Medicare to Cover Acupuncture for Back Pain

By Pat Anson, PNN Editor

The Centers for Medicare & Medicaid Services (CMS) has finalized a decision to cover acupuncture for Medicare patients with chronic low back pain. Up to 12 visits in 90 days to an acupuncture therapist will be paid by Medicare, but no more than 20 treatments annually.

Acupuncture is an ancient Chinese treatment in which practitioners stimulate specific points on the body by inserting thin needles through the skin. About 3 million Americans receive acupuncture treatments, mostly for chronic pain. Some private insurers already cover acupuncture, but there is little consensus in the medical community about its value.

Lower back pain is the world’s leading cause of disability. CMS researchers reviewed clinical studies and found evidence that older adults with chronic back pain showed small improvements in pain and function after acupuncture treatments, although the exact mechanism of action was “unclear” and there was “inconclusive evidence” about the most effective acupuncture technique.

“Expanding options for pain treatment is a key piece of the Trump Administrations’ strategy for defeating our country’s opioid crisis,” Health and Human Services Secretary Alex Azar said in a statement. “Medicare beneficiaries will now have a new option at their disposal to help them deal with chronic low back pain, which is a common and sometimes debilitating condition.”  

The decision to cover acupuncture overturns decades of previous rulings that took a dim view of the procedure. In 1980, CMS said the use of acupuncture as an anesthetic was “not considered reasonable and necessary.”

In 2004, the agency rejected acupuncture as a treatment for fibromyalgia and osteoarthrosis because there was “no convincing evidence for the use of acupuncture for pain relief.”

CMS said it was “keenly focused” on finding alternatives to opioid painkillers.

“We are dedicated to increasing access to alternatives to prescription opioids and believe that covering acupuncture for chronic low back pain is in the best interest of Medicare patients,” said CMS Principal Deputy Administrator of Operations and Policy Kimberly Brandt.

“We are building on important lessons learned from the private sector in this critical aspect of patient care. Over-reliance on opioids for people with chronic pain is one of the factors that led to the crisis, so it is vital that we offer a range of treatment options for our beneficiaries.”

A recent study of over 140,000 Army veterans with chronic pain found that non-drug therapies such as acupuncture significantly reduce the risk of suicide, as well as alcohol and drug abuse.  

FDA Approves Cocaine Nasal Spray

By Pat Anson, PNN Editor

FDA advisory committees have taken a dim view of opioid medications recently, soundly rejecting new drug applications for the “opioid of the future” oxycodegol and a new extended-release version of oxycodone.

There was also a split 13-13 vote on a relatively mild opioid painkiller – a combination of tramadol and the anti-inflammatory drug Celebrex..

Advisory committee recommendations are not binding on the FDA, but the votes reflect a growing reluctance to approve any new medication that may worsen the so-called opioid epidemic.

"We can't approve a drug in the midst of a public health crisis," said advisory committee member Steve Meisel, PharmD, who voted no on oxycodegol.

FDA advisors may be rejecting opioids out of hand, but cocaine is a different story. The agency this month quietly approved a nasal solution containing cocaine hydrochloride (HCI) for use as a local anesthetic. The nasal spray, made by the Lannet Company, is intended to relieve pain in mucous membranes during surgeries and procedures in the nasal cavities of adults.

"The FDA's approval of our Cocaine HCl product, the first NDA approval to include full clinical trials in the company's history, marks a major milestone in Lannett's 70+ years of operations," said Tim Crew, chief executive officer of Lannett in a news release.

"We believe the product has the potential to be an excellent option for the labeled indication. We expect to launch the product shortly, under the brand name Numbrino."

Numb-rino. Get it?

While cocaine is well-known as a drug of abuse, it is classified by the DEA as a Schedule II controlled substance, alongside hydrocodone and oxycodone. Cocaine’s use in medicine is not unheard of. It was commonly used as an alternative to morphine in the last half of the 19th Century until it fell out favor because of high rates of addiction.

Numbrino is not the first nasal spray containing cocaine to be approved by the FDA. In 2017, the agency approved the nasal solution Goprelto, which is also intended for use during surgeries and procedures in nasal cavities. 

Nevertheless, the FDA’s approval of a drug containing cocaine was so unusual that Snopes conducted a fact check to see if it was true. An FDA spokesperson confirmed to Snopes that Numbrino was approved, along with warning labels and other safeguards to discourage its abuse.

“Cocaine hydrochloride nasal solution contains cocaine, a Schedule II substance with a high potential for abuse. However, when used according to the directions provided in the labeling, physical dependence and withdrawal symptoms are unlikely to develop because this drug is for single use during diagnostic procedures and surgeries,” the FDA said.

“To minimize these risks, the labeling suggests that health care facilities using the drug implement effective accounting procedures, in addition to routine procedures for handling controlled substances. Notably, this will be used as an anesthetic by trained health care professionals during diagnostic procedures and surgeries, not by patients directly. It is not available by prescription.”

Numbrino was approved without any of the controversy that surrounds opioid painkillers. In 2018, the FDA’s approval of Dsuvia — a single use opioid intended for severely wounded soldiers and trauma patients — was panned by critics, who called the drug a “dangerously unnecessary opioid medication." Like Numbrino, Dsuvia is not available by prescription and can only be administered by a healthcare professional.

Tolerance Reduces Sleep Benefits of Medical Cannabis

By Pat Anson, PNN Editor

Getting a good night’s sleep can be a godsend to someone suffering from chronic pain. That’s why many pain patients are experimenting with medical cannabis to help manage their sleep problems.

But a small new study found that while cannabis initially helps with sleep, regular use leads to drug tolerance that causes even more sleep problems. A second study raises doubts about the use of cannabinoids in treating cancer pain.

Researchers at the Rambam Institute for Pain Medicine in Israel enrolled 129 volunteers over age 50 with chronic neuropathic pain. About half used medical cannabis for at least a year, either by smoking (69%), oil extracts (21%) or vaporizers (20%). The other half did not use cannabis.

Sleep problems were common among both groups of patients, with about 3 out 4 having trouble falling asleep or staying asleep.

Researchers found that cannabis users were less likely to wake up during the night, compared to those who did not use the drug. But over time the benefits of cannabis were reversed, and frequent users found it harder to fall asleep and woke up more often during the night.

The findings are published in the British Medical Journal's Supportive and Palliative Care journal.

“This study is among the first to test the link between whole plant MC (medical cannabis) use and sleep quality. In our sample of older (50+ years) chronic pain patients we found that MC may be related to fewer awakenings at night. Yet patients may also develop tolerance to the sleep-aid characteristics of MC,” researchers wrote.

“These findings may have large public health impacts considering the ageing of the population, the relatively high prevalence of sleep problems in this population along with increasing use of MC.”

The study was observational and did not establish a direct causal link between cannabis and sleep.  Another weakness is that the specific timing of cannabis use by participants was unknown. Taking cannabis before bedtime may have a stronger association with sleep. The researchers said their findings were preliminary and more larger studies were needed.

Cannabinoids Not Recommended for Cancer Pain

Another study published in the same medical journal found that cannabinoids do not reduce pain in patients with advanced cancer.

Researchers at the University of Hull in the UK reviewed data from five high-quality clinical studies involving 1,442 cancer patients and found that pain intensity was no different between those taking cannabinoids and those given a placebo.

Patients using cannabinoids also had nearly twice the risk of short-term side effects such as dizziness, drowsiness, nausea and fatigue. They were also more likely to drop out of studies.  

“For a medication to be useful, there needs to be a net overall benefit, with the positive effects (analgesia) outweighing adverse effects. None of the included phase III studies show benefit of cannabinoids,” researchers concluded.

“When statistically pooled, there was no decrease in pain score from cannabinoids. There are, however, significant adverse effects and dropouts reported from cannabinoids. Based on evidence with a low risk of bias, cannabinoids cannot be recommended for the treatment of cancer-related pain.”

The American Cancer Society takes a different view, pointing out that studies have found marijuana smoking can be helpful in treating nausea from cancer chemotherapy.  Other studies have also suggested that THC, CBD and other cannabinoids slow the growth of cancer cells in a laboratory setting.

Medical marijuana is legal in 33 In U.S. states and cancer is recognized as a qualifying condition in many of them.

Public Officials Ignorant About Overdose Crisis

By Christopher Piemonte, Guest Columnist

A recent Washington Post article highlights an ongoing debate between the Drug Enforcement Administration and some public officials, who are demanding that DEA further reduce the supply of opioid medication. DEA has responded that, without more precise data, such a reduction would be ineffective and dangerous for Americans that need opioids.

At the center of the debate is the Aggregate Production Quota (APQ) for Schedule I and II opioids and other controlled substances. Every year, the DEA sets the maximum amount for each substance that can be produced. DEA began cutting the opioid supply in 2017 and has proposed further cuts in 2020.  

Congressional lawmakers and state attorneys general argue that the APQ for opioid medication is still too high, and the excess supply leads to overdose deaths. In a recent letter to the Acting Administrator of DEA, six attorneys general claim that the APQ does not account for opioids diverted to the black market, which “factor in a substantial percentage of opioid deaths.”

Citing data from the CDC, they assert that in 2016 “opioids obtained through a prescription were a factor in over 66% of all drug overdose deaths.”

There’s a problem with these claims: They’re wrong.

When asked about the accuracy of the letter, a spokesperson for CDC said prescription opioids were a factor in “approximately 27% of all drug overdose deaths,” a figure nearly 40% lower than that presented in the letter.

It would be one thing if this error were simply a typo or miscalculation. But these state officials, as well as many lawmakers, are insisting on a specific policy response without having made the effort to dig into the data and understand the nature of the problem itself. Specifically, they cite inaccurate data to support the incorrect notion that “prescription opioids have been a dominant driver in the growing crisis.” What’s worse, that false notion is the basis for their intransigent insistence on a blanket reduction in the supply of all prescription opioids.

Experts in law enforcement, medicine and policy agree that the attorneys general made an erroneous factual conclusion, and that an arbitrary opioid quota reduction would be both ill-informed and dangerous.

“There is no question that the DEA, or any agency, attempting to come up with valid quotas for controlled substances will find it difficult if not impossible. One of the problems with interpreting overdose death information is that illicit fentanyl and heroin deaths are frequently lumped together with oxycodone- and hydrocodone-related deaths,” said John Burke, President of the International Health Facility Diversion Association and a former drug investigator for the Cincinnati Police Department.

“The vast majority of people prescribed controlled substances take them as directed. Proposed cuts in quotas will negatively impact Americans who have a legitimate medical need for opioids, causing them even more discomfort and distress. These patients are routinely overlooked when considering the prescribing and dispensing of controlled substances, and it is a tragedy.”

Increased Demand for Street Drugs

Other experts warn that further reducing the supply of opioid medication will lead to drug shortages and increase demand for illicit drugs.   

“On the surface, it appears that limiting the quotas…could, in fact, provide a means to address the overdose crisis,” said Marsha Stanton, a pain management nurse, clinical educator and patient advocate. “That, however, will do nothing more than to minimize or eliminate access to those medications for individuals with legitimate prescriptions. We have already seen the effects of back-ordered medications, which create significant barriers to appropriate patient care.”

“Patients who lose access to prescriptions for opioids, have, in some cases, turned to street drugs as an alternative. This has led to increased morbidity and mortality since street drugs have uncertain content and are often used in a comparatively uncontrolled manner,” said Stuart Gitlow, MD, an addiction psychiatrist and past president of the American Society of Addiction Medicine.

“We, therefore, cannot afford to use a crude blunt instrument such as a quota change to address the drug abuse problem. Rather, we must focus on each patient individually and, through education of clinical professionals, ensure that each patient receives medically reasonable treatment.”

By continually insisting on cuts in opioid production, public officials demonstrate a lack of understanding of America’s overdose crisis. Put simply, they’ve failed to do their homework.

“For more than a decade, experts have urged government officials to focus on much more than reducing the opioid-medication supply. Yet, they remain fixated in intellectual laziness,” said Michael Barnes, Chairman of the Center for U.S. Policy and a former presidential appointee in the Office of National Drug Control Policy.

“Policy makers must reduce demand by prioritizing drug abuse prevention, interventions, and treatment. Prevention is the biggest challenge because it will require public officials to realize and respond to the socioeconomic underpinnings of drug abuse. The time is long overdue for politicians to get serious and do the work necessary to save lives and solve this crisis.”   

The disturbing reality is this: Despite rising death tolls and the shortcomings of recent responses, many officials involved in overdose-response policy misunderstand the complexity of America’s overdose crisis.

Until those individuals are educated about the nuances of the issue, they will continue to demand policy that does not adequately address the problem, and the crisis will carry on. Continued ignorance on the part of government officials would truly be, as Mr. Burke put it, a national tragedy.

Christopher Piemonte is a policy manager for the Center for U.S. Policy (CUSP), a non-profit dedicated to enhancing the health, safety and economic opportunity of all Americans. CUSP is currently focused on identifying and advancing solutions to the nation’s substance abuse, mental health and incarceration crises.

The Real Reasons People Become Addicted

By Dr. Lynn Webster, PNN Columnist

The Atlantic recently published an article, “The True Cause of the Opioid Epidemic,” that shares an underreported view of the complexities of the opioid crisis. The article acknowledges the epidemic is a multi-faceted drug problem that is largely driven by economic despair.

Yet most of the media remains focused on the large volume of opioids being prescribed, while ignoring the fact that opioids fill a demand created by deeply rooted, unaddressed societal problems.

As PNN reported, a recent study found that auto plant closures in the Midwest and Southeast created a depressed economic environment where drug abuse thrived. Poverty and hopelessness, more than overprescribing, were the seeds of the opioid crisis.

But those factors are only part of the issue. The prevalence of mental health disorders, the lack of immediate access to affordable treatment of addiction, and inadequately treated chronic pain — along with poverty and despair — have caused and sustained the continuing drug crisis.

One of the challenges in beginning to solve the crisis is to change how we view people with the disease of addiction. Rather than provide them with access to affordable healthcare, we stigmatize and criminalize them. This creates recidivism rather than rehabilitation. It affects people who use drugs for the wrong reasons, as well as people who use opioids for severe chronic pain.

Debunking Myths About Addiction

Many people make another false assumption. They claim that opioid addiction develops solely because of exposure to the drugs. That is untrue. Genetic and environmental factors determine who will become addicted. Exposure to an opioid — or any drug of abuse — is necessary for the expression of the disease, but by itself it is insufficient to cause it.

Most Americans are exposed to opioid medication at some point in their lives. In fact, the average person experiences a total of nine surgical and non-surgical procedures in a lifetime. An opioid analgesic is administered during most of these procedures and is often prescribed afterward for pain control. The lifetime risk for developing an opioid addiction is less than one percent of the population.

If exposure alone were responsible for addiction, then the 50 million Americans who undergo an operation every year, or those who undergo nine procedures in a lifetime, would develop an addiction.

Commonly, people who investigate and discuss opioid overdoses believe the deaths are exclusively due to the disease of addiction. But here again, they are mistaken.

An estimated 30 percent or more of overdoses are believed to be suicides. Why do some people choose to intentionally overdose? One driver is the despair that develops from inadequately treated pain. People in pain are almost three times as likely as the general population to commit suicide. They often use drugs rather than violent acts to end their lives.

In addition, efforts to curb opioid prescribing have pushed many people to the streets to purchase illegal and more lethal drugs. This is even true for people without a substance abuse disorder who are seeking pain relief.

Despite a more than 30 percent decline in opioid prescriptions over the past decade, there has been a continued surge in drug overdose deaths. We are seeing a shift in the reasons why people are dying from overdoses. Since 2018, the number of overdose deaths from methamphetamines has exceeded the number of deaths from prescription opioids. This underscores the fact that the problem is less about the supply of opioids and more about the demand for relief of psychological or physical pain.

Clearly, America’s drug crisis involves more than just the overprescribing of opioids — and this helps explain why interventions to reduce prescriptions have not succeeded. Understanding the actual causes of the problem may help us find real solutions. It also would change the focus from people in pain who find more benefit than harm in opioids to those who clearly are at risk of harm from them.   

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find Lynn on Twitter: @LynnRWebsterMD.

Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences.

Questioning the New Cannabinoids

By Roger Chriss, PNN Columnist

A new cannabinoid similar to THC was announced last month in Scientific Reports. Dubbed tetrahydrocannabiphorol, or THCP for short, it is being hailed as a “breakthrough discovery” that is 30 times stronger than THC, the chemical compound in cannabis that causes euphoria.

Discovered by a group of Italian researchers, THCP has been shown to have a high affinity for the cannabinoid receptor (CB1) in the brain. Cinzia Citti from the Institute of Nanotechnology told Medical Cannabis Network that THCP likely has pain relieving effects, but pharmacological studies are needed to confirm it.

“Once all pharmacological profile of THCP has been established, I can imagine that THCP-rich cannabis varieties will be developed in the future for specific pathologies,” Citti said.

THCP’s chemical structure makes it nearly optimal for activity at the CB1 receptor. Studies on mice showed that THCP has psychoactive effects at low doses, but research is required to confirm how strongly THCP acts on the human brain.

‘Potential Game Changer’

There is already great enthusiasm for THCP, as well as cannabidiphorol (CBDP), another newly identified cannabinoid compound.

Vice states that “it’s possible these chemicals could treat certain conditions better than their counterparts,” THC and CBD.

Leafly went even further, predicting the new cannabinoids could have “immense therapeutic implications,” with THCP being a “potential game changer.”

Looking beyond the media hype, there appears to be no critical consideration of what a cannabinoid 30 times more potent than THC might mean. THC Is known to have significant negative effects on the human body. The National Institute on Drug Abuse lists side effects such as impaired breathing, increased heart rate, and mental effects such as hallucinations, paranoia and schizophrenia.

Moreover, THC is addictive. Health Canada reports that 1 out of 10 people who use cannabis will develop an addiction. The addiction odds increase to 1 out of 2 for people who use cannabis daily.

In other words, is THCP going to be 30 times more additive than THC? Will it cause 30 times more cognitive impairment? A 30-fold increase in ER visits and hospital admissions?

If THCP acts much more strongly on the CB1 receptor, then it may not really be a good thing for cannabis users or public health. These questions may seem absurd, but potent synthetic cannabinoids like K2/Spice have been a public health concern for many years. THCP may also have unknown side effects.

The difference between THC and CBD comes down to one chemical bond, but their respective effects are quite different. The apparent similarities between THCP and THC cannot be used to draw conclusions about effects in humans, good or bad.  

At present, very little is known about THCP. As Live Science points out, "while THC offers some medicinal effects, including pain and nausea relief, no one knows if THCP has these qualities."

It would be nice if even just one media outlet had mentioned the THCP could have some of the same problems that THC does, and at far lower concentrations.

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. 

Cost of MS Drugs Nearly Tripled

By Pat Anson, PNN Editor

The cost of prescriptions for disease-modifying multiple sclerosis (MS) drugs nearly tripled in the last decade, even with the introduction of cheaper generic versions, according to a new study funded by the National Multiple Sclerosis Society.

Researchers found spending on 15 MS drugs in the Medicaid program increased from $453 million in 2011 to $1.32 billion in 2017.

“Most of these drugs cost more than $70,000 per year on average and costs for these drugs are among the highest drug cost areas for private insurers as well as Medicare and Medicaid,” said Daniel Hartung, PharmD, of Oregon State University in Portland. “Unfortunately for people with MS, the introduction of a generic drug had a minimal effect on prices overall.”

Hartung and his colleagues found that when a generic version of the drug glatiramer acetate (Copaxone) was introduced in 2015, it was only 15 percent cheaper than the brand name drug made by Teva Pharmaceuticals.

Teva also worked to maintain its market share by encouraging doctors and patients to switch from a 20 mg dose of Copaxone to a 40 mg dose, which was not interchangeable with the new generic.

A second company introduced a generic version of glatiramer acetate in October 2017. Only then did the cost start to come down and generic versions started to get a greater share of the MS market.  

“After our study was complete, the company that introduced the second generic drug dropped its costs significantly, making it the lowest cost disease-modifying drug for MS on the market,” Hartung said. “Despite this, there is an urgent need for more robust competition from generics within these MS drugs.”

A similar study published last year found that Medicare paid nearly $76,000 annually per patient for disease modifying therapy (DMT), which reduces the frequency and severity of MS flare-ups. MS is a chronic and progressive disease that attacks the body’s central nervous system, causing pain, numbness, difficulty walking, paralysis, loss of vision, and fatigue.

Many Patients Can’t Afford DMT Meds

A recent survey by the National Multiple Sclerosis Society found that 40% of MS patients who take a DMT drug altered or stopped taking their medication due to the high cost. Only 11% said they could afford the medication without financial assistance.

“People with MS are paying the price, not only financially, but also physically and emotionally,” Bari Talente, executive vice president of advocacy for the National MS Society said in a statement.

“When someone alters or stops the use of their DMT, it can lead to increased symptoms, relapses, stress and anxiety. We need to make these medications affordable and accessible so people already facing a chronic illness don’t have to deal with deciding between buying groceries for their families or paying for their medication.”

The FDA recently approved the first generic versions of Gilenya (fingolimod) for the treatment of relapsing forms of multiple sclerosis (MS). A 30-day supply of brand name Gilenya 0.5mg capsules currently costs about $8,482, according to Healthcare Bluebook, or nearly $102,000 a year.

Few people actually pay the full amount for a DMT drug. About 45% of MS patients do not pay anything out-of-pocket for their DMT. The average annual cost among those who do pay is about $2,300.

‘Opioid of the Future’ Abandoned

By Pat Anson, PNN Editor

A promising new pain medication once touted as the “opioid of the future” because of its low risk of abuse is being abandoned.

Nektar Therapeutics withdrew its new drug application for NKTR-181 (oxycodegol) after two FDA advisory committees voted 27 to 0 against approval of the drug because of lingering concerns about the potential for addiction.

“The Company is disappointed in the Committees' vote regarding oxycodegol and believes it is also disappointing for patients suffering from chronic pain and the physicians that treat those patients who are currently relying on existing opioid therapies,” Nektar said in a statement. “The Company has decided to withdraw the NDA for oxycodegol and to make no further investment into the program.”

The molecular structure of oxycodegol is designed so the drug enters the brain slowly, providing pain relief without the euphoria or “high” that can lead to abuse.

In clinical studies, recreational drug users reported less “drug liking” of oxycodegol compared to oxycodone. Patients with chronic back pain also reported significant pain relief taking the drug twice daily.  

The research was so promising the FDA gave oxycodegol “fast track” designation in 2017 to speed its development.

All that changed, however, when the FDA came under a wave of public and political pressure to tighten its regulation of opioids.  A 60 Minutes report last year claimed the FDA “opened the floodgates” to the opioid crisis by approving the use of OxyContin. The agency also received a petition from Public Citizen calling for a moratorium on new opioid approvals because the agency “can no longer be trusted” due to its “poor record” of regulating opioids.

The FDA advisory committees had concerns about oxycodegol being snorted or injected by drug abusers and its potential for liver toxicity. A staff briefing document also questioned whether Nektar’s clinical studies were adequate.

While the panels’ unanimous recommendation isn’t binding on the FDA, Nektar decided to withdraw its new drug application rather than invest further resources in oxycodegol. That will save the company $75 to $125 million in 2020, according to a news release.

Drug Distributor Stops Opioid Sales

Nektar’s decision came the same day a New York based drug distributor announced it will no longer sell opioid medications. The Rochester Drug Co-Operative (RDC) is the nation’s sixth-largest pharmaceutical wholesaler. It buys medicines directly from drug manufacturers and sells them to 1,300 pharmacies in the Northeast.

"The ever-increasing expenses associated with the legal and regulatory compliance for this segment of drugs are simply not sustainable," RDC said in a statement. "While these specific drugs represent a relatively small percent of total sales, they account for significant legal and compliance expenses." 

Two former RDC executives were charged last year with illegally distributing opioids and conspiring to defraud the government. The company paid a $20 million fine and accepted independent monitoring under a five-year deferred prosecution agreement with the government.

An RDC spokesman said the decision to stop selling opioids was a business decision and not related to the legal case.

The Truth About Chronic Pain

By Dr. Rachel Zoffness, PNN Columnist

I’ve never been an athlete, but I’ve always loved exercising because of how it makes me feel. One beautiful spring day, I went for a run. On the way downhill, I was stopped by a sudden pain in my knee. When I woke the next morning, I couldn’t step out of bed without burning pain radiating from my feet, up my leg and into my hip.

I was couch-bound for the better part of a year. I saw countless doctors, was prescribed many medications, and would’ve done anything to stop the pain. That was the beginning of a decade-long journey with chronic pain.

I’ve dedicated my life to understanding pain, and not just because of that injury.

I’m a pain psychologist and assistant clinical professor at UC San Francisco School of Medicine, where I teach pain neuroscience to medical residents. I also founded a private practice dedicated to people living with chronic pain.

One of my earliest patients was a teenager. He’d been bedridden with multiple medical diagnoses for four years, seen 12 physicians and tried 40 medications. But nothing worked.

Not surprisingly, he was depressed and anxious. He had no life, no friends and no hope.

DR. RACHEL ZOFFNESS

As a pain psychologist, I use cognitive behavioral therapy (CBT) as one of my primary treatment tools, so we started a CBT-for-pain program. In addition to other strategies, it involved “pacing” or resuming select activities one small step at a time.

It was hard work, but little by little, he got healthier. As his functioning and mood improved, his pain did, too. Within 6 months he resumed school and rejoined his soccer team. His pain wasn’t gone – but it was significantly reduced and he knew how to manage it. He says pain will never control his life again.

Many of us have noticed this link between how we feel emotionally and how we feel physically. That’s because pain is never purely physical. This is confirmed by neuroscience research indicating that pain is produced by multiple parts of the brain, including the cerebral cortex (responsible for thoughts), prefrontal cortex (which regulates attentional processes), and the limbic system – your brain’s emotion center.

Dialing Back Pain

Imagine that you have a “pain dial” in your central nervous system that controls pain intensity. The function of this dial is to protect you from danger or harm. It can be turned up or turned down by many factors, including:

1. Stress and anxiety

2. Mood

3. Attention (what you’re focusing on)

When you’re feeling stressed and anxious – your thoughts are worried, your muscles are tense and tight, and the pain volume is turned up.  

When your mood is low, you’re miserable and depressed, and your brain similarly amplifies pain volume. 

This is also true when your attention is focused on pain. When you’ve stopped going to work, seeing friends and engaging in hobbies, your prefrontal cortex (which controls attention) sends a message to your pain dial, turning it way up. 

However, the opposite is also true. 

When stress and anxiety are low – your body is relaxed, your thoughts are calm and you’re feeling safe. Your cerebral cortex and limbic system send messages to your pain dial, lowering the volume so that pain feels less bad. 

When your mood is high, your thoughts are positive, you’re feeling happy and you’re engaged in pleasurable activities. Your brain determines that little protection is needed, so pain volume is reduced. 

And finally, when you’re distracted – you’re absorbed in activities, like watching funny movies with friends. The pain dial is turned down, so pain is less bad. 

In summary, when you’re relaxed, happy, distracted, and feeling safe, your pain volume is lower. The pain is still there -- it hasn’t magically disappeared -- but it’s quieter. Softer. Less. 

The truth about chronic pain is this: Your thoughts, beliefs, emotions and attention can all adjust pain volume. 

This does not mean that pain is “all in your head.” It isn’t. Your pain is real, as real as mine, and no one should ever tell us otherwise. It does mean that there are many ways to change pain. One is medication. Multiple medications have been shown to effectively turn down the pain dial.  

There are other methods for lowering pain volume, too. CBT, mindfulness and biofeedback are three biobehavioral approaches to pain management that research suggests can be helpful. They aren’t magic cures and they take time. But if you’ve never tried to manage your pain with these techniques, consider them. They’ve helped me immensely on my chronic pain journey. 

When I was learning about mindfulness, I remember thinking, “What could mindfulness possibly have to do with physical pain?”  

And then something fascinating happened.  

During the first year of my practice, my pain changed. It didn’t go away entirely and I wasn’t cured. But the pain changed. It became less intense, less frequent, less distracting, and got less in the way of the rest of my life. 

Rachel Zoffness, PhD, is a pain psychologist and assistant clinical professor at the UCSF School of Medicine. Rachel serves on the Steering Committee of the American Association of Pain Psychology, where she founded the Pediatric Division. She is the author of The Chronic Pain and Illness Workbook for Teens. You can find Rachel on Twitter @DrZoffness.  

Obamacare Prevented Thousands of Opioid Overdose Deaths

By Pat Anson, PNN Editor

The expansion of Medicaid under the Affordable Care Act – widely known as Obamacare -- was associated with a six percent lower rate of opioid overdose deaths, according to a new study that estimates thousands of overdoses may have been prevented by expanding access to healthcare for millions of Americans.

Researchers also found a significant and unexpected increase in overdoses involving methadone, an addiction treatment drug sometimes used to treat chronic pain.

Thirty-two states and the District of Columbia opted to expand Medicaid eligibility under the Affordable Care Act (ACA), providing healthcare coverage to uninsured low-income adults. ACA requires that individuals who receive coverage be provided with mental health and substance use disorder treatment.

Researchers at the NYU Grossman School of Medicine and University of California, Davis looked at death certificate data from 49 states and the District of Columbia between 2001 and 2017— looking for changes in overdose rates in counties that expanded Medicaid under ACA compared to those that did not.

Their findings, published online in JAMA Network Open, suggest that Medicaid expansion prevented between 1,678 and 8,132 opioid overdose deaths from 2015 to 2017.

Overall, there was a 6% lower rate of opioid overdose deaths, an 11% lower rate of heroin overdoses, and a 10% lower rate of death involving fentanyl and synthetic opioids other than methadone in states that adopted the ACA.

"The findings of this study suggest that providing expanded access to health care may be a key policy lever to address the opioid overdose crisis," said senior author Magdalena Cerdá, DrPH, director of the Center for Opioid Epidemiology and Policy in the Department of Population Health at NYU Langone Health.

Methadone Overdoses Rose

Cerdá and her colleagues also found a concerning 11% increase in methadone overdose rates in states that expanded Medicaid under the ACA. Methadone is an opioid that has long been used to treat addiction, but it is also prescribed by some doctors to treat chronic pain.

“Although the rate of methadone-related mortality is relatively low compared with other opioid classes, our finding that Medicaid expansion was associated with increased methadone overdose deaths deserves further investigation,” researchers said.

“Past research has found high rates of methadone use to treat pain among Medicaid beneficiaries and that the drug is disproportionately associated with overdose deaths among individuals in this population, underscoring the importance of ongoing local, state, and federal actions to address safety concerns associated with methadone for pain in tandem with Medicaid expansion.”

In 2014, the methadone prescribing rate among Medicaid patients was nearly twice that of commercially insured patients. Medicaid patients were also slightly more likely to be prescribed methadone for pain (1.1% vs. 0.85%) as opposed to addiction.

Expansion Reduced Opioid Deaths

The ACA became law at a time when opioid overdose deaths were rising sharply. Some critics of Obamacare claimed that expanding access to low-cost opioid pain relievers would create an incentive for low-income Medicaid beneficiaries to sell their drugs.

“It stands to reason that expanding the program — particularly to people most susceptible to abuse — could worsen the problem,” a 2018 report by Sen. Ron Johnson (R-WI) claimed. “The epidemic has indeed spiraled into a national crisis since the Obamacare Medicaid expansion took effect in 2014. Drug overdose deaths have risen rapidly, at a much faster pace than before expansion.”

The NYU and UC Davis study found that theory to be false.

"Past research has found Medicaid expansion is associated with not only large decreases in the number of uninsured Americans, but also considerable increases in access to opioid use disorder treatment and the opioid overdose reversal medication naloxone," said lead author Nicole Kravitz-Wirtz, PhD, an assistant professor in the Department of Emergency Medicine at UC Davis.

"Ours was the first study to investigate the natural follow-up question: Is the expansion associated with reductions in local opioid overdose deaths? On balance, the answer appears to be yes." 

Current and Former Smokers Have More Pain

By Pat Anson, PNN Editor

There are many good reasons to stop smoking. Within hours, your heart rate and blood pressure will drop, you’ll cough less and feel more energy. Within a few months your lung function will start to improve. And after 20 years, your risk of dying from lung disease or cancer will be about the same as someone who never touched a cigarette.

Unfortunately, one thing that may not improve is your pain. According to a large new study in the UK, former smokers report higher levels of pain than people who never smoked, and their pain levels are similar to people who still continue to smoke.

Researchers at University College London (UCL) analyzed health data from over 220,000 people in the UK who were asked to report how much pain they experienced during the previous 4 weeks and whether it interfered with their work.  

After adjusting for other health factors such as anxiety and depression, current and former daily smokers were more likely to report bodily pain compared to people who never smoked. The difference was small, but considered significant. Surprisingly, the association between smoking and pain was highest in the youngest group of smokers (aged 16 to 34).

The study was observational and did not establish a cause-and-effect relationship between smoking and pain. But researchers say their findings, published in the journal Addictive Behaviors, suggest that regular smoking at any age results in more pain.

“We cannot rule out that there is some other difference between former smokers and never smokers that is causing these surprising results, but we have to consider at least the possibility that a period of daily smoking at any time results in increased pain levels even after people have stopped smoking,” said lead author Olga Perski, PhD, a research associate in UCL’s Department of Behavioural Science & Health.

“This may be due to negative effects of smoking on the body’s hormonal feedback loops or undiagnosed damage to body tissues. This is certainly an issue that needs looking into.” 

Another possibility is differences in personality. People who take up smoking may handle the psychological stress of illness differently than non-smokers or have a lower level of pain tolerance, which makes them feel pain more acutely. A large study in Norway, for example, found that smokers and former smokers were more sensitive to pain than non-smokers, who had a higher pain tolerance.

Regardless of the reason, smoking is linked with many negative health consequences.

“The possibility that smoking may increase lifelong pain is another important reason not to take up smoking in the first place,” said Perski.

Studies have also found that smoking increases your chances of having several types of chronic pain conditions, such as degenerative disc disease.

A 2011 study of over 6,000 Kentucky women found that those who smoked had a greater chance of having fibromyalgia, sciatica, chronic neck pain, chronic back pain and joint pain than non-smokers. Women in the study who smoked daily more than doubled their odds of having chronic pain.

Back to the Future in Pain Care

By Carol Levy, PNN Columnist

The start of another year started me thinking about my 42-year fight against trigeminal neuralgia (TN) and how things have changed in its diagnosis and treatment.

I was 26 when the pain started. It came out of the blue, like a lightning bolt inside the skin of my left temple. It was horrendous, lasting maybe 20 seconds or so, and then it subsided. After a clinic doctor diagnosed it as trigeminal neuralgia, I was repeatedly told it could not be TN because I did not meet the criteria for the diagnosis.

At that time, it was very simple: TN pain had to be in a specific anatomical area. Mine was. The pain also had to be spontaneously triggered by touch, no matter how slight. Mine was. But you had to be at least 60 years old or, if you had multiple sclerosis, over age 40 to have TN. I was only 26. Too young.

So, regardless of the pain being in the right place and occurring in the proper fashion, it had to be something else, although they had no idea what that might be. It took more than a year before someone finally recognized it as trigeminal neuralgia, despite my youth.

Over the years the definition and diagnostic criteria for TN have changed. There are now two recognized types of TN:

• Trigeminal Neuralgia 1: Intense, stabbing pain attacks affecting the mouth, cheek, nose, and/or other areas on one side of the face.

• Trigeminal Neuralgia 2: Less intense but constant dull aching or burning pain.

You can have both types of TN. I have constant pain, as well as spontaneous and triggered pain. Neither type includes an age factor. This makes it easier for a young person to be diagnosed with TN today. 

Changing Treatments

Not only has the definition changed, but so too have the treatment options. When mine started, there were less anti-convulsants to try, the first line of treatment for TN. Now there are many new medications, including botulinin (Botox) injections.  

Over the years I had many operations, some of them no longer in use. Now there are gamma knife and cyber procedures, things not even a glimmer in someone's eye when I was first diagnosed or being treated. 

Reflex Sympathetic Dystrophy (RSD) is another pain disorder which has come a long way. Even the name was changed, from RSD to CRPS (Complex Regional Pain Syndrome).

In 1981, I entered a residential pain program. There were only 8 of us. One was named Joanne, who had very weird, unbelievable symptoms and complaints, so weird even the doctor had trouble believing her.

Joanne said she had tremendous pain throughout her body, and trouble controlling her bowels and bladder. She insisted it all started right after a statue had fallen on her foot. It sounded fanciful at best. She seemed a perfect example of pain being psychological. 

If that happened today, Joanne’s complaints might be taken more seriously and she could be diagnosed with CRPS. But at that time, it was a disorder that did not appear on anyone's radar. 

Since then many new medications and treatment options have been devised or added to the armamentarium against CRPS, such as ketamine infusions, intrathecal pain pumps, hyperbaric oxygen therapy and bisphosphonates. The same is true for many of the other pain disorders. Research is ongoing, new medications and surgeries are being developed. 

We often lament that nothing new is being done for us. Where is the research? Where is the treatment that will finally give us relief? 

It can be hard to see sometimes where we have been vs. where we are now, much less where we may be going. But history shows that more progress is being made than most of us may realize. And that is a good thing. We have to look to the past to see not only how far we have come, but how much farther we still have to go.   

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.

The Devil We Know

By K. Grahame, Guest Columnist

I was on opioid medication for over 10 years as treatment for acute and chronic pain in 27 diagnosed pain conditions, including herniated lumbar discs, arthritis, spinal stenosis, and torn muscles and tendons in my lower back. 

Now I've been involuntarily taken off opioids by my pharmacy. Guess what? There is NOTHING available that treats pain like opioids.

I am 66. The pain has driven my blood pressure up into the 200/90 range, and since I've already had both heart surgery and malignant melanoma surgery, I'm on so much blood pressure medication that I cannot walk.

The government would not let a human treat a dog like this. The rest of my life looks, at this point, to be short and a piece of hell, thanks to the media blitz on 67,000 annual overdose deaths -- of which only 17,000 were overdoses from prescription opioids. That’s fewer deaths than happen from common falls in the home.

While I'm at it, there were 72,000 alcohol related deaths in 2017. And the Surgeon General estimates that 440,000 people die every year from tobacco-related health conditions. Where are you, FDA and CDC on that?

The reason I care about this so much is not only how it affects my life. In 1978, my mother died in mortal agony from bone cancer, without much in the way of painkillers. The hospital refused repeatedly to give her opioids for pain relief because they were afraid she’d become addicted!

I watched the angel of my life pass away looking like a victim of Nazi Germany death camps, after she begged me to find something that she could poison herself with.

God in heaven, nobody should have to watch someone they love beg them for death! It simply boggles my mind that this is happening in America.

I'm going to die soon, most likely of a heart attack or stroke, and that's what will show on my death certificate. It won't show that I was doing just fine, taking care of myself and the pets who are the joy of my life, while I was taking opioids. The only side effect I had to deal with was constipation, and a GI doctor fixed that for me with simple OTC meds.

I don’t really want to die before my pets, but this ain’t living, people!

The government should be outed as the killers they are, because it sure as hell isn't the legally prescribed and supervised opioids. As for the 17,000 people that died from prescription opioids in 2017, the stats aren't available on how many were deliberate overdoses, if alcohol or other substances were involved, or even if they had a prescription.

Those stats should be provided, because that information should make a BIG difference in how the governments, state and federal, make their decisions.

Please don’t tell me that cognitive behavioral therapy or hypnosis are going to cure the pain in my much-damaged back. Or the arthritis, tendonitis and bursitis. Or the pain from my cancer surgery-severed nerves.

There is just so much to tell people that isn’t known or hasn’t been communicated. It’s the devil you know versus the devil you don’t. I really do think the devil we know is trying to reduce the expensive medical costs associated with the Boomer generation. What happens when death is made cost-effective for the government?

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

Alcohol Deaths Double in U.S.

By Pat Anson, PNN Editor

Alcohol related deaths in the U.S. have doubled in the past two decades, according to a new study that highlights an under-reported aspect of the overdose crisis: while deaths involving prescription opioids are declining, alcohol abuse appears to be increasing.

Researchers at the National Institute on Alcohol Abuse and Alcoholism (NIAAA) found the number of death certificates mentioning alcohol more than doubled from 35,914 in 1999 to 72,558 in 2017.

By comparison, 17,029 deaths in 2017 involved a prescription opioid, according to CDC estimates.

“The current findings suggest that alcohol-related deaths involving injuries, overdoses and chronic diseases are increasing across a wide swath of the population. The report is a wakeup call to the growing threat alcohol poses to public health,” said NIAAA Director Dr. George Koob.

Nearly 1 million alcohol-related deaths were recorded between 1999-2017. About half the deaths resulted from chronic liver disease or overdoses on alcohol alone or with other drugs.

Researchers noted that alcohol-related deaths were increasing among people in almost every age, race and ethnic group. Their study is published in Alcoholism: Clinical & Experimental Research.

“Taken together, the findings of this study and others suggests that alcohol-related harms are increasing at multiple levels – from ED visits and hospitalizations to deaths. We know that the contribution of alcohol often fails to make it onto death certificates. Better surveillance of alcohol involvement in mortality is essential in order to better understand and address the impact of alcohol on public health,” said Koob.

Other drugs besides alcohol are increasingly involved in overdoses. A recent analysis of over one million urine drug tests conducted by Millennium Health found that positive results for illicit fentanyl rose by 333% since 2013, while positive rates for methamphetamine increased by 486 percent.

That study, published in JAMA Network Open, found that positive rates for heroin and cocaine peaked in 2016 and appear to be declining.

The analysis is similar to a 2019 report from the National Institute on Drug Abuse, which found that drug deaths involving prescription opioids and heroin have plateaued, while overdoses involving methamphetamine, cocaine and benzodiazepines have risen sharply.

Unreliable Data

Just how reliable is the federal data on drug use and overdoses? Not very, according to another study published in Drug and Alcohol Dependence.

Troy Quast, PhD, an associate professor at the University of Florida’s College of Public Health, compared overdose data from the Florida Medical Examiners Commission (FMEC) to drug deaths in a CDC database. Quast found the federal data significantly undercounted overdose deaths in Florida linked to cocaine, benzodiazepines, amphetamines and other drugs.

Florida medical examiners are required by law to wait for complete toxicology results before submitting an official cause of death to FMEC. It often takes weeks or months to identify the exact drug or drugs that cause an overdose. By contrast, the CDC data is based on death certificates filed by coroners and other local authorities, which often don't include detailed toxicology reports. This causes significant differences between the two databases.

Between 2003 and 2017, roughly one-in-three overdose deaths in Florida involving illicit or prescription opioids were not reported by the federal government. The discrepancy wasn’t limited to opioids. Quast also found that nearly 3,000 deaths in Florida caused by cocaine were not included in the CDC database. Overdose deaths involving benzodiazepines and amphetamines were also significantly under-reported.

"The CDC data are widely reported in the news and referenced by politicians, which is problematic since those estimates significantly undercount the true scope of the epidemic for specific drugs," said Quast. "The rate of under-reporting for all overdose deaths in Florida is near the national average, so the problem is not to the state."

This isn’t the first time the reliability of CDC data has been questioned. In 2018, CDC researchers admitted that many overdoses involving illicit fentanyl and other synthetic black market opioids were erroneously counted as prescription drug deaths. As result, federal estimates prior to 2017 "significantly inflate estimates" of prescription opioid deaths.

Even the adjusted estimates are imprecise, because the number of deaths involving diverted prescriptions or counterfeit drugs is unknown and drugs are not identified on 20% of death certificates. When the drugs are listed, many overdoses are counted multiple times by the government because more than one substance is involved.

The federal government is working to improve the collection of overdose data. Over 30 states are now enrolled in the CDC's Enhanced State Opioid Overdose Surveillance program, which seeks to improve overdose data by including toxicology reports and hospital billing records.

In 2017, the program reported that nearly 59 percent of overdose deaths involved illicit opioids like fentanyl and heroin, while 18.5% had both illicit and prescription opioids. Less than 18% tested positive for prescription opioids only.

A recent study of drug deaths in Massachusetts found that only 1.3% of overdose victims who died from an opioid painkiller had an active prescription for the drug – meaning the medication was probably diverted, stolen or bought on the street.  

Do Pain Patients Really Get High on Rx Opioids?

By Roger Chriss, PNN Columnist

The standard narrative of the opioid crisis is built on the idea that people feel euphoria or get “high” when exposed to opioids and almost immediately become addicted. Some assert that opioid medications should have no role outside of trauma, surgical, palliative and end-of-life care due to their high risk and side effects.

But reality is more complex.

Euphoria is widely believed to be inevitable with opioids, and increases the risk for misuse and addiction. But in fact, euphoria is not common.

"I think that the notion that opioids [always] cause pleasure is a myth," Siri Leknes, principal investigator at the University of Oslo in Norway, told Live Science.  "I think it's especially important to point out that opioids do not reliably cause pleasure or relief of subjective stress and anxiety in the lab or in stressful clinical settings."

Leknes’ research found that patients receiving remifentanil – a potent, short-acting synthetic opioid -- felt high, but the experience was unpleasant.

"Not everyone experiences the same level of euphoria from opioids, and not everyone that uses opioids will develop an addiction or opioid use disorder,” says Brian Kiluk of Yale School of Medicine.

Major cognitive side effects are often thought to be inevitable with opioids. But a review of 10 clinical studies on older adults with chronic pain found that most “demonstrated no effect of opioid use on cognitive domains.” Only at high daily doses did opioids worsen memory, language and other cognitive skills.

In other words, long-term opioid therapy may cause side effects at doses well above what most people ever receive and beyond thresholds recommended by the CDC and state governments.

The risks of overdose are similarly nuanced. For instance, a study on opioids and mortality looked at a nationally representative sample of over 90,000 people, among whom 14% reported at least one opioid prescription. There were 774 deaths during the study period, with the death rate slightly higher among those taking opioid prescriptions.

However, after adjusting for demographics, health status and utilization, the authors concluded there was “no significant association” between opioids and sudden death. “The relationship between prescription opioid use and mortality risk is more complex than previously reported, meriting further examination," they said.

On the efficacy of opioid therapy, a major review in Germany looked at 15 studies with 3,590 patients with low back, osteoarthritis and neuropathic pain. The quality of evidence was low, but the authors concluded long-term opioid use was appropriate for patients who experience “meaningful pain reduction with at least tolerable adverse events."

Pain Patients Used As ‘Guinea Pigs’

Instead, we have an intense focus on prescribing statistics. States like Minnesota tout a 33% decrease in opioid prescribing for Medicare patients, while ignoring how those poor and disabled people are faring.

“My cat gets better pain management than I do after surgery,” one man wrote to state health officials.

In Ohio, opioid prescriptions have declined by 41% since 2012. Some wonder if the cutbacks went too far.

“There needed to be an adjustment and maybe it did go overboard a bit. I feel bad for the people in chronic pain because they're going to be the guinea pigs for how we get it back to the middle," Ernest Boyd, executive director of the Ohio Pharmacists Association, told the Akron Beacon Journal

So the medical needs of people with cancer, sickle cell disease and other chronic painful conditions are going unmet. And some doctors are even avoiding such patients entirely.

Naturally, there is a need to safeguard the entire opioid supply chain, and to carefully screen and monitor people on any form of opioid therapy. But we also need to track the rapidly evolving policy landscape surrounding prescription opioids to make sure that pain patients with chronic medical needs are being not harmed.

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.