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.

FTC Sues Drug Makers for Oxymorphone Monopoly

By Pat Anson, PNN Editor

It was in 2017 that Endo Pharmaceuticals – under pressure from the Food and Drug Administration -- stopped selling Opana ER, an extended-release version of the opioid painkiller oxymorphone. Opana had been reformulated by Endo to make it harder to abuse, but the FDA maintained the tablets were still being crushed, liquefied and then injected by illicit drug users.

Although Opana has been off the market for nearly four years, a legal battle still rages over sales of generic oxymorphone and whether Endo conspired with another drug maker to control the market for oxymorphone.

This week the Federal Trade Commission sued Endo, Impax Laboratories, and Impax’s owner, Amneal Pharmaceuticals, alleging that a 2017 agreement between Endo and Impax violated antitrust laws by eliminating competition for oxymorphone ER.

It’s the second time the FTC filed complaints against Endo, Impax and Amneal for allegedly creating an oxymorphone monopoly.

“The agreement between Endo and Impax has eliminated the incentive for competition, which drives affordable prices,” Gail Levine, Deputy Director of the FTC’s Bureau of Competition said in a statement. “By keeping competitors off the market, the agreement lets Impax continue to charge monopoly prices while Endo and Impax split the monopoly profits.”

According to the FTC complaint, Opana ER generated nearly $160 million in revenue for Endo in 2016 and was the company’s “highest-grossing branded pain management drug.” Endo explored bringing another oxymorphone drug on the market to replace its lost revenue, but ultimately decided to partner with Impax, which had the only extended-release oxymorphone drug on the market.. Their agreement allowed Endo to share in Impax’s oxymorphone profits, as long as Endo did not bring another generic tablet on the market.

“The purpose and effect of the 2017 Agreement is to ensure that Endo, the gatekeeper to competition in the oxymorphone ER market, has every incentive to preserve Impax’s monopoly. By doing so, it eliminates any potential for oxymorphone ER competition, allowing Endo and Impax to share in the monopoly profits. As a result, patients have been denied the benefits of competition, forcing them and other purchasers to pay millions of dollars a year more for this medication,” the FTC complaint alleges.

The 2017 agreement between Endo and Impax arose from a breach of contract case relating to a patent settlement between the companies over Impax’s generic version of Opana ER, in which Endo paid Impax more than $112 million not to compete. In 2019, the FTC ruled that settlement was an illegal "pay-to-delay" agreement.  

Both Endo and Amneal deny there was any effort to create a monopoly in their 2017 agreement.

“It is Endo’s position that the Agreement had no adverse impact on actual or potential competition.  At the time of the Agreement, the U.S. Food and Drug Administration had asked Endo to withdraw reformulated Opana ER from the market for safety reasons and Endo had publicly announced its intention to comply with the FDA’s request,” Matthew Maletta, Endo’s Executive Vice President and Chief Legal Officer, said in a statement to PNN.

“Significantly, as Endo has explained to the FTC, the Company has not launched or licensed any new opioid product(s) since that time, and the FTC’s theory that Endo would do so in the current litigation environment but for the Agreement is preposterous.”

“Far from being anticompetitive, the 2017 Amendment resolved a dispute between the parties that could have kept Impax's lower-priced generic product off the market entirely,” Amneal said in a statement. “We are confident there is no unlawful restraint in the 2017 Amendment, because nothing in the agreement prevents Endo from competing, and we intend to vigorously defend against the FTC’s claims.”

The FTC decision to sue Endo and Amneal a second time was approved on a split 3 to 2 vote by the agency’s commission. The complaint seeks monetary relief and a permanent injunction to prohibit the companies from engaging in similar conduct.

Extended-released oxymorphone is approved for the treatment of moderate to severe pain.  

Contact Congress to Make Changes in Federal Pain Study

By Richard Lawhern, PNN Contributor

On January 20, I sent a letter by email to the Acting Director and senior staff of the Agency for Healthcare Research and Quality (AHRQ).  The letter requests the federal agency to immediately withdraw its recent review of prescription opioids and other treatments for short-term acute pain. 

Grounds for the request are clear evidence of unjustified anti-opioid bias by the authors and gross fatal errors of methodology – all of which invalidate the review as resource material for efforts to revise and expand the 2016 CDC opioid guideline.

The anti-opioid bias of Roger Chou and his co-authors is revealed by their selective cherry-picking of references that fail to explore the major effects of genetics in patient response to opioid therapy, as well as improperly generalized findings based on trials of weak opioids like tramadol, which were applied to all opioids.

The AHRQ authors also omit any exploration of serious side effects and mortality caused by non-opioid treatments such at acetaminophen.

But the most fundamental error in the methods of the AHRQ Review is improper use of “meta-analysis” to lump together data and outcomes from multiple small-scale studies of opioid therapy for acute pain. A major underlying assumption of meta-analysis is that patient response in each trial is distributed on a Normal (bell-shaped) curve. However, this assumption doesn’t work for patients treated with prescription opioids.

The distribution of patient outcomes is actually “bi-modal.” One group of patients may experience side effects from opioids, but very little short-term pain relief; while a second group may have substantial pain relief from just one dose of opioid medication. This reality invalidates the major findings of the AHRQ review.

A detailed critique of the AHRQ study is available on my website. Feel free to review and share this information with your personal physician.

AHRQ is fully aware of the errors noted above but has no intention of responding to demands for a correction of its malfeasance and fraud.  Thus, it may be necessary for the U.S. House Government Oversight and Reform Committee to direct AHRQ to withdraw or rewrite its review. 

Such an action has precedents.  In 2015, the Oversight Committee reviewed complaints from the Washington Legal Foundation and others concerning inadequate public hearings on the CDC’s proposed opioid guideline. The committee sent a letter to then-CDC Director Thomas Frieden asking him to explain why so much secrecy was involved in the drafting of guideline and why it wasn’t made publicly available.

Faced with a congressional inquiry, CDC reversed course by delaying the guideline’s release and publishing the draft in the Federal Register for a 30-day public comment period. A new advisory committee was also formed to review the guideline, which resulted in some changes to its final recommendations.

Urgent Action Request

A similar effort is urgently needed by pain sufferers and their advocates to bring the AHRQ review to the attention of Congress, specifically to the House Government Oversight and Reform Committee. Those who wish to involve the committee in corrective action should telephone any or all of the Congressional offices of committee members. 

It is very doubtful that the representatives will actually see anything you leave in their contact portals online. But short, focused telephone calls are harder to ignore. The telephone numbers for members of the House Committee can be found here. If you reach a staff member in their office, you might offer the following information:

1) Identify yourself and provide a call-back number. If you are a medical professional, state your qualifications (i.e. “I am a board certified physician” or “I am a former nursing professional now disabled by agonizing pain.”)

2) If you are a resident of the Representative’s district, say so. You don’t have to be a constituent to make your input.

3) Tell the staffer that you want to report fraud and abuse to the Representative and to the House Congressional Oversight and Reform Committee. 

“I want the Committee to demand corrective action from the Agency for Healthcare Research and Quality, in the same way it did in 2015 when it told the CDC to re-open its proposed opioid guideline to extended public review.”

“AHRQ published a review of treatments for acute pain in December 2020. The review is deliberately biased against the only therapies that work, deeply flawed by errors of scientific method, and outright fraudulent in its conclusions. This review must be withdrawn for independent review.”

4)  Thank the staffer for their time.  Ask “May I expect a callback from a member of the Representative’s staff?”

This is an opportunity to be heard, despite the lies being shouted by anti-opioid fringe groups like Physicians for Responsible Opioid Prescribing (PROP) and Shatterproof.

It is time for you to speak up!

Richard “Red” Lawhern, PhD, has for over 20 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  Red is co-founder of The Alliance for the Treatment of Intractable Pain.

Finding Grace in Family-Induced Pain and Trauma

By Cynthia Toussaint, PNN Columnist

About 20 years ago, my mother called to share what felt like a disorientating thought.

“Cynthia, of all the members of our family, you’re the together one, the capable one and the successful one,” she said.

Though flattered, my thinking was, “How can that be? I’m the daughter with all the problems. The pain, the wheelchair, the one left childless without her show-biz career.”

I’m guessing now that my mother was intuitively letting me in on a secret -- a generations-long family secret. By telling me I had the right stuff, Mom was revealing that I’d broken the trauma cycle. She potently advised that I never let my family members hold me back, to “never not succeed because of them.”

That day I realized I’d done something exceptional, but I didn’t fully understand what it was. You’d think 38 years of chronic pain would have opened my eyes, but it took a cancer crisis for me to deeply examine what my mother was shedding light on.

I come from a profoundly dysfunctional family (domestic violence, divorce, mental illness, suicide, alcoholism, etc.), one so traumatizing my doctor believes that the toll of trying to fix my family, along with the inflammation of CRPS, was what gave me cancer. To have a chance at survival, I had to walk away from the toxic members of my family, which was the hardest and best decision of my life.

Unfortunately though, walking away might not be enough. Now that I’m in remission, I’m concerned that my inability to unlock from my frequent harmful thoughts about the trauma of past assaults will bring on a swift and more aggressive cancer recurrence.

Trauma Release

Enter EMDR (Eye Movement Desensitization & Repossessing). For the uninitiated, EMDR is a psychotherapy treatment designed to alleviate the distress associated with traumatic memories. For years studies have shown that people with serious adult-onset illnesses – including high-impact pain and cancer – experienced many adverse childhood events (ACE’s), as I did.

I’ve long considered doing EMDR for trauma release, but feared stirring up the debilitating depression that my family often sparks. I won’t lie to you. My EMDR plunge has been god-awful, as it’s brought on a ton of expected grieving and even rage. That being said, I’m sticking with it - and astonished by EMDR’s effectiveness and the insight it evokes.

My phenomenal practitioner, Kathy, has pointed out two major, life changing themes. The first, that family trauma is handed down over many generations, adversely changing our gene expression through what’s termed epigenetics. Sadly, I was born into the thick of this ever-rolling harm.

When I was seven, my dad jumped off a bridge due to severe mental illness. Much dysfunction led to his suicide, but this was the tipping point that my family of origin never recovered from.

After sharing what limited knowledge I had of my dad’s past, Kathy quickly assessed that, like me, he had a traumatic childhood. I was stunned to learn that his parent’s alcoholism, affairs and abandonments, along with all of the denial and covering-up, deeply wounded him. That insight gifted me great empathy for the person who shattered my world.

Mom’s side of the family was equally trauma-inducing. After her parent’s ugly divorce and Grandma having my loving grandfather committed to an institution, she had my mother kidnapped. Legend has it that this broke my aunt Grace’s heart, as her agonizing death from leukemia at age 20 soon followed.

To this day, even with advanced dementia, my mother describes her own grandmother as “a witch, the most evil person I ever met.” It goes on and on.

Healing My Inner Child

I finally understand that I have a family tree evergreen with trauma, the root of all my physical and psychological illness.

The second theme Kathy put forth is that to release my trauma we have to heal my “inner child.” I now understand that even as a fetus I took in the negative chemicals and vibe of my mother’s nightmarish situation – and it’s my inner child who’s carrying the greatest injury. The work is tricky because to reach her, we must maneuver around the many protective, life-preserving mechanisms she’s used for 60 years.

With Kathy’s guidance via Zoom, I’m slowly making friends with my inner child. While I want to protect her from the knowledge of a tragic future, ultimately I have to be vulnerable enough to let her spill the repressed memories of violence and dysfunction that host the lion’s share of our trauma.

My hope is that by healing my inner child I can end the cycle of excruciating harm I endure when I think about my family’s countless trespasses. If I can get to a strong landing point of understanding and release, my depression will turn to just sadness – and from there I can move on with better wellness.  

I want to be free.        

No matter the outcome, Mom was on to something. Thankfully, I’ve cracked the family code by asking why and doing the hard work. As Kathy reminds me, I choose “to think, not drink” - and because I don’t maintain the dysfunctional status quo, I’ve “jumped out of a sinking ship.”

All this time I thought my life had been upended by pain, but I now realize it was family trauma that caused every ounce of my misfortunate.    

This insight lovingly brings me to my aunt Grace who, by breaking the family trauma cycle, saved my mother. While I never met her, I see Grace as an angel and forever feel a deep connection, so much so I named my work for her goodness.

We’ve always been compared, and I now see that our similarity extends beyond looks and personality. A quote I continue to hear in my research about generational trauma is “The first born daughter often carries what remains unresolved in the mother.”

Grace and I were the eldest daughters and gave everything to save our broken families, an impossible task.

GRACE HAeRING

It cost my dear aunt her life – and I think she’s proud watching me fight for mine.

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 15 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.”

More Data Needed on Covid Vaccine Safety for High-Risk People

By Roger Chriss, PNN Columnist

The Covid-19 vaccine rollout in the U.S. hasn’t been so smooth or fast. Fortunately, however, the vaccines are proving to be generally very safe. But there have been some serious allergic reactions associated with the vaccines. And in a few tragic cases, there have been deaths.

As a result, it is worth looking closely at what is now known about vaccine safety, in particular for high-risk people such as the elderly and those with compromised immune systems.

On January 3, Florida physician Gregory Michael died 18 days after receiving the first dose of Pfizer's vaccine. He was an otherwise healthy adult who developed acute thrombocytopenia, a severe shortage of platelets, soon after being vaccinated. Michael ultimately died of a brain hemorrhage after a two-week effort to raise his platelet count.

This is the only known case of a platelet crisis after vaccination, but it’s not yet clear if the two are connected. Work to understand what happened is ongoing.

“I don’t know what this is. We’ll keep our eyes open and see if it happens to anybody else,” vaccine expert Paul Offit, MD, told The New York Times.

The Platelet Disorder Support Association released a statement calling Michael’s death “tragic and concerning,” but said patients with immune thrombocytopenic purpura (ITP) “should not be hesitant to be vaccinated.”

“The relationship between the occurrence of severe thrombocytopenia and the vaccination, if any, is uncertain. To our knowledge, this is the first such event reported after over 5 million such vaccinations. Based on the available data, the benefit to risk ratio strongly favors vaccination of all adults, including those with ITP,” the statement said.

There have been a few other deaths worldwide. The Jerusalem Post reported in December on the death of an 88-year-old man who died just hours after being vaccinated, and a 75-year-old who died of a heart attack shortly after getting a shot. Both cases are seen as coincidental and no further deaths have been reported as Israel continues to vaccinate its population.

Norway, however, has seen 29 elderly people die after being vaccinated, all of them over the age of 75. The deaths prompted Norway to suggest that Covid-19 vaccines may be too risky for the very old and terminally ill.

“For those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences. For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant,” the Norwegian Institute of Public Health said in a statement.

Information about vaccine safety for higher-risk populations is not easy to get at present. For instance, there is as yet no clinical data on what vaccine risks may exist for women who are pregnant or lactating. Without that data, STAT News says “it’s impossible for any organization or expert to say with absolute certainty that there are no risks.”

As of today, over 60 million doses of vaccine have been given worldwide and nearly 20 million in the U.S. Based on the small number of severe adverse events seen so far, this means that the vaccines are extremely safe for the vast majority of people.

Norway and Israel are reporting side effects and outcomes faster than most other nations. Consequently, the recent deaths may be nothing more than an artifact of good public health statistics offering a complete picture of all risks.

But precautions for people who are elderly, frail or otherwise high risk may turn out to be justified. As more data from vaccination efforts worldwide comes in, the risks will be better understood.

Roger Chriss suffers from 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.

Over-the-Counter Pain Meds and Gabapentin Recommended for Trauma Patients

By Pat Anson, PNN Editor

Over-the-counter pain medications and gabapentin are the best line of treatment for trauma patients suffering from acute short-term pain, according to new study at a Texas hospital that minimizes the use of opioids.

Researchers at the Red Duke Trauma Institute at Memorial Hermann-Texas Medical Center in Houston assessed two different combinations of non-opioid pain relievers in over 1,500 patients being treated for acute trauma, such as bone fractures and head injuries.

The treatment protocol that was deemed superior included a combination of inexpensive over-the-counter drugs such as acetaminophen and naproxen, with the nerve medication gabapentin (Neurontin). Opioids such as tramadol and oxycodone were only prescribed for breakthrough pain.

"Narcotics are not the mainstay of therapy for acute pain," said lead author John Harvin, MD, a trauma surgeon at the hospital and an associate professor at The University of Texas Health Science Center at Houston. "The research shows us that seriously injured people with acute pain can effectively be treated with an opioid-minimizing strategy."

The study findings, published in the Journal of American College of Surgeons, showed that a first-line pain regimen that used acetaminophen, ketorolac, naproxen, gabapentin or lidocaine patches reduced the use of opioids without a significant difference in pain scores. Only 62 percent of the patients were discharged with an opioid prescription.

"We used a generic pain regimen that is affordable at discharge. The discharge medications acetaminophen and naproxen can be bought over the counter. The only drug that requires a prescription is gabapentin and an as-needed opioid, if prescribed," Harvin explained.

The use of gabapentin as a treatment for acute pain is controversial, because recent studies show it has no significant analgesic effect and is increasingly being abused. In 2019, the Food and Drug Administration warned that serious breathing problems can occur in patients who take gabapentin with opioids or other drugs that depress the central nervous system.

But the use of gabapentin and over-the-counter pain relievers is now the standard treatment protocol for trauma patients at Memorial Hermann-Texas Medical Center, and physicians there are working to adapt it for the treatment of acute burn pain.

"The best way to decrease someone's risk for long-term (opioid) use is to minimize their exposure during hospitalization and at discharge, and we now know there are excellent non-opioid medications available that effectively treat pain,” said Harvin. “We know that culture change will take time and effort, but we're excited to be learning how to best leverage opioid-minimizing drugs to improve care, and to offer a new model that can be adopted by any trauma center."

The risk of long-term opioid use after an emergency room visit is actually quite low. A 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.

"Our paper lays to rest the notion that emergency physicians are handing out opioids like candy," said lead author Molly Moore Jeffery, PhD, a Mayo Clinic researcher. “Most opioid prescriptions written in the emergency department are for shorter duration, written for lower daily doses and less likely to be for long-acting formulations."

Antidepressants Ineffective for Back Pain and Osteoarthritis

By Pat Anson, PNN Editor

Antidepressants like duloxetine (Cymbalta) are increasingly being prescribed to treat various types of pain, but a new study shows the medications are largely ineffective for people suffering from chronic back pain or osteoarthritis and may even cause harm.

Many clinical guidelines recommend using antidepressants as pain relievers – even when depression is not involved -- yet evidence supporting that use is uncertain. To address that knowledge gap, researchers at the University of Sydney reviewed data from 33 controlled trials involving more than 5,000 adults who took antidepressants for low back or neck pain, sciatica, or hip or knee osteoarthritis.

Their findings, published in The BMJ, show that for people with back pain the effects of antidepressants were too small to be worthwhile, but for those with osteoarthritis there may be a small beneficial effect.

“The use of antidepressants to treat people with chronic back pain and osteoarthritis is increasing worldwide, but prior to our work, it was not clear whether antidepressants relieved pain or were safe,” said lead author Dr. Giovanni Ferreira, PhD, a postdoctoral research fellow at the Institute for Musculoskeletal Health at the University of Sydney. 

“We conducted a review of all randomised clinical trials evaluating the efficacy of antidepressants for people with back pain or knee osteoarthritis and found that for back pain the antidepressants were either ineffective or provided a very small effect, which was unlikely to be perceived as worthwhile by most patients. For people with osteoarthritis, effects were still small, but could be potentially perceived as worthwhile by some patients” 

Ferreira and his colleagues reviewed six classes of antidepressants: serotonin-noradrenaline reuptake inhibitors (SNRIs); selective serotonin reuptake inhibitors (SSRIs); noradrenaline-dopamine reuptake inhibitors (NDRIs); tricyclic antidepressants; and tetracyclic antidepressants. 

Results showed that SNRIs such as duloxetine reduced back pain after three months, but the benefits were so small they were unlikely to be considered clinically important to most patients. SNRIs had a slightly stronger effect on sciatica and osteoarthritis pain. 

Tricyclic antidepressants were ineffective for back pain, but might reduce pain in people with sciatica, although the evidence for that was weak.  

Industry Funded Studies 

Importantly, about two-thirds of people taking SNRI antidepressants experienced an adverse event such as nausea, fatigue, mood swings and weight gain.

“Many people are being treated with these medications that may not be helping their pain and may be doing them harm,” said Ferreira, adding that doctors need to be upfront with patients about possible side effects.

Researchers say the long-term effects of antidepressants prescribed for chronic pain are not well known and many of the studies that do exist were sponsored by industry, raising the risk of bias. 

“Many people are being treated with these medications that may not be helping their pain and may be doing them harm.”

— Dr. Giovanni Ferreira

“Large, definitive trials free of industry ties are urgently needed to evaluate the efficacy of antidepressants,” Ferreira said. “There needs to be more transparency about how evidence coming from those trials is appraised by guideline panels. A good starting point would be to consider all industry-funded trials to be at high risk of bias, and downgrade the strength of recommendations where industry-sponsored trials represent an important part of the available evidence.”

The Food and Drug Administration recently approved duloxetine as a treatment for fibromyalgia in pediatric patients, largely on the basis of a small trial conducted by Eli Lilly, Cymbalta’s manufacturer. Children enrolled in the study did show a modest improvement in pain, but several of them had serious adverse events, including two attempted suicides, suicidal thoughts, an intentional drug overdose, depression and hallucinations.

In their published findings in the journal Pediatric Rheumatology, Eli Lilly researchers downplayed the adverse events associated with duloxetine, saying they were not drug related or “not significantly different” than those of children on placebo. The two attempted suicides aren’t even mentioned.

A common complaint of patients who take duloxetine is how quickly they become dependent and what happens when they stop taking the drug. Many complain of severe withdrawal symptoms, including electric-like sensations called “brain zaps.”

Duloxetine’s checkered history is well known at the FDA. The agency’s adverse events reporting system has recorded nearly 35,000 cases involving duloxetine since 2007, most of them classified as psychiatric disorders. Over 4,000 of those adverse events resulted in death.