Few Fatal Overdoses Found in Rx Opioid Study

By Pat Anson, PNN Editor

The odds of having an overdose are relatively small for most people after getting their first opioid prescription, but are significantly higher if patients are over age 75, insured by Medicaid or Medicare, and have a history of depression or substance use disorders, according to a large new study.

Researchers analyzed health claims for nearly 237,000 opioid “naïve” patients in Oregon from 2013 to 2018, and found that about 3 in 1,000 (0.3%) experienced an overdose within three years of their first prescription. The vast majority of the 667 reported overdoses were non-fatal, and researchers could not determine if they involved illicit opioids or the opioids that patients were prescribed.  

“There were relative few fatal overdoses - I believe it was less than 100. So we didn't look further than that because there wasn't statistical power,” said lead author Scott Weiner, MD, an emergency physician at Brigham and Women’s Hospital in Boston. “Unfortunately, it is not possible to ascertain if the overdose was from illicit or prescribed opioids from the data.”  

One of the more surprising aspects of the study is that there was little association found between overdoses and high dose prescriptions. The CDC says opioids prescribed at daily doses that exceed 90 MME (morphine milligram equivalent) raise the risk of overdose, but Weiner and his colleagues found little evidence to support that.  

“Incidence of overdose was not associated with varying levels of MME that were received in the first 6 months, which may indicate that patient factors may be more important than the strength of the opioids prescribed. These are both novel findings,” researchers reported in in JAMA Network Open.

The research team did find a higher risk of overdose when patients were prescribed long-acting opioids such as oxycodone, or used opioids concurrently with benzodiazepines, a class of anti-anxiety medication.  

Patients in the study who refilled an opioid prescription 6 or more times also had a higher overdose risk, as did those who got refills from three or more pharmacies. 

Patients with alcohol or substance use disorders had the highest risk of overdose, as did those with a history of depression or psychosis. 

Medicaid, Medicare and Elderly Patients at High Risk

Another high risk factor associated with overdose is insurance coverage. Patients covered by Medicaid had an overdose risk almost four times higher than those covered by a private insurer, while those insured by Medicare Advantage had an overdose risk nearly 8 times higher than commercially insured patients. 

The finding that patients over age 75 had an overdose risk nearly three times higher than other age groups is not surprising, according to one pain management expert.

“Obviously, this older age group has more comorbidities which is also associated with increased risk,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “What we don’t know is why opioids were prescribed and if severity of pain or suicidality or denial to prescribe opioids for severe pain could be contributing factors for the higher risk of overdose with elderly patients.”

Weiner cautioned doctors against taking the findings too literally. For example, although African-Americans were found to have a higher risk of overdose compared to white patients, they make up only a small percentage of Oregon’s population, making the data for them statistically weak.

“I absolutely do not advocate for suboptimal pain control for any patient, regardless of their risk profile. However, I do want prescribers to be careful when prescribing opioids to any previously naive patient, and to be extra careful when prescribing to the higher risk groups,” Weiner told PNN in an email.

“For patients in the higher risk groups, particularly those with diagnosis of substance use disorders, I would counsel the patient and inform them of their elevated risk and come up with a game plan for safety. I am only unwilling to prescribe to anyone when I don't believe an opioid is indicated for their condition.”  

Does Opioid Medication Make You Euphoric?

By Carol Levy, PNN Columnist

“Dose escalation, dose reduction or discontinuation of long term opioid analgesics, have potential to harm or put patients at risk if not made in a thoughtful, deliberative, collaborative, and measured manner.

Clinicians have a responsibility to provide or arrange for coordinated management of patient's pain and opioid-related problems, and they should never abandon patients.”

That was written in a tapering guideline put out by the U.S. Department of Health & Human Services (HHS) in 2019. In some respects, it was an attempt to undo some of the damage caused by the release of the CDC opioid guideline three years earlier, which led to many patients being rapidly tapered and/or abandoned by their doctors.

Out of curiosity, I went back to the CDC guideline. A Google search took me to a 2016 New England Journal of Medicine article, co-authored by then-CDC Director Thomas Frieden, who explained the rationale for the guideline this way:

“Whereas the benefits of opioids for chronic pain remain uncertain, the risks of addiction and overdose are clear…. nearly all the products on the market… are no less addictive than heroin.”

How can patients fight against this kind of propaganda? The purpose seems clear: opioid medication and heroin are basically the same. And when chronic pain patients take them, they get addicted. Not only that, we are told, they enjoy it!

“Heroin and prescription opioid pain relievers both belong to the opioid class of drugs, and their euphoric effects are produced by their binding with mu opioid receptors in the brain,” reads information from the National Institute on Drug Abuse.

In other words, we enjoy our opioids because they make us feel “euphoric.”

I could not find any articles or research that asked people in chronic pain, “Do you feel euphoric when you take opioids? Do you enjoy the opioids you are on? Would you take them if you didn't have chronic pain?”  

No one in the online chronic pain group I administer or the others to which I belong has ever said or written, “Dilaudid makes me feel wonderful, it makes me feel high. I love it.”

But they have said or written, “Demerol makes me feel cloudy-headed and my mouth feels like cotton. But I can do more with my life now that I am on it.”

I cannot find research that asked us if our doctors have made us partners with them when tapering or ending our opioid prescriptions. Where are the papers that use us as the experts about the side effects we have when the reduction or withdrawal of opioids is forced on us?

HHS is right. It has to be a collaborative effort when doctors reduce or end opioid prescriptions. But it seems that most doctors are too afraid or unable to act as partners, instead seeing themselves as the ultimate authority.

Changes in opioid prescribing policy should have input from all of us: researchers, policy makers, doctors and patients. It should be thoughtful, deliberative and collaborative -- just as tapering should be a collaboration between our docs and ourselves.

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

Teen Charged with Murder in Fentanyl Death of 12-Year-Old

By Pat Anson, PNN Editor

A California teenager was arrested and charged with murder this week in the death of a 12-year-old girl who fatally overdosed after consuming a counterfeit painkiller made with illicit fentanyl. The 16-year-old suspect allegedly sold the pill to the girl in 2020, and she overdosed after crushing and snorting the tablet at a party in San Jose.

Like many other counterfeit pills involved in overdoses, the tablet was made to look like a 30 mg oxycodone pill, stamped with a “30” on one side and an “M” on the other. The girl passed out and began snoring soon after ingesting the drug, which prosecutors say is a “telltale sign of a fentanyl overdose.”

“After thousands of deaths, everyone should know that fentanyl is a deadly poison,” Santa Clara County District Attorney Jeff Rosen said in a press release. “Thanks to the San Jose Police Department, the Santa Clara County Specialized Enforcement Team, and our investigators, this child’s tragically short life may help save others.” 

The DA’s office calls the 12-year-old victim “Jane Doe” because of her age, but local media have identified her as Dalilah Guerrero of San Jose. The girl was with two other teens when she bought the “M-30” pill from the alleged dealer. The group later took a video of Dalilah lining up the crushed pill for ingestion.   

The 16-year old suspect’s name has not been released because he is a minor. Investigators looking into his online social media accounts reportedly found screen shots of public service warnings about fentanyl that predated the girl's death.

Failed Policies Made Drug Crisis Worse

The overdose of such a young victim is the latest example of how the “opioid epidemic” has morphed into an even more deadly overdose crisis fueled by illicit fentanyl and other street drugs. Efforts by law enforcement and public health officials to prevent more deaths by prosecuting doctors and restricting the supply of opioid medication have not only failed – they may have made the drug crisis worse.

In recent years, the number of opioid prescriptions has fallen dramatically nationwide and now stand at 20-year lows, while fatal overdoses rose to record levels. Last year the number of U.S. drug deaths crossed 100,000 for the first time, largely driven by illicit fentanyl.

As the charts show below, Santa Clara exemplifies both trends, with prescriptions falling dramatically in the county while fentanyl deaths spiked.

SOURCE: CALIFORNIA DEPT. OF PUBLIC HEALTH

Santa Clara County was the first local government in the nation to file a lawsuit against drug makers alleging that they caused the opioids crisis. The law firm of Motley Rice filed the initial lawsuit in 2014 on behalf of Santa Clara, and the case snowballed from there into nationwide litigation against opioid makers, distributors and pharmacies.

Last year a California judge ruled that drug makers did not use deceptive marketing to promote pain relievers and there was “no evidence” the companies were liable for the state’s opioid crisis.

The tragic death of Dalilah Guerrero is not the first time Santa Clara County has lost a young person to counterfeit pills. In 2019, county health officials announced that 9 fatal overdoses had been linked to fake oxycodone pills, including the deaths of two teenagers.  

In 2020, murder charges were filed against a San Jose man who allegedly sold over Snapchat a counterfeit pill laced with fentanyl to an 18-year-old girl and her 17-year old boyfriend. Both teens overdosed. Paramedics were able to revive the boyfriend, but the girl died.

In 2020, the last year for which full data is available, there were 143 opioid related deaths in Santa Clara County, a 139% increase from 2018.  Fentanyl was involved in most of them.

Saving My Soul From a Real-Life Dopesick

By Cynthia Toussaint, PNN Columnist

While watching Dopesick, the Hulu series that dramatizes Purdue Pharma’s driving of the opioid crisis through their cash-cow OxyContin, I was traumatized to the point of hitting the pause button at least half a dozen times.

The filmmakers were so spot-on with their story telling, I anticipated and said names and organizations out loud before the actors did. You see, I was in the middle of this evil. And I was asked to be a part of the killings for money.

Watching Dopesick reminded me of those god-awful times. Recounting the untold number of people who got addicted to OxyContin and overdosed made me sick. Knowing Purdue and its accomplices nearly got away with it made me sick. How close I was to it all turned my stomach.

In 2003, about a year after I founded For Grace, I was deep in the planning of a California Senate hearing that would shed light on gender care bias toward women with high-impact pain. I loved every crazy-busy moment of this endeavor to give voice to women dismissed by the words, “It’s all in your head.” I was ecstatic to have three female state senators co-sponsoring my hearing that, to this day, remains the most requested event video in Capitol history.     

Out of the blue, Purdue Pharma’s Director of Community Outreach phoned. I’d never heard of Purdue before, but upon overhearing the call, my partner John handed me a note, telling me they were a pharmaceutical company that funded nonprofit pain organizations.

I was flattered that Brenda (not her real name) loved the work I was doing with the hearing, but more than a bit miffed when she recommended her own advocacy people be able to testify. As a start-up nonprofit, For Grace sure as hell needed underwriting, so I agreed to call and get to know her folk. What could it hurt?

I was pleasantly surprised when they were friendly and knowledgeable and, in the end, I chose to go with half my people and half Brenda’s that I and the senators’ staff vetted.

Things went sideways the morning of the hearing when Purdue and those who would testify met with us at the Capitol. After brief intros, Brenda asked for my written testimony and quickly edited it in red pen. I was infuriated by this unwelcomed intrusion.

Still fuming, I arrived late to my own senate hearing as I’d been yelling at John that they had no right to change my testimony just because they’d paid to fly some people in. Who the hell do these creeps think they are?                  

After the successful, standing room only hearing, I was beyond stoked and let the bad energy of the morning pass over dinner with legislators and staffers I adored.

Also in attendance were Purdue and their speakers. That night, at Purdue’s suggestion, we began laying the groundwork for a “Women In Pain” coalition. I was in heaven with the prospects of giving my movement a bigger platform.   

cynthia toussaint (right) testifying at 2004 hearing

Women In Pain (WIP for short) was For Grace’s exciting new project and the cause I wanted most to lead. Springing from a 2001 medical study entitled “The Girl Who Cried Pain” and a follow-up article in The New York Times on the neglect women face in getting their pain treated, I couldn’t wait for the world to learn about WIP. To have a coalition of nonprofit pain leaders and a deep funder behind our movement was a dream.

A dream that would slowly erode into the ugliest kind of nightmare.

When the coalition and Purdue began meeting, the first order of business was to establish an understanding that everyone would be working under For Grace’s umbrella, as we initiated the WIP concept and felt a deep ownership. In fact, we were strongly considering expanding our mission from CRPS awareness to the plight of all women in pain.

Though I’m known for my work ethic, I soon felt overwhelmed by my load. To keep up with For Grace’s everyday activities and the coalition’s needs, John and I were grinding through long hours, seven days a week.

Almost out of the gates, we were getting pushback from coalition members about seemingly everything. Jealousies erupted as I was getting the lion’s share of media attention due to my hustle and drive. Per their demands, I generated media coverage for all members, but that wasn’t enough. Some of them wanted me to script out their answers for interviews. I was beginning to feel beaten.  

‘The Correct Response’

One day I received a call from Purdue inviting me to give the keynote address for pain advocacy conferences they were underwriting in Denver and Philadelphia. The purpose of these events – or so I was told – was to train and inspire pain leaders to effectively interface with media and policy makers.

The person who’d be overlooking this affair was Dr. Richard Sackler, the grand dragon of the family-owned Purdue empire. At the event, Purdue minions were twisted like pretzels in their desire to please this unimpressive man, who struck me as distant and cold.

I was insulted when Purdue insisted that I take a media training class. In a taped, mock interview with their crisis management consultant, I was asked, “What treatment do you advise when a person gets a CRPS diagnosis?”

“Well, there’s a whole range of options out there, including alternative ones,” I answered, spreading my hands a yard wide. “Remember, what works for one person may not work for the next.”

Purdue’s consultant chided me. “As the up-and-coming pain star, you should rethink your answer. The correct response is to take OxyContin,” she said.

Stunned, I responded, “But that would kill people. There’s nothing to rethink.” I felt trapped in a queasy Twilight Zone episode, as not a soul in the crowded room of pain advocacy leaders and healthcare professionals backed me up.

That night, ensconced in our five-star hotel room, it dawned on John and me that everyone in this scheme was training to be a de facto sales force for OxyContin. We were the only schmucks not in on it, though Purdue was actively grooming me to be their #1 patient sales person.           

This bizarre, shady gathering left me with a rancid taste and my enthusiasm curbed for the coalition. But I forged on, at the behest of my advisors, to give Purdue a fair chance to find common ground, a notion I now laugh at.

Next, Purdue offered me an extraordinary opportunity to make WIP fly in an influential, national arena. I was invited to bring our project to “Women In Government”, a powerful organization comprised of female state legislators throughout the country. Thrilled, I introduced my cause at their western regional meeting in Honolulu, then prepared to close the deal at their annual conference in Tucson.

I must admit, I was enjoying Purdue’s lavish courtship – travel, the chauffeur-driven town cars, the choicest suites and the finest meals. After all, I’d earned these perks, I told myself. I was working damn hard and was extremely effective with my message. I knew I was good at what I was doing and it was gratifying to be recognized.

But Purdue continued their insidious attempts to control me. Before my speech, Brenda chided that I’d better knock it out of the park as they were spending a small mint. Further, I was not to go one nanosecond over my 20 minute speaking limit, or else! Hmmm, not the good luck pat on the back I’d hoped for.

Fuming, I made a beeline for the event coordinator, telling her of Brenda’s abuse. Her face turned beet red, angrily telling me that Purdue didn’t run their show. This kind woman reassured me to take a deep breath, then go out and do my thing. So I did.

During my standing ovation, the director came over and hugged me with eyes welling. Joy confided with the room her ongoing bout with chronic pain, along with her ringing endorsement of the WIP movement. Then I was circled by legislators, shaking my hand and thanking me. Most important, they said they’d do whatever I asked.

Later that day, Brenda showed me first-hand what my advocacy future would look like if I played nice with Purdue. During a special session, I watched a Broadway-level singer/actor/cancer survivor entertain the audience, giving them an update about her cause to promote a cervical vaccine. She was living my advocacy dream job – traveling the world, performing, making great money, all the while helping people. That afternoon, she captivated the room.

I had stars in my eyes. For the first time since losing my performance career at 21 due to CRPS, I was being offered a job that would completely feed me. And it was a more noble pursuit than entertaining, as I’d be helping, even saving, many people. But could I get Purdue to come around? They wouldn’t want my services solely to peddle OxyContin, right?

There’s much bigger fish to fry with our shared mission (or so I thought) to put chronic pain and gender care bias on the map. This was my great passion, and I was determined more than ever to thread that needle.

Purdue Wants More

But my naïve hope didn’t float for long. When we restarted our coalition meetings, the women were stone cold toward me, and I felt punished. Their jealousies were amping, and managing all the egos and expectations added to my overload.  I began feeling itchy that the coalition was grinding me to dust in an attempt to heist the project, leaving For Grace behind. The walls were closing in.

I called Brenda and voiced my concern. Oddly, she was warm and reassuring, voicing that, per our agreement, the project would never be taken away from For Grace. To the contrary, she said we were approaching a tipping point where the WIP movement would explode.

I was calm, for about a minute.

On the next call, the gates of hell broke open. The women were backing unethical suggestions from Purdue, including supplying a prominent link from our WIP website to Purdue’s OxyContin marketing page.

John went nuts, sternly stating that was a “slippery slope.” He exploded, “If we give them that link for their money, they’ll want more. And more!"

The women yelled him down, saying For Grace didn’t know how business worked. The back and forth warring finally ended when I pronounced, knowing full well Purdue was on the call, “I won’t be a whore for a pharmaceutical company.” The sounds of phones hanging up followed.

Soon after, I saw in a coalition member’s nonprofit newsletter that she and the others were launching a new organization. It was called “Women With Pain” and parroted our mission. Around that same time, I was abruptly dropped from planned media stories and speaking engagements. Clearly, Purdue’s tentacles ran far and wide. When I threatened to speak to the media about their dirty deeds, Purdue called with a bevy of their attorneys in tow, telling us thuggishly to put a cork in it.

I cried, I yelled, I screamed, I even begged God for mercy. What I’d given birth to had been heisted, and was going to be used to kill people. John and I got deeply ill with what I thought was an epic flu, but looking back, I see it was despair. I became despondent and we were convinced there was no path forward with the good work. Worse, I started thinking deeply about ending my life. I didn’t want to live in a world this soulless.

Saving My Soul

But the fire within hadn’t burned out, and after ample time to grieve, I was able to get out of bed. I was further lifted by For Grace board members who prodded me to not let the bad guys win. Ultimately, I saw that good things could be possible again.

While formally expanding our mission to Women In Pain, I used my persuasiveness to get the pro-bono services of a top-end intellectual property attorney. He sent every coalition member a cease-and-desist letter, advising them not to use the name and idea inspired by For Grace.

I was elated that the letter hit its mark. In fact, the rival organization’s name and announcement were taken down the very next day. Shortly after, I was informed the new coalition was dead on arrival and I knew I’d gotten Purdue, a multi-billion dollar corporation, to buckle.

That’s how I saved my soul from the Sackler family and their savage empire. And I’ve never looked back. Until now.

Those terrible years of trauma surged back while watching the evil dramatized in Dopesick. I was reminded that everything Purdue touched turned to rot. Worse, with few exceptions, everyone enabled them. Without hesitation, they all lapped up Purdue’s dirty money. To make this level of killing possible, Purdue bought support from a wide range of villains: the FDA, policy makers, healthcare professionals and, yes, pain patient advocates. You know who you are.

For years, I’ve watched bad people with bad organizations take bad money to do bad things. And the opioid crisis that Purdue spearheaded has made collateral damage of all of us with pain. Many who need opioids to functionally survive no longer have access.  Many good doctors who responsibly prescribed have been indicted. And for ethical pain organizations who still want to do good work, funding has dried up. I think it’s fair to emphatically state that everyone with pain is suffering in the wake of Purdue’s and their enablers’ sins.               

With apologies, I don’t have my usual up-beat take-away, no words of comfort. Just tears, and a plea. Watch Dopesick, study it, commit this atrocity to memory. Take my word, the pharmaceutical industry is doing just that, and there’s another Purdue in the making that will attempt to make billions off the suffering and murdering of millions. All in the name of pain care. 

I was this close to being one of Purdue’s statistics. But I lived to tell my story. Perhaps it’s not foolish to hope next time more souls will be saved.

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome (CRPS) and 19 co-morbidities for nearly four decades, and became a cancer survivor in 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.”

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.”