Researchers Urge Caution on Using Steroid Injections for Pain

By Pat Anson, PNN Editor

Doctors and patients should be more cautious about using corticosteroid injections for pain relief, according to new studies that warn of rare, but serious long-term complications for patients who receive epidurals during childbirth or high doses and multiple injections in their hips.

Researchers at Kaiser Moanalua Medical Center in Hawaii looked at health data for nearly 700 patients with hip osteoarthritis and found that those who received steroid injections were 8.5 times more likely to develop rapidly destructive hip disease (RDHD), a condition that causes the loss of blood flow and death of bone tissue in the hip.

Higher rates of RDHD were especially apparent in patients receiving multiple and/or high-dose injections of the steroid triamcinolone. The risk of RDHD following a single, low-dose injection was about two percent, but rose to five percent following multiple low-dose injections or a single high-dose injection, and up to 10 percent following multiple high-dose injections.

“While the risk of RDHD following a single low-dose (40 mg or less) triamcinolone injection is low, the risk is higher following high-dose (80 mg or more) injection and multiple injections. These findings provide information that can be used to counsel patients about the risks associated with this common procedure. In addition, caution should be taken with intra-articular hip injections utilizing 80 mg of corticosteroid and multiple injections,” wrote lead author Kanu Okike, MD, of Hawaii Permanente Medical Group in Honolulu.

As they became more aware of a possible link with RDHD, orthopedic surgeons at the hospital started ordering fewer hip corticosteroid injections. In subsequent years, the number of RDHD cases decreased. The hospital also added a discussion of post-injection RDHD to the informed consent process for patients and stopped performing high-dose corticosteroid injections.

The study, recently published in The Journal of Bone & Joint Surgery, is believed to be the largest to date of patients with post-injection RDHD.

Epidural Injections

Two new studies have also found that women receiving epidural injections for pain relief during labor are at high risk of long-term headaches and chronic back pain if the needle accidentally punctures the dural lining of the spinal cord. Dural punctures or “wet taps” cause the leak of spinal fluid, which can result in serious neurological complications.  

“I’ve likely performed more than 10,000 epidurals in my lifetime, and I still have wet taps from time to time,” Pamela Flood, MD, a professor of anesthesiology at Stanford University School of Medicine, told Anesthesiology News. “But no matter how many we’ve seen, we still feel terrible about each one. We’re trying to relieve people’s pain and give them a wonderful childbirth experience, and the last thing we want to do is cause them complications.”

A study published in the journal Anaesthesia found that over half of women (58%) with an accidental dural puncture were still experiencing headaches 18 months after the epidural, and nearly half (48%) suffered from chronic low back pain. A recent study in the British Journal of Anaesthesia had similar findings.    

Dural punctures during epidurals are relatively uncommon. Women are usually warned there is a risk of short-term headaches, but not about long-term health problems.

“While this information has been creeping into our consciousness in the form of retrospective trials, only this year has it been confirmed with two large prospective trials,” Flood said. “Unfortunately, clinicians have been slow to hear this, perhaps because we don’t want to admit that the short-term concern that we have been discussing for years carries long-term consequences in a significant percentage of women.”

The two most common types of medications used during epidural injections are anesthetics (lidocaine or bupivacaine) or corticosteroids (betamethasone, dexamethasone, hydrocortisone, methyl-prednisolone, triamcinolone). 

In addition to treating labor pain, epidural steroid injections are widely used for back pain. About 9 million epidural steroid injections are performed annually in the U.S., even though they are not FDA-approved. The FDA has warned that injection of steroids into the epidural space can result in rare but serious neurological problems, including loss of vision, stroke and paralysis. Some patients have also developed arachnoiditis, a chronic and painful inflammation of the spinal cord, after getting steroid injections for back pain.

Epidemiological Sleuthing During the Pandemic

By Roger Chriss, PNN Columnist

How do we figure out what is really going on with Covid-19? Amid the ongoing surge of Covid cases from the delta variant of SARS-CoV-2, this is very important.

As hospitals are overwhelmed with patients, beds are unavailable, supplies of monoclonal antibody drugs are limited, and frontline healthcare workers are strained. Understanding what is really happening becomes vital to an effective response.

One of the tools most widely used to track the severity of the pandemic is the number of patients that are hospitalized. According to the CDC, we’re currently seeing an average of 9,636 new admissions every day, which is about 14% less than a week ago.   

New Hospital Admissions for Covid-19

But how reliable are these numbers? And just how sick are the patients?

A recent preprint study of VA patients before the delta surge suggested that almost half of hospitalized Covid-19 cases had mild or asymptomatic symptoms. This finding prompted The Atlantic to conclude that the significance of the hospitalization gauge “can easily be misinterpreted.”

As often happens with public health data in the US, information is missing. SFGate recently investigated Covid-19 hospitalizations in the Bay Area and found that simply tracking patient numbers was unreliable. Three major hospital systems -- San Francisco General, Kaiser Permanente and Sutter Health -- could not say if mild and asymptomatic cases made up a large proportion of their Covid patients.

In other words, in many cases hospitals simply don’t have the data needed to assess the severity of outbreaks. We need better ways to validate hospitalization counts and assess local conditions in near real time.  

Fortunately, we have them. Broadly speaking, these include community surveillance, hospital monitoring and indirect signals. Each of these comprises multiple sources of information, and when combined, the result is a deep assessment of Covid conditions.

Carnegie Mellon University’s COVIDCast gives early indicators, including doctor’s visits and symptoms in communities across the nation. This can be paired with public behaviors like masking and distancing, visits to bars or restaurants, local vaccination rates, and searches on Google for Covid symptoms. All of this helps build a risk profile for a community that can be confirmatory for hospitalization data.

Similarly, wastewater epidemiology provides a close look at something all communities produce. For instance, the Sewershed Surveillance Project in Missouri has tracked virus levels in effluent for a year, with spikes often warning of possible outbreaks in cities and counties throughout the state. Wastewater epidemiology is already used in Europe and many parts of the US to help track drug use and disease activity.  

Next comes personnel. Hospital staff is in constant flux, and job postings provide valuable clues about what hospitals are expecting or confronting. For instance, travel nurses move around the US in response to calls for supplementary staff, so job boards like TravelNurse Source offer valuable insight for assessing a hospital’s needs.

The same for respiratory therapists, imaging technicians, and other frontline healthcare workers. Hospitals know their everyday needs, which can be readily found in reports from the American Hospital Association’s Data & Insights database. These reports include the number of staffed beds, admissions, and outpatient visits for most hospitals in the US. If we know what hospitals typically have and see, that allows us to check if they are experiencing a Covid surge.

Further, we have drug and equipment orders. Hospitals have to track all orders for financial and regulatory reasons. So new orders for fentanyl to sedate patients who need intubation, requests for ECMO respiratory machines, or just reordering PPE equipment and other supplies are all readily monitored via federal and state databases.

There are also indirect signals. Hospitals redirecting patients to other facilities, requesting ambulance or helicopter transport, arranging for at-home care for patients they might otherwise admit, or activating emergency plans are all publicly visible, as are signals such as requests for mobile morgues or National Guard assistance.

The above information can be combined to create a reasonably accurate profile of a hospital’s situation. Better, however, is to use such information proactively in order to avoid the severe surges seen in the South over the summer or in Idaho and Montana at present.

Early attempts to use wastewater epidemiology proactively have met with some success. When a wastewater sample from a dorm at the University of Arizona came back positive last year, the school quickly tested all 311 people who live and work there and found two asymptomatic students who tested positive.

All of the above is not limited to the pandemic. The same approach could be used for other infectious diseases, drug overdoses and other areas of public health. If the data streams and information analysis are combined and coordinated, the results could be that much better and more useful.

We cannot and should not rely on a single number, not with so many other tools available to be used. Hopefully we’ll see these tools put to use fast.

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. 

Rare Disease Spotlight: Sarcoidosis

By Barby Ingle, PNN Columnist

This month’s rare disease spotlight is on sarcoidosis. I have many friends living with this complex, autoimmune disorder, which affects about 200,000 Americans.

One of the first visible signs of sarcoidosis is for red bumps and patches called granulomas to form on the skin. Granulomas can also develop in the lungs, lymph glands and other internal organs, causing shortness of breath, abnormal heart rhythm, swollen glands and painful joints. The symptoms often appear suddenly and vary from person to person, depending on which organs are affected.

Although the symptoms usually go away on their own after a few months, the patients I know have lived with sarcoidosis long term. Some are less affected than others, but most people living with chronic sarcoidosis have major changes in every aspect of their body and life activities.

I think it is best to spotlight some of the people in my life who live with sarcoidosis on a daily basis. Frank Rivera and Kerry Wong have a website called Stronger Than Sarcoidosis. Karen Duffy shared her journey with sarcoidosis in one of my favorite books, "Backbone: Living with Chronic Pain without Turning into One."

You’ll see by reading their responses that sarcoidosis is tough to have, but they are tough, too.

How long have you lived with sarcoidosis?

Wong: “I was diagnosed in 2015, but that was after an 8-year search for answers … so I would say probably closer to 14 years.”

Duffy: “I have been living with sarcoidosis for 23 years! It took about 2 years to get a diagnosis of exclusion.”

Rivera: “I have been living with sarcoidosis since 2004, 17 years, but fully diagnosed in 2011. So, 10 years since diagnosis.”  

In what ways has living with sarcoidosis affected your life?

Duffy: “Sarcoidosis has impacted my life in countless ways. I live with neuro-sarcoidosis and I have severe pain issues. I also have Complex Regional Pain Syndrome. I find that the principles of stoic philosophy have really helped me accept that I cannot control what happens, I can only control how I respond.”

Rivera: “I am on disability now due to the bone and joint involvement and the pain I live with is a 6-7 pain level on a pain scale of 1-10, daily.”

Wong: “Oh, so many ways! Because the symptoms can be both severe and so unpredictable, I’m no longer able to work, and have been on disability since 2014. I’ve had to cancel plans with friends and family more times than I can count. And I’ve had to depend on my husband for so much more, for even the little things. But I’m so grateful for how he has stepped up as an incredible caregiver.

And that’s not to mention the emotional toll of the physical manifestations, the anxiety and depression that come from living with chronic pain, fatigue, and disability.”

Have you found anything that was helpful for the symptoms of sarcoidosis?

Duffy: “I believe in the power of the placebo. In Latin, placebo means "I Shall Please." I try to be useful, so I keep up with my volunteer projects. I find reading to help when I am roped to my sofa like Gulliver. On days when I am released from the grip of chronic pain, I love to walk. I follow my doctors’ advice and take my prescription meds.

I have found a pain cream called Tribe Revive---and it works for me! I no longer wear a pain patch, I just rub this CBD infused cream and the relief is instant. I have no connection to the company that makes the pain cream, I am just a very grateful customer. I buy so much of it and give out jars.”

Rivera: “Prednisone helped some, but the side effects almost killed me. Gave me a hole in my colon and diabetes as well as brittle bones.”

Wong: “Yes, thank goodness! Even after all this time, we are still working on finding the right treatment combination to help with my symptoms, but there are a few things that have helped. IVIG (Intravenous Immunoglobulin) therapy; heat and cold therapy; TENS (transcutaneous electric nerve stimulation); eTNS (electric trigeminal nerve stimulator); acupuncture and acupressure; and medical marijuana in a variety of forms.

Aside from that, probably the most helpful thing is learning to listen to my body. When it says I have to rest, I have to rest. Pushing myself to do more, which is what I have always done before, will only make me suffer that much more and that much longer afterward.”

Do you think there is a societal stigma on people living with sarcoidosis and other rare diseases?

Duffy: “I find that living with a chronic, invisible illness has its challenges. The pain from the nerve damage is cataclysmic, and it can be confusing that some days I can walk my dog, go for walks, and socialize with friends. Then other days, I am wiped out and live a smaller, quieter life. On these days, I read and write.”

Wong: “I am not sure if stigma is the word I would use, but there is definitely an additional problem for us. Because most people have never heard of sarcoidosis, they find it hard to understand and try to compare it to things they know. How often do we hear, ‘At least it’s not cancer?’  And because most of our symptoms are invisible, they find it hard to believe what they don’t see. That lack of understanding can have a tremendous impact on both personal and professional relationships.”

Rivera: “Yes, because from the outside we look fine. It is called an invisible illness because it works from the inside out.”

Is there anything you wish the world knew about sarcoidosis?

Wong: “Honestly, the thing I would love for people to understand most is how unpredictable the disease can be. Our symptoms can vary from day to day or hour to hour. That means what we are able to do varies as well. We always see inspirational examples of people who ‘didn’t let xyz stop them,’ but that is just not how it works with an incurable rare disease.

I always strive to do as much as I can to help others, but some days, the symptoms do win. That is not a character flaw or weakness; it is just the fact of the disease. Once those symptoms ease up and I am able to do more, I will always bounce back with purpose.”

Duffy: “I know it can be overwhelming to live with a rare, complicated, multisystem disorder. I have a serious illness, but I do not take it too seriously. Having a painful diagnosis and having a great life is possible. I am grateful for every day.”

Rivera: “Sarcoidosis is when a person's white blood cells become over active from an environmental accelerant. And instead of fighting off colds or foreign substance in the body, they clump together and form masses anywhere in the body as well as skin. This disease is a very painful disease and attacks the physical and mental health of a person.

With sarcoidosis, no two patients are alike. They call it the snowflake disease because no two patients are the same. That makes it very difficult to diagnose as well as treat because each temporary medicine does not work the same for each patient as well. So trying to help a sarcoidosis patient is very tough.”

Getting Help

If you need help with sarcoidosis, you should set up appointments with specialists to add to your treating team. These professionals would include a primary care provider, rheumatologist, pulmonologist, ophthalmologist and dermatologist.

Steroids are usually used to treat sarcoidosis. They reduce inflammation, and can stimulate tissue growth and repair. If steroids don’t work, immunosuppressant medications might be tried to reduce the immune system response. Pain medications may also be prescribed.  

Although the cause of sarcoidosis is unknown, the most widely known theory is it may be due to an immune reaction to a trigger, such as an infection or chemicals in those who are genetically predisposed. I look forward to the day that better testing and treatments exist for this rare disease.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website.

Biosimilar Drugs Are Cheaper Than Biologics, But Are They as Effective?

By Michelle Andrews, Kaiser Health News  

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than four years trying medications before getting her disease under control with a biologic drug called Remicade.

So Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Moxley, who recently started a job as a public relations coordinator for Kansas City Public Schools in Missouri. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

ELLE MOXLEY

Yet the U.S. has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Dr. Jinoos Yazdany, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anti-competitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the U.S. but noted ongoing challenges:

“Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the healthcare system at-large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

‘Highly Similar’ Drugs

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much — 14.6% — according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the U.S.

Biosimilars provide a roughly 30% discount over brand biologics in the U.S. but have the potential to reduce spending by more than $100 billion in the next five years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Dr. Marcus Snow, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Dr. Ross Maltz, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs. However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

AMA: ‘Time to Change Course’ on Overdose Epidemic

By Pat Anson, PNN Editor

With the U.S. facing a record number of drug deaths, the American Medical Association is calling for major changes in the way healthcare providers, insurers, and state and federal policy makers combat the overdose epidemic.

“It’s time to change course,” the AMA says in a new report that documents a 44% decrease in opioid prescribing nationwide over the past decade. At the same time, however, overdose deaths continued rising, fueled primarily by illicit fentanyl, heroin, cocaine and other street drugs.

“With record-breaking numbers of overdose deaths across the country, these are actions policymakers and other stakeholders must take,” AMA President Gerald Harmon, MD, said in a statement. “The focus of our national efforts must shift. Until further action is taken, we are doing a great injustice to our patients with pain, those with a mental illness and those with a substance use disorder.”

The AMA report calls for the CDC to “restore compassionate care for patients with pain” by rescinding “arbitrary thresholds” for opioid doses recommended in the agency’s 2016 prescribing guideline.  Although voluntary and only intended for primary care providers treating chronic pain, the guideline has been widely adopted as a standard of care by states, insurers, pharmacies and physicians of all specialties.

Doctors have also made liberal use of Prescription Drug Monitoring Programs (PDMPs), looking for signs of patients “doctor shopping” or abusing their medications. The databases, which track prescriptions for opioids and other controlled substances, have been accessed 2.7 billion times by physicians, regulators and law enforcement since 2014. State PDMPs were utilized over 910 million times in 2020 alone, according to the AMA.  

As a result of these and other measures to limit opioid prescriptions, millions of pain patients have been tapered to lower doses or completely cutoff from opioids -- yet drug deaths continue rising.

From January, 2020 to January, 2021, over 94,000 Americans died of drug overdoses, the most ever over a 12-month period.

A recent study by the Reason Foundation found that PDMP’s may be making the opioid crisis worse by forcing legitimate patients to turn to street drugs because they lost access to pain medication.

SOURCE: AMA

“The nation’s drug overdose and death epidemic has never just been about prescription opioids,” said Harmon. “We use PDMPs as a tool, but they are not a panacea. Patients need policymakers, health insurance plans, national pharmacy chains and other stakeholders to change their focus and help us remove barriers to evidence-based care.”

One such barrier is limited access to addiction treatment. Although over 100,000 healthcare providers can now prescribe buprenorphine (Suboxone) for the treatment of opioid use disorder, the AMA estimates 80 to 90 percent of people with a substance abuse problem receive no treatment.

The AMA urged policymakers to take these steps:

• Ensure access to affordable treatment for patients with pain, including opioid therapy, by rescinding arbitrary laws and policies that restrict access to pain care.

• Stop insurers from using step therapy and prior authorization to deny or delay treatment for opioid use disorder and other needed medical care.

• Support harm reduction services such as needle and syringe exchange services.

• Make overdose reversal medications like naloxone available over the counter.

• Decriminalize fentanyl test strips and other drug checking supplies.

• Ensure settlement money from opioid litigation cases is used only for public health services.

• Remove structural barriers to healthcare in marginalized and minority communities.

• Improve databases to better track non-fatal overdoses, polysubstance use and local trends in drug use.

“To make meaningful progress towards ending this epidemic, a broad-based public health approach is required. This approach must balance patients’ needs for comprehensive pain management services, including access to non-opioid pain care as well as opioid analgesics when clinically appropriate, with efforts to promote appropriate prescribing, reduce diversion and misuse,” Harmon said.

In recent years, the AMA has become increasingly vocal about the declining quality of pain care in the U.S. and the CDC guideline in particular. In a recent letter to the CDC, the chair of the AMA board said patient stigma and the undertreatment of pain were “a direct result” of the 2016 guideline. The CDC is currently considering an update and possible expansion of the guideline, although a draft revision contains the same dose recommendations as the original guideline.  

“CDC’s threshold recommendations continue to be used against patients with pain to deny care. We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy,” wrote Bobby Mukkamala, MD, a Michigan surgeon.

The AMA’s opposition to the guideline drew a rebuke from the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP). In a February letter to the AMA, PROP’s board said opioid prescribing for pain was still problematic and “a common gateway to illicit opioid use.” The letter also said that opioid medication should only be used for short-term acute pain and end-of-life care.     

Another Drug Shortage Caused by Covid-19 Has Me Worried

By Victoria Reed, PNN Columnist

I recently read a news article about the Food and Drug Administration issuing an emergency use authorization for Actemra (tocilizumab) for the treatment of hospitalized covid-19 patients. The medication was originally developed as a treatment for rheumatoid arthritis (RA), one of the chronic pain conditions I live with.  

Actemra is a biologic drug that calms down overactive immune systems by blocking the interleukin-6 (IL-6) receptor. Persistent dysregulated expression of the IL-6 receptor is involved in the pathogenesis of RA and other chronic inflammatory and autoimmune diseases. It is believed that this over-activation of the IL-6 receptor is also responsible for the so-called “cytokine storm” that causes severe illness and death in covid-19 patients.

The symptoms of RA are pain, fatigue and swelling in the lining of the joints and other parts of the body, including the heart, lungs and eyes. This inflammation can lead to disability, joint destruction and cause serious damage to the lungs and heart.

I have had long-term success controlling my RA symptoms with Actemra and have been getting the drug by IV infusion monthly for about 8 years. Prior to that, I didn’t have good control with other biologic meds such as Enbrel and Orencia.

When I read that news story, I was initially only mildly concerned about Actemra becoming unavailable. Nevertheless, I contacted my doctor for confirmation that I was still on track for my upcoming monthly infusion. However, she did not and could not confirm that the medication would be available to me. Why?

Actemra has now been hijacked by doctors treating covid-19 patients, and this has created a major shortage. I have been informed that its availability for RA patients is uncertain for the foreseeable future. This is really very upsetting!

Covid-19 patients are using up resources in hospitals across the country. The overwhelming needs of these severely ill patients are causing other patients who need surgery or have treatable illnesses to die from a lack of available resources. Hospitals in hard-hit areas are short on everything -- staff, meds, beds and time. As a result, many chronic pain patients like me are being denied the treatments that we rely on to have functional lives. I must say that this seems patently unfair.

What’s even more disconcerting is that Genentech, Actemra’s manufacturer, can’t say when the shortage will end and expects “additional intermittent periods of stockouts (lack of supply) in the months ahead, especially if the pandemic continues at the current pace.”

RA and lupus patients saw this happen earlier in the pandemic when word got out that Plaquenil (hydroxychloroquine) might help treat covid-19. That medication also became scarce and was inaccessible to patients with autoimmune conditions for a while.  

One thing for sure is we are all very tired of the covid virus and its variants. I understand that doctors and scientists are desperate to find things that work, and they want to save lives. But I rely on Actemra to help relieve my pain and fatigue and keep damaging inflammation down. It is the mainstay of my treatment.  

Due to the Actemra shortage, I may have to consider other medications that might not work as well or just wait out the shortage and hope my disease activity doesn’t become unbearable.  

If the pandemic continues, many more people are going to lose their lives from covid infections. However, all patients deserve an equal chance at receiving the care they need, including chronic pain patients. The pain community is already suffering from opioid hysteria and many of us have to fight to stay on these pain medications. We shouldn’t have to fight for our other meds too! 

RA is a serious, systemic and often misunderstood condition that can shorten a lifespan by many years if not treated aggressively and with the proper medications.  Patients sometimes go through many trials of medications before finding one that relieves symptoms and arrests disease activity.  

I truly hope this shortage is short-lived -- for myself and others like me -- who rely on Actemra to remain functional and productive.  

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

Low Dose Naltrexone Being Studied as Treatment for CRPS

By Pat Anson, PNN Editor

Low-dose naltrexone (LDN) is already being used to treat a wide variety of chronic pain conditions, from fibromyalgia and interstitial cystitis to Ehlers Danlos syndrome and temporomandibular joint disorder (TMJ). Some doctors believe the drug may even be useful treating symptoms of a condition so painful it’s been called the “suicide disease.”

Soin Therapeutics, a small pharmaceutical startup based in Ohio, announced this month it has been granted orphan drug status from the Food and Drug Administration to explore using LDN as a treatment for Complex Regional Pain Syndrome (CRPS), a disorder of the nervous system that causes severe, intractable nerve pain.

"Obtaining Orphan Status from the FDA is an important milestone step for us at Soin Therapeutics. We look forward to running a large-scale clinical trial and eventually FDA approval to help patients suffering from CRPS," Dr. Amol Soin, the founder and CEO of Soin Therapeutics, said in a statement.

Currently, naltrexone is only approved by the FDA as a treatment for substance abuse. In 50mg doses, the drug blocks opioid receptors in the brain and decreases the desire to take opiates or alcohol. But in smaller doses of 5mg or less, some patients have found LDN to be a surprisingly effective pain reliever.

How LDN works is not fully understood, but supporters believe the drug modulates the immune system, reduces inflammation and stimulates the production of endorphins, chemicals produced by the body that reduce pain and anxiety.

It's important to note that because naltrexone is an opioid antagonist, it should never be taken with opioid medication – even in small doses -- because it may cause severe withdrawal.

"Low Dose Naltrexone has unique properties to specifically help the disease cascade of CRPS including attenuation of microglial cells involved in pain transmission, reduction of proinflammatory cytokines, antagonism of the Toll-like receptor 4 (TLR4), as well as stimulating release of endorphins which are the body's natural pain killers,” said Soin, who is a practicing pain management physician.

“Basically, this drug seems very well suited to treat several mechanisms of the disease process. All those properties would seemingly be quite helpful in CRPS patients. Best of all, this is a non-addicting and non-sedating drug that could be a new way to treat complex regional pain syndrome."

Soin Therapeutics hopes to develop a novel formulation of LDN and submit an Investigational New Drug application to the FDA before starting a clinical trial.

Because the patent on naltrexone expired decades ago, it’s a generic and cheap drug – perhaps the main reason it is not more widely used as a pain reliever. There is little incentive for pharmaceutical companies to market LDN or conduct expensive clinical trials to prove its effectiveness in treating pain.

Patients interested in trying LDN often encounter doctors who refuse to prescribe it “off label” or don’t know anything about it. The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.

Experimental Implant Repairs Joints With Cartilage Made From Stem Cells

By Pat Anson, PNN Editor

An experimental implant containing cartilage derived from stem cells reduced pain and restored function in dogs with damaged hip joints -- a study that researchers say could be a significant step towards repairing and replacing cartilage in humans with osteoarthritis.

Osteoarthritis is a progressive joint disorder caused by painful inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine.

“One of the holy grails of orthopedics is to replace cartilage, but there hasn’t been an effective way to do it,” says co-author Duncan Lascelles, PhD, a professor of surgery and translational pain research and management at North Carolina State. “Most of the focus is on replacing or restoring the cartilage surface with artificial materials, but regenerating cartilage isn’t possible right now. And many of the artificial products in use don’t integrate with the body.”

Lascelles and his colleagues developed a cartilage repair implant using a textile manufacturing process that utilizes three-dimensional (3D) weaving with composite material. When seeded with a patient’s own stem cells, the “bioartificial” implant is designed to integrate with native bone while preserving the integrity of the joint.

“Combining 3D printing with advanced textiles enabled us to engineer an implant that mimics the function of native, healthy tissues in the joint from day one after implantation,” said co-author Bradley Estes, PhD, President of Cytex Therapeutics, which developed the implant technology. “We also designed it to dissolve over time so that, ultimately, joint function is transferred back to the patient’s own tissues during the healing process.”

The researchers used the implant to resurface damaged hip joints in dogs. Cartilage derived from stem cells was first allowed to grow on the implant for several weeks before surgery, then the implant was placed into the damaged area of the dogs’ joints. Over time, the implant dissolved, leaving only the dog’s own natural tissue in the repaired hip joint.

Four months after surgery, researchers say dogs that received the cartilage implant returned to baseline levels for both pain and function, while dogs in a control group never improved. They also saw evidence that the implant had successfully integrated into the hip joints, effectively resurfacing them.

“We were thrilled that the implant was so effective at restoring the activity levels of the animals,” Estes says. “After all, this is why patients go see their physicians – they want to be able to play tennis, play with their kids, and, in general, re-engage in a pain-free active lifestyle that had been taken away by arthritis.”

While osteoarthritis primarily affects older adults, researchers hope the experimental implant will address some of the problems associated with total joint replacements in younger, active patients.

“There are significant drawbacks to total joint replacements in the young patient,” Lascelles says. “The surgery is more complicated, and the artificial joints are only good for a particular number of years until they must be replaced, often with poorer results each time.

“This procedure is less invasive, and the implant uses the body’s own cells and integrates into the damaged area with little danger of rejection. We believe that it is an early intervention that could be a major advance in postponing joint replacements for dogs and hopefully one day for humans.”

The research findings are published online in Science Advances. The study was funded by Shriners Hospitals for Children, the Arthritis Foundation, the Nancy Taylor Foundation for Chronic Diseases, and the National Institutes of Health.

Turning From Victim to Victor After Being Electrocuted

By Gabriella Kelly-Davies, PNN Columnist

Kim Sullivan’s life changed irrevocably one Black Friday in 1998 when she was electrocuted in a swimming pool. At the time, Kim was enjoying life as a graphic designer and busy mum with two young daughters. They lived on a nine-acre property near the beach in Australia’s Far North Queensland, surrounded by lush tropical rainforest and fruit trees.

“My remote life was idyllic, the perfect place to bring up a growing family,” she recalls.

Kim and her family were staying with friends in Cairns, a city in Queensland, so they could buy groceries and run some errands. It rained overnight, and they woke to a stifling hot, sticky morning. Kim’s daughters asked her if they could swim, so she put on their floaties, and they headed to the kidney-shaped pool in the backyard.

The two girls swam at the front end of the pool near the steps, while Kim kept an eye on them from the edge, still in her white cotton pajamas. Her daughters asked her to turn on the spa jets, so she went down to the spot that housed the electrical switches and turned the dials.

Meanwhile, Kim’s daughters had jumped from the pool. As she joined them, they started screaming. Distraught, they kept falling over and trying to stand up. When Kim wrapped her arms around their little bodies to comfort them, she felt an electric current surge up her legs.

Kim fell to her knees, and then an invisible force catapulted her three meters into the air. She landed in the pool, dazed and barely conscious.

KIM SULLIVAN

Kim’s muscles froze and she struggled to move, but she somehow maneuvered herself to the edge of the pool, all the while screeching at her children to run inside the house. She tried to get out, but when she touched the pebblecrete, it buzzed with 240 volts of electricity.

“It was the most painful experience I ever encountered,” she recalls, “even worse than childbirth.”

Afterwards, blisters formed on Kim’s fingertips. They burned and stung. She had excruciating pain running up the insides of her arms and under her armpits, and a similar pain up the backs of her legs. Her neck and shoulders ached, and so did her lower back. She struggled with a constant headache that tormented her.

Exhausted and traumatized, Kim couldn’t touch a hot cup or put her hands in warm water. Doing up a zipper or buttons was impossible, and her constant flashbacks triggered panic attacks. Her terrifying nightmares disrupted her sleep, leaving her bone tired.

All too soon, Kim fell into a deep depression, and she struggled to look after her family because of crippling headaches, chronic back and neck pain, and debilitating attacks of shingles. She felt shattered with exhaustion every morning when she woke up.

Kim could no longer work as a graphic designer, and she was unable to do the things that previously gave her pleasure because of her chronic pain and fatigue. In the end, she had to rely on a government homecare service to clean her house, change the bedsheets and cook meals for her family. She felt guilty and ashamed about using a service designed for elderly people, and her confidence plummeted.

Learning How to Manage Pain

Kim spent years on the medical merry-go-round consulting rheumatologists, psychiatrists, neuropsychologists, naturopaths, physiotherapists, acupuncturists and massage therapists. But nothing eased her intractable pain or depression. Eventually, she took part in a multidisciplinary pain management program at a regional hospital.

“The defining moment for me was when my doctor explained how the electric shock had disrupted the way my brain cells communicated with my spinal cord and nerve endings. The electric current caused a malfunction in the way my nervous system processed pain signals. My doctor reassured me that my symptoms were normal responses to an electric shock and that I could learn techniques to reduce their impact on my life,” Kim explained.

During the pain management program, Kim started doing carefully graded exercise, gentle yoga and meditation, and she learned psychological techniques that changed the way she thought about and responded to her pain. She also learned to pace herself rather than her usual pattern of doing too much, triggering a flare-up and having to rest in bed for several days.

“I learned valuable techniques on how to manage my pain,” she said. “But it wasn’t easy. It took a lot of practice and patience to master such a different way of living with a disabling condition that had radically transformed my life.”

Once Kim understood why she was the way she was, she stopped feeling stigmatized by people she felt judged her. “Pain is invisible, and people think it’s all in your head. They think you’re a drug-seeker or a malingerer and hypochondriac. Some even claim you are just lazy and looking for attention,” Kim told me.

After the program, Kim focused on being as healthy as she could by carefully managing what she was doing and not overdoing things. Every day she goes for a long walk that energizes her, and she does a carefully graded exercise program with an exercise physiologist. She also meditates and does yoga.

“I still have bad days, but through it all, I feel more confident that I can self-manage my symptoms rather than spiraling back into dependency and brain fog. I was lucky to have an amazing support team. Through them I gradually realized that to turn from victim to victor, I needed to take control by self-managing my condition,” Kim said.

Kim is now an advocate for people living with chronic pain and eager to share what she’s learned.

“Self-management gives you the freedom to make your own choices and not rely on opioids or passive treatments by doctors and other health professionals. The benefits of passive treatments are usually short-lived, and they are expensive. They also disempower you. Self-managing your pain empowers you and boosts your confidence,” she said.

“By sharing my story, I hope I can help people like me who have tried everything, but nothing worked for them. I want to raise awareness of chronic pain and reduce its stigma and social isolation so that more people who live with pain can enjoy a better life.”

Gabriella Kelly-Davies lives with chronic migraine.  She recently authored “Breaking Through the Pain Barrier,” a biography of trailblazing Australian pain specialist Dr. Michael Cousins. Gabriella is President of Life Stories Australia Association and founder of Share your life story.

A Pained Life: False Narratives About the Opioid Crisis

By Carol Levy, PNN Columnist

The common belief that any patient who takes opioids for pain relief soon becomes addicted seems to have started in 2003, when The Orlando Sentinel published a front-page series under the headline "OxyContin Under Fire: Pain Pill Leaves Death Trail.”

The newspaper used the term "accidental addict" to describe patients who "put their faith in their doctors and ended up dead, or broken."

This characterization quickly became the go-to description for most news articles on the emerging “opioid crisis.” An innocent person, often a teenager on the cusp of life, suffers a painful injury. Their doctor prescribes OxyContin or some other highly addictive opioid and their lives are forever changed. They take higher and higher doses, become addicted, and die from an overdose.

Four months after publication, the Sentinel printed a correction. Two patients profiled in the series as “victims” were not newcomers to opioids, as they had been portrayed. They were using illegal drugs and abusing prescriptions long before their first dose of OxyContin. The Sentinel series also grossly overstated the number of overdose deaths that were caused solely by oxycodone, the active ingredient in OxyContin.

The problem was that the presentation of someone falling so far so fast due to prescription opioids remained irresistible to the media. It became the common narrative, especially in “recovery” stories about someone becoming addicted due to thoughtless opioid prescribing by a doctor or dentist.

This helped create the false belief that people in pain become addicted, very quickly and easily, to opioids. The lie took hold, even though a 2008 study found that chronic pain patients taking opioids had a rate of abuse and addiction of only 0.19% — less than one percent.

In 2015, another study was released that reinforced the false narrative. People in chronic pain on long-term opioid therapy had a “misuse” rate between 21 to 29 percent; and their addiction rates averaged between 8 and 12 percent.

Those are horrible numbers. And very misleading. Shortly after the study was published, the researchers admitted they may have exaggerated the potential for addiction.

“We agree that opioid use is not inherently risky, most patients seem to use opioids without misuse or addiction,” said lead author Kevin Vowles, PhD, a Professor of Psychology at the University of New Mexico.

But that kind of clarification we do not hear in the news. Instead, the story is still about patients prescribed opioids becoming addicted and fueling the opioid crisis.

Often ignored by the media is that opioid prescriptions have been declining for a decade and that most overdoses are cause by street drugs. Or that medical students now get more training in pain management. This may actually be the best and safest time to prescribe and receive opioid prescriptions. 

Most of us bemoan and rant against the CDC opioid guideline, and because many of our doctors feel intimidated by the DEA and state medical boards, fearing arrest and prosecution if they prescribe opioids. 

Maybe, though, the place we need to start is with the media, and getting them to tell the true narrative: most pain patients do not become addicted. 

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

Finding Life in the Midst of ‘The Pain-Cancer Connection’

By Cynthia Toussaint, PNN Columnist

In 2019, when I first heard my worst diagnosis, Triple-Negative Breast Cancer – yes, the rare and aggressive kind – I instinctively knew it was tied to my 37 years of high-impact pain. Indeed, for a couple of decades, I’d commented often to my partner, John, that I didn’t understand how my body could take the toll of never-ending torture without getting terminal cancer.

Like so many of us with pain, my chronic depression kept me wondering if that scenario might be a blessing. In fact, my greatest struggle was endlessly debating whether life with pain was worth living. 

Here’s the stunner! After hearing my grim diagnosis, I ultimately deduced it was. So much so, not only did I choose to fight, I took a deep dive into discovering the best chance at surviving my cancer well with the quality of life I still had intact. In short order, I armored myself with a boatload of education and committed to using integrative care all the way. Making bold, unconventional treatment decisions upped my chances to stay on the planet.

I won’t sugar-coat it; fighting breast cancer while trying to keep 19 overlapping pain and fatigue conditions in check was the hardest thing I ever did, and the jury’s still out as to whether I’ll survive. But I’m damn happy and proud to be here today, and want to share what I’ve learned.

Enter “The Pain-Cancer Connection,” the theme of For Grace’s 2021 Women In Pain Conference on Friday, September 24.

Last year when I sat down via Zoom with my sisters in pain that make up For Grace’s event planning committee, I was in the midst of chemo, bald and very ill. After pitching the theme and telling these badass women about the connection between pain and cancer, I was deeply touched that they wanted to move ahead.

None of these women have had a serious cancer diagnosis, and executing a conference, especially in the midst of COVID, is damn-near impossible work. I love these women! They play a critical part in helping me turn suffering into meaning, my primary life force.

CYNTHIA TOUSSAINT

As some wise woman shared, “All good things come in time.” As such, this virtual conference is a year late due to my rough recovery. That’s another thing about my sisters – they unconditionally supported, even insisted on, my need to take time to ramp up to this frenetic pace.

Well, here we are, and what a first-of-its-kind day we’ve got in store.   

After a warm welcome from our Director, John Garrett, I’ll start by divulging my cautionary tale with cancer treatment. Oh boy, I’ve got a ton to say about western medicine failing miserably at every turn – and how taking control of my cancer care got me this far.

Next up, integrative oncology chaplain Michael Eselun will share a touching, personal story about loss and letting go. Michael is a gem of a storyteller who brings his audience to laughter and tears, whilst stepping into the dark side with ample tenderness.  

Sprinkling in some For Grace vibe, woman in pain and comedian Anna Polack will drop a witty take on the self-help movement. Later, she’ll host interactive “fun breaks” to bring in lightness.

Also, throughout our day, we’ll spotlight woman in pain and artist Radene Marie Cook’s exquisite pieces that depict the pain-cancer experience in endless passion and color.

Then we’ll launch into our four themed sessions: Problem, Solution, Experience and Moving On.

Dr. Wayne Jonas, Executive Director of the Samueli Foundation’s Integrative Health Programs, will present the “Problem” – how the inflammation of pain can lead to cancer and how cancer treatment can spark persistent pain. Dr. Jonas will also delve generously into the benefits of integrative care. His brilliant, positive take on healing is eye-opening, and I’m forever grateful for his steady guidance.

The “Solution” session will kick-off with one of my all-time favorite people, Christin Veasley, co-founder of the Chronic Pain Research Alliance. Simply put, Chris is the best, full of information and care. She’ll explore effective tips about how to become your own best advocate, including how to partner with your practitioner for best outcome.

Next up, one of my heroes, Dr. Keith Block, founder of the Block Center for Integrative Cancer Treatment, will go in-depth about how to keep one’s “terrain” healthy throughout active cancer treatment as well as the all-important post period to avoid a recurrence. Tragically, western medicine doesn’t acknowledge the terrain, but this is the stuff that saved me! In fact, Dr. Block’s book, Life Over Cancer, was my bible during treatment.

Dynamite wellness expert and fellow sister in pain, Dr. Susan Nyanzi, will follow with how common-sense, self-care lifestyle choices can help prevent most cancers. I say, “Amen to that, Dr. Nyanzi!” Just wish I’d heard this talk five years ago.

A dynamic panel of real-life pain and cancer patients will make up our “Experience” session. Moderated by the no-holdin’-back Rhonda Smith, breast cancer survivor and executive director at California Black Health Network, these folks will share, with us and each other, inside advice about getting best care, handling adversity, the importance of self-management, and improbable “gifts” along the way.         

We’ll end with the inspiration to “Move On” despite the challenges of these epic diseases. Yes, it’s all about hope and movement with Dr. Melissa Cady, DO. Also known as “The Challenge Doctor,” this force-of-nature will teach us how to reframe illness and use movement to find joy and less suffering.   

To put a bow on the day, cancer survivor and Bump In the Road podcaster, Pat Wetzel, will share how illness and misfortune drove her to transform her life into one of helping others, traveling the world and prompting folks to hit the road to find wellness and meaning. Seriously, there are no brakes on this full-speed-ahead woman, guaranteed to inspire! 

There’s no denying that cancer and pain are upending, life-altering, sometimes terminal diseases. But as this conference will illuminate, we can fight the good fight with dignity and grace.

Last year, during my darkest hours of chemo and COVID, when I actually forgot why I wanted to live, people from my circle of support bolstered me by phone, email, text and good ol’ snail mail, to keep me keepin’ on. Truly, I don’t know if I would have made it without them.

I want this conference to be that kind of support system for those who are wrangling with pain, cancer or both. I want its shared education to make it possible for one disease not to springboard into another. I want the day to remind us that there’s enough love in this world to make life worth fighting for.

Seeing so many beautiful people come together, volunteering their time to help others avoid my fate, humbles me – and makes my heart swell.    

I look forward to connecting with you on Friday, September 24 at 9am PDT (12pm EDT). You can watch the entire conference for free on our YouTube channel.      

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

Misogyny in Medicine Harms Fibromyalgia Patients

By Dr. Denise Phan, Guest Columnist

Anyone who has practiced medicine or been involved in women's health in the past 50 years has encountered fibromyalgia in one form or another. Many of us have seen the fibromyalgia pendulum swing from under-recognition to over-diagnosed, and back to under-diagnosed again.

Although the course of fibromyalgia mirrors our society's recognition and treatment of pain in general, this particular disorder is also handicapped by its association with women. Since women were not part of the medical and research establishment until recently, diseases that affect women exclusively or predominantly have often been ignored or downplayed. 

Admittedly, fibromyalgia is not an easy diagnosis to make and has no reliable treatments. It is also not progressive, does not cause permanent muscle or joint damage, and does not directly cause early death. Until recently, there were no easy blood markers for fibromyalgia as with other rheumatologic diseases. No x-rays or MRI findings can help diagnose it. 

But the main problem with fibromyalgia was that the vast majority of patients who present with this syndrome of widespread pain and tender points are women.

Thus, it was easier for the arrogant and sexist wing of medicine to relegate fibromyalgia to the "histrionic" or "psychogenic" disorders that predominantly affect women. 

DR. DENISE PHAN

Other examples of severe disabling painful conditions that affect women more than men are endometriosis, pelvic pain, polymyalgia rheumatica, migraine, lupus, scleroderma, and trigeminal neuralgia. Some of these disorders are just now being recognized, researched and beginning to get treated. 

Though the term fibromyalgia was first coined in the 1970s, the disease can be traced back thousands of years to biblical times. When I was going through medical school and residency training in the 1980s, many of my attending physicians refused to recognize fibromyalgia as a "real" disorder and often did not offer any treatment for it. 

To some degree, this was due to our poor understanding of how the nervous system affects musculoskeletal tissue. But in the vast majority of cases, the refusal to acknowledge fibromyalgia stemmed from the undercurrent of misogyny that permeates medicine even today. 

Learning How to Treat Fibromyalgia

There were others in the medical community who recognized fibromyalgia and taught me what it was, how to diagnose it, and how to treat it -- despite our very limited, almost non-existent treatment options at the time.

In the 1990s, when I started my private practice in California’s San Fernando Valley, my practical education of fibromyalgia was furthered by the multiple women who presented in my office with this puzzling, intractable disease. Since there were no FDA-approved treatments yet, we would try every and any off-label treatment possible to see if we can get any long-term or even short-term relief of symptoms. 

There were the traditional trials of NSAIDs, tricyclics like amitriptyline, trazodone, SSRI's, low dose opioids, muscle relaxants, warm water physical therapy, trigger point injections; and then the non-traditional treatments like guaifenesin, anti-inflammatory diets, acupuncture, yoga, tai-chi, sauna, infrared therapy, cannabis, low dose naltrexone and moving to a warm, dry climate. 

Although none of these treatments are highly effective; when they did work it was a tremendous relief to restore function to these long-suffering patients. Despite this, I would still occasionally learn of suicide threats and attempts by fibromyalgia patients who did not respond to any of these treatments. 

These patients pushed me and other doctors to treat pain seriously; so that it does not become a cause of other morbid pathologies such as depression, fibro fog, cervicogenic headache, irritable bowel, overactive bladder and chronic fatigue. It also emboldened us to use stronger opioids, if necessary, to control chronic pain. This coincided with the release of longer-acting opioids like MS Contin, fentanyl patches and OxyContin. 

As the recognition of fibromyalgia went mainstream in the 2000s, so did the push to control pain more aggressively with higher doses of opiates. Laws were passed and guidelines were published, urging physicians to treat pain seriously. Physicians were taught, in one seminar after the other, that longer-acting opioids would control pain throughout the day with less need for pill-popping. This would provide more stable blood levels and less euphoria, making opioids less habit-forming and minimize addiction potential. 

In the late 2000s, Lyrica was the first medication specifically approved for the treatment of fibromyalgia, followed in quick succession by Savella and Cymbalta. Fibromyalgia patients benefited from the increased recognition and treatment of their disorder and the aggressive approach to pain control. 

Many of my patients who didn't respond to off-label treatments achieved remission with the new FDA-approved meds. Some who didn't were eventually stabilized on higher doses of hydrocodone, oxycodone, Dilaudid, methadone, buprenorphine, morphine or fentanyl. Some of the more severe cases were able to get off oral meds and restore normal daily function after we implanted subcutaneous pain medicine pumps. 

A New Betrayal

Then in the early 2010s, reports of rising death tolls from opiate overdoses began coming in, often involving drug seekers who were crushing and snorting OxyContin tablets to get high. It was also recognized that patients on chronic opioids were at risk of accidental overdose.

In response, more cautious opioid prescribing guidelines came out from state medical boards and the CDC; followed by the DEA prosecuting pharmacies and pain management doctors. One pain clinic after another started closing down, their patients were often red-flagged and unable to find new doctors. Vast numbers of patients became collateral damage as the news media and legal profession fanned the flames of the war against opiates. 

For chronic pain patients in general, the lack of access to pain meds required them to make serious adjustments to their lifestyles, like not getting out of bed, not holding a job, and not taking care of their family. For many fibromyalgia patients, it was as if the doors to treatment were slammed shut. 

The latest betrayal for these patients is coming from the medical and academic community itself. I was horrified and shocked at my last pain management seminar when the young professor lecturing on the topic of fibromyalgia stated aloud the official current policy of the medical community is that there is no role for opioids in treating fibromyalgia. 

When asked what we should do for patients who have failed all the recommended treatments, FDA-approved and otherwise, he could only recommend yoga. That was when I realized that misogyny was back in style. The medical community has been cowed by “opiate hunters” into toeing the line and spouting what is essentially a ludicrous theory: the idea that we should not use pain medicine in the treatment of chronic pain. 

This is what is being taught today in medical schools all over the country. The next generation of physicians is being trained to think that it's okay to leave people in chronic pain day after day, when there are good medicines available that, when used judiciously, may be able to restore life and function to an incapacitated patient. 

Obviously, there is the risk of serious side effects from opioids, just as there are for any powerful medications. But that is what we are trained to do, to take into account these side effects for each individual patient, to evaluate the risks versus benefits of each treatment, and to monitor them as best we can. That is what my Hippocratic Oath tells me to do. 

Now, if only we can get through to the other less misogynistic side of the medical community. The ones with enough courage to speak truth to power. There are some of them in medical schools and ivory towers everywhere, who can recognize injustice and who will speak common sense to our future doctors. 

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

How I Learned To Live With and Manage Chronic Pain

By Beth Thorp, Guest Columnist

The CDC estimates that 50 million Americans – just over 20 percent of the adult population – have chronic pain.  About 20 million have “high-impact chronic pain,” which is defined as pain severe enough to frequently limit life or work activities. I am one of the “high-impact” ones.

For a long time, I did not believe that I had enough expertise or a unique enough story to share my experiences with pain, except with those closest to me.  But because of how often people tell me, “I don’t know how you do it!”; I began to believe that sharing my struggle to live with and manage chronic pain might help others who also suffer from it.

Like many others with severe chronic pain, I have had experience with using opioids.  Given the crackdown on doctors prescribing these medications, I felt that sharing all the other skills I use to manage my pain might be useful to other patients. 

I believe there are three aspects of our health which must be addressed if we are to have full and productive lives despite our pain. These are physical health, mental health and socialization.

Three-Part Model for Pain Management

Physical Health

When pain begins, the first and logical area to address is our physical health. It’s important to me to rely not just on pain medication, but a wide range of other modalities. These include:

• Physical therapy, including heat, ice, ultrasound, stretching, exercises, TENS

• Injections of steroids and analgesics

• Neuromodulation devices such as spinal cord stimulators

• The use of support tools, such as canes, walkers, wheelchairs, etc.

Some activities, like stretching, might be easy to incorporate into your daily life.  Exercise might take some trial and error to find types that help with pain and that you enjoy. Others, like using a wheelchair, might take overcoming the burden of stigma.   

For me, the idea of getting a wheelchair was initially out of the question.  But then my pain doctor suggested that it would be better to use one to travel in places like airports, museums and zoos so that I can better enjoy the experience, and have less pain during and afterwards.  Once I thought of it this way, it was an easier choice.

Mental Health

As my pain persisted, despite many physical and medical treatments, it became clear to me that I needed some additional resources to help my mind and spirit.  These treatments used to be considered outside of traditional Western medicine.  Additionally, these methods often require out-of-pocket payment. Some examples are:

• Counseling, talk therapy, hypnosis, Reiki

• Meditation and mindfulness

• Participation in activities designed to distract from the pain

• Antidepressant medications

• Focusing on the positive

There are other therapies which address both physical and mental health, including yoga, Pilates, acupuncture, therapeutic massage and tai chi. 

I rely more on distraction than on any other technique.  If one activity does not work, then I will go to another.  When I first heard about distraction, I did not believe that it would work -- but it really does.  Even getting out of one environment into another can help. 

I am still working on the technique of focusing on the positive rather than the negative.  I know this sounds a bit Pollyanna, but I believe it is important to move ahead with a good quality of life.  The goal is to be grateful for the things I can do, not ruminating on the things I have lost or can no longer do. Some examples of this are:

• Take “one day at a time.”  If today is bad, tomorrow is likely to be better

• Try new activities that fit within the scope of your current abilities

• Learn new skills or explore new areas to learn by taking classes, in person or online

• Find others who suffer from chronic pain and share ideas for living better

• Most of all, don’t give up! 

Socialization

The longer pain goes on, the more isolating it can be. I’ve experienced loneliness and solitude. Our world gets smaller as the number of things we can do shrinks and the things we can do become very restricted. 

One of the hardest things for many of us is to ask for help. Similarly, we don’t want to be a burden, so we don’t reach out to ask our friends and family to come over and spend time with us. 

In order to maintain a good quality of life, we must find our own ways to become or stay involved with others.  For example:

• Phone calls or Skype, FaceTime and Zoom meetings with family and friends

• Group activities such as book clubs, crafting circles, games nights, group lunches

To address mental health as well as socialization, joining a religious group, community organization or chronic pain support group can be very helpful.  You can also combine socialization and physical health with activities such as exercise classes or Silver Sneaker programs.

Three Changes Needed

I believe that there are three changes to our healthcare system which must be pursued in order to respond to the opioid crisis in ways that help patients with pain, not hurt them.

First, don’t punish patients by removing access to opioid medications. For some of us, they are the only thing that works. Work with us to help us take them responsibly. 

Second, the pharmaceutical industry should develop safe, effective and non-addictive pain medications for those of us with high impact chronic pain. 

Third, insurance companies should be required to pay for alternative treatments such as massage, acupuncture, yoga, etc. that are often recommended as alternatives to opioids. Those options are not really available to most patients with pain.

Chronic pain may last a lifetime.  Thus, it is critical to find ways to live a full and happy life despite the pain.  Different methods work for different people.  I believe that the most important thing is to try everything you can.  If one doesn’t work, try another.  Be sure to include physical, mental and social solutions.  And try to stay as positive as possible.  That’s how I do it.  You can do it too! 

Beth Thorp has lived with chronic pain from sciatica, neuropathy and osteoarthritis for almost 25 years. She’s had multiple back surgeries, including two implanted stimulators.

Beth worked for 34 years in the pharmaceutical industry, including as a partner in her own consulting firm. She is now retired and spends her time with her family, as well as knitting, quilting, reading and exercising.

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

Is Kratom Right for You?

By Forest Tennant, PNN Columnist

The answer to the headline on this column depends upon whether you can get enough prescription opioids to control Intractable Pain Syndrome (IPS).

In many locales in the country, doctors — for multiple reasons — will not prescribe enough opioids to control IPS and its cardiovascular, endocrine and autoimmune manifestations. If you can’t get enough prescription opioids to keep your pain under control, you should give kratom a try.

What Is Kratom?  

Kratom is a compound found in the tree leaves of the mitragyna speciosa plant that grows in southeast Asia.

It is an herb and not an opioid, but it produces pain relief like an opioid. Biologically, it attaches to the opioid receptors (pain relief sites) in the brain and spinal cord, and relieves pain just like an opioid. 

Kratom is legal in most of the United States and is widely advertised and promoted on the Internet. It is available as a pill, capsule or powdered extract.

It can be used by itself for pain relief or taken simultaneously with a prescription opioid. Most persons with IPS who report kratom use take it between opioid dosages or use it just for flares.

How Do I Know How Much to Take? 

There are several formulations and many brands of kratom. In fact, we have received so many different reports that we can’t really say that one form, color or source is better than another. Our recommendation is that you acquaint yourself with someone who already takes kratom for pain relief. This person is in the best position to “show you the ropes” relative to dosage, types and sources. 

As with any new drug, start at a low dose and work up over time to maximize its effectiveness and prevent any severe side effects. Kratom is available without a prescription, but check with your state laws first. It is currently illegal in a few states and some communities.

Do not let today’s opioid restrictions ruin your health and life by leaving you in severe pain. Kratom may be just right for you. 

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

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.    

Infighting in the Pain Community Made Me Leave Advocacy

(Editor’s note: The pain community lost another one of its advocates this week – not to chronic pain or illness, but to frustration and despair. In a Facebook post, Caylee Cresta said she would no longer be an advocate for people in pain because of chronic infighting and toxicity in the pain community.   

For those who don’t know Caylee, who we profiled in a 2018 PNN article, she is the creator of a series of videos on YouTube and TikTok that explore everything from makeup and relationships to the stigma faced by pain patients and their fear of pharmacists. Caylee’s entertaining videos offer a way for people outside the pain community to see how opioid hysteria has disrupted pain care for millions of patients. Her Facebook post is republished here with Caylee’s permission.) 

By Caylee Cresta 

For my fellow spoonies: I’m going to address this once, and once only. I hear you guys, I know you’re waiting for chronic pain content; but unfortunately, it’s not coming (at this time, at least).  

Rare disease, chronic pain, and the stigma surrounding opioid medications have plagued my life for over a decade at this point. I am not nearly alone in that, and hundreds of thousands of people are suffering daily. That cause is so close to my heart, and will forever be, and it is still something I deal with daily as well.  

When my life was turned upside down as a result of that stigma, I found a community advocating, fighting, and spreading awareness. I met some of my favorite people as a result and made what I believed at that time would be lifelong friends.  

However, that community is by far the most toxic I have ever seen in my life. There is a power struggle that will swallow any attempt at good, and an ugliness that will destroy progress. It will scare any true advocate enough to walk away. The lies I heard spread about myself, my character, and my family were enough to make me sick.

CAYLEE CRESTA

I want you to ask yourself, if someone is fighting for a cause they truly believe in, should they have to defend themselves more vehemently than the crisis at stake? The toxicity doesn’t allow anyone to focus solely on the action of advocacy, and you beat each other down more than any opposition ever could.  

I don’t expect a word of this to change anything, but I do feel as though I owe many of you an explanation for my absence. I can only hope that I will be able to create some change at some point on my own, but that is not a decision I will make today.  

I love creating more than anything in the world, and I let the toxicity of the chronic pain community rob me of that for years. The chronic pain community caused me more pain than the stigma I hoped to fight.  

I remember my first days in the chronic pain community clearly. I remember people saying that they never made any progress. While I hate to be blunt, I think the answer is abundantly clear.  

You will never have the numbers because you constantly let people be torn down and excommunicated. Your viscous behavior will take any passion for this cause and swallow it whole, all before spitting out the shell of someone who was once excited to advocate. You don’t see passion as inspiration, you see it as competition. 

I spent my own resources, offered my assistance to all, and spent hours in hopes of offering support and change, and instead I got hate. I see everyone post the suicide rate with grave concern, and yet you will encourage it with rumors, falsehood, and lies.  

The very people that once called asking for help became my enemy without a word, question, or otherwise. And while I could go on forever, I only ask this: If you see another passionate advocate excited to create change, protect them and don’t let them be destroyed as you did me.  

This isn’t about me, it’s about patients, but the chronic pain community seems too often be about anything but. 

If you take anything from this post, let it be this: you have to care more for this cause than you hate one another. And with this, I close that chapter of my life forever, and I wish you all continued love, happiness, and comfort.