The Gaslighting of Pain

By Ann Marie Gaudon, PNN Columnist

It’s become a buzzword. “Gaslighting” is a term used to describe the repeated denial of someone’s reality in an attempt to invalidate them. Its origins can be found in a misogynistic 1944 film showcasing a husband trying to convince his wife that she is insane.

To be clear, gaslighting is a form of emotional abuse and is not exclusive to romantic relationships. This attempt to manipulate a person’s reality is systemic and can be seen in social media, politics, cable news and even healthcare. When a medical professional invalidates, dismisses or even leads a patient to question their own thoughts and experiences, that is traumatic and abusive.

It is hardly news that women are more often told than men that their pain and other symptoms are emotionally-based and psychogenic: not real. Years ago, I attended a lecture given by a young woman detailing her experience with significant knee pain. She had seen several doctors to no avail; she was told the pain was all in her head. One doctor said the cause of her pain was due to “wearing her jeans too tightly and this is a common problem with teenage girls.”

She wondered out loud if this would have been her diagnosis if she were a male teenager. Eventually she did obtain a correct diagnosis for her knee pain which was osteosarcoma – the very same cancer that Canadian athlete and national hero Terry Fox succumbed to.

 A 2015 study interviewed women who had been hospitalized due to a heart attack but were reluctant to seek medical care, citing anxiety about “being perceived as complaining about minor concerns” and “feeling rebuffed or treated with disrespect.”

Since being diagnosed and treated for the female-only disease of “hysteria” in the 19th century, women’s emotions continue to be used as the cause for all that ails them. This inherent gender bias in healthcare is another form of gaslighting.

“We want to think that physicians just view us as a patient, and they’ll treat everyone the same, but they don’t,” Linda Blount, president of the Black Women’s Health Imperative, told BBC Future. “Their bias absolutely makes its way into the exam room.”

Your chances of being subjected to medical gaslighting increase if you are not white, cisgender or able-bodied -- essentially any marginalized group. However, do not be misled into thinking that all white males will be cared for with dignity and medical acuity. I have had conversations with men who have been dismissed time and again, and had their substantial suffering completely invalidated with the likes of “that [diagnosis] would never bother anyone.” Or they cannot even get a diagnosis and so are labelled as malingerers.  

‘You’re Making This Up’

At times, I am the only person in a patient’s life who actually has validated their pain, because their family does not believe them either. “You’re making this up” or “You’re not getting better because you don’t want to get better” are common themes told to my victimized clients. I watch as their teary eyes fluctuate hurriedly from boring into mine to staring down at the floor as they question their own sanity and if their pain is indeed real.

What happens next can lead to disastrous results. When physicians inappropriately conclude that a patient’s symptoms are all in their head, they delay a correct diagnosis – just like the young woman with knee pain. This can be especially dangerous for patients with rare diseases who already wait longer to be diagnosed as it is. According to a survey of 12,000 European patients, receiving a psychological misdiagnosis can make a proper diagnosis of a rare disease take up to 14 times longer.

The pain patients in my practice (as well as myself) have been told it’s just normal aches and pains, there’s nothing wrong with you, condescended to, yelled at, disbelieved, laughed at, mocked, called names, and dismissed in all manners of arrogance and ignorance.

We’re on the cusp of 2021 and I am still telling my pain patients not to go to any appointment alone because that makes you even more vulnerable to mistreatment. Another person in the room with you can temper abusive treatment by being there as a witness. No one suffering should have to go to any lengths to receive the care they deserve. However, that is reality.

We’ve come too far just to lie down and accept medical gaslighting. Do what you can to defeat this. Find a medical provider that you can connect with; someone who listens, is honest, and frank with you. I have had the privilege of having one physician who completely fits the bill and am now searching for the next.

Become your own advocate. Do not put up with someone who is condescending, arrogant, or mistreating you – fire this person. You and your health need to be taken seriously. Watch for biases and do report a gaslighting doctor. Go to the clinical supervisor, board of the hospital, and the regulating college or agency. Be direct and honest about how you were treated and demand they take action.

There is always a legal option as well if you were harmed physically and/or mentally by the grievous actions of a gaslighting physician. Whatever decision you make, above all else, do not accept this abuse. We must all speak up and speak out!

“Nothing strengthens authority so much as silence.”
Leonardo da Vinci

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for over 30 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website.

Can ‘Magic Mushrooms’ Help Dying Patients?

By JoNel Aleccia, Kaiser Health News

Back in March, just as anxiety over COVID-19 began spreading across the U.S., Erinn Baldeschwiler of La Conner, Washington, found herself facing her own private dread.

Just 48 and the mother of two teenagers, Baldeschwiler was diagnosed with stage 4 metastatic breast cancer after discovering a small lump on her chest, no bigger than a pea.

Within weeks, it was the size of a golf ball, angry and red. Doctors gave her two years to live.

“It’s heartbreaking,” she said. “Frankly, I was terrified.”

But instead of retreating into her illness, Baldeschwiler is pouring energy into a new effort to help dying patients gain legal access to psilocybin — the mind-altering compound found in so-called magic mushrooms — to ease their physical and psychic pain.

“I have personally struggled with depression, anxiety, anger,” Baldeschwiler said. “This therapy is designed to really dive in and release these negative fears and shadows.”

Erinn Baldeschwiler

Dr. Sunil Aggarwal, a Seattle palliative care physician, and Kathryn Tucker, a lawyer who advocates on behalf of terminally ill patients and chairs a psychedelic practice group at Emerge Law Group, are championing a novel strategy that would make psilocybin available using state and federal “right-to-try” laws that allow terminally ill patients access to investigational drugs.

They contend that psilocybin — whether found in psychedelic mushrooms or synthetic copies — meets the criteria for use laid out by more than 40 states and the 2017 Right to Try Act approved by the Trump administration.

“Can you look at the statute and see by its terms that it applies to psilocybin?” Tucker said. “I think the answer is yes.”

Currently, psilocybin use is illegal under federal law, classified as a Schedule 1 drug under the U.S. Controlled Substances Act, which applies to chemicals and substances with no accepted medical use and a high potential for abuse, such as heroin and LSD.

Recently, however, several U.S. cities and states have voted to decriminalize possession of small amounts of psilocybin. This month, Oregon became the first state to legalize psilocybin for regulated use in treating intractable mental health problems. The first patients will have access beginning in January 2023.

It’s part of a wider movement to rekindle acceptance of psilocybin, which was among psychedelic drugs vilified — and ultimately banned — after the legendary counterculture excesses of the 1960s and 1970s.

“I think a lot of those demons, those fears, have been metabolized in the 50 years since then,” Aggarwal said. “Not completely, but we’ve moved it along so that it’s safe to try again.”

He points to a growing body of evidence that finds that psilocybin can have significant and lasting effects on psychological distress. The Johns Hopkins Center for Psychedelic and Consciousness Research, launched this year, has published dozens of peer-reviewed studies confirming that psilocybin helped patients grappling with major depressive disorder and suicidal thoughts.

Researchers are also looking at psilocybin as a treatment for post-traumatic stress disorder (PTSD), Lyme disease syndrome, cluster headaches and migraines. A small placebo-controlled study by Yale researchers found that migraine sufferers experienced a significant decrease in weekly migraine days after only one dose of psilocybin. 

“Psilocybin was well-tolerated; there were no unexpected or serious adverse events or withdrawals due to adverse events. This exploratory study suggests there is an enduring therapeutic effect in migraine headache after a single administration of psilocybin,” researchers found. 

Psilocybin Shifts Perception

Psilocybin therapy appears to work by chemically altering brain function in a way that temporarily affects a person’s ego, or sense of self. In essence, it plays on the out-of-body experiences made famous in portrayals of America’s psychedelic ’60s.

“What psychedelics do is foster a frame shift from feeling helpless and hopeless and that life is not worth living to seeing that we are connected to other people and we are connected to a universe that has inherent connection,” said Dr. Ira Byock, a palliative care specialist and medical officer for the Institute for Human Caring at Providence St. Joseph Health.

“Along with that shift in perspective, there is very commonly a notable dissolution of the fear of dying, of nonexistence and of loss, and that’s just remarkable.”

The key is to offer the drugs under controlled conditions, in a quiet room supervised by a trained guide, Byock said. “It turned out they are exceedingly safe when used in a carefully screened, carefully guided situation with trained therapists,” he said. “Almost the opposite is true when used in an unprepared, unscreened population.”

The FDA has granted “breakthrough therapy” status to psilocybin for use in U.S. clinical trials conducted by Compass Pathways, a psychedelic research group in Britain, and by the Usona Institute, a nonprofit medical research group in Wisconsin. More than three dozen trials are recruiting participants or completed, federal records show.

But access to the drug remains a hurdle. Though psychedelic mushrooms grow wild in the Pacific Northwest and underground sources of the drug are available, finding a legal supply is nearly impossible.

End of Life Washington, a group focused on helping terminally ill patients use the state’s Death With Dignity Act, recently published a policy that supports psilocybin therapy as a form of palliative care. Other treatments for anxiety and depression, such as medication and counseling, may simply not be practical or effective at that point, said Judith Gordon, a psychologist and member of the group’s board of directors.

“When people are dying, they don’t have the time or the energy to do a lot of psychotherapy,” she said.

Baldeschwiler agrees. With perhaps less than two years to live, she wants access to any tool that can ease her pain. Immunotherapy has helped with the physical symptoms, dramatically shrinking the size of the tumor on her chest. Harder to treat has been the gnawing anxiety that she won’t see her 16-year-old daughter, Shea McGinnis, and 13-year-old son, Gibson McGinnis, become adults.

“They are beautiful children, good spirits,” she said. “To know I might not be around for them sucks. It’s really hard.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Low-Dose Naltrexone Gaining Recognition as Chronic Pain Treatment

By Pat Anson, PNN Editor

Low-dose naltrexone (LDN) is finally getting some recognition from the medical community as a treatment for chronic pain. The December edition of the Journal of the American Dental Association (JADA) features a cover story on the use of LDN by dentists – not to manage short term pain during dental procedures – but to treat chronic oral and facial pain conditions such as temporomandibular joint disorder (TMJ).

“Low-dose naltrexone provides an alternative in medical management of chronic pain disorders as a novel anti-inflammatory and immunomodulator. It can offer additional management options, as orofacial pain conditions share characteristics with other chronic pain disorders,” wrote Elizabeth Hatfield, DDS, corresponding author and clinical lecturer at the University of Michigan School of Dentistry.  

Few mainstream medical organizations have recognized the benefits of naltrexone as a pain reliever, largely because the drug is only approved by the Food and Drug Administration as a treatment for substance abuse. In 50mg doses, naltrexone blocks opioid receptors in the brain and decreases the desire to take opiates or alcohol.  

But in smaller doses of 5mg or less, patients with a wide variety of pain conditions have found LDN to be a surprisingly effective pain reliever. PNN columnists have shared their positive experiences using LDN to treat everything from interstitial cystitis to Ehlers-Danlos syndrome to fibromyalgia.  

How naltrexone works is not exactly clear – more research is needed – but LDN supporters believe the drug helps modulate the immune system, reducing inflammation and stimulating the production of endorphins, the body's natural painkiller.  

The lack of good quality research on LDN is evident in the JADA article. Hatfield and her colleagues reviewed nearly 800 studies, but could find only eight that met their criteria for evaluation, most of them focused on treating fibromyalgia. Nevertheless, they say LDN could be an effective and less risky alternative to opioids and non-steroidal anti-inflammatory drugs (NSAIDs) for treating chronic oral and facial pain.

"The unique antinociceptive properties mediated via glial cell modulation, as opposed to previously identified pathways of opioids and anti-inflammatories such as NSAIDs, is attractive as it bypasses certain side effects and concerns with long-term NSAID and opioid use," said Hatfield. "Further benefits include reduction in reported pain levels and measurable increases in quality of life for patients with chronic pain disorders. Additionally, it offers an option for prescribers managing temporomandibular joint disorders with a centralized pain component.”

A 2019 review by British researchers found that LDN is safe to use, but also recommended that more clinical studies be conducted on its potential uses.

Because naltrexone is only approved to treat addiction, LDN needs to be prescribed “off-label” for pain. Patients interested in trying LDN often encounter doctors who refuse to prescribe it or don’t know anything about it. The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.

A Grumpy Old Lady in Pain

By Rochelle Odell, PNN Contributor

As I lay once again, in pain, waiting for my small dose of pain meds to kick in, I stare at the dark ceiling, asking, begging God to please help me. There is nothing but silence around me except for the low volume of my TV.

I find my patience, what little I had, is now gone. I find myself writing a post on Facebook that perhaps did not have to be as blunt as it was or as challenging -- as even I recognized it to be. 

Am I judging others in this battle? Has my nearly 28-year battle with CRPS and it's incessant, never ending pain turned me into someone I am not thrilled about? Am I judging good people, in pain like me, too harshly at times?

I find some online comments are made with little thought or logic by others. I know and tell people there is only one person or deity that can judge anyone and that's the man upstairs, God. And in all honesty, I don't have the right to criticize anyone for what they say or do, except for liberals. Okay, cardinal rule, don't bring politics into our battle for pain relief. I am sorry.

Why do those who obviously haven't read an article or post refuse to admit that their response makes no sense? I spend a lot of time reading articles, but many don't and I feel if you can't find the time to read, don't comment. There are times I may read a post that really galls me and I respond critically, then I think of those I may have upset.

Why did I do or say what I did? I guess because like all in pain, I am tired. Tired of hurting, tired of fighting to get pain management back to where it should be for all. Especially tired of the few wannabes who think it's cool to be part of the pain community -- a community we would all give anything not to be a part of.

The very few I do challenge proudly boast of the ever-growing list of ailments that they wear as a badge of honor. They proudly state no doctor will agree or diagnose them with any of the pain diseases that they have self-diagnosed. You know the type. They have gone down the list of symptoms, convinced they surely must have it.

For shame. They honestly believe they have been wronged. Those people bother me, because there are many who suffer unrelenting pain from diseases physicians have actually diagnosed. I have been diagnosed with several and I want no part of them. I do try to stick with the CRPS only. It was the first and worst of what ails me.

ROCHELLE ODELL

Adding more or reading off what I call our laundry list of ailments won't change my low dose of opioid pain medication. My pain management PA is very sweet and compassionate, but we all know that high doses of opioids are nothing but a memory. A memory of when we used to function. I want my life back without pain and without needing medication. We all want our lives back... period!

I have my life friends who I’ve known since childhood, and new friends I’ve met in the pain community. Like my family, they mean the world to me. Each person brings something I may need or I bring something to them that they need. Pain brought us together. And if it weren't for pain, our paths would never have crossed.

My life has spanned seven decades, sometimes flying by and other times dragging by ever so slowly. The adventures I had, the experiences, I wouldn't trade for anything. I am thankful to have experienced what I did. Too many pain patients don't, especially younger ones. All they know is pain. They can only dream of traveling the world like I did. Those of us who had a life before pain were able to experience places, people and things. The memories are bittersweet.

I suppose at 73 that I am old, very opinionated and faced with the reality God can come knocking on my door anytime. Although for some reason the age of 93 is set in my mind when he will take me. Can't imagine living in this pain for twenty more years.

I have learned in this pain journey that I don't have to win every argument. I don't have to win every point. That if I ignore an annoying Facebook post and simply log off, I don't develop a killer stress headache trying to prove I was right. Being right all the time makes for a probably obnoxious person. I don't want to be that way, I really don't, but it is my reality, my life, me.

When thinking of love, I have loved and have been in love. Do I want to be married again? Odds are no. Like most, I don't want to live my golden years alone but I have become so set in my ways, set in my routine, set in how I choose to live any day my way. If I want to wear my jammies all day and not comb my hair, I can. If another person was around, I would have expectations placed on me I may not want.

But I also get so tired of battling pain with no real source of help I can depend on. I have only me to depend on. I am not the only one alone and we do hurt the most.

If my pain is severe and I want to cry, I can, with no explanations. Although if I do cry my little sidekick Maggie, an 8-year-old dachshund, gets right next to my face crying with me. Don't have any humans that sit next to me and cry with me, although I know of some sweet pain friends who would if I asked. Little Maggie has been so vocal. I look at her and ask do I really sound that bad, that pathetic? Yes!

I don't want to come across as judgmental or too critical. I don't want to be the mean old lady in the neighborhood. But you know what? Living in pain, alone for close to 28 years, well, if the shoe fits...

If my comments come across as mean, try to remember pain has changed us all. I see that in the pain community. 'A' can't stand 'B' and 'B' is thoroughly disgusted with 'C.' Meanwhile, 'D' shakes their head asking why? Why do we say and act in ways that may not be nice?

Guess I will set the timer on my TV, pray to God one more time to please take my pain away, and close my eyes hoping sleep comes, if even for a couple of hours. And pray those around me understand why this grumpy old woman says what she does.

Rochelle Odell lives in California.

PNN invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

COVID-19 Vaccines May Be Risky for People with Chronic Illness

By Roger Chriss, PNN Columnist

Covid-19 vaccine researchers reported good news this week. Pfizer and Moderna both announced encouraging efficacy data and will soon submit applications to the Food and Drug Administration for emergency use authorizations.

Moderna reported that its vaccine was 94.5% effective in a Phase 3 trial of more than 30,000 participants. Similarly, Pfizer’s vaccine had an efficacy rate of over 90 percent, with only 94 confirmed cases of COVID-19 in a study that included over 43,000 volunteers.

Both of these vaccines are based on mRNA technology, a genetic approach to vaccines that directs protein production throughout the body. AstraZeneca took a more conventional approach with its vaccine and just reported promising Phase 2 trial results.

There are of course important questions to sort out, including long-term efficacy and safety. This latter point is particularly important for people with chronic illness.

The vaccine trials have been run with volunteers, who may be more health conscious and healthier than the population at large, and people with specific disorders are excluded. As a result, safety issues for people in treatment for active cancer, people with autoimmune diseases, and people with rare genetic disorders are unclear.

“We also don't know for sure whether this vaccine is safe and effective in different types of people, such as pregnant women, the elderly, or those with a chronic illness,” MedicalXpress reported. “Once a vaccine is deployed ‘in the real world,’ we'll start to understand its true effectiveness. In practice, this is likely to be different to its efficacy in highly controlled clinical trials.”

Specific disorders sometimes require avoiding certain vaccines. The CDC maintains a comprehensive list of vaccine contraindications and precautions, including a recommendation that live virus vaccines “should not be administered to severely immunocompromised persons.”

The CDC cautions that anyone with a “weakened immune system, or has a parent, brother, or sister with a history of hereditary or congenital immune system problems” should talk to their doctor before being vaccinated. People who have had any other vaccines in the past 4 weeks should also consult with a provider first.  

The American Cancer Society recommends against live vaccines for patients getting chemotherapy or radiation treatment.

“In general, anyone with a weak immune system should not get any vaccines that contain live virus. There are a few vaccines that contain live viruses, which can sometimes cause infections in people with weak immune systems that can become life-threatening,” the Society warns.

Autoimmune disorders are also complex. The Hospital for Special Surgery warns that live vaccines “are not recommended for lupus patients, due to the increased risk of infection from the vaccine.”

Most vaccines are very safe for most people. But vaccine safety presents a big question for a small group of people with specific risk factors like cancer or chronic illness. At this point there is simply no safety data on COVID-19 vaccines in such people. Hopefully there will soon be clear answers.

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. 

What Does Intractable Pain Really Mean?

By Forest Tennant, PNN Columnist

Many people have chronic pain. If you are over age 60, you probably have some bothersome pain from arthritis, bunions, carpal tunnel, TMJ or a neuropathy. These common conditions cause intermittent pain which may be quite bothersome.

There are some unfortunate persons, however, who have terrible, grueling pain that just won’t go away. It’s there 24/7. It’s the kind that keeps you awake and makes you feel so sick you can’t read, think or socialize, and it will force you to take cover on the couch or in bed.

The pain can be primarily located anywhere on the body such as the hip, neck or back. But when it flares you feel it “all over” and it is intense.

This constant pain means you have a primary or underlying disease or injury that has emitted and sent so much electricity to the central nervous system (CNS) that inflammation forms inside the brain or spinal cord. The brain chemicals and neurotransmitter-receptor systems (NTRS) that normally control and shut down pain become damaged and impaired. The chemicals your own body makes for pain control, as well as pain medications, ​stop working correctly because of the damage to these chemical-tissue receiving sites.

Constant pain means you ​need a program or protocol to treat your basic injury or disease. One that reduces electric impulses and helps rebuild the damage to the NTRS in your spinal cord and brain. Symptomatic pain relievers are usually a must, but they don’t treat or reverse your basic problem.

Intractable Pain Syndrome

Due to new research, we now call the constant pain condition the Intractable Pain Syndrome (IPS). It’s called a “syndrome” because of the many manifestations of the condition.

IPS is a complication of a disease or injury. To obtain some relief and recovery, every person with IPS must know the name of the disease or injury that started the pain, and the anatomic location on the body that first sustained pain. Our studies have found that many persons with IPS don’t have a diagnosis for the cause of their pain and may have even forgotten the site on their body where the pain originated.

Common causes of IPS are:

• Adhesive Arachnoiditis

• Reflex Sympathetic Dystrophy (RSD) or Complex Regional Pain Syndrome (CRPS)

• Advanced Osteoarthritis

• Genetic Connective Tissue/Collagen Disorder (Ehlers-Danlos Syndrome)

• Traumatic Brain Injury (stroke, trauma)

• Autoimmune Disease

There are other rare causes of IPS, including porphyria, sickle cell disease, interstitial cystitis, Lyme disease and rare genetic disorders.

Vague complaints or diagnoses about back pain, headaches, sprains, strains or “pain all over” are not specific enough to get you much relief or recovery and can’t be considered a legitimate cause of IPS. That’s why it is important to know the specific cause of your pain. What was the specific diagnosis that warranted an epidural injection, surgery or an opioid prescription?

Regardless of what caused your IPS or how long you’ve had it, your original pain site is problematic and needs to be identified. The site is generating inflammation and electricity, and could be scarred in a way that blocks the normal flow of electricity through the body.

The major goal of the IPS Research and Education Project is to bring awareness that simple chronic pain and IPS are quite different entities. A second goal is to bring recognition, prevention and treatment of IPS into mainstream medical practice at the community level. IPS must be known, recognized and treated in the ambulatory medical system like any other long-term care problem such as rheumatoid arthritis, emphysema, diabetes, asthma, or schizophrenia.

It must also be done along with physical, psychologic and pharmaceutical measures that are acceptable to all concerned parties and that don’t require high, risky dosages of abusable drugs.

Forest Tennant is retired from clinical practice but continues his groundbreaking research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here.

The Tennant Foundation has given financial support to Pain News Network and is currently sponsoring PNN’s Patient Resources section.  

Alcohol Yes, But Opioid Meds Not So Easy

By Fred Brown, Guest Columnist

Like everyone else, I have found that living through the past many months of Covid-19 has been very taxing and challenging. Fortunately, our family has been blessed. One of our daughters who works in a local hospital caught a mild case of Covid-19 and has fully recovered. The rest of us are Covid-free. 

As more and more states began to reopen their economies in the spring, I noticed an interesting phenomenon.  Why were some of the first businesses to reopen bars and lounges?   

Before becoming a chronic pain patient, I did enjoy an occasional vodka and tonic or a glass or two of wine.  But now that I am on medications to help reduce the symptoms of pain, I am not stupid enough to drink liquor.  Even during religious holidays, where small amounts of wine are customary, I will drink grape juice. 

Fellow pain patients; please do not combine your medications with any form of liquor. There is plenty of evidence that side effects from the two do not add up. They multiply! 

My objective in this column is to make a point and share an observation about alcohol. Unfortunately, this legal drug kills an estimated 88,000 Americans every year. Alcohol not only hastens the deaths of people who abuse it, but often causes the deaths of other innocent people. 

I am in no way saying that bars, lounges and liquor stores should not open. I would never say what people should or should not do.  But I must still pose the question: Is alcohol really a necessity?  I do not know. But speaking as a patient advocate, I will say that something else most certainly is: Many patients need opioid medication to help control their pain. Not to take the pain totally away, but to help reduce the symptoms and have at least some quality of life. 

Millions of people are in constant, daily pain -- and usually not through any fault of their own. There are hundreds of different diseases that cause severe pain. Or maybe there was a medical error or botched surgery that resulted in a patient having chronic pain. 

I am not going to analyze why an individual drinks alcohol. It is a legal and socially accepted practice during dinner, parties and other events, many times in celebration. But why is this drug sold so freely, while opioid medications have so many obstacles and barriers that prevent patients from obtaining them? Even when a licensed physician legally prescribes them?  

Both alcohol and opioids, when used over time, can cause people to become dependent or, in some instances, addicted. But there is a big difference between addiction and dependence that many people do not fully recognize. Briefly, let us examine the truth about both terms.   

Dependency refers to a person who has been on medication for a specific period (generally at least weeks or months). The body has developed a physical dependence on the drug and has built a tolerance to it. Pain medicine may require increases in dosage and strength over time because of the progression of the underlying medical condition or because the body has adjusted and becomes tolerant. If the medication is withdrawn rapidly, the person may suffer very unpleasant withdrawal symptoms.

Addiction is a compulsive need for and use of any habit-forming substance, such as opioids, nicotine or alcohol. It is characterized by a spectrum of well-defined behaviors that persist even when the substance use is associated with profoundly negative consequences for the user and their family.

Is there an "opioid crisis" as the media has reported? YES!  Was it primarily caused by doctors writing too many prescriptions for opioids? The answer to that question is a resounding NO!   

It is rare for a medical patient to abuse or become addicted to opioid medication. Every person processes medication differently. Their bodies metabolize medicines at different rates.  That is why the current belief in "one size fits all" solutions for pain are not acceptable. There is zero science to back it up.  

Fred Brown is an advocate for pain patient rights who has lived with degenerative disc disease, bone spurs, stenosis and other spinal problems for over two decades. Opioid medication therapy allows Fred to continue functioning and have quality of life.  

GlaxoSmithKline Most Heavily Fined Drug Company

By Pat Anson, PNN Editor

The pharmaceutical industry has long been criticized for engaging in illegal or unethical activities, such as fraud, kickbacks and price gouging. A new study published in JAMA shines a light on the scale of the problem, finding that Big Pharma paid over $30 billion in financial penalties for illegal activities in the United States.

Researchers looked at state and federal settlements from 2003 to 2016 and found that almost every large pharmaceutical company had paid a fine for illegal activity. The biggest transgressor was GlaxoSmithKline (GSK), which paid nearly $9.8 billion to settle 27 cases brought against it for bribery, corruption, improper marketing, pricing violations and selling adulterated drugs. In one settlement alone, GSK was fined $3 billion for encouraging doctors to prescribe its antidepressants to children.  

The fines paid by GSK were over three times higher than the amounts paid by Pfizer ($2.9 billion) and Johnson & Johnson ($2.6 billion) during the study period. Researchers say only four of the 26 drug companies they analyzed were not assessed a penalty.

TOP 10 MOST HEAVILY FINED DRUG COMPANIES

1. GlaxoSmithKline $9.8 billion

2. Pfizer $2.9 billion

3. Johnson & Johnson $2.6 billion

4. Abbott Laboratories $2.5 billion

5. Merck $2.1 billion

6. Eli Lilly $1.8 billion

7. Schering-Plough $1.6 billion

8. Wyeth $1.6 billion

9. Bristol Myers Squibb $1.4 billion

10. Novartis $1.2 billion

“Among the large pharmaceutical companies included in this study, 85% had evidence of financial penalties for illegal activities. Given the scope and nature of the illegal activities involving financial penalties, physicians and regulators should exhibit vigilance over the activities of large pharmaceutical firms,” wrote lead author Denis Arnold, PhD, a professor of business ethics at Belk College of Business, University of North Caroline at Charlotte.

“Four firms were not found to have penalties for illegal activities during the sample period. This may indicate an ability for illegal activity to be undetected, although these firms may instead have effective ethics and compliance programs.”

Because the study period ended in 2016, it did not include any recent settlements with drug companies involving opioid litigation. Nor did it cover fines paid outside the U.S., such as the $490 million fine that GSK paid for bribing Chinese doctors to prescribe its medications.

“This has been a deeply disappointing matter for GSK," chief executive Sir Andrew Witty said in a formal apology to the Chinese government in 2014.

Not much has changed at GSK over the years. This year the company agreed to pay $4.5 million in fines in Australia for marketing and price violations involving the pain relief gel Voltaren.  The British pharmaceutical giant was also recently fined $2.8 million by Romania for failing to supply the country with asthma medication.

Drug company executives rarely serve prison time for illegal activities and the large fines do not appear to be much of a deterrent against unethical behavior. The nearly $9.8 billion paid by GSK amounts to less than 2 percent of its total revenues during the study period. On average, GSK’s illegal activities went on for over seven years before the company stopped them, according to the JAMA study.

GSK did not respond to a request for comment for this story.    

Fraud Alert for Speaker Programs

In recent years, federal watchdogs have become increasingly concerned about the use of speaker fees, free meals, entertainment and other kickbacks paid by healthcare companies to promote their drugs and medical devices. In the last three years, companies paid nearly $2 billion to healthcare providers for speaker-related services.

In a special fraud alert released this week, the Office of Inspector General (OIG) for the Department of Health and Human Services warned against the practice, saying high-priced speaker programs “may be subject to increased scrutiny.” The OIG cited cases where speaker programs were held at wineries, stadiums and restaurants where expensive meals and alcohol were served at no charge to attendees.

“OIG is skeptical about the educational value of such programs. Our investigations have revealed that, often, HCPs (healthcare providers) receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend,” the report warns.

“Furthermore, studies have shown that HCPs who receive remuneration from a company are more likely to prescribe or order that company’s products. This remuneration to HCPs may skew their clinical decision making in favor of their own and the company’s financial interests, rather than the patient’s best interests.”

Tax on Prescription Opioids Costly for Pain Patients

By Anastassia Gliadkovskaya, Kaiser Health News

Mike Angevine lives in constant pain. For a decade the 37-year-old has relied on opioids to manage his chronic pancreatitis, a disease with no known cure.

But in January, Angevine’s pharmacy on Long Island ran out of oxymorphone and he couldn’t find it at other drugstores. He fell into withdrawal and had to be hospitalized.

“You just keep thinking: Am I going to get sick? Am I going to get sick?” Angevine said in a phone interview. “Am I going to be able to live off the pills I have? Am I going to be able to get them on time?”

His pharmacy did not tell him the reason for the shortage. But Angevine isn’t the only pain patient in New York to lose access to vital medicine since July 2019, when the state implemented an excise tax on many opioids.

The tax was touted as a way to punish major drug makers for their role in the opioid epidemic and generate funding for treatment programs. But to avoid paying, scores of manufacturers and wholesalers stopped selling opioids in New York. Instead of the anticipated $100 million, the tax brought in less than $30 million in revenue, two lawmakers said in interviews. None of it was earmarked for substance abuse programs, they said.

The state’s Department of Health, which has twice this year delayed an expected report on the impact of the tax, did not respond to questions for this story.

The tax follows strong efforts by federal and New York officials to tamp down the use of prescription opioids, which had already cut back some supply. Now, with some medications scarce or no longer available, pain patients have been left reeling. And the law appears to have missed its target: Instead of taking a toll on manufacturers, the greater burden appears to have fallen on pharmacies that can no longer afford or access the painkillers.

Among them is Epic Pharma. Independent Pharmacy Cooperative, a wholesaler, confirmed it no longer sells medications subject to the tax, but still sells those that are exempt, which are treatments for opioid addiction methadone and buprenorphine and also morphine. AvKARE and Lupin Pharmaceuticals said they do not ship opioids to New York anymore. Amneal Pharmaceuticals, which manufactures Angevine’s oxymorphone, declined to comment, as did Mallinckrodt.

Since the tax went into effect, Cardinal Health, which provides health services and products, published an extensive 10-page list of opioids it does not expect to carry. Cardinal Health declined to comment.

The New York tax is slowly gaining attention in other states. Delaware passed a similar tax last year. Minnesota is assessing a special licensing fee between $55,000 and $250,000 on opioid manufacturers. New Jersey Gov. Phil Murphy proposed such a tax this year but was turned down by the legislature.

More Expensive Prescriptions

The company that makes the first point of sale within New York pays the tax. That isn’t always the drug maker. It can mean wholesalers selling to pharmacies here are assessed, explained Steve Moore, president of the Pharmacists Society of the State of New York.

Independent Pharmacy Cooperative (IPC) said about half its revenue from opioid sales in New York would have gone to taxes. Mark Kinney, the company’s senior vice president of government relations, said the law is putting companies in a very difficult position. When wholesalers like IPC left the opioid market, competitive prices went with them.

Without these smaller wholesalers, it’s hard for pharmacies to go back to other wholesalers “and say, ‘Hey, your prices aren’t in line with the rest of the market,’” Moore said.

Indeed, nine independent pharmacies told KHN that when they can get opioids they are more expensive now. They have little choice but to eat the cost, drop certain prescriptions or pass the expense along.

“We can trickle that cost down to the patient,” said a pharmacist at New London Pharmacy in Manhattan, “but from a moral and ethics point of view, as a health care provider, it just doesn't seem right to do that. It’s not the right thing to ask your patient to pay more.”

In addition, Medicare drug plans and Medicaid often limit reimbursements, meaning pharmacies can’t charge them more than the programs allow.

Stone’s Pharmacy in Lake Luzerne was losing money “hand over fist,” owner Leigh McConchie said. His distributor was adding the tax directly to his pharmacy’s cost for the drugs. That helped drive down his profit margins from opioid sales between 60% and 70%. Stone’s stopped carrying drugs like fentanyl patches and oxycodone, and though that distributor now pays the tax itself, the pharmacy is still feeling the effects.

“When you lose their fentanyl, you generally lose all their other prescriptions,” he said, noting that few customers go to multiple pharmacies when they can get everything at one.

If pharmacies have few opioid customers, those price hikes have less impact on their business. But being able to manage the costs is not the only problem, explained Zarina Jalal, a manager at Lincoln Pharmacy in Albany. Jalal can no longer get generic oxycodone from her supplier Kinray, though she can still access brand-name OxyContin.

New York’s Medicaid Mandatory Generic Drug Program requires insurers to provide advance authorization for the use of brand-name prescriptions, delaying the approval process. Sometimes patients wait several days to get their prescription, Jalal explained.

“When I see them suffer, it hurts more than it hurts my wallet,” she said.

One of Jalal’s customers, Janis Murphy, needs oxycodone to walk without pain. Now she is forced to buy a brand-name drug and pays up to three times what she did for generic oxycodone before the tax went into effect. She said her bill since the start of this year for oxycodone alone is $850. Lincoln Pharmacy works with Murphy on a payment plan, without which she would not be able to afford the medication at all. But the bill keeps growing.

“I’m almost in tears because I cannot get this bill down,” she said in a phone interview.

Several pharmacists raised concerns that patients who lose access to prescription opioids may turn to street drugs. High prescription prices can drive patients to highly addictive and inexpensive heroin. McConchie of Stone’s Pharmacy said he now dispenses twice as many heroin treatment drugs as he did a year ago. Former opioid customers now come in for prescriptions for substance use disorder.

Cost of Percocet Doubled

Trade groups and some physicians and state legislators opposed the tax before it went into effect, voicing concerns about a slew of potential consequences, including supply problems for pharmacists and higher consumer prices.

New London Pharmacy said one of its regular distributors stopped shipping Percocet, a combination of oxycodone and acetaminophen. Instead, the pharmacy orders from a more expensive company. The pharmacist estimated that a bottle of Percocet for which it used to pay $43 now costs up to $92.

“Even if we absorb the tax, we’re not getting a break from reimbursements either,” a pharmacist who spoke on the condition of anonymity explained, adding that insurance reimbursements have not increased in proportion to rising drug costs. “We’re losing.”

Latchmin Raghunauth Mondol, owner of Viva Pharmacy & Wellness in Queens, has also seen that problem. The pharmacy used to be able to purchase 100 15-milligram tablets of oxycodone for $15, but that’s now $70, she said, and the pharmacy is reimbursed only about $21 by insurers.

Other opioids are just not available.

Mondol said she has been unable to obtain certain doses of two of the most commonly prescribed opioids, oxycodone and oxymorphone—the drug Angevine was on.

After Angevine lost access to oxymorphone, his doctor put him on morphine, but it does not give him the same relief. He’s been in so much pain that he stopped going to physical therapy appointments.

“It’s a marathon from hell,” he said.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation) that is not affiliated with Kaiser Permanente.

Stem Cell Clinic in Colombia Offers Hope to International Pain Patients

By A. Rahman Ford, PNN Columnist

As the U.S. Food and Drug Administration continues to restrict access to stem cell therapy with its overly burdensome regulations, Americans with chronic pain continue to suffer needlessly.

Although many clinics in the U.S. use stem cells to treat arthritis, degenerative disc disease and other pain conditions, FDA regulatory restrictions make affordable access to these therapies inordinately difficult, if not downright impossible, for the average patient. As a result, many Americans are traveling to other countries to receive the pain treatment they need.

The BioXcellerator stem cell clinic in Medellin, Colombia is one of those destinations. Although its corporate headquarters is located in Arizona, BioXcellerator is not constrained by excessive regulations in Colombia, where it has used regenerative medicine for years to treat pain, often with remarkable results.

BioXcellerator CEO Karolynn Halpert, MD, has made it her mission to help pioneer stem cell therapy in Colombia. Dr. Halpert was an emergency room physician and administrator at a Medellin clinic before joining BioXcellerator, following the same career path as her parents, who are both physicians. As Halpert likes to joke about her interest in cellular science, “I guess you could say it’s in my DNA.”

“Not only do I get to work on the frontiers of scientific discoveries we couldn’t even envision a decade ago, I also get a chance to meet patients, help them heal, see the results, and share in their joy as they suffer less pain and enjoy healthier lives,” Halpert said in an email.

“Getting to know patients is what makes you become a ‘real’ doctor, something I think is lost with so much access to technology today.”

BioXcellerator uses mesenchymal stem cells (MSCs) derived from umbilical cord blood, a patient’s own adipose (fat) tissue or their own bone marrow. Treatment protocols are unique to each patient, with stem cells injected into parts of the body where they are most needed.

“For example, if we’re treating a spinal disorder, we inject cells directly into the spinal fluid or intrathecal space,” Halpert explained. “We often see quick results, but mostly the major benefit takes months to develop.”

DR. Karolynn Halpert

BioXcellerator tracks its patients for 12-19 months to confirm results, and to observe how the body uses stem cells to repair and regenerate tissues and joints. Halpert says she gets positive results in about 80 to 90 percent of patients, in large part because she only accepts patients who she believes can benefit from the therapy.

Most of BioXcellerator’s patients suffer from chronic pain. Halpert has treated many conditions, including osteoarthritis, rheumatoid arthritis, joint injuries, spinal damage, autoimmune conditions, orthopedic disorders and neurological conditions. She cites the example of a woman who recently came to her seeking stem cell therapy for a severely and consistently painful spinal condition.

“The day after we injected stem cells into her compressed and degenerated disc, she was here in the office jumping, dancing, hugging all of us, crying in joy, because it was the first day in years that she had suffered no pain,” Halpert recalled.

Another patient had been in a car accident that left him disabled, unable to work and in such excruciating pain that he considered suicide. “Just a few months after treatment he was no longer in pain, went back to work and enjoys life once again,” said Helpert.

Many of BioXcellerator’s patients are professional athletes, including mixed martial art competitors like Ken Shamrock, Chuck Liddell, Chris Cyborg, Frank Mir, Frankie Edgar, Kamaru Usman, Chael Sonnen and Henry Cejudo.

Others who have traveled for treatment in Colombia include professional wrestlers such as Ryback Reeves, Kevin Nash and Bobby Lashley. Other noteworthy patients include social media influencers Amberley Snyder, Jesse Golden and Brian Goldstein.

Response to Stem Cell Critics

Unlike stem cell clinics in the U.S. that are demonized as “bad actors” and “predatory,” BioXcellerator enjoys a good working relationship with INVIMA, Colombia’s equivalent to the FDA. Halpert notes that INVIMA recently approved BioXcellerator’s proposal for a clinical trial to use stem cells to treat COVID-19.

Halpert acknowledges there is a worldwide veil of ignorance among physicians about the therapeutic efficacy and potential of stem cells.  She believes Colombia may be more progressive than other countries, which is why the BioXcellerator clinic in Medellin attracts so many international patients.

As for critics who say stem cell treatments are “unproven” and “risky,” Halpert’s response is unequivocal.

“Let me be clear. We don’t put anyone at risk. Our goal is to help patients live better and stay healthy. If we put patients at risk, not only would our reputation suffer, but skepticism would grow about the entire field of regenerative medicine, and nobody wants that,” she said.

“Those who claim that our therapies are unproven are simply ignorant. Anyone who looks at the evidence with an open mind can see the proof for themselves. I don’t know what ‘critics’ you are referring to but I suspect they are not medical doctors with real experience in the field or PhD’s in biotechnology.”

As for the cost of stem cell treatment, which is usually not covered by insurance, Halpert asserts that cellular therapy is not a routine procedure and its costs are in line with those of other complex treatments such as surgery.

Medical treatment in Colombia is often cheaper than in the United States, and although international patients may be skeptical about traveling to Medellin – where drug cartels openly warred with each other in the 1980’s -- it is now ranked as one of the most innovative and smartest cities in the world.

As for the future of stem cell therapy (SCT), Halpert is optimistic.

“It’s part of a new approach that doesn’t simply mask symptoms with medications or repair structures through surgery,” she told me. “SCT really embraces a wider perspective that recognizes that the body knows how to heal itself. As we learn more about how this process works, we can make significant progress that will lead to a new age in medicine that focuses less on curing sickness and far more on health optimization, immunity, and longevity.”

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

Patient Advocates Critical of Canadian Pain Task Force Report

By Pat Anson, PNN Editor

A new report from the Canadian Pain Task Force is being called “political propaganda” and “shameful” by patient advocates.

The 75-page report was released last week by the task force, an advisory panel created by Health Canada in 2018 to help it address the needs of nearly 8 million Canadians who live with chronic pain. Like many of their counterparts in the United States, Canadian pain patients often have trouble getting access to opioid medication because of fears the drugs will lead to misuse and addiction.

The task force said it released its second report “with a sense of urgency” because the COVID-19 pandemic had reduced access to healthcare and social services for many people. The report calls chronic pain a “legitimate disease” and said better efforts were needed to provide access to pain treatment, improve public awareness and reduce stigma associated with chronic pain.

“Recent dramatic increases in opioid-related overdose deaths in North America have heightened awareness around the risks associated with both short- and long-term opioid use for chronic pain. However, efforts undertaken to respond to the overdose crisis have led to challenging unintended consequences for people living with chronic pain,” the report found.

“Some people in Canada have been unable to access opioid medications, and others who previously relied on opioids to manage their pain have been unable to continue their medications, or have had significant adjustments to lower their prescriptions, sometimes against their will.”

The task force also released findings from surveys and interviews with nearly 2,000 Canadians – both patients and providers -- who often had “differing expectations” about how chronic pain should be treated. Patients complained of limited access to specialists, long wait times, and treatments that didn’t work or were harmful.

“Many people living with chronic pain have experienced trauma in the context of medical care. They may have had invasive investigations and procedures or negative interactions with health professionals. Such experiences can be damaging on their own, but when compounded with previous trauma can lead to more drastic challenges such as changes in sense of self, view of the world, and nervous system dysregulation, which may all contribute to increased pain and difficulties coping,” the report found.

‘Nothing New’

But outside of announcing $3.5 million in funding for three local health projects, no immediate steps were announced by Health Canada or its task force to improve pain care for Canadians. The panel is not expected to release its third and final report until December 2021.

“There is nothing new in this report,” said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, a patient advocacy group. “Have they forgotten this is a 3-year study, which will not be completed until 2021? In the meantime, while they fiddle, Canadians continue to suffer and die when the solutions are already there, yet we continue to spend over $3 million taxpayer dollars. So where is the sense of urgency?”

The task force outlined its “next steps” with a vaguely worded statement that “leadership and resources are needed to amplify, spread, and accelerate current activities, coordinate responses, address current gaps and inequities, and reduce the variability across jurisdictions.”    

“This is simply a carefully constructed document to create the appearance of having listened to patient input, and to suppress the substance of changes demanded by both patients and doctors. It is political propaganda of the worst sort,” said Richard Lawhern, PhD, a patient advocate and co-founder of the Alliance for the Treatment of Intractable Pain (ATIP).

“Contrary to the biased declarations of this report, there is no evidence that increased availability of prescription opioids in medical treatment has been a significant factor in causing the public health crisis.”

“Nothing illustrates the folly of government policies better that the rising number of pain sufferers who turn to street heroin because they can no longer get legal medication.”

— Chronic Pain Association of Canada

Ulmer was frustrated that the report didn’t more broadly address how efforts to prevent addiction and overdoses have harmed pain patients.

“The fact that addiction and overdose deaths continue to soar should convince them they have taken the wrong path. But it hasn’t. Now they have pain patients deprived of their medications, with reduced quality of life, increased pain, patients committing suicide, as they are no longer able to cope, with some seeking street drug dealers to see if they can find some relief,” Ulmer said.

“Nothing illustrates the folly of government policies better that the rising number of pain sufferers who turn to street heroin because they can no longer get legal medication.”
  
Ulmer said the report’s brief discussion of opioid medication was “illogical, gutless, and shameful” and called on the Canadian government to “cease their war on pain patients” by immediately withdrawing Canada’s opioid guideline – without waiting for a final report from the task force.

Understanding the Difference Between Prescription Fentanyl and Illicit Fentanyl

By Roger Chriss, PNN Columnist

The opioid overdose crisis is now being driven by fentanyl. But misunderstandings over what fentanyl is, where it comes from, how it is used and why have become so pervasive that they plague discourse and debate about the crisis. News reports about “fentanyl overdose deaths” appear almost daily.

October saw a particularly tragic death. As reported by the Daily Courier in Prescott, Arizona, a 14-year-old high school student died of an overdose after taking what investigators suspect was a counterfeit pill “laced with the potent narcotic painkiller fentanyl.”

The tragedy of this death cannot be overstated. Nor can thousands of other overdose fatalities caused by fentanyl. But the nature of the drug needs to be better understood if we are to prevent such deaths moving forward.

Fentanyl is not one drug. It is better thought of as a family of synthetic opioids that are structurally similar, and includes sufentanil and remifentanil. These are pharmaceutical fentanyls, used clinically as anesthetics and essential for medical procedures such as open heart surgery.

Collectively, these drugs are part of a super-family known as fentanyl analogues. There are dozens of such drugs. Some are compounds developed by pharmaceutical companies for legitimate medical use, and others are manufactured illegally for use as street drugs. These forms of fentanyl are commonly referred to as “illicitly manufactured fentanyl” by government agencies like the CDC. The DEA has classified “fentanyl-related substances” as Schedule I controlled substances, meaning they are illegal to manufacture, distribute or possess.

To make this even more complicated, the fentanyl drug carfentanil is used legally in the U.S. as a tranquilizer for elephants and other large animals. The DEA authorizes production of a minute quantity of carfentanil for veterinarians every year. But illicit carfentanil from overseas occasionally shows up on the street and causes fatal overdoses.

Further muddying matters is the new fentanyl-like street drug isotonitazene, which is known colloquially as “iso.” It is “fentanyl-like” in its risks and harms, but is not technically a fentanyl analogue. “Iso” is instead related to etonitazene. Neither of these drugs has any recognized medical use in humans.

Risks Are Very Different

In other words, there is a vast gulf between pharmaceutical fentanyl and illicitly manufactured fentanyl. The former is a tightly controlled Schedule II prescription medication, approved for use in hospitals and to treat breakthrough cancer pain. The latter is an illegal substance cooked up in illicit labs that is often added to heroin or used to make counterfeit pills, which are then sold on the street or online.

This distinction is critical for understanding the opioid overdose crisis. The risks of a prescription opioid like fentanyl when given for medical use to a legitimate patient are very different from the risks of an illicit opioid being used non-medically by a random street buyer. Importantly, the risks for medical use can be addressed and managed. The risks of illicit use are much harder to deal with and often prove fatal.

The distinction also leads to confusion. The abundance of fentanyl on the street is rarely a result of diversion, and is unrelated to the supply of pharmaceutical fentanyl. These are different drugs, much as the cocaine nasal spray recently approved by the FDA as a local anesthetic is completely separate from the cocaine bought on the street. Pain experts are now pushing for a new classification for illicit fentanyl analogues, in the hope of clarifying this difference.

But fentanyl has so saturated the street drug market that more than a name change will be needed. As Ben Westhoff explains in the book “Fentanyl, Inc.”, preventing future opioid deaths will require “sweeping new public-health initiatives, including treatment programs and campaigns to educate everyone, from users and medical providers to teachers and police, about the drugs’ dangers.”

Understanding the difference between pharmaceutical fentanyl and illicitly manufactured fentanyl is an essential step in the effort to reduce overdose deaths.

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. 

DEA Expanding Surveillance of Prescription Drug Data

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration is making plans for a major expansion of its monitoring of prescriptions for opioids and other controlled substances, with the goal of identifying virtually every prescriber, pharmacy and patient in the country that shows signs of drug diversion or abusing their medication.

In a request for proposal (RFP) made in early September, the DEA asked software contractors to submit bids for the creation of a nationwide data system that would track “a minimum of 85 percent of all prescriptions” for Schedule II through V controlled substances. The RFP was first reported by the website Filter.

Critics say the surveillance program will have a chilling effect on many healthcare providers, who are already fearful of being flagged by law enforcement for prescribing and dispensing opioids and other medications to patients suffering from pain and other illnesses.  

“This RFP illustrates that the DEA, and U.S. Department of Justice more broadly, remains fixated on monitoring and scrutinizing the medical decisions of licensed health professionals while illegal fentanyl and heroin contribute to two-thirds of opioid-involved drug poisonings in the U.S.,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers.

“DEA agents have no business second guessing health care providers’ decisions on medical need and patient care. That’s a job for state licensing boards – and only when there is a valid complaint to investigate.”

‘Unlimited Access’ to Prescription Data

Hundreds of medications would be covered under the DEA’s surveillance program, including drugs used to treat pain, opioid use disorder, anxiety, and attention deficit hyperactivity disorder (ADHD).  Under the program, DEA investigators would have “unlimited access” to prescription data compiled over the last five years, including the names of prescribers and pharmacists, types of medication, quantity, dose, refills and forms of payment.

The names of patients would be encrypted, but if investigators suspect a medication was being abused or diverted, they could get a subpoena to quickly identify the patients involved.

“The subpoena process would be that we would generate a DEA Administrative Subpoena and send it to you for the unmasking of specified patients. The data provider would then need to respond to us providing the unmasked patient information that was requested within three business days,” the DEA said in response to a contractor who inquired how the subpoena process would work.      

Asked how many DEA investigators would have access to the prescription data, the agency said there could be over a thousand.

“We would start with 1,100 users and would renegotiate if more were needed. It is unlikely that 1,100 users will all access the system concurrently but is hypothetically possible in the future,” the agency replied.

Why the DEA is seeking to expand its monitoring of opioid prescriptions is unclear. In recent years, the number of prescriptions has fallen by about a third and the DEA itself estimates that less than one percent of legally prescribed opioids are diverted.

Bypassing PDMPs

State-run prescription drug monitoring programs (PDMPs) already track much of the information DEA is seeking, but law enforcement access to the data usually requires an active investigation or warrant – no data mining or fishing expeditions allowed. To maintain patient privacy, some states prohibit sharing prescription data with federal or out-of-state law enforcement agencies. Last year, the DEA had to sue Colorado to get access to the state’s PDMP data.

The DEA’s plan would bypass these privacy safeguards and effectively create a national PDMP for law enforcement. The agency would even be allowed to share some prescription data with unnamed “outside agencies and/or organizations without prior review by the Contractor.”      

The DEA did not respond to multiple requests for comment. In the RFP, the agency said it was required by law to maintain “comprehensive, detailed, accessible, and timely prescription, pharmacy, and prescriber information.”

Much of the data mining the agency is planning appears to go beyond the prescription data that is currently covered by PDMPs.  For example, the DEA wants to know the distance patients travel to see their doctors and pharmacies; whether patients living at the same address are getting the same drugs; whether a patient pays in cash for their medications; and whether a patient is getting a combination of opioids and benzodiazepines to treat their pain and anxiety.

“This DEA program will increase the fear associated with prescribing and dispensing controlled medications, making it even more difficult for people with pain, opioid use disorder, anxiety, insomnia, and ADHD to access individualized treatment. More such patients will be left in despair. It’s as though the federal government is unaware or does not care that the U.S. is in the midst of a suicide epidemic,” Barnes told PNN. 

‘Appalling for People’s Health’

The software contractor is also expected to provide DEA with a list of top prescribers and pharmacies that are writing and filling prescriptions for fentanyl, oxycodone, hydrocodone, buprenorphine and other opioids. The inclusion of buprenorphine is troubling to substance abuse treatment experts, because it is a primary ingredient of Suboxone. 

“The impact of including buprenorphine will be appalling for people’s health,” said Dr. Hannah Cooper, the chair of substance use disorder research at Emory University. Cooper fears the DEA surveillance program would make doctors and pharmacies reluctant to supply Suboxone to patients who need addiction treatment. 

“The idea that patient-level data is available to the DEA is quite frightening. We don’t want to make people worry that their decisions will be monitored by this highly punitive federal agency,” Cooper told Filter. “If you’ve been inhabiting a space where you’ve been persecuted by the federal government for some time, and they now have access to your private medical information, there will be tremendous consequences for population health and health equity.”

“This program will undoubtedly decrease the prescribing of controlled medications, including buprenorphine for opioid use disorder,” said Barnes. “Why in the world would the federal government, in the midst of a worsening drug-poisoning epidemic, discourage the prescribing of a medication to treat opioid use disorder and prevent opioid poisonings?”

The DEA deadline for receiving proposals from software contractors was October 20. No contract awards have been announced. The surveillance program could begin as early as December 1, 2020 and continue for a minimum of one year, with an option for up to four years. The potential cost of the program has not been disclosed.

Pilot Study Finds Green Light Therapy Improves Fibromyalgia Symptoms

By Pat Anson, PNN Editor

Fibromyalgia patients exposed to green light therapy had significant improvements in their pain, sleep and quality of life, according to a new pilot study published in the journal Pain Medicine.

The small clinical trial by researchers at the University of Arizona is the first to explore the benefits of green light in treating fibromyalgia symptoms. Previous studies have focused on green light therapy as a treatment for migraine headaches. Green light is believed to have a calming effect on the brain and causes less eye strain.  

Twenty-one adult patients with fibromyalgia being treated at the university’s chronic pain clinic were enrolled in the study. They were exposed to green light-emitting diodes (GLED) for one to two hours daily for 10 weeks. While undergoing treatment, patients were asked to avoid all other sources of light, including computers, smartphones and television, but encouraged to engage in other activities such as reading and listening to music, and to avoid falling asleep.

“To our knowledge, this one-way crossover design efficacy-study clinical trial is the first description of a successful implementation of GLED exposure as a therapy to manage fibromyalgia pain without any reported side effects. The patients enrolled in this study reported significant reduction in their overall average pain intensity, frequency, and duration after GLED treatment,” wrote lead author Mohab Ibrahim, MD, an associate professor in the Departments of Anesthesiology and Pharmacology at UArizona College of Medicine-Tucson. 

In addition to less pain, patients also reported better mood and sleep, and improvements in their ability to work, exercise and perform chores. Eleven patients said they also reduced their use of pain medication, including opioids, while being exposed to green light.    

“GLED may be a safe and affordable method to manage fibromyalgia. We did not observe side effects in animal studies or in reports from our patients. The observed safety and efficacy, coupled with the simplicity of this method, merit further investigation and the design of a randomized clinical trial to fully investigate the role of GLED for fibromyalgia and possibly other chronic pain conditions,” researchers concluded. 

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression. Many patients report conventional treatments for fibromyalgia are ineffective or have unwelcome side effects. 

In an email to PNN, Ibrahim said he was conducting two more studies on the use of green light to treat other pain conditions, but was not ready to release his findings. He recently reported the results of a small study of green light as a preventative therapy for migraine. 

“Should anyone use green light products? The risk is low, but I still suggest people speak with their physicians first before attempting any therapy,” Ibrahim said.    

Light Sensitivity 

Although more research is needed to fully understand how green light therapy works, some commercial products are available to the public without a prescription.

One is a portable green light lamp made by Allay, a company founded by Harvard Medical School Professor Rami Burstein, PhD, who was the first researcher to discover that different colors in the light spectrum can affect light sensitivity – known as photophobia – among migraine sufferers.

Burstein learned that blue light (the light emitted by TVs and computer screens) can trigger migraines, while a narrow band of green light at low intensity can reduce the severity of migraine attacks.

“Green light has a calming effect because it reduces electrical activity (in the brain),” Burstein told PNN. “It is the only color of light that is associated with positive emotion and reducing anxiety. All other colors of light increase anxiety, irritability, being afraid, being scared, being angry, a whole host of negative emotions.”

Burstein and his partners asked lighting experts to design an affordable green light lamp that people can use at home. Initial estimates ran in the thousands of dollars, but they have since managed to reduce the cost to $150.

ALLAY IMAGE

“It is safe. It’s not invasive. It is inexpensive,” Burstein says. “Try it. Give it a month or two. If it doesn’t work, you can return it for free. No questions asked.”

Allay began selling the lamps in January with a money back guarantee. Of the 3,000 lamps sold so far, Burstein says less than 4 percent of customers have asked for their money back. He expects an updated version of the lamp to be available by the end of the year for less than $100.

Burstein says the lamp eliminates photophobia in nearly all migraine patients. He recommends that migraine sufferers use the Allay lamp one to two hours every day to reduce the frequency and severity of headaches.

Clarifying the New Definition of Pain

By Dr. David Hanscom, PNN Columnist

What is pain? We toss the word around a lot without really understanding – or defining -- what it actually means.

There are many different types and sensory levels of pain. A loud noise is uncomfortable. Bitter tastes are unpleasant. Ringing in your ears is more than annoying. Sometimes our feelings get hurt. Physical pain can be mildly irritating or crippling.

The way every living species evolved and survives is by processing these multiple types of sensory input and interpreting them as either safe or dangerous. Then its behavior is directed towards safety and reward, while also avoiding threat.

Short-term acute pain is a warning signal that indicates there is potential damage to a specific body part. Acute pain is necessary and protective. You might even call it a gift. People who are born without a pain system don’t often survive more than 10-15 years. They can’t sense danger. Tissues are destroyed and they die of infection.

But there is nothing useful about chronic pain. When a delicately balanced signaling system is out of kilter, it can no longer accurately interpret the environment. You become trapped by incredibly unpleasant sensations. Chronic pain may be one of the worst experiences of the human condition. It interferes with physical function, social interactions, and psychological well-being.

Recently, for the first time since 1979, the International Association for the Study of Pain (IASP) revised its definition of pain. This was made necessary by neuroscience research showing that pain could arise from sources other than physical tissue damage.

Old IASP definition: "An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage."

New IASP definition: "An unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage." 

Although the revision is a relatively small one, it has big implications for appreciating the complexity of pain. Adding the words “resembling” and “potential” allows for an expanded understanding and appreciation of pain beyond what was previously limited to actual tissue damage. 

Dropping the word "described" allows for recognition of pain in people who may not have the ability to effectively communicate their pain, such as infants, cognitively impaired individuals or those with speech and hearing disorders.  

Pain Is a Personal Experience That Should Be Respected

The new definition expands our understanding of pain in 6 key areas: 

• Pain is a personal experience that is influenced to varying degrees by biological, psychological and social factors 

• Pain cannot be inferred solely from activity in sensory neurons 

• People learn the concept of pain through their life experiences 

• Every report of pain should be respected 

• Although pain often has a protective role, it may also have adverse effects on physical function, as well as social and psychological well-being

• The inability to communicate pain does not negate the possibility that someone is feeling pain

It is logical that pain is personal because each person is genetically different and we are programmed with regards to safety vs threat by our past. If you come from a less than nurturing background, more things in the present will seem dangerous. You will spend more of your time in “high alert” – with a sustained exposure to stress hormones and inflammation that could lead to physical symptoms and illness.

Pain being a learned experience is well established in the medical literature. One classic study involved looking at childhood trauma. A scoring system was developed called the ACE score (Adverse Childhood Experiences) that looked at various kinds of physical and emotional trauma. Higher rates of chronic diseases, including chronic pain, are often associated with childhood trauma.

Since physical symptoms are created by the patient’s interaction with his or her environment, it is critical to know the person and their life circumstances. How can you solve any problem without deeply understanding it?

Unfortunately, mainstream medicine has not incorporated the last 20 years of neuroscience research into their treatment approach. It continues to recommend random simplistic treatments for a complex problem. It can’t and doesn’t work. The new IASP definition is a start and opens the door for a better treatment paradigm.

Chronic pain is solvable with a better understanding of it and informed principles behind the solutions. The starting point is for YOU to better understand it and then solve it while using the medical system as a resource. Once you take charge, it is game on.

Dr. David Hanscom is a retired spinal surgeon who now teaches back pain sufferers how to calm their nervous systems without the use of drugs or surgery. He recently launched a new website – The DOC Journey – to share his own experience with chronic pain and to offer a pathway out of mental and physical pain through mindful awareness and meditation.