‘Great Potential’ in Stem Cell Therapies for Knee Osteoarthritis

By Pat Anson, PNN Editor

Osteoarthritis of the knee is one of the most common forms of arthritis, causing progressive damage and thinning of cartilage in the knee joint.  Over 32 million American adults have knee osteoarthritis (OA), but most are treated with injections or pain medications that provide only temporary relief and often have side effects.

Could stems cells provide a more effective and long-lasting treatment for knee OA? Clinical trials have had mixed results so far, so a group of researchers in China conducted a meta-analysis of nearly 1,200 studies, weeding out the ones that were poorly designed or biased.

They eventually settled on 16 studies involving 875 patients with knee OA, most of them high quality studies that were randomized with control groups to compare results with.

Their findings, published in the Journal of Orthopaedic Research, show that stem cell treatment was associated with significant reductions in patient-reported pain from the third month onwards.

The most pain relief came from mesenchymal stem cells (MSCs) derived from a patient’s own body fat (adipose tissue) and stem cells derived from umbilical cord blood. Injections of MSCs derived from a patient’s fat provided better pain relief than stem cells from other donors and led to the most recovery of knee joint function.

“Stem cell transplantation proved safe and effective for knee osteoarthritis treatment,” the authors wrote. “Different sources of stem cells have a good effect on alleviating knee joint pain, restoring knee joint function, and minimizing patient trauma.”

The researchers said there was “great potential” for MSC therapy in the treatment of knee OA, but larger studies were needed to confirm their findings.

“The safety and efficacy of MSC therapy require rigorous validation with a larger sample size before clinical application. From the perspectives of relieving knee joint pain, promoting knee joint function recovery, and reducing patient trauma, umbilical cord‐derived stem cells should be considered as a priority option, followed by ADSCs (adipose stem cells), and finally bone marrow‐derived stem cells.”

In 2019, a small Canadian study found that stem cells collected from a patient’s bone marrow significantly reduced knee pain from osteoarthritis for as long as a year. But that study only involved 12 patients.

FDA Foot Dragging

Why are there so few good quality studies? Stem cell promoters have long complained about foot dragging by the Food and Drug Administration, which has been reluctant to approve new stem cell therapies that are not tested in randomized, double-blind, placebo-controlled studies — the so-called “gold standard” in clinical trials.

The FDA sent warning letters to 20 stem cell manufacturers and clinics in 2019, saying they were in violation of FDA guidance requiring stem cells to undergo “minimal manipulation.” The agency said the science behind stem cells made from a patient’s own tissue had not been proven safe and effective.

“There’s a false premise being asserted by some in the field that a product derived from a person’s own body and then manipulated and reinserted for another use different from the one it played in its original location is not subject to FDA regulation,” then FDA commissioner Scott Gottlieb, MD, and FDA Biologics Center Director Peter Marks, MD, said in a joint statement.

Critics say the FDA is still slowing down stem cell research, despite a pledge to approve 10 to 20 cell or gene therapies annually by 2025. So far this year, the agency has only approved five.  

“Despite signs of progress and a strong commitment from FDA leadership to improve its readiness for these cutting-edge therapies, the agency remains far off pace. Its risk-averse approach and culture that’s slow to adapt to new science could become a curse for many patients and the scientific field as a whole, with investment in biotech chilling in recent quarters,” Richard Burr, a policy adviser for health and life sciences consultant DLA Piper, wrote in an op/ed published in STAT News.

Burr is a former U.S. senator and congressman from North Carolina.

“During my time in Congress, I was one of the FDA’s toughest critics, but I also fiercely defended its mission because I believe in it. The FDA now has an opportunity to transform its oversight of cell and gene therapies and deliver on promises made to patients,” Burr said.

People in Pain Feel More Stigmatized and Lonely

By Pat Anson, PNN Editor

A new global study of people living with pain found that nearly half feel stigmatized and regularly feel lonely. Women, people of color, and the LGBQ+ community are significantly more likely to feel they are treated differently, not believed, or discriminated against because of their pain.

The consumer health company Haleon conducted an online survey of over 18,000 people in 18 countries, including the United States, Canada, Australia and the UK. It’s the fifth time since 2014 the company has conducted such a survey, which forms the basis for the Haleon Pain Index (HPI), which is “designed to give a voice to those experiencing pain.”

The findings from this year’s survey show that attitudes about pain in a post-pandemic world have grown more judgmental and less tolerant, regardless of where people live. Worldwide, 42% of people in pain said they regularly experience loneliness; with serious loneliness felt by 38% of people in mainland China, 33% in Australia and 32% in the UK.

“Everyday pain is a health issue that can easily be dismissed or trivialized. Many don’t realize its effects can be much worse than the symptoms themselves,” said Linda Papadopoulos, PhD, a psychologist and consultant. “The result of loneliness and mental health impact caused by lack of empathy and being treated differently is only worsening. As a society, we need to improve empathy and understanding in a world that is continuing to harden to these issues.”.

The HPI found that people who already experience bias and discrimination are the most affected by hardening views on pain. 

• 58% of women in pain said they were treated differently, not believed or discriminated against, versus 49% of men. Stigmatization was highest among women in India (74%), Saudi Arabia (74%), Brazil (74%), and mainland China (61%). 

• 59% of people of color said they felt stigmatized because of their pain, versus 48% of white people. This trend is highest in Brazil (71%), Poland (64%), USA (64%), and the UK (60%) 

• 44% of people who identify as LGBQ+ fear that others will make assumptions about them and their pain, compared to 32% of heterosexuals. This trend is highest in India (61%), USA (54%), Canada (49%) and Australia (48%). 

The study also found a striking generational gap in the way people in pain are treated, with younger patients often struggling to make their pain known.

Worldwide, 70% of people in their late teens or 20’s (Gen Z) felt stigmatized because of their pain, compared to just 40% of Baby Boomers aged 60 or older. Levels of stigmatization against Gen Z were highest in India (80%), USA (79%) and UK (74%).

Even just talking about pain can be problematic for younger people. 45% of Gen Z respondents said pain was too much of a taboo for them to speak out, compared to 35% of Baby Boomers.   

“While pain is a universal human experience, resulting in loneliness and stigma for many, its impact varies considerably between social groups, with the most marginalized amongst the worst affected. Our ambition is to break down the barriers to achieving better everyday health for everyone – irrespective of age, race, ethnicity, gender, sexual orientation, disability and other factors,” said Lisa Jennings, Head of Haleon’s global over-the-counter products. 

Despite differences in experience, there is broad agreement among people on the need for a more personalized and compassionate view of pain. Over two-thirds of respondents (68%) said more empathy was needed to address bias and prejudice.

Notably, 69% wished that doctors and 62% wished that pharmacists were better trained on how individual pain is for different patients.

How are you treated by your pharmacist? If you are a pain patient in the United States, please take a few minutes to participate in PNN’s survey on drug shortages and opioid prescribing by clicking here.

Drug Shortages Mostly Involve Low-Cost Generics

By Pat Anson, PNN Editor

Drug shortages in the United States are primarily being driven by low profit margins – not supply chain problems – according to a new analysis that found 84% of medicines currently in shortage are low-cost generics. Prices for some generic medicines are so low that manufacturers have stopped making the drugs.

The study by the IQVIA Institute, a healthcare data tracking firm, identified 132 medications in shortage as of June 2023, with pain/anesthesia drugs as the therapy area with the greatest number (21) of shortages. The shortages are so acute that elective procedures requiring anesthesia are being cancelled or postponed.

“Anesthesia medicines, including general, local, and muscle relaxants, are foundational to inpatient and outpatient surgical procedures, and shortages in these medicines can result in delays for patients receiving procedures and hospitals making prioritization decisions based on available supply,” the IQVIA said.

“Shortages across these medicines complicate scheduling of a wide range of procedures and surgeries, which may be part of a broad-based reduction observed in elective procedures in post-pandemic periods.”

One weakness of the IQVIA report is that it relies solely on drug shortage data from the Food and Drug Administration.  The American Society of Health-System Pharmacists (ASHP) currently lists 242 medicines in short supply, nearly twice the number listed by the FDA.

Three generic opioid medications commonly taken for pain, immediate-release oxycodone, oxycodone-acetaminophen, and hydrocodone-acetaminophen tablets have been on the ASHP shortage list for months, but have yet to appear on the FDA’s shortage list.  

Pain patients are feeling the impact of short supplies. In recent months, many have complained about problems or delays getting their opioid prescriptions filled at U.S. pharmacies.

“It has been a month since I had my last refill and no pharmacy can give me an answer as to when they may be back in stock. In the meantime, I just live in misery,” one patient told us.

“Mobile, Alabama seems to be almost completely out of pain medication, specifically the most widely used mg of oxycodone-acetaminophen and hydrocodone. I was supposed to get my refill from Walgreens… and they are not only out but cannot order more,” another patient said. “This is such a serious issue with a lot of people probably going through withdrawals in our county and nobody seems to care.”

‘Prices May Be Too Low’

Teva Pharmaceuticals, a large generic drug maker, has informed the FDA that it is discontinuing production of immediate-release oxycodone tablets. The move appears to be in line with Teva's announcement that it would reduce its production of generics from 80% of its drug portfolio to 60% over the next few years.  

“The drugs we’re pulling out of are drugs which are low-margin,” Teva CEO Richard Francis recently told Bloomberg.

The IQVIA found that over half (56%) the medicines in short supply are low-cost generics priced at less than $1 per unit. In many cases, that’s below the manufacturer’s cost of production and distribution. Because the generic drug industry is highly concentrated with few suppliers, any disruption or discontinuation of a generic can have an outsized impact.

“Generic medicines are much lower cost than brands and some observers have begun to suggest that some generic prices may be too low to support sustainable markets,” IQVIA found. “Prices driven below the cost of manufacturing and distributing can result in some competitors discontinuing production of molecules (medicines), reducing necessary maintenance activities and generally contributing to less resilience in manufacturing supply of those medicines.”

Other highlights of the IQVIA report:

• 120 of the 132 drug shortages listed by FDA involve generics. Only 12 drugs are brand name

• 75% of current drug shortages have been active for over a year and 58% have lasted at least two years

• Three times as many new drug shortages have been reported than have been resolved in recent years

• 67% of shortages involve injectable drugs

• Shortages of antibacterial medication “are a significant concern affecting multiple aspects of healthcare delivery”

• Shortages of cancer treatment drugs have forced some oncology providers to suspend or delay treatments

Federal agencies appear to have inadvertently contributed to some of the shortages. The IQVIA said FDA inspections of drug manufacturing plants have triggered shutdowns of some sites due to safety or sanitation issues. Those shortages “are difficult for their peers to resolve,” according to IQVIA, because few other companies can pick up the slack.

A generic manufacturer of oxycodone, hydrocodone and ADHD medication recently sued the DEA after the agency suspended its drug production license over record-keeping issues. The lawsuit by Ascent Pharmaceuticals accused the DEA of incompetence and heavy-handed regulation of the nation’s drug supply.

In the past year, under the DEA’s ironically named “Operation Bottleneck” initiative, the agency has taken administrative actions against 143 DEA-registered doctors, pharmacies, drug makers and drug distributors, largely over allegations of poor record-keeping and inadequate controls to prevent the diversion and theft of opioids and other controlled substances.

“These companies have a legal obligation to account for every dose and every pill to protect the safety and health of the American people,” said DEA Administrator Anne Milgram. “DEA will continue using every available tool to prevent the diversion and misuse of opioids and other highly addictive controlled substances.”

DEA recently announced plans to further reduce the supply of opioid pain medication in 2024 -- which would be the eighth consecutive year the agency has reduced opioid production quotas for drug manufacturers. DEA said it was acting on the advice of the FDA, which estimates that medical need for Schedule II opioids will decline on average 7.9 percent from 2023 levels.

Cheap Drugs May Prevent Migraine Just as Effectively as Expensive Ones

By Pat Anson, PNN Editor

Two drugs commonly used to treat depression and high cholesterol are just as effective at preventing migraine as CGRP inhibitors, according to a large new study.

They are also a heck of a lot cheaper.  

Researchers at the Norwegian Center for Headache Research analyzed the prescription drug history of over 100,000 migraine patients in Norway from 2010 to 2020. Their goal was to see if patients reduced their use of medications used to treat acute migraine pain – such as triptan – once they started taking drugs used to prevent migraine.

“When the withdrawal of acute migraine medicines changed little after starting preventive medicines, or people stopped quickly on the preventive medicines, the preventive medicine was interpreted as having little effect,” explained lead investigator Marte-Helen Bjørk, MD, a Professor in the Department of Clinical Medicine, University of Bergen.

“If the preventive medicine was used on long, uninterrupted periods, and we saw a decrease in the consumption of acute medicines, we interpreted the preventive medicine as having good effect.”

Beta blockers are often the first drugs used to prevent migraine attacks, but Bjørk and her colleagues found that three other medications were associated with lesser use of triptans: amitriptyline, simvastatin and CGRP inhibitors.

Amitriptyline is a tricyclic antidepressant that is mostly taken for depression, while simvastatin is a statin used to treat high cholesterol. Both drugs are also used off-label for migraine prevention.

CGRP inhibitors are a relatively new class of medication that block calcitonin gene-related peptides, a protein that binds to nerve receptors in the brain and triggers migraine pain. Since 2018, the FDA has approved over half a dozen CGRP medications, which are considered the biggest innovation in migraine treatment in decades.

However, CGRP drugs are not cheap. Eight doses of Nurtec, a tablet taken daily to prevent and treat migraine, can cost over $1,000, while the listed price for Emgality is $679 for a self-injectable syringe used once a month for migraine prevention. Prices will vary for patients, depending on insurance and whether they qualify for a patient assistance program.

By comparison, amitriptyline and simvastatin are screaming bargains. A bottle of 30 simvastatin tablets will cost about $14, while amitriptyline costs about $13 for a supply of 28 tablets.

When it comes to reducing triptan use, amitriptyline, simvastatin and the CGRP inhibitors performed about the same. During the first 90 days of treatment, nearly 57% of patients taking simvastatin reduced their triptan use, compared to 53% of patients taking amitriptyline and 55% of those taking CGRP medicines.

The study findings, recently published in the European Journal of Neurology, show that patients taking beta blockers, topiramate or clonidine were more likely to keep taking triptans.

“Our analysis shows that some established and cheaper medicines can have a similar treatment effect as the more expensive ones. This may be of great significance both for the patient group and Norwegian health care” says Bjørk, who has already started work on a clinical trial to see if other cholesterol-lowering drugs can prevent migraine.

Migraine affects about 1 billion people worldwide and 39 million in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

Doctor Bison’s Fables: The Crowded Exam Room

By Pat Anson, PNN Editor

Dr. Mark Ibsen is a Montana physician whose license was suspended in 2016 by the state medical board for “overprescribing” opioids and poor record keeping. A state judge later reversed the suspension, ruling the medical board made numerous errors.

Ibsen has since become a strong proponent of medical marijuana and a leading advocate in the pain community. He’s published a new book, “Dr. Bison’s Fables,” using animals as lead characters in a series of stories to convey how many pain patients in the U.S. lack proper treatment and some are in crisis.

This interview with Ibsen has been edited for content and clarity.

PNN: Who is “Doctor Bison’s Fables” intended for and what is your goal? What is the message you're trying to get across?

Dr. Mark Ibsen

IBSEN: I'm not really in the book selling business. I'm in the restoration of the sacred physician-patient relationship business. But all of my screaming from the rooftops about it for the last 12 years has made little progress.  

I was talking to the publisher and he was saying if you write a book about what's going on in medicine today, the pain crisis and catastrophe of it, you'll have a readership of 50,000. If you write a book that talks about the dynamics of what's going on, and put it in the form of a parable or a fable that has a bigger meaning to it, your audience will expand.

When this approach was suggested to me, I rejected it completely out of hand. I said I just want to tell what's going on because the house is on fire. But I slowly came to look at this idea as maybe he's onto something. Maybe Aesop's Fables had some good things to say, maybe the Brothers Grimm had some good things to say. So I thought, okay, let's add some folksiness to this. Give it a Burl Ives approach.

PNN: When you tell your fables in the book, animals are the key characters. Why did you choose them?

IBSEN: The animals are the protagonists. I chose Dr. Bison because of the bullheadedness of the character. As you can see on the book cover, he's examining this cute little otter on the exam table. And the weasel guy with the clipboard is scowling at him and evaluating how he's doing his job and if he's doing it effectively or quickly enough.

The weasel is like an interloper in the exam room, which has been my persistent complaint. We have too many guests in the exam room that have a vote into what's going on between the doctor and the patient. We have an insurance bureaucrat deciding what you can or can't prescribe, and a pharmacist deciding if the prescription is legitimate.

Then there's a law enforcement officer who's looking at whether a crime is being committed. Then there's a DEA agent who may or may not have a college education, who's looking at patterns and matrices. Is Dr. Bison prescribing more than other doctors?

Then there's legislators, like the legislators in the state of Ohio that legislated exactly how much I could get for the pain in my chest after it was split open during heart bypass surgery at the Cleveland Clinic.

So it's really crowded in the exam room now.

PNN: You want to get across the point that you can't treat all patients the same way. Everyone is different. How do you communicate that in your fable scenario?

IBSEN: I think it's basically species dependent. By that I mean that different species have different personal attributes. A mouse is going to attack a problem much different than a bison would. Or an herbivore will attack a problem more than a carnivore will.

I guess you could call it a menagerie. There's a bison and a cougar. There's a possum. There's a wise llama. There's a viper in the chapter about breeding resentment. There's a coyote, the trickster who has a lawyer's briefcase and there's a crow. And then the elk. Elk handle their conflicts by keeping the herd intact, surrounding the weakest member so the wolves can't get to them.

My goal is to is to make this seemingly light and then develop it. Story development pulls them in and readers finish the story. And then they're left with curiosity about the pain crisis, rather than revulsion or rejection or resistance or argumentation.

PNN: Take us to the epilogue and the message that you really want to get across to the reader.

IBSEN:  I guess I would say that I didn't leave medicine, medicine left me. I don't want to project some righteous indignation about it. I'm sad about it more than anything else. I don't think this is limited just to the patient-physician relationship. I think it's a cultural phenomenon. And it's just manifested in medicine in this way.

We now have patients that cannot tell their doctor the truth. It's sort of like a teenager who has to lie to their parents. It's like a patriarchal system. The patriarchal system works if the patriarch supports the people in the system. But these days, if you admit that there's a family history of alcoholism, then suddenly you're not a candidate for opiates.

Or this doctor friend of mine who was recently suspended, he's a residency mate of mine. He had a mother and a daughter, both in chronic pain. I think they lived together and one was on hydrocodone and the other on oxycodone. And it turns out their medications may have gotten mixed up. They had a urinalysis and it looked bad.

But if you live in the same household, then maybe you can get your pills mixed up. I mean, you could have that chance. But do you fire somebody for having hydrocodone in their system? In my training, a lab result is something that you respond to, not something you react to. The first thing you do is you repeat the lab test. If you see something that's completely out of the ordinary, then you have to inquire about it.

But in this system, you have to fire the patient, even when there's no evidence that doing urine drug screens make any difference at all about diversion or patient care or anything. Nobody's done a placebo, double-blind controlled study about that.

I'm now seeing some pain refugees from Billings. The pain doctor there retired and the new guy came in slashing everybody’s dose and then he left. All these patients are trying to recover and none of them are oriented towards taking cannabis because they know that if they found cannabis in their urine that they would be fired. Somebody somewhere will say if you have cannabis in your urine, it's obvious that you're selling your pain pills in order to buy your cannabis. That is not obvious to me. Not even remotely

There’s a huge amount of gaslighting going on between the system and patients, that doctors are willing participants in. I mean, my younger colleagues have loans to pay off, so they are not risk takers. Right now, I am quite a risk taker. Because everything's gone. I don't have anything left.

I would say that in medicine today, the wheels are coming off and maybe they need to all come off. It doesn't operate in the same mentor-apprenticeship relationship that I was trained in. I don't know if I would last in medical training today.

I think that the internet has both good and bad things about it. And the good thing is that patients research their ailments or their symptoms and they come in with that. They come in with a differential diagnosis already. And I get to hear that and respond to it.

The great thing about that is what I call the alignment effect. If a patient comes to me and wants to do something that they read about and it's not going to kill them, if I say yes and it works for them, then they're going to be really persistent about following that therapy because it was their idea. Right? If it fails and they come back to me, then they're willing to listen to my point of view on it. And that builds trust.

If only the hospital administrator, pharmacist, insurance bureaucrat and legislator would trust our medical expertise. I think we're in a period of time where expertise is not thriving. Failing to use the expertise of our specialists is really putting us in a bad way, not only in medicine, but in the entire culture.

PNN: Thank you, Dr. Ibsen.

The Trauma-Pain Connection Explored at For Grace’s Women In Pain Conference

By Cynthia Toussaint, PNN Columnist

Four years ago, I was wheeled into my pain management doctor’s office, not to talk about Complex Regional Pain Syndrome, but rather my newest and most dire diagnosis: Triple Negative Breast Cancer (TNBC). I knew I didn’t have a good chance at survival, but didn’t know why I had the most rare and aggressive form of the disease.

I asked Dr. Richeimer why this cancer would appear now, as my oncologist and genetic counselor were baffled. Without pause, he answered, “Cynthia, you’ve been trying to fix your dysfunctional family your entire life. The toll that’s taken on your body is why you have TNBC.”     

Thus began my trauma-informed journey.

I was already aware and intrigued that many researchers were identifying trauma as the main driver for chronic pain. Despite this, I passed on having trauma release treatment because I’d heard it could be triggering. But now that I was fighting for my very existence, I was all in.

In the midst of full-dose chemotherapy, no less, I took to reading and researching everything I could get my hands on about childhood trauma and how it leads to adult on-set chronic illness. On the trauma release front, I jumped into talk therapy and EMDR (Eye Movement Desensitization and Reprocessing), complimenting those treatments with big doses of music, writing, meditation, inner child work and ancestral healing.

I also started focusing my “For Grace” work on the trauma-pain connection. This included interviewing a boatload of experts and survivors as well as collecting and spotlighting lived experiences, all culminating in Friday’s 11th Annual Women In Pain Conference – “The Trauma-Pain Connection: A Path to Recovery and Growth.”

Radene Marie Cook

You see, I now understand that my 40+ years of pain and chronic illness are the result of serious and sustained trauma, suffered primarily during my early development. In short, trauma is not a piece of my chronic pain puzzle. It’s the whole puzzle.

I want to share all that I’ve learned with women in pain, during a day that I hope will launch your own trauma-informed journey, one that I promise will bring you healing and growth.

To start you on your way, our five-hour online seminar, beginning at 10am PT on November 17, will be broken into three sessions led by world-class speakers, panelists and breakout leaders, all who have survived trauma and volunteered their time.

• Session One will examine what trauma is, how it can be passed down generationally, and how it’s a driver for chronic pain.

• Session Two will highlight trauma release and the myriad of effective techniques, methods and strategies used to achieve that end, both practitioner-led and solo.

• Session Three will celebrate what I call the silver-lining of trauma, Post-Traumatic Growth, a process that paves the way for recovery, deeper meaning, new-found strength, and helping others.            

Themed throughout the conference will be the beauty, struggle and resilience of the Native American people. Because I’ve read time and again that this community suffers greatly from generational trauma, the day will be infused with stunning music and photography, compliments of one of our main speakers, Dr. Noshene Ranjbar, a leader of indigenous studies at the University of Arizona. It touched my heart that two of her students put in hours to gift us these sacred elements.

Perhaps the most poignant part of our event will be the extraordinary gift of intensely personal video vignettes sprinkled in from people who’ve traveled the dimly-lit trauma-pain tunnel, found healing through release, and moved on to the light of growth. The courage of these generous souls is a triumph of the spirit.      

This conference was For Grace’s heaviest lift to date. Coming from a chronic pain background, I didn’t know anyone in trauma and it took several years to build a critical mass of relationships. Also, because this conference is the first of its kind, our planning committee had to build it from whole cloth. Perhaps most difficult and most satisfying, was getting people to talk publicly about their deepest, darkest experiences. I know the challenge well because when I recorded my story, I was brought to tears more than once.

It was worth the sweat and tears because we struck gold.

This is the most important topic For Grace has covered. I’m certain that if you do the work, it will be a catalyst for healing and renewed wholeness. Remembering, facing and addressing our past traumas is our best hope to overcome the scourge of chronic pain.

Don’t wait to get a deadly disease to learn, to explore, to discover trauma’s place in your life. You’re braver than you think - and when you use that courage, you’ll be on the path to finding the last piece to your pain puzzle.

You can watch the conference for free at this link.

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 four decades, and has been battling cancer since 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.”

It’s Not Urgent and They Don’t Care

By Mia Maysack, PNN Columnist

There are no words to convey the extent that I, along with so many others, have endured medical trauma. It’s even more impossible for us to get those who haven't to understand what it's like or the toll that it takes.

A loved one of mine had an injury not too long ago that required a small dose of medical hoop jumping. Just the tip of the broken-healthcare-system-iceberg was enough to leave a lasting impression on them, to the extent they still haven't stopped complaining about it.

But when I attempted to express my own fresh experience with said iceberg, this same person described me as "too sensitive." That is dreadfully inaccurate, especially when you consider I've lived this way for over two decades and they had one adverse experience.

My aim is not to belittle or attempt competitive victimization. I understand how health problems impact us on different levels and in various ways. I simply find the lack of empathy -- yet the simultaneous expectation of it -- to be painfully fascinating.

Within the last few weeks, I've been hospitalized multiple times, essentially back-to-back for the same issue. That's part of what being chronically ill looks like. The difference between these recent visits, as opposed to all the others, is the spite I feel for providers who are supposed to be working for me.

I currently don’t have a primary care provider, so my only option when I have an urgent need is to go to a hospital emergency department. I was in one recently at two o’clock in the morning, freezing on a cot in an isolated exam room.

A nurse came in for the rundown as to why I was there, followed by a brief appearance from a doctor who didn't make eye contact or even face me. He kept his back turned while working on a computer.

The nurse proceeded to speak about me and my situation with Doctor Awesome, as if I was not even there. I interrupted their conversation, because I’ve already endured enough lack of bedside manner and respectfully expressed my concerns and wishes.  I asked for an exam and tests to ensure my medical issue wasn’t progressing, I also needed a prescription to relieve side effects from a medicine I was taking to manage my complications.

After laying all this out in a concise, professional manner, Dr. Awesome finally decides to turn around to face me and dryly asks, “So what brings you in tonight?”

Stunned, I politely responded that I’d previously been to this ER and was advised to return if needed. His reply was that my requests are more of a “clinic thing” and “weren’t necessary.” He then dismissed himself and I did not see him again for the hours I was left alone there. He did not come back to check on me before discharge or bother to report the results of my testing. No one did.

An assistant I hadn’t seen before eventually popped in and provided more warmth than anyone else I’d encountered, just by saying, “Awww, you do not look like you feel very well.” 

I thanked her for the acknowledgement and asked for an exam from anybody who was qualified -- it certainly didn’t need to be Dr. Awesome. She was appalled that I had to ask and left promptly to flag someone down.

So now another person I had never met and who didn’t bother introducing themselves, came in and spent less than a minute with me before they left.

At a different point in my journey, this sort of encounter would’ve completely shattered me, because of how low and how long I’ve been knocked down by those entrusted to aid in healing

Those days are over. Today, I’ll stop at nothing to pursue and obtain what’s in my best interests. Instead of feeling depleted after mistreatment like this, I internalize it as empowerment. I’ve made the decision to give up on them instead of myself, and to continue battling for the sake of my life quality. Even if that means fighting against the harm that they vowed not to inflict in the first place. 

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. She is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill. 

CBD Ineffective for Osteoarthritis Knee Pain

By Pat Anson, PNN Editor

Cannabidiol (CBD) is often touted as an effective pain reliever for arthritis. Studies on animals and anecdotal reports from humans suggest that CBD – the non-psychoactive compound in cannabis -- has anti-inflammatory and pain-relieving effects on joint pain.

But in one of the first randomized, placebo-controlled clinical trials of CBD, researchers at Medical University of Vienna found that CBD is not an effective pain medication for knee osteoarthritis, even at high doses.

The study included 86 men and women who suffered from severe pain due to knee osteoarthritis,  a progressive condition caused by the breakdown of joint cartilage.in the knee. About 10 percent of people over age 60 have knee osteoarthritis (OA).

Half the participants received daily doses of CBD in capsules for eight weeks, titrating up to 600mg per day, which is considered a high dose. The other participants were given placebo capsules with no active ingredient. Neither group knew what they were taking.

The study findings, published in The Lancet Regional Health -- Europe, show that CBD did not have a stronger analgesic effect than the placebo. Adverse events were more common in the CBD group, with over half the participants (56%) reporting diarrhea, abdominal pain, fatigue and other mild side effects.

“Our results do not support the yet clinically unproven hopes for CBD as potential supplement or even replacement of potent analgesics, including opioids,” wrote lead author Sibylle Pramhas, MD, Department of Special Anesthesia and Pain Medicine at MedUni Vienna.

"Our study is the first to provide solid information on the lack of analgesic potential of CBD in a common chronic pain condition, due to the comparatively high oral dosage and the long observation period.”

This isn’t the first time CBD came up short in a clinical study. In 2017, Zynebra Pharmaceuticals tested a CBD gel for knee OA with mixed results. The Phase 2 study did not meet its primary goal of reducing the average pain score, although there were some indications the gel improved function and reduced pain severity. The company has since abandoned plans to use the gel for arthritis pain.

A more recent study of a CBD patch for knee osteoarthritis was withdrawn due to “inadequate funding.” Several other clinical studies of CBD for OA pain are underway or recruiting participants, but no results have been posted.

Currently, osteoarthritis knee pain is treated with analgesics such as acetaminophen (paracetamol), diclofenac, ibuprofen or tramadol. For the time being, they may be the best alternatives for pain relief.   

"CBD is not an alternative for pain therapy for osteoarthritis of the knee, so the search for more effective options must continue," says Pramhas.

The Surprising Connection Between Pain and Politics

By Pat Anson, PNN Editor

“I feel your pain. I feel your pain.”

Bill Clinton was mocked by political pundits for saying that to an AIDS activist while running for president in 1992. Whether he was sincere or not, it was a public display of empathy that helped get Clinton elected.

Clinton may have been prescient about a connection between pain and politics. A large new study suggests that pain could have played a surprising role in the 2020 presidential election. Researchers found that liberals with high levels of pain sensitivity were more likely to vote for Donald Trump, while conservatives who were highly sensitive to pain were more likely to vote for Joe Biden.

Huh? I was skeptical. Initially, so was lead researcher Spike W.S. Lee, an associate professor of marketing at the University of Toronto’s Rotman School of Management.     

“We were honestly not expecting to see this kind of cross-aisle effects of pain sensitivity,” Lee said in a news release. “When we first found it, we thought it might be a fluke. That’s why we ran a replication study. We found it again. We ran extended replications and follow-up studies. We kept finding it.”

Lee and his colleagues ran seven different studies involving over 7,000 U.S. participants to see how pain sensitivity affects our moral and political views. Does it heighten them and make us hold more tightly to them? Or does the pain experience make us more sensitive and accepting of what other people believe?

Lee started thinking about that as a research topic during a dental appointment. He is very sensitive to pain, and asked that a freezing procedure be used to numb his mouth before his teeth were cleaned. Lee found himself enjoying the experience so much that he wondered what having no sensitivity to pain would do to someone’s moral compass.

His research found that liberals with higher pain sensitivity were more likely to endorse traditional conservative values such as loyalty and authority; while pain sensitive conservatives showed more support for traditional liberal values such as caring and fairness.   

The pattern continued when participants were asked about their 2020 voting intentions. As the graphic shows below, liberals (blue line) said they were more likely to vote for Trump if they had more pain sensitivity. Similarly, conservatives (red line) were less likely to vote for Trump over Biden if they were more sensitive to pain.

Journal of Personality and Social Psychology

The pattern not only held up for how participants actually voted in the presidential election, it influenced their support for a diverse group of liberal and conservative politicians, such as Kamala Harris, Mike Pence, Mitch McConnell and Bernie Sanders.

Pain sensitivity also significantly changed the way liberals and conservatives thought about hot button issues such as immigration, global warming, unions, the free-market system and Obamacare.

Does that mean pain sensitivity makes people confused about their political views? Not necessarily. Lee says the more likely explanation is that the pain experience gives people more empathy for others and a greater willingness to look at issues from both sides.

In an age of polarized and often heated politics, that’s not a bad thing. Maybe Bill Clinton was on to something.

The study appears in the Journal of Personality and Social Psychology: Attitudes and Social Cognition.

My Pain Marriage

By Mara Baer

Two years ago this month, I had major surgery to try to address the daily chronic pain that had been with me for seven years. Leading up to that surgery, I was bounced around from specialist to specialist, experiencing many failed attempts to treat my Thoracic Outlet Syndrome, a rare nerve entrapment condition that causes overwhelming nerve pain.

Because the surgery was unsuccessful, the looming anniversary date -- November 30th -- carries a lot of weight as I approach year 10 of my chronic pain journey.

Anniversaries are times of reflection, when we think about where we’ve been and where we are going, celebrate milestones, and commemorate paths taken. We acknowledge wedding anniversaries, work anniversaries, birthdays, deaths, and other important junctures in life.

There are also health recovery anniversaries celebrated by cancer survivors to honor their remissions and recovering addicts who mark their hard-earned sobriety. The anniversary of my surgery brings the same type of evaluation and introspection.

My husband Art and I commonly celebrate our wedding anniversary in a simple way with a nice dinner and a toast.

We just hit 17 years together and noted how much we’ve accomplished; bringing two beautiful kids into the world, making a big move from DC to Denver, and building our own little, special world.

We also reflected on the impact my chronic pain has had on our lives. I shared with him how I feel that I am in a relationship with my pain that is akin to a marriage -- often complex, at times emotional, and deeply reliant on compromise and understanding.

This relationship can feel like a third wheel in our marriage some days, taking over and getting in the way. This is something we both are working to address.    

Mara Baer and Art Maples

And, like a toxic relationship, the “pain marriage” can be all consuming. Chronic pain sufferers commonly report feeling a lack of control and that pain dominates daily life. I’m sure many readers can recall a personal relationship that felt this way.  Just remember that one bad relationship and how it made you feel when tensions were high. Angry. Frustrated. Sad. Helpless. Fearful. Depleted. This is how the pain relationship can feel for most chronic pain sufferers.

Most people in a challenging relationship will say that toxicity feeds greater toxicity, creating a vicious cycle. The pain marriage is no different. When I have been at my lowest due to pain, I found it impossible to have a positive outlook. I tried every ineffective playbook strategy, including disengaging or ignoring it (“pain, you are not there, you just aren’t there”); placating it (not moving, lying in bed, other unhealthy habits); and bargaining (“pain, I’ll do all the right things so you will just leave me”).

I am sure there are others. These strategies never seemed to work. Why? Because like in any relationship, masking or hiding from the raw truth will not be successful.  

All couples argue, and Art and I have had our share. I’ve learned that our greatest challenges come when we are not listening to each other. The words come out, but perhaps my interpretation of his words or his of mine are not the same as what we intended.

When we don’t hear each other, arguments can escalate quickly. It’s the same with pain. When I sense my pain and try to ignore it, I may not be really hearing what my body is telling me.

But when I acknowledge pain’s role in my life and how I feel about it, I can start to gain equal footing or control. Then it’s not about “winning” (like winning an argument), but about managing the dynamics between us.

It might sound odd that I’m referring to my pain in this way. But only when I started to accept pain’s presence could I start to change the nature of the relationship. This is why acknowledging that I am in a relationship with my pain is one of my chronic pain truths.

So as my surgery anniversary nears, I may not be toasting the journey, but I will be reflecting on the ups and downs of my pain struggle, and also celebrating my new outlook and path. I know I’ve got more work to do, and I’ll admit that I am still learning. But when it comes to my pain relationship and my marriage to my spouse, both are worth the effort.

Mara Baer is a writer and health policy consultant offering services through her women-owned small business, AgoHealth. Mara is a member of the Science and Policy Advisory Council for the National Pain Advocacy Center and recently launched a chronic pain newsletter called Chronic Pain Chats.

Why the Ruan Case Won’t Protect Doctors From Prosecution

By Dr. Joseph Parker

Doctors trying to save lives and help pain patients are regularly being sent to prison for prescribing opioids. And despite last year’s Supreme Court ruling in the Ruan case, that’s not changing.  Here’s why. 

First, it’s important to know what you are up against.  When the US federal government goes after a doctor or anyone else, they face a streamlined conviction machine.  Since the time of Ronald Reagan (who I voted for), the rights of an American citizen to challenge the charges against them or try to overturn an unjust conviction have been eroded. 

Then came President Bill Clinton (I voted for him too), who signed into law the Antiterrorism and Effective Death Penalty Act, doing more to ensure that the government can imprison the innocent than any other president since the Civil War.

At the founding of this nation, it was recognized that governments are prone to lock up people they don’t like, finding some legal pretext to justify their actions.  To guard against this, the Constitution and Bill of Rights were adopted to limit the powers of the federal government. 

Originally, there was only one federal crime: an act of treason. This crime was much more limited than the British version had been, when wandering over onto the King’s hunting grounds was considered treason. In the American version, you had to wage war against the United States or give aid and comfort to its enemies during a time of war. 

Then John Adams, the second president of the United States, made sedition a federal crime. Since then, so many federal laws have been added that government itself cannot tell you exactly how many or what they are.

That’s not counting all of the rules and regulations enforced by federal law enforcement, as if they were the law.  Locked up is locked up, after all.  Today the land of the free incarcerates more of its citizens than any other nation.  Not only that, but the sentences have become draconian. 

There is no nation on earth today where the liberty of a citizen has less value than in America.  The US incarcerates an average of 629 people for every 100,000 citizens. The next closest nations are Rwanda, Turkmenistan, El Salvador and Cuba. China and Russia don’t even make the Top 10.

Believe it or not, there are 37 states in the US that beat Cuba’s incarceration rate of 510 prisoners, with Louisiana coming in at a mind numbing 1,341. 

All of those inmates did not end up in prison by accident.  Looking at 2020 numbers, there were about 1,879 criminal cases heard in federal court.  Of those, about 90% of the accused plead guilty without even going to trial. Is that because the US government is absolutely right 90% of the time?  I am cautiously skeptical. Only 0.04% of cases -- 4 out of 1,000 – resulted in acquittal.  Those are not good odds. 

In Ruan v. United States, Dr. Xiulu Ruan appealed his conviction for prescribing opioids in an “unauthorized manner.” In a stunning unanimous verdict, the Supreme Court justices repeated what they said in 1925 in Linder v. United States, and then again in 2006 in Gonzales v. Oregon:  the federal government cannot dictate the practice of medicine and a doctor can only be prosecuted if they knew what they were doing was wrong.

As has happened in the past, US law enforcement doesn’t let something like a Supreme Court ruling slow them down.  They are completely ignoring the Ruan ruling by arguing something called “willful blindness.” What was the doctor willfully blind to?  To whatever opinion the government’s expert witness feels like arguing is the “usual practice of medicine” and “a legitimate medical purpose.”

Even though the Supreme Court made clear that only individual states can regulate the practice of medicine, the government’s hired expert does not have to come from your state or even be familiar with your state’s laws regarding the practice of medicine.

In effect, the DEA argues that there is a national practice of medicine that must be followed.  Where do they draw these medical practice standards when there is no such thing as a federal medical license?  From medical textbooks like the "Principles and Practices of Pain Medicine"?  No.  From the teachings of national medical organizations like the American Academy of Pain Medicine or the American Society of Addiction Medicine?  No again. 

The teachings from those sources are not allowed in court, unless you can get one of the original authors to come testify for you.  And sometimes, not even then.  The chapter on avoiding addiction in pain management from the above textbook was written by Dr. Alan Wartenberg.  Despite his advanced years, Dr. Wartenberg came to my trial to testify for me.  But he was not allowed to be considered as an expert in pain medicine, because he was “only” an addiction specialist. 

This is nothing compared to what happened to Dr. William Bauer of Ohio.  A dozen pharmacists, doctors, and scientists were willing to testify on his behalf, and all of them were disqualified by the court.  But the government’s “experts” in pain medicine can testify about almost anything, including addiction and even chronic cough.

The government does not convict you by proving you are guilty, they convict you by smearing you publicly long before you get to trial, and then making sure that the jury does not have access to the truth, by disqualifying experts, withholding favorable evidence, allowing false testimony, and making false statements to the jury. 

And remember, Dr. Ruan “won” at the Supreme Court. But he’s still in prison. 

Good luck and be prepared.  Ruan will not save you.

Joseph Parker, MD, is Chief Science Officer and Operations Officer at Advanced Research Concepts, a company developing solutions to the challenges of space travel and space-related medical issues.  In clinical practice, Dr. Parker specialized in emergency medicine and served as Director of Emergency Medicine at two hospitals. Prior to that, he had a distinguished career in the U.S. Marines and Air Force. 

In 2022, a federal jury convicted Dr. Parker on two counts of unlawful opioid prescribing. He has filed an appeal as he awaits sentencing.

A Pain Patient's Perspective on Opioid Prescribing

By Barby Ingle, PNN Columnist

It is essential to prescribe pain treatments that are appropriate and effective for each patient. I say that based on my own experiences as a patient, as well as thousands of others I have spoken with over the years as a friend and advocate.

Patients who need opioids, benzodiazepines, antidepressants and other medications should have access to them -- just as a heart patient has access to medication that keeps their heart functioning or a diabetic needs access to insulin.

People living with pain should also be offered individualized treatment. That could be anything from physical therapy and analgesics to surgical procedures and alternative therapies like acupuncture. I have tried over 100 different types of pain treatment; some have worked and others have not. It often made me feel like a guinea pig. Unnecessary surgery hurt me most in the end.

There are many public education campaigns underway to prevent addiction and overdoses by reducing the use of prescription opioids. These campaigns are repeated in the media, but the information does not always include facts or is presented in a misleading way.

For example, there is the DEA’s “One Pill Can Kill” campaign, which is aimed at raising awareness about a surge in counterfeit pills made with illicit fentanyl and other street drugs. Another is the CDC’s “Rx Awareness” campaign, which shares the stories of people whose lives were impacted by prescription opioids. The overall theme is that opioids are “addictive and dangerous.”  

Although well-intentioned, these campaigns have a tendency to demonize FDA-approved medications that have a lot of science and research behind them. Most people are unaware that fentanyl has been used safely and effectively for decades to treat severe pain and as an analgesic in millions of surgeries. Saying “one pill can kill” to a pain patient who has improved their life with a legally prescribed medication is disheartening.

I have seen this misinformation firsthand over the years and how it has put a damper on opioid prescribing. Physicians should prescribe opioids for pain when appropriate, but many are afraid to do so because of potential sanctions and legal threats. As a result, many providers won’t prescribe opioids or will only do so minimally and as a last resort.

Individualized Treatment

I believe each patient is different and should be treated as such. We need providers to operate on the assumption that each individual is unique and requires something different, even when they have the same disease or injury as someone else.

Physicians today can use pharmacogenomics to see if a patient’s DNA can affect how they respond to a treatment or what is chemically right for them. The dosage, brand, procedure and frequency will vary depending on each patient. I often bring my pharmacogenomics information to communicate more effectively with my providers, which benefits us both.

I also know that doing what is least invasive first and then progressing to other options is essential. Sometimes, surgery is the best option. Sometimes, opioids or other pain medications should be used first. Every medical provider should work at finding the treatment that most effectively suits the patient.

It is a considered best practice to prescribe opioids to someone in severe pain from sickle cell disease. Yet, when many sickle cell patients go to the ER or are admitted to a hospital, they are denied opioids because of hospital policy. What is the point of having a trained medical providers on staff if you won’t let them treat a patient the way they should be?

Denying pain relief is not only cruel, it can be the worst practice for everyone involved. For example, a man in severe chronic pain committed suicide after a doctor at a Kentucky pain clinic cut his opioid dose in half. The man’s family filed a lawsuit and won a $7 million judgement against the doctor and clinic.  

Ultimately, it should be the patient's responsibility to weigh the risks and benefits of any treatment, after getting input from their provider and conducting due diligence. Unfortunately, there are many obstacles standing in the way of that. One of the biggest is finding a doctor willing to prescribe pain medication. In addition, there are insurance restrictions, the cost of medication, and other logistical issues such as transportation to appointments.

Here in Arizona, patients must see their provider every month to renew a prescription for a controlled substance. Policies like that were put in place to “protect” pain patients, but only added extra costs, burdens and stigmas to them.

Patient-Physician Communication

How can we change the narrative about opioid prescribing? We can start by emphasizing the importance of effective communication between physicians and patients, even those as young as elementary school. Early education on how to talk to medical professionals and advocate for yourself is vital. I see this as one of the most critical things for patients to do.

Communication and trust are essential. Patients need to know when to take medication, how much to take, and what the potential side effects are. They also need to be able to express how the medication is working and what their symptoms are. Patients should feel comfortable asking questions and discussing their pain management plan. Physicians need to listen, provide feedback and give advice when needed.

Individualized treatment plans should be tailored to the patient’s age, gender, medical history, lifestyle and other factors.  That will help ensure that the treatment is effective and also reduce the risk of adverse reactions and potential complications. Collaborative decision-making makes patients feel more comfortable, confident in their treatment plan, and more likely to follow it.

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and the founder and former President of the International Pain Foundation. You can follow Barby at www.barbyingle.com. 

Study Finds Why Some Patients Do Poorly with Spinal Cord Stimulators

By Pat Anson, PNN Editor

Spinal cord stimulators (SCSs) are often considered the treatment of last resort for people with severe back or leg pain, who don’t respond well to more conventional ways of treating pain.

The neuromodulation devices are surgically placed near the spine and send out mild electrical impulses to mask pain signals. Because stimulators are invasive and have poor success rates, it’s customary for patients to go through a short trial period before having the devices surgically implanted.

A new study has documented why some patients do well with stimulators and others don’t.

In a retrospective analysis, researchers at the University of Kansas Medical Center looked at 237 patients who received SCSs, about a third of them considered “nonresponders.” They found that people with severe pain and disability who fear physical activity because of the pain it might cause – a condition known as kinesiophobia – are significantly less likely to respond to the devices.

The study is being presented this month at the annual meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA).

Researchers analyzed several patient characteristics, such as their age, gender, body mass index, history of spinal surgery, diabetes, alcohol and tobacco use, psychiatric illness, and use of opioids. None appeared to have an association with how a patient responds to SCS.

But researchers found that three out of four (76%) nonresponders had clinically high levels of kinesiophobia, compared to about half (56%) of those who did respond to SCS treatment. Nonresponders were also more likely to have severe pain, disability, and to complain or worry about their pain – a condition known as “catastrophizing.”

“Collectively, our findings indicate a clinically relevant association of high levels of kinesiophobia, greater disability, severe pain intensity and pain catastrophizing, as subtle indicators, and possible predictive factors to nonresponders,” researchers said.

“As such, it may be appropriate to utilize preoperative screening tools for these factors to help optimize patient selection and predict a patient’s response to neuromodulation. Furthermore, if risk factors are present, it might be prudent to consider a pre-rehabilitation program with pain neuroscience patient education prior to SCS therapy to address these modifiable risk factors and potentially enhance outcomes in neuromodulation.”

About 50,000 spinal cord stimulators are implanted annually in the U.S. The devices are often touted as a safer alternative to opioid pain medication, although a growing number of studies have questioned their safety and efficacy.

A recent Cochrane review of SCSs concluded the devices work no better than a placebo for treating chronic low back pain, and provide little to no benefit in improving quality of life. That negative review led some doctors who perform the surgeries to demand a retraction from Cochrane because of “striking errors in the methodology, execution and conclusions” of the study.

Meanwhile, a 2018 investigation found that SCSs have some of the worst safety records of medical devices and called for better FDA oversight of their growing use in pain management. A subsequent FDA review of complaints involving stimulators found that nearly a third were reports of unsatisfactory pain relief.

Yet another recent study found that many patients given stimulators did not reduce their use of opioids, and continued getting procedures such as epidurals, corticosteroid injections and radiofrequency ablation to relieve their pain.

White Patients More Likely Than Blacks to Get Opioids at ER

By Drs. Trevor Thompson and Sofia Stathi, University of Greenwich

White people who visit hospital emergency departments with pain are 26% more likely than Black people to be given opioid pain medications such as morphine. This was a key finding from our recent study, published in the Journal of General Internal Medicine.

We also found that Black patients were 25% more likely than white patients to be given only non-opioid painkillers such as ibuprofen, which are typically available over the counter.

We examined more than 200,000 visit records of patients treated for pain, taken from a representative sample of U.S. emergency departments from 1999 to 2020. Although white patients were far more likely to be prescribed opioid medication for their pain, we found no significant differences across race in either the type or severity of patients’ pain.

Furthermore, racial disparities in pain medication remained even after we adjusted for any differences in insurance status, patient age, census region or other potentially important factors.

Our analysis of prescribing trends spanning over two decades’ worth of records found that opioid prescribing rates rose and fell, reflecting changing attitudes in clinical practice toward the use of opioid drugs. Notably, however, there appeared to be little change over time in the prescribing disparity across race.

These findings are important because they suggest that efforts to promote equitable health care in the U.S. over the past two decades, such as the Affordable Care Act, or “Obamacare,” do not appear to have translated to clinical practice – at least with regards to pain management in hospital emergency departments.

There’s no question that as the ongoing opioid crisis continues to escalate, a careful balance must be struck between the risks and benefits of prescribing opioids. But their appropriate use is an essential component of pain control in the emergency department, and they typically provide superior relief to non-opioids for short-term moderate to severe pain.

Undertreated pain produces unnecessary suffering and can result in a range of negative outcomes, even including a greater likelihood of developing long-term pain. There are over 40 million pain-related emergency department visits annually, so it is clear that equitable pain treatment is a fundamental component of a fair health care system.

We do not know why such marked racial disparities exist. Some researchers have argued that prescribing fewer opioids may be beneficial for Black patients as it reduces the risk of addiction. But this argument doesn’t square with the data, which show that overdose rates have traditionally been lower in Black populations compared with white people. However, this trend has started to change in recent years.

In addition, some evidence suggests that clinicians may hold unconscious biases, incorrectly believing Black patients to be less sensitive to pain or that certain racial groups are less willing to accept pain medication.

While there is preliminary evidence that these factors may be important, there is not enough research that examines the degree to which they influence clinical practice. Researchers like us also know very little about whether promising remedial strategies based on these factors – such as educational training during medical school that challenges stereotypical beliefs – are effective, or indeed even implemented, in the real world.

The need for tackling racial disparities in health was brought into focus once more in February 2023, when the Biden-Harris administration signed an executive order on further advancing racial equity. Given the long history of these issues, it is clear that more research is needed to help develop better strategies for tackling health inequalities.

The most effective strategies for addressing racial disparities in pain treatment are likely to be those that target the underlying causes. We are currently undertaking research to try to better understand these causes, how they contribute to disparities in real-world clinical practice and whether strategies designed to address them are actually effective.

Trevor Thompson, PhD, is an Associate Professor of Clinical Research and works in the Centre for Chronic Illness and Ageing at the University of Greenwich.  

Sofia Stathi, PhD, is a Professor of Social Psychology in the School of Human Sciences at the University of Greenwich, where she leads the Centre for Inequalities.

This article originally appeared in The Conversation and is republished with permission.

DEA Plans Further Cuts in Rx Opioid Supply in 2024

By Pat Anson, PNN Editor

Despite chronic shortages of opioid pain medication around the country, the U.S. Drug Enforcement Administration is planning to further reduce the supply of oxycodone, hydrocodone, morphine and other opioids in 2024.

The DEA sets annual production quotas for opioids and other controlled substances after consulting with the Food and Drug Administration, Centers for Disease Control and Prevention, and individual states about their projected medical and research needs. If the proposed cuts are finalized next month, 2024 will be the 8th consecutive year that DEA reduced production quotas for opioid manufacturers.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2024 will decline on average 7.9 percent from calendar year 2023 levels. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone,” DEA said in a public notice published in the Federal Register.

There will not be 7.9% cuts across the board for every opioid. The steepest cuts will be in the supply of codeine and prescription fentanyl, while production quotas for oxycodone and hydrocodone will be reduced only marginally.  

Proposed Cuts in 2024 Opioid Supply

- 8.3% Codeine  

- 7.6% Rx Fentanyl  

- 4.3% Morphine

- 2.1% Hydromorphone 

- 0.3% Oxycodone   

- 0.3% Hydrocodone

Since reaching their peak in 2015, DEA production quotas have been reduced by over 68% for oxycodone and nearly 73% for hydrocodone, the two most widely prescribed Schedule II opioids.

The primary goal of the DEA in cutting the supply is to reduce the risk of diversion, abuse and overdose, but there is little evidence the policy is working or even needed. Prescription opioid use has been cut in half in recent years, but overdose deaths have grown to record levels, fueled primarily by illicit fentanyl and other street drugs.

Fears about patients selling or diverting their opioid medication also appear overblown, as the DEA estimates the diversion risk for hydrocodone at only 0.31% and 0.28% for oxycodone. That means for every pill that’s sold or stolen, about 300 pills are used by the patient they were intended for.

Federal health agencies appear to have turned a blind eye to opioid shortages. For several months, the American Society of Health-System Pharmacists (ASHP) has warned of shortages of immediate release oxycodone, oxycodone/acetaminophen tablets, and hydrocodone/acetaminophen tablets. But those shortages have not been publicly acknowledged by the DEA or FDA, and have not been added to the FDA’s drug shortage list.

More ADHD Meds, Cannabis and Psychedelics

The DEA and FDA have been more responsive to complaints of shortages of Adderall and other stimulants used to treat attention-deficit/hyperactivity disorder (ADHD). The DEA is modestly raising its production quotas for stimulants after the FDA predicted a 3.1% increase in their medical use in 2024.

“DEA is committed to ensuring that patients who need stimulant medications have access to them and to ensuring that these drugs are being prescribed thoughtfully and responsibly, and we will continue working with our partners inside and outside of government to do so,” DEA Administrator Ann Milgram wrote in a letter released this week. She said 17 out of 18 drug makers had agreed to increase their production of stimulants under existing 2023 quotas.

In addition to stimulants, the DEA is also raising 2024 production quotas for cannabis, psychedelics and hallucinogens in response to an “increased level of research and clinical trials” involving the Schedule I substances.

The DEA’s quota process may undergo significant changes in the years ahead. The agency wants to be “more nimble” in responding to shortages and increases in demand. To do that, it is seeking access to sales and inventory reports from drug makers to better assess the supply that is available.

“DEA believes that changes to reporting requirements are necessary to improve both the type of data collected and the timeliness of that data, allowing DEA to be more nimble in its administration of the quota program. Future regulatory changes may seek to address the lack of real-time inventory and sales data accessible to DEA, the lack of information on production lead times, and issues of timeliness,” the agency said.

“DEA also is considering methods by which it might increase transparency in its quota setting process. Future regulatory proposals may define additional steps, including such concepts as public notification and an opportunity for public input when prescribing rates for controlled substances deviate substantially from FDA's estimate of future use. Furthermore, DEA is considering regulatory changes which will authorize it to reduce a manufacturer's individual manufacturing or procurement quota in order to apportion it to another manufacturer.”

To leave a comment on the DEA’s 2024 production quotas, click here. Public comments must be submitted online or in writing on or before December 4, 2023.