Promising Results for Stem Cell Treatment of Degenerative Disc Disease

By Pat Anson, PNN Editor

An Australian regenerative medicine company has released positive results from a Phase III randomized trial showing that a single injection of its proprietary stem cell product can provide long-term relief for people with chronic lower back pain caused by degenerative disc disease.

Mesoblast Limited said the results are so promising it plans to meet with the U.S. Food and Drug Administration to discuss ways to accelerate approval of the drug as a treatment that reduces the use of opioid pain medication.

The company’s stem cell product -- remestemcel-L -- has been under development for several years. It uses mesenchymal precursor cells taken from the bone marrow of healthy donors to reduce inflammation by inhibiting the production of pro-inflammatory cytokines by white blood cells.

Sixty percent of the patients in the clinical trial who were injected with remestemcel-L reported minimal or no pain after 12 months. After 24 months, 54 percent reported little or no pain, with the greatest pain reduction in patients in the early stages of degenerative disc disease. Many patients also significantly reduced their use of opioids during the study period.

“The durable pain reduction for at least two years from a single administration indicates that rexlemestrocel-L has the potential to change the treatment paradigm for chronic low back pain due to inflammatory disc disease, a condition that affects as many as seven million patients across the United States and Europe, and to prevent or reduce opioid use and dependence,” Dr. Silviu Itescu, CEO of Mesoblast, said in a statement.

Over 400 patients were enrolled in the Phase III trial, which was conducted at 48 sites around the world, mostly in the United States. Although Mesoblast told physicians and patients not to change any medications during the trial, after 24 months there was a 40% reduction in opioid use in patients injected with rexlemestrocel-L. Those who were given a placebo saline injection increased their daily opioid consumption.

In a previous study of patients with chronic lower back pain who did not respond to conventional treatment, a single injection of remestemcel-L also reduced pain for at least two years.

The FDA has prioritized the development of new pain treatments that reduce the use of opioids. Although the agency has taken a dim view of some stem cell therapies as “unproven and potentially dangerous,” Mesoblast believes the FDA will be more open-minded about its rexlemestrocel-L treatment. Last year the agency approved an investigational new drug application for rexlemestrocel-L as a therapy for COVID-19.

“We now have two studies that show significant pain reduction and we’re fully prepared to have a discussion with FDA on a path forward,” said Mesoblast Chief Medical Officer Dr. Fred Grossman. “We’re going to get into discussions to see if there’s an accelerated path. Or, if we do need to do another study, we now have a very defined patient population where we see significant pain reduction.”

New Society Launched to Advance Pain Research

By Gregory Carbonetti, Guest Columnist

“I live with layers of chronic pain,” writes Dr. Richard Hovey, a professor of dentistry at McGill University. Diagnosed with psoriatic arthritis and enduring lower back pain from a bicycling accident, Hovey also faces painful chemotherapy for advanced metastasized prostate cancer.

“The combination of these pain-inducing events presented significant life-changing challenges to retaining my sense of personhood,” Hovey wrote in a personal essay in the Journal of Patient Experience.

Many Americans may relate. Chronic pain is more prevalent in the U.S. than diabetes, coronary heart disease, stroke and cancer combined. It costs our economy some $635 billion a year in direct treatments and lost productivity.

These problems are exacerbated by the ongoing opioid epidemic, which claimed approximately 450,000 lives over the last two decades and stigmatized people who take prescription pain medication. The nation, and the world, lacks efficient and safe pharmaceutical treatments for pain.  

Thus, one might think a scientific and professional society comprising scientists, clinicians, healthcare providers and policymakers exists, working to reduce the burden of pain. There was such a group, the American Pain Society, but it filed for bankruptcy in 2019. This absence was rectified only this past December with the inaugural meeting of the United States Association for the Study of Pain (USASP).

The circumstances leading to the formation of this new organization underlie the importance of pain research in the United States, which scientific societies play a fundamental role in. They foster interdisciplinary collaboration among members; attract young investigators through early-career grants; work to increase policy impact and address social issues; and promote members’ personal and research integrity.

Scientific societies bring together diverse perspectives and translate knowledge into directives for action. The death of the old pain society and the birth of a new one illustrates the importance of transparency for societies of every discipline.

The now-defunct American Pain Society did some good work. It provided clinical guidelines for pain treatments, increased funding for research, and advocated for multidisciplinary care. But it became a victim of toxic philanthropy, tarnished by its connection to opioid manufacturers such as Purdue Pharma, which settled criminal and civil charges last year by agreeing to pay $8.3 billion for its role in the opioid crisis.

Purdue and other opioid manufacturers accounted for nearly $1 million of the American Pain Society’s $6.5 million in contributions between 2012 and 2017, according to a U.S. Senate committee report, and covered over 5% of the society’s expenses during those years.  

The American Pain Society wasn’t the only professional society accepting donations from opioid manufacturers. The Academy of Integrative Pain Management, which accepted approximately $1.3 million between 2012 and 2017, also dissolved in 2019 due to financial problems. While its focus was different, both societies shared members, and its loss was another setback.

For many pain researchers, clinicians and advocates, the American Pain Society’s demise meant losing important support for their work. These professionals soon had difficulty meeting with pain management leaders and experts in other sub-specialties and disciplines.

More Transparency Needed

Many members were stunned by what had transpired, unaware of the American Pain Society’s dependence on opioid manufacturers. According to the Pacific Standard, when the society’s contributions from opioid manufacturers began to dwindle, leaders never directly told members that fewer industry donations were contributing to their financial problems. 

The dissolution of the American Pain Society created a vacuum, and strategies to organize the USASP began. Forming the new society included a GoFundMe campaign to purchase the old society’s Journal of Pain through auction.

While membership in the USASP is similar to the American Pain Society, its leaders stress that they have learned valuable lessons, making the new constitution and expectations of leadership more transparent and talking with members about the role industry will hold. The USASP is committed to “values-based” decision-making.  

Creating a new society will not instantly end either the chronic pain crisis or the opioid crisis. Nor will it absolve certain players of their past errors. Nonetheless, this history should push other scientific societies to strive toward full transparency and remain in service to those they seek to help.

Dr. Hovey wrote of the transformation “that occurs as patients become people again and are awakened by the multitude of challenges that [lie] ahead of them.”

The formation of the United States Association for the Study of Pain is a significant moment for chronic pain research and for sufferers like Dr. Hovey. The work of rebuilding vital infrastructure for understanding and managing chronic pain, the invisible epidemic, begins anew.

Gregory Carbonetti, PhD, is a Civic Science Fellow at the Alan Alda Center for Communicating Science, working to more meaningfully connect science and research with diverse communities and our shared civic life.

This column is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Rare Disease Spotlight: Alexander Disease

By Barby Ingle, PNN Columnist  

February 28th is Rare Disease Day, a global effort to raise awareness about over 7,000 rare diseases and their impact on people’s lives. One of those rare diseases is Alexander disease, which is named after Dr. W. Stewart Alexander, the Australian physician who first described the condition in 1949.

Alexander disease is an autosomal dominant leukodystrophy, which are neurological conditions caused by anomalies in the myelin, a fatty substance which protects nerve fibers in the brain. It’s a rare genetic disorder that primarily occurs in infants and children.

Leukodystrophies are characterized by abnormalities in the brain’s “white matter” which lead to the formation of Rosenthal fibers -- abnormal clumps of protein that accumulate in the brain. Rosenthal fibers are also found in other neurological disorders, such as multiple sclerosis.

Alexander disease is progressive and usually fatal, especially when it develops in infants. The disease occurs in both males and females, and there are no ethnic, racial, geographic, cultural or economic differences in its distribution. It can strike anyone.

The most common type of Alexander disease usually begins during the first 2 years of life. Most children with the infantile form do not survive past the age of six. Juvenile and adult-onset forms of the disease have a slower, lengthier course.

People who develop symptoms later in life may not be aware they have Alexander disease and are often misdiagnosed. Symptoms include excessive vomiting, difficulty swallowing and speaking, poor coordination, pain and loss of motor control. These symptoms mimic those of Parkinson’s disease and multiple sclerosis, or they may be seen as a psychiatric disorder.

For children with Alexander disease, there are delays in mental and physical development, often followed by an abnormal increase in head size and seizures. Chronic pain is a daily occurrence. There is no cure for Alexander disease, but there are treatments that focus on keeping patients comfortable and minimizing symptoms.

Recent studies show approximately 90 percent of people with Alexander disease have a mutation in the gene that makes glial fibrillary acidic protein (GFAP), a protein found in the brain. In most cases these mutations occur spontaneously and do not appear to be inherited from parents.

Current research is aimed at understanding the genetic mutations that cause Alexander disease, developing better animal models for research purposes, and exploring new strategies for treatment. Researchers are also looking for biomarkers for the disease, which would be a major advancement in diagnosis and early treatment.  

There are support groups for patients and families affected by Alexander disease, such as the United Leukodystrophy Foundation. You can find more information on Alexander disease and other rare conditions at the National Organization for Rare Disorders.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of theInternational 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.

Acetaminophen Better Than NSAIDs for Acute Trauma Pain

By Pat Anson, PNN Editor

Acetaminophen (Tylenol) is superior to non-steroidal anti-inflammatory drugs (NSAIDs) in treating acute pain in patients recovering from arm and leg trauma, according to new research published in the journal Academic Emergency Medicine. It’s the latest in a string of studies that recommend the use of non-opioid pain relievers for acute pain after discharge from a hospital.

The research is based on a study of 1,500 adults in the North African nation of Tunisia, nearly half of whom had bone fractures. Upon discharge from a hospital emergency department, the patients received either acetaminophen, a high-dose NSAID, or a combination of the two. Acetaminophen is commonly called paracetamol outside the United States.

After seven days, researchers found that nearly two-thirds (61.8%) of patients receiving paracetamol alone were “satisfied” or “very satisfied” with their pain relief. Only 11.4% required another oral pain reliever. The other two groups had similar satisfaction scores, but had lower rates of medication adherence. Side-effects such as vomiting and gastrointestinal pain were also more common in patients who received NSAIDs.  

“This study found that the combination of a high‐dose NSAID with paracetamol does not increase the analgesic effect compared to paracetamol alone. We also found that paracetamol alone is superior to high‐dose NSAID alone for post-traumatic extremity pain,” wrote lead author Mohamed Amine Msolli, MD, an emergency room physician at Fattouma Bourguiba University Hospital in Tunisia.

“Taking into account its superior efficacy and tolerability, paracetamol appears to be the most suitable first‐line therapy for managing mild to moderate posttraumatic extremity pain after discharge from the ED.”

Opioid analgesics are not widely available in Tunisia and most other Middle East countries, and were not included in the study. Nevertheless, the study findings are being cited as evidence that paracetamol is superior to both NSAIDs and opioids in treating acute trauma pain.

“The surprising efficacy of paracetamol over an NSAID, as shown by a 6.4% lower need for additional oral analgesics, may impact prescribing practices,” Andrew Chang, MD, a professor of emergency medicine at Albany Medical Center, said in a statement.

“Many ED patients who have a contraindication to NSAIDs but require analgesics upon ED discharge might be prescribed an opioid. Given the ongoing opioid epidemic, this study lends evidence to support the use of acetaminophen alone in such patients."

But the risk of long-term opioid use after an emergency room visit is actually quite low. A large 2017 study by the Mayo Clinic found that only about one percent of emergency room patients given an opioid prescription progressed to long term use.

Acetaminophen also has risks that are not acknowledged in the Tunisia study. Excessive use of acetaminophen can lead to liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

How to Reduce Brain and Spinal Cord Inflammation

By Forest Tennant, PNN Columnist

Intractable pain syndrome (IPS) is constant pain with cardiovascular and endocrine dysfunction. IPS occurs when the initial cause of pain creates inflammation in the brain and spinal cord. This is called neuroinflammation.

Inflammation in the brain and spinal cord is what causes the worsening of IPS symptoms. Inflammation does its dirty work by burning out or damaging neurotransmitter systems such as dopamine, endorphin, cannabinoid, serotonin, and gaba aminobutyric acid (GABA). Common symptoms of neuroinflammation:

• Constant pain

• Fatigue

• Amotivation (Lack of motivation or purpose)

• Attention deficit

• Memory impairment

• Elevated blood pressure & pulse

• Social withdrawal

• Dietary change

• Weight gain

• Sugar craving

• Depression

Every person with IPS must attempt to control and reduce their brain and spinal cord inflammation. To reduce neuroinflammation, we recommend regular consumption of one or more of these non-prescription, natural herbal medicinal agents:

• Tumeric/Curcumin

• Ashwagandha

• Boswellia

• Palmitoyethanolamine (PEA)

• Traumeel

• Cannabidiol (CBD)

• Andrographis

You can take any of these on different days or several together, as long as you use at least one daily.

If the disorder that started your pain and IPS ends in “itis” -- arthritis, arachnoiditis, pancreatitis, cystitis, colitis or myositis -- you will also need a periodic (e.g., 1-2 times a week) low dose of a corticosteroid such as hydrocortisone, methylprednisolone, prednisone or dexamethasone.

Don’t rely on pain relievers alone. You must have an inflammation reduction component as part of your IPS treatment program.

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 has given financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Are Cannabis Dispensaries Really Associated with Fewer Opioid Overdoses?

By Roger Chriss, PNN Columnist

A new study published in The BMJ claims that U.S. counties with medical and recreational cannabis dispensaries have fewer opioid-related deaths.

Researchers at Yale and University of California at Davis found that an increase of just one or two storefront dispensaries in a county was associated with a 17% reduction in all-opioid mortality rates. Deaths involving illicit fentanyl and other synthetic opioids fell by 21 percent.

Although the researchers cautioned that “the associations documented cannot be assumed to be causal,” cannabis supporters were quick to praise the findings.

“The data to date is consistent and persuasive: For many pain patients, cannabis offers a viable alternative to opioids, potentially improving their quality of life while possessing a superior safety profile,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

While the study findings are interesting, they highlight the importance of considering the complex supply side of legal and illegal drug markets, and how it shapes opioid use and misuse. The study looked at data from over 800 counties with legal dispensaries, and compared them to counts of fatal overdoses between 2015 and 2018.

It turns out many of these counties were on the West Coast, where illicit fentanyl had yet to became as pervasive on the black market as it had in other parts of the country. Since 2018, deaths involving fentanyl have soared on the West Coast. 

“If you were to do the same study with current data, you’d find something different because of the way both opioid deaths and cannabis dispensaries have shifted since then,” Chelsea Shover, PhD, an assistant professor at UCLA School of Medicine told Healthline. 

In general, the opioid overdose crisis has gotten worse in the past couple of years. The CDC recently reported that in the 12 months ending in May 2020, ten western states reported a nearly 100 percent increase in deaths involving illicit fentanyl and other synthetic opioids. The increase was particularly sharp in states that legalized recreational cannabis.  

This is the problem with ecological data and associational findings. If you pick the right time or place, you can get an appealing result. And you may ignore other important issues.  

States that legalized cannabis tend to have better public health and more addiction treatment services. They generally have adopted the Affordable Care Act and Medicaid expansion, and have stronger social safety nets. All of these factors are believed to contribute to rates of substance use disorders and overdose risk.

Ecological data alone never proves anything. It merely suggests associations. If the association holds up over time, then researchers can look into a possible causal relation. If however, the association does not hold up, then claims about causality are pointless.

At this point cannabis does not seem to reliably reduce opioid overdose deaths. Further research will be needed to tease out the effects of cannabis legalization amid all the other factors involved in the overdose crisis.

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.

Online Race for Vaccines Leaves Many Seniors Behind

By Will Stone, Kaiser Health News

With millions of older Americans eligible for covid-19 vaccines and limited supplies, many continue to describe a frantic and frustrating search to secure a shot, beset by uncertainty and difficulty. 

The efforts to vaccinate people 65 and older have strained under the enormous demand that has overwhelmed cumbersome, inconsistent scheduling systems.

The struggle represents a shift from the first wave of vaccinations — health care workers in health care settings — which went comparatively smoothly. Now, in most places, elderly people are pitted against one another, competing on an unstable technological playing field for limited shots.

“You can’t have the vaccine distribution be a race between elderly people typing and younger people typing,” said Jeremy Novich, a clinical psychologist in New York City who has begun a group to help people navigate the technology to get appointments. “That’s not a race. That’s just cruel.”

While the demand is an encouraging sign of public trust in the vaccines, the challenges facing seniors also speak to the country’s fragmented approach, which has left many confused and enlisting family members to hunt down appointments. 

“It’s just maddening,” said Bill Walsh, with AARP. “It should be a smooth pathway from signing up to getting the vaccine, and that’s just not what we’re seeing so far.” 

Glitchy websites, jammed phone lines and long lines outside clinics have become commonplace as states expand who’s eligible — sometimes triggering a mad dash for shots that can sound more like trying to score a ticket for a music festival than obtaining a lifesaving vaccine. 

“You can’t have the vaccine distribution be a race between elderly people typing and younger people typing. That’s not a race. That’s just cruel.”

— Jeremy Novich, Psychologist

After being inundated, some public health departments are trying to hire more staff members to handle their vaccination hotlines and specifically target seniors who may not be able to navigate a complicated online sign-up process.  

“Just posting a website and urging people to go there is not a recipe for success,” said Walsh. 

‘Terribly Competitive’ 

Like many other seniors, Colleen Brooks, 85, had trouble sorting through the myriad online resources about how to find the vaccine where she lives, on Vashon Island in the Puget Sound near Seattle.

“It was an overwhelming amount of information,” she said. “I knew it was here someplace, but it wasn’t easy to find out how to get it.”

After making calls, Brooks eventually got a tip from a friend who had spotted the vaccines being unloaded at their town pharmacy. When she dropped by her health clinic to inquire about how to sign up, it happened they were giving out shots that same day.  

“That was totally serendipitous for me, but I actually personally know several seniors who just kind of gave up,” said Brooks. 

Finding out how to get a vaccine appointment was more straightforward for Gerald Kahn, 76, who lives in Madison, Connecticut. 

Kahn got an email notice from the state’s vaccine registration system telling him to make an appointment, but he ran into problems at the very end of the sign-up process. 

“As much as I would pound my finger on the face of my iPad, it didn’t do me any good,” he said.

So Kahn did what many have and called a younger family member, who was able to help him finish signing up. 

“I think there are a lot of people my age, maybe the preponderance, who can only go so far into the internet, and then we’re not only stymied but also frustrated,” he said. 

When Helen Francke, 92, logged on for a vaccine at the designated time, she discovered the spots available in Washington, D.C., filled up almost instantaneously. 

“It was evident that I was much too slow,” she said. “It’s terribly competitive and clearly favors those with advanced computer skills.” 

The next week, Francke tried calling and going online — this time with the help of her neighbors — without success.

“If I had had to depend on the D.C. vaccination website and telephone, I’d still be anxious and unsuccessful,” said Francke, who got a shot only after finding information on a neighborhood discussion group that directed her to a hospital. 

In Arizona, Karen Davis, 80, ended up on a roundabout quest through state and hospital websites with no clear sense of how to actually book an appointment. 

“I kept trying to do it and kind of banged my head against the wall too many times,” she said. 

Davis, a retired nurse, called her doctor and the pharmacy and then eventually turned to a younger relative, who managed to book a 5 a.m. appointment at a mass vaccination site. 

“I’m sure they did not expect older people to be able to do this,” she said. 

Miguel Lerma, who lives in Phoenix, said his 69-year-old mother has been unsuccessful in finding a shot. 

“She’s not an English speaker and doesn’t know technology well, and that’s how everything is being done,” said Lerma, 31. 

Lerma said it’s especially painful to watch his mother struggle to get the vaccine — because he lost his father to covid last year. 

“She’s mourning not only for my dad, but she’s also suffering as an adult now because she depended on him for certain tasks,” Lerma said. “He would’ve handled all this.” 

‘Desperate’ Seniors Look for Help  

Philip Bretsky, a primary care doctor in Southern California, said his older patients would typically call him or visit a pharmacy for vaccines like the annual flu shot, rather than rely on novel online scheduling systems. 

“That’s not how 85-year-olds have interacted with the health care system, so it’s a complete disconnect,” he said. “These folks are basically just investing a lot of time and not getting anything out of it.” 

California’s recent decision to change its vaccination plan and open it up to those over 65 only adds to the confusion. 

Bretsky said his patients are being told to call their doctor for information, but he isn’t even sure when his office, which is authorized to give the vaccines, will receive any. 

“Patients in this age group want to know that they’re at least being heard or somebody is thinking about the challenges they have,” he said. 

There are some local efforts to make that happen.  

In the village of Los Lunas, New Mexico, public health workers held an in-person sign-up event for seniors who needed assistance or simply a device connected to the internet. 

A Florida senior center recently held a vaccination registration event and a clinic specifically for people over 80 who might not have a computer. 

Novich, the clinical psychologist in New York, teamed up with a few other people to create an informal help service for older adults. It began as a small endeavor, advertised through a few synagogues and his Facebook page. They’ve now helped more than 100 people get shots.  

“We have a huge number of requests that are just piling up,” said Novich. 

“People are really desperate and they’re also confused because nobody has actually explained to them when they are expected to get vaccinated. … It’s a big mess.” 

The ongoing shortage of vaccines has led Novich to halt the service for now. 

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

Advocacy Group Seeks to Expand Insurance Coverage of Ketamine

By Pat Anson, PNN Editor

A coalition of patients and healthcare providers is launching an effort to expand insurance coverage for ketamine, a non-opioid anesthetic increasingly used to treat chronic pain, depression and post-traumatic stress disorder (PTSD).

Ketamine is typically administered by infusion under strict medical supervision, a process that that can take up to an hour and cost thousands of dollars. The first goal of the Ketamine Taskforce is to get ketamine infusions fully covered by Medicare.

“Medicare doesn’t officially pay for ketamine infusions. What they will pay for is a generic infusion code similar to if someone was getting an antibiotic infused. The level of reimbursement is very low,” says Kimberley Juroviesky, a retired nurse practitioner and task force co-chair who receives ketamine infusions for Complex Regional Pain Syndrome (CRPS). 

“Since these reimbursement rates are so low, the majority of small ketamine clinics don’t accept insurance. This leaves the majority of pain patients without the pain relief they could otherwise be benefiting from.”

Ketamine is approved by the Food and Drug Administration as a surgical anesthetic, but a growing number of ketamine clinics provide off-label infusions for depression, PTSD and difficult chronic pain conditions such as CRPS. The infusions put patients into a hypnotic, dream-like state — leaving them with less physical and emotional pain once the ketamine wears off. Many insurers consider this off-label use experimental.

“If we could get Medicare to officially put ketamine on their schedule as a treatment for chronic pain, this would hopefully raise reimbursement rates to a level where all providers could afford it. Also, this would force private insurers to pay for ketamine infusions as well and no longer refuse to pay saying it’s experimental,” Juroviesky said in an email. 

PNN columnists Barby Ingle and Madora Pennington have both had ketamine infusions, Barby for CRPS and Madora while recovering from foot surgery.

“The swelling in my foot dramatically improved. Chronic, low-grade discomfort along my spine also disappeared. I felt emotional relief from past trauma, from pain and other life experiences,” Madora explained.

“I went into the hospital in a wheelchair, but walked out on my own a week later,” said Barby, after seven days of ketamine infusions. She now gets “booster” infusions four times a year and no longer takes daily pain medication.

Some ketamine users report lingering side effects, such as hallucinations and visual disturbances. Guidelines from the American Society of Anesthesiologists, American Society of Regional Anesthesia and Pain Medicine, and the American Academy of Pain Medicine only support ketamine infusions for CRPS and short-term acute pain.

“Excluding CRPS, there was no evidence supporting ketamine infusions for intermediate or long-term improvements in pain," the guidelines warn.

The Ketamine Taskforce is working with a consortium of ketamine clinics, collecting data on the safety and efficacy of infusions. That research will be shared with the Centers for Medicare and Medicaid Services (CMS) in an effort to expand Medicare coverage of ketamine for pain and mental health conditions.

WHO Guideline Only Recommends Opioids for Children Who Are Dying

By Pat Anson, PNN Editor

The World Health Organization (WHO) has released new guidelines on the treatment of chronic pain in children, recommending that prescription opioids only be used for children who are dying or seriously ill and not expected to recover.

The 56-page guideline calls access to pain management a “fundamental human right,” while at the same time warning that “evidence of the effectiveness and safety of opioids is completely lacking in children.”

The guideline emphasizes the use of physical and psychological pain therapies, while taking a cautious approach to opioids. Morphine is only recommended for children in palliative care and those with “life-limiting” conditions for which there is no cure and “an early death is expected.”

“Children who are appropriately prescribed morphine for chronic pain in the context of end-of-life care or in children with life-limiting conditions, may require morphine for the management of intercurrent, acute or breakthrough severe pain,” the guideline states.

“Time-limited use of morphine in these contexts should be at the lowest appropriate dose and duration possible and must be regularly reviewed in order to ensure the fewest possible adverse events. Healthcare providers and caregivers need to perform frequent and repeated reassessments of pain and other symptoms, and the principles and relevant guidelines for acute pain management should be followed, including having an opioid stopping plan.”

The new recommendations for children between 0 and 19 years of age are a marked departure from previous WHO guidelines for chronic pain, which said that opioids “are known to be safe and there is no need to fear accidental death or dependence.”

Those guidelines were withdrawn in 2019, after two U.S. congressmen accused the United Nation’s health agency of being “corruptly influenced” by opioid manufactures.  A coalition of palliative care organizations objected, saying WHO caved-in to political pressure.

“We are extremely concerned that the withdrawal of these guidance documents will lead to confusion and possible extreme measures that will hinder access to patients with legitimate medical needs,” the coalition said in a joint statement. “Lack of availability and limited access to these medications for legitimate medical treatment is a human rights violation.”

‘Very Low Certainty’ of Evidence

Most of the recommendations made by a WHO advisory panel – the Guideline Development Group (GDG) — are vague, conditional and based on “very low certainty” of evidence. One of GDG’s members was Andrew Kolodny, MD, a psychiatrist and addiction specialist who founded Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

Despite an admitted “paucity of high-quality research” on how to treat pain in children, the GDG recommended that children be treated from a “biopsychosocial perspective” that incorporates physical therapy and psychological interventions such as cognitive behavioral therapy.  

“Children with chronic pain and their families and caregivers must be cared for from a biopsychosocial perspective; pain should not be treated simply as a biomedical problem,” the GDG said.

There is surprisingly little discussion in the guideline about the risks and benefits of non-opioid drugs such as acetaminophen. Some of the recommendations border on platitudes, such as treatment being “child and family-centered” and “tailored to the family’s values, cultures, preferences and resources.”

One area where the GDG is adamant is the importance of treating childhood pain to prevent it from becoming a lifetime problem.

“Exposure to chronic pain in early life may have implications for the incidence, severity and duration of chronic pain, and may be associated with long-term, maladaptive neurological changes,” the guideline warns.

“Chronic pain in childhood is associated with progression of pain into adulthood and potentially predisposes these children to other chronic health problems in later life. The negative impacts of chronic pain also extend to family members who report a higher burden of care and a detrimental effect on family function. As such, chronic pain during childhood has a very significant negative impact on the child over their life course as well as their wider family unit, making appropriate diagnosis and management essential.”  

The GDG said large, multi-center trials are needed to examine the safety and efficacy of virtually all pain management therapies. Additional research is also needed for children suffering from cancer pain and those with developmental and intellectual disabilities.

Former President Trump withdrew the United States from WHO last year in a dispute over its handling of the COVID-19 pandemic. President Biden reversed that decision on his first day in office.  

Long-Haul Covid Shedding New Light on Chronic Fatigue Illness

By Kevin Cool, Kaiser Health News

Four weeks after San Diego pediatric nurse Jennifer Minhas fell ill with covid-19 last March, her cough and fever had resolved, but new symptoms had emerged: chest pain, an elevated heart rate and crushing fatigue.

Her primary care physician told her she was just anxious, and that none of her other covid patients had those issues. “That wasn’t what I needed to hear,” Minhas said.

At times, she’s been too exhausted to hold up her head. “I was kind of a zombie for months, shuffling around unable to do much of anything.”

The clinical term for the flattening fatigue Minhas describes is “post-exertional malaise.” It is a common symptom among patients who have not recovered from covid. It is also consistent with a standard feature of another chronic illness: myalgic encephalomyelitis, also known as chronic fatigue syndrome, or ME/CFS.

ME/CFS patients also report cognitive impairment — “brain fog” — and orthostatic intolerance, in which standing upright produces a racing heart rate and lightheadedness. Minhas has experienced these symptoms, as have many other “long-haulers,” the tens of thousands of post-covid patients who haven’t recovered.

The percentage of covid patients who become long haulers is hard to pin down — in part because many early covid patients were not tested in time to detect the virus. But “long covid” is potentially an enormous problem. A recent study of 1,733 covid patients in Wuhan, China, found three-quarters of them still had symptoms six months after being released from the hospital.

As of January, doctors had documented more than 21 million cases of covid in the United States. “If just 5 percent develop lingering symptoms,’’ — about 1 million cases — “and if most of those with symptoms have ME/CFS, we would double the number of Americans suffering from ME/CFS in the next two years,” Harvard Medical School professor Dr. Anthony Komaroff wrote recently in the Harvard Health Letter.

ME/CFS Linked to Viral Infections

The cause of ME/CFS is unknown, but multiple studies have found it follows acute infections with viruses — everything from the 1918 Spanish flu to Ebola. “A certain percentage of people don’t recover,” said Leonard Jason, a researcher at DePaul University.

Scientists are trying to figure out the mechanisms of the disease and why it develops in certain people and not others. According to the Centers for Disease Control and Prevention, ME/CFS shares certain characteristics with autoimmune diseases, in which the immune system attacks healthy tissue in the body. Multiple studies are underway to explore this and other potential causes.

Doctors who specialize in treating ME/CFS are beginning to pivot to long-covid patients. Dr. Peter Rowe, whose clinic at Johns Hopkins is one of the country’s leading centers for ME, has so far seen four long haulers at his practice. “All of them meet the criteria for ME/CFS,” he said.

Despite years of research, there is no biomarker for ME/CFS, so blood tests are ineffective as a diagnostic tool. Rowe’s approach is to tease apart which symptoms may have identifiable causes and treatments, and address those.

One example: A 15-year-old boy Rowe was treating for ME/CFS was so sick that even sitting upright a few hours a day exhausted him and made schoolwork virtually impossible. The boy’s heart rate while lying down was 63; when he stood up it skyrocketed to 113. This effect is known as postural orthostatic tachycardia syndrome, or POTS.

Rowe knew from interviews with the boy’s mother that he had an extraordinary appetite for salt. So much so that he kept a shaker at his bedside and would regularly sprinkle salt on his hand and lick it off.

Rowe hypothesized that he was dealing with a sodium retention problem. To counter it, he prescribed the steroid fludrocortisone, which promotes sodium resorption in the kidneys. Three weeks later, the boy had recovered so dramatically he was helping a neighbor with a landscaping project, pushing rocks around in a wheelbarrow. “He was a different kid,” Rowe said.

Such a course of treatment would not be applicable in a typical case, Rowe said, “but it does emphasize the potential for patients to get a substantial improvement in their CFS symptoms if we address the orthostatic intolerance.”

ME/CFS Usually Misdiagnosed

Beginning in the 1980s, many doctors treating ME/CFS prescribed a combination of cognitive behavioral therapy and an exercise regimen based on a now discredited assertion that the illness had no biomedical origin. That approach proved ineffective — patients often got demonstrably worse after pushing beyond their physical limits. It also contributed to a belief within the medical establishment that ME/CFS was all in your head, a narrative that has largely been refuted.

“ME/CFS was never a mostly behavioral problem, although it has been cast as that,” Rowe said.

Answers have been slow to arrive, but attitudes about the illness are beginning to change. Advocates of patients point to a 2015 report by the Institute of Medicine that called ME/CFS “a serious, chronic, complex, systemic disease” and acknowledged that many doctors are poorly trained to identify and treat it. The CDC says as many as 90% of the estimated 1 million U.S. patients with ME/CFS may be undiagnosed or misdiagnosed.

The problem is exacerbated by a reluctance to provide health care coverage to patients whose illnesses aren’t easily diagnosed, said Joe Dumit, a medical anthropologist at the University of California-Davis.

“Making patients prove they are not just suffering, but suffering from a documented illness, saves money. So, I worry about the way in which covid long haulers will be treated as the numbers rise.” The best treatment in many cases may be rest or reduced workload, “which translates into some form of disability coverage,” he said.

But since long haulers typically sicken immediately after having had a testable viral infection, perhaps they won’t be disbelieved, Rowe said — after all, their illness “starts as a ‘real’ illness.’’

Long haulers may also help researchers better understand the onset of the illness because they are being studied as their symptoms emerge, while ME/CFS patients often aren’t seen until they’ve been ill for two or more years, he said.

“There’s no question that this legitimizes in many ways the experience of people with ME/CFS who have felt they weren’t believed,” DePaul’s Jason said.

In July, the nonprofit Solve ME/CFS launched an initiative aimed at understanding similarities between long haulers and patients with ME/CFS. Dubbed You+ME and underwritten by the National Institutes of Health, it includes an app that enables registrants to record their symptoms and their effects over time.

Such efforts may further diminish the tendency of doctors to ignore patients’ complaints of symptoms that seem to have no evident cause, said Lauren Nichols, 32, a long hauler with a long list of miseries — everything from severe gastrointestinal problems to shingles in her left eye.

“I was one of those people who falsely believed that if you can’t see the illness it’s psychosomatic,” said Nichols, who helps administer Body Politic, a support group for long-covid patients that has found common cause with the ME/CFS community.

“Now I’m living it,” she said. “If I have one message for doctors, it’s ‘Believe your patients.’”

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

Are You a Covid Long-Hauler?

By Pat Anson, PNN Editor

Body aches, fatigue, depression and brain fog -- symptoms that are all too familiar for people living with fibromyalgia, rheumatoid arthritis, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and other chronic pain conditions.

They are also long-term symptoms for many people who become infected with Covid-19 -- so-called “long-haulers” who never quite recover. Estimates vary widely, with one unpublished study finding that up to 80 percent of patients infected with SARS-CoV-2 developed one or more long-term symptoms. Even patients who were never seriously ill from Covid face health problems months after their initial infection.

“My body aches, some of them got better, some of them got worse. I developed pains in my hands and in my wrists,” Covid survivor Catherine Busa told the Associated Press. “I know I’m going to sleep, I just can’t wake up. It’s like I don’t feel refreshed. I feel worse in the morning than I did the night before.”

The long-term symptoms of Covid are not fully understood and there is no cure.  But in an effort to get a better understanding of what’s happening, a self-organized group of long-haulers surveyed nearly 3,800 Covid patients around the world to document their lingering neurological and cognitive problems.    

Only 8 percent of long-haulers said they were sick enough to be admitted to a hospital for Covid-19. But the vast majority reported having fatigue, headaches, cognitive dysfunction, malaise and other health problems six months after the onset of symptoms. Nearly half have been unable to return to work.

“Among the most common symptoms were fatigue, worsening of symptoms after physical or mental activity, shortness of breath, trouble sleeping, and ‘brain fog,’ or difficulty thinking clearly,” National Institutes of Health Director Dr. Francis Collins said in a recent blog on the survey findings. “A small percentage of respondents, thankfully, seemed to have bounced back from brief bouts of Long COVID, though time will tell whether they have fully recovered.”

What makes the research into long-term Covid symptoms all the more pressing is the growing awareness that long-haulers may be acting as incubators for more communicable and deadly strains of the virus. These viral mutations could make Covid vaccines less effective in the future.

If you’re a long-hauler over the age of 18 who has not fully recovered from Covid, you can take the survey by clicking here. The survey is lengthy and will take between 45-75 minutes to complete. Researchers will use the data to release more studies on long-haul Covid in coming months.

A Pained Life: Our Dirty Words

By Carol Levy, PNN Columnist

You may remember the late comedian George Carlin’s monologue: “Seven Words You Can Never Say on Television." I won’t list them here, but they are “dirty” words better off not being said, even off television.

I thought about Carlin’s list the other day when I realized there were some words that I use all the time. They’re not dirty words, but for many of us who have chronic pain, they’re words that often prove to be hurtful. Words that we need to let go of.

For example, a major portion of my trigeminal neuralgia pain comes from eye usage and eye movement. I love to read and whenever I pick up a book I know it’ll cause pain, but I refuse to let the pain take this from me.

As I read, the pain starts to grow and becomes demanding: “Stop! STOP NOW!”  

But the plot is thickening and the killer will be soon be unmasked (I hope) in the next few paragraphs, so I keep reading. And the pain keeps growing.

The voice in my head yells: “You have to stop. You have to stop NOW!”

The other voice, the one that refuses to accept my limitations, answers: “Just one more page. Just one more paragraph. Just one more sentence.”

I can listen to the sensible voice and stop now. Or I can read just a little more. And be in tremendous pain. Most of the time the “just” voice wins. It is a word that is anathema to controlling the level of pain. But I let it win anyway.

Shoulda Woulda Coulda

“Should” is another word that causes us to do so many things we know we shouldn't: “I should make the bed” or “I should make the kids dinner even though the pain is so bad.”

That’s often followed by the self-flagellating counterpoint “I shouldn't have made the bed or read that book. I knew it would make the pain worse.”

“Could” is another one. I find this word to be a favorite of rueful thoughts in the “coulda woulda shoulda” variety. It is also a favorite of others who ironically think it is a compliment: “You could have been a doctor, lawyer or teacher.”

Yes, that’s a nice thing to say. It is usually an effort to compliment us, our intelligence or intrinsic worth. And it is so hurtful. Yes, I know I could have been those things. I may have even tried, but the chronic pain took those options away.

Pretending or refusing to accept our limitations, and knowing when to say when, is often very hard to do. Because we want so much to do more than what the pain allows us to do.

I am sure there are many other words that describe our plight, but in thinking about it they all seem to come under one umbrella word: Denial.

It is hard to do, but we need to learn to accept what we work so hard to deny. When it comes to deciding what we can and cannot do, the pain is king.

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.”

Feds Withdrew Request to Ban Kratom in 2018

By Pat Anson, PNN Editor

Federal health officials quietly withdrew their request for kratom to be classified as a Schedule I controlled substance in August 2018, according to a previously undisclosed letter to the U.S. Drug Enforcement Administration.

The letter from Brett Girior, MD, Assistant Secretary for Health & Human Services (HHS), to the DEA’s acting administrator cited concerns that “there is a significant risk of immediate adverse public health consequences to potentially millions of users if kratom or its components are included in Schedule I.”

Kratom is an herbal supplement comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom, using it to self-treat their chronic pain, anxiety, depression and addiction. Classifying kratom’s two active ingredients, the alkaloids mitragynine and 7-hydroxymitragynine, as Schedule I substances would effectively ban kratom by making its sale and possession illegal.  

The 2018 letter from HHS was made public this week by the American Kratom Association (AKA), an advocacy group for kratom consumers and vendors, which said it obtained the letter from Rep. Mark Pocan (D-WI).

“The decision by the FDA to not disclose the recission of their recommendation for scheduling of kratom that took place more than 2 ½ years ago has significantly misled policy makers, the media, and kratom consumers in the belief a scheduling decision was imminent,” Mac Haddow, Senior Fellow on Public Policy for the AKA, said in a statement. “Six states were duped by this messaging to pass bans on kratom sales, and a number of local county and city governments also based their bans on the FDA’s claims.

“Through all of this the FDA has remained silent and has failed to disclose that HHS reviewed their scheduling recommendation and took the unprecedented action to rescind the recommendation because the FDA had failed to meet its burden under the CSA (Controlled Substance Act).”

An FDA spokesperson said it was not up the agency to disclose the letter’s existence.

“While the FDA is an agency within HHS, the letter at issue was not the FDA’s to publicly disclose and any announcement regarding a decision to schedule or not schedule a potential controlled substance is made by the Drug Enforcement Administration, not the FDA,” the spokesperson said in an email to PNN.

‘Lack of Evidence’ Kratom is Harmful

Girior’s letter to DEA said there was a “relative lack of evidence” that kratom can be abused and posed a public health threat.

“Although there remains cause for concern for 7-hydroxymitragynine and potentially mitragynine, the level of scientific data and analysis presented by the FDA and available in the literature do not meet the criteria for inclusion of kratom or its chemical components in Schedule I of the CSA at this time,” Girior wrote. 

“There is still debate among reputable scientists over whether kratom by itself is associated with fatal overdoses. Further analysis and public input regarding kratom and its chemical components are needed before any scheduling should be undertaken.”  

The DEA tried unsuccessfully to list kratom as a Schedule I substance in 2016, calling it an “imminent hazard to public safety,” a decision that was reversed after a public outcry from kratom supporters. 

But federal efforts to demonize kratom continue to this day, led for a time by FDA Commissioner Scott Gottlieb, who claimed kratom was an opioid and should not be used to treat any medical condition. Gottlieb resigned as FDA Commissioner in 2019, eight months after Girior’s letter. The agency he led remains opposed to kratom.   

“Kratom products have been associated with significant potential safety concerns. While it is important to gather more evidence, data suggest that certain substances in kratom have opioid properties that expose users to the risks of addiction, abuse and dependence,” the FDA spokesperson said.

“There is no FDA-approved drug containing, or derived from kratom, and the agency has received concerning reports about the safety of kratom. The FDA is actively evaluating available scientific information on this issue. In addition, FDA has sent numerous letters to firms that have marketed kratom products with unsubstantiated claims that their products can treat opioid withdrawal and addiction and other serious medical conditions.”

Kratom use has been growing in the U.S. as people seek alternatives to opioid pain relievers and other pharmaceutical drugs. Most kratom users say the leaves have a mild analgesic and stimulative effect, similar to coffee.  

A recent study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and is “relatively safe” to use.

Nearly Half of Primary Care Clinics Won’t Take New Patients on Rx Opioids

By Pat Anson, PNN Editor

A new study has confirmed what many pain sufferers have known for years: many primary care physicians in the U.S. are reluctant to accept new patients taking prescription opioids for chronic pain.

Researchers at the University of Michigan used a “secret shopper” technique by posing as female patients who have been taking opioids for years to relieve pain. They called 452 primary care clinics in nine states, asking if the clinic was taking new patients.

If the answer was yes, the “patient” said she was covered by insurance and was looking for a new provider because her primary care physician had either retired or stopped prescribing opioids. Each clinic was called twice with one of the two scenarios.

Nearly half (43%) of the clinics said their providers would not prescribe opioids in either scenario, while less than a third (32%) said their primary care providers (PCPs) might prescribe in both cases.

The remaining 25% of clinics gave mixed signals about what they would do. Simulated patients who said their doctor had retired were twice as likely to be told the clinic might prescribe opioids, compared with those who said their provider had stopped prescribing for an unknown reason – a scenario that suggested the patient may have been abusing opioids.

“These findings suggest that primary care access is limited for patients taking opioids for chronic pain, and differentially further reduced for patients whose histories are suggestive of aberrant use. This denial of care could lead to unintended harms such as worsened pain or conversion to illicit substances,” researchers reported in the journal Pain.

Many of the clinics that refused to prescribe said it was due to new policies, fear of legal ramifications, or administrative burdens involved in writing opioid prescriptions.

The findings are similar to another “secret shopper” study by the same research team in 2019,  which found that 40% of primary care clinics would not accept new patients on opioids, no matter what kind of health insurance they had.

Lead researcher Pooja Lagisetty, MD, an internal medicine physician at Michigan Medicine, says the new findings suggest that primary care clinics should consider whether they are discriminating against patients on opioid therapy.

"We need to make sure we're training prescribers and their teams in addressing the systemic biases that this research highlights," says Lagisetty. "We shouldn't even be thinking about the reason that patients are giving when they seek to access care.

"Even if you think that someone is using opioids for a reason other than pain, or that long-term opioids are not an effective pain care strategy, those are exactly the patients we in primary are should be seeing."

A 2019 PNN survey of nearly 6,000 pain patients found that nearly three out of four had difficulty finding a doctor willing to treat their chronic pain. Over a third of patients in our survey said they’d been abandoned by doctors and 15 percent said they were unable to find a new doctor.

If I Have MS or an Autoimmune Condition, Should I Get the Covid Vaccine?

By Judith Graham, Kaiser Health News

As public demand grows for limited supplies of covid-19 vaccines, questions remain about the vaccines’ appropriateness for older adults with various illnesses, including those with cancer, multiple sclerosis or autoimmune conditions.

Recently, a number of readers have asked me whether older relatives with these conditions should be immunized. This is a matter for medical experts, and I solicited advice from several. All strongly suggested that people with questions contact their doctors and discuss their individual medical circumstances.

Experts’ advice may be helpful since states are beginning to offer vaccines to adults over age 65, 70 or 75, including those with serious underlying medical conditions. Twenty-eight states are doing so, according to the latest survey by The New York Times.

Q: My 80-year-old mother has chronic lymphocytic leukemia. Should she get vaccinated?

First, some basics. Older adults, in general, have responded extremely well to the two covid-19 vaccines that have received special authorization from the Food and Drug Administration. In large clinical trials sponsored by drug makers Pfizer and Moderna, the vaccines achieved substantial protection against significant illness, with efficacy for older adults ranging from 87% to 94%.

But people 65 and older undergoing cancer treatment were not included in these studies. As a result, it’s not known what degree of protection they might derive.

Dr. Tobias Hohl, chief of the infectious diseases service at Memorial Sloan Kettering Cancer Center in New York City, suggested that three factors should influence patients’ decisions: Are vaccines safe, will they be effective, and what is my risk of becoming severely ill from covid-19?

Regarding risk, he noted that older adults are the people most likely to become severely ill and perish from covid, accounting for about 80% of deaths to date — a compelling argument for vaccination.

Regarding safety, there is no evidence at this time that cancer patients are more likely to experience side effects from the Pfizer-BioNTech and Moderna vaccines than other people. “We are confident that these vaccines are safe for [cancer] patients,” including older patients, said Dr. Armin Shahrokni, a Memorial Sloan Kettering geriatrician and oncologist.

The exception, which applies to everyone, not just cancer patients: people who are allergic to covid-19 vaccine components or who experience severe allergic responses after getting a first shot shouldn’t get covid-19 vaccines.

In new guidelines published late last week, the National Comprehensive Cancer Network, an alliance of cancer centers, urged that patients undergoing active treatment be prioritized for vaccines as soon as possible. A notable exception:  Patients who’ve received stem cell transplants or bone marrow transplants should wait at least three months before getting vaccines, the group recommended.

The American Cancer Society’s chief medical and scientific officer, Dr. William Cance, said his organization is “strongly in favor of cancer patients and cancer survivors getting vaccinated, particularly older adults.”

Q: Should my 97-year-old mom, in a nursing home with dementia, get the covid vaccine?

The federal government and all 50 states recommend covid vaccines for long-term care residents, most of whom have Alzheimer’s disease or other types of cognitive impairment. This is an effort to stem the tide of covid-related illness and death that has swept through nursing homes and assisted living facilities — 37% of all covid deaths as of mid-January.

The Alzheimer’s Association also strongly encourages immunization against covid-19, “both for people [with dementia] living in long-term care and those living in the community, said Beth Kallmyer, vice president of care and support.

Minimizing suffering is a key consideration, said Dr. Michael Rafii, associate professor of clinical neurology at the University of Southern California’s Keck School of Medicine.

“Even if a person has end-stage dementia, you want to do anything you can to reduce the risk of suffering. And this vaccine provides individuals with a good deal of protection from suffering severe covid,” he said. “My advice is that everyone should get vaccinated, regardless of what stage of dementia they’re in.”

Q: I’m 80 and I have Type 2 diabetes and an autoimmune disease. Should I get the vaccine?

There are two parts to this question. The first has to do with “comorbidities” — having more than one medical condition. Should older adults with comorbidities get covid vaccines?

Absolutely, because they’re at higher risk of becoming seriously ill from covid, said Dr. Abinash Virk, an infectious diseases specialist and co-chair of the Mayo Clinic’s covid-19 vaccine rollout.

“Pfizer’s and Moderna’s studies specifically looked at people who were older and had comorbidities, and they showed that vaccine response was similar to [that of] people who were younger,” she noted.

The second part has to do with autoimmune illnesses such as lupus or rheumatoid arthritis, which also put people at higher risk. The concern here is that a vaccine might trigger inflammatory responses that could exacerbate these conditions.

Philippa Marrack, chair of the department of immunology and genomic medicine at National Jewish Health in Denver, said there’s no scientifically rigorous data on how patients with autoimmune conditions respond to the Pfizer and Moderna vaccines.

So far, reasons for concern haven’t surfaced. “More than 100,000 people have gotten these vaccines now, including some who probably had autoimmune disease, and there’s been no systematic reporting of problems,” Marrack said. If patients with autoimmune disorders are really worried, they should talk with their physicians about delaying immunization until other covid vaccines with different formulations become available, she suggested.

Last week, the National Multiple Sclerosis Society recommended that most patients with multiple sclerosis — another serious autoimmune condition — get the Pfizer or Moderna covid vaccines.

“The vaccines are not likely to trigger an MS relapse or to worsen your chronic MS symptoms. The risk of getting COVID-19 far outweighs any risk of having an MS relapse from the vaccine,” it said in a statement.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.