FDA Approves Pain Reliever for Cats Considered Too Risky for Humans

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved a new medication to treat osteoarthritis pain in cats, the first monoclonal antibody drug approved by the FDA for use in any animal. The same type of drug has been rejected for use in humans because of safety risks.

Solensia (frunevetmab) is an injectable monoclonal antibody made by Zoetis that targets nerve growth factor (NGF), a protein that increases in animals and humans due to injury, inflammation or pain. Solensia is designed to bind to NGF and inhibit pain signals from reaching the brain.

Osteoarthritis (OA) is a progressive joint disorder that leads to thinning of cartilage and joint damage.  Feline OA is a common condition in older cats, but treatment options for them are limited, as they are for humans.

“Advancements in modern veterinary medicine have been instrumental in extending the lives of many animals, including cats. But with longer lives come chronic diseases, such as osteoarthritis," said Steven Solomon, DVM, director of the FDA's Center for Veterinary Medicine.

"Today's approval marks the first treatment option to help provide relief to cats that are suffering from this condition and may significantly improve their quality of life. We also hope that today's approval of the first monoclonal antibody by the FDA for any animal species will expand research and development of other monoclonal antibody products to treat animal diseases."

Safety Issues with NGF Inhibitors

Last year the FDA refused to approve tanezumab, a monoclonal antibody and NGF inhibitor, as a treatment for OA in humans after two of its advisory panels said the drug caused OA joint damage to accelerate. Rapidly progressing osteoarthritis (RPOA) was so severe that some patients in clinical trials had to stop taking the drug and needed total joint replacements.

The side effects of NGF inhibitors have been known for over a decade. The FDA slowed the development of NGF inhibitors in 2010 because of concerns they make osteoarthritis worse in some patients. But under pressure to approve more non-opioid pain relievers, the FDA allowed clinical studies of tanezumab to resume in 2015.

Eli Lilly and Pfizer invested heavily in tanezumab research, but ended their joint development of the drug in 2021 after the FDA and European Medicines Agency said they would not approve tanezumab for humans because of safety concerns.

In a press release announcing the approval of Solensia for cats, the FDA makes no mention of RPOA in its list of side effects, which includes vomiting, diarrhea, injection site pain, scabbing, dermatitis and itchy skin. The release said side effects were mild and did not require ending treatment during observational animal studies.  

In the FDA’s more detailed Freedom of Information Summary for Solensia, the agency said “RPOA has not been characterized or reported in cats,” but has this stark warning for humans who administer the drug:

“Women who are pregnant, may become pregnant, or are breastfeeding should take extreme caution to avoid accidental self-injection of Solensia. It is well-established that NGF is important in the normal development of the fetal nervous system, and laboratory studies in nonhuman primates have shown that human anti-NGF mAbs can cause reproductive and developmental toxicity. Fetal abnormalities, increased rate of stillbirths, and increased postpartum fetal mortality were noted in rodents and nonhuman primates receiving anti-NGF mAbs.”

Solensia is not recommended for pregnant or lactating cats. It will only be available by prescription from a licensed veterinarian who administers the injection monthly.

“The approval of Solensia is a significant step forward in the control of feline OA pain. Cat owners and veterinarians alike can feel confident that Solensia, with active substance frunevetmab, a monoclonal antibody (mAb) designed specifically for felines, has been studied and demonstrated to control OA pain and help cats get back to moving more freely again,” Mike McFarland, DVM, Chief Medical Officer for Zoetis, said in a statement.

The use of Solensia in cats was approved by the European Medicines Agency last year. The drug is expected to be available to U.S. veterinarians in the second half of 2022.

Study Finds Opioids Not Always Needed After Heart Surgery

By Pat Anson, PNN Editor

It’s become common in recent years for U.S. hospitals to reduce or even eliminate the use of opioids for post-operative pain. For the most part, these non-opioid policies only apply to “minimally invasive” arthroscopic or laparoscopic surgeries, in which small incisions are made and patients are often sent home from the hospital the same day.

A new study by researchers at the University of Michigan suggests that many patients who have more complicated and invasive heart surgeries may also be able to control post-operative pain without opioids after they are discharged.

“In some cases, patients assume that after surgery, especially a big operation like cardiac surgery, that they will need to go home with prescription pain medicine,” said Catherine Wagner, MD, a cardiothoracic surgery resident at University of Michigan Medicine. “This study shows that discharge without opioid pain medicine after cardiac surgery is extremely well tolerated by some patients. In other words, we should not be reflexively prescribing pain medicine to people after surgery just in case they need it.”

Wagner and her colleagues looked at for over 1,900 patients who had coronary bypass and/or heart valve repair surgery at Michigan hospitals in 2019. Both procedures require a sternotomy, in which a doctor uses a saw to cut through the breastbone (sternum), which is then spread apart to gain access to the heart. When the surgery is finished, doctors reconnect the sternum with stainless steel wires. Full recovery from a sternotomy will usually take months.  

The study findings, published online in The Annals of Thoracic Surgery, showed that more than one-fourth of the surgery patients (28%) did not receive an opioid prescription at the time of discharge and used non-opioid pain relievers instead. Researchers say not getting an opioid appears to have been “well tolerated” by these patients, because less than 2% needed an opioid prescription before their 30-day follow-up appointment.

The study did not look at patient outcomes, whether patients were satisfied with their pain management, or if patients who did receive opioids developed signs of addiction or dependence. But researchers concluded that opioids were often not necessary after heart surgery.

“These data suggest that not all patients require an opioid prescription after cardiac surgery and that discharge without an opioid prescription is well tolerated in select patients. Cardiac surgery providers should consider shifting focus from the amount of opioid to prescribe to patients to instead determine which patients do not need any opioid prescription at discharge,” researchers concluded.

Before concerns rose about opioid addiction and overdose, it was common for surgery patients to be discharged with 50 to 100 opioid pills. Many of those pills would go unused.

“One should consider if these opioid prescriptions were truly necessary for patient pain relief,” said Wagner. “Our study shows that, particularly for patients who did not take any opioids on the day before leaving the hospital, discharge without opioids is safe. I think we need to ensure that only patients who truly need opioids get sent home with a prescription.”

Patients rarely become addicted to opioids after surgery. A large 2016 study found that less than one percent of older adults were still taking opioid medication a year after major elective surgery.  Another large study in 2018 found only 0.6% of surgery patients prescribed opioids were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

A recent survey found nearly 8 out of 10 U.S. adults believe opioids are sometimes necessary to manage post-operative pain. Most people are more worried about treating surgical pain than they are about becoming addicted to opioids.

What’s Missing in ‘Opioids: The Big Picture’

By Roger Chriss, PNN Columnist

Canadian family physicians Mark Dubé and Henry Chapeskie recently created a video called “Opioids: The Big Picture” to give what they describe as a “short history of how we got into trouble with opioids, how even a small number of opioid pills can lead to addiction, and why they should not be used in non-cancer chronic pain.”

Drs. Dubé and Chapeskie spend the first third of their hour-long video on the history of opioids, mostly the 19th century Opium War in China, and the remaining time on modern prescription opioids. They refer to opioids as a “global environmental toxin” which cause “narcotic neurotoxicity.”

They also claim that opioid-induced hyperalgesia is common, that no studies show any benefit to opioids for pain management, and that opioids cause permanent brain damage. They argue that the current opioid crisis is driven by the steadily increasing supply of prescription opioids and should be addressed the way we handle air pollution. They conclude by saying that “opioids are neurotoxic, cause pain, and are toxic to the individual and society.”

None of this holds up well to close scrutiny. The Opium War was about more than a “state-sponsored monopoly with an illicit drug.” In fact, there were two Opium Wars, with the first being about trading rights, open trade and especially diplomatic status, and the second war directed at expanding trade, including opium, between Europe and China.

The notion that opioids are a “global environmental toxin” comparable to air pollution assumes exposure is passive and inevitable. But opioids are not like mercury or asbestos, emitted as a contaminant from industrial processes that could be cleaned up. Their claims about neurotoxicity are also problematic. Although small-scale imaging studies do show changes to some brain structures upon opioid exposure, the significance of this is unclear.

Their emphasis on opioid-induced hyperalgesia (OIH) – the theory that prolonged use of opioids leads to greater pain sensitivity -- is also greatly overstated. A 2021 review of published studies found only 72 patient cases of OIH, all of which were easily diagnosed and managed by opioid rotation, opioid cessation or switching to non-opioid pain medications.

Last and most important, Dubé and Chapeskie claim that “there is no evidence (zero!) to support use of opioids” for chronic non-cancer pain. They cite the 2018 SPACE trial as their major source of evidence, although that study showed opioids were no better or worse than non-opioids for pain relief. More importantly, the SPACE study didn’t find any evidence of abuse, misuse, addiction or overdose among the 108 people on opioids for a whole year, which argues against the very risks that Dubé and Chapeskie describe as inevitable.

Dubé and Chapeskie point to a single study on opioid tapering that showed good outcomes. That 2020 study found only minor improvement in cognitive function after opioid tapering. Multiple other studies show the risks and harms of tapering often outweigh its benefits, especially when tapering is rapid.

Moreover, there are clinical studies showing that opioids are effective and safe when used appropriately. A 2021 German study, for example, found that tapentadol relieves chronic low back pain, and a 2017 review found tapentadol was effective and well-tolerated by patients with moderate to severe pain for up to two years.

The video “Opioids: The Big Picture” could have been a useful introduction to opioid pharmacology, chronic non-cancer pain, and clinical practice. It could have introduced current best practices for opioid initiation and tapering. And if the focus was to be on the public health risks and harms of opioids, then it should have followed the fine work of David Courtwright's book "Dark Paradise”, Sam Quinones's "Dreamland”, or Chris MacGreal's "American Overdose".

It is unfortunate that even in the 2020s we are still struggling to get basic information about opioids right. This is arguably part of why we have a worsening opioid crisis and deteriorating pain management situation.

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.  

Gabapentinoids and Anti-Depressants Recommended for Diabetic Neuropathy

By Pat Anson, PNN Editor

People with painful diabetic neuropathy (PDN) should be treated with gabapentinoids, anti-depressants and sodium channel blockers, according to updated guidelines from the American Academy of Neurology (AAN). The guidelines also recommend some alternative treatments, such as ginkgo biloba, capsaicin patches and cognitive behavioral therapy, but strongly discourage the use of opioids.

The AAN’s new guidelines, published online in the journal Neurology, acknowledge that many of the recommended therapies for PDN don’t directly treat physical pain, but they improve mood and sleep, and that helps reduce “pain perception.”

“In treating patients with PDN, it is important to assess other factors that may also affect pain perception and quality of life. Patients with diabetes are more likely to have mood disorders (most commonly, major depression) and sleep disorders (especially obstructive sleep apnea) than the general population,” an AAN panel of experts found. “Therefore, treating concurrent mood and sleep disorders may help reduce pain and improve quality of life, apart from any direct treatment of the painful neuropathy.”

Nearly 26 million Americans have diabetes and about half have some form of neuropathy, according to the American Diabetes Association. PDN causes nerves to send out abnormal signals, causing patients to feel stinging or burning pain, as well as loss of feeling in their toes, feet, legs, hands and arms. More severe cases can result in ulcers or amputation of the affected limbs.

The last update to the AAN guideline was in 2011, when opioids such as morphine and oxycodone were said to be “probably effective and should be considered.” Much has changed over the last decade, and the AAN no longer supports their use for PDN.

"Current evidence suggests that the risks of the use of opioids for painful diabetic neuropathy therapy outweigh the benefits, so they should not be prescribed," said lead author Brian Callaghan, MD, an associate professor of neurology at University of Michigan Health.

‘Probably’ Better Than Placebo

The only oral medications the AAN now recommends for PDN are gabapentinoids (pregabalin and gabapentin); serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine; tricyclic anti-depressants such as amitriptyline; and sodium channel blockers such as valproic acid, which are usually used to treat seizures. An SNRI can also be combined with a weak opioid like tramadol for PDN.

There are caveats to all of these drugs since the evidence for them is limited and they were originally developed for other conditions such as depression or epilepsy. For example, the guidelines state gabapentin is “probably more likely than placebo to improve pain” and pregabalin is “possibly more likely” to help with PDN.

Topical medications such as capsaicin and buprenorphine patches also get the lukewarm endorsement of “possibly” being better than a placebo.

When one class of medication doesn’t work for PDN, experts say patients should try another.

“Managing expectations is also important,” Callaghan said. “Our second recommendation urges the provider to be frank with patients that the goal is to reduce their pain. It may not be possible to completely resolve the symptoms.”

A 2017 study by the Agency for Healthcare Research and Quality found that duloxetine (Cymbalta) and some other anti-depressants are moderately effective at relieving PDN, but found little or no evidence that opioids and gabapentinoids are helpful in treating neuropathic pain.

Researchers say a significant limitation for all pain relievers – not just opioids – is that few studies examine their safety and efficacy longer than three months. PDN is a progressive disorder that is likely to last a lifetime.  

“Given the chronicity of pain in those with diabetic neuropathy and the potential for evolving side effects, long-term studies are needed to better inform the long-term pain management in this population. Specifically, future studies should focus on the long-term effects (positive and negative) of opioids in this population to determine whether there is any role for these medications in this population,” the AAN’s expert panel concluded.

Supreme Court Case May Decide Future of Opioid Prescribing

By Pat Anson, PNN Editor

Over a dozen patient and physician advocacy groups have filed legal briefs with the U.S. Supreme Court in support of two doctors appealing their convictions for criminal violations of the Controlled Substances Act.

The nation’s high court has consolidated the cases of Dr. Xiulu Ruan of Alabama and Dr. Shakeel Kahn, who practiced in Wyoming and Arizona. Both doctors were sentenced to lengthy prison terms after being convicted on a variety of charges – including the prescribing of high doses of opioid pain medication to patients “outside the usual course of professional practice.”

Oral arguments will be heard by the Supreme Court on March 1, with a decision expected later in 2022. Monday was the deadline for interested parties to file “amicus curiae” briefs on the case, which could have a significant impact on opioid prescribing practices nationwide if the appeals are successful. Many doctors have stopped or reduced their prescribing of opioids because they fear being prosecuted under the Controlled Substances Act (CSA).

“It is no exaggeration to say that CSA prosecutions of physicians have already impaired the treatment of chronic pain,” Ruan’s attorneys said in their appeal. “In response to the opioid crisis, fear of prosecution has increasingly prompted pain management doctors to avoid or reduce opioid prescriptions, even when those decisions leave chronic pain patients without recourse.”

A successful appeal would mean Ruan and Kahn could ask for new trials, along with dozens of other doctors convicted of similar charges under the CSA.

“It will also avoid what I see as the chilling effect that it’s had on lots of doctors who are not doing anything even remotely suspicious, but are afraid that they are going to get caught because they prescribe a higher dose, and so they’re dropping people from care or tapering them,” said Kate Nicholson, Executive Director of the National Pain Advocacy Center (NPAC).

NPAC, along with other advocacy groups and the U.S. Chamber of Commerce, are asking the high court to clearly state how the practice of medicine should be regulated under the CSA. Some argued it is best left to state medical boards, not federal prosecutors or law enforcement.

“Patients with pain, addiction, or both desperately need appropriate care and treatment. If practitioners are held strictly liable under (the CSA), patient abandonment will become ever more common as practitioners act to avoid scrutiny,” Jennifer Oliva and Kelly Dineen, professors of health law and policy, said in their brief. “Progress in medical care in these areas can only recover if the regulation of medical practice is returned to the province of the states except in narrow circumstances.”

‘Good Faith’ Practice

At issue in the Ruan/Kahn case is what constitutes the “standard of care” and “usual course of professional practice” under the CSA. Doctors traditionally have been given wide latitude in determining what’s appropriate for a patient, as long as they act in “good faith” with a medical purpose. But that laissez-faire approach came to an end as the overdose crisis intensified and doctors came under more scrutiny for their opioid prescribing practices. 

“No other country criminalizes physician behavior like the federal prosecutors have done in the US. This is especially the case as these prosecutions are all based on a whim with an ‘expert’ opinion rendered by a hired government expert and orchestrated by a new generation of overzealous and unchecked federal prosecutors pointing fingers at wealthy doctors as greedy drug pushers and fraudsters,” Physicians Against Abuse argued in its brief.

“Doctors are just a ‘sitting duck’ for these federal prosecutors who raid medical offices and unlike the career drug pusher on the streets who gets caught and charged with one or two counts, federal prosecutors pile up count after count because doctors are required to keep records and those records are used against them in these out of control prosecutions against physicians.”  

Pain Clinic ‘Factory’

Complicating Ruan’s appeal is that he often gave patients Subsys, an expensive and potent fentanyl spray that was only approved by the FDA for breakthrough cancer pain. Ruan prescribed Subsys “off label” to patients who didn’t have cancer, which made him an easy target for federal prosecutors who were building a massive fraud and bribery case against Insys Therapeutics, the manufacturer of Subsys.

In his new book, “The Hard Sell: Crime and Punishment at an Opioid Startup,” author Evan Hughes depicts Ruan as a greedy and ruthless physician who was more interested in acquiring luxury cars and Insys stock than he was in treating patients. According to Hughes, Ruan and his business partner ran their pain clinic and adjoining pharmacy like a factory.

“Instead of collecting a mere $200 or so for an office visit, Couch and Ruan treated each patient as a profit center, an opportunity to bill for tests and procedures in-house, or to refer out to some other provider who would cut them in on the business. They reinvested to grow their factory, buying new machines that added lucrative capabilities,” Hughes wrote.

In addition to the charges against him under the CSA, Ruan was convicted of taking kickbacks from Insys in exchange for prescribing “massive quantities” of Subsys. Ruan was one of the top prescribers of Subsys in the United States.

Kahn was convicted of more than 20 counts involving excess prescribing of oxycodone and other controlled substances, and running a criminal enterprise that resulted in the death of a patient. When federal agents raided his properties in Wyoming and Arizona, they found firearms and over $1 million in cash.

Advocates hope the Supreme Court will overlook the seedier aspects of both cases and rule in a way that clearly defines the rights of doctors under the CSA to prescribe medications they deem appropriate.

“I think our biggest concern is having the correct standard moving forward so that doctors have space to practice medicine appropriately and patients stop suffering,” Nicholson told PNN. “My guess is that they’ll do something to clarify, but how objectively or subjectively they go, I think that’s anyone’s guess.”  

Steep Cuts in Opioid Prescribing ‘Raises More Questions’

By Pat Anson, PNN Editor

Several studies in recent years have documented how opioid prescribing has declined significantly in the United States, with per capita consumption of opioid medication recently falling to its lowest level in two decades.

For the first time, a new study by the RAND Corporation breaks the decline down by medical specialty, showing that some doctors may have gone too far in their effort to reduce opioid prescribing and lower the risk of abuse and addiction.

“Oftentimes when I do studies, I think we have a clear answer. This one in my mind raises more questions,” says Bradley Stein, MD, a senior physician researcher at RAND and lead author of the study published in the Annals of Internal Medicine.

Stein and his colleagues looked at opioid prescriptions filled at U.S. pharmacies in 2008-2009 and compared it to prescriptions filled in 2017-2018. Over that period, per capita morphine milligram equivalent (MME) doses for opioids fell by over 21% nationwide.

What surprised researchers is that many doctors treating patients with cancer pain, acute trauma pain or surgery pain significantly reduced their opioid prescribing even though most federal and state guidelines didn’t call for it.

The influential and much criticized 2016 CDC opioid guideline, for example, only applies to primary care physicians who treat chronic non-cancer pain. Yet emergency physicians, psychiatrists and oncologists cut their opioid prescribing significantly more than primary care providers and pain specialists.

MME Decline By Medical Specialty (2008 to 2018)

• -70% Emergency Physicians

• -67% Psychiatrists   

• -60% Oncologists  

• -49% Surgeons 

• -41% Dentists    

• -40% Primary Care Providers

• -15% Pain Specialists     

Stein attributes the steep decline in opioid prescribing not just to the CDC guideline, but to state regulations and insurance company policies. While some of the decline was appropriate, he thinks it may have gone too far.   

“There are probably populations where a decade ago, someone may have given 30 days of opioids, where maybe 3 days or 7 days would be fine. Or maybe they didn’t need to prescribe it at all,” Stein told PNN. “But there are other populations for whom several days of opioids may very well be appropriate. And those are individuals that probably we should not be seeing substantial decreases in. An example is individuals with late-stage cancer.”

The CDC guideline specifically says it is “not intended for patients undergoing active cancer treatment, palliative care, or end-of-life care.” But in practice, many of those patients are being forced to follow the CDC’s recommended dose limits. Some get no opioids for pain relief. A recent study in Oregon found a significant decline in opioids being prescribed to terminally ill patients being admitted to hospice care.

“The blunt policy approach that called for reduced opioid prescribing across-the-board clearly affected some medical specialties more than others. But even patients receiving palliative care have felt the negative impact of opioid policies that have lacked nuance and depth,” says Dr. Chad Kollas, a palliative care specialist in Florida who has called federal opioid policy an “abject failure” because it has not reduced overdose deaths. 

“Patients with cancer and sickle cell disease who are fortunate enough to have a palliative care physician still face challenges filling prescriptions for controlled pain medications at many pharmacies.” 

PNN readers may be familiar with the story of April Doyle, a terminal breast cancer patient who posted a tearful video online after she was denied opioids at a Rite Aid pharmacy in 2019. Doyle went to another pharmacy and her prescription was filled, but only after a lot of unnecessary physical and emotional pain. She died the following year. 

Geographic Variability

Another surprise uncovered by RAND, a nonprofit research organization, is the extreme variability of opioid prescribing from state to state and county to county.

The map below shows a checkerboard pattern across the United States, with counties in blue showing a 50% or more decline in opioid prescribing, and counties in red showing a 50% or more increase from 2008 to 2018.

Change in County Per Capita MME (2008-2018)

RAND CORPORATION

Per capita opioid prescriptions declined the most in large metropolitan counties (-22.6%) and in counties with higher rates of fatal opioid overdoses (-34.6%).

But even in states that were hit hard by the opioid crisis, such as West Virginia, Ohio and Kentucky, there are blue counties where prescribing fell significantly right next to red counties where opioid prescriptions spiked. Kansas and Missouri have more red counties than blue.  

“It was eye-opening to see the variation across states and counties,” said Stein. “We’re seeing variation by payer. We’re seeing variation by community. We’re seeing variation by type of prescriber. And I think this is a reminder to us all that this is probably an issue where one-size-does-not-fit all.  

“And I think coming to a better understanding of that will help us make sure that while we’re appropriately decreasing the amount of opiates being prescribed for people whose pain we can manage effectively in different ways, the decrease has been greater than it needs to be for some populations. We need to make sure that people who need adequate pain management get it.”

The RAND study was funded by grants from the National Institutes of Health.

Does Childhood Trauma Increase Risk for Opioid Misuse?

By Pat Anson, PNN Editor

Did a parent humiliate or swear at you as a child? Were you ever molested? Did you live with a problem drinker or someone who went to prison? Were your parents ever separated or divorced?

Those are some of the questions posed to over 1,400 college students in a study by researchers at the University of Georgia, who wanted to assess the relationship between childhood trauma and the misuse of prescription opioids later in life.

Their research, recently published in the Journal of American College Health, found that most students had at least one adverse childhood experience (ACE). But those who reported four or more ACEs were almost three times more likely to misuse opioid medication.

Based on that finding, the researchers say healthcare providers should consider a patient’s experience with childhood trauma before prescribing them opioids.

“Our findings suggest need to include assessment of ACEs as a screening criterion for opioid prescription and administration among college-aged individuals,” wrote lead author Janani Thapa, PhD, an associate professor in UGA’s College of Public Health.

Many doctors already use screening tools to assess whether a patient is at risk for opioid misuse. They look up their prescription drug history, or ask patients if they’ve been sexually abused or have family members with a substance use disorder.

But Thapa and her colleagues think that assessment should go further, incorporating a wider range of childhood trauma, such as whether a patient didn’t have enough to eat or had to wear dirty clothes as a child.  

“Prevention of opioid misuse demands careful consideration of the traumatic exposure of the patient,” they said. “Current opioid assessment measures, including patient or family interviews, and prescription monitoring, may need to incorporate patients’ traumatic history for proper chronic pain management and integrated care.”

Penalizing Patients

The use of opioid screening tools is controversial. Some patients resent being asked about their childhood trauma – which they see as irrelevant to their health problems and pain management as adults.   

“I overcame my early life abuse until an ignorant doctor used that childhood abuse without psychiatric consultation to put labels on me and refuse medicine for pain,” one patient told us.

“Just because a patient may have been sexually abused or has family members who are addicts/alcoholics, does not mean the patient will be,” said another. “To penalize a person who is in excruciating pain due to no choice of their own, is cruel and inhumane.”

But a pain management expert says opioid screening tools have their place, because childhood trauma can have a lasting impact. 

“Most studies have shown that 4 in 5 people with an Opioid Use Disorder have at least one ACE,” says Lynn Webster, MD, past president of the American Academy of Pain Management and a PNN contributor. “I consider ACEs a form of post-traumatic stress disorder. It affects emotion regulation, causing an inability to modulate distressing emotions in a healthy and adaptive way. ACEs create a maladaptive response to stress. The earlier in life the ACEs occur, the more effect they will have later in life.” 

Over 20 years ago, Webster developed one of the first opioid screening tools for doctors, a short survey that asked patients if they had a history of substance abuse, sexual abuse, or any mental health issues. In his own practice, Webster found the survey helpful in identifying patients at risk of abusing opioids, but he later came to regret how the screening tool was “weaponized” against patients, particularly women, and used by other doctors as an excuse to deny patients opioids. 

“The Opioid Risk Tool (ORT) incorporates pre-adolescent trauma to help identify females who were at greater risk of OUD from what I believe is a form of PTSD. If I were to develop the tool today, I would probably make it gender neutral, but the increased risks for females would remain,” Webster said in an email. 

Webster agrees with the University of Georgia researchers that ACEs should be used to help assess whether a patient is at risk of abusing medication. But he says a high number of ACEs should not be used to avoid prescribing opioids to someone who has a medical need for them.  

Illicit Drug Use by Teens Fell Significantly in 2021

By Pat Anson, PNN Editor

Substance abuse by U.S. teenagers declined significantly this year, according to the results of a new national survey that found the use of prescription opioids by adolescents fell to the lowest level in nearly two decades.

Illicit drug use by 10th graders fell by nearly 12 percent in 2021, and by about 5% for eighth and 12th graders. The findings represent the largest one-year decline in illicit drug use by teens since the Monitoring the Future survey began in 1975.

The study by University of Michigan researchers found that teenagers reported increased feelings of boredom, anxiety, depression and loneliness in 2021 – no doubt fueled by pandemic-related fears and isolation. But unlike their adult counterparts, young people overall did not increase their use of marijuana, alcohol and other drugs.

“We have never seen such dramatic decreases in drug use among teens in just a one-year period. These data are unprecedented and highlight one unexpected potential consequence of the COVID-19 pandemic, which caused seismic shifts in the day-to-day lives of adolescents,” Nora Volkow, MD, Director of the National Institute on Drug Abuse, said in a statement.

“Moving forward, it will be crucial to identify the pivotal elements of this past year that contributed to decreased drug use – whether related to drug availability, family involvement, differences in peer pressure, or other factors – and harness them to inform future prevention efforts.”

The Monitoring the Future survey is given annually to students in eighth, 10th and 12th grades, who self-report their drug use behaviors and attitudes. The results from this year’s survey were collected from February through June 2021. Over 32,000 students enrolled in 319 public and private schools in the U.S. participated, with some taking the survey at home and others while at school.

The percentage of students who reported using any illicit drug other than marijuana within the past year decreased significantly. Among 12th graders, for example, 7.2% reported using an illicit drug in 2021, compared to 11.4% in 2020.

Decreases were also reported in the use of alcohol by 12th graders (46.5% in 2021 vs. 55.3% in 2020) and in marijuana (30.5% in 2021 vs. 35.2% in 2020).

Significant declines in use were also reported by students in 2021 for a wide range of drugs, including cocaine, heroin, hallucinogens, cigarettes and nonmedical use of amphetamines, tranquilizers, and prescription opioids.

The decline in drug use by teens is not a one-year fluke and is part of a long running trend. For example, the use of Vicodin by 12th graders has fallen by nearly 92 percent since its peak in 2003. The use of OxyContin has declined by 83% since its peak in 2005.   

MONITORING THE FUTURE SURVEY

“In addition to looking at these significant one-year declines in substance use among young people, the real benefit of the Monitoring the Future survey is our unique ability to track changes over time, and over the course of history,” said Richard Miech, PhD, who led the Monitoring the Future study at the University of Michigan. “We knew that this year’s data would illuminate how the COVID-19 pandemic may have impacted substance use among young people.”

Not all the news is good. The researchers found that adolescents who suffered severe stress, anxiety or depression due to the pandemic, experienced financial hardship, or whose parents used drugs were most likely to use drugs themselves.

Other studies have found that adults who regularly use recreational drugs increased their drug usage during the pandemic. A new study of alcohol sales in 16 U.S. states found a major increase in wine and liquor sales in the first few months of the pandemic, by as much as 20 to 40 percent in some states.

Another recent study found that opioid prescribing briefly increased in the early stages of the pandemic, as patients postponed corrective procedures and it became harder to obtain non-opioid therapies for pain such as massage and physical therapy. Opioid prescribing returned to previous levels after a few months.   

The CDC announced last month that the U.S. has seen over 100,000 drug deaths in the 12-month period ending in May, 2021. The record-high spike in overdoses is thought to be primarily a result of pandemic lockdowns and the continuing spread of illicit fentanyl.   

Gabapentin Is Not a Good Substitute for Rx Opioids

By Crystal Lindell, PNN Columnist 

Gabapentin (Neurontin) is not a good medication for pain relief. If it was, everyone in pain would just take it. 

A lot of doctors seem to think it is a direct substitute for opioids though. And it’s leading to a lot of suffering. 

A doctor first gave me gabapentin back in 2012. That’s when I started having debilitating pain around my right ribs. I didn’t know it yet, but it was the kind of pain that would never go away.

At the time, I was extremely uninformed on how I’d be treated as a patient with no known cause for my pain. I assumed that because I could point to exactly where the pain was coming from that the doctors would be able to figure out the cause and then fix it. That’s what always happened on House, ER, Scrubs, Grey’s Anatomy, and General Hospital.

When that didn’t happen, I still assumed my doctor would believe me. That, while I sat there crying in his office, confessing my plan to kill myself to escape the pain, at the very least he would give me the most effective medication he knew of for treating the pain. 

I was wrong on all accounts.  

While my doctor pretended he was giving me the most effective medication he knew of, he instead handed me a prescription for gabapentin. 

And I took it. Exactly as prescribed. 

He never went over side effects with me, and the list on the pharmacy pamphlet was so long that I assumed most of them were rare. So when I started gaining weight, I blamed it on being home and in pain all the time.  

When gabapentin didn’t help with the pain, I went back to my doctor and told him as much. He increased the dose, while assuring me that that was all that was needed. 

Wash, rinse, repeat, until I was on the highest allowable dose. Still with no relief. 

And to be clear, the pain was awful. It was worse than whatever you just thought of. And it was constant. That’s the killer. It never let up. I never got a break. I’d go days without even minutes of sleep because the pain kept me awake. 

The pain was so bad that suicide became a logical treatment option. What’s the point in living a life with no quality in it?

I started showing up at my doctor’s office when they opened, in tears after being awake all night in excruciating pain, asking for help. Still giving my doctor 100 percent of my trust. Still assuming he had my best interest in mind.  

I remember sitting on the exam table, wanting to die, while my friend who had driven me to his office at 7 a.m. held my hand. I begged my doctor for help. And he said, “Well what do you want me to do? I can’t up your gabapentin prescription any more. You’re on the max dose.” And then he sent me home. 

I didn’t even know enough about pain management at that point to want opioids, much less to know they were being denied to me. I didn’t know the doctors were prescribing a seizure medication because of opioid phobia. 

Not long after that, my doctor would break up with me. Or, well, whatever you call it when a doctor says he will no longer treat you and then follows it up with, “So don’t come in anymore.”

He literally gave up. And I would have too, if my pain had gone on much longer. 

‘Opioids Saved My Life’

Eventually, I found a new doctor at a university hospital. He believed me. He prescribed me enough opioids to function. And that’s literally the reason I’m still here. 

Opioids saved my life. In many ways, gabapentin almost took it. 

But it also did something else. It destroyed my trust in doctors and medical professionals. If they could look me in the eye while handing me a prescription they knew wouldn’t help me, what else could they lie about? What else were they hiding from me?

Back then, prescribing gabapentin in place of opioids was a relatively new practice. After that experience, I had hoped it would go away. Instead, it gained traction. 

According to data from IQVIA, gabapentin was prescribed over 33 million times in the U.S. in 2011, which is about the time opioid prescriptions peaked. By 2018, the number of prescriptions for gabapentin had increased to over 67 million. 

Anecdotally, a lot of people I know with various pain ailments have been offered gabapentin in place of opioids by their doctors as recently as this year.

Since I’m so open when discussing my health issues, it’s common for people I know to ask what my experience was like on various medications. I never know what to tell them when they ask about gabapentin. I’m too worried about being wrong to warn them off of it completely. After all, what if it helps them? I don’t want to keep them from anything that might relieve their pain.

Doctors don’t seem to grapple with this though. For them, addressing patient pain has moved over into optional, right alongside unnecessary cosmetic surgery.

They are literally doing harm. And the practice of giving unproven medication out for pain continues.

Here’s a 2019 article by The New York Times detailing this problem, and the lack of evidence supporting the use of gabapentin for pain.

“One of the most widely prescribed prescription drugs, gabapentin, is being taken by millions of patients despite little or no evidence that it can relieve their pain,” wrote columnist Jane Brody.

In other words, it’s been two years since The New York Times made this clear, but doctors are still prescribing it for pain.

That article misses one key point though. Brody says there are non-gabapentin alternatives to opioids that help pain, but then goes on to list “physical therapy, cognitive behavioral therapy, hypnosis and mindfulness training.”

As a pain patient, I’m here to tell you that none of those are real alternatives to opioids either. While they can all be helpful tools, they can’t replace opioids for real pain relief.

Which brings us to the problem. Our society, with guidance from the CDC, decided to take away everyone’s opioids – without having a real plan to replace them. Because there are no alternatives as good as opioid pain medication.

The general public might worry about their pain treatment if the CDC admitted that. So instead, we are sold a lie about gabapentin. We are told it is just as effective as hydrocodone for all sorts of pain, and that anyone who insists on opioids is just looking to get high.

No matter how much people use gabapentin, physical therapy and mindfulness to treat pain, they just don’t work the way opioids do.

Opioid-phobia is a big messy topic, and doctors replacing opioids with gabapentin are just one small part of that story. But for people who are suffering because of their doctor’s overreliance on gabapentin, it often feels like the most important part. 

There’s such an easy answer to this problem too: Just give people opioid medication. When used responsibly, it’s incredibly safe, cheap, and best of all, it actually works.

Crystal Lindell is a journalist who lives in Illinois.  After five years of unexplained rib pain, Crystal was finally diagnosed with hypermobile Ehlers-Danlos syndrome.

How to End the ‘Opioid Paradox’

By Pat Anson, PNN Editor

Three public health and pain management experts are calling for a major shift in strategy to combat the U.S. opioid crisis, one that doesn’t just focus on pill counts and punishing doctors deemed to be “overprescribing” opioids.

In an op/ed recently published online in Anesthesiology, the official journal of the American Society of Anesthesiologists, Editor-in-Chief Evan Kharasch, MD, Editor J. David Clark, MD,  and former U.S. Surgeon General Jerome Adams, MD, said current policies are failing to address what they call the “opioid paradox” --- how opioid overdose deaths have risen to record levels even as opioid prescribing has fallen to 20-year lows.

SOURCE: ANESTHESIOLOGY

“Overall, the nation’s response to the oral opioid crisis has been to tighten patient supplies and impose institutional and practitioner quality indicators based on pill counts. Governments, payers, and pharmacies have assumed authority for limiting opioid prescribing, often in indiscriminate ways, based on misinterpretation of Centers for Disease Control guidelines or based on no real guidance at all,” they wrote.

“Pill counts have become de facto standards employed by healthcare organizations to highlight their success in reducing opioid use, yet there is no discussion of how those reductions are affecting patient outcomes. One crucial problem is that agencies mandating policy restrictions do not measure, nor are they accountable for, patient outcomes. Mandated opioid prescribing limits may be too low to adequately control pain, or too high to reduce oversupply.”

The three authors say more novel and comprehensive approaches are needed to better manage the supply of prescription opioids, prevent diversion and address the opioid paradox.

“It involves immediate action to address opioid use, storage, return, and harm reduction, with a specific focus on patients and communities,” they explained.

Reduce Demand

In recent years, federal and state agencies, healthcare organizations and insurers have created new guidelines for treating pain – many of which take a one-size-fits-all approach to opioid prescribing that doesn’t take into account an individual patient’s needs.   

“Legislative, regulatory, and insurer limitations on opioid prescribing alone have not met their intended goals and are considered unlikely to achieve them. One reason is that they impose tight restrictions on an extremely heterogeneous patient population,” the authors said.

Rather than limiting or withholding opioids after surgery – which has become increasingly common --  Drs. Kharasch, Clark and Adams urge anesthesiologists and surgeons to provide patients with enough opioids for adequate pain relief, because undertreated acute pain can turn into chronic pain and become a risk factor for opioid misuse.

Smaller opioid doses may be effective in treating postoperative pain, the authors said, if they are combined with multimodal strategies that also employ non-opioid medications and therapies. So too may the use of longer-acting opioids such as methadone, which can result in less postoperative pain and relief that lasts for weeks or months after a single dose.

Proper Disposal of Leftover Pills

Hundreds of millions of opioid pills are dispensed to patients but go unused each year, according to the authors. Most leftover pills are kept by patients and few are safely stored. Only a fraction are disposed of properly or returned.

"The current difficulty of returning prescription opioids contrasts markedly with the ease of obtaining them. This is illogical and unsafe," Drs. Kharasch, Clark and Adams said.

They believe pharmacies that dispense opioids should be required to provide patients with instructions for proper return and disposal; the addresses and telephone numbers of disposal stations; and a pre-addressed, prepaid envelope for returning unused pills. Disposal stations should be available year-round, not just on “Prescription Drug Take Back” days.

Another novel approach would be opioid “buy-back” programs, similar to the gun buy-backs used by law enforcement agencies to get unneeded firearms off the street. One pilot compensation program for opioids found that 30% of surgery patients were willing to participate in buy-backs, selling their leftover opioids for up to $50.

Partial Fills

Kharasch, Clark and Adams also suggest more partial filling of opioid prescriptions. A 2016 federal law allows both patients and clinicians to request partial filling of prescriptions for hydrocodone, oxycodone and other strong Schedule II opioids. Partial filling for schedule III–V weaker opioids has been permitted for decades, but is not widely practiced.

According to one estimate, 36 million postoperative opioid prescriptions could be partially filled each year. One hurdle for partial fills is the extra paperwork and cost to pharmacies, estimated at $15 for each prescription.

“Partial opioid fills could be the single most effective intervention to deplete America’s medicine cabinets of unused prescription opioid pills, shrink the opioid pool, improve the prescription opioid ecosystem, and prevent misuse, diversion, and death,” the authors said. 

Kharasch, Clark and Adams place an emphasis on reducing diversion, even though less than one percent of legally prescribed opioids are diverted, according to the DEA. Partial fills may reduce leftover pills in medicine cabinets, but they won’t do anything to prevent the wholesale theft of opioids from hospitals, pharmacies and the pharmaceutical supply chain.

The authors also buy into the myth that most street drug users start with prescription opioids, and that pain patients denied opioids “switch to illicit drugs” and fentanyl-laced counterfeit pills.

But Kharasch, Clark and Adams do have some interesting ideas about addressing the opioid paradox – chief among them the long overdue recognition that current opioid reduction strategies have been a complete failure.

“Attempts to solve the problem by restricting patient supply alone have not succeeded, and the prescription opioid pool remains large. Additional novel efforts to shrink the pool are needed, both by diminishing demand (reducing pain through better treatment) and by facilitating opioid disposal and return,” they concluded.

Little Evidence Opioid Use by Children Leads to Addiction

By Pat Anson, PNN Editor

Healthcare providers have become more cautious in recent years about giving opioid pain medication to children, fearing that even short-term use could lead to a lifetime of addiction or even a fatal overdose.

But in a review at the University of Alberta, pediatric researchers found little evidence to support a link between short-term opioid use in childhood and opioid use disorder (OUD) later in life.

“We actually didn’t find a lot of evidence to directly answer our question,” said senior author Michele Dyson, PhD, assistant professor of pediatrics in the Faculty of Medicine & Dentistry and associate director of the Alberta Research Centre for Health Evidence.

“If opioids are used as indicated, they can be a safe and effective strategy for pain management,” she said. “In some cases, they really are part of the best treatment plan to manage a child’s pain.”

Dyson and her colleagues reviewed 21 observational studies involving nearly 50 million patients under the age of 18 who were exposed to opioids for less than 14 days. Most of the studies were considered low quality and did not look at the duration of opioid use.

One study did show a potential link between short-term exposure and later abuse. But researchers concluded the findings overall were not definitive because they did not specify duration of exposure or lacked a control group. Their findings are reported in the journal Pediatrics.

“There is limited evidence to determine if short-term therapeutic exposure to opioids in childhood is
definitively associated with future nonmedical opioid use or development of an OUD; however, this review suggests a link between lifetime therapeutic opioid use (unknown duration) and nonmedical opioid use. The existing evidence on risk factors for nonmedical opioid use or OUD after short-term therapeutic exposure is unclear,” researchers concluded.

Conflicting Advice

Whether opioid medication is appropriate for children is a controversial issue. Earlier this year, the World Health Organization (WHO) released new guidelines recommending that opioids only be used for children who are dying or seriously ill and not expected to recover.

Like the Alberta study, a WHO advisory panel found little good quality research on how to treat childhood pain, but recommended that children with chronic pain be treated with physical therapy and psychological interventions such as cognitive behavioral therapy.  

An international study in The Lancet came to a very different conclusion, warning that opioid prescribing guidelines intended for adults are being “inappropriately applied to young people.” Because of the stigma associated with opioids, researchers said childhood pain was often untreated or poorly treated, leading to chronic pain, disability and other negative consequences in adulthood.

“Health-care professionals, young people, and parents continue to hold misconceptions and believe myths about opioid use in pediatric patients, whereby the media depicts opioids as the villain and the underlying reason for substance misuse,” researchers said. “Opioids have their place in pediatric pain medicine.”

That finding is at odds with a 2018 warning from the U.S. Food and Drug Administration, which said that cough and cold medications containing opioids pose “serious risks” to children and should no longer be prescribed to patients younger than 18.

A recent study found that opioid misuse is relatively rare in U.S. adolescents and young adults. Less than 1% of those who filled an opioid prescription for the first time overdosed or developed opioid use disorder within the next 12 months.

The conflicting advice can be confusing to both parents and providers.

“Parents see stories about overdoses in the news and are afraid for their children, while physicians and prescribers are also worried because they don’t know what the evidence is,” says Dyson. “Health-care providers don’t want to cause harm, and at the same time, they still want to be able to treat pain appropriately.”

Dyson and her team at the University of Alberta have developed a series of infographics to help physicians, parents and young people recognize that opioid pain relievers are sometimes needed.

One such graphic plainly states: “Opioids don’t have to be scary!”

View fullsize

UNIVERSITY OF ALBERTA INFOGRAPHIC

“While we can’t say for sure that a short-term prescription for pain is linked with misuse, there is some evidence that that could happen,” she explained. “There is likely some risk, but it needs to be balanced with the harms of stigmatizing opioid use and under-treating pain, which comes with its own significant short- and long-term consequences.”

Are You in Palliative or Curative Care?

By Dr. Forest Tennant, PNN Columnist

If you are in medical treatment for a chronic disease, you are either in curative or palliative care. Every patient with intractable pain syndrome (IPS), their family and physicians need to be very clear as to which category they are in.

A major reason that IPS patients can’t get the help they need is because they have not made the determination and been declared to be in palliative care. If you are not in palliative care, you may be restricted from obtaining certain drugs, dosages and financial benefits you need for your well-being. 

What is Curative Care?

Curative care is treatment that is focused on resolving a specific disease or disorder that is causing symptoms such as pain, fatigue, depression or physical impairments. Treatment can be directed either at total or partial cure of the disease or disorder.

What is Palliative Care?

Palliative care is symptomatic treatment to provide relief and quality of life to someone with an incurable condition. Palliative care will also hopefully prevent an incurable disease or disorder from worsening and causing further complications.

There are two reference books published for physicians so they can quickly look up the latest on diagnosis and treatment.  Their definitions of palliative care are given here to help all parties know which care -- palliative or curative --- best fits any given patient.

“Palliative care is medical care focused on improving quality of life for people living with serious illness. Serious illness is defined as a condition that carries a high risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms, treatments and caregiver stress.” -- Current Medical Diagnosis and Treatment

“Palliative care is treatment that is focused on pain and symptom management as well as quality of life for patients and their families. It can be rendered at any point in the course of treatment of illness, whether that illness is life threatening or not.” – Current Therapy

The World Health Organization defines palliative care as “prevention and relief of suffering in adults or pediatric patients and their families facing the problems associated with life-threatening illness.”

Misconceptions About Palliative Care

There are many misconceptions about what qualifies a patient to be palliative care. Here are just some of the common misconceptions and fallacies:

• Must be at “end-of-life.” No! An incurable disease may occur at any age.

• Must be in a hospice. No!

• Must be on Medicare. No!

• Must be in a nursing home, assisted living or hospital. No!

• Must have cancer. No! Palliative care applies to any incurable disease.

• Must enroll in a program called “palliative” or with a “palliative care organization.” No!

• Must go to a doctor who specializes in palliative care. No!

• Palliative care requires the patient to have a permit or certificate. No!

Even though there are some physicians and programs that specialize in palliative care, any MD or DO can declare a patient to be “palliative” and provide the necessary medication for relief of pain and other symptoms.

You may have to be declared to be in “palliative care” and have it stated in your medical record, so that you can obtain the medications and dosages to adequately relieve your pain. Federal guidelines specifically exempt palliative care patients from a recommendation that daily opioid doses not exceed 90 milligrams morphine equivalence (MME). If you have not been declared to be in palliative care and it isn’t in your medical record, your opioid dosage may be reduced. 

Presenting Your Case for Palliative Care

In order to obtain proper care and necessary medications in today’s healthcare system, you will likely need to be declared “palliative” by one of your personal physicians. This declaration will need to be recorded in your medical record and all concerned parties informed of it. Your pharmacy, insurer, laboratory and other healthcare providers should all be told that you are in palliative care.  

Most IPS patients need palliative care and meet the necessary requirements to be declared as palliative. One of your doctors needs to simply write into your medical record the name of your incurable disease, and that your treatment will focus on symptom management, comfort and quality of life. There is no requirement to state how long you may live.

The only required documentation is a written chart note in your medical record by a licensed physician in your state. They will need to state the specific name of your incurable disease and that you are in palliative care.

Every IPS patient and family needs to determine whether their treatment needs to be palliative or curative.  While everyone would like a cure, this may not be practical or possible.  What evidence or experience tells you that you can achieve a cure?  It may be depressing to recognize that a complete cure is not possible, but you must face reality.

Keep in mind that an incurable disease and pain doesn’t have to keep you from having a meaningful, productive and good quality of life. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here. The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

Does U.S. Have Opioid Crisis or Overdose Crisis?

By Pat Anson, PNN Editor

A lot of people were surprised by an alarming report from the CDC last week, showing that a record 100,306 Americans died of a drug overdose in the 12-month period ending in April, 2021. That’s a 28.5% increase in a single year.

Among those who were caught off-guard was Andrew Kolodny, MD, an opioid researcher at Brandeis University and founder of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

“I was surprised by the latest tally from the CDC showing that for the first time ever, the number of Americans who fatally overdosed over the course of a year surpassed 100,000,” Kolodny wrote in an op/ed for The Conversation that’s been republished in several major newspapers.

“The soaring death toll has been fueled by a much more dangerous black market opioid supply. Illicitly synthesized fentanyl – a potent and inexpensive opioid that has driven the rise in overdoses since it emerged in 2014 – is increasingly replacing heroin. Fentanyl and fentanyl analogs were responsible for almost two-thirds of the overdose deaths.”

It’s refreshing to see Kolodny finally address the elephant in the room – illicit fentanyl – instead of always blaming prescription opioids for America’s addiction and overdose problem. But he continues to frame the drug crisis as an “opioid crisis” when repeated studies show that multiple substances are usually involved in overdoses, including non-opioid drugs like cocaine and methamphetamine.  

“It is especially tragic that these deaths are mainly occurring in people with a disease – opioid addiction – that is both preventable and treatable. Most heroin users want to avoid fentanyl. But increasingly, the heroin they seek is mixed with fentanyl or what they purchase is just fentanyl without any heroin in the mix,” Kolodny wrote.

“Opioid-addicted individuals seeking prescription opioids instead of heroin have also been affected, because counterfeit pills made with fentanyl have become more common.”

Here Kolodny sidesteps the fact that many pain patients are turning to street drugs because of government and law enforcement policies that restrict the prescribing of opioid medication – policies that Kolodny and PROP had a significant role in creating. They’re not addicts “seeking prescription opioids instead of heroin.” They’re patients seeking pain relief.

“Our misdirected efforts to solve the overdose epidemic have led to even more deaths. As long as we myopically focus on reducing prescription opioids for people in pain, the overdose epidemic will continue and worsen,” says Lynn Webster, MD, a pain management expert, Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript.  

“Some of those who need opioids will be driven to the streets where they will find illicit and, potentially, lethal opioids. Some people may even choose to end their own lives. Your readers may have seen the recent article that described a suit against a physician for denying opioid treatment of a patient. The patient committed suicide as a result.” 

Webster says it is wrong to single out opioids – legal or illicit – for America’s escalating drug problem when the causes are complex and embedded in society. 

“We do have an overdose epidemic. Unfortunately, policymakers and the media have wrongly categorized it as an opioid epidemic rather than a drug overdose epidemic,” says Webster. “The roots of the overdose crisis are deep and seeded in despair from major shifts in socioeconomic conditions and lack of adequate and affordable healthcare. The Covid pandemic has made clear that social and mental health issues must be addressed if the overdose crisis is to be reversed. 

“The only solution to the overdose epidemic is to lower the demand. This will require a broad approach that involves addressing socioeconomic and mental health drivers of demand. More affordable and accessible treatment is important but will not solve the crisis.” 

Invested in Opioid Crisis 

Changing the narrative about the overdose crisis won’t be easy, since so many lawyers, politicians, healthcare companies and media outlets have invested in perpetuating the “opioid crisis.” Kolodny and other PROP board members have lucrative side hustles testifying as expert witnesses in opioid litigation cases for plaintiff law firms, which stand to make billions of dollars in contingency fees if their lawsuits are successful. 

One such case was decided by a federal jury in Cleveland today, which found that Walgreens, CVS and Walmart substantially contributed to addiction and overdoses in two Ohio counties by dispensing opioids in their pharmacies. The companies said they would appeal. 

“Plaintiffs' attorneys sued Walmart in search of deep pockets while ignoring the real causes of the opioid crisis-such as pill mill doctors, illegal drugs, and regulators asleep at the switch,” Walmart said in a statement. “And they wrongly claimed pharmacists must second-guess doctors in a way the law never intended and many federal and state health regulators say interferes with the doctor-patient relationship.”

Judges in Oklahoma and California recently ruled that opioid manufacturers are not “public nuisances” and can’t be held responsible for what people ultimately do with their drugs.  

Do You Get Adequate Pain Management?

By Victoria Reed, PNN Columnist

For the last few weeks, I’ve been suffering from persistent sinus and dental pain. Sinus pain is not new to me, as I have long-standing allergies which cause swelling in the nasal passages and chronic congestion that sometimes leads to an infection. The medications that I take for my rheumatoid arthritis increase the risk for all types of infections, as they suppress the immune system.  

After seeing a doctor, a sinus infection was diagnosed. Towards the end of a course of antibiotics, I had marked improvement with the sinus symptoms, but was still having considerable pain when chewing, which radiated to my right ear and jaw.  

Initially, I assumed that the pain was related to the sinus infection, but when that didn’t go away after finishing the antibiotics, I made an appointment to see my dentist. He did the usual poking and prodding around my gums and teeth, trying to find the source of the pain, and discovered two areas that could be the culprits. He did a flushing procedure of the gums to try to alleviate the pain. 

However, after the procedure was completed, I had such severe pain that all I could do was hold my head in my hands, while tears seeped out of my eyes. The pain was as bad as the pain I had felt while giving birth without an epidural! 

After more than a few minutes, my face and jaw continued to throb and the pain had not subsided. The dentist could see that I was in quite a bit of distress. He then asked me what the pain level was before I had come in. I replied that it had been a 5, but “now it’s a 10.”  

He sat down beside me and tried to explain what he believed the problem was. It was hard to concentrate, but I was able to understand what he was saying. He told me that he thought a tooth was cracked and that I needed to see an endodontist, a root canal specialist. He also prescribed another antibiotic.  

The dentist then stood up and patted me on the shoulder with compassion. Clearly, he was sorry for having amplified my pain. I appreciated his compassion, but I was ready to leave. At that point, all I wanted was to move on to whichever provider could relieve the awful pain.  

Then, to my surprise, I was offered opioid pain medication! 

This was something I absolutely did not expect. I had root canals for severe infections in the past, but no prescription opioids had been offered and I was sent home with instructions to take over-the-counter pain relievers. The days of getting opioid medication for severe dental pain were over, I assumed.  

However, after my initial shock, I politely declined the prescription. Why? Because I already receive a mild prescription opioid for my chronic pain conditions. Sure, I could have taken the prescription and not said a word about that, but I knew that I should honor the pain management contract I had signed with my doctor.  

While I believed that a stronger medication would have been helpful for my tooth pain, I did not want to risk being ejected from my pain management program. My contract (and nearly all pain management contracts) explicitly states that I am not allowed to receive any additional opioids from any other provider.  

I turned down the possibility of immediate relief of my dental pain so that I wouldn’t lose my regular prescription for chronic pain. I felt that I had no other choice. In addition, I didn’t want to be “red-flagged” by the pharmacy as a drug seeker, even though I did have a legitimate need for the new prescription.  

The pendulum has swung too far in the effort to control opioid overdoses and many people do not receive appropriate medications to treat their pain. I realize that I am one of the lucky ones to still get a prescription opioid, and I feel for those who aren’t as fortunate as me.  

Every patient should advocate for themselves, but if you are unable or afraid to, try having a family member or friend do it for you. Don’t settle for treatment that is less than optimal. If you are unhappy with your treatment or have intolerable side effects, discuss it with your doctor and ask for a different treatment plan. Doctors generally want to help, but some may feel that their hands are tied when it comes to prescribing opioids.  

Unfortunately, chronic pain patients must continue to jump through hoops in order to be treated ethically, fairly and adequately. Many are denied appropriate treatment due to prescribing limits and doctors’ fear of prosecution for prescribing opioids. I am hopeful that with the upcoming revision of the CDC opioid guideline, things will change for the better.  

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis. 

OHSU Focused on Opioid Tapering, but at What Cost to Patients?

By Pat Anson, PNN Editor

An internal medicine clinic at Oregon Health & Science University has significantly reduced the use of opioid pain medication through the use of a review board that oversees whether prescriptions are in line with federal and state guidelines, according to a new study.

“The question was, how do clinics actually implement those guidelines in practice?” co-author Jonathan Robbins, MD, assistant professor of medicine at the OHSU School of Medicine, said in a press release. “The opioid review board was a way to turn high-level recommendations into action steps we can take in our clinic to treat patients and create a culture of safe prescribing.”

The study highlights the declining use of high dose opioids at the clinic since 2017, along with increased prescriptions for the addiction treatment drug Suboxone (buprenorphine). But critics say the research failed to address whether pain relief and quality of life improved for patients or if they suffered side effects when they were tapered to lower doses or prescribed buprenorphine.

“This is a frustratingly vague account of a practice that could have serious implications for treating a large number of people with chronic pain,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management. 

“The summary statistics presented give us some idea about how frequently people are being tapered, and how often they are being transitioned to buprenorphine, but we really could use some better data analysis, especially with respect to outcomes,” Twillman wrote in an email. “The article continues a trend in the literature, in which an output of these interventions (i.e., the change in prescribing) is confused with an outcome (i.e., what happens to the patient as a result). Basically, the article says, ‘We decided to do this, and we think it's great.’ But there are no data presented to back that up.”

“We’ll let the article stand for itself,” is the response PNN received from Erik Robinson, a senior communications specialist at OHSU. Robinson declined a request to speak with the authors of the study and to identify members of the review board.

“The article published in the Annals of Family Medicine describes a clinical practice in general terms, and we will not engage questions about specific patient outcomes and clinical discussions among physicians,” Robinson said in an email.

‘High-Risk Cases’ Reviewed

What can be gleaned from the article is that patients with more than 6 opioid prescriptions in a 9-month period had their cases reviewed, along with those on high daily doses that exceed 90 MME (morphine milligram equivalent) or those co-prescribed benzodiazepines. The 90 MME threshold is based on a recommendation in the 2016 CDC opioid guideline.

“We combed through 14,000 patients in our clinic and developed a registry about who we’re chronically treating with opioids,” co-author Mary Pickett, MD, associate professor of medicine in the OHSU School of Medicine, said in the press release. “We picked out high-risk cases to review and invited those patients’ primary care doctors to consult with us.”

The review board initially identified 664 patients on chronic opioid therapy (COT). Three years later, there were only 458 COT patients at the clinic, the number of high-dose opioid prescriptions was reduced significantly, and buprenorphine prescriptions increased over 300 percent.  

But there is no information on how many patients experienced withdrawal, whether their pain levels and quality of life improved, or if patients were satisfied with their treatment. The study only notes that “a subset of patients have had adverse response to tapering.” Those cases were reviewed a second time, but again there are no details about patient outcomes or if the tapering was stopped..

The FDA warned in 2019 that rapid tapering or abrupt discontinuation of opioid therapy could result in serious harm to patients, including withdrawal, uncontrolled pain, psychological distress and suicide. A recent study found that tapered patients were 68% more likely to be hospitalized for withdrawal, overdose or alcohol intoxication, and twice as likely to have a mental health crisis such as depression, anxiety or suicide attempt.  

“We’re coaching primary care providers to approach this carefully, and, when necessary, slowly taper their patients,” Robbins says in the OHSU press release. “We don’t do anything abruptly, and patients have supported this careful process.”

But Twillman wonders if the tapering was voluntary and if patients agreed to have their cases reviewed. The press release mentions a waiver being signed by patients, but the study does not.

“That detail is missing from the scientific publication, and it raises a concern about the extent to which that signature is truly voluntary, or if it is coerced by a threat to stop prescribing if the waiver is not signed. What is the consequence for patients who don't sign the waiver?” asked Twillman.

“And what happens if tapering or transition to buprenorphine is recommended, and the patient doesn't agree? We've seen the dangers of involuntary tapers in several studies now, so is any tapering that happens truly voluntary, and supported appropriately with ancillary services? In sum, this article raises more questions than it answers.”

Patient Urged to Taper

“In my experience, they care more about de-prescribing than they do about their patients' individual needs,” says Emma, a patient at OHSU’s Comprehensive Pain Center who lives with an intractable pain condition. She asked that we not use her real name because she fears retaliation or being discharged from the pain clinic.

Emma gets opioids from her primary care provider, but can’t get any from the pain clinic, which she says has a strict policy against prescribing opioids at any dose.

Emma says she is constantly urged to taper by her OHSU doctor. The pain clinic emphasizes non-opioid alternative treatments such as physical therapy, acupuncture, yoga, massage and psychotherapy. 

“I’m getting pretty damn fed up with OHSU’s total lack of concern for my wellbeing. They’ve all but eliminated individualized care when it comes to the treatment of pain.”

— OHSU patient

“I told them that I had spent years trying every possible alternative, and had become suicidal due to severe untreated pain. That was when my primary doc asked me to at least consider opioids as an alternative to taking my own life. I did try them, and they gave me my functionality back,” she told PNN.

“I'm getting pretty damn fed up with OHSU's total lack of concern for my wellbeing. They've all but eliminated individualized care when it comes to the treatment of pain. And how they can label the Comprehensive Pain Center a ‘pain management clinic’ while completely eliminating an entire class of effective medications is beyond me.”

Roger Chou’s Role

Patients at OHSU’s Comprehensive Pain Center were apparently not included in the study on tapering. But they too have their cases regularly reviewed by a panel of pain management experts.

One of the experts is Roger Chou, MD, a prolific researcher and longtime critic of opioid prescribing who heads OHSU’s Pacific Northwest Evidence-based Practice Center (EPC). According to the website GovTribe, over the last five years OHSU has been awarded over $2 billion in federal grants – much of it going to the EPC to support Chou’s medical research.

In addition to his research, Chou co-authored the CDC’s 2016 opioid guideline and has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid advocacy group.

In 2019, Chou co-authored an op/ed with PROP President Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to consider tapering “every patient receiving long term opioid therapy.” He also served on a state task force that supported a rigid opioid tapering policy for Medicaid patients in Oregon.

Emma considers Chou “a major player behind all of OHSU’s anti-opioid policies” and is concerned that guidelines that he helped write are being used to justify tapering.

“It’s concerning to me that they’re justifying these actions by stating that they’re ‘in alignment with the guidelines.’ So essentially, they are both creating and enforcing their own set of guidelines with no transparency and no real oversight,” she said.

Last year, the American Medical Association called for a major overhaul of the CDC guideline, saying it was clear the agency’s recommendations “harmed many patients” by setting arbitrary limits on opioids.

The CDC is currently in the process of revising and possibly expanding the guideline, with the goal of releasing a new version next year. One of the authors drafting the revised guideline is Roger Chou.