UK Study Finds Weather Can Worsen Chronic Pain

By Pat Anson, PNN Editor

Do you feel “under the weather” when its rainy and cold outside? About 75% of chronic pain sufferers believe certain weather conditions can aggravate their pain. Some even think they can predict a storm coming because they “can feel it in their bones.”

A new analysis of weather patterns in the United Kingdom suggests there may be some truth to those old clichés.

For 15 months, researchers at the University Manchester collected data from over 10,500 UK residents, who recorded their daily pain levels on a smartphone app. The GPS location of their phones was then compared to local weather conditions.

The study found a modest association between weather and pain, with people more likely to feel pain on days with low barometric pressure – and the wet and windy weather that usually comes with it.

The key appears to be the upper level jet stream – a narrow band of air currents that circle the globe several miles above the earth. On days when the jet stream was aimed right at the UK, with above normal wind, humidity and precipitation, about 23% of people reported more pain.

But when the jet stream blew north of the UK, and pressure was above normal with less humidity and precipitation, only 10% of people reported higher pain levels.

“Although the weather may not be the primary cause of people’s pain, our results through multiple independent methodologies demonstrate that weather does modulate pain in at least some individuals,” lead author David Schultz reported in the Bulletin of the American Meteorological Society.

“The results of this project should give comfort and support to those who have claimed that the weather affects their pain, but have been dismissed by their friends, their coworkers, and even their doctors.“

The new analysis builds on earlier research from the Cloudy With a Chance of Pain study, which is the largest in both duration and number of participants to examine the link between weather and pain.  Previous studies have found little or no association between the two.

A 2014 Australian study, for example, found that acute low back pain was not associated with variations in temperature, humidity and rain.  And a 2013 Dutch study concluded that weather had no impact on fibromyalgia symptoms in women.

“Part of the reason for this lack of consensus is that previous researchers have treated the different measures of the weather such as pressure, temperature, humidity separately, which assumes that one could vary the temperature while holding all of the other weather measures fixed. Of course, the real atmosphere does not behave like this, as all the variables are changing simultaneously,” says Schultz.

Schultz and his colleagues plan to further study the data to see how environmental conditions modulate pain, insight that could be used to develop better treatments and individualized pain forecasts.

The Importance of Slowing the Pandemic

By Roger Chriss, PNN Columnist

The U.S. economy is starting to reopen amid the coronavirus pandemic. It’s still early, but Health and Human Service Secretary Alex Azar told CNN’s “State of the Nation” on Sunday that there has not been an increase in new infections in states that have reopened.

“We are seeing that in places that are opening, we’re not seeing this spike in cases,” Azar said. “We still see spikes in some areas that are, in fact, closed.”

However, over the weekend Texas reported its highest single-day increase in new cases, and Wisconsin saw a record number of new infections.

The coronavirus has become entrenched. CDC Director Dr. Robert Redfield tweeted Friday that all 12 forecasting models used by the agency forecast over 100,000 deaths by month’s end.

The Institute for Health Metrics and Evaluation predicts over 147,000 American will die by early August. Infectious-disease researchers estimate over a quarter million fatalities by year’s end.

Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told USA Today that “this damn virus is going to keep going until it infects everybody it possibly can.”

Epidemiologist Dr. Johan Giesecke wrote in The Lancet  that "measures to flatten the curve might have an effect, but a lockdown only pushes the severe cases into the future — it will not prevent them."

But even if everyone will eventually be infected, there is little sense in rushing headlong into that future.

Covid-19 is deadly and damaging. The mortality rate of Covid-19 is still uncertain, but an estimate of 1% is common. So a rush toward infecting most people in the U.S. means at least 200 million sick people, the number associated with herd immunity. This means two million deaths, possibly more if the healthcare system is overwhelmed or the virus is more virulent than now believed.

Even if the mortality rate is much lower, there is still considerable disease burden. The Guardian reports that about 1 in 20 people with Covid-19 have a chronic course of illness that lasts for months.

And Covid-19 is more than a respiratory virus impacting only vulnerable adults. CNN reports that it is also causing blood clots and multiple organ failure in young adults, and multi-system inflammatory syndrome in children.  

All of this will cost a lot. The Kaiser Family Foundation estimates that the average cost of COVID-19 treatment for someone with employer insurance is $9,763. Someone whose treatment has complications may see bills about double that. Hospitals are spending between $6,000 and $8,000 a day on coronavirus patients, meaning an extended hospitalization could cost well over $100,000.  

Slowing the pandemic will buy time to better understand the virus and develop more effective responses to make the future less risky and costly. We already have tools and technologies to make that happen.

First and foremost, social distancing. A new study in Health Affairs reports on the success of strong social distancing measures. Based an analysis from April, government-imposed social distancing reduced the daily infection rate by 5.4% after 1-5 days, 6.8% after 6-10 days, 8.2% after 11-15 days, and 9.1% after 16-20 days. That translates to millions of fewer cases of Covid-19.

Second, hygiene. Yale University researchers looked at the impact of face masks in mitigating the spread of Covid-19. They conservatively estimate the value of each additional mask worn by the public at $3,000 to $6,000.

Third, systematic tracing and tracking of cases. This includes state and federal health measures to identify new cases, track chains of transmission, and alert people who have potentially been exposed. Washington state will require restaurants that reopen to keep customer logs, a simple measure that may help slow the spread of Covid-19.

Last, planning. Society needs to function but cannot just go back to pre-pandemic ways. Instead, staggered work schedules, flextime and telework can lower transmission. Some cities are closing streets to vehicles to make more space for people, who can then dine and shop. Schools are looking at part-time programs and adaptive scheduling to promote safer educational environments. And medical facilities are offering more telehealth and remote services.

There are many ways to slow the spread of Covid-19 and a myriad of benefits to doing so. Society does not need to be sacrificed in the process. Instead, we can adapt. The virus adapted to people, but people can be clever and cooperative enough to outcompete it.

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. 

Where Are You Most Likely to Contract COVID-19?

By Dr. Lynn Webster, PNN Columnist

As the country reopens, some people may be at greater risk of contracting COVID-19 due to a lack of understanding about how the virus is transmitted. Having too little information (or too much misinformation) about how the coronavirus spreads and how we can protect ourselves can cause people to feel a false sense of security and unnecessarily place themselves in harm's way.

It may also lead to poor outcomes for those who fail to seek medical care for heart attacks, strokes and other urgent conditions. They may believe that going to a hospital where COVID-19 patients are present is dangerous, but their exaggerated fear may cost them their lives.

While panic is counterproductive, we do need to be realistic. Recent projections suggest the United States will see more than 140,000 deaths before September. If there is a second wave of the virus this fall, the number of deaths by Christmas may be staggering.

How We Transmit the Coronavirus

Initially, COVID-19 was thought to target elderly people with co-morbid health conditions. But many younger, healthy people have also died. Children with Pediatric Multi-System Inflammatory Syndrome and women who have miscarried because of a SARS-CoV-2 infection are awakening scientists to new horrors and challenges.

Erin Bromage, PhD, an Associate Professor of Biology at the University of Massachusetts Dartmouth, recently posted one of the most informative articles that I have read on how the virus is transmitted. It is worth reading.

We know that transmission most commonly occurs in dense gatherings and at home. Bromage explains that inhaling 1,000 viral particles can infect you with COVID-19 -- and that a single sneeze spews as many as 200,000,000 virus particles, moving at a speed of 200 miles per hour.  

Engaging in a conversation with a carrier can expose you to hundreds of thousands of virus particles with each exhalation. A single breath can expel 100 or so virus particles. Assuming we each exhale 16 times per minute, it takes less than one minute of conversation to exceed the 1,000 particles necessary to cause an infection.

The droplets released via a conversation can be aerosolized into a fine spray that remains suspended in the air for several minutes. That means people standing more than 6 feet away who walk through the virus mist within 5 to 10 minutes after the carrier has left the scene are also at risk of becoming infected.

Bathrooms, according to Bromage, are cesspools of transmissible virus particles. Even flushing a toilet can aerosolize droplets. 

Restaurants are common sites of transmission. Airflow from heating and air conditioning systems circulates viral particles through closed environments. As an asymptomatic carrier enjoys dinner, viral particles from breathing travel through the ventilation system of the restaurant to reach far beyond 6 feet.

If there are ceiling or standing fans, it is even easier for an infected person who is only talking to seed the air with viral particles from a distance. If the carrier stays at the restaurant for an hour or more, there could be enough virus particles circulating through the dining area to infect people at tables throughout a small restaurant.

Workplaces, choirs, church services, weddings, funerals, birthdays, and indoor sports gather people in close proximity and are responsible for a large portion of transmissions. Bromage points out that these venues, along with public transportation, are responsible for 90 percent of all transmissions. 

Calculating the Risk of Infection

We can calculate the risk of acquiring the contagion. As Bromage states, dose and time determine the risk: the amount of virus a person is exposed to and the length of time they are exposed to that dose. 

Runners or bicyclists may spew large amounts of virus as they breathe heavily. But, because they are outdoors, the exhaled particles can be quickly diluted in the air if people are separated by several feet. Runners' and bicyclists' diluted virus particles are less likely to pose a threat because of the limited amount of time people are exposed to them.

People who are less mobile, like the elderly or many people with advanced illness, are generally indoors, either at home or in hospitals. These people are at the greatest risk when they are exposed due to the dose and time factors. Small doses over long intervals of exposure in a home, nursing home, or hospital greatly increase the chances of contracting the disease.

As our communities adapt to the changing needs of society, we need to understand how this deadly virus can penetrate our barriers. Knowledge about how the virus spreads can help minimize our risk of contracting and spreading COVID-19. This may require us to rethink the wisdom of many of our traditions for the next year or more.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find Lynn on Twitter: @LynnRWebsterMD.

The opinions expressed in this column are those of the author alone and do not inherently reflect the views, opinions and/or positions of Pain News Network.

The Unnerving Impact of COVID-19 on the Chronically Ill

By Pat Akerberg, Guest Columnist

Let’s face it. Living with a debilitating chronic health condition and a global pandemic at the same time are a “double whammy” with unthinkable impacts. Trigeminal Neuralgia (TN) happens to be my medical vulnerability. Yours may be a different one putting you at risk.

Known as the “suicide disease,” TN is an excruciating facial pain disorder that is considered the worst pain known to medicine. With a tenuous prognosis, TN significantly compromises life quality and puts its sufferers at risk both medically and psychologically.

Covid-19 needs no introduction as it continues to hold a worldwide population hostage -- isolating, living in fear and starved for hopeful news.  Add living with a serious co-morbidity like mine or yours, and the stress of getting hit with the double whammy increases.

Destabilizing factors shared by TN (or your condition) and Covid-19 are several. TN patients, already vulnerable with compromised neurological and immune systems, have to be hyper-vigilant now about staying safe to avoid the scary risks Covid-19 can bring. The effects of this fear, stress and worry loom large when considering the possibility of our chronic conditions being compounded by Covid-19. 

“In my field, we have conducted a lot of work to look at what predicts who gets colds and different forms of respiratory illnesses, and who is more susceptible to getting sick,” says Christopher Fagundes, PhD, a psychological scientist at Rice University.  

“We’ve found that stress, loneliness and lack of sleep are three factors that can seriously compromise aspects of the immune system that make people more susceptible to viruses if exposed. Also, stress, loneliness and disrupted sleep promote other aspects of the immune system responsible for the production of proinflammatory cytokines to over-respond. Elevated proinflammatory cytokine production can generate sustained upper respiratory infection symptoms.”

With intractable pain, sensitized nervous systems are already compromised. Add prolonged anxiety and exhaustion to the isolation, loneliness and a loss of physical connections necessitated by social distancing, and the ground is fertile for hopelessness and depression to take root.

A form of medical neglect is taking shape too, making it harder to cope as important medical, ER or clinic visits and medication refills have been pushed aside by Covid-19.  Yet they remain urgent needs for those afflicted with ongoing conditions.

Caring families and friends are rendered helpless as they witness previously healthy, vibrant loved ones reduced by the chronic conditions that take them over.  Like Covid-19, the life altering stories of TN sufferers are hard to take in. Listen to what some are dealing with:

“I’ve had two surgeries for TN after medications were unable to stop the pain… recently, after 15 years, the pain has come roaring back!  The stress in my life caused by my inability to work during the Covid-19 isolation has triggered the TN pain… it has made it enormously worse… and I can’t even reach my doctor… sometimes I feel like giving up.”

“Things are ridiculously difficult right now. Everyone in our family is feeling it.  My husband and I feel defeated and my Mom feels stressed and overwhelmed. The kids are struggling, flip-flopping between difficult emotions. For nearly 5 years we have been telling ourselves that things will get better as we do our best to live in ‘survival mode.’ But we feel extreme failure as we are starting to see the damage survival mode has done. We aren't sure how to fix it or keep this ship afloat. It feels like we’re the Titanic after it hit the iceberg.” 

“When newly diagnosed, TN patients and their loved ones are worried sick when they discover its’ reputation as the suicide disease.  In searching for answers, they come up against gut punches instead – the discouraging lack of research historically, the poor performance of medications, and/or the disappointing impermanence or complications of risky treatments. Yet, the drive for relief is so great, they’re forced to roll the dice and choose among shortfalls.  Familiar with horror stories of what can go wrong, like a recurring nightmare they are haunted by what might happen to them, fearing their capacity to endure.” 

While we may all share the threat of this pandemic together, the truth is those of us deemed “at risk” can also feel alone as we cope with our personal medical plights. To counter such destabilizing vulnerabilities, we must recognize that the potential for this double whammy fuels an urgent need for HOPE and concrete progress now that can change lives for the better.

Hope and progress – in the forms of more research funding, lasting treatments, promising prognoses and encouraging scientific breakthroughs – can’t come soon enough! 

Pat Akerberg is a member of the TNA Facial Pain Association and serves as a moderator for their online support forum. She is also a supporter of the Trigeminal Neuralgia Research Foundation.

Former CEO of U.S. Pain Foundation Released Early from Prison

By Pat Anson, PNN Editor

The founder and former CEO of the U.S. Pain Foundation will spend the next six months in home confinement after being given “compassionate release” from a federal prison due to COVID-19 concerns. Paul Gileno suffers from asthma and other health issues, which puts him at high risk from the coronavirus.

Gileno abruptly resigned from U.S. Pain in 2018 and was later charged with embezzling millions of dollars from the Connecticut-based charity, which at one time claimed to be the largest advocacy group for pain patients. Gileno cut a deal with prosecutors, pleaded guilty to fraud and tax evasion, and in January began serving a one-year sentence at a minimum-security prison in Minersville, Pennsylvania.  

In correspondence with this reporter from prison, Gileno complained about conditions at the facility and said he was worried about becoming infected with COVID-19.

“Basically 100 of us are locked in one building, all sharing the same bathrooms and common areas. I sleep on a top bunk in a room of 30 people which is all open,” said Gileno.

“The CO's (correctional officers) and staff do not wear masks and they come from the outside world. They say they test them, but that consists of taking their temperature. They won’t let us out to get fresh air, only to go eat and come back which is less than 10 minutes.”

PAUL GILENO

PAUL GILENO

In March, Gileno’s attorney filed a motion asking that the remainder of his sentence be modified to home confinement.  A judge rejected that request, but on April 17 a second motion was submitted and Gileno’s release was approved.

“Mr. Gileno has demonstrated that he suffers from asthma and respiratory conditions that place him at greater risk from COVID-19, and that he is unable to properly guard against infection while incarcerated,” Judge Victor Bolden said in his order. “Undue delay in his release could result in catastrophic health consequences for him.”

Prisons and jails around the country have become hot spots for COVID-19. Over 3,000 federal inmates and prison staff have been infected with the virus, with 51 inmate deaths to date. Last month, Attorney General William Barr ordered the federal Bureau of Prisons to identify low-risk inmates who could be released to home confinement. Over 2,500 have been released so far.

Gileno’s sentence has been reduced to time served and he was released from prison April 20. He will remain in home confinement until November 12, and then begin a two-year period of supervised parole. Under another court order, Gileno is required to pay over $3.1 million in restitution to the U.S. Pain Foundation.

Permanent CEO Named

This month U.S. Pain announced the appointment of two new members to its board of directors: Edward Bilsky, PhD, an academic administrator and professor at Pacific Northwest University of Health Sciences, and Jessica Begley, a marriage and family therapist from Texas.

They join board members Ellen Lenox Smith, a retired teacher; Marv Turner, a producer and filmmaker; and Shawn Dickens, a government defense contractor. Dickens was elected Chairman and Treasurer.

The revamped board also voted to appoint Nicole Hemmenway as permanent CEO. Hemmenway had been acting CEO of U.S. Pain in the two years since Gileno’s departure. She had previously served as vice-president and board chair while working with Gileno.

Gileno’s misuse of donated funds allegedly went undetected for three years due to poor oversight by the board, which apparently held no annual meetings or elections as required by Connecticut state law.

“I still find it difficult to believe that nobody else who’d been in upper management of the foundation for several years, knew anything regarding the going out and coming in of money/funds,” former board member Suzanne Stewart wrote in her blog. Stewart resigned in frustration in 2018 because she felt the board was “left in the dark” about how money was being spent.

At one time, U.S. Pain claimed to have over 90,000 members and nearly a quarter of a million social media followers. The non-profit later admitted having only 15,000 people on an email subscriber list.  

According to an audit and U.S. Pain’s 2018 tax return, the charity spent over $1.2 million that year on salaries, employee benefits, lawyers, accountants, tax penalties and business losses – including a failed attempt to operate a bakery. The foundation’s 2019 tax return has not yet been filed.

Hospitals ‘Ready to Get Back to Work’ After First Wave of COVID-19

By Pat Anson, PNN Editor

One of the biggest ironies of the coronavirus pandemic is that – in the middle of a healthcare crisis -- many hospital emergency rooms, surgery centers and waiting rooms sat empty. Elective surgeries and non-essential medical tests were cancelled to clear the decks for the first wave of COVID-19 patients.

In PNN’s recent survey of over 2,200 patients with chronic pain or chronic illness, over 71 percent said they had a medical appointment cancelled or postponed.   

“My surgery for a tumor has been postponed because of the pandemic, yet there are more than enough hospital beds to provide for my needs. I am angry and disappointed,” one cancer patient told us.

“I am very upset to have had my shoulder surgery delayed again. I have already waited over 2 years and now this! My pain level is something terrible,” another patient said.

“I need to have surgery for my hernia but I'm not sure when I can get the surgery now. It's frustrating because it hurts every day,” said another.

It’s not just doctors cancelling appointments. Many patients in life-threatening situations, with chest pain or stroke symptoms, are staying home rather than go the ER and risk exposure to the virus.

“In the past, people went to the ER maybe a little bit too often for minor conditions. And now we’re seeing a complete swing of the pendulum to another dangerous level where people are not going when they should,” says Mary Dale Peterson, MD, a hospital administrator in Corpus Christi, Texas who is President of the American Society of Anesthesiologists (ASA).

In March, many hospitals were forced to cancel elective surgeries because of chronic shortages of surgical gowns, face masks and other personal protective equipment (PPE) that were needed for the care of COVID-19 patients.

The ASA recently joined in a campaign to reassure patients that it’s safe to reschedule those surgeries. Peterson say the supply chain is “still somewhat fragile,” but most hospitals are well-equipped to perform surgeries again.

“We’re ready to get back to work,” she told PNN. “I understand people’s concerns and we want people to shelter in place, but at the same time, they should be confident that the healthcare facilities have worked really hard to make the environment as safe as possible. A lot safer than going to your local grocery store.”

Pent-Up Patient Demand

The ASA recently joined with medical societies representing nurses and surgeons in adopting new guidelines for healthcare facilities to resume elective surgeries when the following conditions are met:

  • Sustained reduction of at least 14 days in new COVID-19 cases in a geographic area

  • Regular testing of patients and hospital staff for the virus

  • Adequate supplies of anesthesia drugs and PPE, including an emergency supply for a potential second wave of cases

  • Prioritize surgery scheduling based on medical need and availability of staff.

“When the first wave of this pandemic is behind us, the pent-up patient demand for surgical and procedural care may be immense, and health care organizations, physicians and nurses must be prepared to meet this demand,” the guideline warns.

Peterson says patients should expect to be tested for COVID-19 and to self-isolate before their surgeries. She’s also encouraging patients to ask questions.

“I think patients are free to ask, ‘What have you done to make your hospital safe?’ I think that’s a fair question,“ Peterson says. “We’ve worked really hard to do that. We’re testing patients before they come in for coronavirus and asking them to isolate themselves after the test to protect themselves and others.”

Florence Nightingale Was Born 200 Years Ago and Is More Important Than Ever

By Roger Chriss, PNN Columnist

This week marks the 200th anniversary of Florence Nightingale’s birth. She was born on May 12, 1820, and is considered the founder of modern nursing and an innovator in the use of medical statistics.

Named for the city of Florence, Italy, where she was born, Nightingale grew up in a wealthy British family and demonstrated a gift for mathematics. She traveled extensively throughout Europe during her youth and announced her decision to enter the nursing field when she was 24, despite the opposition of her family and the restrictive social mores of Victorian England.

Nightingale made fundamental contributions to nursing and biostatistics during the Crimean War, during which she managed and trained nurses, and organized care for British soldiers.

In 1854, she identified poor care for the wounded at Selimiye Barracks in what is now Istanbul due to overworked and under-equipped medical staff and official indifference. Medicine was limited, hygiene neglected and soldiers suffered as a result, she found.

Nightingale collected meticulous records of patient outcomes in the military field hospital she managed. Then she summarized this information in a form of pie chart now known as the polar area diagram, clearly showing the benefits of improved patient care.

FLORENCE NIGHTINGALE

FLORENCE NIGHTINGALE

This visual representation of statistics was much more readily understood than conventional columns of numbers and helped convince civil servants and even members of Parliament that her findings were significant.

Nightingale applied the same methodology to a study of sanitation in rural India, playing a key role in improving medical care and public health services in that country. She found that bad drainage, contaminated water, overcrowding and poor ventilation were important risk factors in the spread of disease. Her work ultimately helped reduce mortality among British soldiers stationed in India from 69 to 18 per 1,000.

But Nightingale is best known for her role in the foundation of modern nursing. She led by example, with a commitment to patient care and medical administration.

Florence_nightingale_at_st_thomas.jpg

She developed the first official nurse training program, the Nightingale School for Nurses, which opened in 1860. It is now known as the Florence Nightingale Faculty of Nursing and Midwifery at King's College London.

Her work is also remembered in the Florence Nightingale Medal for outstanding service in nursing, among many other honors in her name.

Nightingale’s work in public health and record keeping dovetailed with the first epidemiological success in Britain. In the summer of 1854, English physician John Snow showed that a cholera outbreak could be traced to the contaminated Broad Street Pump, which he stopped by simply removing the handle of the pump so people couldn’t use it anymore.

Snow’s methods involved what we would now call outbreak maps and contact tracing. And his findings inspired improvements in water and waste systems in London and around the world.

NIghtingale’s 1859 book, “Notes on Nursing: What It Is, and What It Is Not,” is a seminal text about the nature and practice of nursing. In it she wrote: “The very first requirement in a hospital is that it should do the sick no harm.”

Today, amid the global coronavirus pandemic, the dedication of nurses and the importance of medical statistics cannot be understated. Nurses are falling sick and dying at alarming rates, in part because institutional leadership is failing them. One-third of Covid-19 deaths in the U.S. are occurring among nursing home residents and staff.

Nightingale’s example needs to be recognized and followed. Her bicentennial provides a timely opportunity to emulate her lifelong dedication to medical care and public health.  

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. 

Arachnoiditis Nearly Destroyed My Life

By Robert Perry, Guest Columnist

I was a pipe welder when I first hurt my back in 1992. The doctor ordered a myelogram imaging test on my back with a chemical dye. It was one of the most painful tests I ever had. After the test the doctor told me I had to learn to live with my pain. At that time, I was only 27 years old. The doctor told me I might be able to work for another 15 years.

He was right about that. In 2008, I was a project manager at ATT and started losing the ability to use my legs. One day I couldn’t get out of bed for about 3 hours because I was having so much pain in my legs and lower back. I was screaming from the pain and the muscles spasms were so bad it made me cry.

I started falling at work and hurting so bad it was unreal, so they did an MRI on me and found I had Arachnoiditis. Since then my life has been a hard road. It’s unreal how many doctors don’t know anything about this disease. One doctor did 5 epidural steroid injections on me and made it worse.

Another doctor put a spinal cord stimulator temporarily in my back to see if it would help, but he accidentally punctured my spine and left an air bubble. I went home and late that night got a terrible headache that felt like it was killing me. My ex-wife and kids took me to the emergency room. I was about to die from the bubble in my body.

They finally found the bubble in my body by cat scan. The only way you can get a bubble out is to remain really calm, so they started giving me a strong painkiller in an IV drip.  But the nurse wasn’t paying attention and I overdosed. I knew I was dying and thank God that a person came in to clean my room and I got her to go get help.

ROBERT PERRY

ROBERT PERRY

I had her call my family on my cell phone. I was able to tell my family goodbye. Right after that, I lost consciousness. I finally woke up 8 hours later and the doctor was waiting on me to ask me things to see if I had any brain damage. The first thing I asked was for my dad, but I couldn’t remember that my dad was dead until they told me.

I have been through a lot because of Arachnoiditis. I lost my family and now I am married to a wonderful lady who knows I am a very sick person.  This disease is the one of the most painful. I have to take two shots a month and I am on a lot of meds. I have a good doctor now who put me on a fentanyl pain patch and my life has been a lot better.

I am a preacher and have a lot of faith. One night at church I was in so much pain the congregation was about to take me to the hospital. And I told God that night either heal me or take me. They prayed over me and I walked out of the church without any pain or my cane.

That’s was 5 years ago and I am still doing a lot better and able to live now. The doctors can’t help, but God can. I am very thankful for that night in prayer.

Arachnoiditis nearly destroyed my life. I hope they one day find a cure for this terrible disease. Before God touched me that night, I was about ready to take my life because of the pain.

Robert Perry lives in Kentucky.

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

FDA's Stem Cell Reformation Must Go Beyond COVID-19

By A. Rahman Ford, PNN Columnist

The COVID-19 crisis has been a catalyst for new regulatory flexibility at the U.S. Food and Drug Administration. The FDA is pushing aggressively to develop new vaccines and treatments for coronavirus, including dozens of clinical trials of stem cell therapies on critically ill patients.

Mesoblast recently dosed its first patients on ventilators in a 300-patient trial using its Remestemcel-L stem cell product to treat acute respiratory distress syndrome (ARDS). Pluristem Therapeutics is using placenta-derived stem cells in another trial, while The Cure Alliance is using umbilical-cord derived stem cells. GIOSTAR has a trial approved for its mesenchymal stem cells under the FDA’s “compassionate use” program. And Athersys has begun a large trial using stem cells derived from bone marrow on patients with moderate to severe ARDS.

A stem cell reformation of sorts is underway at the FDA due to the coronavirus pandemic. But what about the chronic pain crisis? About 50 million American lives with chronic pain, as opposed to 1.3 million confirmed cases of coronavirus in the U.S. to date.

The reformation is not only the result of COVID-19, but due to the simmering pressure of the American people, who have long demanded greater democracy and autonomy in medical treatment. The voice of the people and the virulence of the pandemic have merged into a veritable stem cell Martin Luther, the German monk who rejected the teachings of the Catholic Church during the Protestant Reformation.

Like those told to wait for the promise of stem cell therapy to materialize while being inundated with propaganda about “unproven” cellular treatments, Christians in the Midieval era were told to wait for a salvation controlled by an entrenched religious establishment -- when the salvation they sought was always right inside of them. 

One aspect of our current medical crisis is not new. Americans suffering with intractable chronic pain have endured perpetual crisis for a seeming eternity, waiting for the FDA to abandon its rigid, doctrinaire, one-size-fits-all approach to medical care in favor of more flexible, forward-thinking and tailored treatments.

The COVID-19 crisis — and Americans' consequent demand for solutions — has forced the FDA's hand. This demand compelled the FDA to reconsider its bureaucratic veneration of regulatory relics that denied the revolutionary novelty of stem cells.

The FDA deserves some credit for finally acknowledging the need for exploration and innovation in its clinical trial procedures. But now the agency must recognize that chronic pain - like COVID-19 - is a national medical crisis that necessitates a similar creative solution.

Stem cell regulatory innovation must not end with coronavirus. In fact, it must continue and accelerate. Yes, the current progress is heartening. However, more must be done. And needs to be done immediately. The chronic pain crisis demands it.

The FDA's current push for stem cell innovation must proceed beyond the therapeutic necessity of coronavirus. The agency needs to reform its restrictions on the use of our own stem cells for treating arthritis, neuropathy, degenerative disc disease and other chronic pain conditions.

This reform must no longer be the subject of directionless academic debate or an issue for consideration by medical "ethicists" and self-proclaimed protectors of the common good. The time for debate and delay has ended. The time for decisive action has arrived.  

At the core of the matter are the cries of millions of Americans in a critical crisis of pain that existed well before the face masks, latex gloves, hand-washing, social distancing and trillions of dollars in federal appropriations that COVID-19 has spawned.

To the FDA and Commissioner Stephen Hahn, your effort in pursuing stem cell therapy for COVID-19 treatment has not gone unnoticed. Now it is time to relax FDA regulations on the use of our own stem cells. Devolve regulatory authority to the states and their oversight, and let physicians and patients decide when stem cell therapies are appropriate.

This is the next logical step in the FDA's reformation. It is a necessary step. It is the right step.

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

The opinions expressed in this column are those of the author alone and do not inherently reflect the views, opinions and/or positions of Pain News Network.

 

Chronic Pain and COVID-19: Why Is Treating One Disease More Noble Than the Other?

By Dr. Lynn Webster, PNN Columnist

During the coronavirus pandemic, our frontline healthcare providers have put their lives on the line, and many have paid a price. Their sacrifice is quintessentially noble, and we feel boundless respect and gratitude for their work.

Similar compassion is felt for COVID-19 patients. We are moved by the tireless efforts made to provide them with proper care, medication and life-supporting equipment.

This outpouring has led me, as a pain and addiction medicine physician, to reflect: When is healthcare noble? And why is some healthcare noble and other healthcare suspect?

There is a stark, bittersweet disparity between the esteem and appreciation we rightly bestow on COVID-19 frontline providers and the suspicion we direct toward chronic pain physicians.

Our frontline heroes in the coronavirus crisis -- regardless of patient outcomes -- are viewed as inherently noble and courageous. Conversely, those who treat people with chronic pain -- especially in cases with an adverse outcomes -- are often threatened with harsh judgment, loss of medical licenses and even incarceration.

Recently passed federal legislation provides “broad immunity” from legal liability to providers treating COVID-19 patients. Pain physicians have no such immunity.

This disparity is also mirrored in patient treatment, sometimes involving the same drug. There is a shortage of injectable fentanyl and other painkillers ventilated coronavirus patients need. The Drug Enforcement Administration recently increased the production quota for those drugs so manufacturers could produce more of them. But DEA-ordered cutbacks in the production of other opioids remain in place.

People in pain -- whether they have the coronavirus or not -- deserve the same effective and humane treatment.

As a pain physician, I have watched people with chronic conditions who are forced to live with undertreated pain for years. I have seen them fight to get through each day as the medications they need are tapered due to governmental regulations and cultural biases, rather than their physicians' decisions. I have observed their struggles with desperate options, including suicide, in the face of daily, oppressive and almost unimaginable pain.

Even as I recognize the heroism of the frontline practitioners caring for people with COVID-19, I have to wonder: How did patients with chronic pain end up on the wrong side of the empathy divide?

Pain patients feel this empathy inequity. It's not uncommon for some healthcare providers to treat them like exiles from society, as drug-seekers, malingerers or even criminals. But these "criminals" are people who have a disease that saddles them with long-term pain. Does their suffering matter less than coronavirus patients’ pain?

How must they feel about society’s outpouring of love for COVID-19 fighters and victims compared to the suspicion, derision and slander they receive?

An Opportunity for Reflection

I submit that the heroic and selfless medical response to those afflicted with COVID-19 should prompt valuable reflection by all providers on empathy and equitable treatment for all patients.

What is it about certain medical conditions that results in unprecedented concern, a willingness to muster all resources, and an outpouring of selflessness from practitioners and the public alike? Why are healthcare professionals willing to risk their lives for coronavirus patients, but not their reputations to treat chronic pain?

Some may argue that it is the immediacy of the threat and risk of death that makes the difference. But that’s a false argument. All pain is immediate and, despite what is commonly thought, people with severe chronic pain have dramatically shortened life expectancy

Providers on the frontlines of the lengthier, more widespread and complex pain crisis are as noble as those fighting the current pandemic. They often take on patients that others don’t want to treat. They show open-mindedness, concern and great courage in risking the respect of their peers, running afoul of misinformed authorities, or being persecuted by misguided legislation. They put aside their professional well-being to serve a seriously oppressed and underserved population.

We need to find a way to professionally restore belief in the nobility of those providers who may not cure patients, but who do offer comfort and relief. These are professionals who are willing -- often for months and years -- to fight wearying and risky battles for their patients.

If such battles received the respect they deserved, there would be nothing bittersweet about watching all members of the same profession going above and beyond the call of duty for all.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find Lynn on Twitter: @LynnRWebsterMD.

The opinions expressed in this column are those of the author alone and do not inherently reflect the views, opinions and/or positions of Pain News Network.

Public Health Experts Cautious About Reopening

By Julie Appleby, Kaiser Health News

As many states begin to reopen — most without meeting the thresholds recommended by the White House — a new level of COVID-19 risk analysis begins for Americans.

Should I go to the beach? What about the hair salon? A sit-down restaurant meal? Visit Mom on Mother’s Day?

States are responding to the tremendous economic cost of the pandemic and people’s pent-up desire to be “normal” again. But public health experts remain cautious. In many areas, they note, COVID cases — and deaths — are still on the rise, and some fear new surges will follow the easing of restrictions.

“Reopening is not back to normal. It is trying to find ways to allow people to get back out to do things they want to do, and business to do business,” said Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials. “We can’t pretend the virus has gone away. The vast majority of the population is still susceptible.”

So far, state rules vary. But they involve a basic theme.

“They are making assumptions that people will use common sense and good public health practice when they go out,” said Dr. Georges Benjamin, executive director with the American Public Health Association.

As states start to reopen, people will have to weigh the risk versus benefit of getting out more, along with their own tolerance for uncertainty. The bottom line, health experts say, is people should continue to be vigilant: Maintain distance, wear masks, wash your hands — and take responsibility for your own health and that of those around you.

“It’s clearly too early, in my mind, in many places to pull the stay-at-home rules,” said Benjamin. “But, to the extent that is going to happen, we have to give people advice to do it safely. No one should interpret my comments as being overly supportive of doing it, but if you’re going to do it, you have to be careful.”

An added caveat: All advice applies to people at normal risk of weathering the disease. Those 60 or older and people with underlying health conditions or compromised immune systems should continue staying home.

“Folks who are at higher risk of having a more severe reaction have to continue to be very careful and limit contact with other people,” Plescia said.

Should I go to the beach?

There’s nothing inherently risky about the beach, said Benjamin. But, again, “if you can, avoid crowds,” he said. “Have as few people around you as possible.”

Maintain that 6-foot distance, even in the water.

“If you are standing close and interacting, there is a chance they could be sick and they may not know it and you could catch it,” Plescia said. “The whole 6-foot distance is a good thing to remember going forward.”

Still, “one thing about the beach or anywhere outside is that there is a lot of good air movement, which is very different than standing in a crowded subway car,” he said.

Even so, recent images of packed beaches and parks raise questions about whether people are able or willing to continue heeding distancing directives.

Do I really need to stay 6 feet away if I have a mask?

Yes, for two reasons. First, while masks can reduce the amount of droplets expelled from the mouth and nose, they aren’t perfect.

Droplets from sneezing, coughing or possibly even talking are considered the main way the coronavirus is transmitted, from landing either on another person or surface. Those who touch that surface may be at risk of infection if they then touch their face, especially the eyes or mouth. “By wearing a mask, I reduce the amount of particles I express out of my mouth,” said Benjamin. “I try to protect you from me, but it also protects me from you.”

And, second, masks don’t protect your eyes. Since the virus can enter the body through the eyes, standing further apart also reduces that risk.

Should I visit Mom on Mother’s Day?

This is a complex choice for many families. Obviously, if Mom is in a nursing home or assisted living, the answer is clearly no, as most care facilities are closed to visitors because the virus has been devastating that population.

There’s still risk beyond such venues. Data from the Centers for Disease Control and Prevention shows 8 out of 10 reported deaths from the coronavirus are among those 65 or older. Underlying conditions, such as heart or lung disease and diabetes, appear to play a role, and older adults are more likely to have such conditions.

So, what if Mom is healthy? There’s no easy answer, public health experts say, because how the virus affects any individual is unpredictable. And visitors may be infected and not know it. An estimated 25% of people show no or few symptoms.

“A virtual gathering is a much safer alternative this year,” said Benjamin.

But if your family insists on an in-person Mother’s Day after weighing Mom’s health (and Dad’s, too, if he’s there), “everyone in the family should do a health check before gathering,” he said. “No one with any COVID symptoms or a fever should participate.”

How prevalent COVID is in your region is also a consideration, experts say, as is how much contact you and your other family members have had with other people.

If you do visit Mom, wear masks and refrain from hugging, kissing or other close contact, Benjamin said.

What about going to a hair salon?

Again, no clear answer. As salons and barbershops reopen in some states, they are taking precautions.

States and professional associations are recommending requiring reservations, limiting the number of customers inside the shop at a given time, installing Plexiglas barriers between stations, cleaning the chairs, sinks and other surfaces often, and having stylists and customers wear masks. Ask what steps your salon is taking.

“Employees should stay home if they are sick or in contact with someone who is sick,” said Dr. Amanda Castel, professor of epidemiology at Milken Institute School of Public Health at the George Washington University. “Also, employers should make sure they don’t have everyone congregating in the kitchen or break room.”

Some salons or barbers are cutting hair outside, she noted, which may reduce the risk because of better ventilation. Salons should also keep track of the customers they see, just in case they need to contact them later, should there be a reason to suspect a client or stylist had become infected, Castel said.

Consider limiting chitchat during the cut, said Plescia, as talking in close proximity may increase your risk, although “it feels a little rude,” he admitted.

What if your stylist is coughing and sneezing?

“I would leave immediately,” he said.

What about dining at a restaurant?

Many states and the CDC have recommendations for restaurants that limit capacity — some states say 25% — in addition to setting tables well apart, using disposable menus and single-serve condiments, and requiring wait staff to wear masks.

“That’s the kind of thing that does help reduce the chance of spread of infection,” Plescia said.

If your favorite eatery is opening, call to ask what precautions are in place. Make a reservation and “be thoughtful about who you are having dinner with,” said Plescia. Household members are one thing, but “getting into closer physical contact with friends is something people should be cautious about.”

Overall, decide how comfortable you are with the concept.

“If you’re going to go to a restaurant just to sit around and worry, then you might as well do takeout,” he said.

And travel?

Consider your options and whether you really need to go, say experts.

Driving and staying in a hotel may be an option for some people.

If hotels are adequately cleaned between guests, “you could make that work,” said Plescia. Bring cleaning wipes and even your own pillows. Again, though, “if you’re going to see an elderly parent, you don’t want to contract something on the way and give it to them.”

Regarding air travel — airlines are taking steps, such as doing deep cleaning between flights. Fresh and recirculated air goes through special HEPA filters. While there is little specific research yet on the coronavirus and air travel, studies on other respiratory and infectious diseases have generally concluded the overall risk is low, except for people within two rows of the infected person. But a case involving an earlier type of coronavirus seemed to indicate wider possible spread across several rows.

Maintaining distance on the plane and in the boarding process is key.

“Wear a mask on the plane,” said Benjamin.

And plan ahead. How prevalent is the coronavirus in the areas you are traveling to and from? Are there any requirements that you self-isolate upon arrival? How will you get to and from the airport while minimizing your proximity to others?

But if it’s not essential, you might want to think twice right now.

“People who absolutely don’t have to travel should avoid doing it,” said Plescia.

What about attending religious services?

The distance rule applies as houses of worship consider reopening.

“As much as you can within religious rules, try to avoid contact,” said Benjamin.

He is not giving any advice on Holy Communion, saying that is up to religious leaders. But, he noted, “drinking from the same cup raises the risk if a person is sick or items are touched by anyone who is sick.”

Finally, keep in mind that much is being learned about the virus every day, from treatments to side effects to how it spreads.

“My own personal approach is, try to play it on the cautious side a bit longer,” said Plescia.

Castel agreed.

“We need a little more time to fully understand how COVID-19 works and more time to ramp up our testing, find treatments and hopefully a vaccine,” she said. “We all have social distancing fatigue. But we can continue to save lives by doing this.”

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.

The Other Side of Cannabis

By Madora Pennington, PNN Columnist

I knew from my friend Nick’s Facebook feed that he was a cannabis enthusiast. His posts preached how it cures pretty much everything and will lead us to world peace.

Nick never tired of encouraging me to try it for my pain from Ehlers-Danlos Syndrome, even as I explained repeatedly that since my mother was psychotic, I avoid all drugs which may cause psychosis. Theoretically, I am at higher risk for that adverse reaction.

Psychosis is a disconnection from reality. A person may have delusions, hallucinations, talk incoherently and experience agitation. Since the 1970s, researchers have been investigating whether cannabis can trigger a psychotic break or full-blown schizophrenia. Daily users of highly potent cannabis are five times more likely to develop psychosis. The risk comes not only from genetic factors, but also from early-life neglect or abuse and even being born in the winter.

Having a rare and complicated medical condition, I get a lot of advice. I took Nick’s insistence I go on cannabis as kindness, as I take all unsolicited health tips. Our social media friendship grew. When my husband and I took a trip to his part of the world, he invited us to stay with him.

Nick picked us up at the train station in the English countryside looking like a dashing movie star. Slim and trim in a crisp Oxford shirt and Ray Bans, spryly maneuvering our luggage, he was still attractive in his 70s. Speaking English like Prince Charles, he confessed, “I am actually a cannabis farmer. I expect no trouble from the local police, but would you prefer to get a hotel room in town?”

My husband and I once risked our lives in the back alleys of Hong Kong to get me a fake Hermes bag. We did not need to consult with each other. We opt for adventure. I would not miss my chance to live a Jane Austen fantasy.

We ate off Nick’s three centuries-old family silver, the forks worn down from hundreds of years of scooting food across the plate. We sat beneath the Regency era portraits of his ancestors. Nick had a room devoted to his cannabis crop, growing fast underneath sun simulating lamps. The odor from the plants permeated his entire country home.

In real life, just as on Facebook, Nick’s favorite subject was the virtues of cannabis. He had been using it since he was a young man. Decades ago, he had spent a couple of years in prison for distribution. Recently his wife had left him over his devotion to marijuana. It was clear from Nick’s stories and life choices that cannabis had created tremendous tension with his family.

We talked of him coming to stay with us in Los Angeles, how we could all go to San Francisco to visit the Haight, as Nick was a genuine 1960s hippie. But leaving home to travel was a problem for him. When he does, he has to ask a friend to tend to his plants, which also means asking the friend to break the law.

Our days with Nick at his charming cottage were governed by his need to partake. Our visits to local sites were cut short, so he could be done driving and functioning for the day, and get home to get high. He did not seem to enjoy the excursions and seemed overwhelmed by being out and about, his anxiety growing, urging us to wrap up and get back home.

Cannabis Side Effects

Like Nick, many people are certain that marijuana helps them get by. On it, life is tolerable and pleasant. Anxiety is calmed. They are out of pain and able to sleep. But are they really benefiting?

At first, marijuana has a calming effect, but over time it negatively changes the way the brain works, causing anxiety, depression and impaired social functioning. With regular use, memory, learning, attention, decision-making, coordination, emotions, and reaction time are impaired. Heavy cannabis use lowers IQ

This damage can persist, even after use stops. Teenage users are more likely to experience anxiety, depression and suicidality in young adulthood. According to the CDC, about 1 in 10 marijuana users will become addicted. For people who begin using younger than age 18, 1 in 6 become addicted.

As is the case with other mood-altering substances, cannabis withdrawal symptoms — which include irritability, nervousness, anxiety, depression, insomnia, loss of appetite, abdominal pain, shakiness, sweating, fever, chills and headache — provokes the desire to use.

If someone is using cannabis to escape emotional distress, they never get the chance to deal with underlying problems. Psychiatrist Dr. David Puder recommends to his patients on cannabis that they stop in order to benefit from therapy.

“When they are off of marijuana, they have the ability to be present and really process what they will need to process in therapy in order to get over anxiety and depression,” Puder says, noting that users will often experience a flood of emotions and memories once they stop.

Medical marijuana has been approved for chronic pain and over 50 other health conditions by various states. Whether it actually helps with pain is uncertain. The U.S. Surgeon General warns the potency of marijuana has changed over time and what is available today is much stronger than previous versions. Higher doses of THC (the psychoactive chemical in cannabis) are more likely to produce anxiety, agitation, paranoia and psychosis. Consumers are not adequately warned about these potential harms.

House Guests

Our friend Nick was sure his marijuana use was his choice and that he was not addicted. He insisted my husband and I get high with him.

What is a polite house guest to do? Go along, of course, although we prefer whiskey and a steak. Nick promised we would love it, and that we were free to go upstairs and have sex and open up about anything. We giggled awkwardly. I ingested the smallest possible dose.

Nick then got higher than we had seen him during our entire visit, wolfing down his dinner in minutes. Then, after promising we’d have a tremendous evening of emotional openness and transcendent sharing, he burst into tears recounting how he was the victim of violence in his youth.

I felt for him, it was a horrifying event. Was this unresolved trauma the cause of a lifetime of drug use, denial and self-isolation? We had to wonder. It was truly awkward and uncomfortable, but Nick didn’t seem to remember his outburst. When we returned home, he continued to hound me to take up cannabis.

Madora Pennington writes about Ehlers-Danlos Syndrome and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

The opinions expressed in this column are those of the author alone and do not inherently reflect the views, opinions and/or positions of Pain News Network.

How to Cope with Anxiety During the Pandemic

By Ann Marie Gaudon, PNN Columnist

Some folks do not cope well when anxiety comes for a visit. They don’t consider anxiety a normal emotion or call to action, but rather as something bad that must be gotten rid of.

There is no fault here, we live in a “feel good” society bombarded by messages that if we feel distress of any kind, we must do or take or buy something to get rid of it.

I explained how emotions contain a message in my column about loneliness during the coronavirus lockdown. The message is that you must make an effort to end your loneliness by changing your behaviour. Expand your world. Talk with people, laugh with people and cry with people. Find ways to interact.

Anxiety is another emotion. The research is very clear. If you try to deny, dismiss, avoid or overreact to anxiety, it is very likely to get worse. This in turn, can wreak havoc on your overall health.

Consider for a moment that you have a “struggle switch” for anxiety (or any emotion). If you overreact to anxiety or try to avoid it, your struggle switch is flipped “ON.” 

The message during a pandemic is loud and clear: There is something serious going on and we must take action to protect ourselves and others. That anxious feeling you have is trying to protect you, not harm you. It’s a very old evolutionary response. Very good copers have learned how to make peace with their anxiety, realizing it is there in an attempt to keep them safe.

Here are ways to flip that struggle switch to “OFF.”

Pay attention on purpose. Slow down, notice and name what you are feeling. For example, “I am feeling anxious. My heart is pounding fast, and my stomach has knots in it.”

Let these bodily sensations be just as they are, without judging or evaluating them. Just breathe, slow down, and let go of the urge to do anything at all with this feeling of anxiety.

Again, this is a normal response to an abnormal situation and your body is wise to this, so just be still and observe. If you need help with this, there are endless mindfulness activities online that allow you to have your experience without trying to escape from it. Here is one you can try.

Make an intention. Ask yourself, “What will I do with this feeling of anxiety? My mind sees this as something that makes me weak and vulnerable, however I choose not to get hooked by this. I accept this anxiety as mine. What will I do with it now that it is here?”

How you respond will be clear if you remember what is important to you. Even in a world that is fearful, you can be in touch with your values. Ask yourself, “What do I want to stand for in the face of this pandemic?”

You can hold this anxiety gently, as you would a nervous puppy, and change your behaviour -- with puppy in tow.

Expand your experience. Rather than running away from anxiety, learn from it. Anxiety tells us that we are alive and there is work to be done to protect ourselves. Even in times of fear and uncertainty, there is opportunity. Necessary life changes are not all negative. You can use this anxiety as a wake up call.

In addition to protective measures such as social distancing, are there other behaviours you can take that reflect how you want to be in this world? Can you commit to actions that improve the way you treat yourself and others?

Infectious disease, like any life stressor, presents a major challenge to our coping skills. I speak about this on my website. Binge eating and zoning out on Netflix will not improve your coping skills. They are just ways to try to escape from anxiety. Hoarding toilet paper or panic buying will also not accomplish this. They are signs of over-reacting to anxiety.

Instead, focus on what you can do in this moment. Worry is normal and natural, and can help us to eliminate threat. However, worry cannot get all of our troubles to take a hike. Once we have taken our protective actions, we can focus on how to make our lives better and to nurture and enjoy our relationships and all that is important to us.

Once that struggle switch is turned “OFF,” you will see that you can commit to your values – even with anxiety coming along for the ride. 

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

Should Children Be Prescribed Cymbalta?

By Pat Anson, PNN Editor

The Food and Drug Administration has quietly expanded the use of an antidepressant to treat fibromyalgia in pediatric patients between 13 to 17 years of age – despite the known risk of suicidal behavior by children on antidepressant drugs.  

Cymbalta (also known by its generic name, duloxetine) is a serotonin and norepinephrine reuptake inhibitor (SNRI) made by Eli Lilly that was first approved by the FDA as a treatment for depression in 2004.

In the years that followed, Cymbalta’s use greatly expanded as it was also approved as a treatment for anxiety, diabetic neuropathy, chronic musculoskeletal pain and fibromyalgia in adults.

The approvals came with a major caveat: a black box warning label that specifically cautioned patients and providers that “Cymbalta is not approved for use in pediatric patients” because it could increase the risk of suicidal thinking and behavior in children.

2007 Cymbalta warning label

So why is the FDA now approving the use of Cymbalta by children?  

The federal agency issued no press release when it sent a letter to Eli Lilly on April 20 notifying the company that it was approving its longstanding request to allow Cymbalta to be prescribed for juvenile fibromyalgia. Lilly itself has made no public announcement about the approval.

Health and Human Services Secretary Alex Azar, who oversees the FDA, was President of the U.S. division of Eli Lilly from 2012 to 2017, a period when the cost of Cymbalta doubled.

‘No New Safety Concerns’

The FDA’s approval of Cymbalta for pediatric cases appears to be based on a single placebo-controlled study -- sponsored by Eli Lilly -- in which 184 children with juvenile fibromyalgia were given duloxetine, placebo or a combination of the two over the course of 39 weeks.

Eli Lilly not only funded the study, but its employees designed it, collected data, conducted the analysis, and wrote the article that reported on its findings, which was published last year in the journal of Pediatric Rheumatology.

While the study did not show that duloxetine was significantly better than placebo, patients taking the drug did show a modest improvement in pain severity. Notably, Eli Lilly researchers also said they found “no new safety concerns” about duloxetine.

Which doesn’t mean there were no safety concerns, it just means they didn’t find any new ones. Duloxetine is well known to have side effects in adults, such as fatigue, nausea, mood swings and weight gain.

“The safety profile of duloxetine observed in this study was similar to that observed in previous pediatric duloxetine trials of other indications, as well as in duloxetine trials in adults with FM (fibromyalgia). Nausea, headache, vomiting, and decreased appetite were the most frequently reported AEs (adverse events) in the present study, which are similar to those reported previously in adult population with FM,” wrote lead author Himanshu Upadhyaya, Global Lead Physician in Psychiatry at Eli Lilly.

But a closer look at the study findings – which anyone can see for themselves at clinicaltrials.gov – shows that 6 children taking duloxetine exhibited alarming signs of self-harm. There were two attempted suicides and one intentional drug overdose. One child intentionally injured himself and two had suicidal thoughts. Three other children on duloxetine experienced depression, hallucinations and a seizure.

Granted, nine children in total isn’t that many – but in a small study with 184 participants, it’s concerning – especially when no one in the placebo group had the same behavior or symptoms, according to study results posted on the government-run website.

However, in their published findings in Pediatric Rheumatology, Eli Lilly researchers downplayed the suicidal thinking and other side effects associated with duloxetine, saying they were “not significantly different” than those of children on placebo. The two attempted suicides aren’t even mentioned.

“In the present study, the suicidal ideation events reported with duloxetine were not significantly different from placebo-treated patients. Similar results were reported previously, including the exposure-adjusted analysis of suicidal ideation events, which have not shown any significant difference between duloxetine and placebo,” researchers said.

“None of the SAEs (serious adverse events) reported were considered to be study drug-related and none have led to study discontinuation. There were no deaths reported during the study. There were no significant differences between groups in suicide-related behaviors or ideation.”

Eli Lilly went to great lengths to conduct the study. Its researchers said it took almost 7 years and significant recruitment efforts to find enough children to participate with parental approval. Most of the participants were in the United States, but some were recruited as far away as India and Argentina.

Suicide has long been associated with duloxetine, going back to its earliest clinical trials. A 19-year college student participating in one study killed herself in 2004, four days after being taken off the drug. Four other patients who took duloxetine during clinical trials also committed suicide, although Eli Lilly said at the time there was no evidence directly linking those deaths to the drug.

Withdrawal ‘Brain Zaps’

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

PNN columnist Crystal Lindell went through withdrawal when she started weaning herself off Cymbalta in 2015. Her column on that experience (see “How I took Myself Off Cymbalta”) has become a reference point for hundreds of patients trying to get off the drug.

Crystal thinks expanding the use of Cymbalta to include pediatric patients is not a good idea.

“I would urge extraordinary caution when it comes to giving Cymbalta to teenagers,” Crystal says. “When I was first given Cymbalta about seven years ago, I was 29. At that time, the doctor told me I may be too young to take it because it was known to cause suicidal thoughts in young people. He advised me to be in touch with him if that starts to happen. And I was much older than the age group they just approved to take this drug.  

“I hope doctors will be more cautious about giving Cymbalta to teenagers than they have been about giving it to adults. I always advise readers to listen to their doctor first and foremost, but don't be shy about pressing them on which medications they prescribe you. Ask them about side effects and withdrawal so that you can feel comfortable about what you’re taking.”

The FDA’s new warning label for Cymbalta still cautions about suicidal thinking and behavior in children, but no longer warns that the drug is not approved for use by pediatric patients.

NEW CYMBALTA WARNING LABEL

Duloxetine’s checkered history is well known at the FDA. The agency’s adverse events reporting system has recorded over 33,500 serious cases involving duloxetine since 2007, most of them classified as psychiatric disorders. Over 3,900 of those adverse events resulted in death.

Although Eli Lilly’s patent on duloxetine expired years ago, Cymbalta remains a top money-maker for the company. Cymbalta sales during the first quarter of 2020 were up 28% from a year ago to more than $210 million.

In addition to treating juvenile fibromyalgia, Cymbalta could be repurposed in other ways to boost sales for Eli Lilly. Over 300 clinical studies are underway to explore the use of duloxetine to treat a smorgasbord of other conditions, including shingles pain, cancer pain, surgical pain, post-traumatic stress disorder, attention deficit disorder, and cocaine addiction.

In short, a drug with risky side effects that was originally developed to treat depression is being used for health conditions it was never intended to treat. And more could be added to the list.

Take Your Shot (Or Not)

By Mia Maysack, PNN Columnist

Modern day pandemics aside, we’re fortunate to live in an age when there are continual advances in medicine. More forward momentum in the pursuit of migraine and headache treatment has occurred within the past two years than we’ve seen in decades. New injectable drugs help prevent migraine and others promise relief during migraine attacks.

Injections for migraine are not new to me. I received about 30 Botox shots every 90 days for longer than most people even had their headaches. Let's just say, it was for an extraordinarily long time.

A few years ago, I was awaiting another round of shots to the head and noticed my tummy was in knots for some reason. The nurse came in and told me they were trying a new brand of Botox, which basically means they found a cheaper version. This meant you sometimes get a batch of the medicine you've become accustomed to and sometimes it was a mystery combo, mixed with “similar” fillers containing the "same" active ingredient of botulinum toxin.

At the last session, I'd gone in for my regularly scheduled shots and got one of the worst migraines ever instantaneously. This was out of the normal for me and it led to almost a yearlong cluster that forced me to pause my med school pursuit and nursing career. I still have yet to bounce back from it.

They claimed I could have possibly received a “bad batch,” which I accepted due to how many times I've gotten this treatment with little to no adverse effects. Things cannot always be perfect, right? 

I wonder, however, still living with the repercussions to this day, if it was an adverse or allergic reaction to something.

Adding to my doubts is that I had been waiting on the doctor for over 45 minutes. Don't mind me! I don’t have anything else happening in my life, not like they even bothered asking. 

While waiting, I looked over at all the syringes full of who-knows-what and realized it just didn't align with me, my purpose or path anymore. 

I have nothing but good things to say about Botox, as it sincerely helped me for many years. It's one of the only things that ever has. But as we all must understand, no one knows the long-term repercussions of consistent use of any treatment option. 

Honoring the fact that we would all do just about anything to lessen our pain, I willingly took well over a thousand shots out of desperation for even a small fraction of relief. But what it often boils down to is trading one problem for another, even without being aware of it at the time.

Regarding a lot of the options out today, we are the guinea pigs and lab rats. There's no way of knowing how they could interfere with our well-being over time.

Earlier that same week, I was at a different appointment and they were inquiring about medications I take. By then, I had phased myself off nearly everything and Botox was the last traditional path I hung onto.

I told the nurse that, she replied and I quote: "That's probably for the best, I cannot tell you how many have come through with liver issues and kidney failure from their exposure to consistent prescription drug use." 

I’m proud to say my approach to healthcare is entirely holistic these days. Most providers are not extensively trained on how to treat pain, that's why they call it practicing medicine. They're only human as well and everyone is different -- thereby resulting in different outcomes for everybody -- hence the one-size-fits-all approach not working.

I share my Botox experience not to suggest anything or to instill fear, but to show that we don't always know what we are doing and it's no one else's responsibility to inform us. It is your body and your life. I urge you all to take control and remain curious, ask important questions, and don't eat everything that's fed to you. 

Unfortunately, we are living in a time where our best interest comes only after a check has been written. But by that point, as in my case, the damage may have already been done. I left that office and don't plan on ever going back.

Remember that every patient cured is a customer lost. Look out for and protect yourself!

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. 

Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill.