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.  

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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.

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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.

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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.

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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.

How Chronic Pain Affects Relationships

By Victoria Reed, PNN Columnist

People with chronic pain are often engaged in a battle with their own bodies. Unfortunately, sometimes we also struggle to be believed and supported by family members, friends and doctors. While some may be fortunate to have a supportive spouse or significant other, many pain sufferers lose their life partners along the way, as well as friends.

Pain can take a toll on our relationships. In my own experience, a good friend slowly faded into the background during a particularly difficult time when I was having numerous flares from rheumatoid arthritis and fibromyalgia. The flares cause debilitating fatigue and severe pain. I would often need to cancel plans and never could (and still can’t) predict which day I would wake up feeling awful.

Sometimes when I did not cancel plans, I would end up being miserable the entire time and would regret my decision. Eventually, the invitations and phone calls dwindled, as I was probably considered unreliable.

During that time, I would go for weeks struggling to function and keep going for the sake of my family and young children. But life doesn’t stop when you have a chronic illness. Homework still has to get done, as well as housework, financial matters and shuttling the kids to and from school and to sporting events.

One time, as I was driving my daughter home from gymnastics practice, I was so tired that my car ended up nose to nose with another car in a turning lane! I just barely missed having a head-on collision! Fortunately, the woman I almost hit wasn’t angry, but was actually concerned and asked if I was okay. The experience was frightening because I’d put my child in danger by driving when I was so fatigued.

It was then that I realized how serious my fatigue was and worried about the effect it was having on my relationships and family. Unless you actually experience this kind of fatigue, it can be hard to really understand it.

Additionally, my husband (at the time) was having trouble coping with my illnesses. We had been married for 18 years when we decided to divorce. I obviously wasn’t the same person that I was in the beginning and couldn’t contribute an equal share in the relationship.

The truth of the matter is that chronic pain is hard on everyone. It takes its toll not only on those physically suffering, but on spouses and significant others as well. Some make it known that it’s not working, while others quietly build resentment until they can no longer stay in the relationship. Then, seemingly out of nowhere, it’s “I want a divorce” or “I’m leaving” or “I can’t do this anymore.”

Perhaps they are overwhelmed by increased household chores and responsibilities or feel neglected in some way. Or maybe they fall out of love because you are not the person they married or agreed to be with. Perhaps they are stressed because of the additional financial burden resulting from your lack of income. Perhaps they don’t believe in your illness or think that you are faking your symptoms.

I certainly don’t have all the answers, but you must then pick up the pieces, move on and try to create a new life for yourself. If you have kids, you may have guilt about having an illness or believe that you are the cause of your family’s dismantling. 

Having chronic pain is like having a third person in the relationship. That “person” demands constant attention and spends many hours trying to get between the two of you, taking time away from you and your loved one.

However, if you are lucky enough to have that special someone who is capable and willing to deal with your chronic illness and truly understands and accepts, it might not mean the end of your relationship. Many people do stick with and endure the challenges of having an ill partner. It takes a very special person to be able to do that.

It’s good to have a few good friends who are supportive and understanding, rather than a bunch of people who say they are friends, but never step up to the plate. I’ve learned that family members who can’t be supportive have no place in my life. I believe it’s important to surround myself with positive people. Negative people can be emotionally draining and almost always are takers, rather than givers.

Those of us who have been abandoned must move on for our own emotional and physical well-being. As awful as it might seem at the time, it gives us the opportunity to meet new people who are able to give the love, support and compassion that we deserve.

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis.

CBD Reduced Burnout and Depression in Healthcare Workers

By Pat Anson, PNN Editor

After a year and a half of social distancing, masks and isolation, are you feeling emotionally burned out from the pandemic?

If so, you’re not alone. A recent survey of over 1,000 workers found that over half reported they were fatigued, depressed and had trouble concentrating.  Another study in the UK found that healthcare providers and other essential workers were particularly at risk of depression due to the stress of COVID-19.

With that in mind, researchers at the University of São Paulo in Brazil recently conducted a study to see if daily doses of cannabidiol (CBD) could relieve emotional exhaustion and burnout symptoms in a cohort of 120 frontline healthcare professionals.

Half of the study’s participants received 300mgs of CBD oil daily for four weeks. The other half did not receive CBD. All participants were evaluated weekly by a psychiatrist and encouraged to exercise.

The research findings, published in JAMA Psychiatry, found that participants who received CBD treatment had a significant reduction in emotional exhaustion and burnout compared to those who did not. CBD consumption was also associated with less anxiety and depression, but had no impact on post-traumatic stress syndrome (PTSD).

Five participants in the CBD group dropped out of the trial after suffering from serious adverse events, mostly elevated liver enzymes. Those cases resolved after CBD of discontinued.

“This randomized clinical trial found that the efficacy and safety of daily treatment with CBD, 300 mg, for 4 weeks combined with standard care was superior to standard care alone for reducing the symptoms of emotional exhaustion, anxiety, and depression among frontline health care professionals working with patients with COVID-19,” researchers reported.

“Burnout among health care workers is an important issue for health care systems, with a direct impact on quality of care. No pharmacological treatment is currently available for the prevention or treatment of burnout symptoms and emotional exhaustion among frontline health care professionals working with patients with COVID-19… Therefore, the results of the present study could have a relevant impact on the mental health of health care staff worldwide.”

The researchers said more placebo-controlled trials were needed to assess whether CBD could be used more broadly as a mental health treatment.

Previous studies have also found that medical cannabis reduced symptoms of depression. A 2020 study conducted in New Zealand found that people consuming up to 300mg daily in CBD oil reported significant improvement in their pain, mobility, anxiety and depression. Some also said they slept better and their appetite improved.

Another 2020 study found that 95% people who smoked or inhaled cannabis through a vaporizer reported a decline in depression within 2 hours. Cannabis with high levels of tetrahydrocannabinol (THC) was particularly effective in reducing depression.

Experts Debate Need for Covid Booster Shots

By Rachana Pradhan, Kaiser Health News

The Biden administration’s plans to make covid-19 booster shots available next month has drawn a collective scream of protest from the scientific community.

As some scientists see it, the announcement is rash and based on weak evidence, and they worry it could undercut confidence in vaccines with no clear benefit of controlling the pandemic. Meanwhile, more information is needed on potential side effects or adverse effects from a booster shot, they say.

Perhaps even worse, the announcement has fueled deeper confusion about what Americans need to do to protect themselves from covid.

“I think we’ve scared people,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the National Institutes of Health and the Food and Drug Administration.

“We sent a terrible message,” he said. “We just sent a message out there that people who consider themselves fully vaccinated were not fully vaccinated. And that’s the wrong message, because you are protected against serious illness.”

As of Thursday, 51% of the U.S. population was fully vaccinated, Centers for Disease Control and Prevention data shows. Biden administration officials ― citing data from Israel, a study from the Mayo Clinic that is not yet peer-reviewed and new CDC studies ― say it’s necessary to plan for boosters to prevent a worsening of the pandemic as the delta variant powers a surge in cases and overwhelms hospital intensive care units.

In essence, officials are caught between a rock and a hard place ― trying to be prepared while simultaneously not undermining messaging about how well the existing vaccines work.

Virus Unpredictable

Officials must weigh two unknowns: the risks of moving ahead aggressively with booster shots versus the risks of waiting to learn much more about the virus and the power of the vaccines. The government’s normal path to regulatory approval is, by design, slow and deliberate. The virus has its own schedule, fast and unpredictable.

“Arguably, I think that the federal government is simply trying to stay ahead of the curve,” said Dr. Joshua Barocas, associate professor of medicine at the University of Colorado. But, he said, “I have not seen robust data yet to suggest that it is better to boost Americans who have gotten two vaccines than invest resources and time in getting unvaccinated people across the world vaccinated.”

Beginning in late September, boosters would be made available to adults (age 18 and up) eight months after they received the second dose of a Pfizer-BioNTech or Moderna covid vaccine, President Joe Biden said. But his plan comes with big caveats: It does not yet have the blessing of a CDC advisory panel, and the FDA has not authorized boosters for all adults.

The urgent question is whether the vaccines are losing their power against covid.

“We are concerned that this pattern of decline we are seeing will continue in the months ahead, which could lead to reduced protection against severe disease, hospitalization and death,” Surgeon General Vivek Murthy said.

But many scientists and public health experts say the data doesn’t demonstrate a clear benefit to the public in making booster shots widely available, and the Biden administration’s message confuses people about what the covid vaccines were designed to do.

“They’re not a force field. They don’t repel the virus from your body. They train your immune system to respond when you become infected … with the goal of keeping you out of the hospital,” said Jennifer Nuzzo, an epidemiologist and associate professor at the Johns Hopkins Bloomberg School of Public Health.

Meanwhile, questions abound. Will boosters for fully vaccinated adults make the virus less transmissible ― that is, slower or less likely to spread to others?

“I certainly hope that’s the case … but the bottom line, with full transparency, we don’t know that right now,” Dr. Anthony Fauci, Biden’s chief medical adviser, said Wednesday.

What about side effects? “It would be nice to understand what side effects people have after their third dose,” Nuzzo said.

“We don’t have any reason to believe, based on the safety profile of the vaccine itself, that we’re going to see significant adverse events with booster shots,” Barocas said. However, those things are “just now being studied.”

The concerns are real. While serious side effects from covid vaccines have been rare, some have caused alarm ― including mRNA vaccines being linked to cases of myocarditis, or inflammation of the heart.

“At the individual level, we need to know the side effect profile of a 3rd dose, especially in younger people. Until now, the benefits of vaccination have far outweighed the potential side effects,” Dr. Jeremy Faust, an emergency medicine physician at Brigham and Women’s Hospital in Boston, wrote in a blog post outlining why he was skeptical about a plan to give boosters to everyone.

Vaccines Still Effective

Even in light of the new CDC studies published Wednesday, experts say one thing is clear: The vaccines still work very well at what they were meant to do, which is to protect people against the worst outcomes of getting infected with the virus.

One study, relying on data from 21 hospitals in 18 states, found no significant change in the vaccines’ effectiveness against hospitalization between March and July, which coincides with delta becoming the prevalent covid strain. Another, using data from New York, also found the vaccines highly effective in preventing hospitalization, even as there was a decline in effectiveness against new infections. The third, evaluating the Pfizer and Moderna vaccines in nursing home residents, saw a drop in how effective they were at preventing infection ― but the research didn’t distinguish between symptomatic and asymptomatic cases.

“It’s like we’re engaged in friendly fire against these vaccines,” Nuzzo said. “What are we trying to do here? Are we just trying to reduce overall transmission? Because there’s no evidence that this is going to do it.”

Fauci, in outlining the case for boosters, highlighted data showing that antibody levels decline over time and higher levels of antibodies are associated with higher vaccine efficacy. But antibodies are only one component of the body’s defense mechanisms against a covid infection.

When the antibodies decrease, the body compensates with a cellular immune response. “A person who has lost antibodies isn’t necessarily completely susceptible to infection, because that person has T-cell immunity that we can’t measure easily,” said Dr. Cody Meissner, a specialist in pediatric infectious diseases who sits on the FDA’s vaccine advisory panel.

John Wherry, director of the Penn Institute of Immunology at the University of Pennsylvania, recently published a study finding that the mRNA vaccines provoked a strong response by the immune system’s T cells, which researchers said could be a more durable source of protection. Wherry is working on a second study based on six months of data.

“We’re seeing very good durability for at least some components of the non-antibody responses generated by the vaccines,” he said.

For protection against serious disease, “really all you need is immunological memory, and these vaccines induce immunological memory and immunological memory tends to be longer-lived,” Offit said. Federal scientists also are studying T-cell response, Fauci said.

FDA Approval Needed

Pfizer and Moderna have said they think boosters for covid will be necessary. But it’s up to the government to authorize them. Federal officials say they are sifting through new data from the companies and elsewhere as it becomes available.

There’s not a deep playbook for this: Emergency use authorization, or EUA, of vaccines has been sparingly used. The FDA has already amended Pfizer’s prior EUA clearance twice, first in May to expand the vaccines to adolescents 12 to 15 years old and, again, this month to allow immunocompromised people to obtain a third dose. The FDA did not respond to questions about the process for authorizing widespread booster shots.

Pfizer announced in July that it expects $33.5 billion in covid vaccine revenue this year. Its stock has risen 33% this year, closing at $48.80 Thursday. Moderna reported sales of $5.9 billion through June 30 for 302 million doses of its vaccine. The company’s stock has skyrocketed 236% year-to-date, closing at $375.53 Thursday.

In applying for emergency authorization, the FDA requires vaccine manufacturers to submit clinical efficacy data and all safety data from phase 1 and phase 2 clinical trials as well as two months of safety data from phase 3 studies. For full approval, the FDA requires manufacturers to submit six months of data.

Pfizer this week announced it has submitted phase 1 clinical trial data to the FDA as part of an evaluation for future approval of a third dose. The company said phase 3 results are “expected shortly.”

Pfizer said its preliminary trial results showed a third dose was safe and increased antibody levels against the original virus and the delta variant. Moderna found a third dose had safety results similar to a second dose and produced a strong antibody response. 

Typically, any distribution of shots would occur after the CDC’s Advisory Committee on Immunization Practices also developed recommendations. But with the Biden administration’s announcement about boosters, public health experts worry the message suggests the outcome is preordained.

“They have completely and unfairly jammed FDA and ACIP. They’ve left them no choice. If there’s no booster program, FDA gets blamed and that’s not appropriate,” said Dr. Nicole Lurie, a former senior Health and Human Services official in the Obama administration and U.S. director of the Coalition for Epidemic Preparedness Innovations, the global epidemic vaccines partnership.

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

Electro-Medical Therapy Can Help Treat Intractable Pain

By Forest Tennant, PNN Columnist

To maximize relief and recovery from Intractable Pain Syndrome (IPS), it is advisable to employ one or more electro-medical (EM) therapies. All persons with IPS are highly encouraged to try a variety of EM therapies, but only as an adjunct or add-on to their current medical treatment.

Electric Current Devices

Electric current (EC) therapy is probably the best known of the EM therapies. Electric currents primarily have an anesthetic effect, much like a local anesthetic such as lidocaine. They anesthetize nerves or spinal cord nerve roots and provide temporary pain relief. In some cases, EC therapy may even bring about long-term pain relief because electric currents sometimes reset electrical conduction of nerves.

EC devices can vary, like light bulbs, in power and frequency. One advance is called “micro current.” This is a low power frequency in which the current can be transmitted through the earlobe or scalp to treat headaches or central pain.

Electric currents of various powers and frequencies are now combined in products and devices such as transcutaneous electrical nerve stimulators (TENS units), Calmare “Scrambler” therapy, and spinal cord stimulators. Devices with multiple currents usually bring a superior result compared to a single current device.

Unfortunately, only a therapeutic trial will tell you which EC therapy will help you. Many self-help TENS units are available for home use, and they should be tried. All persons who have IPS from a stroke or traumatic brain injury should consider a trial with micro-current therapy.

If you find an EC device that gives you relief, don’t use it every day. As with drugs, you may become tolerant, and the device will become ineffective. Give at least a day between treatments.

Electromagnetic Devices

Electromagnetic (EMT) devices are new to pain treatment and are quite different from EC devices because they use energy that is 50% electric and 50% magnetic. The energy is comprised of sub-atomic particles not usually visible to the naked eye.

EMT energy is generated by devices that manipulate the electric current that is found in every battery or household electrical socket. The energy is condensed into a wave that can be sent into human tissue with a transmitter wand, probe or plate. The energy wave can be administered in different frequencies and wave lengths that vary from a very slow, long wave to a very fast, short wave.

The three major types of EMT are laser, infrared and radio. Infrared is a low-frequency long wave, while radio has long, slow waves. Lasers can put out infrared waves, and also emit visible high energy frequencies which can cut, dissolve or ablate tissue.

In medical administration, long slow waves may penetrate several inches into the human body, while the short high frequency waves of laser and infrared will not normally penetrate human tissue by more than an inch. Some devices pulse the waves to get deeper tissue penetration. These devices are known as “Pulsed Electromagnetic Energy Frequency“ or PEMF.

Lasers may be able to totally remove or dissolve a pain “trigger.” For example, an experienced practitioner may be able to identify a pain trigger along the spine, or neuropathy in the face or extremity, and actually cure the condition with laser treatment.

Infrared is the most effective EMT for pain relief of a recent injury to the spine, joint or soft tissue. It is quite effective for contusions or joint swelling. Infrared can also help drive medication through the skin, so it is very effective if a cortisone cream is applied to the skin during infrared treatment.

Radio waves penetrate deeply. Their best use appears to be for spinal conditions, including herniated discs and other spinal inflammatory conditions, such as arachnoiditis. Deep penetrating radio waves will probably, at least in some cases, reach the interior of the spinal canal.

Major Take Home Point

Patients with IPS are constantly bombarded with the pitch that they need an electromagnetic “savior” such as an implanted electrical stimulator, or an expensive multi-electric current or electromagnetic course of treatment. The parties who sell and promote these devices are invariably unknowledgeable about the serious, relatively rare condition of IPS.

EC and EMT devices are made for acute or short-term pain and injury problems, not constant incurable pain with cardiovascular, endocrine and autoimmune complications.

Implanted electrical stimulators may be a “godsend” to some IPS patients, but they may not work or even cause more pain for others. This is why trials are done prior to implantation. The big problem is that there is so much money to be made with implanted stimulators that some unethical practitioners don’t tell you that they are mainly for breakthrough or flare pain.

There are many risks to implanted stimulators, so every IPS patient needs to remain on a 3-component medical program that combines suppression of inflammation, repair of damaged tissue and pain control.

Once you are on this 3-component protocol and have a good nutritional and physical program solidly in place, then give electromedical measures a try. Simple measures like water soaking or magnets may  also be very helpful. Electromagnetic administration is relatively new and shows great promise!

Forest Tennant is retired from clinical practice but continues his research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.    

Widespread Pain Raises Risk of Dementia and Stroke

By Pat Anson, PNN Editor

Widespread body pain caused by fibromyalgia and other chronic pain conditions raises the risk of stroke and dementia, including Alzheimer’s disease, according to a new study.

Researchers looked at health data for nearly 2,500 second generation participants in the long-running, community-based Framingham Heart Study. Participants in the “offspring” phase of the study were given a comprehensive check-up that included a physical exam, lab tests and detailed pain assessment when they enrolled in the early 1990’s. They were then reassessed every four years for signs of cognitive decline, dementia or stroke.

Over the next two decades, 188 of the participants were diagnosed with some form of dementia and 139 had a stroke.

While the number of cases was small, researchers found an association between pain and cognitive decline. Participants with widespread pain were 43% more likely to have some type of dementia, 47% more likely to have Alzheimer’s disease, and 29% more likely to have a stroke compared to those without widespread pain (WSP). 

“These findings provide convincing evidence that WSP may be a risk factor for all-cause dementia, AD dementia (Alzheimer’s), and stroke,” researchers concluded. “While it is known that chronic pain or persistent pain without detailed classification is associated with poorer cognitive performance in cross-sectional or cohort studies, our study was based on much more accurate assessments for pain at a longitudinal population level. The specific presence of WSP… has long-term implications for dementia and AD.”

The researchers said there were three possible explanations for the link between pain and cognitive decline. First are lifestyle factors associated with pain, such as reduced physical activity, poor diet, alcohol and weight gain. Second is that stress caused by widespread pain may impair cognitive function; and third is that WSP may be a “preclinical phase” of dementia and AD.

Previous studies have also linked chronic pain to dementia. A large 2017 study found that older people with chronic pain experience faster declines in memory and are more likely to develop dementia. A more recent study suggests that people with chronic pain are at higher risk of memory loss and cognitive decline if they have lower levels of education, income and access to healthcare.

Antidepressants, anti-psychotics, antihistamines and other common medications may also cause confusion and disorientation that is mistaken for dementia, especially in older adults. When patients are taken off the drugs, their cognitive function may improve.  

Previous studies have also linked widespread pain to cancer, peripheral arterial disease, cardiovascular disease and increased mortality.

Stem Cell Marketers Sued for Misleading Health Claims

By Pat Anson, PNN Editor

The U.S. Federal Trade Commission and the Georgia Attorney General are suing the co-founders of the Stem Cell Institute of America for marketing misleading health claims to seniors about stem cell therapy.

The agencies’ 40-page complaint against chiropractors Steven Peyroux and Brent Detelich alleges they promoted stem cell treatments nationwide through deceptive marketing schemes with other chiropractors and healthcare providers.

The promotions claimed that stem cell injections were superior to surgery, steroids and pain medication in treating arthritis, joint pain and other orthopedic conditions. The injections cost as much as $5,000 per joint, with patients often getting multiple injections.

“These defendants advertised expensive stem cell injections with baseless pain-relief claims, and provided marketing materials and training to chiropractors to do the same,” Samuel Levine, Acting Director of the FTC Bureau of Consumer Protection, said in a statement.

“At best, the use of unproven products or therapies can cost consumers thousands of dollars without affording them any results,” said Georgia Attorney General Chris Carr. “At worst, it can be harmful to their health. Our office will continue to hold accountable businesses that make unsubstantiated claims and violate the law – especially those that target our older or at-risk adults.”

Peyroux and Detelich founded the Georgia-based Stem Cell Institute of America (SCIA) in 2015 and operated under various business names, including Regenerative Medicine Institute of America, Superior Healthcare and Physicians Business Solutions.

According to the Georgia Attorney General’s Office, the companies “generated millions of dollars in revenue” by advising chiropractors around the country how to add stem cell therapy to their practices. It also trained them how to recruit new patients, and provided marketing and advertising material.

One newspaper ad invited patients to attend a free seminar where they could learn how stem cell therapy “can change your life” and stop their joint pain “without costly and painful surgery.”

SCIA also had its own YouTube channel, where videos pitched stem cells as “one of the most cutting-edge noninvasive and nonsurgical treatments for joint and arthritis pain.”

The complaint alleges that SCIA conducted no clinical testing to demonstrate its advertised claims and that no scientific studies supported them. The complaint also alleges the defendants violated Georgia’s Fair Business Practices Act related to the distribution of false or misleading information.

SCIA ad.png

STEM CELL INSTITUTE AD

SCIA, Regenerative Medicine Institute of America, and Superior Healthcare filed for Chapter 7 bankruptcy protection in 2019.  

Physicians Business Solutions continues to operate and recently hosted a training seminar for chiropractors in Atlanta. It is scheduled to hold another seminar in October at the Trump Hotel in Chicago. The company did not respond to a request for comment.

A Pained Life: Do You Know the Magic Words?

By Carol Levy, PNN Columnist

My chronic pain started with a spontaneous, horrific and sharp pain, like a blade slicing through my left temple. Within two weeks, I was disabled by it. Almost everything triggered the pain, even the tiniest wisp of hair or whisper of a breeze.

I was 26 at the time. I could only afford to go to a local hospital clinic. No matter which doctor saw me or their specialty, no one could figure it out.

Then I started dating Scott, one of the ophthalmology residents. On our date, Scott kept trying to touch the left side of my face. I kept pulling away.

“Where shouldn’t I touch you?” he asked.

I mapped out the area on the left side of my face, from my scalp down to my cheek. The exact same area I indicated at all of my clinic visits. Scott looked shocked.

“I know what you have. You have trigeminal neuralgia,” he said.

I knew of the horrors of this pain. I didn't want this diagnosis. But at least now I had a name for it.

Fast forward to when I could afford a private doctor. I went to see a neuro-ophthalmologist and told him my story. Feeling anxious and afraid, I related it in a manner that may not have been very coherent as it might otherwise have been.

“Don’t be so schizophrenic,” the doctor said. “Tell me what happened more clearly.”

He decided I was “anxious” and that was probably the cause of my pain. He told me to come back in three months and see if anything had changed by then.

I didn’t want to go back, but what choice did I have? It turned out to be a very good decision.  It was at this appointment I learned that “magic words” exist in the medical world.

“Is the pain the same?” the doctor asked. When I said yes, he said to come back in another three months.

I was walking to the door when a thought hit me. “You know for a few seconds today I thought it was finally over,” I said. He immediately perked up

“What made you think that?” he asked.

I was on the train and a lady had brushed against my face. And the pain didn’t come right away. I was happy for abuut 20 seconds, when the pain hit me like a sucker punch.

“It’s time we brought you into the hospital,” the doctor said. “We need to do some tests.”

I had no way of knowing, but I had uttered the magic words. Unbeknownst to me, that specific change was a distinct sign of trigeminal neuralgia. 

How many times have we gone to the doctor and gotten the “I dunno” or “I don’t understand your complaint” answer? 

I have a feeling for many of our disorders there are magic words like “abracadabra” or “open sesame” that change the way doctors see us. The sad part is there is no good way to figure them out. Do too much research and you may get labeled a hypochondriac. Do none and you'll never know the secret words. Is there a middle ground? 

It reminds me of the fairy tale Rumpelstiltskin, about an imp who spins straw into gold in exchange for a girl's firstborn child. If the girl guesses his name within three days, she could keep her baby. She does, and Rumpelstiltskin goes away. 

For many of us, if we guess the right words, we get the right tests, the right diagnosis and maybe even the right treatment. If only it wasn’t a fairy tale.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

State Laws Reduced Number of Days Opioids Prescribed

By Pat Anson, PNN Editor

State laws that limit initial opioid prescriptions to seven days or less have reduced the number of days that opioid medication is prescribed to Medicare patients for short-term acute pain, according to a new study.

Nearly two dozen states implemented laws limiting the initial supply of opioids after the CDC released its 2016 opioid prescribing guideline. Seventeen states limited prescriptions to 7 days, two states capped them at 5 days, and four states limited prescriptions to just 3 days.  

“The state legislation on opioid prescribing primarily targets initial opioid prescriptions provided for acute pain, and we observed decreases that were most pronounced among surgeons and dentists,” wrote John Cramer, MD, an assistant professor at Wayne State School of Medicine and lead author of the study published in JAMA Internal Medicine.   

Cramer and his colleagues found that state laws capping initial opioid prescriptions were associated with an average reduction of 1.7 days in supply for each Medicare patient. Prescribing also fell in states without such laws, although not as much. Despite the declines, the study concluded that “excess opioid prescribing” was still prevalent among all patient populations.

The caps on duration were imposed to reduce the initial exposure of patients to opioids, with the goal of reducing the potential for diversion, addiction and overdose. The researchers did not examine whether those goals were achieved or if patients were satisfied with their pain relief.

“Because this study used administrative data, we do not know how the patients did — was their pain adequately controlled, did they have adverse effects from the opioids, did they have trouble renewing a prescription, or continue to take opioids months later?” asked Deborah Grady, MD, and Mitchell Katz, MD, in a JAMA editorial.

Grady and Katz said it was reasonable to limit initial prescriptions to seven days, but they are concerned about imposing stricter limits on opioids.

“We worry that restricting initial prescriptions to shorter periods, such as 3 or 5 days, as occurred in 6 states in this study, may result in patients with acute pain going untreated or having to go to extraordinary effort to obtain adequate pain relief,” they wrote. “We think the data in this study suggest that limiting initial prescriptions to 7 or fewer days is helpful, but we would not restrict any further given that we do not know how it affected patients with acute pain.”

It’s not just states that have imposed limits. Some insurers and pharmacy chains have also adopted policies that put caps on first-time opioid prescriptions.

A federal bill that would have limited initial opioid prescriptions to just three days nationwide was amended earlier this year after complaints from patient advocates. The new version of the Comprehensive Addiction and Recovery Act (CARA) contains no limits on the number of days opioids can be prescribed. Congress has not acted on the bill yet.

10 Reasons for Lawmakers To Oppose Limits on Rx Opioids

By Matthew Giarmo, PhD, Guest Columnist

1. Government Leaders Have a Choice

History may record one day that politicians and policymakers had a choice: They could champion the rights of 50 million Americans in chronic pain who desperately need a hero or they could be scorned for unnecessary cruelty and playing politics with people's pain.

The gathering storm is a backlash to the heightened regulatory and surveillance culture that has commandeered our nation’s healthcare system. It will not go unanswered. We no longer allow government into our bedrooms to police sexual behavior, gender identity and abortion rights. And we sure as hell will not allow government to spy on our doctors and medicine cabinets.

The government has blood on its hands from chronic pain patients resorting to suicide and street drugs after being abandoned by physicians who fear imprisonment by DEA agents who have no medical training or patient knowledge.

2. Opioids Misunderstood

Opioids are not only cheap; they are uniquely effective in restoring quality and functionality to millions of Americans who suffer from chronic or intractable pain. Opioid medication is safe when used properly, while long term use of ibuprofen and acetaminophen is toxic.

When we examine data on efficacy, toxicity, dependency, teen use, mortality and preventable causes of death, opioids do not warrant consideration as a threat to national health security. There is no opioid "crisis" or "epidemic."

I believe any determination to the contrary is a byproduct of inappropriate agency regulation (the 2016 CDC Opioid Guideline) and biased and conflicted advice from an extremist sect (Physicians for Responsible Opioid Prescribing) operating at the fringes of the medical community. The growing realization among doctors and patients is that "the fools are in charge" and "the foxes are guarding the hen house.”

Inappropriate prescribing that resulted in spikes of opioid abuse, such as pill mills and dentists disposed to trade 60 Percocet for wisdom teeth, ended several years ago. So did the marketing of extended-release formulations like OxyContin.

3. Junk Science

You may have been seduced by contrived overdose statistics (“500,000 people died from an opioid overdose”) that remain viral, despite the CDC itself acknowledging that 48% of deaths due to illicit fentanyl were erroneously counted as deaths due to a prescription opioid.

When we break down the politically convenient and alarmist statistics into deaths involving polysubstance use, suicide, reckless dosing out of frustration with pain, and drugs that were never prescribed to the decedent, the 125 deaths per day initially claimed by the CDC looks more like 5 deaths a day.

It would be more appropriate to attribute these fatalities more to pain itself than to pain medication, as well as drug experimentation, depression or diversion. Most of those who abused OxyContin reported never having a valid script. That is no basis on which to separate chronic pain patients from their medication.

But as long as an opioid shows up in a post-mortem toxicology screen, deaths are being classified as an opioid overdose; even when the opioid was one of several drugs consumed, when it cannot be determined whether the opioid was consumed in a medically relevant way, and even when the decedent was hit by a bus.

The overdose numbers had to be gamed, which makes sense when you consider that in 70% of cases, rulings on causes of death are made before the toxicology data is even available. Especially when you consider that those sky-high opioid fatalities seem out of step with the low rates of dependency (6% for chronic pain patients, 0.7% for acute pain and less than 0.1% for post surgical pain).

As a social psychologist, government analyst and research critic, I have identified about a dozen ways the science of opioids has been corrupted for financial gain, professional survival or advancement, and in service of a political cause.

One example is the claim that 80% of heroin users first misused prescription opioids.” That canard was violently ripped from a SAMHSA report and is misleadingly used to imply that 4 in 5 patients prescribed painkillers eventually use heroin. On the contrary, less than 4% of prescription opioid users turn to heroin. 

Incidentally, 67% of heroin addicts reported that their prior use of prescription painkillers had not occurred in the past year. Hardly seems like an irresistible urge to me.

4. Not Knowing When to Say When

Much like Sen. Joe McCarthy wreaked havoc on a nation with reckless claims about communist infiltrators, opioid McCarthyism is killing our most vulnerable and innocent populations -- veterans, senior citizens, persons with disabilities and the chronically ill.

Regulations complicate and delay the dispensing of legal scripts for these patients at the pharmacy, creating a "what's-it-gonna-be-this-time" syndrome in which patients endure a new burden every month.

Prescriptions for opioid painkillers have declined 40% since 2011, while overdoses on heroin and illicit fentanyl have soared. As National Public Radio falsely reported that doctors are “still flooding the U.S. with opioid prescriptions,” solid research offers definitive evidence that prescriptive austerity is helping to drive the spike in overdose fatalities.

A recently published study found that among 113,000 patients on long-term opioid therapy, the incidence of a non-fatal overdose among those subjected to tapering was 68% higher than those who were not tapered. The incidence of a mental health crisis such as depression, anxiety or attempted suicide was 128% higher among those who were tapered.  

5. The Inherent Absurdity of MME Thresholds

Forced tapering is undertaken to achieve an arbitrary one-size-fits-all threshold that makes no sense. There is no basis in science or nature for determining how much medication is too much. As long as patients are started at the lowest effective dose and titrated up gradually, as dictated by unresolved pain and any side effects, there is no limit to how much a patient might need 5, 10 or 15 years downstream.

Arbitrary dose limits defined in terms of morphine milligram equivalents (MME) ignore the importance of individual differences in medical diagnosis, treatment history (tolerance), and enzyme-mediated (genetic) sensitivity to pain and to pain medication. MME thresholds falsely assume that all opioids are equal and impact all patients the same way.

MMEs may be convenient for bureaucrats and expedient for politicians, but their scientific utility -- and by extension the CDC guideline itself -- is nullified by differences in the half-life of different drugs, differences in their absorption into the bloodstream, and differences in their rate of metabolism in different people.

6. Without Liberty or Justice for All

For arguments sake, let us suppose that we lose as many souls to prescription opioids as we do to car accidents. What have we done to rein in this other preventable cause of death? We create laws requiring safety belts, air bags, annual inspections, and compliance with speed limits. We do not criminalize the sale, operation and distribution of Honda Civics. We do not restrict the number of cars on the road. And we do not drop DEA teams behind enemy lines in Detroit.

But at a time when Americans are growing weary with a drug war that has lasted longer than our wars in Vietnam and Afghanistan -- and when Americans have softened their views on marijuana -- the DEA, perhaps in a desperate search for new bogeymen, expanded its theater of operations to treat pharmaceutical companies as drug cartels, doctors as dealers, and patients as addicts.

As we speak, your state is creating a mini-DEA inside its Department of Health or Medical Board that weaponizes the Prescription Drug Monitoring Program as a surveillance and detection tool, to spy on and red flag each patient and doctor whose script or “NARX Score” exceeds an arbitrary limit for which no basis in science or nature exists.

Think about all the sacred ideals we’ve abandoned to support our failed effort to bring a specious “opioid crisis” under control: the Constitution; a compassionate care system that had been the cornerstone of a civilization; a physician’s right to exercise clinical judgement; their right to due process; and a system of individualized, patient-centered care.

Government is obliged to ease civil unrest -- not foment it. But federal and state governments are hell bent on driving wedges between groups of stakeholders: physicians against patients; patients and physicians against pharmacists; patients against the public at large; physicians against their own office staffs; patients against employers; and physicians against medical boards. That is McCarthyism.  

All too commonplace on social media are acrimonious altercations between the grieving survivors of overdose victims and those caring for friends or family living with chronic pain. There's no reason we can't simultaneously provide the medicine, assistance and requisite sympathy to Americans who need addiction treatment and Americans who need pain medication -- especially when we consider that only 6% of chronic pain patients prescribed painkillers develop dependency.

The NARX Score itself, a deeply flawed hotdog of a composite that ostensibly assigns a number to a person based on their supposed risk of overdose, is morally and intellectually offensive. It does little to assuage those who use the term “pain patient genocide" and compare it to the demonization and murder of 11 million Jews, gypsies, homosexuals and criminals in Germany during the Second World War.

7. Opioid Crisis As a Scapegoat

Have we as a nation become more addicted to the "opioid crisis" than we ever were to opioids? For our nation’s leaders, opioids have become an irresistible diversion and scapegoat. It’s a means to repair a tarnished reputation (see Chris Christie) or display rare bipartisan unity to disarm a cynical and frustrated constituency.

In a striking reversal of cause and effect, government officials would have you blame opioids for the loss of jobs, identities, finances and relationships that have come to define life in 21st century America. In reality, we have two crises: a crisis of chronic pain estimated to involve 50 million Americans and a psychosocial crisis linked to the combined effects of economic disparity, globalization, automation, immigration, social media, terrorism, pandemics, and the dissolution of national unity into political sects and interests.

Opioid critics like to point out that opioids only mask painful symptoms rather than address the underlying cause. But isn’t that what government officials do when they attempt to conceal or compensate for the true ills of our nation by playing whack-a-mole with prescription pain relievers?

8. The One-Track Mind

Last year a record 93,331 Americans died of a drug overdose, the vast majority involving illicit fentanyl and other street drugs, not prescription opioids.

We observed a 190% rise in cocaine overdoses and a 500% rise in overdoses involving methamphetamine. We have also seen increases in the abuse of alcohol and OTC substances like dextramorphan, diphenhydramine, ibuprofen, acetaminophen and loperamide, a drug used to treat diarrhea.

How many of those deaths can we blame on Purdue Pharma? Will collecting billions of dollars in settlement money from opioid distributors solve our overdose problem? Or will it enrich plaintiff law firms just like the Tobacco Settlement did?

9. An Unfair Fight

I was inspired to write this by a family -- MY family. I know what it’s like to see a patient’s treatment plan forcibly altered and how it affects not only the patient, but all those who cherish and depend on them. Children get less attention. Spouses assume a greater share of household responsibilities. Employers deal with lower productivity.

This memo and a lengthier report will go out to families and physicians across the country with the aid of hundreds of patient-advocate communities I mobilized on social media platforms. Still, it hardly seems like a fair fight. The meek of the Earth versus an army of federally funded Type A regulators and paid expert witnesses falling over one another to advance their careers and pad their bank accounts by making life harder for people to treat their pain.

10. Taking the Battle to the States

You may decide against reading my report, but you will likely hear about it from peers, co-workers or constituents in the months to come. It is making the rounds. State legislatures. Medical boards. Medical associations. Patient advocacy groups. Defense attorneys (I was twice asked to serve as an expert witness by physician counsel). Federal agencies.

In the past two weeks, my associates have disseminated my report to the American Medical Association, AARP, federal and state officials, members of Congress and the White House.

I invite readers to do the same by downloading my report, “There Is No Crisis.” We’re just getting started.

Matthew Giarmo, PhD, is a social psychologist who has worked with terminally ill cancer patients. Matthew authors research-based reports in social phenomena, including the impact on workforce development of the Software Revolution and Great Recession, and the degradation of science by professional and institutional requirements. 

My Migraine Journey: From Electrodes to Cannabis

By Gabriella Kelly-Davies, PNN Columnist

The room swirled as my eyes fluttered open, and I could feel something tight around my neck. It felt like a vice, making it difficult to swallow. The antiseptic smell was familiar, but I couldn’t quite place it. Struggling to focus my eyes, I heard a voice I knew well — it was Ben, a doctor at the hospital where I worked as a physiotherapist.

“How do you feel?” Ben said, shining a bright torch into my eyes.

“Where am I?”

“You’re in emergency. An ambulance brought you here. You were lying on the side of the road, unconscious.”

Ben told me the ambulance officers had received reports of cyclists being pushed off their bikes at the quieter end of the beach. They assumed that’s what had happened to me.

That day, my twenty-fourth birthday, heralded the onset of a life of migraine attacks.

Gabriella Kelly-Davies

Gabriella Kelly-Davies

During the 1990s, I regularly traveled around Australia for work while studying business at night. In the plane as I read my textbooks, a pain like an electric shock would shoot up the back of my neck and head.

It lasted for several minutes, then a deep ache started in the base of my skull. The pain eventually spread upwards, fanning out until it covered the entire back of my head and temples.

All too soon, the pain I experienced while flying became more regular and was most severe after sailing and playing my piano or cello. Cycling and tennis also triggered it.

In 1996, I started a job in Parliament House, Canberra as a policy adviser to a senior politician. Mid-morning, I would feel shooting pains running up the back of my head, accompanied by waves of intense nausea. Soon afterwards, a deep ache in the base of my skull started, quickly spreading up over my head and into my temples. My eyes felt gritty, as if they were full of sand, and I yearned for them to explode to release the mounting pressure inside them.

Often when the pain was at its worst, I couldn’t think of the words I wanted to say, infuriating some colleagues. Sometimes I couldn’t string two words together coherently. My mouth refused to form the words I wanted to say, as if the messages weren’t getting through from my brain to the muscles in my face.

The Merry-Go-Round

Returning to Sydney in 1999, I despaired of ever being free of pain and nausea. I consulted an endless round of specialists and health professionals, but none of them helped much. I felt overwhelmed by head and neck pain and a general sense of ever-increasing pressure inside my head and eyes. I fantasized about boring a hole through the base of my skull with an electric drill to release the tension.

Between 2000 and 2005, I progressively stopped doing all the things I most loved because they triggered migraine attacks. My goal became getting through a day of work, returning home and lying in a dark room with a series of ice packs under my neck.

Anxiety about being stigmatized and the intolerance I perceived in some colleagues at work prevented me from admitting I was in pain. Instead, I worked like a Trojan to ensure I maintained a high level of performance and no one could accuse me of using pain as an excuse to under-perform.  

While on the endless merry-go-round of seeking solutions, I ended up at the Michael J. Cousins Pain Management and Research Centre in Sydney. Dr. Cousins and a team of health professionals assessed me. They diagnosed occipital neuralgia, a form of headache that can activate migraine attacks. I had chronic pain, a malfunction in the way the nervous system processes pain signals.

The team suggested an experimental treatment. It involved implanting tiny electrodes into the back of my head and neck to block the pain signals from traveling along the nerves in my head. I agreed to the surgery and afterwards; I had fewer migraine attacks than previously. I even had a few completely pain-free days.

One year later, I felt something sharp sticking out from the base of my skull. My pain specialist discovered an electrode wire protruding through the skin. Tests revealed the electrodes were infected, so they were removed. Afterwards, migraine attacks returned in full force.

Three months later, new electrodes were implanted, but they didn’t work as well, possibly because scar tissue blocked transmission of the electric current. Still, overall I was better than before the initial surgery. I worked full time and sang in a choir at Sydney Opera House.

Disappointingly, disaster struck in 2008. A superbug infected the electrodes, forcing my doctor to remove them. Once the infection cleared and the electrodes were re-implanted, they were only partially successful, and my life returned to its pre-electrode state.

Multidisciplinary Pain Management

A significant turning point occurred in 2009 when I participated in a three-week multidisciplinary pain management program. Each day, a team of pain specialists gave lectures on topics such as chronic pain and how it differs from acute pain. The physiotherapists started us on a carefully graded exercise program, and a psychologist taught us cognitive behavioural therapy techniques to help us change the way we thought about and dealt with pain. Surprisingly, the exercises didn’t cause a flare-up and at last I felt as if I was making progress.

The pain management program taught me to stop catastrophizing and to believe I had the power to change how I reacted to pain. For years, I practiced the stretches and strengthening exercises every night after work. I also applied the psychological techniques, and they became central to my daily routine.

Twelve years later, I continue to live with migraine. I’ve tried several migraine preventatives, but none helped. Eight months ago, I started taking medicinal cannabis and it has significantly reduced the frequency and severity of migraine attacks.

Over the years I’ve learned to reduce the impact of migraine on my life by using techniques such as mindfulness meditation and carefully paced exercise that turn down the volume of pain signals racing through my malfunctioning nervous system.

Chronic pain is complex and difficult to treat but it is possible to live well with pain. I encourage you to do a multidisciplinary pain management program and continue your search for approaches that reduce the impact of pain on your life.  

Gabriella Kelly-Davies is a biographer and studied biography writing at the University of Oxford, Australian National University and Sydney University. 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.

The Fentanyl Exposure Myth Must End

By Roger Chriss, PNN Columnist

There is a pervasive belief that exposure to even a speck of illicit fentanyl can be immediately life-threatening. The most recent example is a story from USA Today.

“Dramatic body camera footage shows that a sheriff’s deputy in California nearly died after being exposed to fentanyl at an arrest last month,” the story begins, explaining that Deputy David Faiivae collapsed after finding a “white substance” in the trunk of a suspect’s car on July 3.

Faiivae appears to be revived by his training officer with a nasal spray of naloxone, an anti-overdose medication. The body camera video of the incident was so dramatic, the San Diego County Sheriff’s Department turned it into a training video:

There are reasons to be cautious with stories like this. Fentanyl is a potent synthetic opioid responsible for tens of thousands of overdose deaths, but experts say it’s not nearly as dangerous as it is often portrayed.

"You can't just touch fentanyl and overdose," Ryan Marino, medical director for toxicology and addiction at University Hospitals in Cleveland told NBC News. "It doesn't just get into the air and make people overdose.

"We have a lot of scientific evidence and a good knowledge of chemical laws and the way that these drugs work that says this is impossible."

Casual contact with fentanyl is not generally life-threatening. As Marino explains in a guide for first responders, fentanyl powder is not absorbed through the skin and powdered opioids do not aerosolize.

This is a well-founded view. Drs. Lewis Nelson and Jeanmarie Perrone wrote in STAT News that “there is clear evidence that passive exposure to fentanyl does not result in clinical toxicity.”

But stories of passive exposure to fentanyl being life-threatening are becoming more common. Google Trends shows a rapid uptick from 2017 onward after media coverage of an Ohio patrol officer supposedly overdosing on fentanyl after brushing a bit of powder from his shirt.

According to a 2020 study in the International Journal of Drug Policy, there were 551 news articles in 48 states about casual contact with fentanyl from 2015 to 2019. The reports received about 450,000 Facebook shares, potentially reaching nearly 70 million people.

“Fueled by misinformation, fentanyl panic has harmed public health through complicating overdose rescue while rationalizing hyper-punitive criminal laws, wasteful expenditures, and proposals to curtail vital access to pain pharmacotherapy,” the study found.

If passive exposure to fentanyl were as risky as media and law enforcement suggest, wouldn’t there be a flood of bodies from illicit drug operations? Drug labs do not operate with robust safety measures and street dealers handle drugs in ways that would make passive exposure inevitable. Deaths result when fentanyl is ingested, not from casual contact.

The misperceptions of passive exposure risks are impacting law enforcement, emergency services and medical care. As a result, pharmacy professor Lucas Hill joined with Marino and others to write an open letter this week to media outlets called “Retraction Request for Dangerous Drug Misinformation.”

“We are issuing this letter to request a retraction and correction of your recent article which perpetuates a myth: that casual contact with potent synthetic opioids such as fentanyl poses a health risk to first responders. This is dangerous misinformation that can cause harm both to people who use opioids and to members of the law enforcement community. We greatly appreciate your cooperation in addressing this error.”

The letter is the latest attempt to reduce the harms of media misinformation about drugs. But as with so many things involving drugs, mythology drives too much of the media and law enforcement narrative.

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.