States Need to Protect Pain Patients From Uncaring Pharmacists

By Leslie Bythewood, Guest Columnist

The unthinkable just happened again.

A Walgreens pharmacist got away with refusing to fill my prescriptions. It’s the second time that has happened to me at a retail chain pharmacy; the first time was at a CVS pharmacy.

The Walgreens pharmacy manager called and said she would not be able to fill the two prescriptions my board-certified physician had submitted electronically; despite the fact my health insurance had given prior approval for the medications and the pharmacy has been filling them month after month since December 2020.

Contrary to my physician’s best judgment and clinical decision making, this new head pharmacist suddenly decides she cannot fill the prescriptions because:

• The prescriptions are not in keeping with good-faith dispensing

• The prescriptions are not appropriate or safe to dispense

• The pharmacy’s therapeutics committee red-flagged the prescriptions as being too high a dose

• North Carolina limits the number of tablets that can be dispensed each month

• Filling the prescriptions goes against the pharmacist’s professional judgment

When I realized that my pharmacist would not fill the prescriptions and refused to even discuss the matter with my doctor, I wasted no time filing an electronic complaint with the North Carolina Board of Pharmacy, hoping for some recourse short of having to get the prescriptions filled at another pharmacy.

But little did I know about a North Carolina Board of Pharmacy rule entitled “Exercise of Professional Judgment in Filling Prescriptions.” That esoteric rule says a pharmacist “shall have a right to refuse to fill or refill a prescription order if doing so would be contrary to his or her professional judgment.”

It also states that a pharmacist “shall not fill or refill a prescription order if, in the exercise of professional judgement, there is or reasonably may be a question regarding the order’s accuracy, validity, authenticity, or safety for the patient.”

Federal law also gives pharmacists a “corresponding responsibility” not to fill a prescription for controlled substances if they believe it is “not in the usual course of professional treatment.”

Basically, the Walgreens pharmacist had the audacity to call into question the validity of my prescriptions being for a legitimate medical purpose, which not only is an insult to my physician, but second-guesses and overrides his many years of medical judgment and authority.

Worse yet, the North Carolina Board of Pharmacy agent I spoke with said that “refusing to fill the doctor’s prescriptions is not a violation of the Pharmacy Practice Act.” She went on to say the board cannot force the pharmacist to fill a prescription if the pharmacist is not comfortable doing so.

Bottom line: In North Carolina and many other states, the patient and doctor have no recourse and no avenues for appeal if a pharmacist refuses to fill a prescription. The only path forward is to have the doctor submit the prescriptions electronically to another pharmacy.

What I find so unconscionable about this whole ordeal is that it doesn’t seem to matter one iota to the uncaring pharmacist that I am a certified pain patient and that my doctor’s prescriptions are entirely legitimate and medically necessary, as has been documented in my medical records.

Nor did it matter that I’ve been on the same opioid strength since December 2020 without any adverse side effects, or that I am highly tolerant of my medications (a physiologic state that does not equate with psychological addiction) and have no history of overdose, substance abuse disorder, misuse or addiction. 

The pharmacist’s ability to get away with overpowering my doctor with unsound, medically unsafe arguments is exactly why we need to enact laws at both the state and federal level to protect pain patients from this type of abuse.

Leslie Bythewood is a freelance writer who lives in North Carolina. Leslie has intractable cranial pain syndrome caused by idiopathic severe chronic migraines and clusters.

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

Diet Changes Reduce Migraine Headaches

By Pat Anson, PNN Editor

There are many new treatments available for migraine sufferers; everything from CGRP inhibitors to neuromodulation to green light therapy. But there may be a simpler and less expensive way to reduce the frequency and severity of migraine headaches: changing your diet.

A new study funded by the National Institutes of Health found that migraine sufferers who ate more fatty fish and reduced their consumption of polyunsaturated vegetable oils had fewer headaches.

The findings are similar to another recent study that found foods containing healthy omega-3 fats – such as fish, flaxseed and walnuts – can reduce inflammation and neuropathic pain. Researchers say the two studies suggest that dietary changes can affect pain levels for other types of chronic pain.  

“It may ultimately be possible to integrate targeted dietary changes alongside medications to improve the lives of patients with chronic pain,” said Chris Ramsden, MD, a clinical investigator and adjunct faculty member at the University of North Carolina at Chapel Hill.

“Biochemical findings from both studies support the biological plausibility for this type of approach and could open the door to new approaches for managing many types of chronic pain. What is needed now is more evidence from randomized controlled trials in other populations with chronic pain.”

Ramsden is lead author of a study, published in the British Medical Journal, in which 182 adults with frequent migraines were broken into three groups and put on special diets for 16 weeks.

One group received meals that had high levels of fatty fish and low amounts of linoleic acid, a polyunsaturated fatty acid commonly found in American diets of corn, soybean and other vegetable oils. A second group received meals that had high levels of fatty fish and higher linoleic acid. The third control group received meals with high linoleic acid and low levels of fatty fish to mimic what an average American consumes.

"Our ancestors ate very different amounts and types of fats compared to our modern diets," said co-first author Daisy Zamora, PhD, an assistant psychiatry professor in the UNC School of Medicine. "Polyunsaturated fatty acids, which our bodies do not produce, have increased substantially in our diet due to the addition of oils such as corn, soybean and cottonseed to many processed foods like chips, crackers and granola."

When the study began, participants averaged over 16 headache days per month and over five hours of migraine pain each headache day -- despite taking multiple headache medications.

Those who consumed a diet low in vegetable oil and high in fatty fish had 30% to 40% reductions in total headache hours per day, severe headache hours per day, and overall headache days per month compared to the control group.

Blood samples from this group also had lower levels of pain-related omega-6 fatty acids found in processed foods.

“The effect we saw for the reduction of headaches is similar to what we see with some medications.”

— Daisy Zamora, PhD, UNC School of Medicine

“Our trial is the first moderate sized controlled trial showing that targeted changes in diet can decrease physical pain in humans,” Ramsden told PNN, noting that fatty acids appear to regulate the production of calcitonin gene-related peptides, the same protein targeted by CGRP medications.

“Diets alter the amounts of omega-3 and omega-6 fatty acids in the nervous system and other tissues linked to chronic pain. These fatty acids are converted by the body into biochemical mediators of pain. Several of these biochemical mediators act on receptor channels to regulate CGRP release,” he said in an email.

"I think this modification in diet could be impactful," Zamora added. "The effect we saw for the reduction of headaches is similar to what we see with some medications.”

Zamora, Ramsden and their colleagues are currently working on a new study to test diet modification for other chronic pain syndromes.

Most Sickle Cell Patients Face Stigma During ER Visits

By Pat Anson, PNN Editor

Nearly two-thirds of people with sickle cell disease in the U.S. feel judged and stigmatized when they visit an emergency department due to a pain flare, according to a new survey by Health Union.

About 100,000 Americans live with sickle cell disease (SCD), a genetic disorder that mainly affects people of African or Hispanic descent. SCD causes red blood cells to form in a crescent or sickle shape, which can create blockages in blood vessels that cause intense pain.  It’s not uncommon for someone with SCD to visit an ER a few times each year due to pain or complications such as anemia, stroke, infection and organ failure.

Health Union surveyed 111 people living with SCD to share their experiences dealing with the disease and how they are perceived by healthcare professionals, coworkers, teachers, friends and family members. Most said they did not feel judged or stigmatized by others – except when dealing with ER staff.

Many felt ER staff were rude, ignorant or misinformed about sickle cell disease, didn’t take their pain seriously, and believed they were drug seekers. Nearly half of those surveyed (43%) said they avoided going to the ER because they worried that people would judge them.

“A doctor judged me during a hospitalization. He stated I wasn’t in that much pain to be using Dilaudid. He also stated I was drug seeking because a sickle cell crisis can be managed with Motrin. His statement is not true!” one participant told Health Union.

Sickle cell patients had an entirely different take on their pharmacists, hematologists and primary care providers. Over half (53%) trusted their providers and felt their primary care doctors were friendly, understanding, easy to talk to, and provided excellent care.

"Navigating the healthcare system can already be complex, but undergoing such wildly different experiences can make access to reliable, timely, effective care even more difficult for people with sickle cell disease," said Olivier Chateau, Health Union's co-founder and CEO.

The finding that many people are not happy with their pain treatment in hospitals is not unique to sickle cell patients.  A 2016 PNN survey of over 1,250 hospitalized pain patients found that most felt they were labeled as addicts or drug seekers. Over 80% believed hospital staff were not adequately trained in pain management and over half rated the quality of pain care in hospitals as poor or very poor.  

A report last year by the National Academies of Sciences, Engineering, and Medicine found that sickle cell patients often face discrimination and stigma when navigating the healthcare system. The report found that SCD received little attention from the healthcare community compared to other chronic illnesses. To get proper treatment, many sickle cell patients have to educate themselves about their disease and become their own advocates.

The Health Union survey found that nearly three out of four sickle cell patients (73%) were currently using a prescription analgesic. Many others took prescription strength NSAIDs (35%), muscle relaxants (23%) or anti-anxiety/antidepressant drugs (16%). Only 5% said they experienced an issue with substance abuse.

Finding Inner Peace and Justice

By Mia Maysack, PNN Columnist

The vast majority of people who live with chronic pain and illness are blameless. It’s not our fault that we’re sick.  

I, for example, was a kid when an ear infection that led to a lifelong traumatic brain injury.  An innocent student and young career person who constantly missed class and work because of chronic migraines. Lack of proper care only further complicated matters.  

My health conditions were my biggest bullies; repeatedly huffing, puffing and blowing down any chance I had for normalcy or life without them. I often felt as though I were a prisoner within my own body. There were moments that I almost didn't make it through.

I'd be lying if I didn't confide some days still push me to my limits. But I’ve learned to pace myself and honor my capabilities one breath at a time.

Ask yourself this question: If you had to name all the things in life that you love, how long would it take for you to name yourself?  

Learning self-love is probably one of the biggest aspects of my self-care plan. But even deeper than self-love is a new concept I am exploring, called Inner Justice. 

When I feel well enough, I participate in a local campaign I began called “Honk4Justice.” A sign is held at busy intersections, inviting drivers to participate in the civil rights movement by simply honking. 

Often the question is asked:  "Justice for who?"

There are many answers.  Justice is waiting for proper verdicts and sentencing for killers. Justice is the same treatment for others that I'd hope to receive for myself. Justice is an equal amount of justice from one person to the next. Justice for the inner climate that makes up our individual perceptions of reality. 

Something that became very apparent early on in my journey with medical justice is that all pain and all hurt matters. Each of us, as part of this human experience, suffer somehow. Something has tested, caused inconvenience, broken our hearts or inflicted trauma in our lives.   

Instead of fixating on what separates us, we should focus on the commonalities to be found in the human experience. That includes physical and emotional pain. 

Whether it’s enduring systemic oppression or maltreatment, everything in existence is valid, causes a ripple effect and is connected. This means any one of us is only as strong as the weakest. That is why addressing our own personal judgement, ego, issues, privilege and wounds is paramount to move forward with individual healing and wellness.  

The beginning of this process for me meant developing a two-way relationship with my symptoms. I learned to approach myself as I would a dear friend, because ultimately the longest standing fellowship we’ll ever have is with ourselves. I've learned to navigate uncertainty, embrace the grand master plan, and surrender to the present as it comes. 

Living with a traumatized nervous system that constantly feels threatened and cultivating a sense of safety can seem like an impossible task, but it provides an opportunity for self-compassion. Once we’ve internalized that,  it becomes an available source of energy to pull from for understanding, accepting and having empathy for others. 

For as many more days as we have left, let us be open to learn, listen, teach and try for ourselves, each other and all those still to come.

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

Fibromyalgia Patients Substituting CBD for Pain Medication

By Pat Anson, PNN Editor

With opioid medication increasingly harder to obtain, many people with chronic pain are turning to cannabis-based products for pain relief.  A new survey of fibromyalgia patients suggests that cannabidiol (CBD) works well not only as an alternative to opioids, but for many other pain medications.

Researchers at Michigan Medicine surveyed 878 people with fibromyalgia who were currently using a CBD product and found that 72% of them had substituted CBD for a conventional pain medication.

Over half (59%) reduced or stopped taking non-steroidal anti-inflammatory drugs (NSAIDs), while 53% used CBD as a substitute for opioids, gabapentinoids (35%) or benzodiazepines (23%), an anti-anxiety medication that was once commonly prescribed for pain.

"I was not expecting that level of substitution," said Kevin Boehnke, PhD, a research investigator in the Department of Anesthesiology and the Chronic Pain and Fatigue Research Center at Michigan Medicine.

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Standard treatments for fibromyalgia such as gabapentinoids often prove to be ineffective or have unwelcome side effects.

"Fibromyalgia is not easy to treat, often involving several medications with significant side effects and modest benefits," said Boehnke. "Further, many alternative therapies, like acupuncture and massage, are not covered by insurance."

CBD is one of the chemical compounds found in cannabis, but it doesn’t have the same intoxicating effect as tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana.  Some cannabis products contain a combination of THC and CBD, while others just have CBD.

Survey participants who used CBD products containing THC were more likely to report symptom relief and to use them as substitutes for pain medication. This suggests that THC may enhance the therapeutic benefits of CBD.

A recent Israeli study found that people with fibromyalgia who took daily doses of cannabis oil rich in THC had significantly less pain and fatigue.

Another recent study in Israel found that cannabis products – both with and without THC – reduced pain and depression in fibromyalgia patients. Like the findings of the Michigan study, about one out of five patients either stopped taking or reduced their use of opioids and benzodiazepines.

"People are using CBD, substituting it for medication and doing so saying it’s less harmful and more effective,” said Boehnke. “If people can find the same relief without THC's side effects, CBD may represent a useful as a harm reduction strategy."

The Michigan Medicine study was recently published in The Journal of Pain.

Can a Low-Fat Diet Reverse Neuropathic Pain?

By Pat Anson, PNN Editor

Low fat diets are often recommended for people suffering from obesity and cardiovascular disease, but changes in eating habits are rarely recommended for people who live with chronic pain.

That could be changing thanks to a new study by researchers at the University of Texas Health Science Center, who found that diets high in omega-6 fats are strongly associated with inflammation and neuropathic pain. Omega-6 fats are widely found in typical Western diets of fast food, processed snacks, cakes, and fatty or cured meats.

Conversely, researchers say foods containing healthy omega-3 fatty acids – such as fish, flaxseed and walnuts – could reduce or even reverse neuropathic pain associated with diabetes. Their findings were recently published in the journal Nature Metabolism.

Diabetic neuropathy is a progressive and painful disease that causes burning or stinging sensations in the hands and feet. Many drugs used to treat neuropathic pain, such as gabapentin and pregabalin, often don’t work or have unpleasant side effects.

“This paper is a high-profile contribution for a huge unmet translational need as there are no treatments altering the nature of this neurological disease,” said José Cavazos, MD, director of the South Texas Medical Scientist Training Program at UT Health San Antonio.

In experiments on humans and laboratory animals, UT researchers found that mice fed a diet high in omega-6 polyunsaturated fats became hypersensitive to pain, cold and heat stimulation – signs of peripheral nerve damage. Lowering the amount of omega-6 fats and increasing omega-3 fatty acids reduced pain sensitivity in the mice.

The researchers also found that high levels of omega-6 lipids in the skin of patients with Type 2 diabetes were strongly associated with neuropathic pain and the need for analgesic drugs.

“We believe that these data warrant continued investigation of peripheral fatty acid and metabolite levels as potential pain biomarkers. Such biomarkers could provide clinicians with reliable objective endpoints to guide diagnoses as well as decision making on treatment regimens, including therapeutic diets,” wrote lead author Jacob Boyd, MD, UT Health San Antonio.

About 34 million people in the U.S. have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.

A 2015 study found that a vegetarian diet coupled with vitamin B12 supplements significantly reduced pain and improved the quality of life of people with diabetic neuropathy. Participants also had lower blood pressure and cholesterol levels, and lost an average of 14 pounds.

Tiny Electrode Could Expand Use of Spinal Cord Stimulators

By Pat Anson, PNN Editor

A tiny inflatable device – about the width of a human hair – could make spinal cord stimulation less invasive and more practical for millions of people who suffer from chronic back or leg pain, according to researchers at the University of Cambridge.

Long considered the treatment of last resort, spinal cord stimulators (SCSs) are bulky devices implanted along the spine that use electrode wires connected to a battery to emit electric currents that block pain signals from reaching the brain. About 50,000 stimulators are surgically implanted every year, but many wind up being removed due to complications from surgery or because they are ineffective.

“Our goal was to make something that’s the best of both worlds – a device that’s clinically effective but that doesn’t require complex and risky surgery,” said Christopher Proctor, PhD, a research fellow at Cambridge’s Department of Engineering and one of the senior authors of a study published in Science Advances. “This could help bring this life-changing treatment option to many more people.”

Proctor and his colleagues developed a miniaturized electrode that is so small it can be rolled up into a tiny cylinder, inserted into a needle, and implanted into the epidural space of the spinal column.

As the video below shows, the device can then be inflated with water or air so that it unrolls like a tiny air mattress and covers part of the spine. When connected to a battery, the ultra-thin electrode can send small electric currents to the spinal cord, just like a traditional stimulator.

“In order to end up with something that can be implanted with a needle, we needed to make the device as thin as possible,” said co-author Ben Woodington, a PhD candidate in Cambridge’s Department of Engineering.

Researchers made the device with flexible electronics used in the semiconductor industry; tiny fluidic channels used in drug delivery; and shape-changing materials used in robotics.

“Thin-film electronics aren’t new, but incorporating fluid chambers is what makes our device unique – this allows it to be inflated into a paddle-type shape once it is inside the patient,” said Proctor.  

Early versions of the device were so thin they were invisible to x-rays, which surgeons would need to confirm the device was in the right place before inflating it. Researchers added some bismuth particles to make the device visible without increasing the thickness too much.

The experimental device has only been tested in human cadavers. More extensive testing and clinical trials will be required before the device can be used on patients – possibly in two or three years. The Cambridge research team is currently working with a manufacturer to further develop and improve the device.

“The way we make the device means that we can also incorporate additional components – we could add more electrodes or make it bigger in order to cover larger areas of the spine with increased accuracy,” said senior co-author Damiano Barone, MD, a clinical lecturer in Cambridge’s Department of Clinical Neurosciences.

“This adaptability could make our SCS device a potential treatment for paralysis following spinal cord injury or stroke or movement disorders such as Parkinson’s disease. An effective device that doesn’t require invasive surgery could bring relief to so many people.”

“This technology has the potential to transform clinical treatment, significantly improve pain management for so many people, and reach patients who cannot be treated with existing devices,” said Rachel Atfield, PhD, Commercialisation Manager at Cambridge Enterprise, which has patented the device.

A 2018 study by a team of investigative journalists found that spinal cord stimulators have some of the worst safety records of medical devices tracked by the U.S. Food and Drug Administration. A review of FDA data found over 500 deaths and 80,000 injuries involving stimulators since 2008. Patients reported being shocked or burned by the devices and many had them removed.  

OHSU Researchers Find ‘No Evidence’ to Support Use of Kratom

By Pat Anson, PNN Editor

A federally funded review of plant-based treatments for chronic pain has yet to find adequate clinical evidence on the benefits or harms of kratom, an herbal supplement used by millions of Americans to relieve pain, anxiety, depression and other medical conditions.

In an update released this week, researchers at Oregon Health & Science University (OHSU) reported that some cannabis products provide small to moderate pain relief, a finding based on a systematic review of two dozen clinical trials of cannabis.  But no similar studies were found to support the use of kratom or any other plant.   

“No evidence on other plant-based compounds, such as kratom, met criteria for this review,” researchers said.

OHSU was awarded a contract last year by the Agency for Healthcare Research and Quality (AHRQ) to review the evidence for cannabis, kratom and other plant based treatments for chronic pain.  

Kratom comes from the leaves of the mitragyna speciosa tree in southeast Asia. Although it has been used for centuries as a natural stimulant and pain reliever, few clinical trials have been conducted to test kratom’s efficacy or safety. The few studies that have been conducted were excluded by OHSU researchers due to their size, methodology or because they weren’t published in English.

For example, a 2020 Malaysian study that found kratom provided “a substantial and statistically significant increase in pain tolerance” was excluded because the young men who participated in the one-day trial were considered an “ineligible population.” OHSU researchers excluded all studies lasting less than 4 weeks.

“The conclusion that there is no evidence to support the effects of kratom on chronic pain is absurd.”

— Mac Haddow, American Kratom Association

“Setting aside the disappointment that AHRQ does not appear to be taking the purpose of the review of plant-based compounds very seriously, the conclusion that there is no evidence to support the effects of kratom on chronic pain is absurd,” said Mac Haddow, a lobbyist for the American Kratom Association.  “It’s like denying that Chicago is a windy city because the instrument that was selected for assessing wind speed was not used.”

Haddow said the AHRQ review should be expanded to include survey results from kratom users, animal studies and other types of research that don’t rise to the level of a clinical trial.

“The review appears to be excluding any research that is not a pharmaceutical development clinical trial model that would involve controlled kratom administration in a full-blown human clinical trial,” Haddow told PNN. “The deeply embedded bias against plant-based compounds that offer potential values for addressing the opioid crisis — or even providing a non-addictive and safer alternative for the management of acute and chronic pain should be a priority for the AHRQ.”

This isn’t the first time the quality of federal research into the safety and efficacy of kratom has been questioned. In 2018, the Department of Health & Human Services quietly withdrew an FDA request to classify kratom as a Schedule I controlled substance because of “lack of evidence” it can be abused or posed a public health threat. A former HHS official recently said the FDA’s recommendation was rejected because of “embarrassingly poor evidence & data.”

$2 Billion in Federal Grants

A final report on plant-based treatments for chronic pain is expected in August. As PNN has reported, OHSU researchers have recently conducted a series of reviews on a wide variety of pain therapies for the AHRQ, which are being used by the Centers for Disease Control and Prevention to revise and possible expand its controversial 2016 opioid guideline.   

Much of that research is being led by Dr. Roger Chou, a primary care physician who heads the Pacific Northwest Evidence-based Practice Center at OHSU.  Chou, who co-authored the CDC opioid guideline, is a prolific researcher who has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to reduce the use of opioid medication.

The contract on plant-based pain treatments is potentially worth up to $1.4 million for OHSU, a public research university that the federal government often turns to for medical research. According to the website GovTribe, in the last five years OHSU has been awarded nearly $2 billion in federal research grants to study everything from cancer and contraceptives to Alzheimer’s and Parkinson’s Disease.

OHSU paid $1.3 million back to the government to settle allegations that it misused grant money in its primate research center. Although the settlement was reached in 2018, it was not made public until recently in an Inspector General’s report, according the animal rights group Rise for Animals.

Does Cannabis Increase Risk of Suicide?

By Roger Chriss, PNN Columnist

A new National Institute of Health study confirms a long-standing association between cannabis use and suicidality in younger adults.

NIH researchers looked at data from over 280,000 people aged 18 to 34 who participated in the National Survey of Drug Use and Health from 2008 to 2019. Their findings, published in JAMA Open Network, concluded that cannabis increased the risk of suicidal thoughts (ideation), planning and attempts by young adults.

“While we cannot establish that cannabis use caused the increased suicidality we observed in this study, these associations warrant further research, especially given the great burden of suicide on young adults,” Nora Volkow, MD, director of the National Institute on Drug Abuse, said in a statement.

Cannabis use is rising fast in the United States. Use more than doubled from 22 million people in 2008 to 45 million in 2019, and regular use tripled to nearly 10 million people by the end of the study. The increased use of cannabis coincided with a spike in suicides among young adults, which rose by 52% for women and 45% for men from 2008 to 2019.

NIH researchers found that daily cannabis use and a history of a major depressive episode (MDE) increased the risk of suicide, particularly for women. The prevalence of a suicide plan in the past year was 52% higher for women with MDE than for men with MDE.

But even when a young adult was not depressed, suicide ideation rose in tandem with the frequency of their cannabis use. Seven percent of those who used cannabis occasionally had suicidal thoughts, a number that rose to 9% for people who use cannabis daily and to 14% for people with cannabis use disorder.

The NIH study supports prior findings. Stanford researchers recently reported that in states that legalized recreational marijuana there was a 46% increase in self-harm injuries among 21- to 39-year-old men.

A 2020 study in the Journal of Addiction Nursing and a 2019 study in JAMA Psychiatry also found a strong association between cannabis and suicidality.

But the relationship is complex. The 2020 study looked at recreational cannabis use, while the 2019 study examined adolescent use. The new NIH study looked at national survey data over a period that started well before adult-use legalization in Colorado and Washington. It makes no distinction between medical and recreational cannabis, a distinction that could be important.

Explanations for the suicide association also vary, such as the higher potency of cannabis and increased availability of cannabis products. But these trends vary by state and over time, so more granular analysis is needed in order to tease out relationships among these factors.

More important, it is not clear at this point if cannabis use is simply associated with an underlying trend, exacerbating a growing problem, or is itself an independent risk factor. Sorting this out will be extremely difficult, because cannabis use does not occur in a vacuum and cannabis itself is a delivery system for a slew of cannabinoids whose effects and interactions are not fully understood.

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. 

Have You Been Labeled a 'Difficult' Patient?

By Ann Marie Gaudon, PNN Columnist  

We’re all aware of doctors labeling a patient as “difficult” or some other derogatory term. There are even entire categories set up for these “heartsink” patients, who behave in ways that doctors consider dependent, entitled, manipulative or even self-destructive.

Imagine if doctors moved the conversation away from “difficult patient” to “difficult doctor-patient interactions” by taking a closer look at behaviour patterns that can occur in their relationships with patients.

Let’s start at the beginning – literally — by studying interactions between infants and their caregivers. “Attachment Theory” was first developed by the English psychologist, psychiatrist and psychoanalyst John Bowlby.  He proposed that infants have a biological drive to seek nurture and closeness to their primary caregivers. How the caregiver attunes to that baby will actually shape how the infant’s brain develops. Ultimately, our adult selves are influenced by these layers of memory and how we adapted to that care.

There are four main “Attachment Styles” seen in adults, according to Bowlby and psychologist Mary Ainsworth. How do these four styles play out in the doctor’s office? Do you see yourself in any of them?

1) Secure Patient

• Is often trusting, comfortable seeking help and values advice

• Doctor feels sympathetic to patient’s needs and confident that advice will be followed

• Successful outcomes are maximized with this relationship

2) Avoidant/Dismissive Patient

• Is often distant and does not trust the doctor; may miss appointments

• Displays a lack of engagement; may minimize symptoms and dismiss need for treatment

• Doctor may become frustrated with patient saying “I can’t” or “It’s not really that bad”

• May increasingly withdraw from care; denial of problems and emotions

• Patient may be in crisis when their hyper self-reliance strategy begins to fail

3) Ambivalent/Anxious Patient

• Has little trust in ability of self and others; expects rejection; can be highly emotionally reactive

• Doctor may feel confused by patient’s alternating avoiding and approaching; being unpredictable

• Doctor may get upset with inconsistency of behaviour, especially if patient pulls away when help is offered

• Patient anxiety increases, depression may also appear; may withdraw and miss appointments or leave in the middle of one

4) Disorganized Patient

• Little trust in others; cognitive ability becomes disorganized when stressed

• May be fearful of doctor and treatment; may be triggered by earlier traumas

• Doctor may become fearful for patient and inability to contain patient’s overwhelming emotions

• Doctor may feel like a failure and try harder

• Overwhelming complexity of patient’s problems can fragment clinical teams

• Patient and doctor may reinforce feelings of being overwhelmed and loss of control of the situation

• Care may be chaotic, ineffective; mental health crisis may prevail

If physicians were familiar with Attachment Theory and the style for each patient, they could tailor their approach to best serve the patient. Predicting and planning for possible poor outcomes could benefit with a reduction in negative experiences for both patient and physician.

Shifting away from “difficult patient” attitudes and pejoratives toward “Attachment-Based Care” would be a shift away from what is unproductive and a move toward helpful and effective treatment approaches.

Patients with an Avoidant Attachment Style could be provided a predictable treatment framework (no surprises) and information that is clear and not emotionally challenging. These patients can help themselves by being honest with the physician if they are not happy with their care. Keeping a journal and using internet-based telehealth may also be beneficial for the patient to use.

Patients with an Ambivalent/Anxious Attachment Style could be encouraged to build self-confidence to increase their ability to tolerate anxiety and uncertainty. Scheduling regular appointments to avoid the patient feeling it is necessary to magnify symptoms to receive care is another strategy. Being consistent and clear will also help to decrease anxiety. If these patients can learn to regulate their emotions, this will go a very long way in clinical interaction benefits. Regular exercise and mindfulness techniques will also help. A therapist will almost certainly be required.

A physician being aware that patients with a Disorganized Attachment Style are often inconsistent in attending appointments and show ambivalence in decision-making will allow the professional to plan ahead and pull in a support person if they feel overwhelmed. The seriousness of this patient in a stressed state must be understood and supported, as anger and decompensation are common. For this patient, a patient advocate may be very beneficial as well as a management plan that all can collaborate on.

Attachment Styles are influential in all areas of life and important determinants of therapeutic interactions and relationships. Using an Attachment-Based Care approach would provide a framework to understand these interactions and how best to serve the needs of patients.

In an ideal world, all non-securely attached patients as well as non-securely attached physicians would explore their maladaptive strategies with a trained therapist to help move them toward a Secure Attachment Style that has less suffering and psychologically flexible strategies for living. Until that time, let’s stop the name-calling and work toward compassionate care for all patients.

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

Cutting My Opioid Dose in Half Left Me in Unbearable Pain

By Virginia Brandford, Guest Columnist

Imagine living with a rare genetic bone disease that has no cure and causes excruciating pain. Then imagine the medication that effectively alleviated that pain for 29 years is abruptly tapered and you are forced to take only half the dose your body has become dependent on.

Not only is the pain unbearable, but the resulting stress placed on the body prevents you from exercising or participating in physical therapy, which is vital to someone with alkaptonuria (AKU) to prevent chronic joint pain and inflammation.

AKU is known as “Black Bone Disease” because it turns bones black and brittle. It is the oldest metabolic disease on earth and has even been found in Egyptian mummies. Watch this video if you want to learn more about my disease.  

After being diagnosed with AKU, I was placed on a very high dose of morphine to stop my body from producing Homogentisic Acid (HGA). People like me born with AKU are missing an enzyme that prevents them from fully breaking down HGA.

When it accumulates at high levels, HGA devours my bones, turning them black and stripping the cartilage and cushions between them.

My longtime physician identified morphine as a pain medication that helped, without causing side effects. I was able to function again and live a decent life, in spite of having such a debilitating disease.

Virginia Brandford

But in 2017, many of the recommendations in the CDC opioid guideline were adopted in Hawaii as state law, and my doctor was driven out of practice. I cannot find a new doctor willing to prescribe the same dose of morphine. They all see my need for opioids, but they do not want to risk their livelihoods by taking me on as a patient. I am being harmed by the state and no one will do anything to help me!

Due to the morphine being reduced to half of my original dosage, the HGA accumulation has eaten two holes into my heart valves, resulting in a life-threatening heart condition. HGA has also accumulated in my spine, liver and kidneys.

I have endured irreparable damage by being forced off my old dosage of medication in such an inhumane manner. Every doctor I have been referred to has refused to accept me as a patient once they look over my medical records and see I have a rare genetic bone disease that requires opioids.

I have never abused drugs or alcohol in any form. I have comprehensive medical records, including MRIs and x-rays documenting my illness and treatment history. It will also show that for 29 years on the original morphine dose, my liver stayed strong and clean, compared to a patient who has been on a toxic medicine like Suboxone that is just as addictive.

Legitimate pain patients like me who never abused drugs are being treated like addicts and demonized for taking prescribed medicines from licensed doctors.

Please help me obtain the help I need before this disease spreads even more. I am totally bedridden and need help. I pray that a revision of the CDC opioid guideline will allow doctors to do their jobs again without being persecuted, and will give me back my life so that I can grow old with dignity.

Virginia Brandford lives in Hawaii. PNN invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

Experimental Brain Implant Automatically Relieves Pain

By Pat Anson, PNN Editor

An experimental brain implant that automatically detects and relieves pain in laboratory animals has the potential to be adapted for human use, according to researchers at NYU Grossman School of Medicine. The computerized device is the first of its kind to target both acute and chronic pain, and may also be effective in treating anxiety, depression, panic attacks and other brain-based disorders.

“Our findings show that this implant offers an effective strategy for pain therapy, even in cases where symptoms are traditionally difficult to pinpoint or manage,” said senior author Jing Wang, MD, an Associate Professor of Anesthesiology at NYU Langone Health.

The technology, known as a closed-loop brain-machine interface, detects brain activity in the anterior cingulate cortex, a region of the brain that is critical for pain processing. A computer linked to the device identifies pain signals in real-time, triggering a therapeutic stimulation of another region of the brain, the prefrontal cortex, to ease pain sensations.  

Wang and his colleagues installed the tiny electrodes in the brains of dozens of rats and then exposed them to carefully measured amounts of pain. The animals were closely monitored to see how quickly they moved away from a source of acute pain.

The study findings, published in the journal Nature Biomedical Engineering, showed that rats withdrew their paws 40 percent more slowly from the pain source when the device was turn on. In addition, animals in acute or chronic pain spent about two-thirds more time in a chamber where the device was turned on than in another chamber where it was not.

Researchers say the implant accurately detected pain up to 80 percent of the time. Since the device is only activated in the presence of pain, it lessens the risk of overuse, tolerance and addiction.

“Our results demonstrate that this device may help researchers better understand how pain works in the brain,” says lead investigator Qiaosheng Zhang, PhD, a doctoral fellow in the Department of Anesthesiology, Perioperative Care and Pain at NYU Langone. “Moreover, it may allow us to find non-drug therapies for other neuropsychiatric disorders, such as anxiety, depression, and post-traumatic stress.”

Zhang says the implant’s pain-detection properties could be improved by installing electrodes in other regions of the brain besides the anterior cingulate cortex. He cautions, however, that the technology is not yet suitable for use in people. Researchers are investigating whether less-invasive forms of the implant can be adapted for human use.

Brain implants – also known as deep brain stimulators -- are currently used to prevent seizures and tremors in people with Parkinson’s disease and epilepsy.

Follow Treatment Guidelines for Low Back Pain and Get Back to Work Sooner

By Pat Anson, PNN Editor

Employees with acute low back pain miss fewer days of work if they exercise, take over-the-counter pain relievers and are not prescribed opioid medication, according to a large new study of worker compensation claims in California.

"The closer people's care follows evidence-based guidelines, the faster their back pain resolves, by quite a bit," said Kurt Hegmann, MD, director of the University of Utah Rocky Mountain Center for Occupational and Environmental Health.

Hegmann and his colleagues analyzed insurance data for nearly 60,000 people with low back pain from 2009 to 2018, comparing their treatment to guidelines created by the American College of Occupational and Environmental Medicine. Those guidelines recommend non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants and physical therapy for low back pain, while frowning on the use of opioids or invasive procedures such as spinal injections.

The research findings, recently published in PLOS ONE, showed that people who didn’t follow treatment guidelines missed an average of 11 more days of work each year compared to those who only had recommended treatments.

Opioids were once commonly prescribed for low back pain, a practice that has fallen out of favor due to fears of addiction and overdose. In the nine years of the study, researchers found that opioid prescribing for low back pain declined by 86 percent, fueled in part by insurers who were unwilling to pay for the drugs.

"The reduction in opioids prescription is particularly impressive," Hegmann said. "In this case, the insurer is likely to not pay for opioids even if they are prescribed. It suggests what's possible when the 'carrot' of good health care is missed and instead the 'stick' of compliance with a guideline is in place."

Nearly two-thirds of the people included in the study received at least one non-recommended treatment, although adherence to treatment guidelines improved over time. In 2009, 10% were treated according to guidelines, but that rose to 18% by 2018.

Low back pain is the world’s leading cause of disability. It mostly affects adults of working age in lower socioeconomic groups, who often have physically demanding jobs.

Treatment guidelines for low back pain have changed considerably in the last 20 years. At one time, bed rest was commonly recommended, a treatment now seen as counterproductive. Moderate exercise and physical activity help people return to work sooner.

"Being out of work impacts many facets of your life," said first author Fraser Gaspar, PhD. "In addition to the physical disability that's causing the person to miss work, the worker is making less money, while they often incur additional costs and experience mental strain. Getting people back to their normal lives is really important, and our research shows that following guidelines makes that happen faster."

Researchers Warn of Deadly New Illicit Opioid

By Pat Anson, PNN Editor

A new illicit opioid that is 20 times more potent than fentanyl has been linked to at least eight fatal overdoses in the U.S. in the last month, according to a public safety alert released by a Pennsylvania research laboratory.

The Center for Forensic Science Research & Education (CFSRE) said its scientists detected N-pyrrolidino etonitazene -- also known as etonitazepyne -- in eight blood samples taken during recent death investigations in West Virginia, Pennsylvania, New York, Florida and Colorado.  Four of the deaths occurred in West Virginia.

“The toxicity of N-pyrrolidino etonitazene has not been examined or reported but recent association with death among people who use drugs leads professionals to believe this synthetic opioid retains the potential to cause widespread harm and is of public health concern. Identifications of N-pyrrolidino etonitazene have also been reported recently from agencies in Europe,” the safety alert said.

Etonitazepyne is a synthetic opioid that is chemically similar to etonitazene, another powerful narcotic that started appearing in illicit drug markets and counterfeit pills in the U.S. and Canada last year.  While etonitazene is classified as an illegal Schedule I controlled substance by the DEA, etonitazepyne has not specifically been scheduled. Several websites even list it for sale for “chemical research.”

"The current drug landscape in the United States is unstable and unpredictable – especially the opioid market – which can ultimately lead to deadly outcomes," said Dr. Alex Krotulski, an associate director at CFSRE. "The purpose of this public alert is to raise awareness about a new and already deadly synthetic opioid so that way people who use drugs are able to modify use patterns and so that laboratories know to test for this new drug in their states or jurisdictions.”

Etonitazepyne may be new to law enforcement, coroners and public health officials, but illicit drug users have been warning each other about the drug for several months in online message boards.

“I got a report about an overdose with only 1 MG of Etonitazepyne (snorted) that caused a pretty high tolerance user to become unconscious and stopped breathing, and he had to be rescued from paramedics,” a poster said on Reddit.

“Everyone needs to be careful with this one. It's not for anyone who has no tolerance to opioids, and can still be dangerous for those who do,” another poster wrote.

Medical Device Makers Paid Billions to Doctors To Use Their Products

By Fred Schulte and Elizabeth Lucas, Kaiser Health News

Dr. Kingsley R. Chin was little more than a decade out of Harvard Medical School when sales of his spine surgical implants took off.

Chin has patented more than 40 pieces of such hardware, including doughnut-shaped plastic cages, titanium screws and other products used to repair spines — generating $100 million for his company SpineFrontier, according to government officials.

Yet SpineFrontier’s success arose not from the quality of its goods, these officials say, but because it paid kickbacks to surgeons who agreed to implant the highly profitable devices in hundreds of patients.

In March 2020, the Department of Justice accused Chin and SpineFrontier of illegally funneling more than $8 million to nearly three dozen spine surgeons through “sham consulting fees” that paid them handsomely for doing little or no work. Chin had no comment on the civil suit, one of more than a dozen he has faced as a spine surgeon and businessman. Chin and SpineFrontier have yet to file a response in court.

Medical industry payments to orthopedists and neurosurgeons who operate on the spine have risen sharply, despite government accusations that some of these transactions may violate federal anti-kickback laws, drive up health care spending and put patients at risk of serious harm, a KHN investigation has found.

These payments come in various forms, from royalties for helping to design implants to speakers’ fees for promoting devices at medical meetings to stock holdings in exchange for consulting work, according to government data.

Health policy experts and regulators have focused for decades on pharmaceutical companies’ payments to doctors — which research has shown can influence which drugs they prescribe. But far less is known about the impact of similar payments from device companies to surgeons. A drug can readily be stopped if deemed harmful, while surgical devices are permanently implanted in the body and often replace native bone that has been removed.

‘Staggering’ Amounts of Money

Every year, a torrent of cash and other compensation flows to these surgeons from manufacturers of hardware for spinal implants, artificial knees and hip joints — totaling more than $3.1 billion from August 2013 through the end of 2019, a KHN analysis of government data found. These bone specialists make up a quarter of U.S. doctors who have accepted at least $100,000 or more, and two-thirds of those who raked in $1 million or more, from the medical device and drug industries last year, the data shows.

“It is simply so much money that it is staggering,” said Dr. Eugene Carragee, a professor of orthopedic surgery at the Stanford University Medical Center and critic of the medical device industry’s influence. Much of the money is deemed to be compensation for consulting duties or medical research, or royalties for inventing, or fine-tuning, new surgical tools and techniques. In some cases, it pays for trips or splashy junkets or rewards surgeons for promoting products to their peers.

Device makers say the long-established practice leads to higher-quality, safer products. “Doctors help develop and refine medical devices, and they even create new devices themselves, sharing their intellectual property with companies to help save and improve patients’ lives,” said Scott Whitaker, president and CEO of AdvaMed, the medical technology industry’s trade group.

But industry whistleblowers and government investigators say all that money changing hands can corrupt medical judgment and tempt surgeons to perform unnecessary and wasteful operations. In ongoing lawsuits, patients say they have suffered life-altering injuries from screws or other spinal hardware that snapped apart or live with disabilities they blame on defective knee or hip implants.

Patients alleging injuries range from seniors on Medicare to celebrities such as Olympic gold medalist Mary Lou Retton, who had surgery to replace both her hips. The gymnast sued device maker Biomet in January 2018, alleging the hip implants were defective. The suit has since been settled under confidential terms.

The case of Chin’s company, SpineFrontier, is among more than 100 federal fraud and whistleblower actions, filed or settled mostly in the past decade, that accuse implant surgeons of taking illegal compensation from device makers — from surgeon entrepreneurs like Chin to marquee names like Medtronic and Johnson & Johnson. In some cases, device makers have paid hundreds of millions of dollars in fines to wrangle out of trouble for their involvement, often without admitting any wrongdoing.

Court pleadings examined by KHN identified more than 700 surgeons who have taken money, including dozens who pocketed millions in royalties, fees or other compensation from 2013 through 2019. The names of hundreds more surgeons were redacted in court filings or sealed by judges.

Court filings named 35 spine surgeons who used SpineFrontier’s surgical gear, some for years. At least six of those surgeons have admitted wrongdoing and paid a total of $3.3 million in penalties. Another has pleaded guilty to criminal charges. It’s illegal under federal law to accept anything of value from a device maker for using its wares, though most offenders don’t face criminal prosecution.

Chin, 57, who lives in Fort Lauderdale, Florida, and owns SpineFrontier through his investment company, declined comment about the DOJ lawsuit or the consulting agreements.

“There is a court date [for the DOJ case] as ordered by a judge,” Chin said via email. “If we get to that point the facts of the case will be litigated.”

Back Surgeries Under Scrutiny

The nation’s outlay for spine surgery to treat back pain, or to replace worn-out knees and hips, tops $20 billion a year, according to one industry report. Taxpayers shoulder much of that cost through Medicare, the federal program for those 65 and older, and Medicaid, which caters to low-income people.

In one common spinal procedure, surgeons may replace damaged discs with an implant and screws and metal rods that hold it in place. The demand for surgery to replace worn-out knees and hips also has mushroomed as aging boomers and others seek relief from joint pain that restricts their movement.

Perhaps not surprisingly, the competition for sales of orthopedic devices is fierce: Some 250 companies proffer a dizzying array of products. Industry critics blame the Food and Drug Administration, which allows manufacturers to roll out new hardware that is substantially equivalent to what already is sold — though it often is marketed as more durable, or otherwise better for patients.

“The money is just phenomenal for this medical hardware,” said Dr. James Rickert, a spine surgeon and head of the Society for Patient Centered Orthopedics, an advocacy group. He said most of the products are “essentially the same,” adding: “These are not technical instruments; [it’s often] just a screw.”

Hospitals can end up charging patients $20,000 or more for the materials, though they pay much less for them. Spine surgeons — who make upward of $500,000 a year — bill separately and may charge $8,000 to $20,000 for major procedures.

Which equipment hospitals choose may fall to the preference of surgeons, who are wooed by manufacturing sales reps possibly present in the operating room.

And it doesn’t stop there. Whistleblower cases filed under the federal False Claims Act allege a startling array of schemes to influence surgeons, including compensating them for joining a medical society created and financed by a device company. In other cases, companies bought billboard space or other advertising to promote medical practitioners, hired surgeons’ relatives, paid for hunting trips — even mailed checks to their homes.

Orthopedic and neurosurgeons collected more than half a billion dollars in industry consulting fees from 2013 through 2019, federal payment records show.

These gigs are legal so long as they involve professional work done at fair market value. But they have drawn fire as far back as 2007, when four manufacturers that dominated the hip and knee implant market, including a J&J division, agreed to pay $311 million to settle charges of violating anti-kickback laws through their consulting deals.

KHN found at least 20 whistleblower suits, some settled, others pending, that have since accused device makers of camouflaging kickbacks as consulting work, including paying doctors to sit on suspect “advisory boards” or other activities that entailed little work to justify the fees.

In November 2019, device maker Life Spine and two of its executives admitted to paying consulting fees to induce dozens of surgeons to use Life Spine’s implants in the operating room. In all, 21 of the top 30 Life Spine adopters were paid and they accounted for about half its total device sales, according to the Justice Department. Life Spine and the executives paid a total of $6 million in penalties. The company did not respond to requests for comment.

Similarly, SpineFrontier received “the vast majority” of its sales, more than $100 million worth, from surgeons who were compensated, the Justice Department alleges. Often, they were paid by way of a “sham” company run by Chin’s wife, Vanessa, from a mail drop in Fort Lauderdale, according to the Justice Department. Vanessa Dudley Chin, a defendant in the DOJ civil case, had no comment.

Kingsley Chin told KHN via email that he takes no salary from SpineFrontier, based in Malden, Massachusetts. In 2013, Chin received $4.3 million in income from the company, according to court filings in a divorce case in Philadelphia from an earlier marriage. In 2018, SpineFrontier valued Chin’s interest in the company at $75 million, according to government records, though its current worth is unclear.

SpineFrontier’s management thought paying doctors was “the only reliable way to steadily increase its market share and stave off competition,” Charles Birchall, a former business associate of Chin’s, alleged in a whistleblower complaint. The case is one of two whistleblower suits filed against SpineFrontier that the DOJ has joined and consolidated. Chin has yet to file a response in court.

From March 2013 through December 2018, the company offered some surgeons $500 or more an hour for “consulting,” which could include the time they spent operating on patients — even though they already were being paid by Medicare or other health insurers. Other surgeons were paid repeatedly to “evaluate” the same products, though their feedback was “often minimal or nonexistent,” according to the DOJ complaint.

Patient Injuries Pile Up

While the payments have piled up for doctors, so have injuries for patients, according to lawsuits against device makers and whistleblower testimony.

Orthopedic surgeon-turned-whistleblower Dr. Manuel Fuentes is suing his former employer, Florida device maker Exactech, alleging it offered “phony” consulting deals to surgeons who had complained about alarming defects in one of its knee implants.

Their findings should have been forwarded to the FDA to protect the public, Fuentes and two former Exactech sales reps alleged in their suit. Instead, the company paid the surgeons “to retain their business and secure their silence” about patients needlessly undergoing a second operation to address the defects implanted in the first, according to the suit. Lawyer Thomas Beimers, who represents Exactech in the case, said the company “emphatically denies the allegations and looks forward to presenting the real facts to the court.” In a court filing, the company said the suit was “full of conclusory, vague and immaterial facts” and said it should be dismissed.

In Maryland, spine surgeon Dr. Randy F. Davis faces a lawsuit filed in early 2020 by 14 former patients who claim he implanted counterfeit hardware from a device distributor that had paid him hundreds of thousands of dollars in consulting fees and other compensation.

Davis used the hardware, which had not been FDA-approved, on about 250 patients at the University of Maryland Baltimore Washington Medical Center in Glen Burnie, Maryland, according to the suit. Several patients say screws or other implants failed and they sustained permanent injuries as a result. One woman said she was left with little feeling in her right foot and needs a cane or walker to get around. Others claim “extreme mental anguish” for fear the hardware inside them will fail, according to the suit.

The patients allege that Davis improperly disposed of defective screws and other hardware he removed rather than send the items for analysis or report the failures to authorities. Instead, the University of Maryland hospital sent “hush” letters to patients that falsely told them that no defects had been found, according to the suit. A spokesperson for the hospital, which also is a defendant in the suit, denied the allegations, noting: “We will vigorously defend this lawsuit and at its conclusion are quite confident we will prevail.” Davis and his lawyer didn’t respond to repeated requests for comment. The lawsuit is pending in Anne Arundel County state court.

Surgeons are free to implant devices they helped bring to market or promoted, though doing so can prompt criticism when injuries or defects occur.

That happened when three patients filed lawsuits in 2018 against Arthrex, a Florida device company. The patients argued they were forced to undergo repeat operations to replace defective Arthrex knee devices implanted by Pennsylvania orthopedic surgeon Dr. Thomas Meade.

Meade was not a defendant in the cases. But the patients accused him of misleading them about the product’s safety and a recall. One noted that Meade had served as a prominent consultant to Arthrex and had “participated in the design, testing, marketing, promotion and sales” of the knee implant. The patient alleged that Arthrex had paid Meade more than $250,000 for work that included “promotional speaking, travel, lodging, and consulting.”

In court filings, Arthrex admitted making payments to Meade for “consulting and royalties” but denied wrongdoing. The cases were settled in 2020. Meade did not respond to requests for comment.

Chin’s dual roles as SpineFrontier’s CEO and user of its hardware was called a “huge” conflict of interest by a judge in a pending malpractice case filed against him and the company in South Florida.

In that case, Miami resident Patrick Chapoteau alleges Chin performed back surgery in 2014 using SpineFrontier hardware even though it had little chance of success. According to the suit, a Chin-designed screw implanted to stabilize Chapoteau’s spine broke in half, causing him pain and disabling injuries.

In a legal brief, Chin’s lawyers argued that he regularly operates on people with disabling back problems, noting: “The surgery is sophisticated and challenging. On a few rare occasions, his patients have not obtained the relief they expected or experienced unanticipated complications that required additional care.”

Joseph Wooten, a former Chin patient and Florida power company employee, alleged in a 2014 lawsuit in Broward County Circuit Court that Chin had 15 previous malpractice claims that had ended in more than $8 million in settlements, an assertion Chin’s lawyers disputed.

“He never told me of his bad record injuring people,” Wooten, 64, wrote in a court filing. He and his wife, Kim, said the surgery caused “debilitating and life-altering injuries.” The case has since been settled. Chin acknowledged no wrongdoing and the terms are confidential.

KHN reviewed court pleadings in nine settled malpractice cases in Philadelphia, where Chin served on the faculty of the University of Pennsylvania Medical School from 2003 to 2007, and six in South Florida filed since 2012. Details of the settlements are confidential. Five of the six South Florida cases are pending, including one filed in December by the widow of a man who died shortly after spine surgery. In all the cases and settlements, Chin has denied negligence.

In her lawsuit pending against Chin in South Florida, Nancy Lazo of Hialeah Gardens, Florida, said she slipped and tumbled down the stairs outside her Miami office, landing on her back and arm. When the pain would not go away, she turned to Chin and had two operations, in 2014 and 2015. Her lawyers allege that a SpineFrontier screw Chin implanted in her spine in the second procedure caused nerve damage. Lazo, 51, a former billing clerk with two adult sons, said she can no longer work and remains in “constant” pain. “Based on what my doctors have told me,” she said, “I will never get back to normal.” Chin denied any negligence and the case is pending.

Government Struggles to Keep Pace

Concerns that industry payments can corrupt medical practice have been aired repeatedly at congressional hearings, in media exposés and in federal investigations. The recurring scandals led Congress to require that device makers and pharmaceutical companies report the payments, starting in August 2013, to a government-run website called Open Payments. That website shows that payments to all doctors have risen from $8.6 billion in 2014 to just over $10 billion last year. A recent study found payments by device makers exceeded those of pharmaceutical companies by a wide margin.

Both the North American Spine Society and the American Academy of Orthopaedic Surgeons told KHN that close ties with the industry, while seeming to generate huge payouts to some surgeons, lead to the design of safer and better implants.

“These interactions are really essential for good outcomes in patient care and that needs to be preserved,” said Dr. Joshua J. Jacobs, who chairs the orthopedic surgery department at Rush University Medical Center in Chicago and the AAOS’ ethics committee.

Although more than 600,000 American doctors lap up industry largesse, most do so through small payments that cover the cost of food, drinks and travel to industry-sponsored events. When it comes to big money, however, orthopedists and neurosurgeons dominate, collecting 25% of the total — even though they represent only 5% of the doctors accepting payments, according to the KHN analysis of Open Payments data.

Dr. Charles Rosen, a spine surgeon and co-founder of the advocacy group Association for Medical Ethics, said he was once offered $2,000 just to show up and watch an industry-sponsored panel. “It was quite unbelievable,” he said.

Rosen said while he believes a “relatively small number” of surgeons cash whopping industry checks, many who do so are influential figures who can “help direct medical care.”

Government data confirms that even as several orthopedic and neurosurgeons received tens of millions of dollars in 2019, 81% of them got less than $5,000 from industry.

Federal officials recently signaled their displeasure with the hefty fees paid to doctors who promote their products to peers, especially at restaurants, entertainment or sports venues that feature free food and booze but little educational content. In November, the inspector general at the Department of Health and Human Services issued a special fraud alert that such gestures could violate anti-kickback laws.

Companies that ignore the reporting law can be fined up to $1 million, though no fines were levied from 2014 through spring 2020, according to a CMS report. That changed in October, when device giant Medtronic agreed to pay the government $9.2 million to settle allegations that it paid kickbacks to Sioux Falls, South Dakota, neurosurgeon Dr. Wilson Asfora to promote its goods.

Officials said the company sponsored more than 100 events at a Brazilian restaurant owned by the surgeon to clinch the sales. Just over $1 million of the fine was assessed for failing to report the transactions. A Medtronic spokesperson said the company fired or took other disciplinary action against the sales employees involved and “remains committed to maintaining the highest standards of ethical conduct.”

KHN identified four spinal device makers — including SpineFrontier — that have been accused in whistleblower cases of scheming to hide consulting payments from the government.

Responding to written questions, a CMS spokesperson said the agency “has multiple formal compliance actions pending which it is unable to discuss further at this time.”

But penalties for paying, or accepting, kickbacks often are small compared with the profits they can generate.

“Some people would say if you penalize companies enough, they won’t be making these offers,” said Genevieve Kanter, an assistant professor at the University of Pennsylvania Perelman School of Medicine. She said small fines may be chalked up to the “cost of doing business.”

The Federation of State Medical Boards does not keep data on how often its members discipline doctors for civil kickback offenses, according to spokesperson Joe Knickrehm. The federation has “long advocated for stronger reporting requirements,” Knickrehm said.

Justice Department officials would not discuss whether they are seeking fines from more surgeons. But in a statement in April 2020, then-U.S. Attorney for the District of Massachusetts Andrew E. Lelling noted that the government will investigate any doctor “who accepts money from a device manufacturer simply for using that company’s products.”

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