California Doctor Reluctantly Agrees to Probation for Opioid Prescribing

By Pat Anson, PNN Editor

After a two-year battle with the state medical board, a northern California doctor accused of overprescribing opioid pain medication has agreed to a settlement that allows her to continue practicing while under probation for the next 35 months.

“I settled because I could not afford the legal fees to fight it further and because I was offered a deal that allowed me to continue to prescribe as I see fit, so that no one would get cut off their meds suddenly,” says Corinne (Connie) Basch, MD, a primary care physician in Arcata, a small city in rural Humboldt county.

“I was afraid if I went to a hearing and tried to appear pro se (without an attorney) and somehow pissed off the judge I might wind up with a settlement that prohibited prescribing for a year, which was their initial proposal, and that there might be preventable deaths in my patient population as a result.”

If Basch’s medical license was suspended or revoked, all 1,500 of her patients would have to find new doctors, not a simple task in a remote community where healthcare choices are already limited, especially for pain patients.

The 2019 complaint against Basch by the Medical Board of California centered on her treatment of five patients on relatively high doses of opioids and benzodiazepines, an anti-anxiety medication.

Although Basch tried to taper the patients to lower doses, the complaint alleges their dosages were still excessive and placed them at risk of overdose. No allegations were made that any of Basch’s patients were harmed while under her care.

DR. CORINNE BASCH

“I have a number of people who have been absolutely unsuccessful with every attempt to taper, for whom I was afraid,” Basch wrote in an email to PNN. “I also read some old decisions, basically convictions of doctors in my region. I read how the judges made their decisions: basically going completely on the credibility of this or that expert witness, imputing expertise on state expert witnesses who had not seen any patients for multiple years. 

“It was becoming increasingly clear to me that nobody was going to actually read any of the medical literature that objects to forced tapers and so on — that this whole thing was not going to be argued on its merits, that I was going to be perceived as a defensive miscreant, not as someone bound by conscience to make a different choice.”

Under the strict terms of her settlement, which takes effect today, Basch is required to keep detailed records of all controlled substances she prescribes, which must be “available for immediate inspection and copying” by board investigators. She must also take a series of educational classes on safe prescribing and medical record keeping, and have her practice monitored by another physician throughout her probation – all at her own expense.

Basch is worried about how she will pay for it all -- her entire income last year was $50,000 – but feels obligated to her patients to keep practicing.

“I have some guilt about caving, and also some fear about whether I can actually survive the financial costs of the probation, particularly in the middle of this pandemic which has been so incredibly expensive and challenging for my practice already, but ultimately I felt that I was going to be best able to protect my patients with this choice,” she said.

“As you can tell, I am still incredibly angry about the whole thing, and I feel that the medical board is actually contributing to increased deaths in California, as well as tragically harming our profession.” 

Doctors Shamed for Prescribing Opioids

The California medical board has come under fire in recent years for its controversial “Death Certificate Project,” which resulted in threats of disciplinary action against hundreds of doctors who wrote opioid prescriptions for patients who fatally overdosed, sometimes years later.

The goal was to shame doctors to reduce opioid prescribing, but a recent study found that overdose deaths actually increased in the state after the project was launched. Many of the deaths involved street drugs, not prescription opioids.

Critics say the Death Certificate Project and other enforcement actions have had a chilling effect on doctors statewide.

“I am still incredibly angry about the whole thing, and I feel that the medical board is actually contributing to increased deaths in California, as well as tragically harming our profession.”

— Dr. Corinne Basch

“Through your project, you have attacked many prominent, respected physicians, publicly shaming them as careless prescribers and threatening any doctors who had ever prescribed opioid pain medications for someone who ultimately died. This ‘witch hunt’ has caused many deaths and much suffering,” Kristen Ogden and other patient advocates with Families for Intractable Pain Relief wrote in a recent letter to the medical board.

“When you consider how many California physicians have left the practice of pain care, only a small percentage of the patients harmed have managed to continue to receive pain care at all. Most have not found any pain care, and are suffering agonizing lives for no reason. A few patients we knew have committed suicide because they did not find adequate care and were unable to live with the agony of untreated severe, constant intractable pain.”

The Death Certificate Project is now under review by the medical board and has been given the less inflammatory name of “Prescription Review Program.”

Basch was not targeted under program, but believes the board’s disciplinary actions against her and other doctors have only made the opioid crisis worse.  

“I feel there is a significant parallel to the medical board claiming to ‘do something about the opioid crisis’ and in fact doing the exact wrong thing, taking stable patients off of predictable prescribed medications and throwing them out to street supply which is increasingly adulterated and hazardous. This triumph of appearance over substance is at the root of so many wrongs in our current system,” Basch said.

“I do feel that the medical board should in some way be held accountable for their own negligence, for making policies and not monitoring the outcome, for doubling down on these policies even when the error has been pointed out to them. I am not sure how to get politicians interested in the situation, because it implies understanding the situation with enough depth to see that ‘opioids – bad’ is not a well- conceived policy.”

Insurance Claims Show Lyme Disease More Widespread

By Pat Anson, PNN Editor

A new analysis of insurance claims by the Centers for Disease Control and Prevention suggests that Lyme disease may be far more widespread in the United States than current estimates.

CDC researchers looked at data from MarketScan, a large commercial insurance claims database, and found that Lyme disease diagnoses from 2010 to 2018 were six to eight times higher than the number of cases reported to a federal disease surveillance program.

Lyme disease is a bacterial illness spread by ticks. When left untreated, it can lead to chronic disorders such as fatigue, muscle and joint pain, cognitive issues and other symptoms that are often diagnosed as fibromyalgia, neuropathy and autoimmune disorders.

Most reported cases of Lyme disease occur in 14 states in the Northeast, mid-Atlantic and upper Midwest, especially during the summer months when more people spend time outdoors. Recent studies show Lyme is spreading to neighboring states and is no longer just a seasonal disease, possibly do to the effects of climate change.

The CDC analysis of insurance claims filed by nearly 23 million Americans identified over 140,000 people who were diagnosed with Lyme disease during the study period. That works out to a nationwide rate of 73 cases for every 100,000 people, a rate substantially higher than the 9 cases per 100,000 reported by the surveillance program.

“Age and sex distributions among Lyme disease diagnoses in MarketScan were similar to those of cases reported through surveillance, but proportionally more diagnoses occurred outside of peak summer months, among female enrollees, and outside high-incidence states,” wrote lead author Amy Schwartz, an epidemiologist in the CDC’s Bacterial Diseases Branch.

Schwartz and her colleagues say the larger number of Lyme cases reported by MarketScan may be the result of misdiagnoses, but the volume of claims warrant further investigation.

“Although Lyme disease diagnoses identified from claims data are not supported by the robust evidence of infection required for surveillance reporting, they are a consistent indicator of trends in the healthcare system. In addition, the sheer volume of data available through MarketScan provides potential for new insights into the epidemiology of Lyme disease diagnoses in the United States,” they said.

The CDC findings are similar to a 2017 analysis of insurance claims by the non-profit FAIR Health, which found an unexpected surge in Lyme disease cases during the winter and early spring.

Early symptoms of Lyme disease include fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes. A delayed rash often appears at the site of the tick bite. The rash grows in size and sometimes resembles a bulls-eye. Lyme disease is usually treated with antibiotics.

About 30,000 cases of Lyme disease are reported annually by state and local health departments to the surveillance program. The CDC acknowledges, however, that the actual number of cases is probably much higher and that about 300,000 Americans may become infected every year.

Skin Patch Reduces Pain Without Use of Drugs

By Pat Anson, PNN Editor

A drug-free skin patch that uses nanotechnology to help dial down pain levels provided significant relief to people living with arthritis, neuropathy and musculoskeletal pain, according to the results of a small study.

The Kailo pain patch contains billions of tiny nanoparticles made with copper, silver and silicon that help transmit electromagnetic signals from the nervous system. In theory, the nanoparticles act as a “bridge” over inflamed nerve pathways and restore their ability to transmit pain signals properly.

The patch is made by Utah-based Pain Relief Technologies, which claims in marketing material that its patented technology provides “natural relief anywhere on your body, in seconds.”

In the study, 66 patients wore the Kailo patch while continuing to take oral analgesic medications such as opioids and non-steroidal anti-inflammatory drugs (NSAIDs).

After 30 days, self-reported pain levels dropped significantly and 98 percent of patients said they reduced or stopped using oral medication. Their mood, sleep, walking ability, and other quality of life measures also improved.

The study findings, published in the journal Anesthesia and Pain Research, suggest that the analgesic effects of the Kailo patch are long lasting. About one in every four patients said their pain did not return after the patch was removed. Over half said it took at least a day for the pain to resume.

CLARITY SCIENCE IMAGE

“Modern science has allowed the incorporation of nanotechnology into topical patch systems, minimizing, and in the case of Kailo, eliminating the need for drugs/pharmacological agents. The interim results of this study are incredibly positive, and we look forward to providing the next phase of data that we have collected from patients with mild, moderate or severe pain,” lead investigator Jeffrey Gudin, MD, said in a statement.

Gudin was compensated by Clarity Science for conducting the study. You may recognize him from TV commercials for SalonPas, a rival pain relief patch.

An anesthesiologist by training, Gudin has become a prolific researcher, consultant and public speaker for dozens of companies involved in pain management, including Purdue Pharma, Salix, BioDelivery Sciences and Quest Diagnostics. He’s been paid over $1.5 million for his services since 2013, according to the OpenPayments database. In an email to PNN, Gudin said most of the money has been used for research and consulting on new analgesic therapies.

The Kailo patch is reusable and can be purchased without a prescription for $119. Reviews on Amazon for Kailo are mixed.

“Immediately upon placing it on my low back I could feel a warmth and my pain decreased rapidly. I was able to go to work the next day with relative comfort,” wrote one buyer who suffered pain from a hamstring injury.

“Did not reduce pain actually increased pain level,” said a disappointed user.

“Nothing else has worked for me but this significantly reduced my pain. It does not completely remove the pain, so don't expect that. But it reduced it enough that I can play with my kids, mow the lawn, work, essentially be a normal human being without medication,” said another user.

“I used it for a week, received no relief whatsoever,” wrote another buyer. “I am very dissatisfied and would like my money back.”

Topical Gel Shows Promise as Treatment for Neuropathic Pain

By Pat Anson, PNN Editor

An experimental gel developed to prevent skin damage caused by aging and ultraviolet light is showing promise as a treatment for chronic neuropathic pain, according to research underway in Australia.

The topical gel – known as RM191A – contains a copper-based compound that is absorbed by the skin and prevents the buildup of free radicals that cause skin damage associated with aging and skin cancer.

In a study recently published in the journal Redox Biology, RM191A was found to have potent antioxidant, anti-inflammatory and wound-healing properties in laboratory mice.

The gel is currently being evaluated in 24 patients at a Sydney hospital as a treatment for chronic nerve pain caused by surgery, chemotherapy, trauma and diabetes.  Results are expected later this month.

“Early sample uses of this topical formulation indicated it could be a significant in the management of certain types of chronic nerve pain,” says Llewellyn Casbolt, chief scientist and co-founder of Sydney-based RR MedSciences, which is developing the gel.

“In many ways, scientists see our discovery as a new class of anti-inflammatory that acts by the modulation of free radicals as well as reducing several inflammatory cytokines, providing a drug that can be therapeutically useful where the reduction of inflammation, as well as cellular and tissue healing - indeed pain relief - is also advantageous for a patient.”

The company plans to release an over-the-counter version of its gel in the next 12-18 months as a treatment for skin damage. It will take longer to get regulatory approval for the gel as a treatment for nerve pain and may require a prescription.

RR MedSciences (RRMS) plans to conduct further trials and is seeking additional partners and funding to accelerate the gel’s development.

“The management of pain, often related to conditions of inflammation or trauma that results in nerve or chronic pain is an area of great need.  Advancing the ability for people to modulate their pain, in a safe and effective manner that improves quality of life, is a core objective,” said Helena Libershal Casbolt, CEO and co-founder of RRMS.

A subsidiary of RRMS is currently selling a copper-based body cream called Blue Healer Care as a treatment for damaged skin and for relief from skin irritation and muscle soreness.

Mild Withdrawal Common Among Pain Patients Who Use Cannabis

By Pat Anson, PNN Editor

About 10 percent of patients who use medical cannabis to relieve chronic pain develop more severe withdrawal symptoms, according to a new study that found most patients have only mild symptoms and remain stable after long-term cannabis use.

Researchers at the University of Michigan Medical School and the VA Ann Arbor Healthcare System followed 527 Michigan residents with chronic pain for two years, asking whether they experienced any of 15 different withdrawal symptoms – such as craving, nausea, irritability and aggression - when they had gone a significant amount of time without using cannabis.

At the start of the study, most had only mild (41%) or moderate (34%) withdrawal symptoms, with 25% of the patients classified as having severe withdrawal.  Researchers say many patients were not even aware they experienced withdrawal, attributing symptoms such as fatigue and poor sleep to their underlying pain conditions, not to any dependence on cannabis.

"Some people report experiencing significant benefits from medical cannabis, but our findings suggest a real need to increase awareness about the signs of withdrawal symptoms developing to decrease the potential downsides of cannabis use, especially among those who experience severe or worsening symptoms over time," says lead author Lara Coughlin, PhD, an addiction psychologist at U-M Medical School.

After one year, about 13% of the patients experienced more withdrawal symptoms, with 8% reporting more severe symptoms after two years. People who were younger, smoked cannabis, used larger doses, and had poor mental health were more likely to have severe symptoms.

However, the vast majority of cannabis users did not experience more withdrawal symptoms, with those who reported mild symptoms likely to stay that way. About 20% of patients reported fewer symptoms after one year and 14% had fewer symptoms after two years. Older age and vaping were associated with lower odds of having severe symptoms.     

“The majority of participants remained in their initial withdrawal class throughout the 2-year study period, with the highest stability among those with mild withdrawal symptoms at baseline. Of those who transitioned to another symptom class, transitioning to milder symptoms was slightly more common than transitioning to more severe symptoms,” researchers reported in the journal Addiction.

“For the majority of patients, the current findings indicate that the severity of withdrawal symptoms are likely to remain stable over time.”

Poor sleep was the most common withdrawal symptom, followed by depressed mood, decreased appetite, craving, restlessness, anxiety and irritability. The study did not assess whether cannabis was effective for pain relief or what form of ingestion worked best.

Cannabis Not Perceived As Risky

Most Americans believe cannabis has less abuse potential than alcohol and many commonly prescribed anti-anxiety and pain medications, according to survey results recently published in the journal Addictive Behaviors.

Researchers at the University of Delaware and Michigan State University surveyed over 1,000 adults in 2019 about their views on cannabis products such as hemp, CBD, THC and marijuana. The vast majority felt cannabis products have a valid medical use and have less abuse potential than hydrocodone, oxycodone, Xanax and Valium.

source: addictive behaviors

“These results suggest that consumers perceive CBD as more like an over-the-counter pain reliever such as Tylenol or Advil and less like prescription opioids,” researchers found. “They perceive CBD and hemp as medicinal and as having little potential for abuse, making them an attractive replacement for addictive pain relievers.”

The researchers acknowledged that there is little clinical evidence to support these views, but blame the lack of studies on the federal government’s classification of marijuana as a Schedule I Controlled Substance, saying it has “severely limited research.”

A longtime critic of federal marijuana policy was not surprised by the survey findings.

“The overwhelmingly majority of Americans have long abandoned the federal government’s ‘Flat Earth’ position that marijuana is highly dangerous substance without any therapeutic efficacy,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“It is time for Congress to jettison this intellectually dishonest position as well and remove cannabis from the Controlled Substances Act in a manner similar to alcohol — thereby ending the existing state/federal conflict and permitting state governments, not the federal government, to be the primary arbiters of cannabis policy.”

Serious Complications Caused By Poorly Treated Pain

By Forest Tennant, PNN Columnist

Most anyone will tell you that blood pressure goes up due to pain. What is almost unrecognized in medical practice today, however, is that untreated or undertreated pain has such profound and devastating effects on the cardiovascular and endocrine systems that it will inevitably shorten the lifespan of individuals with intractable pain syndrome (IPS).

Constant pain elevates adrenaline and glucose at the same time that it overstimulates the autonomic nervous system, resulting in these cardiovascular (CV) complications:

• High Blood Pressure (Hypertension)               

• Elevated Pulse Rate (Tachycardia)                             

• Elevated Cholesterol (Lipids)                       

• Arteriosclerosis  

• Angina Pectoris

• Cardiac Arrythmias

• Heart Attack

• Sudden Death

The body needs a rest from constant pain to rejuvenate and re-energize the body’s CV and endocrine systems. The first goals of pain treatment must include the attainment of at least some pain free or nearly pain free hours, which enables the body to sleep and let the CV and endocrine system recuperate.

Calcium Complications

For many years, patients, families and doctors were bewildered when a chronic pain patient developed osteoporosis, scoliosis, arthritis, or even their teeth fell out. Now we know why. It is primarily because IPS causes multiple abnormalities in the endocrine system that lower calcium levels. 

Intractable pain is a huge stress that never shuts off, so it causes constant demand on the body’s glands to elevate the “Big 3” hormones: insulin, cortisol and adrenaline. This is made worse if pain is untreated or undertreated. 

Over time, the constant elevation of cortisol causes calcium to dissolve and leave the tissues of the teeth, joints and spine. Vertebrae may become so fragile with osteoporosis that the spine may collapse in places and give you scoliosis. When calcium leaves the joints, you get arthritis. People with IPS frequently have fractured hips and knee joints that have to be replaced. 

When cortisol is raised too long by constant pain, testosterone and estradiol levels may drop, and these two hormones are critical to prevent osteoporosis as they function to build bone, joints and teeth.

When cortisol is too high for too long, glucose and insulin are also raised, causing a nutritional state that may reduce vitamin D, magnesium, and other nutrients critical for tooth and bone maintenance.  

All persons with IPS and their families need to know about the cardiovascular and endocrine complications from untreated or undertreated pain. You may also need to inform your medical and dental practitioners about these health risks. Ask them to test you for high blood pressure, elevated pulse rate, high cholesterol and glucose levels. Most can easily test you for osteopenia (early osteoporosis), endocrine function and vitamin D levels.

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 has given financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Cannabis Significantly Reduced Rx Opioid Use in Chronic Pain Patients

By Pat Anson, PNN Editor

Nearly half of chronic pain patients using medical cannabis reported significant improvement in their pain levels and most were able to reduce or stop their use of opioid pain medication, according to a large new study.

The findings, recently published in the journal Cureus, involved 550 chronic pain patients being treated at three licensed medical cannabis clinics in the northeastern United States. The study is one of the first to look at patients who were prescribed opioids for at least three months and continued to use opioids after starting cannabis therapy.

“Our results show a remarkable percentage of patients both reporting complete cessation of opioids and decreasing opioid usage by the addition of medical cannabis, with results lasting for over a year for the majority,” wrote lead author Kevin Takakuwa, MD, an emergency medicine physician affiliated with the Society of Cannabis Clinicians.

“We hypothesize these effects may be due to the reported synergistic decrease in pain that has been shown with adding cannabis to opioids. Likely, as a result, the majority expressed not wanting opioids in the future, particularly those in the younger age group.”

Pain patients enrolled in the study initially took a small amount of cannabis orally (a balanced blend of THC and CBD) and titrated to a higher dose until it had an effect.

Almost half (48%) reported a significant decrease in their pain, and most said they had improved quality of life (87%) and better physical function (80%) while using medical cannabis.

Most reported they either stopped using prescription opioids (40%) or reduced their opioid use (45%).  Nearly two thirds said they sustained the change for over a year (65%) and did not want to take opioids again (63%).  

“One reason for our impressive results may be the focused protocol employed by the study sites, which recommends a small amount of oral cannabis taken in conjunction with each opioid medication dose with small increments to titration, in a motivated patient population,” wrote Takakuwa.

“There has never been a randomized controlled human trial examining how to use medical cannabis in combination with opioids and there is no established protocol that exists. Experts disagree on how to manage opioid prescriptions in patients with chronic pain who use cannabis, and many clinicians defer to the patient or dispensary agent on decisions regarding specific cannabis products and dosages.”

But some doctors take another approach and simply get rid of patients after learning they use cannabis. It’s worth noting that nearly one in four patients (24.8%) enrolled in the study reported losing access to prescription medication or medical care as a result of their cannabis use or after testing positive for THC.

The Centers for Disease Control and Prevention specifically recommends that doctors not test for THC or dismiss patients for their cannabis use “because this could constitute patient abandonment and could have adverse consequences for patient safety” by forcing them to live with untreated pain or turn to street drugs.

Rare Disease Education: Paget’s Disease

By Barby Ingle, PNN Columnist

One of my personal missions is to educate others on the rare diseases and conditions that cause chronic pain. This year I will be posting a series of monthly articles on 12 different rare and ultra-rare conditions.

According to the National Human Genome Research Institute, a rare condition is generally considered a disease when it affects fewer than 200,000 people in the United States. Just because a person has a rare disease does not mean that they are alone. Altogether, rare disease affects up to 30 million Americans.

There are about 7,000 rare diseases, but less than 5 percent of them have an FDA approved treatment option. I have seen some great improvements over the past few years in recognizing rare diseases and in developing new treatments.  

The first condition being looked at in this series is Paget’s disease of bone. I do not know anyone with this condition personally, but I thought it was a good place to start. My hope is you will recognize some of these symptoms and can pass them on to give someone hope, help and a place to start a conversation with their health providers.

Paget’s disease causes the body to generate new bone tissue faster than normal, resulting in bones that are softer, weaker and more fragile. According to the Mayo Clinic, risk factors for Paget’s disease include being over the age of 40, male, having a family history of the condition, and being of European descent. Researchers suspect a combination of environmental and genetic factors contribute to the disease.

They test for Paget’s disease in three ways to get a diagnosis: x-rays, blood tests and bone scans. In its early stages, most people have no symptoms, so Paget’s disease is sometimes found by accident, such as when one of the tests is done for another reason and they end up with Paget’s as the final diagnosis.

Symptoms of Paget’s disease include difficulty walking, bone deformities, bone fractures, bowlegs, headaches, and joint stiffness. The chronic pain associated with Paget’s disease typically shows up first in the back, hip, legs or skull.

The pain and other symptoms worsen over time. Initially, patients often have a “pins and needles” sensation in their extremities, but the pain can become very unpleasant over time. Bone pain is typically described as extreme tenderness and aching, and is present whether you are moving or not.   

Currently there is no cure for Paget’s disease but there are some treatments that may be helpful, such as bisphosphates and dietary supplements to help strengthen bones. As with many rare and chronic diseases, early intervention is best, but a lifetime of care is important.

There are a few online support groups for patients with Paget’s disease, such as the Facebook page of the Paget's Association. You can also check out this video that helps explain the condition further.

I will be back next month to continue this series with a new rare condition.

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.  

Does Chronic Pain Lead to Hoarding?

By Pat Anson, PNN Editor

People living with chronic pain often face stigmas in their daily lives. In addition to being unfairly labeled as drug seekers, pain sufferers are often perceived as lazy malingerers who use their pain as an excuse to stay home, avoid social activities and not work.

Unfair or not, there is some truth to the notion that people in pain are less active physically – and for some that’s led to compulsive hoarding, according to a new study at the University of Florida.

Researchers surveyed over 20,000 people about their hoarding habits and identified over 2,600 cases of “hoarding disorder,” a condition characterized by difficulty in parting with possessions because of a compulsive need to save them. These extreme hoarders were more likely to have chronic pain and other potentially life-shortening medical conditions such as obesity, diabetes, heart problems, high cholesterol and sleep apnea.

On average, compulsive hoarders were about 17 pounds heavier than people without the disorder. They were also more likely to be women, less likely to have a college degree, less likely to see a doctor, and more likely to suffer falls in their home. 

“Hoarding behaviors are associated with limited activity involvement, an increased risk of falls and difficulties with self-care — all of which likely contribute to substantial functional impairment and reduced physical well-being,” lead author Sara Nutley, a data analyst at University of Florida Health, reported in the Journal of Psychiatric Research. 

Hoarding disorder is more than just collecting or being unwilling to part with a few cherished mementos. The American Psychiatric Association says compulsive hoarders save everyday items that most people consider worthless and become emotional at the thought of getting rid of them. Hoarded items are often stored haphazardly, leading to clutter that causes health and safety issues and disrupts hoarders’ lives and living space.

Hoarding not only contributes to health issues, Nutley and her colleagues say medical problems like chronic pain can lead to even more hoarding.

“First, it is possible that profound functional impairment and low levels of health care utilization contribute to the progression of medical comorbidity among individuals with hoarding disorder,” they wrote. “Second, it is possible that individuals with existing medical conditions experience increased impairment in daily self-care activities that lead to the build-up of clutter.

“Medical conditions may worsen hoarding behavior and the underlying causes of hoarding behavior may be a risk factor for both hoarding disorder and medical morbidity.”

The Mayo Clinic says the treatment of hoarding disorder is difficult because many people don’t recognize the impact of hoarding on their lives. If hoarded items are removed, people become frustrated and angry, and start collecting again. The main treatment for hoarding disorder is cognitive behavioral therapy and medications to treat anxiety and depression.  

It’s High Time to Stop the Hurt

By Leslie Bythewood, Guest Columnist

Imagine waking up one morning with the worst pain you could ever dream up.

That’s what happened to me in 2000, only it would take another seven years before my now retired doctor broke the news that I had Arnold-Chiari malformation, a rare and incurable disease that causes unrelenting head pain.

A brain MRI revealed that my skull was squeezing my brain like a sponge, putting extreme pressure on the arteries in my brain. “It herniates out,” my doctor explained.

Fortunately, he was willing to prescribe opiates and my pain was well-managed for the next decade.

But in 2017, the year I became eligible for Medicare, I learned my doctor had opted out of that federal program, forcing me to find a new primary care physician. That’s when my life suddenly took a nosedive.

For the next year, four different physicians would attempt to taper me off opiates without my consent, causing my chronic pain to escalate exponentially and inflicting all sorts of adverse side effects from the anticonvulsants and antidepressants they prescribed.

I eventually found a caring doctor who understood my pain and immediately put me back on the tried-and-true opiate treatment plan that enabled me to function.

LESLIE BYTHEWOOD

One year later that doctor was forced to abruptly surrender his DEA license without justification, preventing him from prescribing opiates to any of his patients, including me. Nevertheless, undeterred and refusing to leave his patients in the lurch, he provided a soft landing by referring all of us to new doctors, enabling me to carry out my daily activities with no pain or intolerable side effects.

Opiates are the only class of medication that work for me and millions of other Americans with intractable pain, but it’s hard for many of us to find doctors willing to prescribe them. What caused the vast majority of doctors to go running the other way with their tails tucked between their legs was the 2016 CDC opioid guideline, which encourages cautious prescribing and arbitrary 90 MME dose limits.

Almost immediately after the guideline was released, patients could no longer count on their doctor to make informed clinical decisions about whether to prescribe opiates. The CDC had driven a big fat wedge between the doctor and the patient.

Many doctors never considered the CDC guideline as voluntary and viewed it as an unbending rule that tolerates no wiggle room. They gave their patients two choices: either taper off opiates or be dismissed for good.

The truth of the matter is that only a small percentage of patients become addicted to opiates. The vast majority take their medications as prescribed and are never at risk for addiction or overdosing. And that’s exactly why, despite the fact that opioid prescribing is at a 20-year low, the number of U.S. overdose deaths continues to soar, driven by street drugs such as heroin, cocaine, illicit fentanyl and methamphetamines, not pain medication.

The blame for this lies squarely with the CDC, DEA, Department of Justice and the news media, who continue to point the finger at doctors for “overprescribing” when the real culprit is street drugs. We don’t have an “opioid epidemic” at all. What we have is a street drug overdose epidemic, plain and simple.

The harm that’s been inflicted on millions of chronic pain patients needs to be rectified by throwing out the misguided CDC guideline and leaving it to the Food and Drug Administration to publish a new set of guidelines that do not encourage arbitrary dosage limits and restore the doctor-patient relationship.

But scrapping the CDC guideline doesn’t go far enough.

We desperately need federal and state laws that protect doctors and patients from the unwarranted, overreaching scrutiny of the DEA and ensure that patients with serious and debilitating diseases get adequate care without delay. Forced tapering and leaving people to suffer in pain are not the answer.

Once and for all, the war on drugs must come to a screeching halt. Restricting legitimate patients from access to opiates is not going to end the street drug overdose epidemic.

Leslie Bythewood is a freelance writer who lives in North Carolina.

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

Opioid Prescribing Limits Failed to Reduce Overdoses in British Columbia

By Pat Anson, PNN Editor

British Columbia’s opioid guideline failed to have any significant impact on overdoses, hospital admissions or deaths in the year after it was adopted, according to new research published in CMAJ Open. The study is the latest to show that opioid prescribing limits have been misdirected and ineffective in slowing North America’s opioid crisis.

The College of Physicians and Surgeons of British Columbia released strict professional guidelines for the “safe prescribing” of opioids and sedatives in 2016, after the Canadian province was hit by a wave of overdoses and deaths. The BC guidelines, which are similar to the CDC’s opioid guideline in the United States, warn doctors to be cautious about opioid prescribing and to avoid increasing doses over 90 morphine milligram equivalents (MME) per day.

Researchers at the University of British Columbia wanted to see how effective the BC guideline was in reducing overdoses, so they analyzed health data on over 68,000 patients on long term opioid therapy. A previous study by the same research team found a “modest” reduction in opioid use in the 10 months after the guideline was introduced, as well as more tapering.

Did the reduced prescribing result in fewer overdoses?  No.

Researchers found no significant change in opioid overdose hospital admissions, opioid overdose mortality, all-cause emergency department visits, all-cause mortality, or all-cause hospital admissions after the BC guideline was adopted. They also found no evidence that pain patients turned to street drugs after their opioid prescriptions were reduced or stopped.

“Concern has been expressed that policies focused on reducing prescribing of opioid analgesics could increase opioid-related deaths if patients unable to access prescription opioids for adequate pain relief turned to street drugs and were exposed to dangerously high levels of synthetic opioids. Our study did not find evidence that the standards and guidelines had the unintended consequence of increasing opioid overdose hospital admissions or opioid overdose mortality,” wrote lead author Richard Morrow, a senior research analyst at UBC.

Critics say the lack of evidence is proof that opioid prescribing has little to do with British Columbia’s overdose crisis.   

“The results are not unexpected and demonstrate the folly of limiting opioids to pain patients in a futile attempt to deal with overdoses from illicit street drugs. The policy has created considerable pain and anxiety along with a worsening quality of life for nothing,” said Marvin Ross, a patient advocate with the Chronic Pain Association of Canada. 

British Columbia’s Coroners Office expects 2020 to be a record breaking year for overdoses in the province, with about five drug deaths every day. A recent study found that the vast majority of BC’s overdoses involved illicit fentanyl and other street drugs. Only 2.4% of the nearly 1,800 fatal overdoses in BC from 2015 to 2017 involved opioid medication alone.

Stricter opioid prescribing policies have also been ineffective in slowing the overdose crisis in the United States. Prescription opioid use in the U.S. is at its lowest level in 20 years, while more Americans are dying from overdoses than ever before.

Why Water Soaking Works

By Forest Tennant, PNN Columnist

There is no medical treatment older than water soaking. It is legend and still works. Adhesive Arachnoiditis and other Spinal Canal Inflammatory Disorders (SCID’s) are particularly helped by water soaking – so much so that we consider it an essential treatment.

Why water soaking relieves pain has been a mystery until recent times. It is known that damaged or “dead” nerves won’t conduct  the body’s natural electric currents, so electricity backs up and is trapped or retained in body tissues. The result is more inflammation and pain “all over.”

Electricity has a negative charge and water tends to have a positive charge, so it pulls out excess electricity from the body, reducing inflammation and pain. If the water contains a mineral, it will pull out even more electricity. That is why mineral hot baths and Epsom Salts are so effective.

The lumbar-sacral spinal canal is loaded with nerve roots. They constantly conduct electric currents that go from the spinal cord to the legs, feet, bladder, sex organs and intestine.

Any damage, by any cause, to the spinal canal nerve roots causes a backup of electricity which is painful and produces even more inflammation. To prevent disease progression, daily water soaking can be most helpful.

Types of Water Soaking

You don’t have to have a jacuzzi or pool to do water soaking. A bathtub is great, but most of us take showers. When you shower, keep the water as hot as you can stand, and massage and stretch your back muscles as the hot water runs over your back. Soaking for 10 to 15 minutes in a jacuzzi, pool or bathtub is preferable, but hot showers morning and night is about as good.

Don’t forget the Epsom Salts. The body normally excretes its excess electricity into the air, mainly through nerve ends in the hands, head and feet. Foot soaking, particularly with Epsom Salts or other herbal salts, is an age-old remedy that attracts the electric currents that travel down the sciatic and other leg nerves.

Another soaking technique is a warm, water-soaked towel or other wet wrap placed over the lower back for 5-10 minutes. Remember, water soaking isn’t an “all wet” idea.

Forest Tennant is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from bulletins recently issued by the Arachnoiditis Research and Education Project . Readers interested in subscribing to the  bulletins should send an email to tennantfoundation92@gmail.com.

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

FDA Tightens Regulation of Fentanyl Medication

By Pat Anson, PNN Editor

Illicit fentanyl may be a deadly scourge on the black market, but for thousands of Americans in severe cancer pain, prescription fentanyl is an essential medicine. And for some, the potent synthetic opioid may soon be harder to obtain.

The U.S. Food and Drug Administration recently announced plans to tighten its Risk Evaluation and Mitigation (REMS) program for transmucosal immediate-release fentanyl (TIRF) products. TIRF medicines such as Actiq and Subsys are approved for breakthrough pain in cancer patients, who regularly take other opioids around-the-clock and are considered “opioid tolerant.”

TIRF lozenges, sprays and tablets are so effective that they’re often prescribed off-label for other types of breakthrough pain. The problem with that, according to the FDA, is that up to 55% of patients prescribed a TIRF medicine are not opioid tolerant and received a TIRF prescription for an unapproved use.

“Data have suggested that prescribing of TIRF medicines still occurs in patients who are not opioid tolerant,” FDA Commissioner Stephen Hahn, MD, said in a statement. “With this in mind, the FDA finalized modifications to the REMS program to address the persistence of these concerning prescribing practices. These changes will also improve our ability to monitor for adverse events and ensure safe use of these medicines.”

Under the strengthened REMS program, prescribers and pharmacies will be required to document a patient’s opioid tolerance for every TIRF prescription that is written or dispensed, including refills. A new patient registry is also being established for everyone who receives a TIRF medicine, so the prescriptions can be monitored for signs of misuse, addiction and overdose.

“All patients prescribed for outpatient use must be enrolled in the registry prior to receiving the first TIRF prescription. The Patient Enrollment Form is used to ensure that patients are aware of the registry requirement and that patients have been counseled appropriately about the safe use of the TIRF medicines, including the risk of respiratory depression, the need to be opioid tolerant as defined in labeling and proper storage of the TIRF medicines,” an FDA spokesperson explained in an email to PNN.

The email said the patient registry would not be available to law enforcement. Prescribing information will only be collected by TIRF manufacturers and will not publicly identify individual patients or prescribers.

“Collection of patient registry information is intended to help assure the safe use of these products, not for law enforcement purposes,” the email said. “FDA’s disclosure laws and regulations relating to information in FDA’s possession protect from public disclosure any information where the release would constitute a clearly unwarranted invasion of personal privacy.”

That pledge is noteworthy, because prescription drug monitoring programs (PDMPs) and other databases are being weaponized by law enforcement agencies to target physicians, pharmacies and patients who are deemed to be lawbreakers based on the dose and quantity of opioid prescriptions.

Fewer TIRF Prescriptions

Why the FDA is acting now is a bit unclear, because the number of people prescribed TIRF products has been declining for years, from about 14,400 patients in 2012 to just 4,700 patients in 2017. TIRF medications in 2017 accounted for just 0.02% of all opioid prescriptions dispensed at retail pharmacies.  

Reports of deaths and other adverse events from using the drugs have also fallen sharply. The FDA’s Adverse Events Reporting System received over 20,500 reports of adverse events involving Actiq in 2018, but there were only a few dozen cases in 2019.

“I would like to know what data the FDA has that prompted this action,” says Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine. “TIRF opioids are rarely abused or associated with overdoses.”

Webster is also concerned that the additional paperwork and scrutiny by the REMS program may discourage doctors and pharmacists from writing or filling TIRF prescriptions. 

“Since TIRF opioids are only indicated for cancer related pain, more barriers to prescribing these medications may mean they will not be prescribed.  That would be unfortunate because the TIRFs are the most effective treatment for severe breakthrough pain,” Webster said. “I hope this policy is more than just checking a box for the FDA, and that they plan to measure the impact on patients' access to the medication and on their pain relief.”

The tougher REMS regulations for TIRF products go into effect in March 2021.

Gabapentinoids Riskier for Surgery Patients

By Pat Anson, PNN Editor

Another study is casting doubt on the use of gabapentinoids such as Lyrica (pregabalin) and Neurontin (gabapentin) for pain relief during and after surgery.

Gabapentioids are a class of nerve medication originally developed to treat convulsions, but the drugs are increasingly being used as a trendy alternative to opioids for acute and chronic pain. Some U.S. hospitals are even using gabapentinoids for surgical pain and have phased out or reduced the use of opioids.

In an analysis of over 5 million adults admitted for major surgery in the U.S. from 2007 to 2017, researchers at Harvard Medical School found that using gabapentinoids with opioids increases the risk of overdose, respiratory depression and other adverse events. Researchers say the additional risk was “extremely low” and would result in one additional overdose for every 16,000 patients.

“Our findings add to the growing evidence that gabapentinoids can potentiate the respiratory depressant effects of opioids,” researchers reported in JAMA Network Open. “The events were rare… (but) patients receiving multimodal pain management therapy that includes gabapentinoids should be closely monitored for possible respiratory depression.”

The study did not examine whether gabapentiniods were effective in treating surgical pain or if they improved the analgesic effect of opioids.

In an editorial also published in JAMA Network Open, a pain management expert said more studies were needed to see if gabapentiniods were worth the additional risk.

“The evidence in support of the analgesic benefit of gabapentinoids combined with opioids for postoperative analgesia is equivocal; there is no real support that adding gabapentinoids to opioid pain relievers offers additive, much less synergistic, enhancements to pain control,” wrote Joseph Pergolizzi, Jr, MD, Chief Operating Officer of NEMA Research.  

“Considering that combination analgesic regimens generally reduce overall opioid consumption, this study is important because it shows that this may not necessarily translate to reducing opioid-associated adverse events. As combination analgesia gains traction for in-hospital acute painful conditions, such as postsurgical pain, it is important to be guided by evidence rather than intuition.”

No Significant Analgesic Effect

A recent study by Canadian researchers also found little evidence to support the use of gabapentinoids for surgical pain.

“No clinically significant analgesic effect for the perioperative use of gabapentinoids was observed. There was also no effect on the prevention of postoperative chronic pain and a greater risk of adverse events,” wrote lead author Michael Verret, MD, a resident at Laval University in Quebec City.  

These and other findings contradict guidelines published by the American Pain Society in 2016, which advocate “around the clock” use of gabapentin, pregabalin and other non-opioid drugs both before and after surgery.

The risk of becoming addicted or dependent on opioids after surgery is actually quite low. A 2016 study found that only 0.4% of elderly patients who were prescribed opioids for post-operative pain were still using them a year after their surgeries. Another study by Harvard researchers found that only 0.2% of surgery patients prescribed opioids were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Growing Concerns About Opioid Tapering

By Roger Chriss, PNN Columnist

A common belief about the opioid crisis assumes that patients develop a substance use disorder from taking opioid medication, and that many derive no long-term benefit from opioids and need to be tapered.

There is some truth to this, but reality is much more complicated.

First, not all patients who take opioids become addicted. The National Institute on Drug Abuse reports between 8 and 12 percent of patients prescribed opioids for chronic pain develop an opioid use disorder (OUD). Even that estimate may be too high, because the diagnosis of OUD is sometimes mistaken.  

In a recent study of 90 patients diagnosed with OUD at three Veterans Health Administration medical centers, physician Ben Howell and colleagues found that nearly a third of the diagnoses were probably wrong.

“Our study identified significant levels of likely inaccurate OUD diagnoses among veterans with incident OUD diagnoses. The majority of these cases reflected readily addressable systems errors,” researchers concluded. “If these inaccuracies are prevalent throughout the VHA, they could complicate health services research and health systems responses.”

Second, not all people who are tapered off prescription opioids improve. A new study in the Journal of Pain Research looked at 40 chronic pain patients who were tapered from an average daily dose of 80 MME (morphine milligram equivalent) down to 19 MME. The results were disappointing. There was only minor improvement in the patients’ cognitive function and no improvement in their quality of life, depression and anxiety.

There is at present no well-established approach to opioid tapering and little effort made to study patient outcomes.  In a recent paper, lead author Stefan Kertesz, MD, and colleagues say there is a “pill dynamic” approach to tapering that focuses on dose reduction alone.

"When a multi-faceted, complex health issue becomes a public health crisis, the desire to ‘solve’ or ‘mitigate’ takes hold with a momentum of its own. A crisis deserves no less. However, nationally adopted quality metrics have convinced some patients with pain that their survival and functioning are no longer concerns for the systems in which they receive care. This outcome is unacceptable," they concluded.

Patient Suffering and Suicides

The risks of forced opioid tapering are so urgent that nearly 100 physicians, academics and patient advocates recently published an open letter in the journal Pain Medicine warning of “an alarming increase in reports of patient suffering and suicides” caused by aggressive tapering:

“We therefore call for an urgent review of mandated opioid tapering policies for outpatients at every level of health care — including prescribing, pharmacy, and insurance policies — and across borders, to minimize the iatrogenic harm that ensues from aggressive opioid tapering policies and practices.

We call for the development and implementation of policies that are humane, compassionate, patient-centered, and evidence-based in order to minimize iatrogenic harms and protect patients taking long-term prescription opioids.”

The public health issue of opioid overdoses is complex, urgent and largely driven by street drugs, not pain medication. Opioid prescriptions are at 20-year lows, and the American Medical Association recently said it was “alarmed by an increasing number of reports of opioid-related overdoses, particularly from illicit fentanyl.”

And as National Institute of Drug Abuse director Nora Volkow, MD, stated in a recent blog post:

“Although deaths from opioids continue to command the public’s attention, an alarming increase in deaths involving the stimulant drugs methamphetamine and cocaine are a stark illustration that we no longer face just an opioid crisis. We face a complex and ever-evolving addiction and overdose crisis characterized by shifting use and availability of different substances and use of multiple drugs (and drug classes) together.”

Opioid tapering is no more a universal good than opioid prescribing was a universal evil. And opioid tapering will no more solve the overdose crisis than opioid prescribing alone caused it. Instead, opioid tapering may harm the very people it is intended to help, and it may not help the crisis that it is motivated by. Better public health policy and clinical practice are urgently needed.

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.