FDA Requires Stronger Warning Labels for Benzodiazepines

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is ordering drug manufacturers to update warning labels for benzodiazepines to strongly caution patients and providers about the risk of abuse, addiction, dependence and withdrawal. The agency said current warning labels are inadequate about the risks associated with anti-anxiety medications such as Xanax and Valium, even when they are taken as prescribed.

Benzodiazepines are generally used to treat anxiety, insomnia, seizures and social phobia, and they were once commonly prescribed to chronic pain patients to reduce anxiety and help them sleep. In recent years, many pain patients were taken off the drugs because they are considered risky when taken with opioid medication.

“While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol and illicit drugs,” said FDA Commissioner Stephen Hahn, MD. “We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction and dependence.”

In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed by U.S. pharmacies, with alprazolam (Xanax) being the most common, followed by clonazepam (Klonopin) and lorazepam (Ativan).

The FDA said it reviewed post-marketing databases and its Adverse Events Reporting System, and found that benzodiazepines were often prescribed for long periods. In 2018, about half of patients prescribed the drugs received them for two months or more, even though most benzodiazepines are only recommended for short-term use. Physical dependence can occur after taking benzodiazepines for several days or weeks, according to the FDA.

“They are also widely abused and misused, often together with alcohol, prescription opioids, and illicit drugs, which worsen the risks of serious problems. We also found that some patients have had serious withdrawal reactions after benzodiazepines were stopped suddenly or the dose was reduced too quickly. Some patients experienced withdrawal symptoms lasting many months,” the agency said.

The FDA previously warned about the risks of combining benzodiazepines with opioids in 2016. Opioids and benzodiazepines are both central nervous system depressants that can cause sleepiness, respiratory depression, coma and death. In 2016, the number of emergency department visits due to non-medical use of benzodiazepines was higher than the number of ER visits for non-medical use of prescription opioids.

Fatal overdoses involving benzodiazepines increased from 1,298 deaths in 2010 to 11,537 deaths in 2017. The vast majority of those overdoses also involved other substances.

Study Finds Cannabis Effective for 82% of Migraine Patients

By Pat Anson, PNN Editor

Nearly a third of migraine patients have tried medical marijuana or cannabinoids to relieve their pain and other symptoms, according to a large new study that found 82 percent of those who used cannabis found it effective in providing pain relief.

The study gathered data from nearly 10,000 migraine sufferers in the U.S. and Canada who use Migraine Buddy, a migraine tracking app made by Healint, a healthcare technology company based in Singapore. Participants ingested cannabis by a variety of different methods, such as smoking, vaping, tinctures, oils and edibles. No form of ingestion was signficantly more effective than another.

"Cannabis is becoming a prominent treatment option for chronic pain patients, especially for migraineurs," Healint CEO and co-founder Francois Cadiou said in a press release.

"With more and more states across the United States legalizing medical marijuana, migraine patients are becoming acquainted with cannabis as a natural remedy that can help alleviate migraines and even prevent them. Research about the benefits of cannabis use among migraine patients is slowly emerging, but more must be done to properly inform individuals about the use and dosage of medical marijuana to treat migraines."

The findings are similar to a 2019 study, published in The Journal of Pain, that found inhaled cannabis cut headache and migraine severity in half. The effectiveness of cannabis diminished over time, however, as migraine patients appeared to develop a tolerance for the drug and used larger doses for pain relief.

Another recent study, published in the Journal of Integrative Medicine, reported that 94 percent of migraine sufferers who inhaled cannabis experienced symptom relief within two hours.

A major weakness of all three studies is that there was no control group or use of a placebo, and the data was self-reported by patients on mobile software apps. The Migraine Buddy app allows users to report the duration, frequency and intensity of their migraines and medication use, as well as information about sleep, diet and weather-related triggers.

“Migraines have a debilitating impact on tens of millions of Americans and, in many cases, are poorly addressed by conventional therapies. Therefore, it is not surprising to see a significant percentage of migraine sufferers turning to cannabis as a therapeutic option. Those that do so are consistently reporting it to be safe and effective at reducing both migraine symptoms and migraine frequency,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

About a billion people worldwide suffer from headaches caused by migraines, which affect three times as many women as men. Over 37 million people in the United States live with migraines, according to the American Migraine Foundation.

American Mystery: Why Do Middle-Aged Adults Have More Pain?

By Pat Anson, PNN Editor

A provocative new study is warning that middle-aged Americans are experiencing more acute and chronic pain than the elderly, a dramatic shift in pain demographics that is putting further strain on the U.S. healthcare system.

Researchers at Princeton University and the University of Southern California (USC) analyzed survey responses from more than 2.5 million people in the U.S. and European Union. They found a unique pattern in the United States: Physical pain is rising in working class and less-educated Americans under the age of 60.

The findings run counter to long held assumptions that the elderly are more likely to feel pain due to arthritis and other chronic illnesses associated with old age.

“This is the mystery of American pain. Using multiple datasets and definitions of pain, we show today’s midlife Americans have had more pain throughout adulthood than did today’s elderly,” researchers reported in the Proceedings of the National Academy of Sciences (PNAS). “If these patterns continue, pain prevalence will continue to increase for adults; importantly, tomorrow’s elderly will be sicker than today’s elderly, with potentially serious implications for healthcare.”

Researchers Anne Case, PhD, and Sir Angus Deaton of Princeton University and Arthur Stone, PhD, a psychology professor at USC, have studied morbidity and mortality rates around the world. It was the husband-and-wife team of Case and Deaton who first reported on the so-called “deaths of despair” in 2015, an unusual spike in deaths of nearly half a million middle-aged, mostly white Americans.

To build on that groundbreaking research, Case, Deaton and Stone looked at different generations born between 1930-90. They found that men and women of all races usually reported more pain as they aged. But that finding did not hold true for less educated Americans who do not have a college bachelor’s degree – about two-thirds of the adult U.S. population.

"Our expectation was that pain would increase as one's age increases, due to physical deterioration and higher probability of chronic illnesses," said Stone. "But our research found middle-aged Americans had higher levels of pain than the elderly, which is especially pronounced for people without a college degree, and the question was, why?"

Researchers say their findings have major policy implications. As less educated, middle-aged Americans become elderly, they are likely to experience more pain, adding further strain on pain management practices and the healthcare system in general.

Many patients already feel their pain care is inadequate, due to lack of access to opioid pain medication and alternative treatments that are either ineffective or not covered by insurance.

“Pain is getting worse for less-educated Americans. This not only makes their lives worse, but will pose long-term problems for a dysfunctional healthcare system that is not good at treating pain.”

— Sir Angus Deaton, Princeton University

Researchers believe the rise in pain in the working class was caused by the deterioration of their social and economic conditions. Less-educated Americans born after 1950 are more likely to experience social isolation, more fragile home lives, less marriage and more divorce, as well as stagnant wages and job loss. This “epidemic of despair” has barely touched more-educated Americans.

Another explanation for the increase in pain is that people could be more likely to report minor pain than in the past. The growing number of Americans who are obese could also be contributing to the problem, because more weight increases the risk of health problems like arthritis, diabetes and cardiovascular disease.

Whatever the cause, researchers say their findings should signal to policymakers that less-educated Americans are experiencing more distress, and that tomorrow's elderly will feel more pain than today's elderly.

"Pain undermines quality of life, and pain is getting worse for less-educated Americans," Deaton said. "This not only makes their lives worse, but will pose long-term problems for a dysfunctional healthcare system that is not good at treating pain."

My Pain Doctor Abandoned Me, But I'm Not Going Away Quietly

By CindyLee Calaluca, Guest Columnist

Recently I was terminated by my pain management physician without notice and with no plan for continued care. Why? I complained to the physician that I did not appreciate getting no call back when I repeatedly contacted his practice — over an 8-day period — to report that my chronic pain now had a severe acute component to it.

The acute problem is caused by a severe deep vein thrombosis, extending from the groin to the toes in my left leg – the result of a surgical wound from a toe amputation tearing open from severe swelling. Additionally, an old pressure ulcer had abscessed. The acute pain I am experiencing is because of an overlap with my poorly controlled chronic pain, thanks to the CDC guideline for prescribing opioid medication.

All I can do now, because of the pain, is lay in bed and force myself to sleep to cope with the pain. I am totally incapacitated and unable to do daily activities independently. I am 70 years old, a widow, and my only living relative is a 69-year-old brother who lives 2,000 miles from me.

The physician responded to me inappropriately. He told me he gets 3,000 phone calls a day and saw no reason to respond me, because there was nothing he was going to do about my pain. Furthermore, he had an arrogant demeanor and feels he isn't required to call me. I get an appointment once a month with him and that's where his responsibility for my care ends, he said.

Naturally, that opened the door wide open to abandonment and neglect of a patient. His practice has no after-hour or weekend coverage beyond an answering service.

Before he walked out on me, he insulted my career experience, called me uneducated, and said I didn't know what I was talking about regarding health care or laws.

It is a shame that in his superiority complex, he forgot, if he ever knew, my career or educational background. You see, I am an adult and geriatric nurse practitioner who holds a doctorate in nursing practice with 55 years of clinical experience, along with 20 years of simultaneous healthcare administration. That physician is about to find out how "uneducated, stupid and wrong" I actually am.

That's the story behind my being abandoned and put in my place for complaining. I tried to be nice and have an adult conversation with this man. What a shame his child showed up!

I completely understand the problems created when patients arbitrarily lose their providers without adequate and proper notice. I live in a community of less than 500 people. The nearest pain management practice that uses oral medication is 45 miles away. The next one is two and a half hours away. Then there's University of Alabama Medical Center, which is six hours away. Right, I'll just pop into the pain center tomorrow. Like that's happening.

I have had it with all the buck passing by politicians, law enforcement agents, and the CDC making doctors too afraid to practice pain management correctly. Putting a sign in the lobby stating that under no circumstance does the practice treat pain is not correct medical intervention. In fact, since pain is a symptom of illness and that the body is imperiled, it is turning a blind eye to abandonment.

I am no longer going to be a good patient and not respect myself. I refuse to play the game anymore. Since I am dying, I am not going quietly into the night. I am going to advocate and do so loudly, visibly and boldly. I will advocate for patients one last time.

CindyLee Calaluca lives in Alabama. Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

Ironic Partners: Suicide Prevention and Pain Awareness Month

By Dr. Lynn Webster, PNN Columnist

September is National Suicide Prevention Month. It is also Pain Awareness Month. It may appear coincidental or ironic that we recognize suicide and pain during the same month. However, there is an unfortunate association between the two: pain -- either emotional or physical -- too often leads to suicide. Conversely, awareness and treatment of either type of pain, can often prevent suicide.

According to the World Health Organization, 800,000 people worldwide take their own lives each year. The number of suicide attempts is many times greater. Suicide is a serious problem globally and it is often linked to mental health problems.

Many military veterans, like civilians, suffer from both physical and emotional pain. This can lead to substance abuse and increased suicide risk. Veterans frequently experience post-traumatic stress disorder (PTSD) as a result of their military service, but they often don’t get the help they need because the military's mental health system may not take their struggles seriously. The Pentagon has even refused to award Purple Hearts to veterans with PTSD because it is not considered a physical wound.

Transitioning to civilian life after leaving the military can be stressful due to disruptions in social support, financial strain and changes in access to health care. Between 6 and 12 months after they separate from the military, veterans are at the highest risk of suicide.

Suicides associated with serving in the military are at a crisis level -- perhaps because of a lack of pain awareness and cuts in funding to suicide prevention programs. The Department of Veterans Affairs estimates 17 veterans commit suicide every day. Veterans' suicides account for 18% of all suicides in the U.S., even though veterans only make up 8.5 percent of the adult population.

More People at Risk

It’s not just veterans at risk. Over 48,000 Americans took their own lives in 2018. The suicide rate in the U.S. has increased by about 1.8% annually since the year 2000 and is one of the highest among wealthy nations.

The coronavirus pandemic may be adding to the problem. According to the Centers for Disease Control and Prevention, adults have recently reported considerably increased adverse mental health conditions associated with COVID-19. The CDC says groups that are suffering the greatest numbers of COVID-19 cases, including minorities, essential workers and caregivers, have experienced “disproportionately worse mental health outcomes, increased substance use, and elevated suicidal ideation."

People with substance use disorders are also more likely to contract the coronavirus. Those who do become infected bear the double burden of COVID-19 and addiction.

All suicides are tragic, and the losses affect families and entire communities. But suicides can be prevented by understanding the warning signs. Aggression, mood changes, relationship problems, prolonged stress, another person's suicide, and access to firearms or lethal drugs are all risk factors. Intractable pain, too, is a red flag.

According to the American Foundation for Suicide Prevention, depression, substance use disorders, bipolar disorder, and schizophrenia all elevate the possibility of suicide.

Suicidality has become omnipresent in our society. We probably all know of someone who has committed suicide. Even worse, we may have lost a family member or loved one due to suicide. It affects people of all socio-economic levels.

The National Suicide Prevention Lifeline (1-800-273-8255) provides a hotline for anyone who is having a mental health crisis or suicidal thoughts. Free, confidential help for a loved one, or for you, is only a phone call — or online chat — away. 

We may not always know who is struggling with emotional pain, but it is generally apparent when someone experiences insufferable physical pain. The partnership between suicide ideation and severe untreated pain can be mitigated if society will see people in pain as deserving of treatment. 

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. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find him on Twitter: @LynnRWebsterMD.

After Brief Decline, ‘Exponential Trajectory’ of U.S. Overdose Crisis Resumes

By Pat Anson, PNN Editor

A brief decline in fatal overdoses in 2018 was just a blip in the trajectory of a 40-year pattern of rising drug deaths in the United States, according to a new study published in the journal Addiction.

Researchers at the University of Pittsburgh Graduate School of Public Health analyzed over a million overdose deaths in the U.S. between 1979 and 2019 – and developed a startling chart that shows an exponential curve in overdoses that continues to rise virtually unchecked. The number of deaths has doubled every 10.7 years.   

"The U.S. has not bent the curve on the drug overdose epidemic," said lead author Hawre Jalal, MD, an assistant professor of health policy and management at Pitt Public Health. "We are concerned that policymakers may have interpreted the one-year downturn in 2018 as evidence for an especially effective national response or the start of a long-term trend. Unfortunately, that isn't supported by the data."

PITT PUBLIC HEALTH

Overdose deaths fell about 4% in 2018, which public health officials attributed to a decline in deaths involving prescription opioids and heroin. However, overdoses began rising again in 2019 and preliminary data for 2020 suggests the upward trajectory has resumed.    

Jalal and co-author Donald Burke, MD, say the 2018 decline in overdoses was largely caused by a reduced supply of carfentanil, an illicit drug and potent analogue of fentanyl that is 10,000 times more powerful than morphine.

China added carfentanil to its list of controlled substances in 2017 and began shutting down illicit drug factories that produced it. The U.S. supply of carfentanil soon began to dry up and law enforcement seizures of the drug fell dramatically in five states -- Ohio, Florida, Pennsylvania, Kentucky and Michigan. It was the “sudden rise and then fall of carfentanil availability” that led to the drop in overdoses, researchers found.

"We all celebrated when the overdose death rate dropped, but it was premature," said Burke, former dean of Pitt Public Health and a professor in the Department of Epidemiology. "When policymakers believe a problem is solved, history has shown that funding is reprioritized to other efforts. The drug overdose epidemic is not solved. It continues to track along an ever-rising curve, with deaths doubling nearly every decade. We must address the root causes of this epidemic."

Jalal calls the U.S. overdose crisis an “entangled epidemic” that’s been fueled by multiple drugs, including prescription opioids, but is now largely caused by illicit fentanyl.

“There is a force that keeps overdose deaths on an exponential trajectory. This is in spite of policies that have been trying to bend the curve,” Jalal told PNN. “The main problem is that we don’t know why it keeps tracking an exponential trajectory. I think we should do everything we can to bend the curve, but the policies that we’ve used so far have been more targeted toward drugs that can be modified easily. We can target prescription opioids and we can increase the use of naloxone and methadone, but I think we also have to invest in understanding what’s driving people to use drugs. That’s a major problem that we still don’t have an answer for.”

Jalal says lack of economic opportunity and social isolation — so-called “deaths of despair” — may be partly responsible for the overdose crisis, but more research is needed into the underlying causes. As for possible solutions, he’s as stumped as anyone.

“I wish I knew. I truly wish,” Jalal said. “I think we have to pay attention to what’s driving this whole epidemic. Without understanding it, we are basically targeting our policies toward whatever we think might work or think we have control over. We’re not targeting why people use drugs or what’s causing people to die from drugs.”

A recent study by the CDC found that nearly 85% of overdose deaths in the first six months of 2019 involved illicit fentanyl, often taken in combination with other drugs. About 20% of overdoses were linked to prescription opioids.

The CDC study did not determine whether the opioid medication was obtained legally, or if it was diverted, stolen or bought on the street. Previous research in Massachusetts and British Columbia found that only about 2% of fatal overdoses involved a legitimate prescription for opioids.

LSD Won’t Make a Good Painkiller

By Roger Chriss, PNN Columnist

Recent news that a small pilot study found LSD has a “protracted analgesic effect” at low doses garnered a lot of enthusiasm and hype. Headlines declared that LSD “could replace opiates” and be a “potent weapon against pain.”

The study looked at two dozen healthy volunteers given low doses of LSD or a placebo and then subjected them to a “cold pressor test” – immersing a hand in near-freezing water. Researchers found that 20 micrograms of LSD “significantly increased the time that participants were able to tolerate exposure to cold (3°C) water.”

Despite this, LSD has a clear problem: Its therapeutic index is very low.

The therapeutic index is a measure of the relative safety of a drug, computed by dividing the toxic dose by the dose needed for a therapeutic response. A toxic dose represents a threshold beyond which undesirable side effects or adverse events become common.

A high therapeutic index is better. It signifies a broader range of possible doses, letting clinicians adjust a dose precisely for a specific patient. Body weight, age, gender and metabolic status all influence drug metabolism and a high therapeutic index improves clinical safety.

A high therapeutic index also means that the drug can be given in multiple doses. If an initial dose is inadequate, a second dose can be given. Or a dose of another medication from the same class can be given. Or the drug can be given repeatedly over a short time without risky cumulative effects. All of this is important, because acute pain associated with trauma, injury or surgery may last for days.

The therapeutic dose of LSD in the simulated pain study was 20 micrograms (lower doses were ineffective). In general, a hallucinogenic dose starts at 25 micrograms. This suggests that LSD’s therapeutic index is 1.25.

Other measures of drug safety look even worse. The measure known as the margin of safety looks at how a dose may be toxic for 1% of people while being clinically effective for the other 99 percent. This accounts for variations in dose-response curves. Since some people experience LSD’s psychoactive effects at well below the standard 25 microgram threshold, LSD’s margin of safety is also very low.

LSD probably has little future as an over-the-counter analgesic or in a standard clinical setting for acute or chronic pain. It may instead have potential as a narrow therapeutic index (NTI) drug, which the FDA defines as a drug “where small differences in dose or blood concentration may lead to serious therapeutic failures and/or adverse drug reactions that are life-threatening or result in persistent or significant disability or incapacity.”

Current NTI drugs include lithium and methotrexate, which are used to treat serious conditions such as bipolar disorder and rheumatoid arthritis in carefully selected patients under close medical supervision. LSD could wind up being designated as an NTI drug, but only if clinical trials demonstrate safety and efficacy in the management of specific types of pain.

In general, however, LSD is unlikely to be a broadly useful analgesic. Pain relievers need to have a wide therapeutic index in order to succeed, and there seems to be no practical way to do this with LSD.

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. 

Turmeric Moderately Effective in Treating Osteoarthritis Pain

By Pat Anson, PNN Editor

A yellow spice used in food and traditional Chinese medicine – turmeric – is effective in treating osteoarthritis knee pain, according to small placebo-controlled study published in the Annals of Internal Medicine.

Researchers from the University of Tasmania, Australia randomly assigned 70 participants with knee osteoarthritis to receive either 2 capsules per day of turmeric or a placebo. Changes in pain and swelling in the knees were assessed by questionnaire and MRIs.

After 12 weeks, researchers found that patients taking daily turmeric supplements reported moderate improvement in pain compared to the placebo group. They also consumed fewer pain medications. There was no difference in the cartilage or structural changes in the knees between the two groups.

Due to the modest effect of turmeric on knee pain, small sample size and short duration of the study, researchers suggest that multi-center clinical trials with more patients are needed to assess the clinical significance of their findings.

Osteoarthritis (OA) is a joint disorder that leads to thinning of cartilage and progressive joint damage. Knee OA is quite common and affects over 250 million people worldwide. Women are more likely than men to have knee OA and to have more severe pain. Studies have also found that women with knee OA are at greater risk of early death from cardiovascular disease.

No disease-modifying drugs are currently available to treat osteoarthritis. Common pain relievers, such as acetaminophen (paracetamol) and non-steroidal anti-inflammatory drugs (NSAIDs) have only mild to moderate effects on OA pain and can have side events.

Turmeric is a medicinal herb that is used in Indian, Southeast Asian and Middle Eastern foods as a spice. Curcumin is the main active ingredient in turmeric. It has potent anti-inflammatory effects and is a strong antioxidant.

In a PNN guest column, Judie Plumley reported that curcumin supplements helped ease the chronic back pain that left her bedridden. “I am amazed with the results!  My pain is now bearable. I can do about twice as much as I could before, and I am spending much less time in bed,” wrote Plumley.

Turmeric and curcumin are often touted as treatments for everything from diabetes and depression to cancer and high cholesterol. However, research results on their effectiveness have been mixed.

The Other Side of Chronic Pain

By Donna Corley, Guest Columnist

As I contemplated how to begin this article on a subject that has troubled me for some time, I continue to hear Paul Harvey’s famous tag line, “And now you know the rest of the story.”

I’ve noticed for a while that when we share our stories about life with chronic pain, we often focus on the physical struggles and lack of proper treatment, but leave out the emotional side. We rarely tell anyone how vulnerable and afraid we feel, especially our families and doctors, for fear of them thinking we are faking it or even a little crazy.

I’ve hidden that side of myself very well -- as have many of you -- and for good reason. But in doing so, I’ve only told half of my story and only shared half of who I am.

It is very hard to show vulnerability to anyone because we are judged by so many people. No one wants to be ridiculed for how they feel.

We should not be made to feel this way. None of us asked for pain conditions and diseases. Yet, we are shunned and doubted, and made to feel like we should not talk about the emotional side of our journey or the fear of “what comes next.”

That is the secret we hide from the world.

DONNA CORLEY

My story is a little unique in the sense of how long it has been. My journey started my senior year of high school, when I broke my back in a bad car accident. I was unaware that one accident could manifest into conditions called Adhesive Arachnoiditis (AA) and Tarlov Cyst disease. It took 23 years before I was properly diagnosed with AA. I still have moments when I think, “If only I was diagnosed sooner.”

I think there’s a big misconception about patients who suffer with chronic pain conditions, especially those with no cure. The public doesn’t realize that there is more to us than our pain. But if we don’t talk about our emotional torment, how could they know?

Living in Fear

Being a mother brings worry naturally. When you add massive pain with weird symptoms that make you feel like an alien has taken over your body, well that’s fear. Full-fledged, terrifying “I’m dying” fear. Fear brings anxiety, which brings doubt, and this can bring on depression. And it all started with pain no doctor could explain or diagnose, let alone treat!

The medical community is still being taught that Tarlov Cyst isn’t worth looking for in an MRI because they believe the disease doesn’t cause pain or other symptoms. That’s not true in my case at all. I went years before Tarlov Cyst was diagnosed and only because part of my pain couldn’t be explained. Even then the physicians refused to admit the Tarlov Cyst was causing any symptoms.

I can remember when my children were little having anxiety so severe that I would hyperventilate. Fear gripped me worse than the pain. Fear of dying and leaving my children. Fear that I had something terminal. No doctor wanted to dig deeper to find out what was wrong with me. My pain would be so severe at times it felt as if someone was ripping my spinal cord out, yet I kept this to myself.

I never told anyone the extent of my pain for fear of people thinking I was exaggerating, or worse, that it was all in my head. I quit driving for several years because I was scared my pain would become so severe I wouldn’t be able to make it home.  

Looking back, I see how pain ruled my life to the extent that it brought on major anxiety. I missed out on so many things with my children, their school functions, church, ball games, etc., all because of pain, fear and anxiety.

You learn how to hide your pain. Even if it means sneaking off to the bathroom to cry for a few minutes because you are hurting so much. You become a pro at clenching your jaw and smiling through the pain. Constant pain keeps us in a “fight or flight” state that can be very hard to manage alone.

I’ve seen doctor after doctor more times than I can count. They would all ask me, “Why are you here?” I finally stopped going. I stopped asking my primary care physician to refer me. What was the point? Physicians used to look outside the box to find answers, but it seems that “patient centered care” is gone. I had a doctor tell me a couple years ago that he couldn’t help me because I had too many health problems!

Doctors can’t always fix us, but their words and actions have lasting consequences, and some are just resoundingly bad.  Many patients have developed severe emotional trauma from being bullied by physicians who talk down to them like they were stupid and insignificant.

There is another important subject that everyone shies away from, even in patient support groups, and that’s sex. I can understand it being a sensitive subject, but it affects more patients than people realize. Whether it’s erectile dysfunction, the inability to have sex because of pain, or the inability to have an orgasm, these conditions can tear marriages and relationships apart. But the subject is not often discussed with physicians or even family members.

I had to give up a job and career I loved due to chronic pain and had to find a new purpose. That was a very hard part of my life. First, it was hard accepting that I could no longer work, and then it was hard accepting that I would be in pain for the rest of my life.

I thought it was a death sentence when I was first diagnosed with AA. Then I realized, “Hey, I’ve had it for 23 years and I’m not dead yet.” Being a quitter isn’t in my DNA, and I love my family too much to quit. I did a lot of praying, asking God, “Why me?” It was like he said to me, “I need you here.”

That’s truly when I began to have a passion, a drive to fight for awareness, to help other patients get a timely diagnosis and find new doctors.  Praise God, we have quite a few great ones, but we need more.

No one should be made to feel like they are crazy, ignorant, insignificant or lying because they are in pain. I’m still here trying to love the life God has blessed me with. Yes, I see my life as a blessing. If I had not been diagnosed with these diseases, I wouldn’t know how to empathize with others in pain.

We as patients should be able to discuss our fears and concerns with our physicians and families without fear of negative consequences. It is past time people quit condemning those of us who suffer in pain because of the way we feel.

Donna Corley is the director of the Arachnoiditis Society for Awareness and Prevention (ASAP) and creator of the Tarlov Cyst Society of America. She lives in Mississippi with her family.

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

Over 75% of MS Patients Face Financial Hardship

By Pat Anson, PNN Editor

Over 75% of American adults with multiple sclerosis face financial toxicity or hardship that has forced them to cut spending on food, clothing and housing. Many have gone into debt or filed for bankruptcy, and over a third have delayed or stopped filling prescriptions because they can’t afford them.

The findings come from a survey of 243 multiple sclerosis (MS) patients conducted by the Harvey L. Neiman Health Policy Institute. The study is the first of its kind to evaluate how financial hardship is forcing MS patients to forego treatment and make drastic changes in their lifestyles and spending.

In recent years, the cost of prescriptions for many disease-modifying MS drugs has nearly tripled to about $76,000 a year. While insurance pays for most of it, many patients are overwhelmed by deductibles and other out-of-pocket expenses. The lifetime cost of treating MS in the United States is estimated at over $4 million per patient.

“Over the last 20 years, higher out-of-pocket costs for advanced imaging tests and increased cost sharing have caused the financial burdens on MS patients to escalate. Among medically bankrupt families, MS is associated with the highest total out of-pocket expenditures exceeding those of cancer patients,” said lead author Gelareh Sadigh, MD, an assistant radiology professor at Emory University School of Medicine.

“Our study results demonstrate the high prevalence of financial toxicity for MS patients and the resulting decisions patients make that impact their health care and lifestyle.”

More Debt, Less Spending

The findings, published in the Multiple Sclerosis Journal, show that over half of MS patients (56%) reported decreases in their income due to disability, unemployment or retirement. To make ends meet, many cut spending on food and clothing (35%) and leisure activities (50%) or withdrew money from their savings (40%) and retirement accounts (15%). Others went into debt by borrowing money (19%) or charging their credit cards (30%).

Over a third of MS patients decided to forego some type of medical care or treatment, such as not filling a prescription (16%), skipping doses (13.5%) or stopped taking medication (13%).

“These data underscore the need for shared decision-making and an awareness of patient financial strain when planning treatment strategies,” said co-author and Neiman Institute researcher Richard Duszak, MD, a professor and vice chair for health policy at Emory University. “In addition to the impact on adherence, financial toxicity was associated with significantly lower physical health-related quality of life, demonstrating the broad consequences of treatment costs for many MS patients.”

MS is a chronic and progressive disease that attacks the body’s central nervous system, causing pain, numbness, difficulty walking, paralysis, loss of vision and fatigue. Disease modifying therapy (DMT) reduces the frequency and severity of MS flare-ups, but many patients can’t afford the drugs.

A 2019 survey by the National Multiple Sclerosis Society found that 40% of MS patients who take a DMT drug altered or stopped taking their medication due to the high cost. According to Healthcare Bluebook, a 30-day supply of a brand name DMT like Gilenya costs about $8,845, or over $106,000 a year.

Criticism of the high cost of MS drugs is growing. Last year when the FDA approved a new MS medication called Vumerity, drug maker Biogen set its wholesale price at $88,000 a year. That brought a rebuke from the National MS Society, which released a statement that accused Biogen of price gouging.

The Social Consequences of Chronic Pain

By Ann Marie Gaudon, PNN Columnist

When someone suffers acute pain from an accident or injury, a positive consequence is that it evokes care and compassion from others. However, when that pain becomes chronic, you don’t often receive flowers, cooked meals and offers of help. Your social connections may suffer, too.

That’s not a small issue for pain patients. A 2008 study found that maintaining social activities are just as important for people in pain as many of the physical and psychological consequences of chronic pain.

Let’s take a look at a short list of five ways that chronic pain challenges the maintenance of social relationships.

1) Reduced participation in social activities  

Chronic pain physically takes people away from their social networks. Pain flares can be a disincentive to planning and engaging, and can inhibit participation in activities. Fear of judgment can also lead to social withdrawal. And a lack of invitations to social gatherings may mean others are judging or making assumptions about your capabilities.

2) Impaired interpersonal functioning

Chronic pain induces self-focused attention by latching your attention on an area that may be under threat. For example, persistent back pain may draw your attention away from others and put it on your lower back. 

When attention is taken away from others, it reduces your ability to show empathy, social interest and attentiveness. This in turn reduces pro-social behaviour and impinges on your ability to self-regulate and monitor your emotions -- skills we rely on to adapt our behaviour to different social situations and norms.

For example, we might want to laugh loudly while reading a funny book in the library, but we stop ourselves. Or we might be at a work event and notice there is no foul language, so we self-monitor and do not swear ourselves.

These types of social skills require attention.  When chronic pain is taking up attention, there will be less capacity for self-regulation and self-monitoring. The end result: pro-social behaviours suffer.

3) Chronic pain and negative mood

Although being in a bad mood is a normal but unwanted reaction to chronic pain, it is not considered socially appropriate. Pain sufferers often try to mask their mood to help others feel more comfortable.

Negative moods are contagious and can influence the mood of other people, resulting in less enjoyment for everyone. It can also induce more negative judgments and bias against others.

4) Loss of social roles and identity  

Social relationships are founded upon shared social identities and interdependent social roles. For example, as we grow and develop, we have childhood friends that we have much in common with and are close to. But as we become adults, we often go in different directions and no longer have so much in common.

Relationships erode or dissolve because of this. If a chronic pain patient can no longer work, enjoy activities or be on a team, this can erode self-identity and the commonalities that were once in place with friends.

5) Difficulty connecting with others  

Chronic pain can lead to a focus on the differences we have with others, rather than the similarities. This can fuel beliefs that you are less than, not reliable or even less competent due to your pain. As a result, you may withdraw from others rather than others removing themselves.

This is not an exhaustive list but it gives you an idea of the challenges faced in the social world by pain sufferers. It’s important for overall health to assess your social functioning as part of a biopsychosocial approach to pain management.

As a therapist, I need to understand a patient’s level of satisfaction with their social roles and identities, and the health of their interpersonal relationships with others in order to help them with strategies and coping skills to restore and maintain their social connections.

Interventions can be utilized such as group therapy, which is beneficial in the realization that you are not alone, and for strengthening relationships, reducing isolation, helping you to find your voice, and providing a safety net. Support groups offer many of these same benefits. You may learn helpful information and gain hope from the social support of others. Many support groups are free or charge a nominal fee.

Therapy can also provide social skills training. And couples training can help caregivers understand their loved one’s pain and acquire their own coping skills to avoid burnout and social isolation.

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.

Report Calls for Overhaul of Sickle Cell Treatment

By Pat Anson, PNN Editor

A new report by the National Academies of Sciences, Engineering, and Medicine is calling for major changes in the way sickle cell disease is treated in the United States, including an end to the discrimination and stigma that many sickle cell patients face while navigating the healthcare system.

About 100,000 Americans live with sickle cell disease (SCD), a genetic disorder that mainly affects people of African or Hispanic descent. SCD causes red blood cells to form in a crescent or sickle shape, which can create blockages in blood vessels that prevent the normal delivery of oxygen throughout the body. As a result, sickle cell patients often suffer from chronic pain, anemia, infections, strokes and organ failure.

Compared to other chronic illnesses, SCD has received little attention from the healthcare community, resulting in a lag in the development of new treatments. Until 2018, only one drug was approved by the Food and Drug Administration to treat sickle cell patients. Bone marrow and stem cell transplants are currently the only curative therapies for SCD.

“People with sickle cell disease show incredible resilience. They often have to become their own advocate to get the treatment and services they deserve — whether in the health care system, at school, at work, or in the community,” said Marie McCormick, MD, a pediatrician and professor at the Harvard School of Public Health, who chaired the committee that wrote the report.

Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action calls for the National Institutes of Health to designate SCD as a “health disparity” to incentivize more research, and for the Department of Health and Human Services to fund efforts to identify and mitigate disparities in health outcomes for sickle cell patients.

Lack of Compatible Donors

Although stem cell and bone marrow transplants are the only cures for SCD, it’s often difficult to find compatible donors, especially for children who can benefit the most from treatment.

“Unfortunately, less than one in five individuals with sickle cell disease have compatible donors. Those children fortunate to have a fully matched sibling as a donor enjoy very high success rates with very few complications after transplantation,” said Enrico Novelli, MD, an Associate Professor of Medicine and Director of the Adult Sickle Cell Disease Program at University of Pittsburgh Medical Center.

“The success of the procedure decreases as people get older. For many adults living with sickle cell disease, stem cell transplantation is not an option, either because they are too ill to undergo the procedure, or because of a lack of donor,” Novelli said in an email to PNN.  

“And for those who are cured by transplantation and no longer have sickle cell disease, some challenges remain; for instance, the treatments to prepare the recipient for the donor stem cells may cause infertility, and years of exposure to the disease may leave a mark in terms of organ dysfunction and chronic pain. Thus, it may take a while for some patients to overcome their sickle cell-related chronic pain after a successful stem cell transplant.”

The report recommends that the Centers for Medicare & Medicaid Services and state Medicaid programs, as the lead insurers for most sickle cell patients, explore new payment methods to encourage and pay for coordinated care delivered by certified SCD centers. Insurance coverage is also needed to finance the cost of experimental new treatments, such as gene therapy.

The report calls for more diversity and “cultural competency training” for SCD care providers, as well as better training in managing acute and chronic pain. It also recommends that federal health agencies work with states to standardize newborn screening for SCD and to develop a national registry of people living with sickle cell disease.

Green Light Therapy Reduces Migraine Pain

By Pat Anson, PNN Editor

New research is shining a light on an unusual treatment for migraine headaches: green light therapy.

In a small study involving 29 migraine patients, University of Arizona Health Sciences researchers found that exposure to green light for one to two hours daily reduced headache pain by 60% and significantly reduced the frequency of migraines.

"This is the first clinical study to evaluate green light exposure as a potential preventive therapy for patients with migraine, " said lead author Mohab Ibrahim, MD, an associate professor in the Departments of Anesthesiology and Pharmacology at UArizona College of Medicine-Tucson. "As a physician, this is really exciting. Now I have another tool in my toolbox to treat one of the most difficult neurological conditions: migraine."

Of the 29 patients who participated in the study, seven had episodic migraine and 22 had chronic migraine. All were exposed to white light for one to two hours a day for 10 weeks. After a two-week break, they were exposed to green light for 10 weeks.

Participants also completed regular surveys and questionnaires to track the number and intensity of their headaches, as well as quality of life issues such as the ability to fall and stay asleep or to work.

Using a pain scale of 0 to 10, participants self-reported that green light exposure resulted in a 60% average reduction in their headache pain, from 8 to 3.2.

Green light also shortened the duration of headaches, and improved participants' ability to fall and stay asleep, perform chores, exercise, and work. None of the patients reported any side effects.

"In this trial, we treated green light as a drug," Ibrahim said. "It's not any green light. It has to be the right intensity, the right frequency, the right exposure time and the right exposure methods. Just like with medications, there is a sweet spot with light."

Participants were given green light emitting diodes – LED lights – with instructions to follow while completing the study at home. They were also allowed to continue current migraine therapies and to initiate new treatments if directed by their physicians.

"One of the ways we measured participant satisfaction was, when we enrolled people, we told them they would have to return the light at the end of the study. But when it came to the end of the study, we offered them the option to keep the light, and 28 out of the 29 decided to keep the light," said Ibrahim.

Most of the study participants - 86% of episodic migraine patients and 63% of chronic migraine patients - reported the number of headache days per month was reduced by at least 50 percent. Episodic migraine is characterized by up to 14 headache days per month, while chronic migraine is 15 or more headache days per month.

Ibrahim and co-author Amol Patwardhan, MD, have been studying the effects of green light therapy for several years.

"Despite recent advances, the treatment of migraine headaches is still a challenge," said Patwardhan, an associate professor and the vice chair of research in the Department of Anesthesiology. "The use of a nonpharmacological therapy such as green light can be of tremendous help to a variety of patients that either do not want to be on medications or do not respond to them. The beauty of this approach is the lack of associated side effects."

Dr. Ibrahim has been contacted by doctors in Europe, Africa and Asia, asking for information about green light therapy for their own patients.

"As you can imagine, LED light is cheap," Ibrahim said. "Especially in places where resources are not that available and people have to think twice before they spend their money, when you offer something affordable, it's a good option to try."

The study findings were published online in Cephalalgia, the journal of the International Headache Society.

A 2016 study by researchers at Beth Israel Deaconess Medical Center in Boston also found that green light therapy reduced headache severity in migraine sufferers. Patients in that study were exposed to different intensities of blue, green, amber and red light. Most patients said their migraines got worse when exposed to white, blue or amber light, while green light was found to reduce pain in 20 percent of patients.

About a billion people worldwide suffer from headaches caused by migraines, which affect three times as many women as men. Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

FDA Targets Online Pharmacies for Selling Opioids

By Pat Anson, PNN Editor

The Food and Drug Administration is once again playing whack-a-mole with illegal online pharmacies, warning 17 website operators to stop selling unapproved or misbranded opioid medications to U.S. consumers, including some drugs offered for sale without a prescription.

In recent years, the FDA has sent hundreds of warning letters to online pharmacies for illegally selling opioids and other controlled substances. Many of the websites are located overseas and outside U.S. jurisdiction or they shut down and soon reappear under new domain names.

According to the Alliance for Safe Online Pharmacies, there are over 30,000 online pharmacies operating worldwide, with 20 new illegal pharmacy websites being launched every day.

“Those who illegally sell opioids online put consumers at risk and undermine the significant strides we have made to combat the opioid crisis,” said Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We remain committed to using all available tools to stop the illegal sale of opioids online to help protect consumers from these potentially dangerous products.”

The 17 warning letters were issued late last month. Most of the online pharmacies appear to have been shut down or blocked, although some are still operating.

RxEasyMeds, for example, continues to sell an opioid medication called “Nalbin” that is “used to treat moderate to severe pain associated with acute and chronic medical disorders.”

Nalbin is produced by a drug company based in Islamabad, Pakistan called Global Pharmaceuticals.

The FDA warning letter to RxEasyMeds – which is located in China -- says Nalbin is not approved for sale in the U.S. and does not have an adequate warning label.  

“Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether,” the FDA letter warns. “Accordingly, FDA requests that you immediately cease offering violative drugs for sale to U.S. consumers.  This is critical to shielding the American public from harm.”

In addition to Nalbin, RxEasyMeds advertises codeine, morphine, tramadol, oxycodone and other controlled substances, which are all apparently available without a prescription.

In June, the FDA launched a pilot program to put more teeth into efforts to stop the illegal sale of opioids online. Under the program, the FDA will notify three internet registries when a warning letter is sent to an online pharmacy. The registries could then block or suspend the website domains, which would effectively take them offline.

Study Debunks Warning About Taking NSAIDs for COVID-19

By Pat Anson, PNN Editor

We’ve learned a lot about COVID-19 over the last few months, including what medications help and don’t help coronavirus patients. While much attention has been focused on the antiviral drugs hydroxychloroquine and remdesivir, other more common medications used to treat pain and inflammation have been found to be useful in treating COVID-19 infections.

In the early stages of the pandemic, some health experts warned that non-steroidal anti-inflammatory drugs (NSAIDs) – ibuprofen in particular – could weaken the immune system and make coronavirus symptoms worse. The French government even warned of "grave adverse effects" linked to the use of NSAIDs by COVID-19 patients and recommended acetaminophen (paracetamol) as a safer alternative.

“Taking anti-inflammatory drugs (ibuprofen, cortisone, ...) could be an aggravating factor of the infection. If you have a fever, take paracetamol,” tweeted Dr. Olivier Véran, France’s Health Minister.

That claim has now been debunked by Danish researchers, who reported in PLOS Medicine that ibuprofen and other NSAIDs do not increase the risk of serious illness from coronavirus infections. The researchers reached their conclusion after analyzing the health data of over 9,300 Danish residents who tested positive for the SARS-CoV-2 virus between February 27 and April 29, 2020.

In Denmark, NSAIDs are sold by prescription, except for low-dose ibuprofen that is sold over-the-counter. Researchers identified 248 coronavirus patients who filled a prescription for NSAIDs within 30 days of their positive COVID-19 tests and found they had the same risk of being hospitalized and dying from the coronavirus as those who did not take NSAIDs.

“Use of NSAIDs was not associated with increased 30-day mortality, a finding that was robust in a range of supplementary analyses. Likewise, use of NSAIDs was not associated with an increased risk of hospitalization, ICU admission, mechanical ventilation, or renal replacement therapy in the adjusted analyses,” researchers reported.

“Considering the available evidence, there is no reason to withdraw well-indicated use of NSAIDs during the SARS-CoV-2 pandemic. However, the well-established adverse effects of NSAIDs, particularly their renal, gastrointestinal, and cardiovascular effects, should always be considered, and NSAIDs should be used in the lowest possible dose for the shortest possible duration for all patients.”

Concerns about steroid drugs resulting in poor outcomes for coronavirus patients are also misplaced, according to an analysis of studies recently published in JAMA. Researchers found that corticosteroids can actually be lifesaving for coronavirus patients and should be the first-line treatment for critically ill patients.

Two other recent studies found that patients with lupus and other forms of arthritis are not at increased risk of serious illness from COVID-19 due to the medications they take. Arthritis is often treated with steroids, biologics and other immune suppressing medications, which had raised concern that the drugs could make patients more susceptible to coronavirus infections. But researchers found that patients with arthritis in the New York City area had the same risk of hospitalization as the general population during the height of the city’s pandemic.