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.

Are NSAIDs Really Better Than Opioids for Post-Operative Pain?

By Pat Anson, PNN Editor

There have been a rash of recent studies promoting the use acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) over opioids for post-operative pain.

One such study at a Houston hospital led surgeons to conclude that patients were better off with Tylenol. "This study provides us with a strategy to successfully manage pain after surgery using over-the-counter pain medication,” said Min Kim, MD, head of thoracic surgery at Houston Methodist Hospital.  

But critics point out that most of the studies never examine how patients feel about the effectiveness of their pain treatment — focusing instead on the number of opioid pills and smaller opioid doses being prescribed. Pain relief was a secondary consideration, if it was considered at all.

A rare exception to that is a study recently published in the Canadian Medical Association Journal (CMAJ), which found that ibuprofen and other NSAIDs gave better post-operative pain relief than the opioid codeine. In a systematic review of 40 clinical trials involving over 5,000 patients who had outpatient procedures, researchers said patients who took NSAIDs had lower pain scores 6 and 12 hours after surgery than patients taking low doses of codeine.

"In all surgery types, subgroups and outcome time points, NSAIDs were equal or superior to codeine for postoperative pain," wrote lead author Matthew Choi, MD, Associate Professor of Surgery at McMaster University in Ontario. "We found that patients randomized to NSAIDs following outpatient surgical procedures reported better pain scores, better global assessment scores, fewer adverse effects and no difference in bleeding events, compared with those receiving codeine.

“These findings are of general importance to any clinician performing painful medical procedures. The various trials in our meta-analysis evaluated a range of procedures, different NSAID types and various degrees of acetaminophen coadministration.”

But critics say the McMaster study also has flaws. The claim that “all surgery types” and “a range of procedures” were included in the analysis is misleading at best. Most of the studies — 28 of the 40 that were analyzed — involved dental surgery, a fact that is not sufficiently disclosed. The rest of the outpatient procedures were for plastic surgery and orthopedic corrections – which can hardly be compared to more serious surgeries that require more pain relief and days or weeks of recovery, not just 6 to 12 hours.      

Another issue is the use of codeine as a research subject. Stefan Franzen, PhD, a chemistry professor at North Carolina State who has an extensive background in biomedical research, questions whether low doses of codeine should even be compared to NSAIDs.

“I question the premise that codeine is the drug that is or should be used by dentists,” said Franzen, author of “Patient Z,” a book the examines the criminalization of pain care. “I read a few papers not cited by this report and they too do not find a great efficacy for codeine. Part of this may be dose. Most commonly they are using 30-60 mg of codeine, which is 5-10 mg of morphine. Not very much if you have severe pain.

“Codeine may be a poor choice, but it may also be a straw man. Why not use tramadol, for example?”

‘Manipulated Data’

Patient advocate Bill Murphy also has doubts about the selection criteria used in studies touting the benefits of non-opioid pain relievers. He believes some researchers cherry-pick evidence to support a conclusion they’ve already reached.

“Opioid sparing post-op surgery programs are nothing more than an attempt to solve a non-problem and in doing so, patients suffer needlessly. The data produced from such programs are very often manipulated by those who designed the program in an obvious attempt to skew the results in favor of a program they endorsed,” said Murphy, who helped get legislation passed in New Hampshire to ensure that pain patients have access to opioid medication.

Murphy has advocated on behalf of patients at Portsmouth Regional Hospital, which has an “Enhanced Surgical Recovery” program that significantly reduced the use of opioids. Instead of Vicodin, patients get Neurontin or nerve blocks for pain relief.

“I was personally called in to advocate on behalf of several patients who were left to suffer in pain following surgery only to have staff assure them their pain was being well managed,” Murphy explained in an email. “Surgeons and nurses reported they were doing very well with Portsmouth Regional’s new protocol for managing post-op pain when in fact, they were not doing ‘very well’ at all.

“These patients were in horrible pain. Of the three I spoke with, none were ever provided any relief. I was with one patient as she was discharged. She was in tears and moved at a glacial pace due to pain as her son and I helped her into his vehicle outside. It was heartbreaking to watch. Her adult son was furious. I stayed in touch with each patient for several weeks afterwards. Each suffered greatly, one was not making any gains in physical therapy due to her lasting pain.”

In 2019, only 11% of patients were prescribed an opioid while at the Portsmouth hospital, and less than 6% were discharged with an opioid prescription. Murphy says the hospital’s policy inevitably leads to some patients with poorly treated pain.  

“What Portsmouth Regional Hospital’s ‘Enhanced Surgical Recovery’ program was doing is akin to making patients bite down on a piece of wood, grind it out, and then convince them the whole experience was for their own good,” says Murphy.    

Did Pacira Lie to Investors or a Federal Judge?

By Pat Anson, PNN Editor

The war of words between Pacira BioSciences and the American Society of Anesthesiologists (ASA) continues to escalate, with new allegations that the drug company either lied to its investors or a federal judge.

New Jersey-based Pacira filed a lawsuit in April over three articles in the ASA journal Anesthesiology that disparaged Pacira’s flagship product Exparel, an injectable non-opioid analgesic used for postoperative pain. An editorial and two peer-reviewed research articles said Exparel worked no better than other bupivacaine products, even though it costs 10 times more.

Pacira filed a libel complaint against the ASA in federal court seeking a retraction and damages for “significant pecuniary harm.” The company said “multiple existing customers” had either stopped using Exparel or were considering it because of the journal articles.

If true, that would be a significant blow to Pacira, since Exparel accounted for 96% of the company’s revenues in 2020.

The ASA filed a motion last week asking a federal judge to dismiss the case, calling the lawsuit “an egregious and unjustified public relations campaign that seeks to chill scientific research and debate.”

‘Nothing to Worry About’

The ASA motion quotes a statement from a May 4 earnings call, in which Pacira CFO Charlie Reinhart told analysts that “we don’t have anything to worry about” and “actually things are going very, very well,” despite the negative reviews of Exparel in the medical journal.

In a preliminary report released last week, Pacira even boasted about sales of the drug. “Exparel sales continue to significantly outperform the elective surgery market recovery, with May marking our fourth consecutive month of sequential growth in average daily sales,” the company said in a statement that didn’t mention the lawsuit.

“In other words, Pacira is lying either to a federal judge or its investors,” the ASA said in a press release Monday.  

A Pacira spokesperson declined to respond to the ASA statement, telling PNN that “our corporate policy is not to comment on pending litigation.”

Exparel was first approved by the FDA in 2011 as a local anesthetic for post-operative pain in adults.  Its use has since been expanded to include children and as a nerve blocking agent.  Pacira says over 8 million patients have been treated with Exparel. The drug is primarily sold to hospitals and ambulatory surgical centers. One of the biggest purchasers is the U.S. Department of Defense.

In the past, Pacira has gone to great lengths to promote Exparel and silence critics.  In 2014, the company filed a lawsuit against the FDA after the agency sent a warning letter to Pacira for off-label marketing of Exparel. In 2020, Pacira agreed to pay $3.5 million to resolve allegations that it gave kickbacks to doctors to promote Exparel in research articles.

Chronic Pain Runs in My Family

By Victoria Reed, PNN Columnist

While I was growing up, I knew my mother used a lot of over-the-counter pain relievers. At the time, I didn’t think much of it. As a child, I didn’t view my mother as sick, especially since she rarely went to doctors.

I knew she had a history of major back surgery, and besides being frequently tired and living with sore muscles and a lack of sleep, she seemed to just carry on without the help of doctors.

Now as I look back and take a closer look into the past, I believe my mother suffered from the same or similar chronic pain conditions as I do: degenerative disk disease, fibromyalgia and possibly rheumatoid arthritis.

Two of my sisters also suffer from degenerative disk disease, fibromyalgia, RA and lupus. My brother had severe scoliosis and longstanding chronic back pain. He lived most of his life in pain and died at a relatively young age. In addition, a maternal aunt had chronic pain from multiple sclerosis and eventually died from the disease.

I often wondered if there was anything I did to earn my many diagnoses, but knowing my family’s history has answered that question for me. Studies show that some chronic pain conditions and autoimmune conditions do, indeed, have a genetic origin. This genetic predisposition can be activated by something in the environment, such as a virus, and subsequently could trigger the onset of an illness.

When one of my sons was 6-years old, a respiratory virus caused his immune system to attack his kidneys, resulting in renal failure. He had glomerulonephritis, a condition where the kidneys’ filters become inflamed and scarred. The result is that waste products build up in the blood and body. He had only 15% of his kidney function remaining at the time of diagnosis.

Unfortunately, my son received three misdiagnoses in the two weeks prior to receiving the correct one! Being a fierce advocate for him and knowing with a mother’s intuition that something was seriously wrong, I pushed for doctors to not dismiss his symptoms and look deeper for the problem, as he had begun to swell up. Without proper treatment, he could have ended up on dialysis, the kidney transplant list or suffered from chronic kidney disease for the rest of his life.

Fortunately, after finally getting an accurate diagnosis and quality in-patient supportive care, he began to recover. Today he is a healthy, active 19-year-old with no residual kidney problems.

My 16-year-old daughter has also been diagnosed with fibromyalgia. She suffers from muscle pain, soreness and severe fatigue. I have seen doctors unwilling to take her complaints seriously and unwilling to treat her with anything.

Furthermore, one of my sons also has scoliosis, and having seen what my brother experienced, his future concerns me as well. Many people with scoliosis suffer from back pain throughout their lives.

I am concerned about what my children’s futures may look like, in light of the difficulties that many chronic pain patients face today. As a mom, I will continue to advocate for my daughter’s care and encourage her to advocate for herself as she grows up. It is my hope that compassion and willingness to treat patients properly will return to the specialty of pain management. Parents should not have to fear that their children will be allowed to suffer.

I’m sure that my family is not unique. Families with multiple chronic pain conditions should rally together for support, understanding and most importantly, adequate pain care!

My sisters and I often compare notes and discuss our various treatments. We support each other through our toughest days, and just having that emotional support from each other makes a world of difference. However, many in our chronic pain community do not have that kind of support and are either not believed or taken seriously. Support groups can be very useful in these situations, and I have found that they are helpful. Being a part of a support group assures me that I am not alone in my struggles.

I encourage anyone who feels alone to reach out to someone or join a support group. With social media, it’s now easier than ever to be connected with people when there is no family support.

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

Medical Cannabis No Help to Lobsters

By Pat Anson, PNN Editor

Do lobsters feel pain when they’re boiled alive?

Seafood lovers, cooks, academics, animal rights activists and even governments have debated that question for years, with the general consensus being that they do. Lobsters, crabs and other crustaceans will often writhe in pain and try to escape when dropped into a pot of scalding hot water. The practice is considered so cruel that Switzerland and New Zealand made it illegal to boil a live lobster.

Some cooks try to ease the lobsters’ pain by stunning them with a jolt of electricity or putting them on ice to dull their senses before cooking them.  In 2018, a restaurant owner in Maine even blew marijuana smoke on a lobster named Roscoe, who reportedly grew so mellow he never wielded his claws as weapons again while in captivity.

We’ll never know the long-term effect of getting a lobster stoned because Roscoe was returned to the ocean as a thank you for his service. Good for him.

Which brings us to a bizarre study recently completed by scientists at the University of California San Diego and the Scripps Research Institute, who decided to replicate the Roscoe experiment in a lab.

"The 2018 minor media storm about a restaurant owner proposing to expose lobsters to cannabis smoke really was the starting point. There were several testable claims made and I realized we could test those claims. So we did," lead author Michael Taffe, PhD, an adjunct professor at Scripps Research told IFLScience.

Taffe and his colleagues purchased ten Maine lobsters at a local supermarket, fed them a last meal of frozen krill and fish flakes, and placed them in an aerated vapor chamber.

For the next 30 to 60 minutes, the lobsters were exposed to vapor rich in tetrahydrocannabinol (THC), the psychoactive ingredient in cannabis.

Afterwards, some of the lobsters were “rapidly euthanized” with a kitchen shear and dissected, while others were immersed in hot water to see how they’d react.

bioRxiv

Detectable levels of THC were found in the muscles and organs of the euthanized lobsters, so from that standpoint the experiment was a success. But the THC apparently had little effect on the remaining live lobsters, who displayed “distinct motor responses” and other signs of pain when put in hot water.   

"The effect of vapor THC on this nociceptive (pain) behavior was very minimal. Statistically supported in one case, but of very small magnitude," said Taffe.

We’ll leave it to readers to decide whether a study like this is humane, worthwhile or even makes sense. But it is worth noting that taxpayers helped pay for it.

The lobster cannabis study was supported by grants from the U.S. Public Health Service. Researchers were careful to note that federal funding was not directly used to purchase the lobsters. That money came from La Jolla Alcohol Research, a private company that is developing vapor inhalation technologies.  According to GovTribe, La Jolla Alcohol Research has received about $3 million in federal funding in recent years, most of it coming from the National Institute on Drug Abuse.

Did CDC Opioid Guideline Have ‘Unexpected Benefit’ for Surgery Patients?

By Pat Anson, PNN Editor

Since its release in 2016, the CDC’s opioid prescribing guideline has had a sweeping impact on pain management in the United States. Although only intended for primary care physicians treating chronic pain, the guideline’s recommended limits on opioids have been widely adopted by states, insurers, pharmacies, hospitals and doctors treating all types of pain.

A new study published in JAMA Network Open documents how opioid prescribing for post-operative acute pain fell significantly in the first two years after the guideline’s release.      

Researchers looked at prescribing data for over 360,000 patients who had 8 common surgical procedures and found that the amount of opioids initially prescribed after surgery fell by an average of 16 percent. The decline for each patient was the equivalent 11 oxycodone 5mg tablets.  

“This study has important policy and practice implications. Although the primary focus of the 2016 CDC guideline was on opioid prescribing for chronic pain, our findings suggest that the guideline was associated with clinically relevant changes in patterns of opioid prescribing after surgery,” wrote lead author Tori Sutherland, MD, a Professor of Anesthesiology at the Perelman School of Medicine, University of Pennsylvania.

The study didn’t look at what alternatives surgery patients were given for pain management or whether they were satisfied with their pain relief. But because refill rates were unchanged after the guideline’s release, Sutherland and her colleagues concluded that “it is unlikely that guideline misapplication led to significant opioid underprescribing for surgical pain.”

An editorial also published in JAMA Network Open called the decline in opioid prescribing for post-operative pain “a promising trend” and said further cuts were needed to reduce the number of leftover pills.

“The 2016 CDC guideline for chronic pain may have provided an unexpected benefit to surgical patients by accelerating the alignment of opioid prescribing with amounts recommended in surgery-specific prescribing guidelines. Nonetheless, much room for improvement remains,” wrote lead author Mark Bicket, MD, an anesthesiologist at the University of Michigan School of Medicine.

“We have known for a long time that the average patient has been prescribed nearly twice as much opioid as they need, or will use, following surgery,” said Dr. Lynn Webster, a PNN columnist and pain management expert. “This unused medication has been a major source of diverted opioids that have contributed to the national illicit drug use problem. In this regard, their observation does suggest fewer drugs are available for diversion. That is a good thing.

“However, mean data does not take into account an individual’s need. Some patients need more medication than other patients for the same surgical procedure. It is unhelpful to use dose reduction as a measure of improved care. We should focus on using the appropriate amount of opioids for the appropriate length of time to achieve improved prescribing.”

Webster said it was speculative to suggest that the CDC guideline had an “unexpected benefit” for surgery patients. The best measure is whether overdose deaths are decreasing – and by that standard the guideline has been a failure. Five years after its release, opioid prescribing is at 20-year lows while overdose deaths are at record highs, fueled largely by illicit fentanyl and other street drugs.

“Cleary, the decline in opioids prescribed for post-op pain has not improved that outcome which is, arguably, the most important outcome to measure,” said Webster.

Opioid addiction is actually rare after surgery.  A large 2016 study found only 0.4% of older adults were still taking opioids a year after major elective surgery.  Another large study in 2018 found only 0.6% of patients who took opioids for post-operative pain were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Rare Disease Spotlight: Dupuytren’s Contracture

By Barby Ingle, PNN Columnist 

This month’s rare disease spotlight looks at a painful hand deformity called Dupuytren’s contracture. My father had this condition and I know two other men who have it; one white and one Hispanic. It is most common in older men of Northern European descent, which is why it is known as the “Viking disease.” It occurs in about 5 percent of people in the United States.

Dupuytren’s contracture usually affects the ring and “pinky” fingers, making it difficult to completely straighten them or pick up objects. It develops over time when knots of tissue form under the skin, creating a think cord that can pull one or more fingers into a bended position. Only rarely are the thumb and index finger affected. Dupuytren's can occur in both hands, though one hand is usually affected more severely.

Doctors don’t know what causes Dupuytren's and there is no evidence that hand injuries or occupations that involve the hands contribute to it. My father used to say his condition developed from playing football and getting his fingers smashed between the pads of other players. Interestingly, former NFL quarterback John Elway has Dupuytren’s and recently began appearing in TV commercials promoting a non-surgical treatment.

Dupuytren’s can be very frustrating for those trying to do everyday actives like putting your hands in your pockets, putting on a glove or just shaking hands. As it progresses, the skin on your palm might appear puckered or dimpled. A firm lump of tissue can form on your palm that is sensitive to touch.

I had similar symptoms for several years, but for a very different reason. My right hand and foot curled up due to Reflex Sympathetic Dystrophy (RSD). My symptoms improved after I began infusion therapy in 2009, but my fingers remain affected and the lump in my palm is still sensitive.  

My dad’s fingers were so bent up, he had surgery to straighten them. They just curled up again and never functioned well, before or after surgery. This is known as treatment-resistant Dupuytren’s. There is no way to know if you have a treatment resistant version until surgery is tried.  

Dupuytren's contracture occurs most commonly in men over the age of 50. Men are also more likely to have severe symptoms than women. The condition tends to run in families so there may be a genetic component that has yet to be confirmed. If you are the first in your family to get it, it’s possible that tobacco and alcohol use may contribute to it developing. My dad had diabetes II, which is also a risk factor, although he had Dupuytren's prior to being diabetic.

For those with mild forms of this condition, you can do a few things to help slow its progress. Start with avoiding projects with tight grip requirements, like mechanical work with small tools, or use padding on your hands to protect them.

In some cases, Dupuytren's does not progress or does so slowly. But if treatment is needed, it may involve surgically removing or breaking apart the cords that are pulling your fingers toward your palm. The choice of procedure depends on the severity of your symptoms and other health problems you may have.

There is a procedure less invasive than surgery where a needle is inserted through your skin. If contractures recur, the procedure can be repeated. This option requires little to no physical therapy, but can damage nerves or tendons in your hand.

There is also a medication, called Collagenase Clostridium Histolyticum, which can be injected into your hand so the provider can try to break up the cord and straighten your fingers. The injections are not widely offered and have similar drawbacks to the needling option.

My father chose surgery because his condition was advanced and he had limited use of his hand.  His provider surgically removed the tissue in his palm that was affected by the disease and closed it up with a skin graft. The results were mixed. For a few years, my father could open his hand and spread some of his fingers, but he did not get total strength or movement back and it progressively worsened as he aged. He also had physical therapy while recovering from the surgery, which took about 6 months for him. He said it was worth the try.

If you are looking for a Dupuytren's resource center and support group, one of the better ones I found is run by University of California, San Francisco. They provide a variety of services, including social workers and condition-specific support groups, as well as classes to help patients and their families.

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

Why Good Nutrition Is Needed for Intractable Pain Syndrome

By Forest Tennant, PNN Columnist

If you have Intractable Pain Syndrome (IPS) or a condition that commonly causes IPS, such as arachnoiditis, adhesive arachnoiditis, cauda equina syndrome, Ehlers-Danlos Syndrome, traumatic brain injury, stroke or Complex Regional Pain Syndrome (CRPS), you should underpin your treatment program with a nutritional one.

Our research and experience clearly tell us that a proper nutrition program is essential for pain relief and to prevent the progression of IPS. Without a good nutritional program, neither medication or other medical measures will be very effective.

Persons who have IPS develop what is known as a “catabolic state.” The term means that the cellular matrix of the body is slowly degenerating, rather than its normal state of constant cellular regeneration, known as an “anabolic state.”

In IPS, cells and tissues inside and outside of the brain and spinal cord (CNS) progressively degenerate because of IPS’s combined effects of inflammation, hormonal deficiencies, and autoimmune attacks on tissues. If one has a genetic connective tissue/collagen disorder (EDS or other), then cellular catabolism or deterioration is grossly multiplied.

Cellular deterioration in IPS initially attacks small nerve fibers and the small cells in the CNS and skin, but later other tissues may be involved. Muscle mass deteriorates and is replaced by fatty tissue, so weight gain occurs. In late stages of catabolism, severe muscle loss may occur, giving the patient the appearance of starvation and emaciation. Weakness and fatigue set in. Memory, reading ability and logical thinking decline. Medications, including opioids, may not be as effective as they once were.

Persons with IPS must daily attempt to control catabolism through proper nutrition, which helps stop disease deterioration, reduces inflammation, regrows damaged nerves (neurogenesis), alkalizes body fluids, and improves pain relief and energy.

There are five basic components of an IPS nutrition program:

1. Eat protein every day and include protein in ALL meals.

2. Eat green vegetables, and select fruits and nuts

3. Control cholesterol and glucose

4. Daily multi-vitamins and minerals

5. Daily supplements for nerve regrowth and inflammation

Protein is Key

The most critical component of an IPS nutrition program is protein. IPS tends to decrease a desire for protein and promotes a craving for sugar and starches. The major protein foods are beef, pork, lamb, chicken, turkey, seafood, cottage cheese and eggs. Protein drinks and bars can also be used as alternatives.

Why is protein so important? It contains all the fuel (amino acids) needed by the body to make more endorphin, serotonin, dopamine, norepinephrine, insulin and other hormones. Protein builds tissue, repairs cells and helps stabilize blood sugar. Meals with no protein will likely increase pain and inflammation, which prevents healing.

Foods that are mainly sugar and starches (carbohydrates) cause sugar (glucose) to rise in the blood. Fatty foods cause cholesterol to raise in the blood. New research shows that high levels of glucose and fat may cause inflammation and damage to the neurotransmitters and receptor systems that control pain. 

IPS patients should have their glucose and cholesterol levels tested on a regular basis. If abnormally high or low, work with your medical practitioner to normalize them.  

You can help by reducing sugars and fats in your diet, and by eating meals on a regular schedule, even if you are not hungry. This will help balance your glucose and lessen your pain over time.   

You may also want to consider a gluten free trial. Stop eating bread, cereal, noodles and other foods containing gluten for one week to see if you feel better. 

Green Is Good 

Vegetables, fruits and nuts can also help reduce inflammation, alkalinize your body fluids, and promote tissue healing. The best green vegetables are broccoli, kale, brussel sprouts, asparagus, green beans, spinach, snap peas, chard, mustard greens, turnip greens, collards, and cabbage. Avoid eating potatoes and corn, which are loaded with carbohydrates. 

The best fruits are blueberries, pineapple, raspberries, blackberries, cherries, oranges, plums, apples, strawberries, and peaches. Avoid eating bananas. The best nuts to eat are pistachios, almonds and peanuts. 

To help regrow damaged or diseased tissues, take daily supplements containing vitamins B12 and C, collagen, amino acids and natural hormonal agents such as colostrum or DHEA. A daily multi-vitamin and mineral tablet is also helpful, along with a daily plant-based anti-inflammatory agent such as curcumin/turmeric or quercetin. 

Ask yourself: Is what I am eating right now helping or hurting? If you don’t know or want more information, the IPS Research and Education Project has just published a 12-page nutritional program designed specifically for people with IPS. You can download a free copy by clicking here.  

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

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

Addiction Is the Problem, Not Pain

By Carol Levy, PNN Columnist

The war on drugs always seems to target pain sufferers. We are the number one example of what happens when someone is given opioids. We are the villains, our pain the “gateway” to addiction -- a fiction that no one seems able to dispel, regardless of the evidence and common sense.

Why are we the bad guys? Is it because we are the easiest to single out?

Maybe.

I was watching an episode of the old TV show “ER.” One of the main characters, Dr. John Carter (Noah Wyle), was stabbed repeatedly by a psychotic patient. His pain was horrendous, his need for opioids obvious. Dr. Carter survived the attack, but became addicted. In one scene, he even goes to the extreme of injecting himself with fentanyl.

I began to recall other shows where the plot was the same: injury, opioids to manage the acute pain, and then full-blown addiction.

In an episode of “The Golden Girls,” Betty White's character, Rose Nyland, discloses she was addicted to pain pills. She started taking them 30 years earlier after she injured her back. Her doctor never told her to stop taking them, so she continued using opioids for decades. It was her secret until her roommates figured it out.

It is a shame that TV shows like these don’t include a disclaimer: These characters had acute pain, not chronic. Most people with chronic pain do not become addicted.

It’s a common belief that if you have acute or chronic pain and are given opioids that you will probably become addicted. But has anyone ever studied the two types of pain and their rates of addiction?

I Googled it using the words "chronic pain and addiction vs acute pain and addiction." There were no studies that directly compared the two. The results were either about chronic pain and addiction, or acute pain and addiction. I changed the search terms to “acute pain, opioids, addiction rates.” The results were the same.

Why hasn't anyone looked into the differences in addiction in these two very dissimilar populations?

Why has no one done studies with a population of acute pain patients who became addicted after an injury or surgery? Then compare those rates with chronic pain patients who become addicted?  If they have, I wasn’t able to find them.

Are chronic pain patients being villainized because we are the most visible population?

It is always easier to go after the most desperate and the most vulnerable -- and when it comes to opioids and managing pain, we fit the bill. We will continue to be the bogeyman in the “opioid crisis” until this changes.

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.