Medical Cannabis Provides Only Minor Relief for Chronic Pain

By Pat Anson, PNN Editor

An international team of researchers has concluded that medical cannabis and cannabinoids do not provide relief to most people with chronic pain, but are of some benefit to others.

The findings, based on a limited review of 32 medical cannabis studies, were published in the journal BMJ. They are the third set of international guidelines released this year to discourage the use of cannabis as an analgesic because clinical evidence is lacking.

“We are hopeful that patients and physicians will find our guideline helpful, and take away that while medical cannabis will not be effective for most people living with chronic pain, it may provide important benefits for a minority of patients,” said lead author Jason Busse, associate director of McMaster University’s Medicinal Cannabis Research Center in Ontario, Canada.

“For example, we found that 10% more patients that used medical cannabis vs. placebo in trials reported an important improvement in pain relief. This means that only one patient of every 10 treated with medical cannabis experienced this improvement.”

Busse and his colleagues said medical cannabis might provide a “small increase” in pain relief, sleep quality and physical function, with a “small to very small increase” in side effects such as dizziness, nausea and cognitive impairment.

It’s important to note that the panel’s recommendations do not apply patients in palliative care or to smoked or vaporized cannabis. The research team, which included a diverse group of physicians, academics and patient representatives, could not find a good quality clinical study that explored the use of inhaled cannabis.

“We hope that such trials will be forthcoming, as cross-sectional data has found many (perhaps the majority of) people living with chronic pain who use cannabis therapeutically use dried flower products that are typically inhaled or vaporized,” Busse told PNN in an email.

“The most robust evidence base is probably for use of cannabidiol (CBD) to help manage certain forms of pediatric epilepsy; however, most patients use cannabis to manage chronic pain and there are important evidence gaps that urgently need to be addressed so that patients can make fully-informed decisions.”

Due to the limited research on inhaled cannabis, the guideline’s recommendations only cover cannabis products such as edibles, sprays, oils and tinctures, which are usually low in tetrahydrocannabinol (THC), the psychoactive ingredient in cannabis that makes people high.

The panel recommended that non-inhaled cannabis or CBD only be used on a trial basis by patients when “standard care” for pain management is not sufficient. The recommendation applies to adults and children with moderate to severe chronic pain caused by cancer, neuropathy, nociceptive pain or nociplastic pain. The latter two categories cover conditions such as osteoarthritis and fibromyalgia.

“Our weak recommendation in favour of a trial of medical cannabis or cannabinoids reflects a high value placed on small to very small improvements in self reported pain intensity, physical functioning, and sleep quality, and a willingness to accept a very small to modest risk of mostly self limited and transient harms,” researchers said.

“The panel, including patient partners, believes that there is great variability in how much reduction in pain severity, improvement in physical functioning, or sleep quality each patient would consider important. Patients who place a high value in improving these symptoms by any amount are more likely to pursue a trial of medical cannabis or cannabinoids.”

The researchers recommend that patients start with a low-dose CBD product, and gradually increase the dose and THC level depending on how the patient responds.

Two medical guidelines released earlier this year also take a dim view of cannabis as a pain reliever. The Australian and New Zealand College of Anaesthetists (ANZCA) urged doctors not to prescribe medical cannabis for patients with chronic pain unless they are enrolled in a clinical trial.

The International Association for the Study of Pain also said it could not endorse the use of cannabinoids to treat pain because there was not enough evidence on the safety and efficacy of CBD.

Spine Surgeon Charged in Device Kickback Scheme

By Fred Schulte, Kaiser Health News

A Florida orthopedic surgeon and designer of costly spinal surgery implants was arrested Tuesday and charged with paying millions of dollars in kickbacks and bribes to surgeons who agreed to use his company’s devices.

Dr. Kingsley Chin, 57, of Fort Lauderdale, Florida, is the founder, chief executive officer and owner of SpineFrontier, which also does business as LESspine, a device company based in Malden, Massachusetts. Chin and the company’s chief financial officer, Aditya Humad, 36, of Cambridge, Massachusetts, were each indicted on one count of conspiring to violate federal anti-kickback laws, six counts of violating the kickback statute and one count of conspiracy to commit money laundering, officials said.

The indictment alleges that SpineFrontier, Chin and Humad paid surgeons between $250 and $1,000 per hour in sham consulting fees for work they did not perform.

In exchange, the surgeons agreed to use SpineFrontier’s products in operations paid for by federal health care programs such as Medicare and Medicaid. Surgeons accepted between $32,625 and $978,000 in improper payments, according to the indictment.

“Kickback arrangements pollute federal health care programs and take advantage of patient needs for financial gains,” said Nathaniel Mendell, acting U.S. attorney for the District of Massachusetts. “Medical device manufacturers must play by the rules, and we will keep pursuing those who fail to do so, regardless of how their corruption is disguised.”

DR. KINGSLEY CHIN

(Update: In a 1/20/25 press release, SpineFrontier said that federal prosecutors filed a motion to dismiss all kickback charges against the company and Dr. Chin. Money laundering charges had previously been dropped. A civil case against SpineFrontier and Chin also ended after financial settlements were reached with the claimants.

According to the press release, Chin and his new firm, KIC Ventures, “have implemented rigorous compliance measures to proactively identify and mitigate potential risks. By prioritizing compliance and transparency, KIC Ventures aims to ensure a higher standard of regulatory adherence in the development and commercialization of innovative spine surgery technologies.”)

Chin and SpineFrontier were the subjects of a KFF Health News investigation that found that manufacturers of hardware for spinal implants, artificial knees and hip joints had paid more than $3.1 billion to orthopedic and neurosurgeons from August 2013 through 2019. These surgeons collected more than half a billion dollars in industry consulting fees, federal payment records show.

Chin, a self-styled “doctorpreneur,” formed SpineFrontier about a decade after completing his training at Harvard Medical School. Chin has patented dozens of pieces of spine surgery hardware, such as doughnut-shaped plastic cages, titanium screws and other products that generated some $100 million in sales for SpineFrontier, according to government officials. In 2018, SpineFrontier valued Chin’s ownership of the company at $75 million, though its current worth is unclear. He maintains a medical practice in Hollywood, Florida.

Seth Orkand, a Boston attorney who represents Humad, said his client “denies all charges, and looks forward to his day in court.”

The Department of Justice filed a civil lawsuit against Chin and SpineFrontier in March 2020, accusing the company of illegally funneling more than $8 million to nearly three dozen spine surgeons through the “sham” consulting fees. Chin and SpineFrontier have yet to file a response to that suit.

However, at least six surgeons have admitted wrongdoing in the civil case and paid a total of $3.3 million in penalties. Another, Dr. Jason Montone, 45, of Lawson, Missouri, pleaded guilty to criminal kickback charges and is set to be sentenced early next year. Federal law prohibits doctors from accepting anything of value from a device-maker for agreeing to use its products, though most offenders don’t face criminal prosecution.

The grand jury indictment lists seven surgeons as having received bribes totaling $2,747,463 to serve as “sham consultants.” One doctor, identified only as “surgeon 7,” received $978,831, according to the indictment. Many of the illicit payments were made through a Fort Lauderdale company controlled by Chin and Humad, according to the indictment.

“Medical device companies that pay surgeons kickbacks, directly or indirectly, corrupt the market, damage the health care system, and jeopardize patient health and safety,” said U.S. Attorney Andrew E. Lelling of the District of Massachusetts. 

The SpineFrontier executives set up the separate company partly to evade requirements for device companies to report payments to surgeons to the government, according to the indictment. Some surgeons were told they could bill for more consulting hours if they used more expensive SpineFrontier products, officials said.

Conspiring to violate the kickback laws can bring a sentence of up to five years in prison, while violating the kickback laws can result in a sentence of up to 10 years, officials said.

“Kickbacks paid to surgeons as sham medical consultants, as alleged in this case, cheat patients and taxpayers alike,” said Phillip Coyne, special agent in charge of the U.S. Department of Health and Human Services Office of Inspector General.

“Working with our law enforcement partners, we will continue to investigate kickback schemes that threaten the integrity of our federal health care system, no matter how those schemes are disguised.”

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

UK Migraine Sufferers Face ‘Broken Healthcare System’

By Pat Anson, PNN Editor

The United Kingdom has a “broken healthcare system” that leaves millions of migraine sufferers without treatment or a proper diagnosis, according to a new study.

The report by The Migraine Trust estimates that one in every seven people in the UK – about ten million -- suffer from migraine attacks. Most say they haven’t been officially diagnosed by a doctor and have never seen a headache specialist.

Those who have been diagnosed often have trouble getting a new class of drugs to prevent migraine -- calcitonin gene-related peptide (CGRP) inhibitors – even though the medications have been approved for use by the UK’s National Health Service (NHS).

“My migraine has never been managed properly by the NHS. I’ve suffered for 13 years and they’ve increasingly become worse each year. I’m bed bound at least once a week,” a migraine sufferer told the charity. “I visit my GP regularly and they send me away with a different drug to try for another year before I can be considered for another. I asked for a referral to the migraine clinic and was refused by my doctor.”

The Migraine Trust filed Freedom of Information requests with nearly a hundred NHS healthcare systems in England, Northern Ireland, Scotland and Wales and found that only a few were giving eligible patients access to CGRP treatment.

“There is clearly a postcode lottery of care where only the lucky few can access a treatment which has proven transformational for many migraine patients,” Rob Music, CEO of The Migraine Trust, said in a statement. “This should be such an exciting and positive time for those needing migraine care, but right now this lack of access is leading to continued poor health and deep frustration.” 

CGRP inhibitors have been available in the United States since 2018, including a drug recently approved for both migraine prevention and treatment. The medications – which block a protein released during migraine attacks from binding to nerve receptors in the brain – are not cheap. Eight tablets of Nurtec, for example, cost nearly $1,000. 

Not treating migraines can be costly as well. The Migraine Trust estimates that lack of adequate migraine treatment in the UK results in 16,500 emergency admissions and 43 million lost workdays every year.  

The charity says migraine attacks also have a negative impact on the lives of migraine sufferers. In surveys, nearly a third said migraines negatively affect their mental and physical health. About one in four said migraines disrupt their family and social life. 

The pandemic has also taken a toll on migraine patients, with 68% saying their symptoms have worsened. Some reported it was because of stress, some because their lifestyle was harder to manage, and others because they couldn’t access the treatment they had been receiving. An increase in computer screen time during the pandemic also contributed to worsening migraine attacks.    

The Migraine Trust recommends that everyone seeing a doctor for head pain should be assessed for migraine and receive an individualized care plan. More headache specialists and neurologists should also be recruited to bring the UK in line with other European nations. The Trust called for public awareness campaigns to improve understanding of migraine symptoms and reduce the stigma associated with migraine. 

About a billion people worldwide suffer from migraine headaches, which affect three times as many women as men. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound.

How Pacing Can Stop the Boom-Bust Cycle of Pain

By Gabriella Kelly-Davies, PNN Columnist

Many people living with chronic pain are stuck in a boom-bust cycle. I was one of them until I took part in a multidisciplinary pain management program and learned how to pace my activities and exercises.

On the good days when our pain level is low, we try to catch up on doing all the things we couldn’t do when the pain was bad the previous day. But this can cause a flare-up and the natural response is to rest or take a pain medication. Once the pain eases, we might try again, only to repeat the pattern of overactivity, flare-up, rest, easing of pain, then overactivity.

When this happens repeatedly, we can become frustrated and despair of ever being able to live a normal life. It becomes difficult to plan ahead because we never know how we will be on any day. Over time, there are fewer good days and more bad days and we feel as if we have lost control of our life. We become so afraid of causing a flare-up that we avoid any activity that aggravates our pain.

The end result is that our bodies lose conditioning and become less able to cope with a higher level of activity. Muscles weaken, joints stiffen, and less and less activity causes a flare-up.

The good news is that we can use a pain management technique known as pacing to increase our activity levels without stirring up the pain. Pacing involves starting at a level of activity that doesn’t aggravate our pain, breaking up tasks into smaller steps, gradually increasing the amount we do, and taking frequent, small breaks. Over time, it is possible to increase our tolerance to a range of daily activities and exercises. 

Set Goals and Build Up Gradually

Pacing can be applied to everything you do. If sitting increases your lower back pain, try to use pacing to build up your sitting tolerance. You can also pace exercises such as walking and swimming, and use it to increase your tolerance to activities such as housework, gardening and driving.

The first step is to decide which activities or exercises are your priorities, then determine your baseline tolerance to them. A starting point 20 percent below your current level is a general rule of thumb. If sitting exacerbates your lower back pain, determine how long you can sit comfortably. If you can sit for five minutes without triggering a flare-up, set your baseline at 80 percent of five minutes, which is four minutes.

Once you know your baseline, set short and long-term goals and record them in a chart. Each day, increase the time you do the activity or exercise by a predetermined small amount.

If your long-term goal is to sit and watch a movie for two hours without causing a flare-up and your baseline is four minutes, your short-term goal might be to increase your sitting by one minute each day. At the end of the week if you can sit comfortably for 10 minutes, you can repeat this pattern for the following weeks until you reach two hours. However, if you find that increasing by one minute every day stirs up your pain, try increasing by one minute every second or third day.

Record your progress in a chart like the one below so you can see how much you are building sitting tolerance.

SHORT-TERM GOALS

SITTING PROGRESS

Break Up Activities

Pacing also involves breaking up tasks into smaller amounts that don’t cause a flare-up. If carrying heavy bags of groceries from the supermarket exacerbates your back pain, try buying smaller amounts of groceries more often. For example, go to the supermarket three times a week and buy small amounts rather than doing one big shop each week.

Taking short and frequent breaks is another way of gradually building up your tolerance to an activity. For example, if you can weed your garden for 10 minutes without flaring up your pain, make your baseline 80 percent of 10 minutes, which is eight minutes. Work in the garden for eight minutes, rest for 15 to 30 minutes, garden for another eight minutes, rest for 15 to 30 minutes, and so on. During your rest period, it’s a good idea to practice your relaxation exercises and stretches.

As your tolerance to gardening increases, you can gradually build up the time you garden before you rest.

Fine-Tuning Your Plan

Pacing is a process of trial and error, and your initial goals might need to be fine-tuned if you find that pain interferes with you achieving them. Try to be patient and don’t overdo it. It’s better to take baby steps and achieve your goals than to race ahead and fall back into the boom-bust cycle.

It’s crucial you stick with your plan each day. If you are having a good low-pain day, don’t be tempted to increase each activity for longer than the predetermined time because you might risk flaring up your pain. On the other hand, if you are having a bad day, try to stick with your goals for the day, but take brief breaks and do your relaxation exercises and stretches during the breaks.

Pacing is an important part of an armory of pain management strategies. Like other multidisciplinary pain management approaches, it takes time to learn, but once you master the technique, it will put you in control of your day rather than your pain level dictating what you can and can’t do.

By keeping to your plan in a disciplined way, you will gradually build up your tolerance to activities of daily living and leisure. With practice, you, rather than your pain level, will determine how much you can do, giving you more control and a better quality of life.

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

Why the Pain Community Should Support Voting Rights Legislation

By Dr. Lynn Webster, PNN Columnist

I believe to my core that all people should be able to vote without experiencing intimidation or hardship. People who are in chronic pain -- many of whom require opioids to enjoy any quality of life -- live outside of society's safety net. They don't run for political office because they can't. They don't make the laws that oppress them. And now they're in danger of being unable to vote against those laws.

The House of Representatives recently passed H.R. 4, which is a revised version of the John Lewis Voting Rights Advancement Act. The bill is designed to restore provisions of the 1965 Voting Rights Act that were diminished by the U.S. Supreme Court in 2013 and further gutted last year. Essentially, the court’s 2013 ruling allowed some states to change their election laws without receiving federal approval. While H.R. 4 passed the House on a party line vote, it now faces opposition in the evenly divided Senate.

H.R. 1, the For the People Act 2021, is another voting rights bill that is being considered. It would ensure same-day voter registration and early voting throughout the country for national elections. This flexibility is precisely what many people in pain need. The law also attempts to correct the corrupt gerrymandering that contributes to the country’s hyper-partisan divide. This bill would also be important to support.

Voter Suppression Impacts the Most Vulnerable

On August 28, I marched in Salt Lake City in support of easier and more practical ways to vote and to protect the right of everyone to participate in our democratic process. When I attended this rally, I learned that voter suppression is a much broader problem than I had realized. It isn't only an issue involving people of color. Intentionally or not, voter suppression prevents many subsets of Americans from having a voice in our democracy.

Although the voting rights movement has been championed mostly by people of color, everyone should be involved. This affects all of us. It targets people who are poor and can’t afford to take a day off to vote, and those who can't leave their home because they can't pay for childcare, are caregivers for the elderly or sick, or are sick or disabled themselves. People with severe, disabling pain and those who provide care for them are affected by voter suppression laws as much as those of any other minority. 

During my walk from Utah’s state capital to Washington Park on that hot Saturday, I realized my 40-minute hike was nothing compared to the challenges that many had to endure during the last election, and may have to experience in future elections, including waiting for hours. I was sweating and thirsty. Fortunately, the organizers provided us with cold water. Others may not be so lucky.

In Georgia, restrictions have recently been passed to prevent voters standing in line from receiving water. The laws also limit absentee ballots and the number of ballot boxes, which makes it more difficult for caregivers, the disabled, and people with disabling pain to vote.  

As I marched, I began to wonder how people in pain would be able to tolerate standing in a long line. How could people who use a wheelchair or walker, or who suffer from chronic migraine headaches, fibromyalgia or severe arthritis, endure the wait? Even healthy senior citizens and others who must void their bladders frequently may be unable to stand in a long line to have their voice heard.

If one person’s rights are diminished, the rights of all people are diminished. These restrictive laws are unnecessary and it would be an injustice for us to allow their passage.

The Pain Community Needs a Voice

There are 20 million people in the U.S. with disabling pain. This represents more than 12 percent of the total number of people who voted in the last presidential election. That is more than three times the difference in votes between Biden and Trump. It is a consequential population.

Pain and addiction don’t preferentially affect Republicans, Democrats or Independents. They harm all people equally, and people with pain and addictions are not tied to any political tribe.

People in pain do not have a collective political voice. They have been marginalized and forced into the darkness. People with substance use disorders also have been silenced. Our drug laws are punitive and utterly disastrous. The only way to change this is by voting for those who will represent our interests.

Therefore, it's important for the pain and addiction communities, regardless of their political allegiances, to support the John Lewis Voting Rights Act. The law would help restore the rights granted under the Voting Rights Act of 1965 and empower the federal government to enforce those rights.

What We Can Do

I suggest everyone call or email their senators, even if their senators support the bill. They need to know where their constituents stand. If possible, join and donate to an organization fighting for your right to vote. Write an op-ed for your local newspaper or media outlet expressing your views on how to make it easier, not harder, for you to vote.

Disenfranchised people are in danger of losing their right to vote, and people in pain are an important constituency. Forming a collective voice to advocate for all people who suffer chronic pain is just as important, although it is a topic for another day. The time to support these voting rights bills is now…before it’s too late.

Lynn R. Webster, MD, is a Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript. He also consults with the pharmaceutical industry. Lynn 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.

Overdoses Tripled in New Jersey Despite Limits on Rx Opioids

By Pat Anson, PNN Editor

In 2017, New Jersey became one of the first states in the country to impose a hard limit on initial opioid prescriptions, with patients allowed only a 5-day supply of opioid pain medication. If they needed more, their doctor would have to write a new prescription, enroll patients in a pain management program, and counsel them about the risks of opioid addiction and overdose.

"We are here today to save lives," then-Governor Chris Christie said after signing the legislation into law. "New Jersey now leads the way first and foremost in recognizing this is a disease."

Four years later, there is little evidence the 5-day limit has reduced opioid addiction or saved lives in New Jersey. In fact, it may have made the overdose crisis worse by forcing some patients to turn to increasingly dangerous street drugs.

A new study at Rutgers University, recently published in The Journal of Substance Abuse Treatment, found that medically treated opioid overdoses among Medicaid patients more than tripled in New Jersey from 2014 to 2019.

Researchers found the overdose rate continued to rise even after the 5-day opioid limit was imposed, with opioid prescription rates nearly cut in half for Medicaid beneficiaries, falling from 23 percent in 2015 to 13 percent in 2019.   

The rising number of overdoses was primarily due to heroin and illicit fentanyl, and often involved alcohol and other drugs. Medicaid patients suffering from alcoholism, benzodiazepine addiction, depression, hepatitis C, heart failure and pneumonia had overdose rates at least 1.5 times higher than other beneficiaries.

“While high rates of opioid prescribing likely contributed to earlier increases in OUD (opioid use disorder), actions to further limit such prescribing alone may do little to reduce opioid overdose in the current environment,” wrote lead author Stephen Crystal, PhD, director of the Rutgers Center for Health Services Research.

“Policies also need to be attentive to the possibility that, if not well managed, reductions in access to prescribed opioids could lead some individuals with pain conditions and other complications, including OUD, to turn to heroin and other illicit drugs, in an increasingly dangerous environment.”

Since their peak in 2015, when over 5,640,000 opioid prescriptions were filled in New Jersey, opioid prescribing has fallen over 35% in the state. That coincided with an alarming increase in overdose deaths as illcit fentanyl began to flood New Jersey.

OPIOID PRESCRIPTIONS DISPENSED IN NEW JERSEY

Source: NJ Cares

NEW JERSEY FATAL DRUG OVERDOSES

Source: NJ Cares

Comorbid Conditions

Rutgers researchers say more attention needs to be paid to people who survive overdoses, who often live with multiple health problems and comorbid conditions. In 2019, over half suffered from major depression (51%), while others had alcohol use disorder (39%), hepatitis C (30%), bipolar disorder (28%), cannabis use disorder (26.5%) sedative/hypnotic use disorder (21%) or schizophrenia (11.5%).  

Notably, less than a third (30.4%) of New Jersey’s overdose survivors were diagnosed with a chronic pain condition, suggesting the state’s focus on limiting pain medication was misdirected at a time when more resources were needed throughout the state’s healthcare system, particularly for mental health.  

“The high level of behavioral health and medical comorbidity that we identified among individuals with overdoses has important implications for interventions in a system in which substance use treatment, mental health care, and primary medical care are often siloed,” Crystal and his colleagues wrote.

“Interventions for conditions such as alcohol use disorder, sedative-hypnotic use disorder, and chronic obstructive pulmonary disease could reduce overdose risk. High rates of mental health comorbidity among this population, including major depression, bipolar disorder and schizophrenia, also highlight the need for concomitant mental health treatment.”

New Jersey is not alone in its failed attempt to end the overdose crisis. As PNN has reported, nearly two dozen states have implemented laws limiting the initial supply of opioid medication; 17 states limit prescriptions to 7 days supply, two states cap them at 5 days, and four states limit prescriptions to just 3 days.  

These and other efforts to reduce opioid use, such as prescription drug monitoring programs (PDMPs), have resulted in prescription opioid use falling to 20-year lows in the United States, even while overdose deaths surged to record highs. Over 93,000 Americans died of drug overdoses in 2020, with the vast majority linked to illicit fentanyl and other street drugs.

The trend continues in New Jersey. In the first six months of 2021, the state reported 1,626 fatal overdoses, nearly three dozen more deaths than were recorded during the same period last year. New Jersey is on track to have a record 3,250 fatal overdoses by the end of the year.

Study Finds Childhood Trauma Increases Risk of Opioid Addiction

By Pat Anson, PNN Editor

Several studies have found that if you experienced physical or emotional trauma as a child you are more likely to have migraines, fibromyalgia and other painful conditions as an adult.

Australian researchers have taken that theory a step further, with a small study that found adults with a history of childhood abuse or neglect are more likely to feel the pleasurable effects of opioids, putting them at greater risk of addiction.

That finding, recently published in the journal Addiction Biology, is based on a double-blind, placebo-controlled study that compared the effects of morphine on 52 healthy people – 27 with a history of severe childhood trauma and a control group of 25 who had no such experiences as children.

Participants in both groups were given an injection of morphine or a placebo dose, and then asked how it made them feel. People in the trauma group reported more euphoria or feeling high and more “liking” of morphine. They also felt less nauseous and dizzy after taking the drug compared to the non-trauma control group.

“Those with childhood trauma preferred the opioid drug morphine and they felt more euphoric and had a stronger desire for another dose,” lead author Molly Carlyle, PhD, a research fellow at The University of Queensland, said in a statement. “Those with no childhood trauma were more likely to dislike the effects and feel dizzy or nauseous.

“This is the first study to link childhood trauma with the effects of opioids in people without histories of addiction, suggesting that childhood trauma may lead to a greater sensitivity to the positive and pleasurable effects of opioids.”

Researchers say people in the trauma group were significantly more likely to have a history of anxiety or depression, and to use over-the-counter pain relievers regularly.  They were also more likely to report stress, loneliness and less social support and self-compassion than the control group.

“One possible explanation for the differing responses to morphine is that childhood trauma affects the development of the endogenous opioid system – a pain-relieving system that is sensitive to chemicals including endorphins, our natural opioids,” Carlyle explained. "It's possible that childhood trauma dampens that system.

“When a baby cries and is comforted, endorphins are released, so if loving interactions like this don't happen, this system may develop differently and could become more sensitive to the rewarding effects of opioid drugs."

Pain was also measured during the study, with participants immersing a hand in cold water both before and after receiving morphine. Researchers measured how long it took for them to find the cold water painful and how long it took before they pulled their hand out. Morphine was found to increase pain threshold and tolerance in both groups, regardless of whether they experienced childhood trauma.

“The findings of this study are a stepping stone in highlighting the role of childhood trauma in OUD (opioid use disorder), emphasising the need to address trauma symptoms in this vulnerable group, and targeting early interventions at traumatised young people,” researchers concluded. “These findings have many clinical and social implications including reducing the guilt and shame common amongst those with OUD about the reasons behind the development of this damaging addiction.”

A Third of Long Haulers Have ‘FibroCOVID’

By Pat Anson, PNN Editor

Nearly a third of patients with long-haul covid have symptoms strikingly similar to fibromyalgia, according to a new study by Italian researchers who say being male and obese are strong risk factors for developing “FibroCOVID.”  

“In the light of the overwhelming numbers of the SARS-CoV-2 pandemic, it is reasonable to forecast that rheumatologists will face up with a sharp rise of cases of a new entity that we defined (as) ‘FibroCOVID’ to underline potential peculiarities and differences,” wrote lead author Francesco Ursini, MD, an Associate Professor of Rheumatology at the University of Bologna.

The study findings, published online in RMD Open: Rheumatic & Musculoskeletal Diseases, are based on a survey of over 600 patients with post-acute COVID-19 – also known as "long COVID."

Nearly 31% of the long-haulers had musculoskeletal pain, fatigue, cognitive impairment and sleep disturbances – classic symptoms of fibromyalgia, as defined by the American College of Rheumatology.

Unlike traditional fibromyalgia, which primarily affects women, a higher percentage of men (43%) had symptoms of FibroCOVID. They were also more likely to be obese, have high blood pressure, and a severe COVID-19 infection.

“Globally, respondents with FM (fibromyalgia) exhibited features suggestive of a more serious form of COVID-19, including a higher rate of hospitalisation and more frequent treatment with supplemental oxygen,” Ursini and his colleagues reported. “Taken together, our data suggest a speculative mechanism in which obesity and male gender synergistically affect the severity of COVID-19 that, in turn, may rebound on the risk of developing post-COVID-19 FM syndrome and determine its severity.”

The long-term effects of a COVID-19 infection are currently unknown. While some patients have minor symptoms and recover quickly, about a third will develop long COVID and have symptoms that persist for several months after the initial infection.  

Previous studies of long-haul covid have also found similarities with autoimmune conditions such as lupus and myalgic encephalomyelitis, also known as chronic fatigue syndrome (ME/CFS).  

Vaccines Cut Risk of Long Covid

Being fully vaccinated against COVID-19 cuts the risk of developing long covid in half, according to a new UK study. Researchers at King’s College London looked at health data from a mobile app used by millions of people in the UK and found that those who received two doses of the Moderna, Pfizer or AstraZeneca vaccines had significantly lower risk of a “breakthrough” infection that turns into long covid.

“We found that the odds of having symptoms for 28 days or more after post-vaccination infection were approximately halved by having two vaccine doses. This result suggests that the risk of long COVID is reduced in individuals who have received double vaccination, when additionally considering the already documented reduced risk of infection overall,” researchers reported in the journal The Lancet Infectious Diseases.

“Almost all individual symptoms of COVID-19 were less common in vaccinated versus unvaccinated participants, and more people in the vaccinated than in the unvaccinated groups were completely asymptomatic.”

Fully vaccinated.people aged 60 or older were more likely to have no symptoms of a breakthrough infection, according to researchers.

The Tangled Mess of Prescription Opioid Guidelines

By Roger Chriss, PNN Columnist

The opioid overdose crisis has impacted medical practice in unanticipated and unfortunate ways. A recent JAMA study warned that efforts to reduce opioid prescribing through tapering raises the risk of overdose and mental health crises in pain patients on stable, long-term opioid therapy.

This study is the latest to find that opioid tapering is fraught with risks. Amid this, the American Medical Association has issued a call to revamp the CDC’s problematic 2016 opioid prescribing guideline because of its “devastating” impact on pain patients.

“The CDC should remove arbitrary thresholds, restore balance and support comprehensive, compassionate care as it revises the guideline,” wrote AMA news editor Kevin O’Reilly.

But revising the CDC guideline may not have much effect. The guideline is voluntary and doesn’t have the force of law, but many states have implemented their own guidelines in ways that make them enforceable. They are often paired with requirements and regulations covering everything from daily dose and prescription duration to drug testing, pain management agreements, and tapering. These state guidelines do not necessarily follow the CDC guideline on even basic issues of dose, duration or recommended use.

Some states, including Minnesota and Oregon, have adopted the CDC’s recommended threshold of 90 morphine milligram equivalents (MME) as a maximum daily dose not requiring consultation with a pain management specialist or a special exemption. Other states make their own rules. Washington has kept to 120 MME in its latest guideline update, as has Tennessee.

State policies also differ on the merits of using opioids for chronic pain. The Medical Board of California recommends that physicians and patients “develop treatment goals together” for long-term use of opioids, while Arizona’s opioid guideline flatly warns physicians: “Do not initiate long-term opioid therapy for most patients with chronic pain.”

On tapering, states do not agree much at all and generally do not follow federal HHS guidelines that tapering be individualized and “slow enough to minimize opioid withdrawal symptoms.”

Minnesota’s opioid guideline recommends that physicians “routinely discuss tapering with patients at every face to face visit” and allows for forced, rapid tapers or discontinuation under some circumstances.

Tennessee’s guideline notes that there are “many reasons to discontinue chronic opiate therapy” and “several different weaning protocols outlined by various sources.” It does not recommend any specific one, leaving it up to individual doctors to decide how to taper their patients.

The VA and Department of Defense have their own guideline, which contains a complex set of treatment algorithms that span several pages and effectively exclude almost all patients from long-term opioid use. Further, according to a separate algorithm, the VA is clearly aiming to taper or discontinue opioids in as many patients as possible. The guideline states "If prescribing opioid therapy for patients with chronic pain, we recommend a short duration.”

The Trouble With Algorithms

Many of the state guidelines are paired with a prescription drug monitoring programs (PDMPs) and use NarxCare, a private analytics system that gives individual risk scores to every patient based on their medical and prescription drug history. PNN first covered NarxCare in 2018, noting that patients can be automatically “red flagged” by the system for seeing too many doctors or using multiple pharmacies.

Maia Szalavitz recently wrote about Narxcare in Wired, noting that legitimate patients were being denied medications or abandoned by doctors because of their Narxcare scores.

“A growing number of researchers believe that NarxCare and other screening tools like it are profoundly flawed,” Szalavitz wrote. “None of the algorithms that are widely used to guide physicians’ clinical decisions — including NarxCare — have been validated as safe and effective by peer-reviewed research.”

A similar problem exists for data from PDMPs. A well-documented analysis by Terri Lewis, PhD, found that “machine learning” algorithms are often based on untested assumptions and financial incentives for providers, not on patient care.

“The worst part of machine learning (ML) snake-oil isn’t that it’s useless or harmful — it’s that ML-based statistical conclusions have the veneer of mathematics, the empirical facewash that makes otherwise suspect conclusions seem neutral, factual and scientific,” wrote Lewis. “What the PDMP is NOT designed to do, is detect patients who are using their opioids correctly from patients who are misusing their medications.”

All of the above imposes a significant risk and burden on patients, in particular if they relocate for work or school, or seek medical care outside of their state of residence.

In essence, patients are subjected to a set of federal recommendations from the CDC that may inform some state laws or regulations that are then implemented in a privatized process with little transparency or accountability. Patients simply cannot tell what is happening at the time of implementation, and if they see a problem after the fact, it is usually too late to fix it.

The AMA’s current effort to improve the CDC guideline for opioids is a laudable step forward. But the mess is far larger and more complex, and the role of the CDC is smaller than is generally appreciated amid an abundance of contradictory guidelines and regulations.

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. 

Pain Desensitization: How to Overcome Fear of Chronic Pain

By Gabriella Kelly-Davies, PNN Columnist

Something common to us all is a dislike of pain. Sudden or acute pain is a warning signal that something is wrong. When it strikes, we try to escape from it by taking a pain reliever, distracting ourselves, resting or seeing a health professional.

This approach usually works after an injury or surgery while waiting for the damaged tissues to heal and the acute pain to settle. But it is not as effective for chronic pain when the cause of the pain is a malfunction in the processing of pain signals in the central nervous system, rather than tissue damage.

While chronic pain is not generally a warning sign, the brain may still see it as a threat. It prompts the same avoidance behaviors we use for acute pain. Many people living with chronic pain are so fearful of triggering a flare up, they avoid anything they believe exacerbates their pain. This fear can be so intense it prompts them to leave the workforce prematurely, stop doing usual daily activities such as shopping and housework, and give up doing all the things that previously gave them pleasure.

Australian psychologist Michael Nicholas, PhD, was worried that many of his patients at the Michael J. Cousins Pain Management and Research Centre in Sydney limited their daily activities to avoid pain. Some patients even tried staying in bed all day to prevent provoking their pain.

Nicholas wondered whether an exposure technique used by psychologists to treat phobias such as fear of heights could be applied to pain management. In exposure therapy, psychologists create a safe environment, then gradually expose an individual to the thing they fear. With repeated exposures in a safe environment, anxiety and fear can be reduced.

“I thought exposure therapy might reduce the fear of pain and the resulting avoidance behaviors,” Nicholas told me. “This would mean training the brain to learn not to react to chronic pain. I started encouraging my patients to sit quietly for 20 minutes, acknowledge their pain, but not react to it. After doing this repeatedly over a few weeks, many patients told me their pain was still there, but they were no longer so bothered by it. They lost the urge to escape from it.”

Nicholas described the technique as pain desensitization because his patients were familiar with the idea of pain sensitization, and he thought this could be a way of countering that effect.

For the last few decades, Nicholas and his colleagues have used this approach in the multidisciplinary pain management programs at their center. As with learning any new skill, he says mastering pain desensitization takes a lot of practice.

“You’ve got to practice pain desensitization regularly,” Nicholas explained. “Often people aren’t prepared to do that.” He likens it to lifting weights at the gym to build up muscle strength, something that usually takes weeks or even months.

“If you’re trying to change the way your brain responds to pain; you’ve got to do a lot of workouts. It can take up to two to three months of daily practice to master pain desensitization. But once you get the hang of it, it reduces the distress caused by your pain.”

I learned pain desensitization in 2008 in a three-week pain management program. It took me several weeks of twice-daily practice to fully grasp it, but I soon incorporated it into my usual routine. For years it has been a seamless part of my day, and I practice it regularly, especially when I have a flare-up.

Learning Pain Desensitization

Try making pain desensitization a part of your daily relaxation practice. Close your eyes, take a deep breath and let it out slowly, focusing your mind on breathing calmly. After a couple of minutes of gentle breathing and relaxing, turn your attention to the pain. If you have several painful sites, choose one of them.

While focusing attention on the pain, try not to think about how bad it is. You can’t stop yourself from thinking, but you don’t have to respond to the thoughts. Just let thoughts pass you by like a leaf floating on the stream. Calmly focus on the sensation you call pain and see what happens. Don’t try to change the pain or attempt to make it go away because that is trying to escape from it. Simply let it be there and continue relaxing.

Sometimes the pain might start to feel worse because you are used to trying to escape from it. If this happens, continue with your breathing exercises and any increase in pain will settle. Try to observe your pain as calmly as possible, almost as if it is in someone else’s body. Or imagine you are doing a scientific experiment and focus on the pain like a scientist might observe a leaf or a bug under a microscope. Be as objective as possible, without reacting emotionally to it.

If your mind wanders, bring it gently back to focusing on the pain. Continue relaxing and use your breathing exercises to calm yourself. Keep this up for about 15 to 20 minutes and see what happens. Look at it as a type of experiment and evaluate what you notice. Remember, you’re just allowing yourself to experience the pain that will be there anyway, even if sometimes masked by medications. You aren’t doing anything that can harm you.

By allowing yourself to feel the pain repeatedly, you can habituate to it, because our brains naturally habituate to repetitive stimuli. This effect is similar to what happens when you put a new painting on your living room wall. At first, you notice it whenever you walk past it. But after a while you notice it less. You remain aware that it’s there, but you don’t notice it as much.

Don’t expect too much too soon. Just keep practicing because eventually you will retrain your brain to not respond with alarm to the pain. You’ll find that as you get better at desensitizing, you also become more relaxed when feeling your pain.

Once you have learned the technique, try it whenever your pain starts to trouble you, particularly during exercise or other activities that aggravate your pain. If pain stops you from falling asleep, try desensitizing in bed at night.

Start with a mix of long and short sessions -- two or three 20-minute sessions each day. In between, try brief sessions of one to two minutes whenever you notice your pain or when exercising. After a few weeks it will become a habit and you’ll find yourself doing it without realizing it.

Pain desensitization isn’t a miracle cure for chronic pain. Instead, it is one of the many techniques used in multidisciplinary pain management programs to modify the experience of pain. Importantly, it helps people reduce the impact of pain on their life.

“You have to see it as a training exercise, not as a gimmick,” Nicholas advises. “It’s a skill you’ve got to learn, like learning to play tennis. But as with tennis, once you’ve mastered it, you’ll find you do it automatically without thinking. Many people are surprised by how effective it can be for reducing the distress caused by their pain.”

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

Study Finds Marijuana Reduces Pain, but Worsens Self-Care

By Pat Anson, PNN Editor

The 1998 comedy “The Big Lebowski” has a cult-like status as a stoner film, largely because of the way Jeff Bridges portrays a weed-smoking slacker who has no job, can’t pay the rent and spends half the movie in a bathroom robe. The Dude abides life at his own pace.

A new study may have inadvertently reinforced some of that stoner stigma, finding that marijuana use reduces pain but significantly worsens patient “self-care” – a broad category that includes behavior such as motivation, physical activity and appearance.

The study involved 181 pain patients enrolled in Pennsylvania’s medical marijuana program, who used marijuana for eight weeks and regularly completed surveys on its effects.

The study findings, recently published in the journal Medical Cannabis and Cannabinoids, showed that participants reported significant improvement in their pain and anxiety, and a small improvement in quality of life. But there was a caveat.

“One sees that the improvements to the pain and anxiety dimensions are tempered by a decline in the area of self-care. This is important because the side effect profile of cannabis may be diminishing the improvement in (quality of life),” wrote lead author Andrew Peterson, PharmD, University of the Sciences in Philadelphia. “A review of the literature found no other study connecting the use of marijuana with declines in self-care in pain patients using MM (medical marijuana).”

The study did not look at the doses used by participants, but since all products in Pennsylvania’s medical marijuana program contain some level of tetrahydrocannabinol (THC) – the psychoactive substance in marijuana – researchers believe there might be a connection. They said further studies were needed to see if there’s a relationship between THC, self-care and quality of life.

“There are many sources describing the negative consequences of marijuana,” Peterson wrote. “Given that our study found a decline in self-care among pain patients using MM (medical marijuana), it would be of interest to learn what aspects of self-care change when using MM for pain.”

According to the National Institute on Drug Abuse, some of the negative consequences of marijuana use include changes in mood, difficulty with thinking and problem-solving, impaired memory and an altered sense of time.  

The Inside Story of Elvis Presley’s Death

By Donna Gregory Burch

When Elvis Presley first hit the music scene during the 1950s, he was both beloved and vilified for the hip-thrusting, leg-shaking and gyrating that changed the art form of musical performance forever.

But what many don’t realize is that Presley’s ability to do those iconic dance moves came with a cost and may have actually contributed to his sudden death in 1977 at the age of 42.

In a new book entitled “The Strange Medical Saga of Elvis Presley,” Dr. Forest Tennant, a retired physician who specialized in pain medicine and addiction treatment, explores the fascinating medical history of Elvis.

Turns out, it wasn’t all those peanut butter, banana and bacon sandwiches that killed him. But what did?

I recently had a chance to interview Tennant about his latest book and what really caused Elvis’ death.  

Donna Gregory Burch: When I think about Elvis’ death, I recall the rumors that he died while taking a bowel movement on the toilet and that his autopsy revealed a very full colon. Are either of those stories actually true?

Forest Tennant: Yes, they are. We knew about these events [surrounding his death], but we had no scientific or medical explanation as to why they occurred. Fifty years after he dies, we finally have a scientific explanation as to why he died like he did.

What happened to him and why he died so suddenly in the bathroom was … a medical controversy that … ended up in a criminal trial and with all kinds of emotionalism.

Nothing happened to Elvis Presley that we don't have a good logical, scientific explanation for now. But certainly back in those days we didn't.  

You were involved in a court proceeding about Elvis’ death. Could you tell me about that and what role you served during the lawsuit?

Well, what happened was that because he died suddenly and because the pathologists couldn't agree on why he died, and because Elvis was found to be abusing drugs as well as being prescribed a lot of drugs, a criminal trial was brought against his physician (Dr. George Nichopoulos).

The attorney that decided to defend (Nichopoulos) was a man by the name of James Neal, who was a federal prosecutor who prosecuted Jimmy Hoffa and the offenders in the Watergate scandal, and so he was the nation's top attorney at that time. He investigated the case and found out that the doctor that treated Elvis Presley was not a criminal at all and was doing his best to help him.

Some dozen physicians at the Baptist hospital in Memphis saw Elvis Presley, but nobody knew what was the matter with him. They knew he had some kind of mysterious, systemic disease, which is a disease that can affect multiple organs at the same time.

He was a baffling medical case for the doctors in Memphis at that time, and we didn't know what he had up until about three or four years ago. We did not understand the genetic collagen connective tissue disorders, now usually referred to by doctors as Ehlers Danlos syndrome (EDS). Nobody understood that his glaucoma and his colon [issues] were connected [due to EDS]. They knew it was connected somehow but they didn't have an explanation for it at that time.

What do we know today about why Elvis died that we could not explain back when he actually passed away?

He had a severe heart problem.

Elvis’ heart problem was directly tied to his diet, right? I mean he was well-known for his fat and sugar-laden diet.

Yes, his diet was part of it, but his autoimmunity also affected his heart.

But the major controversy of the day is one that's maybe a little hard for the public to understand. A drug overdose in 1977 was said to only occur if the lungs filled up with fluid. He had no fluid in his lungs, so the only thing that he had at his autopsy of any significance was a huge heart. And so the pathologist and the county medical examiner said he had to have died of a heart attack because his heart was so bad.

The catch was that he had about 11 drugs in his bloodstream. The highest level was codeine, so there became a dispute among the doctors. A certain group of pathologists who were highly qualified said he died of a heart problem. Another group of highly qualified physicians who were called forensic pathologists said no, he died of his drugs. Up until about two or three or four years ago, the argument was still going on.

Now, I hate to say thanks to the opioid crisis, but because of the overdose deaths that have occurred in recent years, a lot of studies have been done, and enzymes have been discovered, and metabolism has been discovered showing that drugs like codeine can cause a certain heart stoppage without having pulmonary edema (fluid filling the lungs].

It turns out that 24 hours before he died, a dentist gave him codeine. He was already thought to be allergic to it anyway, and that was because he had all these metabolic defects due to his genetics, and so the codeine built up in his system. He had this terrible heart, so he died suddenly, within seconds, as he was trying to sit on the commode. He fell forward.

There is a forensic pathologist, the best one of the day, called Dr. Joseph Davis, and in about 1997, he described exactly, second by second, what happened to Elvis in the bathroom. But the cause is pretty clear: He took the codeine, and it caused a cardiac arrhythmia. If he had a good heart, he might have survived, but he had a bad heart.

So, it’s really a combination. You had these two sides of doctors arguing – they even ended up in a criminal trial – but it turns out that they were both right. It was a combination of a terrible heart and a drug that causes cardiac arrhythmia, and that's why he died with no pulmonary edema.

So many times in the medical community, we always look for that one cause, right? His case is very illustrative. Because the body is so complex, it's often multiple factors that are causing health issues.

Elvis Presley had multiple diseases. He was terribly ill, and he died accidentally in some ways with a dentist giving him codeine for his bad tooth, and his bad teeth were also part of the same disease that gave him a bad colon and a bad eye and a bad liver. They were all connected.

EDS is what connects all of those health problems, correct?

Yes, scientifically, EDS is a genetic connective tissue collagen disorder, and what that means is that you are genetically predetermined to have your collagen in certain tissues either disappear or deteriorate or become defective, and to put it bluntly, you can have a rectal problem and an eye problem at the same time due to the same cause because your collagen is deteriorating in these tissues, and you were programmed to develop this when you are born. It is a major cause of the intractable pain syndrome.

Now some of the diseases are very mild. You have a little double jointedness, and your skin is a little lax, and you might develop some arthritis, but you become a good gymnast in the Olympics or you become a good football player in some of the mild cases. But if you get a severe case like Elvis Presley, your life is going to be very miserable, and you're going to die young unless you get vigorous treatments, which are being developed right now.

I don't think EDS was even recognized back when Elvis was living, was it? It wasn't even a known diagnosis. Not many people even know about it today.

No, Dr. Peter Beighton didn't even come up with the (diagnostic screening tool for EDS) until long after Elvis Presley died.

As amazing as it may seem, I'm the only person in the United States who had the autopsies of both Elvis Presley and [aviator and businessman] Howard Hughes and their medical records, and was able to interview their physicians who took care of them. So I felt obligated to put these into books. I don't care whether anybody buys the books or not, but I do think these cases are marvelous cases, and I think these are icons and heroes of the last century, and somebody needed to write it down, and I'm the only one who had the material.

And you know something? For 50 years nobody cared that I had them. Maybe they still don't, but I've got them in the books now, so it'll be recorded for posterity, and that was my goal … to make sure that history is recorded.

Was EDS responsible for the way Elvis was able to move and dance?

Yes, we've got some pictures in the book, and I think we put the question in there. Can you hold these positions and sing and hold a microphone at the same time? And of course, [most people] can't. [EDS was] why he was able to do those things.

But on the other hand, we [recently had] the Olympics, and some of those Olympic [athletes] couldn't possibly do this if they didn't have these hypermobile joints. Whether they will develop the disease in later life is unknown.

When you're young, and you have these joints that are hyperextended, you can do things that other people can't do.

In your recent book about Howard Hughes’ medical issues, you had written about how Hughes was still very successful in life despite the fact he was in an enormous amount of chronic pain due to his medical conditions. Elvis was in the same predicament, wasn’t he?

Very much so, and I'm hoping that people who have intractable pain syndrome, who have EDS, complex regional pain syndrome, autoimmune diseases and traumatic brain injuries, read these books or at least hear about the books, and get some hope and realize that here are two men who did great things in very disparate fields but were terribly ill. I've had many, many patients who read about Howard Hughes tell me that he was an inspiration to them.

Elvis was in a great deal of chronic pain as a result of his EDS. Is that what led to his addiction to opioids?

Yes, we will never quite know how much of the drug taking that Elvis was doing was him self-treating his medical condition and how much of it was just abuse, but that's just the way it is. You can't quantitate it.

I was actually asked to deal with both of these cases because, back in the 1970s, I was trying to deal with patients who appeared to abuse opioids and other drugs and also had legitimate pain, and that's how I got involved with these cases.

It's an issue to this day, and society can't deal with it. They just refuse to talk about it, refuse to deal with it. You've got one group of doctors who just want to treat the addiction. You've got another group who just want to treat the pain, but you've really got to treat some of both and have doctors who understand both, but at this point in time, it's not happening.

I would love to see these books bring about some rational discussions about opioids and about pain and addiction, but I don't see it happening. I see nothing but controversy, accusation, falsehoods, fabrications. Society and the media can't seem to have rational discussions anymore about these issues, unfortunately.

I think with all of Elvis’ health issues and his subsequent drug addiction, it was almost like the perfect storm, right? He has EDS that's causing him extreme pain. The doctors give him pain medications to try to remedy that, so he can actually perform on stage, but then he’s still not able to perform up to the standards of his fans because of his addiction to those drugs.

He was really in a damned if you do, damned if you don’t predicament.

Yes. Also, these drugs probably caused him to have a terrible traumatic brain injury. We couldn't document it, but I suspect that's what happened. He did have a terrible traumatic brain injury, which accelerated all his other problems.

Yes. Apparently, he had fallen in a bathroom and had injured his head, and that was part of what was going on with him in the last years of his life as well.

Yes, it sure was. So again as you pointed out, it was the perfect storm. That's exactly what happened.

You know what I think is so interesting about these two books that you've written? We as the public have this view of Howard Hughes that he was a recluse because he was eccentric and that was just part of his personality. But he was actually really suffering a great deal from chronic pain.

And it's the same situation with Elvis. When we think about his death, we think he was just a drug addict who took too many pills one night, fell off the toilet and died, right? But Elvis was also living with extreme pain and suffering, and he was likely just trying to medicate himself out of that misery.

In our research studies, I saw four people yesterday who have EDS as well as spinal canal problems, and they're just miserable. I sometimes don't know how Elvis and Howard Hughes and the people I hear from daily, I don't know how they make it, you know? I marvel at it.

I'm hoping that everybody who's got intractable pain syndrome or EDS or traumatic brain injuries reads these books. That's who they're written for.

Why did you think it was important to write for those audiences?

I think that the audiences that we deal with are terribly neglected in society. I hate to say it, but I think people who have intractable pain are disdained by a great segment of the population. They're ignored by the political structure, neglected by the medical profession. I hate to say it, but the people we deal with, somebody has got to look after them.

My wife and I… we've managed to put together a foundation and use our business successes to try to help people, and I think that's not normal either. My study of the best physicians over time have been doctors who stepped up to the plate for people who needed it because nobody else in society is going to.

I feel sorry for all the groups that have been out lobbying their legislators, their politicians, their medical boards, and they get deaf ears. They get nothing but yes, yes, yes, but then nothing happens. The medical profession we have, it doesn't stand up for people with intractable pain syndrome or EDS, and that is because a huge part of the medical profession is based on treating well people or simple problems.

And so these are people in society who are disdained, neglected and abused, and are put in the corner by huge segments of not only society at large and the government, but also by the medical profession itself.

Yes, I understand exactly what you're saying. I've encountered it myself as a chronic pain patient.

I bet you do.

Any final thoughts?

I have read I don’t know how many books on Howard Hughes and Elvis Presley, and almost all of them are antagonistic. They are hostile. They blame somebody. They are looking for something that's bad, okay?

And I don't know whether it's the authors. I don't know whether it's their publishers. I can't tell you, except I know one thing: In my review of Howard Hughes and Elvis Presley, and like I say, I'm the last person who knew their doctors and had any real contact with their physicians and even the media, I don't see all this negativism.

I think people as a group try to deal with the Elvis affair legitimately, honestly and with care, and the idea that somebody should be blamed, somebody should be bad-mouthed, it's just not there.

These are great stories. They're tragic stories, but I think there are an awful lot of positive, really good things that happened to these men and to people who were around them, so I don't think we're going to get anywhere dealing with some of these issues with just total negativism.

And I think the whole situation, if you read it, is somewhat uplifting and motivating. We are here to try to help our fellow man and women have better lives, and I think there's a lot of that in both of these men.

Donna Gregory Burch was diagnosed with fibromyalgia after several years of unexplained pain, fatigue and other symptoms. She was later diagnosed with chronic Lyme disease. Donna covers news, treatments, research and practical tips for living better with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com. You can also find her on Facebook, Twitter and Pinterest.

All proceeds from sales of “The Strange Medical Saga of Elvis Presley” will go the Tennant Foundation, which gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.

Rare Disease Spotlight: Friedreich’s Ataxia

By Barby Ingle, PNN Columnist 

This month’s rare disease spotlight is on Friedreich’s ataxia, a genetic nervous system disorder, first described by Nikolaus Friedreich, a German doctor, in the 1860’s.

Dr. Friedreich may not have fully understood how genes worked over 150 years ago, but now we know that Friedreich’s ataxia is inherited by children who receive two defective copies of the FXN gene, one from each parent.

People born with Friedreich’s ataxia (FA) usually develop their first symptoms in childhood. They often have difficulty walking, poor balance and slurred speech due to nerve degeneration in their spinal cords. The symptoms are progressive and steadily worsen with time.

As we learned in high school biology class, the nervous system continually carries information from the brain to the body and back again to the brain. The nerves tell our bodies how to move and walk, without us having to think about every step. With FA these sensory signals are disrupted and the brain has difficulty coordinating balance and movement, resulting in impaired function. Fortunately, FA does not affect reasoning and thinking, just the ability to communicate.

There are other types of ataxia diseases, all rare, but FA is the most common hereditary ataxia condition in the United States. According to the National Organization for Rare Disorders, about 1 in every 50,000 people inherit this disorder.  

As I was researching this rare disease, I reached out to a teenager with FA to see how she was handling the symptoms at such a young age. To protect her identity, I will call her Ken.

It has been noted that it takes about 10 years of dedication in an area of study to become an expert on a topic. In Ken’s case, she has lived her whole life with FA and become an expert as her symptoms developed. Ken has difficulties with her balance, coordination and movement. She is on medication, but still has muscle spasms and soreness.

Ken also has anxiety and depression due to the disruptive effects of FA on her life. She believes there is a societal stigma on people with rare diseases and wishes the world wouldn’t judge her.  

About 15% of people with FA do not have any onset of symptoms until they are 25 or older. Some with FA can live well into their 60’s and beyond. Older patients with FA may develop scoliosis that requires surgical procedures or back braces.

Similar to other neurological conditions such as central pain syndrome, FA patients may develop difficulty swallowing. FA can also lead to cardiomyopathy, a disease of cardiac muscle that causes heart failure or arrhythmia. About a third of people with FA develop diabetes.

Genetic testing can now provide a conclusive FA diagnosis, so if an infant or toddler is showing symptoms of the disease, they should have an evaluation by a neurologist or another medical professional to determine the cause.  FA is not yet one of the genetic conditions covered by newborn screening legislation that I have spoken to my state representatives in Arizona about. But there are federal laws that help us check for inherited conditions like FA.

I look forward to the day that all 7,000+ rare diseases are screened for at the time of birth so that preventative care and coordination can take place, giving children a better chance at a fuller and longer life.  If you have Friedreich’s ataxia and are interested in being a part of the research to help find a cure and treatment, please contact the FA Research Alliance (FARA).

My hope for Ken and all those living with FA is that a cure will be found someday. In the meantime, we can do our part to help lower stigma about rare conditions by advocating for research and meaningful support for the millions of people who live with them.

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

Fibromyalgia Patients Needed for Online Therapy Study

By Pat Anson, PNN Editor

A digital therapeutics company is looking for volunteers to participate in a clinical trial to see if smartphone-based therapy can improve symptoms of fibromyalgia.

Swing Therapeutics recently announced that its acceptance and commitment therapy program (ACT), a form of cognitive behavioral therapy (CBT), has received Breakthrough Device Designation from the Food and Drug Administration. CBT is a form of psychotherapy, in which patients are encouraged to reduce unhelpful thinking and behavior.

“Currently, most people living with chronic pain conditions like fibromyalgia are offered medications and some suggestions for modifying their lifestyle. Behavioral therapies have evidence supporting their effectiveness for pain management, but are not widely available or easily accessed by the average individual,” said David Williams, PhD, Associate Director of Chronic Pain and Fatigue Research Center at the University of Michigan, who is an advisor to Swing Therapeutics.

The company says a pilot study of its online therapy program has shown promise in managing fibromyalgia, a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression. The self-guided daily program includes interactive lessons and exercises designed to help fibromyalgia sufferers understand, accept and manage their symptoms. The core program lasts 12 weeks, followed by a maintenance phase for extended use.

Swing is looking for 500 participants in the U.S. who are at least 22 years of age and have a diagnosis of fibromyalgia. The digital therapy program can be conducted at home, with no in-person medical visits or medications required.  Participants will receive compensation after completing surveys at the end of the 12-week program. Click here to learn more about the study.

“Our team is committed to creating valuable digital therapies and demonstrating strong clinical evidence to support their use. The results of our initial studies are encouraging, and with the support of the FDA, we look forward to optimizing the product as we advance through our pivotal trial,” said Mike Rosenbluth, PhD, founder and CEO of Swing Therapeutics.

The FDA has approved only three drugs to treat fibromyalgia: the antidepressants duloxetine (Cymbalta) and milnacipran (Savella), and the anti-seizure medication pregabalin (Lyrica). Many patients say the drugs are ineffective and have side effects. A recent analysis found little evidence to support the long-term use of any medication or therapy to treat fibromyalgia.

Thailand Decriminalizes Kratom as WHO Considers Banning It

By Pat Anson, PNN Editor

For the first time since World War II, it is legal again in Thailand to grow and sell kratom, a tropical tree used for centuries in Southeast Asia as a natural stimulant and pain reliever. In 1943, the military junta that ruled Thailand banned the planting of kratom trees because the popularity of kratom in rural areas was interfering with tax revenue from the opium trade.  

Ironically, the decriminalization of kratom in Thailand comes as the World Health Organization (WHO) considers placing international restrictions on kratom and six other psychoactive substances.

With kratom no longer listed as a narcotic in Thailand, thousands of pending criminal cases involving kratom are being dismissed and 121 inmates convicted of kratom crimes will be released from prison. Possession of kratom had been punishable by up to two years in prison.

In recent years, Thailand has been liberalizing many of its drug laws to ease pressure on its justice system. There was also growing recognition that kratom could become an important cash crop for Thai farmers. The global trade in kratom has grown significantly in recent years, with millions of Americans using kratom to self-treat their pain, anxiety, depression and addiction. Most kratom exports currently come from Indonesia.

It remains illegal in Thailand to mix kratom with other drugs. Some recreational users boil the leaves and mix it with codeine cough syrup, creating a “kratom cocktail.”

"To decriminalise kratom is the right thing to do. Local people or patients who need it will be able to access it more easily. However, I am concerned that teenagers will use it in a wrong way, for example, mixing kratom with other narcotics. We have to control this strictly, otherwise, it can cause damage," Ramdin Areeabdulsorma, a Thai politician, told the Associated Press.

‘Kratom Saved Me’

Under international treaties, WHO is required to assess the use of psychoactive substances and advise the United Nations on whether they pose a public health risk. WHO’s annual assessment will begin in October and U.N. members have been asked to submit their recommendations.

Kratom is legal in most U.S. states, although some states and communities have banned it. The Food and Drug Administration has tried -- unsuccessfully so far – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States.

Today is the last day for people to submit comments on the Federal Register for the FDA to consider as it prepares its response to WHO. Over 8,500 comments have been received so far, the vast majority asking the FDA and WHO not to ban kratom.  

“Kratom saved me from a lifetime opiate addiction. At 45 years old, I was unemployable and on my way to prison or death. Methadone or Suboxone hadn't kept me clean,” wrote Cecelia Lore. “I have never abused (kratom) as I hear some do. It has never caused a disruption in my life. I honestly feel that you should be looking at soda and junk food as the real dangers to our communities.”

“Kratom has helped both my wife and I stop taking opioids altogether. We never experienced withdrawals and we continue to use kratom rather than any other pain reliever because of its cost, lack of addictive nature and overall effectiveness. Rather than any kind of ban, what we need is regulation of the quality of the products,” said Nick Simpson.

“Kratom has made a direct impact on my life by helping me quit a debilitating alcohol addiction. I was an alcoholic for 6 years and to the point of being hospitalized several times with seizures from withdrawals,” wrote Tyler Davis.  “(Banning kratom) would harm a very large number of people recovering from addiction and force many back to destructive lifestyles.”

The American Kratom Association, a group of kratom vendors and consumers, has claimed the FDA instigated WHO’s review of kratom as a way to bypass the drug scheduling process in the U.S. An FDA spokesperson denied that, telling PNN the agency “does not determine for the U.S. government which substances shall be proposed” for WHO to review.