Colostrum: A Regenerative Hormone for Arachnoiditis

By Dr. Forest Tennant, PNN Columnist

Persons with adhesive arachnoiditis (AA) and other severe painful conditions such as Ehlers-Danlos syndrome (EDS) have multiple tissues that become damaged, painful and dysfunctional.

Healing those damaged tissues and reversing the pain and neurologic impairments will require regenerative hormones. This is in contrast to other types of hormones that control inflammation (cortisone), metabolism (thyroid) or sexual functions (estradiol).

The human body makes some natural regenerative hormones, and they are now available for clinical use. Our first realization of their value in treating AA was with human chorionic gonadotropin (HCG). Other regenerative hormones that can be used to treat AA include colostrum, pregnenolone, dehydroepiandrosterone (DHEA), nandrolone, and human growth hormone (HGH). We have used all of these and believe that persons with AA should use at least one of them. But our first choice is colostrum.

Colostrum is in mother’s milk produced during the first few days after birth. It contains high levels of tissue growth factors, anti-inflammatories, pain relievers, and anti-infectious agents. Its natural purpose is to allow the newborn baby to initiate growth, protect against infection, and provide pain relief from the trauma of birth.

Colostrum supplements are sold by a number of companies and are usually made from the milk of cows that have recently given birth. Colostrum is recommended for use at least 3 to 5 days a week by persons with AA or EDS, who may wish to double the labeled recommended dosage. Colostrum is non-prescription, relatively inexpensive, and has few side effects. It can be taken with opioids and other drugs.

Regenerative hormones work best when they are used simultaneously with a high protein diet, collagen or amino acid supplements, vitamin C, B12, and polypeptides.

If a person with AA is not doing well or deteriorating, we recommend adding a second regenerative hormone such as nandrolone. A significant reversal of AA symptoms may require one or more regenerative hormones.

Several times a week we get inquiries from people who have just been diagnosed with AA and are pleading for information on what to do. 

The Tennant Foundation recently published an inexpensive short handbook for persons with newly diagnosed AA that gives a step-by-step plan that can hopefully slow progression of this disease.

If you have had AA for a while and aren't doing well, you may still benefit from some of our most up-to-date knowledge and recommendations in the “Handbook for Newly Diagnosed Cases of Adhesive Arachnoiditis.”

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from bulletins recently issued by the Tennant Foundations’s Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

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

Cannabis Study Finds ‘Significant Improvements’ in Physical and Mental Health

By Pat Anson, PNN Editor

The use of medical cannabis was associated with “significant improvements” in physical and mental health in a large survey of Australian adults suffering from chronic pain and other health problems.

Over 3,100 people participated in the survey. Chronic non-cancer pain was the most common condition reported (68.6%), followed by cancer pain (6%), insomnia (4.8%) and anxiety (4.2%).  

Australia has relatively stringent rules for medical cannabis. Patients have to exhaust all other forms of treatment and consult with a physician, who reviews their medical history and suitability for cannabis before writing a prescription.

Most of the prescriptions for survey participants were for cannabis products taken orally, such as oils and capsules, with only a small number for dried cannabis flower. About 80% of the cannabis products were rich in cannabidiol (CBD), with the rest dominant in tetrahydrocannabinol (THC) or a balanced mix of CBD and THC.

Patients were asked to rate their wellness and quality of life in eight categories on a scale of 0-100, including general health, body pain, physical functioning, physical limitations, mental health, emotional limitations, social functioning and vitality. The surveys were conducted at the start of the study and then every 45 days after cannabis therapy was initiated, with a total of 15 follow up surveys.   

The study findings, recently published in JAMA Network Open, showed sustained improvement in all eight wellness categories after participants started taking cannabis, with body pain improving an average of 10 to 15 points on the 100-point scale. Researchers also found “pronounced and statistically significant improvements” in mental, social and emotional health.

“This study suggests a favorable association between medical cannabis treatment and quality of life among patients with a diverse range of conditions. However, clinical evidence for cannabinoid efficacy remains limited, and further high-quality trials are required,” wrote lead author Thomas Arkell, PhD, a psychopharmacologist at the Swinburne University of Technology in Melbourne.

Adverse events such as sleepiness and dry mouth were relatively common during cannabis therapy, but were usually mild or moderate.

Before starting cannabis therapy, patients were taking an average of nearly five medications a day, the most common being simple analgesics (54%), opioids (48%), antidepressants (45%), benzodiazepines (34%) and gabapentinoids (22%). The study did not examine if medication use declined once participants started taking cannabis.  

“While we cannot exclude the possibility that adverse events may have been caused in whole or part by the disease state and concomitant medications, the relatively high incidence of adverse events still affirms the need for caution with THC prescribing and careful identification of patients with contraindications,” Arkell wrote.

Medical cannabis was legalized in Australia in 2016. Since then, over 332,000 Australians have been given cannabis prescriptions, mostly for chronic pain (55%), anxiety (23%) and sleep disorders (6%).

Pain management experts in Australia have long taken a dim view of cannabis. In 2021, the Australian and New Zealand College of Anaesthetists released new guidance urging doctors not to prescribe medical cannabis for chronic non-cancer pain because of a lack of good quality research.

Pain Care Should Be Individualized, Without Interference from Others

By Barby Ingle, PNN Columnist 

Trigeminal neuralgia, arachnoiditis, Ehlers Danlos syndrome and Complex Regional Pain Syndrome (CRPS) have all been called the “suicide disease” – the worst pain possible. But saying which disease or condition causes the most pain is subjective because people experience pain differently.  

• According to U.S. News & World Report, passing a kidney stone is one of the most painful medical conditions you can have.  

• News Medical Life Sciences lists sickle cell disease as one of the 20 most painful chronic conditions, with episodes of pain occurring when sickle-shaped red blood cells block small blood vessels.  

• McGill University in Canada has a “pain index” based on a questionnaire that asks people to describe what kind of pain they experience. The index consistently lists CRPS as the worst known pain to humans.

• Verywell Health reports that fibromyalgia is one of the most common pain conditions, affecting 10 million people in the U.S. and causing widespread body pain, sleep problems, fatigue and distress.  

After living with multiple pain conditions for over 20 years and speaking with tens of thousands of other patients, I no longer believe it matters which type of pain a person has or who has the most pain. We all experience pain. How much pain we feel depends on the individual and a host of other factors, such as genetics, life experiences, and whether effective treatment is available and affordable. That is what matters.

When we do not manage pain effectively, suicides go up. We also see drug abuse and misuse rise. According to a report by the National Institute on Drug Abuse, about 5% to 7% of drug overdose deaths in the U.S. are intentional suicides. Many of those deaths are pain patients.

Since 2011, we have seen a steady decrease in opioid prescribing. Be it acute or chronic, providers are weary of prescribing opioids for pain. It’s not because opioids don’t work. More often than not, the reason they stop prescribing is because they have invested so much into becoming a provider (education, cost, time, family and social connections) that they are now at risk of losing due to laws and medical guidelines based on misleading information about opioids. 

We need to get away from the generalities of treating pain and into individualized patient care. It may or may not involve pain medication, surgery, implants, cognitive therapy and other treatments. For those who have the audacity to say that anyone else should remain in pain because you are not comfortable with their form of treatment -- shame on you.

I have chosen not to use opioids for over 10 years because I have other options that work for me. I want all people to get whatever treatment they need to control their pain. It will be different for each of us and whatever condition or comorbidities we live with. We all need and deserve to get the care we choose after careful consideration, research and discussions with our providers. Laws and guidelines should not be used to take away medications that have been available since the beginning of time.

At a recent pain education event I attended, I heard the argument that there were no long-term studies on the use of opioids for pain. But there are millions of patients who have taken opioids safely for years who will tell you otherwise. Opioids actually gave them more life, because they were able to work, exercise and function when their pain was properly managed.

As a pain patient myself, I want the freedom to do what is best for me. I am currently working on getting access to ketamine infusions again after my ketamine clinic closed down. I want that same right in selecting treatment to be available to others. It should be left to patients and their providers to decide on treatment, without interference from others.

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and best-selling author on pain topics. Barby has received over 25 awards for her advocacy efforts. You can follow her at www.barbyingle.com.   

The Fading Power of the White Coat

By Carol Levy, PNN Columnist

I wrote a column in 2018 about the arrogance and poor listening skills of some doctors ("Tyranny of the White Coat”). I ended it with these words: “It’s a sad state of affairs when you take a liking to a doctor because they took the rare action of actually listening, hearing and respecting their patient.”

Most physicians see the exam room as a teeter-totter; the doctor sitting high up on one side and the patient below them on the ground. That is often still the case, but I notice when I go to blogs written by doctors (such as KevinMD), that they often write about the loss of respect they find almost everywhere.

Doctors no longer have the “power of the white coat.” In public settings such as hospitals and restaurants, the staff no longer looks at them in awe or bow down to their titles: “Yes doctor, your table is waiting for you.”

I understand the sadness from losing status as the top gun, but I thought most doctors went into medicine to help their patients, not for the superiority their degree gives them. I thought the work they put in at medical school was to learn their craft, not to use as a banner of privilege: “I spent years in school and had to work very, very hard to get where I am. Therefore, I deserve to be looked at as superior.”  

I also go to blogs written by patients, many with chronic pain, and I read the opposite: “How dare these 'doctors' think they're so much better than me? I shouldn't have to be obeisant to them, yet that's what they want from me.”

What if we didn't have the hierarchy of the exam room? What if we were able to come together as patients and doctors, to have a round table or focus group where we could talk freely? How educational that would be, for both sides.

We could then look at doctors as our equals and they could see us in the same way -- not someone to be talked down to. Too many doctors seem to believe we are uninformed, misinformed or just ignorant, and need to be spoken to like a 12-year-old.

We might then see the doctor as a person, someone with more knowledge and experience with our diseases and disorders. Someone who can be a helper, not a protagonist. We could then see them as teachers, which in many ways they are.

What a great appointment that would be. We’d smile at each other and see one another as human.

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.

Chatbot ‘Doctor’ Preferred Over Real Ones

By Crystal Lindell, PNN Columnist

Would you rather get your medical advice from a human physician or a chatbot powered by artificial intelligence?

According to an unusual study recently published in JAMA, you’d be better off listening to the chatbot, which gave advice that was rated significantly better both in quality and empathy.  

A team of researchers asked the chatbot -- called ChatGPT – 195 hypothetical questions a patient might ask that were posted online in a Reddit forum called "Ask a Doctor."  A team of healthcare providers then compared the chatbot’s responses to those posted by actual physicians in the same forum.

The responses from ChatGPT were the clear winners. The evaluators preferred the chatbot responses over the physicians’ answers about 79% of the time. The average rating for the chatbot was "better than good," while the physicians overall were given a lackluster grade of "acceptable response."

The evaluators also gave the ChatGPT high marks for empathy, while the physicians’ responses were rated as only “slightly empathetic.”

One of the hypothetical questions involved a patient who accidentally swallowed a toothpick and wanted to know if they were at risk of dying. Here’s how the chatbot and a physician responded:

Physician Response:

If you've surpassed 2-6 (hours), chances are they've passed into your intestines. Which means it can't be retrieved easily.

Many people can swallow razorblades and toothpicks without issues. In case you develop stomach ache, then don't hesitate seeking out an emergency room, and remember to point out the swallowed tooth pick. For now, they won't be doing much.

Chatbot Response:

It's natural to be concerned if you have ingested a foreign object, but in this case, it is highly unlikely that the toothpick you swallowed will cause you any serious harm.

Toothpicks are made of wood, which is not toxic and will not cause poisoning. However, it is possible for a toothpick to cause injury if it becomes stuck in the throat or if it punctures the digestive tract. However, this is unlikely to happen with a dull, cooked toothpick that is only 2 cm long.

If you are experiencing any discomfort or symptoms such as abdominal pain, difficulty swallowing, or vomiting, it is important to contact a healthcare provider for further evaluation. However, if you are not experiencing any symptoms, it is safe to assume that the toothpick has passed through your digestive system, and you do not need to be concerned.

It's always a good idea to be cautious when consuming food and to remove any foreign objects before eating. It's understandable that you may be feeling paranoid, but try not to worry too much. It is highly unlikely that the toothpick will cause you any serious harm.

Which answer would you rather get as a patient? The evaluators preferred the chatbot’s response to the toothpick question, as they did for other questions about a head injury, a lump possibly being cancerous, and if getting bleach in your eye might cause blindness. The chatbot response to those questions also got high scores for empathy.

As a chronic pain patient, I have to admit I felt a little smug when I first saw the headlines about this research. My initial thought was, of course, the chatbot was more empathetic than the doctors! Doctors are often mean, rude and dismissive. I even wrote a column about using a weird trick to manage their egos.

Is this the beginning of the end for human doctors? The short answer is: No. This was a very narrow study with a number of limitations. The authors said they were only trying to look into the possibility of physicians using artificial intelligence (AI) to essentially ghostwrite responses to patients.  

“Chatbots could assist clinicians when messaging with patients, by drafting a message based on a patient’s query for physicians or support staff to edit,” they said. “Such an AI-assisted approach could unlock untapped productivity so that clinical staff can use the time-savings for more complex tasks, resulting in more consistent responses and helping staff improve their overall communication skills by reviewing and modifying AI-written drafts.”

The possibilities for using AI in medical settings are only just emerging, and it could radically change how we think of healthcare and how doctors think of us.

One thing that might improve is how doctors and patients communicate. I know doctors are capable of giving more empathetic answers on their own. The problem is, in the United States at least, they usually just don’t have the time to do so. If AI can help, we should let it.  

However, it should be noted that several authors of the study, which was led by researchers at the University of California San Diego, disclosed ties to the artificial intelligence industry, which means they may financially benefit from any attempts to sell AI to medical professionals.

Also, as the researchers acknowledge, the study doesn’t prove that chatbots are better doctors than actual doctors, just that their answers were better. Physicians would likely respond to medical questions differently in an office setting, as opposed to an online post.

Researchers also did not assess the chatbot responses for accuracy — which is a pretty big deal when it comes to medical care. It’s one thing to write an empathetic reply, it’s another to correctly diagnose and decide on a treatment.

That said, when comparing the various responses, the chatbot did seem to give similar advice as the doctors, which makes me think they were mostly accurate. That may not sound great, but consider how often doctors are wrong. Medical errors are one the leading causes of death in the U.S.

AI technology is rapidly improving, and it’s impossible to predict what it will be capable of in the coming years. But I do believe it’s going to radically change many aspects of our lives, including healthcare. Hopefully, it makes it better. But at this point, I’ll settle for not making it worse.  

Crystal Lindell is a freelance writer who lives in Illinois. After five years of unexplained rib pain, Crystal was finally diagnosed with hypermobile Ehlers-Danlos syndrome. She and her fiancé have 3 cats: Princess Dee, Basil, and Goose. She enjoys the Marvel Cinematic Universe, Taylor Swift Easter eggs, and playing the daily word game Semantle. 

Should I Laugh or Should I Cry?

By Mia Maysack, PNN Columnist

Right now, I’m having one of those moments when the pain level is so high, it's almost unbelievable. It made me remember when a fellow chronically ill friend shared a story about her time in a grocery store.  She said that it felt as though a knife was cutting her open, all while she was just attempting to buy a few things.

Her response to this experience was laughter!

Perhaps you've heard the saying, "Should I laugh or should I cry?" Personally, I feel as though there's something to that. As I write this, I'm turning to the written word as my savior and deliverer from the wretched flare I'm in the midst of. I can barely see, let alone keep thoughts straight in my mind. But I'm choosing to smile, at least on the inside, because I'm thinking of my friend.

She said she laughed because it was comical in that moment -- her essentially feeling like the walking dead but having to function normally in a public place. No one else in the store could possibly know the inner crisis she was having. 

I can attest to this sort of thing making me feel a little crazy. Perhaps what helps to push us toward the bright side is the madness that's produced along the way. 

It’s been said that laughter is the best medicine. I've yet to have an ailment cured by laughing, but it's important to remember that despite our health or hardships, we possess a playful side. We are more than just a condition or diagnosis, there are other aspects of our identities. We're not what has occurred to us; what we are becoming is a result of our choice.

I'm choosing to laugh about the fact I've been attempting to get in touch with a provider, but cannot seem to get a call back. A previous appointment with the provider was so draining it left me feeling worse than I did upon arrival. It's all a reminder of how much it took to reach out to the provider in the first place, and the countless other let downs when the healthcare system falls short, which is most of the time. Healthcare is a joke and patients are often the punchline.

A common response to a person who is struggling is to advise them to seek help. That is a valid suggestion, but if “help” is the remedy, then it must be available and within reach.

We need to see what we need within ourselves, not to solely exist, but to excel in our experiences -- as opposed being dependent on systems that don’t serve our interests.

An example:  Recently when the exact opposite thing I felt like doing was grinning, I beamed in an effort to trick my brain into stimulating an increase in endorphins. This technique is readily available to me at any point, plus it’s free and doesn’t cause any adverse side effects! 

Laughter is another great way to assist in boosting mood, as is exercise to any extent that’s doable. The idea is to consciously work to counteract the pain signals that are firing as best we can, while living with unmanageable pain of one sort or another. 

Presently, I am choosing to be mentally mindful and to rejoice in breathing. This is how I prevail. I also find solace in knowing that what I’ve already endured will give me the strength I’ll need to face whatever is coming. Until then, I’ll strive to greet every moment that tests me with a smile. 

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. She is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill. 

‘No Reliable Evidence’ That Antidepressants Work for Chronic Pain

By Pat Anson, PNN Editor

Medical guidelines in the United States and United Kingdom may recommend antidepressants for treating chronic pain, but there is “no reliable evidence” that the medications actually work for that purpose, according to a new Cochrane review.

Cochrane reviews are considered the gold standard in medical research because they use robust methodology to gather good quality evidence, while dismissing poor quality research.

A team of UK researchers, led by scientists at the University of Southampton, spent two years examining 176 clinical trials involving nearly 30,000 patients who were prescribed antidepressants for pain. Among the drugs studied were fluoxetine (Prozac), sertraline (Zoloft), amitriptyline (Elavil), milnacipran (Savella), citalopram (Celexa), paroxetine (Paxil) and duloxetine (Cymbalta).

“Our review found no reliable evidence for the long-term efficacy of any antidepressant, and no reliable evidence for their safety for chronic pain at any point. Though we did find that duloxetine provided short-term pain relief for patients we studied, we remain concerned about its possible long-term harm due to the gaps in current evidence,” said lead author Tamar Pincus, PhD, a Psychology Professor at the University of Southampton.

“This is a global public health concern. Chronic pain is a problem for millions who are prescribed antidepressants without sufficient scientific proof they help, nor an understanding of the long-term impact on health.”

In the United States, duloxetine is FDA-approved for fibromyalgia, diabetic neuropathy and musculoskeletal pain. The recently updated CDC guideline recommends that duloxetine and other SNRI antidepressants be used for fibromyalgia and neuropathy, because they provide “small to moderate improvements in chronic pain and function.”

The UK’s National Institute for Health and Care Excellence (NICE) guideline goes even further, stating that antidepressants are better than opioids and other analgesics in treating fibromyalgia, chronic headache, Complex Regional Pain Syndrome (CRPS), musculoskeletal pain and other types of “primary chronic pain” for which there is no known cause.   

The authors of the Cochrane review say regulators in the US and UK should reconsider their recommendations.

“We are calling on governing health bodies NICE and the FDA to update their guidelines to reflect the new scientific evidence, and on funders to stop supporting small and flawed trials. Evidence synthesis is often complex and nuanced but the evidence underpinning the use of these treatments is not equivalent, so current treatment modalities are hard to justify,” said co-author Gavin Stewart, PhD, a statistician at Newcastle University.

Amitriptyline is one of the most commonly prescribed antidepressants for chronic pain in the world. In the last year, around 10 million prescriptions for amitriptyline were given to patients in England for pain, about twice the number prescribed for depression. Many other antidepressants are also prescribed “off-label” for pain, despite limited evidence to support their use.

“Though previous investigations show that some antidepressants might relieve pain, there has never been a comprehensive study examining all medications across all chronic conditions – until now,” said co-author Hollie Birkinshaw, PhD, a Research Associate at the University of Southampton.

“The only reliable evidence is for duloxetine. Adopting a person-centered approach is critical to treatment and, when patients and clinicians decide together to try antidepressants, they should start from the drug for which there is good evidence.”

The reviewers say duloxetine was the highest-rated antidepressant for treating fibromyalgia, musculoskeletal and neuropathic pain. Standard doses of duloxetine were just as effective as higher ones. Milnacipran was also effective at reducing pain, although the evidence was weaker.

“We simply cannot tell about other antidepressants because sufficiently good studies are not available – but it does not mean that people should stop taking prescribed medication without consulting their GP,” said Pincus.

A common complaint of patients who take duloxetine is that it makes them dizzy and nauseous. Many quickly become dependent on the drug and then have severe withdrawal symptoms when they stop taking it.

Several previous studies have also raised questions about using antidepressants for pain. A recent review of over two dozen clinical trials by Australian researchers found little evidence to support the use of antidepressants in pain management. Nearly half of the trials had ties or funding from the pharmaceutical industry.

Long Covid May Affect Genes Involved in Pain Signaling

By Pat Anson, PNN Editor

About 16 million people in the United States have Long Covid, a poorly understood disorder that causes body aches, headaches, fatigue, insomnia, brain fog and other symptoms long after an initial infection with COVID-19. For some, the symptoms are mild, but for other they are so severe they become disabling.

Why do some people quickly recover from Covid, while about one in five have lingering symptoms?

A new animal study found that thousands of genes involved in nervous system function are affected by SARS-CoV-2, and may cause lasting damage to dorsal root ganglia, the spinal nerves that carry pain and other sensory messages to the brain. Scientists believe that genetic damage may be what causes Long Covid.

“Several studies have found that a high proportion of Long Covid patients suffer from abnormal perception of touch, pressure, temperature, pain or tingling throughout the body. Our work suggests that SARS-CoV-2 might induce lasting pain in a rather unique way, emphasizing the need for therapeutics that target molecular pathways specific to this virus,” explains co-author Venetia Zachariou, PhD, chair of pharmacology, physiology & biophysics at Boston University’s Chobanian & Avedisian School of Medicine.

Zachariou and her colleagues infected hamsters with SARS-CoV-2 and studied how it affected the animals’ sensitivity to touch, both during the initial infection and after the infection had cleared. Then they compared the effects of SARS-CoV-2 to those triggered by an influenza A virus infection, and were surprised by what they found.

In the hamsters infected with Covid, researchers observed a slow but progressive increase in sensory sensitivity over time – one that differed substantially from influenza A infections, which caused a sudden hypersensitivity that returned to normal once the initial infection ended.

Although the studies were performed on animals, researchers say they align with the acute and chronic symptoms caused by Covid in humans. They hope further studies on human genes and sensory pathways affected by the Covid virus will lead to new treatments for Long Covid and conditions such as ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome),

“We hope this study will provide new avenues for addressing somatosensory symptoms of long COVID and ME/CFS, which are only just now beginning to be addressed by mainstream medicine. While we have begun using this information by validating one promising target in this study, we believe our now publicly available data can yield insights into many new therapeutic strategies,” adds Zachariou. 

The study findings appear online in the journal Science Signaling.

The federal government’s Covid public health emergency officially ends this week, but the impact of the pandemic will likely be felt for years to come.

What Kind of Pain Care Would JFK Get Today?

By Pat Anson, PNN Editor

This year marks the 60th anniversary of the assassination of President John F. Kennedy, an event that shocked the world. Kennedy was only 46 when he died in 1963.

At the time, Kennedy was widely seen as a healthy, handsome and vigorous man. The truth, which emerged years later, is that JFK was chronically ill almost from birth. Scarlet fever nearly killed him as an infant, and as a child he was thin, sickly, and suffered from chronic infections and digestive problems.

Not until decades after his death did we learn that Kennedy was born with an autoimmune condition called polyglandular syndrome, and that a series of failed back surgeries may have led to adhesive arachnoiditis, a chronic and painful inflammation in his spinal canal. Historians and physicians also confirmed rumors that JFK suffered from Addison’s Disease, a well-guarded family secret.

Kennedy was given the last rites at least twice before becoming president and reportedly told his father that he would “rather be dead” than spend the rest of his life on crutches, paralyzed by pain.

In short, it’s a bit of miracle that JFK even lived to see his 46th birthday. The American public never had a full understanding of his health problems until long after he was dead.

How did Kennedy pull it off? The answers can be found in Dr. Forest Tennant’s latest book, “The Strange Medical Saga of John F. Kennedy.”

“The reason I decided to write it was mainly that I had become aware that he was an intractable pain patient,” says Tennant, a retired physician and one the world’s foremost experts on arachnoiditis and intractable pain. “Fundamentally, my book is really taking a lot of other people's work and putting it together in a historical chronological fashion. I just felt it needs to be done to really understand what happened to him.”

Although Kennedy’s chronic health problems were largely hidden from the public, many of his medical records still exist – a reflection of his family’s wealth and access to the best medical care available. Good doctors keep good medical records, especially when their patients are rich and famous.

“Until I got into doing this, it was not appreciated by me. Unless a person is very famous and has a lot of medical records, physicians never get to see a case from start to finish. Meaning from birth to death. I've never really realized how rare that is,” says Tennant.

A Controversial Drug Cocktail

In the mid 1950’s, Kennedy found a team of innovative medical experts who helped relieve his pain, elect him as president, and achieve his best health ever while living in the White House.

Dr. Max Jacobson put Kennedy on a controversial “performance enhancing” cocktail. The ingredients were secret, but Tennant says the cocktail probably included methamphetamine, hormones, vitamins and steroids.

Exhausted from months of campaigning, Kennedy was injected with the cocktail just hours before his first debate with Richard Nixon, a nationally televised debate that likely won the election for Kennedy because he appeared more energetic than Nixon.

Kennedy continued taking the cocktail as president, over the objections of White House physicians.

High Dose Opioids

Dr. Janet Travell also played a key role in revitalizing Kennedy’s health, putting him on a comprehensive pain management program that included physical therapy, hormone replacement, anti-inflammatory drugs, and the opioids methadone, codeine and meperidine (Demerol).

One of the first things she noticed was the callouses under Kennedy’s armpits from using crutches so often.

“On the day she met him, she put him in a hospital and started methadone that day, as a long-acting opioid, and then she also had him on Demerol and some other miscellaneous opioids. But his two main opioids were methadone and then Demerol for breakthrough pain,” said Tennant.

The precise dosage given to JFK is unknown, but Tennant estimates it was initially 300 to 500 morphine milligram equivalents (MME) a day, a level that would be considered risky under the CDC’s 2016 opioid prescribing guideline. The guideline recommended that dosages not exceed 90 MME.

“It would have exceeded the CDC guidelines by far,” says Tennant. “The methadone dose would have exceeded the CDC guidelines itself. But she knew to put him on methadone and if it hadn't been for methadone, he’d never have been president. He had to have something to stabilize himself right at that time. And he had to have a second opioid for breakthrough pain.”

Dosages that high today would likely attract the attention of the Drug Enforcement Administration, which investigates and prosecutes doctors for writing high-dose prescriptions. Tennant himself came under scrutiny from the DEA for giving intractable pain patients high doses, and his office and home were raided by DEA agents in 2017. Tennant was never charged with a crime, but he retired from clinical practice a few months later.

Raids like that have had a chilling effect on doctors nationwide. Many now refuse to see pain patients on opioids, regardless of the dose.

“JFK would not have been welcome today in pain clinics,” says Tennant. “My patients were very similar to JFK, almost same disease, same kind of doses, and the same kind of therapies. And of course, today that is taboo. But that was the standard in the 1950’s.  

“It's only been in the last few years that the government has decided that the standard treatment that has been there for half a century is now almost a crime.”

Dr. Travell never came under that kind of scrutiny, but Dr. Jacobsen did. Dubbed “Dr. Feelgood” by critics for his unconventional treatments, Jacobson’s medical license was suspended in New York state a few years after Kennedy’s death. The 1972 Controlled Substances Act ensured that his cocktail would never be prescribed again.

Tennant says there is no evidence the cocktail harmed or impaired JFK, who was never hospitalized or bed-bound during the 8 years he was under Jacobson’s care.

Without Jacobson and Travell, Tennant believes it unlikely Kennedy would have run for president or been elected.

“That's one of the reasons why I wrote the book. I think people need to know that JFK’s treatment was opioids. And his treatment was the standard of the day, up until the recent fiat by the federal government and state medical boards. The country got along for half a century with those standards quite well,” Tennant said.

In addition to his book about JFK, Tennant has written books about Howard Hughes and Elvis Presley, who also lived with -- and overcame -- chronic health problems.

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

CDC Study Shows Oxycodone Plays Minor Role in Overdose Crisis

By Pat Anson, PNN Editor

A new study by the CDC highlights the sharply rising death toll in the U.S. caused by illicit fentanyl, while at the same time revealing the minor role played by oxycodone in the nation’s overdose crisis.

The study, released this week by the CDC’s National Center for Health Statistics, looked at overdose death rates from 2016 to 2021. Deaths involving fentanyl more than tripled during that period, rising from 5.7 deaths per 100,000 people in 2016 to 21.6 deaths per 100,000 in 2021. Drug deaths involving methamphetamine and cocaine also rose sharply, while fatal overdoses involving heroin declined.

And what about oxycodone, the most commonly prescribed opioid pain medication? It turns out oxycodone has always played a relatively minor role in the overdose crisis, although regulators and public health officials said otherwise in a concerted campaign against all prescription opioids.

“Overprescribing opioids – largely for chronic pain – is a key driver of America’s drug overdose epidemic,” then-CDC director Dr. Thomas Frieden said in a 2016 news release.

But the facts don’t support Frieden’s claim. In 2016, the year the CDC released its controversial opioid prescribing guideline, there were only 1.9 deaths per 100,000 people that involved oxycodone. By 2021, the rate had fallen 21% to 1.5 deaths -- well below the death rates of fentanyl, methamphetamine, cocaine and heroin.   

Drug Overdose Deaths in U.S. (2016-2021)

SOURCE: CDC

CDC researchers used an unusual method to conduct this study. Instead of relying on medical ICD-10 codes in death certificates, which lump drugs together into broad categories, the CDC used a “literal text” analysis.

“To address the limitations of ICD–10- coded mortality data, the National Center for Health Statistics has developed a method that searches the literal text of death certificates to identify mentions of specific drugs and other substances involved in the death. Death certificate literal text is the written information provided by the medical certifier, usually a medical examiner or coroner for drug overdose deaths, that describes the causes, manner, and circumstances contributing to the death,” the researchers explained.

Flawed Data

The literal text method is not foolproof, but it’s an improvement over the ICD-10 codes, which the CDC admitted in 2018 “significantly inflate” the number of deaths involving prescription opioids — flawed data that Frieden used to make his “key driver” of the epidemic claim in 2016.

How inflated were the overdose numbers back then?  Using the old ICD-10 method, which counted illicit fentanyl as a prescription opioid, Frieden’s CDC estimated that nearly 32,500 Americans died from overdoses of opioid medication in 2016. The death toll was later revised downward to about 17,000 overdoses after the CDC came clean about its flawed methodology.

Patient advocate Richard “Red” Lawhern has long been suspicious of CDC data, including studies that use literal text analysis.  

“CDC suggests an incidence of drug overdose deaths ‘involving’ oxycodone at only 1.5 per 100,000.  But they neatly avoid telling us that such a rate is so low that it confounds the non-uniformity of reporting from county to county, creating such statistical noise that the contribution of this agent (oxycodone) to overdose mortality is too small to accurately measure or report,” Lawhern said.  

Another problem is the qualifications of county coroners and medical examiners varies. Some are elected to their positions without any medical training or experience. The death certificates they fill out usually don’t say if a prescription drug was obtained legally or illicitly, or what specific drug or combination of substances caused the death. That is determined later by a toxicology test. As a result, a drug may be “involved” in a death and be listed on the death certificate, but have little or nothing to do with someone’s demise.

“It is startling that CDC has so consistently and deliberately conspired to disguise the fact that oxycodone really isn't significant in drug overdose mortality, and probably never has been,” Lawhern told PNN. 

Of course, every death is a tragedy in some way, regardless of the cause or substance involved. The graphic below helps bring oxycodone’s role into more context – comparing the five leading causes of death in 2021 to those involving fentanyl, oxycodone and the other drugs.

SOURCE: CDC

Despite the minor role played by oxycodone in 2021 deaths, efforts continue to restrict its availability. This year the Drug Enforcement Administration reduced the supply of oxycodone for the seventh consecutive year. Since their peak in 2013, DEA production quotas for oxycodone have fallen by 65 percent. The tightened supply has resulted in recent reports of oxycodone shortages and patients unable to get their prescriptions filled.

The DEA justifies the cuts by saying it is concerned about diversion and abuse, but the agency’s own data shows that less than one percent of legally prescribed oxycodone (0.3%) is diverted to someone it was not intended for.

How to Manage Dental Care with Chronic Pain

By Dr. Michael Cooney, Guest Columnist

More than 75 percent of the chronic pain patients we have treated also suffer from chronic dental issues. Apprehension about dental care from our neuropathic pain community is certainly understandable. But bypassing care of your teeth, gums and mouth can allow potential problems to grow and ultimately become more painful when treatment is no longer an option. It then becomes a necessity.

I sought out the advice of a dentist who specializes in treating people with chronic pain conditions and asked him for dental hygiene maintenance and treatment guidance. Here’s what he told me.

Do I Need a Special Dentist?

First, take time to perform due diligence in locating a dentist who treats patients with chronic nerve pain and understands your special needs. Once you’ve found one, ask about specific tools, techniques and anesthesia options to help minimize and control any potential pain before and after your dental treatment.

One unfortunate byproduct of chronic pain management is the common use of medications. Be sure to address your medication use with the dentist beyond just listing them on your intake forms. These medications commonly contribute to xerostomia (dry mouth). Without adequate saliva, tooth decay and gum disease are more likely to flourish, and also cause:

• Interference with normal swallowing

• Taste disorders (dysgeusia)

• Speech difficulty

• Inability to maintain oral tissue integrity

• Mucositis (chronic mouth irritation and inflammation)

• Dental decay

• Erosion

To combat dry mouth, hydrate your mouth by sipping water throughout the day. Chewing sugarless gum can also help. You may also wish to use a moisturizing mouth spray.

Periodontal Disease

Over time, gums can pull away from the teeth and form pockets which become infected. The body’s immune system fights the bacteria as plaque spreads and grows below the gum line. Bacterial toxins and the body’s natural response to infection start to break down the bone and connective tissue that hold teeth in place.

If not treated, the bones, gums and tissue that support the teeth are destroyed, requiring the diseased teeth to be extracted.

Understandably, people with chronic pain want to avoid potential pain triggers, including during dental visits. So when tooth or gum pain or sensitivity presents, it is often in the latter stages of decay when the tooth cannot be salvaged. The unfortunate result is the need to remove the tooth.

Best Defense Is a Strong Offense

At home, brush your teeth a minimum of twice daily and floss. Yes, we know flossing is gross, but isn’t it better to get that stuff out of your mouth and into the garbage?

Give your tongue a good brushing to remove bacteria that leads to plaque and chronic bad breath. Twice-yearly teeth cleanings and exams are also necessary to prevent and offset any issues before they become more serious and require more invasive treatment.

Before your visit, talk with your treating physician to determine any special protocol or medication requirements needed. Be sure that your doctor and dentist are in touch to fully understand the nature of your care needs.

After cleaning or dental treatment, allow extra time to rest and recover. Eat soft food for a few days and avoid foods (meats, popcorn, hard candy) that can potentially become lodged in those clean and disease-free pearly whites!

Preventing dental disease can improve holistic health, allowing your immune system to perform at its optimal level and provide the highest quality of daily life possible.

Michael Cooney, DC, is Clinical Director of Calmare NJ.  He is one of the original Calmare certified providers in the U.S. to use scrambler therapy to significantly reduce or alleviate treatment-resistant neuropathic pain.

Cooney specializes in treating children, adults and seniors battling medication and treatment-resistant neuropathy due to fibromyalgia, CRPS / RSD, diabetes, shingles (PHN), post-surgical pain and pain after chemotherapy (CIPN).

Cannabis Helps Relieve Cancer Pain

By Pat Anson, PNN Editor

Good news for patients suffering from cancer pain or side effects from cancer treatment. Two new studies found that medical cannabis helps relieve cancer pain, and offer some lessons to non-cancer patients about which cannabis products might work best for them.

The first study involved 358 adult cancer patients enrolled in a cannabis registry created by the Quebec Medical College. The patients were being treated for a variety of different cancers and were referred to the registry by their doctors. The primary complaint of most was pain (72%), with others experiencing symptoms such as nausea, anorexia, weight loss, anxiety and insomnia.

Participants were assigned to one of three groups, using cannabis products that were high in tetrahydrocannabinol (THC), high in cannabidiol (CBD), or a balanced blend of THC and CBD. The cannabis was ingested orally, through inhalation or a combination of the two. Patients were monitored and assessed every three months for a year.

The study findings, published in the journal BMJ Supportive & Palliative Care, show that pain levels dropped significantly after 3, 6 and 9 months, with pain slightly worsening after 12 months. Patients using balanced THC-CBD products reported the most pain relief, and many were able to reduce their use of opioids and other medications.

A small percentage of patients suffered adverse events from cannabis, such as sleepiness, dizziness and fatigue. Only 5 patients had side effects so severe that they stopped using cannabis.

Researchers concluded that medical cannabis should have a role as a complimentary pain management option in cancer patients who don’t get adequate relief from conventional analgesics.

“We found MC (medical cannabis) to be a safe and effective treatment option to help with cancer pain relief. THC:CBD balanced products appear to perform better as compared with THC-dominant and CBD-dominant products. Furthermore, we observed consistent decreases in medication burden and opioid use in our patient population,” researchers said.

Less Pain = Better Cognition

The second study, by researchers at University of Colorado Boulder, involved 25 cancer patients being treated by oncologists at the CU Anschutz Medical Campus. The patients’ pain levels, sleep patterns, cognition and reaction times were assessed at the start of the study; and they were asked to select edible products from a cannabis dispensary, such as chocolates, gummies, tinctures and baked goods containing different ratios of THC and CBD.

After just two weeks of regular use, patients reported less pain, better sleep, and the unexpected benefit of improved cognition – they were able to think more clearly.

“When you’re in a lot of pain, it’s hard to think,” said senior author and cancer survivor Angela Bryan, PhD, a professor of psychology and neuroscience at CU Boulder. “We found that when patients’ pain levels came down after using cannabis for a while, their cognition got better.”

The improved cognition didn’t happen right away. Patients who used edibles rich in THC got high from it and their cognition initially decreased. But after a few days of regular cannabis consumption, a new pattern emerged. Patients reported improvements in pain, sleep and cognitive function, including reaction times.

“We thought we might see some problems with cognitive function,” said Bryan. “But people actually felt like they were thinking more clearly.”

Patients who ingested edibles high in CBD reported bigger improvements in sleep quality and pain intensity.

Bryan’s study, published in the journal Exploration in Medicine, is one of the first to assess the efficacy of cannabis purchased at dispensaries — rather than less potent government supplied cannabis or synthetic cannabis medications that are primarily used to treat nausea.

Bryan had just begun studying medical cannabis in 2017, when she was diagnosed with breast cancer. After surgery and chemotherapy, she looked to cannabis for pain relief as an alternative to opioids. Neuropathic pain is a common side effect from chemotherapy.

Bryan used her own customized regimen of potent THC products when pain was intense and took mostly CBD products when the pain was more manageable. She was not completely pain-free, but she didn’t take a single opioid during treatment. She hopes others will learn from her experience.

“I was extremely lucky because I had some knowledge about this. Most patients don’t,” Bryan said. “People are open to trying whatever they think might be useful, but there's just not much data out there to guide them on what works best for what.”

As many as 40% of U.S. cancer patients use cannabis, but only a third of doctors feel comfortable advising them about it.

U.S. Prescription Opioid Use Fell 7.4% in 2022

By Pat Anson, PNN Editor

The amount of prescription opioids sold in the United States fell another 7.4% last year, according to a new report by the IQVIA Institute, a healthcare data tracking firm.

Since their peak in 2011, per capita use of prescription opioids by Americans has declined 64 percent, falling to levels last seen in the year 2000. Despite that historic decline, fatal overdoses in the U.S. have climbed to record levels, fueled primarily by illicit fentanyl and other street drugs.

“The greatest reductions in prescription opioid volume — measured in morphine milligram equivalents (MME) — have been in higher-risk segments receiving greater than 90 MMEs per day,” the IQVIA report found. “Despite significant progress in reducing opioid prescriptions to combat the opioid overdose epidemic, overdose deaths have been rising, primarily due to illicit synthetic opioids.”

The CDC estimates there were 108,712 overdose deaths in the 12-month period ending in November, 2022. About 72,000 of those deaths involved heroin or synthetic opioids such as fentanyl.

By comparison, drug deaths involving legal prescription opioids have remained relatively flat, averaging about 16,000 a year since 2017. They ticked upwards in 2020 and 2021, but appear have trended downward again in 2022, according to the IQVIA.

Prescription Opioid Use and Opioid Overdose Deaths

It appears likely that prescription opioid use will fall again in 2023, due in part to further cuts in opioid production quotas imposed on drug makers by the Drug Enforcement Administration. The DEA says the opioid supply will still be “sufficient to meet all legitimate needs,” but as PNN has reported, some manufacturers are currently reporting shortages of oxycodone and hydrocodone.      

Pain patients have complained for years about chain pharmacies being unable or unwilling to fill their opioid prescriptions, but the problem seems to have grown worse in recent months, particularly at CVS.

“Every month I have to spend hours on the phone trying to find a location that has them in stock,” a CVS customer in Indiana told us. “We should not have to be subjected to this every month!” 

“Some pharmacists are anti opiate. No matter what. She was rude and she is the manager. While it’s hard every month to fill, this time her rude attitude was over the top,” said another CVS customer in Colorado.

Medication Costs Declining 

There is some good news in the IQVIA report: medications are getting cheaper. The average amount paid out-of-pocket for a retail prescription fell from $10.15 in 2017 to $9.38 in 2022. Uninsured patients who pay the full amount in cash have also seen their drug costs decline slightly.

The use of manufacturer copay assistance programs and coupons is growing, collectively saving patients about $19 billion in 2022.

Over the next five years, growth in the use of biosimilar drugs to treat autoimmune conditions, diabetes and cancer is expected to save consumers over $180 billion. Like generic drugs, biosimilars are medications that can replace more expensive biologics such as Humira, which are losing patient protection.

Altogether, spending on medicines for the next five years is expected to be flat, according to the IQVIA, with rising costs in some drug classes offset by declines in others.

Retraining Your Brain Can Reduce Pain

By Dr. Joshua Pate, University of Technology Sydney

For every feeling we experience, there is a lot of complex biology going on underneath our skin.

Pain involves our whole body. When faced with possible threats, the feeling of pain develops in a split second and can help us to “detect and protect.” But over time, our nerve cells can become over-sensitized. This means they can react more strongly and easily to something that normally wouldn’t hurt or would hurt less. This is called sensitisation.

Sensitisation can affect anyone, but some people may be more prone to it than others due to possible genetic factors, environmental factors or previous experiences. Sensitisation can contribute to chronic pain conditions like fibromyalgia, irritable bowel syndrome, migraine or low back pain.

But it might be possible to retrain our brains to manage or even reduce pain.

Our body senses possible threats via nerve endings called nociceptors. We can think of these like a microphones transmitting the word “danger” through wires (nerves and the spinal cord) up to a speaker (the brain). If you sprain your ankle, a range of tiny chemical reactions start there.

When sensitisation happens in a sore body part, it’s like more microphones join in over a period of weeks or months. Now the messages can be transmitted up the wire more efficiently. The volume of the danger message gets turned way up.

Then, in the spinal cord, chemical reactions and the number of receptors there also adapt to this new demand. The more messages coming up, the more reactions triggered and the louder the messages sent on to the brain.

And sensitisation doesn’t always stop there. The brain can also crank the volume up by making use of more wires in the spinal cord that reach the speaker. This is one of the proposed mechanisms of central sensitisation. As time ticks on, a sensitised nervous system will create more and more feelings of pain, seemingly regardless of the amount of bodily damage at the initial site of pain.

When we are sensitised, we may experience pain that is out of proportion to the actual damage (hyperalgesia), pain that spreads to other areas of the body (referred pain), pain that lasts a long time (chronic or persistent pain), or pain triggered by harmless things like touch, pressure or temperature (allodynia).

Because pain is a biopsychosocial experience (biological and psychological and social), we may also feel other symptoms like fatigue, mood changes, sleep problems or difficulty concentrating.

Neuroplasticity

Around the clock, our bodies and brain are constantly changing and adapting. Neuroplasticity is when the brain changes in response to experiences, good or bad.

Pain science research suggests we may be able to retrain ourselves to improve wellbeing and take advantage of neuroplasticity. There are some promising approaches that target the mechanisms behind sensitisation and aim to reverse them.

One example is graded motor imagery. This technique uses mental and physical exercises like identifying left and right limbs, imagery and mirror box therapy. It has been tested for conditions like complex regional pain syndrome (a condition that causes severe pain and swelling in a limb after an injury or surgery) and in phantom limb pain after amputation.

Very gradual exposure to increasing stimuli may be behind these positive effects on a sensitised nervous system. While results are promising, more research is needed to confirm its benefits and better understand how it works. The same possible mechanisms of graded exposure underpin some recently developed apps for sufferers.

Exercise can also retrain the nervous system. Regular physical activity can decrease the sensitivity of our nervous system by changing processes at a cellular level, seemingly re-calibrating danger message transmission. Importantly, exercise doesn’t have to be high intensity or involve going to the gym. Low-impact activities such as walking, swimming, or yoga can be effective in reducing nervous system sensitivity, possibly by providing new evidence of perceived safety.

Researchers are exploring whether learning about the science of pain and changing the way we think about it may foster self-management skills, like pacing activities and graded exposure to things that have been painful in the past. Understanding how pain is felt and why we feel it can help improve function, reduce fear and lower anxiety.

Don’t Go It Alone

If you have chronic or severe pain that interferes with your daily life, you should consult a health professional like a doctor and/or a pain specialist who can diagnose your condition and prescribe appropriate active treatments.

In Australia, a range of multidisciplinary pain clinics offer physical therapies like exercise, psychological therapies like mindfulness and cognitive behavioural therapy. Experts can also help you make lifestyle changes to improve sleep and diet to manage and reduce pain. A multi-pronged approach makes the most sense given the complexity of the underlying biology.

Education could help develop pain literacy and healthy habits to prevent sensitisation, even from a young age. Resources, such as children’s books, videos, and board games, are being developed and tested to improve consumer and community understanding.

Pain is not a feeling anyone should have to suffer in silence or endure alone.

Joshua Pate, PhD, is a Senior Lecturer in Physiotherapy at University of Technology Sydney. He is on the Scientific Program Committee for the Australian Pain Society.

Josh’s research focus is on childhood pain. He is the author of a series of five books designed to help children learn and talk about pain, called Zoe and Zak's Pain Hacks.

This article originally appeared in The Conversation and is republished with permission.

Petition Asks FDA to Take NarxCare Off the Market

By Pat Anson, PNN Editor

A citizen’s petition filed with the U.S. Food and Drug Administration is asking that controversial software used by Bamboo Health to analyze health data and give patients “risk scores” be declared a misbranded medical device and taken off the market.

The petition by the Center for U.S. Policy (CUSP) says the software “has fundamentally altered the practice of medicine in the U.S. to the detriment of patients” by depriving many of them of access to opioids and other controlled drugs.

(Update: On July 21, the CUSP petition was rejected by FDA on procedural grounds because it was “not within the scope” of the agency’s petition process.)

The clinical decision support (CDS) software – known as NarxCare -- uses proprietary algorithms to gather and analyze prescription drug and other health information for millions of patients, creating risk scores for them based on their potential for misuse. The risk scores are widely used by hospitals, pharmacies, insurers and other healthcare providers to decide whether to prescribe and dispense controlled substances to patients.

Patient advocates have long said the Narxcare scores are inaccurate and being abused, depriving legitimate patients of medications to treat pain, anxiety, depression and opioid use disorder (OUD). Some also believe the scores are being used by law enforcement to identify and take action against doctors writing high-dose prescriptions.

“There are a lot of cases of people being harmed,” says Lynn Webster, MD, a pain management expert and Senior Fellow at CUSP. “What tipped the scale for me was when I was asked to look at records for a doctor who had been accused of prescribing inappropriately, totally based on a risk score. And his records did not justify being investigated or asking that his DEA license to be forfeited.

‘There is actually no validity to the scores that they provide. Too many people are being harmed from a lot of different perspectives. It’s only hurting people, not helping.”  

Having NarxCare declared a misbranded medical device is a novel approach, but Webster says the software is no different than any other device used to diagnose and treat a patient. Medical devices need prior approval from the FDA, which the agency has not given to NarxCare. Bamboo Health closely guards what data is used to create its risk scores.

“If you’re going to have a decision support tool for physicians, they have to have enough information to take a look at the content of what goes into developing that score, so they can override it and make their own judgements. But there is no information about what has really gone into it that’s publicly available that I can find,” Webster told PNN.

The petition asks the FDA to issue a warning letter to Bamboo Health, start a mandatory recall, and inform healthcare providers not to use the NarxCare risk scores.

Bamboo Health did not respond to requests for comment. In the past, the company has defended its software as an important clinical tool to help providers identify patients at risk of abusing opioids, antidepressants, sedatives and stimulants. Much of the data is collected from state-run Prescription Drug Monitoring Programs (PDMPs), which gather information on virtually every patient in the country who has been prescribed a controlled substance.

A 2021 clinical study looked at NarxCare scores for nearly 1,500 patients who were prescribed opioids in Ohio and Indiana. Researchers concluded that their risk scores were a “useful initial screening tool” for prescribers. The scores were deemed 86.5% accurate in identifying patients who are at low risk of opioid misuse.  

But prescribers are not the only gatekeepers in the process. If a physician decides to go ahead and write a prescription for a “high risk” patient, a pharmacy or insurer could still refuse to dispense or pay for the medication, based on their NarxCare score.

“When patients with pain, OUD, anxiety, or insomnia, for example, have inadequate access to controlled medications their health care providers deem necessary, the resultant harms can include relegation to the illicit drug market, exposure to substances adulterated with illegal fentanyl, prosecution and incarceration, drug poisoning, suicide, and death,” Michael Barnes, CUSP’s chairman, said in a statement.