benefit from routine perioperative administration of gabapentinoids has diminished, while evidence of harm has increased.”

— Dr. Evan Kharasch

Critics say gabapentinoids have become a trendy alternative for post-surgical pain relief, even though evidence supporting their use is minimal.

“It is now clear that over the past two decades, evidence of benefit from routine perioperative administration of gabapentinoids has diminished, while evidence of harm has increased. If any potential benefits exist in ‘special populations,’ published reports have yet to identify the benefits or the populations,” lead author Evan Kharasch, MD, Editor-in-Chief of Anesthesiology, wrote in an editorial.

“The good intentions that led to routine gabapentinoid use should be redirected to lead the way out. The French Society of Anesthesia and Intensive Care Medicine now states that gabapentinoids should not be used systematically or in outpatient surgery. Other societies should follow. As the weight of evidence has shifted and the risk–benefit balance tilted away from benefit, evidence-based practice impels revising if not eliminating the routine use of perioperative gabapentinoids in adults.”

It's too late for the APS to change its guideline. The organization filed for bankruptcy in 2019, ironically because of the high cost of legal fees in defending itself against opioid litigation.

While the CDC’s controversial opioid guideline does not advocate using gabapentinoids for post-surgical pain, it does recommend their use in treating chronic pain -- with little to no mention of their side effects.

One of the co-authors of the CDC guideline, Dr. Roger Chou, also played a significant role in drafting the APS guideline. Chou is currently heading much of the research being conducted by the CDC as it prepares to update and possibly expand its 2016 guideline.

Long-Term Use of Muscle Relaxants Has Tripled

By Pat Anson, PNN Editor

Long-term use of muscle relaxants has nearly tripled in the U.S. since 2005, according to a new study by researchers at the University of Pennsylvania, who say the drugs are often prescribed inappropriately for chronic pain and to older adults.

Skeletal muscle relaxants (SMRs) like carisoprodol (Soma) and metaxalone (Skelaxin) were approved years ago for short-term treatment of muscle spasms and back pain. Researchers believe many doctors are now prescribing the drugs as an alternative to opioids for long-term pain management.

"There are few studies on the short-term efficacy and safety of skeletal muscle relaxants, and almost no data on their long-term effects, so it is very concerning that patients, and particularly older adults, are using these drugs for an extended period of time," said Charles Leonard, PharmD, an assistant professor of Epidemiology at Perelman School of Medicine. "Providers seem to be reaching for them despite incomplete information on their potential benefits and risks."

Medical guidelines generally recommend limiting the use of muscle relaxants to three weeks because they have not been shown to work for muscle spasms beyond that duration. The drugs can also have side effects such as falls, fractures, vehicle crashes, abuse and dependence. Because of those risks, muscle relaxants should be avoided altogether in elderly patients, according to the American Geriatrics Society.

To measure national trends in muscle relaxant prescribing, researchers analyzed the number of office visits that resulted in muscle relaxant prescriptions from 2015 to 2016. They found the number of new prescriptions remained stable at about 6 million per year. But office visits for renewals of muscle relaxant prescriptions tripled -- from 8.5 million in 2005 to 24.7 million in 2016.

Over two-thirds (67%) of the patients getting renewals for muscle relaxants in 2016 were also taking opioid medication, despite an FDA warning that co-prescribing the drugs could lead to respiratory depression and overdose. Older adults accounted for about one in four (22%) office visits for muscle relaxants.

"For older adults, I think the message should be to avoid using muscle relaxants, especially when we consider the side effects and increased risk of falls and fractures, and to find alternatives for pain management," said first author Samantha Soprano, MPH, a research coordinator and student in Penn's Master of Behavioral and Decision Sciences program.

In addition to potential side effects, researchers say muscle relaxants may not be any more effective in managing pain than medications like Tylenol or Advil.

"Muscle relaxants' place in therapy is really limited. Based on most guidelines, they're normally reserved as second- or third-line therapies," Leonard said. "Our findings suggest that prescribers may be reaching for these drugs sooner than that."

The findings are published in JAMA Network Open.

Overdose Deaths Are Rising Again and the Pandemic Is Making It Worse

By Roger Chriss, PNN Columnist

The nation’s overdose crisis seemed to ease a bit in 2018, when fatal drug overdoses dropped 4.1% compared to 2017. This was heralded as a turning point in the crisis, a possible light at the end of the tunnel of overdoses that rose annually for nearly three decades.

But new data from the CDC shows that 2019 saw increases that almost wiped out the drop in 2018. Although provisional, the data shows a 3% increase in overdose deaths between November 2018 and November 2019.

Overdoses are rising but the drugs are largely the same: Illicit fentanyl is involved in the vast majority of deaths, with an uptick in overdoses involving cocaine and other psychostimulants, too. Deaths involving prescription opioids and heroin both fell a little. Overdoses rose in the West, Midwest and South, while declining in New England and Mid-Atlantic states.

SOURCE: cdc

The early data for 2020 is mixed. Rhode Island’s preliminary data show a 22% increase in drug overdose deaths in the first quarter compared to the same period in 2018. Other states were doing better, at least until March.

Then came the coronavirus pandemic. State-mandated lockdowns, combined with reduced access to addiction treatment and talk therapy, along with loss of work and social support, were quickly seen as a perfect storm of risk factors for substance use problems, relapse and overdose, accidental or otherwise.

And that’s what is happening. Psych Congress reports that drug overdoses are up 16.5% nationwide from January to April 2020. Fatal overdoses rose by 11.4% during that period and nonfatal overdoses by 18.6%. This trend continued in early May, too.

The risks of the pandemic were recognized early. In March, Buzzfeed predicted that fatal overdoses were likely to increase during the pandemic because of disruption to recovery routines and access to treatment.

“The people who were getting help aren’t really getting any help right now at all,” said Danny Pont, who is part of an opioid treatment program in Rhode Island. “I suspect there will be a lot of relapses — and with a lot of relapses, there’s going to be an uptick in overdoses.”

National Public Radio also reported that treatment options are even more scarce during the pandemic, with inpatient and outpatient programs ill-equipped to operate under physical distancing rules.

All of this and more is now happening. The Well Being Trust has forecast an additional 75,000 deaths from overdose, alcohol abuse and suicide resulting from the socioeconomic stress of the pandemic, so-called deaths of despair.

The American Medical Association is trying to “reignite the fight” against the opioid crisis amid Covid-19. The AMA is calling on states to adopt new federal rules for telemedicine prescribing; removing prior authorizations or step therapy for treating opioid use disorder; removing arbitrary barriers on dose, quantity, and refill requirements; and allowing harm reduction strategies.

But the federal and state response to Covid-19 is a fragmented patchwork of policies, according to The Atlantic. The country cannot even agree on whether or not the pandemic exists, let alone if people should wear masks in public or engage in social distancing. And the rapidly shifting outbreaks, hotspots and epicenters of the pandemic make what little agreement there is transitory at best.

Sadly, the American response to the pandemic echoes the response to the overdose crisis. Too little science and too much ideology muddies what should be a clearly focused public health effort. As a result, 2020 may become the worst year for the opioid 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.

CDC Study Finds ‘No Significant Change’ in Use of Rx Opioids

By Pat Anson, PNN Editor

A new study by CDC researchers has a surprise finding, concluding that there has been “no significant change in the use of prescription opioids” over the past decade by U.S. adults.

The study is based on the National Health and Nutrition Examination Survey, in which a nationally representative sample of nearly 20,000 adults is asked every two years about their healthcare and nutrition.

Although the number of opioid prescriptions in the U.S. has dropped 43% since their peak in 2011, the survey found that the use of opioid medication hasn’t changed much at all.  

In 2017–2018, the survey found that 5.7% of U.S. adults used one or more prescription opioids in the past 30 days, compared to 6.2% of adults a decade earlier.

“Between 2009–2010 and 2017–2018, no significant trend in the use of prescription opioids was observed; however, an increasing trend in the use of nonopioid prescription pain medications without prescription opioids was seen,” researchers found.

USE OF PRESCRIPTION PAIN MEDICATIONS BY U.S. ADULTS

SOURCE: CDC

In 2017-2018, women (6.4%) were more likely to be prescribed opioids than men (4.9%). The use of opioids increased with age, from 2.8% among young adults aged 20–39 to 8.2% for those aged 60 and over.

The use of opioid prescriptions was highest among whites (6.4%), followed by blacks (5.2%), Hispanics (3.4%) and Asian adults (1.4%).

The survey did not ask respondents about the dose of opioids they were prescribed, which may account for the discrepancy with other prescription drug databases.    

A 2018 study by the health analytics firm IQVIA found a significant decline in the number of high dose opioid prescriptions of 90 MME (morphine milligram equivalent) or more. But low dose prescriptions of 20 MME or less remained relatively stable.

While the percentage of Americans using opioid prescriptions has remained relatively flat over the past decade, according to the survey, there was a notable increase in the use of non-opioid prescription pain relievers, which rose from 4.3% in 2009-2010 to 5.7% in 2017-2018.

Migraine drugs, COX-2 inhibitors, and non-steroidal anti-inflammatory drugs (NSAIDs) were classified in the survey as non-opioid prescription pain relievers, but anti-depressants and anti-convulsants were not – even though they are increasingly used to treat pain. The IQVIA study found 67 million prescriptions for the anti-convulsant medication gabapentin (Neurontin) in 2018 — a fact that is not reflected in the CDC findings.

The CDC is currently preparing an update of its controversial 2016 opioid guideline, which has been widely adopted as policy by other federal agencies, states, insurers, pharmacies and many doctors — who have used it as an excuse to take people off opioids or greatly reduce their doses.

The updated guideline – which is expected in late 2021 -- is likely to expand the CDC’s recommendations to include the use of opioids for treating short-term acute pain.